Kornimate/medical-research-clean huggingface dataset:
saliva and dried blood spot therapeutic drug monitoring for mdr-tb in tanzania

Conditions: MDR-TB

Summary: dried blood spot and saliva samples are collected during multidrug resistant tuberculosis (mdr-tb) treatment to measure the drug concentration of levofloxacin. feasibility of both analytical procedures in a high burdened setting is explored.

background: measuring pharmacokinetic variability of anti-tuberculosis (tb) drugs and responding by dose correction will allow individualized treatment to improve microbiological response, curb acquired drug-resistance, protect and extend the efficacy of novel drugs rolled-out to endemic areas (pharmacovigilance), reduce toxicity to patients and lead to treatment duration shortening. aims and objectives: implement dried blood spot (dbs) collection for performance of high-performance liquid chromatography (hplc) to optimize multidrug resistant tb (mdr-tb) treatment in tanzania. simultaneously, provide a proof-of-principle-demonstration that the developed saliva point of care drug assay for measurement of fluoroquinolone concentration works in a field setting. methods: this will be a phase ii prospective diagnostic study among patients from a national referral of mdr-tb in tanzania. the investigators anticipate recruiting a minimum of 50 study participants to power for the primary aim. subjects will have a minimum amount of blood and saliva collected for therapeutic drug monitoring and the investigational drug assays respectively. expected results include agreement of saliva point-of-care and dbs for measurement of fluoroquinolone concentrations in hplc. other important findings related to field-testing include the best time for sample collection within the dosing interval and the algorithmic use of dbs and saliva, and clinical - demographic factors such as hiv coinfection, concomitant drugs, and diabetes mellitus that may influence the saliva drug assay results. performance characteristics (sensitivity, specificity, negative and positive predictive values) of the saliva point-of care (poc) and dbs will be calculated as a measurement of accuracy with reference to the gold standard.

Eligibility criteria:
inclusion criteria: * participant is receiving care at kibong'oto hospital * age of 18 years or above exclusion criteria: * pregnancy at any gestation * co-morbid conditions such as generalized severe ulcers, kaposi sarcoma, * hemophilia * participants with medical conditions like malignancy, dementia or those who will be critically ill and unable to consent and provide dbs and saliva. * patients with karnofsky score less than 40% or moribund
a study to evaluate the safety and efficacy of paltusotine for the treatment of acromegaly (acrobat evolve)

Conditions: Acromegaly

Summary: a phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly crn00808) in subjects with acromegaly that are responders to octreotide lar or lanreotide depot.


Eligibility criteria:
inclusion criteria: 1. male and female subjects 18 to 75 years of age 2. confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide lar or lanreotide depot 3. females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 4. willing to provide signed informed consent exclusion criteria: 1. treatment naïve acromegaly subjects 2. prior treatment with paltusotine 3. pituitary surgery within 6 months prior to screening or radiation therapy at any time prior to the study entry. pituitary radiation therapy (within 3 to 4 years or more than 4 years prior to study entry) with recently documented elevated igf-1 may be eligible. 4. history or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years. 5. use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer 6. positive test at screening for hiv, hepatitis b surface antigen (hbsag) or hepatitis c antibody (hcv-ab) or has a history of a positive result 7. history of alcohol or substance abuse in the past 12 months 8. any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study 9. cardiovascular conditions or medications associated with prolonged qt or those which predispose subjects to heart rhythm abnormalities. 10. subjects with symptomatic cholelithiasis 11. subjects with clinically significant abnormal findings during the screening period, and any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or ability to complete the study 12. subjects who have been taking the following prior medications: pegvisomant (within the last 3 months), dopamine agonists (within the last 3 months) and pasireotide lar (within the last 6 months) 13. subjects taking octreotide lar at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 mg 14. subjects who usually take octreotide lar or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)

Keywords: acromegaly acrobat evolve paltusotine
the olmsted nafld epidemiology study (tones)

Conditions: Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis

Summary: researchers are assessing the prevalence of non-alcoholic fatty liver disease (nafld) and nonalcoholic steatohepatitis (nash) in the population and assembling a well-characterized cohort of adults with nafld and nash to validate models of nafld diagnosis and determine long-term outcomes.

non-alcoholic fatty liver disease (nafld) is the most common cause of chronic liver disease in the world and a major public health issue in the us. recent information on the prevalence of nafld in general and non-alcoholic steatohepatitis (nash) with fibrosis in particular is very scarce. such information is crucial for defining the epidemiology of nafld, identifying risk factors for advanced fibrosis and longitudinal outcomes. this study will enroll a random sample of adults from olmsted county, minnesota, to validate machine learning models for nafld diagnosis and disease severity. these data would be fundamental for the development of screening strategies in the community, which are urgently needed for early diagnosis of liver fibrosis and therapeutic interventions before cirrhosis develops.

Eligibility criteria:
inclusion criteria: * olmsted county residents at the time of search * age 18 or older * no personal history of nafld diagnosis (administrative codes) exclusion criteria: * alcohol in excess (more than 20 gm per week in women and 30 gm per week in men) * currently pregnant * have contraindications to mri (mri incompatible implanted devices, severe claustrophobia)
a study of hr18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy

Conditions: Postsurgical Pain Management

Summary: the study is being conducted to evaluate the efficacy, and safety of hr18034 for postoperative analgesia in subjects undergoing hemorrhoidectomy.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent 2. subjects requiring hemorrhoidectomy under subarachnoid anesthesia 3. 18 kg/m2 ≤ bmi ≤ 30 kg/m2 4. conform to the asa physical status classification 5. women of childbearing age have a negative pregnancy test and are not nursing exclusion criteria: 1. subjects with a history of myocardial infarction or unstable angina pectoris 2. subjects with atrioventricular block or cardiac insufficiency 3. subjects with a history of ischemic stroke or transient ischemic attack 4. subjects with a history of mental illness and a history of cognitive impairment epilepsy 5. subjects with concurrent painful physical condition that may affect postoperative pain assessment 6. spinal or spinal lesions that were determined by the investigator to be unable to tolerate subarachnoid anesthesia 7. subjects with a history of hemorrhoidectomy 8. subjects with a history of constipation 9. subjects with a history of perianal disease 10. abnormal values in the laboratory 11. subject with heart rate \ 100 beats per minute. 12. subject with refractory hypertension 13. history of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics, opioids, or other drugs that may used in study 14. history of prohibited drug use 15. participants who may be affected by alcohol, or drug abstinence during the study period; 16. participated in clinical trials of other drugs (received experimental drugs) 17. the inestigators determined that other conditions were inappropriate for participation in this clinical trial
replication of the record1 anticoagulant trial in healthcare claims data

Conditions: Deep Vein Thrombosis, Pulmonary Embolus

Summary: investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. the investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

this is a non-randomized, non-interventional study that is part of the rct duplicate initiative (www.rctduplicate.org) of the brigham and women's hospital, harvard medical school. it is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. investigators assume that the rct provides the reference standard treatment effect estimate and that failure to replicate rct findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original rct finding.

Eligibility criteria:
please see https://drive.google.com/drive/folders/1wd618wrywyjeaxzfltcuk-vccnb6b-gv for full code and algorithm definitions. inclusion criteria: * at least 18 years of age * scheduled to undergo elective total hip arthroplasty exclusion criteria: * scheduled to undergo staged, bilateral hip arthroplasty \[day -30, day 0\] * pregnany or breastfeeding \[day -180, day 0\] * had active bleeding or high risk of bleeding \[day -180, day 0\] * had conditions preventing bilateral venography \[day -30, day 0\] * congestive heart failure \[day -180, day 0\] * pulmonary hypertension \[day -180, day 0\] * edema of legs \[day -180, day 0\] * substantial liver disease \[day -180, day 0\] * severe renal impairment (creatinine clearance \<30 ml per minute) \[day -180, day 0\] * concomitant use of protease inhibitors for the treatment of hiv \[day -180, day 0\]
regulation of brain glucose metabolism in type 1 diabetes

Conditions: Diabetes Mellitus, Type 1; Hypoglycemia Unawareness

Summary: this is a prospective randomized placebo-controlled double-blind crossover pilot study determining the effect of dichloroacetate on brain function under clamped hypoglycemia in t1dm.

this study is a prospective randomized placebo-controlled double-blind crossover study designed to address the hypothesis that dichloroacetate has the ability to re-activate brain glucose metabolism under clamped hypoglycemia. the study population is comprised of intensively treated persons with t1d with frequent exposure to hypoglycemia, who have cognitive deficits under hypoglycemia that could be attributed to changes in brain glucose oxidation. the investigators will test the experimental compound dca in a study that determines whether restoring brain glucose metabolism under hypoglycemia helps maintain cognitive function.

Eligibility criteria:
inclusion criteria: t1dm subjects with: * a history of severe hypoglycemia and/or hypoglycemia unawareness or * a history of severe hypoglycemia with a blood glucose \<54 mg/dl, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or * at least 2 values \<54mg/dl during 2 weeks of cgms testing during the week prior to study. exclusion criteria: * age \ 55 years. * body weight \>85 kg at screening visit * bmi \> 30 (female) and \>30 (male) kg/m2. * untreated proliferative retinopathy * carriers of glutathione transferase z1 (gstz-1) gene polymorphisms that predispose to dca accumulation and toxicity
effects on hemostasis, lipids, carbohydrate metabolism, adrenal & thyroid function of the combined oral contraceptive nomac-e2 compared to a coc containing lng-ee (292004)(completed)(p05764)

Conditions: Contraception

Summary: the primary purpose of this study is to evaluate the effects of the combined oral contraceptive (coc) nomac-e2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function.


Eligibility criteria:
inclusion criteria: * sexually active women, at risk for pregnancy and not planning to use during trial medication use; * women in need for contraception and willing to use an oral contraceptive (oc) for 6 months (6 cycles); * at least 18 but not older than 50 years of age at the time of screening; * body mass index = 17 and = 29 kg/m\^2; * good physical and mental health; * willing to give informed consent in writing exclusion criteria: * present use or use within 2 months prior to screening of any other hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception for local dermatological use); * contraindications for contraceptive steroids * presence or history (within 1 year before screening) of alcohol or drug abuse as judged by the (sub)investigator. * an abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia \[cin\], sil, carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months before screening; * clinically relevant abnormal laboratory result at screening as judged by the (sub) investigator; * use of an injectable hormonal method of contraception prior to screening; within 6 months of an injection with a 3 -month duration, within 4 months to screening of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration; * before spontaneous menstruation has occurred following a delivery or abortion; * breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication; * present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, lipid-lowering drugs, anticoagulants and herbal remedies containing hypericum perforatum (st john's wort); * use of pharmacological agents which affect the hemostatic system during the pretreatment blood sampling: vitamin k (only prohibited within two weeks prior to sampling), nonsteroidal anti-inflammatory drugs (nsaids) and aspirin (both only prohibited during the week prior to sampling); * administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
the association of b-7 lung ultrasound pattern with the development of postoperative pulmonary edema

Conditions: Pulmonary Edema

Summary: the objective of this proposal is to conduct a randomized controlled study to examine the association between the increase in extravascular lung water as determined by lung ultrasound and the development of radiologic pulmonary edema as diagnosed by chest roentgenogram in patients undergoing major elective open intra-peritoneal surgeries under general endotracheal anesthesia.

this study will be conducted at the university of alabama at birmingham's post- anesthesia care unit (pacu). a total of 60 patients will be randomly selected from the 5th and 7th floor surgical suite daily display boards and enrolled in the study. a preoperative and postoperative point of care (pocus) lung u/s exam and point of care (pocus) transthoracic echo will be performed with a sonosite edge ii bedside u/s machine (approved by uab biomedical and clinical engineering dept-#9365) in the pre-anesthesia holding area before the surgical procedure, and after the end of the procedure in the post- anesthesia care unit (pacu). evlw will be defined as b-line score ≥7 before and after the surgical procedure. pulmonary edema will be defined by the official radiology report on a chest x ray in the first 72 hrs postoperatively. pre and post op pocus pulmonary capillary wedge pressure (pcwp) will be obtained via trans-thoracic bedside ultrasound measuring mitral valve inflow (e) velocity and early diastolic lateral mitral annulus velocity/tissue doppler imaging (e'). a 5-1mhz phased array probe will be used to obtain images. the pcwp data obtained will be used to correlate with evlw findings. ultrasound windows for pcwp measurements will be obtained using the apical 4-chamber view and/or modified subcostal view.-

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age, undergoing major elective intraperitoneal surgeries expected to be in hospital for 72 hours exclusion criteria: * patients \< 18 years * pregnant females * cardiac ef 40% on last pre-operative echo * prisoners
bdd with udca therapy after laparoscopic cholecystectomy

Conditions: Cholecystitis, Acute; Cholecystitis, Chronic

Summary: prospective study for the effects of biphenyl dimethyl dicarboxylate and ursodeoxycolic acid therapy on liver function and quality of life after laparoscopic cholecystectomy primary endpoint: peak level of postoperative ast (aspartate transaminase) and postoperative alt (alanine tansaminase) secondary endpoint: postoperative giqli (gastrointestinal quality of life index) score

because the gallbladder is adjacent to the liver, liver enzymes are often elevated when cholecystitis occurs. bdd and udca drugs are known to be effective in preserving liver function. the use of bdd and udca drugs in patients with cholecystitis is expected to inhibit elevated liver enzyme levels and to maintain liver function. the aim of this study is to analyze the effects of bdd and udca medication on postoperative changes in hepatic enzyme levels and quality of life in patients lft elevated cholecystitis.

Eligibility criteria:
inclusion criteria: * patients scheduled for surgery due to chronic cholecystitis and acute cholecystitis exclusion criteria: * failure to obtain consent * under 19 years * if you have intellectual ability to understand this study * when performing cholecystectomy with other operations * total bilirubin levels\> 2 mg / dl * if you are enrolled in another clinical trial
evaluation of the relationship between mediterranean diet and menopausal symptoms in postmenopausal women

Conditions: Menopausal Complaints

Summary: this cross-sectional study aimed to evaluate the relationship between the frequency and severity of postmenopausal symptoms in women aged 45-65 years and the level of compliance with the mediterranean diet, and the main question it aimed to answer is: do women with higher compliance with the mediterranean diet have milder symptoms?

this cross-sectional study was conducted between 01.01.2024 and 01.06.2024 with women aged 45-65 who were registered at tuzla e-asm affiliated with marmara university pendik hospital and who had been in menopause for at least 1 year. the sample size was calculated as 272 and the target number was determined as 305. after obtaining written consent from the participants who agreed to participate in the study and met the inclusion criteria, a questionnaire form was applied to these individuals, which questioned their sociodemographic characteristics, age of menstruation onset, pregnancy history, smoking and alcohol use, use of supplements, mediterranean diet adherence scale (medas) and menopause rating scale (mrs). the presence, type and severity of menopausal symptoms with the mediterranean diet were evaluated.

Eligibility criteria:
inclusion criteria: * those who volunteered to participate in the study, exclusion criteria: * those with a diagnosed eating disorder, * those using medication for obesity, * those with a chronic metabolic disease that is not receiving treatment and whose values related to the disease are not regulated (pronounced hypo/hyperthyroidism, uncontrolled diabetes, etc.), * those with a mental or physical condition that prevents communication (some neuropsychiatric diseases and mental retardation), * those who do not understand and/or speak turkish, * those who do not give consent to participate in the study, •-those who are currently using any hormonal supplements to prevent or reduce menopausal symptoms were excluded from the study.

Keywords: menopausal complaints climacteric menopausal symptoms mediterranean diet
metabolic pattern of cyclosporine a and acute renal failure

Conditions: Heart Transplantation; Acute Renal Failure

Summary: following heart transplantation many patients develop acute renal failure in the early posttransplant phase and some are in need of renal replacement therapy for shorter or longer time. the cause of this acute renal failure is most probably multi factorial but many reports indicate that cyclosporine has a central role in the pathophysiology and it is generally recommended to lower the cyclosporine load to patients developing acute renal failure in this population. several in vitro studies on renal cells in culture indicate that the primary metabolites of cyclosporine (am1, am9, am4n) are less toxic to the kidney than cyclosporine itself. however, the secondary metabolite am19 as well as the cyclic metabolites am1c and am1c9 has been associated with decreased renal function and nephrotoxicity renal transplant recipients. the primary objective of this pilot study is to investigate if the concentrations of secondary- and cyclic metabolites of cyclosporine (am19, am1c, am1c9) is related to development of acute renal failure in the early posttransplant phase following heart transplantation. secondary objectives are to investigate associations between genotypes of p-glycoprotein and cyp3a5 and the metabolic pattern of cyclosporine.


Eligibility criteria:
inclusion criteria: * heart transplant recipients receiving csa as part of their immunosuppressive therapy. * 18 years of age or older. * signed informed consent. exclusion criteria: * none

Keywords: cyclosporine metabolites metabolic pattern genotypes