Kornimate/medical-research-clean huggingface dataset:
a prospective cohort study to describe the evolution of persistent hyperparathyroidism in kidney transplant recipients

Conditions: Hyperparathyroidism

Summary: the purpose of this study is to see if hyperparathyroidism (hpt) is common in people who receive a kidney transplant. patients with hpt often have high parathyroid hormone (pth) levels and may have large parathyroid glands in the neck. patients with hpt can develop bone disease (osteodystrophy). this bone disease can cause bone pain, fractures, and poor formation of red blood cells. other problems from hpt may include increases in blood levels of calcium (hypercalcemia) and low blood levels of phosphorus (hypophosphatemia). the high calcium levels may cause calcium to deposit in body tissues. calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), heart and lung problems, or kidney transplant dysfunction (worsening of kidney transplant function). the purpose of this research study is to better understand the evolution of hpt in people during the first 12 months after receiving a kidney transplant.

subjects are enrolled in the study and a 12-month observational phase will begin. during the observational phase, subjects will attend a total of 8 visits at approximately 1, 2, 4, and 8 weeks after kidney transplantation and at 3, 6, 9, and 12 months after kidney transplantation. during these visits, subjects will have a review of medication history, blood tests, and a kidney function test. the blood will be used to test the level of certain components of you blood to see if your hpt has resolved, stabilized, or advanced. at selected visits throughout the study, you will have a urine sample collected and a health questionnaire that will ask about your health. information regarding transplant kidney biopsy (if performed) also will be collected.

Eligibility criteria:
inclusion criteria: * diagnosis of ckd receiving hemodialysis prior to transplant; * admission for kidney transplant surgery; * men and women at least 18 year of age; * one or more plasma pth values determined during during the 6 months before screening that is greater the 65pg/ml; * plasma pth greater than 65pg/ml at screening before kidney transp\[lant as measured by the central lab. exclusion criteria: * history of medical conditions that cause hypercalcemia such as primary hpt, active malignancy, and granulomatous diseases. * receipt of multiple organ transplant.

Keywords: hyperparathyroidism
ponatinib in chronic myeloid leukemia patients in chronic phase

Conditions: Chronic Myeloid Leukemia, Chronic Phase

Summary: the goal of this retrospective observational study is to evaluate any possible association between plasma concentrations of ponatinib and its pharmacodynamics (efficacy/tolerability) in patients affected by chronic myeloid leukemia in chronic phase (cml-cp). in particular, the aims of the study will be: * primary aim: to investigate the relationships (if any) between plasma concentrations and activity/toxicity of ponatinib in a population of cml-cp patients enrolled in several italian hematological centers; * secondary aim: to set up an algorithm aimed at helping physicians to improve drug dosing based on several variables (i.e., plasma drug concentrations, tolerability, molecular response to therapy). the study will enroll cml-cp patients who were exposed to ponatinib as second, third or fourth line of chemotherapy.

the study protocol is a non-interventional, retrospective observational study which involves the collection of data from medical records relating to the plasma dosages of ponatinib performed as per clinical practice, all carried out at the pharmacokinetics laboratory of the unit of clinical pharmacology and pharmacogenetics of azienda ospedaliero universitaria pisana (aoup). these data will be collected in crf and will be correlated to efficacy data (extent of molecular response) and toxicity of ponatinib (haematological, extra-haematological adverse events, together with adverse event severity). real-life experience (dosage adjustments made by clinicians based on plasma dosage) will be used to propose an algorithm that can help in choosing the correct dosage of ponatinib. classical statistical analyses (for descriptive and comparison aims) will be used according to their appropriateness. moreover, factors affecting the pharmacokinetics (pk) of ponatinib will be investigated by nonlinear mixed effect modeling adopting the monolix 2021r2 suite. final model will be used as parte of the dosing algorithm. notably, all clinical and laboratory data will be anonymized to protect patients' privacy, and harvested in a database that will be used to perform pharmacometric and statistical analyses.

Eligibility criteria:
patients will be enrolled according the following inclusion criteria: * subjects ≥18 years old affected by cml * patients being treated with ponatinib at a dose of 45, 30 or 15 mg/day for more than 14 days * patients who have provided informed consent to the study exclusion criteria: * subjects \<18 years old * patients who did not provide an informed consent to the study the co-administration of drugs other than ponatinib will not be considered an exclusion criterium, but all of the drugs will be registered (together with daily doses and duration of treatment) as possible factors of ponatinib pk variability.

Keywords: chronic myeloid leukemia, chronic phase ponatinib therapeutic drug monitoring efficacy tolerability
human outreach to improve adherence with scheduled pain clinic appointments

Conditions: Patient Compliance

Summary: patients tend to miss their scheduled appointments in chronic pain clinics for unknown reasons. this study will test the hypothesis in a prospective pragmatic trial that a human telephone call in the primary language of the patient, promising a clinical encounter in this language improves attendance at scheduled appointments in an academic inner city pain clinic.

language barriers may lead to poor attendance at pain clinic appointments, especially in underserved patients. targeted interventions can help overcome barriers and significantly improve adherence, but have rarely been rigorously investigated in randomized clinical trials. our objective is to investigate if (1) making a telephone call in the patient's preferred language increases adherance with scheduled appointment in an inner city academic pain clinic or at least reduces failure to attend without a prior cancellation call and (2) if this intervention is more effective in spanish speakers. after institutional review board approval and waiver of informed consent, we enroll all adult patients (18 years and up) with a scheduled first appointment at our outpatient pain center at montefiore medical center located in the bronx, new york from october 2014 through october 2015. participants are randomized to receive a phone call in their preferred language before their appointment, or not. we recorded if participants attended as scheduled and/or called to cancel. we fit stratified and multivariate multinomial logistic regression models. in a methodologically rigorous randomized design, we seek to demonstrate that a human phone call in the patient's primary language increases adherence with scheduled appointments in an ethnically diverse, poor population, typical for an inner city pain clinic. our targeted intervention may provide considerable cost savings to the institution while bolstering the patient-doctor relationship and overcoming barriers to access much needed care.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * have scheduled appointment at montefiore medical center exclusion criteria: * none

Keywords: language scheduled appointment
evaluation of patients with methicillin-resistant staphylococcus aureus hospital-acquired pneumonia treated with linezolid or vancomycin

Conditions: Methicillin-Resistant Staphylococcus Aureus (MRSA); Hospital-Acquired Pneumonia

Summary: the objective of this study is to review the local management of patients with methicillin-resistant staphylococcus aureus hospital-acquired pneumonia treated with vancomycin or linezolid with the goal to define if any difference exists among these antimicrobials in regard to clinical and economic outcomes.

non-randomized, retrospective, observational study

Eligibility criteria:
inclusion criteria: patients will be enrolled in the study if they fulfill the following three inclusion criteria: 1. protocol criteria for hap/vap: criteria for making a correct diagnosis of hap will be met if the patient develops a new or progressive pulmonary infiltrate associated with at least two of the following: new or increased respiratory symptomatology (cough, sputum or tracheal secretions, shortness of breath), fever or hypothermia, leukocytosis, left shift, or leukopenia, or deterioration of pulmonary function. 2. isolation of mrsa from a respiratory sample or blood culture within 48 hours of the diagnosis of hap/vap 3. treatment of mrsa hap/vap with either vancomycin or linezolid with incorporation of 100 patients in the vancomycin arm and 100 patients in the linezolid arm exclusion criteria: patients not meeting enrollment criteria.

Keywords: linezolid vancomycin ventilator-associated pneumonia respiratory tract infections
indoprocaf effervescent tablets effectiveness in acute treatment of migraine and/or episodic tension-type headache and patients' satisfaction with the treatment in routine clinical practice

Conditions: Headache Disorders, Primary; Migraine With Aura; Migraine Without Aura; Tension-Type Headache

Summary: headaches are a common medical problem that physicians frequently encounter in their practice. one of key findings of the atlas of headache disorders prepared by world health organization (who) is: headache disorders, including migraine and tension-type headache (tth), are among the most prevalent disorders of mankind. the fixed combination of indomethacin, prochlorperazine and caffeine (indoprocaf) showed efficacy and safety in acute treatment of migraine and episodic tension-type headache attacks. indoprocaf (difmetre®) is widely used in common daily practice only in italy from early 1970s, is available at the commonwealth of independent states (cis) pharmaceutical market now. there are limited data regarding indoprocaf usage from post-marketing settings. this will be a first post-marketing observational study which aimed to evaluate the effectiveness and patients' satisfaction of primary headaches acute treatment in routine clinical settings in ukraine and kazakhstan.

the study is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing study where indoprocaf will be prescribed in the usual manner per standard clinical practice of the treating physician and in accordance with the terms of the locally approved instruction for medical use. no additional procedures (other than the standard of care) shall be applied to the patients.

Eligibility criteria:
inclusion criteria: * diagnosis of primary headache (migraine with or without aura and/or episodic tth) and whose headache attacks required acute pharmacological treatment. * were administered indoprocaf (difmetre®) effervescent tablets therapy according to the local product labelling. * adults 18 years and older (male, female). * provide authorization to the investigator to use and/or disclose personal and/or health data. exclusion criteria: * meet contraindications for treatment with indoprocaf (difmetre®) effervescent tablets as outlined in the latest version of local product labelling. * patients who are required prescription by physician of indoprocaf and nonsteroidal anti-inflammatory drug-containing products at the same time for acute headache attacks treatment. * previous discontinuation of indoprocaf treatment due to safety (i.e. hypersensitivity) events, lack of efficacy. * female patients who are pregnant or are breast-feeding.

Keywords: indoprocaf indomethacin caffeine prochlorperazine migraine with aura migraine without aura tension-type headache
reliability of a food frequency questionnaire in the assessment of dietary intake including fodmaps in different populations, and relationship with ibs symptoms and the degree of self-assessed physical activity

Conditions: Irritable Bowel Syndrome

Summary: during an online assessment participants will fill in questionnaires evaluating demographic data, psychological variables, the degree of self-assessed physical activity and symptoms of irritable bowel. dietary intake will be assessed by a newly developed food frequency questionnaire (ffq) and a 4 days food diary. in order to validate the ffq in different populations, participants will be recruited from university students, staff of uz brussel and vub, and from the community by advertisement (including social media). ibs patients will be recruited from the gastro-enterology outpatient clinic.


Eligibility criteria:
inclusion criteria: * 18 - 65 years; * provide written informed consent; * living in belgium exclusion criteria: * diet \< 8 weeks prior to participation; * known or suspected eating disorder; * major psychiatric disorder; * known gastro-intestinal disease (ibs is allowed); * any malignancy in the past 3 years (basocellular carcinoma is allowed); * chemotherapy in the past 6 months; * infectious gastro-enteritis in the past 6 months (infectious gastro-enteritis defined as the concurrent presence of one of the following signs during 2 or more consecutive days: fever, vomiting, sudden onset of diarrhea, hospitalization because of these symptoms); * previous abdominal surgery (appendectomy and cholecystectomy are allowed); * alcohol abuse defined as \> 14 u per week; * use of illicit drugs; * intake of drugs with known major gastro-intestinal side effects. * initiation of neuromodulators less than 3 months before participation. neuromodulators are allowed when taken at a stable dose for at least 3 months; * pregnancy.
a study to investigate the safety and efficacy of replenine®-vf in haemophilia b patients under the age of 6 years

Conditions: Haemophilia B

Summary: the objective of this study was to assess the safety and efficacy of replenine®-vf in children enrolled in the study, under the age of six years, with severe haemophilia b.


Eligibility criteria:
inclusion criteria: * patients under six years of age at the time of entry with severe haemophilia b at the time of diagnosis without inhibitors to fix and requiring factor ix therapy. exclusion criteria: -
a comparing transversalis fascia plane block and quadratus lumborum block for post-cesarean pain management: efficacy, execution time, and practicality

Conditions: Regional Anesthesia Block

Summary: transversalis fascia plane block (tfpb) and quadratus lumborum block (qlb) provide superior analgesia to transversus abdominis plane block (tapb) for post-cesarean pain management. this study evaluates whether tfpb or qlb is preferable when their analgesic efficacy is nearly equal, focusing on ease of performance and execution time.

cesarean delivery is one of the most common surgical procedures worldwide and is associated with significant postoperative pain that includes both somatic and visceral components . effective pain management not only enhances patient comfort and satisfaction but also facilitates early mobilization and reduces maternal morbidity . although the transversus abdominis plane (tap) block is widely used as part of a multimodal analgesia strategy, its relatively short duration of action and limited ability to relieve visceral pain have prompted the search for improved alternatives . recent advancements in ultrasound-guided regional anesthesia have introduced the quadratus lumborum block (qlb) and the transversalis fascia plane block (tfpb) as promising techniques for post-cesarean analgesia. the qlb, first described by blanco (2007) , offers extended analgesia due to its paravertebral spread, thereby addressing both somatic and visceral pain . in contrast, tfpb targets the transversalis fascia to block the t12 and l1 nerves, effectively reducing postoperative pain following cesarean delivery . although both qlb and tfpb have been shown to provide superior analgesia compared to tap blocks , limited data exist regarding their comparative ease of performance and procedural efficiency. given that the analgesic efficacy of tfpb and qlb appears comparable, it is essential to evaluate additional factors such as the time required to perform the block and the technical ease of the procedure. these factors are particularly critical in high-volume obstetric settings, where efficiency can significantly impact clinical workflow . therefore, this study aims to compare tfpb and qlb not only in terms of analgesic efficacy but also regarding ease of performance and execution time, to determine which technique may be preferable for post-cesarean analgesia.

Eligibility criteria:
inclusion criteria:- 1. pregnant women aged 20-40 years scheduled for elective cesarean delivery under spinal anesthesia . 2. american society of anesthesiologists (asa) physical status of ii 3. body mass index (bmi) of less than 35 kg/m² . exclusion criteria :- 1. history of allergy to local anesthetics. 2. contraindications to regional anesthesia (such as coagulopathy or infection at the injection site). 3. severe systemic diseases (renal, hepatic, or cardiovascular dysfunction). 4. weight less than 50 kg (to avoid exceeding safe doses of local anesthetic). 5. pregnancy complications like severe preeclampsia, eclampsia, or postpartum hemorrhage. -
glp-1 response in women with pcos and prediabetes

Conditions: Incretin Hormones in PCOS With Prediabetes

Summary: women with pcos are more prone to obesity which exacerbates insulin resistance, the abdominal fat disposition and metabolic risk of these patients. with development of obesity these women have high conversion rate from normal glucose tolerance to impaired glucose tolerance and in turn to type 2 diabetes. glucagon-like peptide 1 (glp-1) is involved in body weight maintenance. beside energy balance it is also involved in glucose homeostasis. functional deficit in glp-1 facilitates obesity. we investigated the link between the concentration of incretin hormones and glucose homeostasis, metabolic complications and the distribution of body composition in obese women with pcos.


Eligibility criteria:
inclusion criteria: * 18 years old to menopause * polycystic ovary sindrome (nichd criteria) * bmi of 30 kg/m2 or higher exclusion criteria: * type 1 or type 2 diabetes mellitus * cushing's syndrome or congenital (non-classic) adrenal hyperplasia * personal or family history of men 2 * the use of medications known or suspected to affect reproductive or metabolic functions * the use of statins within 90 days prior to study entery
early identification and prognosis prediction of sepsis through multiomics

Conditions: Sepsis

Summary: this study aims to integrate multi-omics data and clinical indicators to reveal pathogen-specific molecular patterns in patients with sepsis and establish prognostic prediction models through multiple machine learning algorithms.

this study aims to quantify the plasma metabolome, single nucleotide polymorphisms (snps) of exons and immunocytokines of septic patients with different pathogen infections and prognostic outcomes. multi-omics data, cytokines, and clinical indicators will be integrated through multiple machine learning algorithms to reveal pathogen-specific molecular patterns and multi-dimensional prognostic prediction models.

Eligibility criteria:
inclusion criteria: * patients with sepsis or septic shock who meet the diagnostic criteria (2016 sepsis 3.0 standard); * age 18～85 years old. exclusion criteria: * icu stay of the subjects less than 72 hours; * female subjects who are pregnant; * the subjects not sure if infected; * the subjects performed cpr; * the subjects suffer from chronic renal disease; * the subjects with incomplete clinical data.

Keywords: prognosis inflammation immune multiomics machine learning
comparison of general anesthesia hemodynamics between r and p in patients undergoing laparoscopic hepatectomy

Conditions: Hypotension During Surgery

Summary: this study is a randomized controlled trial designed to investigate the effects of two anesthetics, remimazolam and propofol, on intraoperative hemodynamics in patients undergoing laparoscopic liver resection. the experimental group receives remimazolam, while the control group receives propofol. the primary objective is to compare the hemodynamic responses of patients in both groups during the surgical procedure, aiming to provide insights into the potential differences in cardiovascular stability and anesthetic management associated with these two drugs


Eligibility criteria:
inclusion criteria: * scheduled for lmh; * age 18-80 years, bmi 18-28 kg/m2; * american association of anesthesiologists（asa）i-iii; * child-pugh grade a or b; * no serious heart, brain and other important organ lesions; * informed and consent, and signed informed consent. exclusion criteria: * asa iv-v or child-pugh c; * left ventricular ejection fraction (ef) \<30%; * implanted with temporary or permanent pacemakers; * organic heart disease; * uncontrolled hypertension, diabetes and other chronic diseases; * prolonged use of sedative and analgesic drugs (such as opioid analgesics, benzodiazepines, antianxiety, antidepressants, antipsychotics, etc.); * alcohol addiction; * allergic to benzodiazepines or propofol, or to any ingredient in the studied drug; * known history of allergy to other anesthetics; difficulty in airway and intubation during induction.

Keywords: hypotension hemodynamics general anesthesia remimazolam propofol