Kornimate/medical-research-clean huggingface dataset:
beta-lactam therapeutic drug monitoring in singapore

Conditions: Infection, Bacterial

Summary: this is a prospective cohort study to evaluate clinical utility and feasibility of beta-lactam therapeutic drug monitoring in singapore. the investigators hypothesise that conventional beta-lactam dosing regimens based on manufacturer's recommendations (derived from phase i studies on healthy volunteers) will produce sub-optimal levels in at least half of the patients. hence, beta-lactam therapeutic drug monitoring and dose individualisation will be required for optimal clinical outcomes. the investigators' secondary aims include correlating various therapeutic targets with clinical outcomes to identify a suitable therapeutic target for clinical use and to characterise beta-lactam pharmacokinetics in sub-group of patients with complex pharmacokinetics so that local empirical dosing regimens can be formulated.

despite widespread use, conventional beta-lactam dosing regimens, derived from healthy volunteers, are sub-optimal clinically as patients display variable pharmacokinetics. this problem is further confounded by rising antimicrobial resistance and the need for high dose beta-lactams, exceeding licensed recommendations. in order to optimise beta-lactam therapy, dose individualisation using therapeutic drug monitoring (tdm) has been suggested. however, experience with beta-lactam tdm is limited with varying practices worldwide. therapeutic targets are also variable and have not been extensively validated. hence, this study primarily aims to establish clinical feasibility and utility of beta-lactam tdm. the investigators hypothesise that conventional beta-lactam dosing will produce sub-optimal levels in at least half of the patients, justifying need for tdm and dose individualisation to improve clinical outcomes. the secondary aims include correlating various therapeutic targets with clinical outcomes to identify a suitable therapeutic target for clinical use and to characterise beta-lactam pharmacokinetics and recommend local empirical dosing regimens. the investigators propose a prospective cohort study on adult patients (≥21 years) admitted to sgh. four blood samples will be obtained over a dosing interval and assayed using liquid chromatography with tandem mass spectrometry. levels and dose adjustment recommendations will be reported to physicians by infectious disease pharmacists.

Eligibility criteria:
inclusion criteria: * adult patients (21 years and above) * admitted to singapore general hospital * receiving beta-lactam therapy for documented or suspected infection * indication for beta-lactam therapeutic drug monitoring: critically ill, altered pharmacokinetics (burns, obese, on extracorporeal therapy, dialysis), immunocompromised, resistant pathogens, deep-seated infections, suspected or at risk for adverse effects exclusion criteria: * expected mortality within next 24 hours * pregnancy
study to assess the efficacy, safety and tolerability of idebenone in the treatment of friedreich's ataxia

Conditions: Friedreich's Ataxia

Summary: this study is meant to assess the effectiveness of idebenone on neurological outcome measures in patients with friedreich's ataxia over a 6 months period.

the study involves 6 clinic visits and upon completion the possibility to join a 12 months extension study where all patients will receive high dose idebenone.

Eligibility criteria:
inclusion criteria: * documented diagnosis of friedreich's ataxia (frda) with confirmed frda mutations * patients 8 - 17 years of age at baseline * patients with a body weight greater than 25 kg/55 lbs at baseline * patients able to walk at least 10 meters without accompanying person (icars walking capacities score ≤6) at screening and baseline * patients who in the opinion of the investigator are able to comply with the requirements of the study, including swallowing the study medication * negative urine pregnancy test at screening and baseline (female patients of childbearing potential) exclusion criteria: * treatment with idebenone, coenzyme q10 or vitamin e (if taken at a dose 5 times above the daily requirement) within the past month * patients with international cooperative ataxia rating scale (icars) score of greater than 54 or less than 10 at screening * pregnancy and/or breast-feeding * clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal of aspartate aminotransferase (ast; also known as got), alanine aminotransferase (alt; also known as gpt) or creatinine * history of abuse of drugs or alcohol * participation in the previous (phase ii) study of idebenone at the national institutes of health (nih) * participation in a trial of another investigational drug within the last 3 months

Keywords: friedreich's ataxia idebenone icars
early cpap in respiratory distress syndrome

Conditions: Respiratory Distress Syndrome

Summary: the purpose of this study is to establish if a strategy of ebcpap application in a subgroup of vlbwi, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality.

the application of cpap has been described as an alternative respiratory support for premature newborns with respiratory distress.many studies support that the early use of cpap results in a better respiratory evolution and less need for mechanical ventilation. hypothesis: - the hypothesis is that ebcpap will decrease the need for this more invasive therapy. the primary endpoint in this multicenter controlled study is to establish if an strategy of ebcpap application in a subgroup of vlbwi, 800 to 1500g birthweight, decreases the need for mechanical ventilation in this group, without affecting mortality. . as secondary outcome, the investigators will analyse: days of oxygen therapy, days of mechanical ventilation, need for surfactant , pulmonary airleak, intraventricular hemorrhage, persistent ductus arteriosus, retinopathy of prematurity and bronchopulmonary dysplasia (bpd) at 28 days and 36 weeks corrected gestational age. comparison(s): early bubble cpap (ebcpap)with standard therapy which is oxygen.

Eligibility criteria:
inclusion criteria: * all infants born at the units belonging to the south american neocosur network with a birthweight between 800 to 1500g and breathing spontaneously at birth or after hand bagging with neopuff or transient intubation are eligible. * an informed consent form should be obtained preferable prenatal. exclusion criteria: * acute life threatening congenital malformations or genetics diseases. * apgar score equal or less than 3 at 5 minutes * disapproval of informed consent.

Keywords: respiratory distress syndrome early bubble cpap mechanical ventilation surfactant
randomized phase iii trial of surgery alone or surgery plus preoperative gemcitabine-cisplatin in clinical early stages of non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: randomized phase iii trial of surgery alone or surgery plus preoperative gemcitabine-cisplatin in clinical early stages of non-small cell lung cancer


Eligibility criteria:
inclusion criteria: * patients with early stage nsclc

Keywords: nsclc
behavioral activation (ba) for medication-responsive chronically depressed patients with impaired social functioning

Conditions: Persistent Depressive Disorder

Summary: the investigators aimed to assess the ability of a modified version of behavioral activation for occupational and social improvement to produce change in: 1. social adjustment, 2. work functioning, 3. avoidance behavior and 4. behavioral activation.

psychosocial functioning was assessed before and after ba treatment in medication responsive depressed individuals who continued to have impaired social functioning. the primary goal was to demonstrate feasibility of recruitment and retention, and obtain an open pilot sense as to whether there are benefits from this brief psychotherapy approach in this population. the investigators also planned to refine measures and estimate the effect size of any treatment response to estimate power and sample size with the goal of completing a future controlled study.

Eligibility criteria:
inclusion criteria: * adults aged 20-75 years * a primary diagnosis of dysthymic disorder, chronic major depressive disorder or double depression * a \>50% decrease in 17 item hamilton rating scale for depression (hrsd-17) score and a final hrsd-17 score ≤ 10 with an adequate antidepressant medication (adm) trial (\> 4 weeks on at least 50% physician's desk reference maximum adm dose) * a rating of 1 ("very much improved") or 2 ("much improved") on the clinical global impressions-improvement scale (cgi-i) * continued functional impairment, defined by scores \>1.9 on the social adjustment scale (sas) * unemployment (jobless, looking for work) according to the bureau of labor statistics: jobless and looking and available for work, or underemployed. exclusion criteria: * structured clinical interview for diagnostic and statistical manual, fourth edition (dsm-iv) axis i disorders-diagnosed cognitive or psychotic disorders * bipolar disorder * active eating disorders * severe borderline personality disorder * alcohol or drug dependence (except nicotine) in the last 6 months * current suicide risk * unstable medical conditions * use of psychotropic medications other than antidepressants

Keywords: chronic depression dysthymic disorder double depression behavioral activation therapy work impairment unemployment
efficacy and safety of rhgh (jintropin®) in pediatric participants with iss

Conditions: Dwarfism

Summary: phase 1: to evaluate the safety and efficacy of 0.05mg/kg/d of rhgh (jintropin®) in the treatment of children with idiopathic short stature (iss) in 52 weeks. phase 2: to evaluate the safety and efficacy of rhgh (jintropin®) in the treatment of children with iss in 2 years


Eligibility criteria:
inclusion criteria: * boys are between 4 and 10 years old age and girls are between 4 and 9 years old age; * height \<-2.25 sd (standard deviation) for chronological age; * gh (growth hormone) peak concentration ≥10.0 ng/ml in gh stimulation tests; * the bone age (ba) ≤chronological age (ca)+6 months; * prepubertal status (tanner stage i); * birth weight within the normal range; * growth hormone treatment-naive; * participants are willing and able to cooperate to complete scheduled visits, treatment plans and laboratory tests and other procedures, to sign informed consent. exclusion criteria: * participants with abnormal liver and kidney functions (alt \> upper limit 1.5 times of normal value; cr \> upper limit of normal value); * participants are positive for anti-hbc, hbsag or hbeag in hepatitis b virus tests; * participants with known highly allergic constitution or allergy to investigational product or its excipient; * participants with systemic chronic disease and immune deficiency; * participants diagnosed with tumor, or with potential high tumor risks such as tumor markers exceed normal range and some other relative information may be excluded from the treatment; * participants with mental disease; * participants with other types of abnormal growth and development; 1. growth hormone deficiency (ghd) (confirmed by gh stimulation test); 2. turner syndrome (confirmed by karyotype test of girls); 3. noonan syndrome (hypertelorism, pectus carinatum, hypophrenia, frequently with skin disease and congenital heart disease, missense mutation of the protein tyrosine phosphatase, non-receptor type 11 (ptpn11) gene on chromosome 12 for half of the participants, for both male and female participants); 4. laron syndrome (confirmed by igf-1 generation test); 5. small for gestational age ( the birth height or weight is below the tenth percentile or 2 sd, with catch-up growth uncompleted at 2 years old); 6. growth disorders caused by malnutrition or hypothyroidism (thyroid function test). * participants with impaired glucose regulation (igr) (including impaired fasting glucose (ifg) and/or impaired glucose tolerance (igt) ) or diabetes; * bmi (body mass index) ≥22kg/m²; * congenital skeletal abnormalities or scoliosis, claudication; * participants who took part in other clinical trials within 3 months; * participants who received medications which may interfere gh secretion or gh function, or other hormones within 3 months (such as sex steroids, glucocorticoids, etc.); * other conditions which is inappropriate for this study in the opinion of the investigator.
effect of skin stretching on pain reduction during local anesthetic injections: a randomized clinical study

Conditions: Lumbar Spinal Stenosis With Bilateral Lower Extremity Radiculopathy

Summary: the purpose of this study is to investigate the potential analgesic effect of skin stretching during local anesthetic injection in patients with chronic lumbar pain and bilateral lower extremity radiculopathy undergoing selective transforaminal nerve block. this research is based on the hypothesis that mechanical skin stretching can reduce injection-related pain by facilitating the dispersion of the anesthetic agent and decreasing tissue resistance. by comparing the skin stretching technique with the conventional method of local anesthetic administration, this study aims to evaluate differences in pain perception, discomfort, and behavioral pain responses. the ultimate goal is to provide evidence for a simple, non-invasive, and effective intervention that can improve patient comfort and enhance the quality of clinical pain management.


Eligibility criteria:
inclusion criteria: * adults aged 19 years or older with chronic low back pain lasting for more than 3 months, accompanied by bilateral lower extremity radiculopathy, who require selective transforaminal epidural block (steb). * patients with a numerical rating scale (nrs) score of 5/10 or higher, with pain that affects daily life activities. exclusion criteria: * patients whose pain is influenced by mechanisms other than radiculopathy, such as peripheral neuropathy or myelopathy. * patients with a history of lumbar surgery within the last 6 months, or spinal injection treatment within the last 3 months. * patients with a history of allergy to local anesthetics, steroids, or contrast agents, or those at increased bleeding risk due to anticoagulant use (inr \> 1.2). * patients with localized infections, sepsis, uncontrolled diabetes, or hypertension. * patients who are unable to consent or cooperate with the study procedures (e.g., cognitive impairment, severe mental illness).

Keywords: skin stretching local anesthetic injection pain lumbar spinal stenosis
eye rubbing and keratoconus in montpellier chu

Conditions: Keratoconus

Summary: evaluate the illness experience of patients with keratoconus as well as the rubbing habits of this population compared to the general population. to do this, the investigators used a questionnaire made by a bordeaux team with questions on the experience of the patients' illness, their management and their friction habits


Eligibility criteria:
inclusion criteria: - having a keratonus at least in one eyes exclusion criteria: - refus to participate

Keywords: primitive corneal ectasia ophthalmology eyes rubbing keratoconus
intervention study to evaluate the importance of information given to patients with contact allergy

Conditions: Dermatitis, Allergic Contact

Summary: the purpose of this study is to determine whether extended information given to patients with contact allergy improves knowledge, treatment efficacy and daily functioning.


Eligibility criteria:
inclusion criteria: * patients with suspected contact allergy * age above 18 years * participants have given informed consent exclusion criteria: * mental or language disabilities

Keywords: intervention studies eczema randomized controlled trial knowledge quality of life
same-day discharge versus overnight stay following pulmonary vein isolation for atrial fibrillation

Conditions: Atrial Fibrillation

Summary: prospective, randomized, controlled, multicentre study to compare the safety and efficacy of a same day discharge (sdd) protocol in combination with a perclose prostyle (pps) /proglide (ppg) suture mediated vascular closure device to the current gold standard: an overnight stay (ons) protocol associated with manual compression ± figure-of-eight suture for the patients receiving interventional pulmonary vein isolation (pvi).

the aim of the study is to prove that the use of a sdd protocol does not lead to a higher rate of adverse events (minor and major), unplanned medical visits (emergency department or outpatients' clinic) and unplanned readmissions, while substantially reducing the costs associated with the medical care and increasing the comfort of the patients on a period of 30 days, when compared to ons and manual compression ± figure-of-eight suture. moreover, the safety, efficiency, and feasibility of the sdd protocol should be proven during a follow-up (fu) period of 12 months. the definition of endpoints will be trained in all participating study sites to preserve consistency.

Eligibility criteria:
inclusion criteria: * patients age \>=18 years * elective catheter ablation for atrial fibrillation using 6 to 14 fr inner diameter introducer sheath with a minimum of 1 and maximum of 2 femoral venous access sites, independent of the energy source use exclusion criteria: * active systemic or cutaneous infection, or inflammation in vicinity of the groin * platelet count \< 50,000 cells/mm3 * body mass index (bmi) \> 45 kg/m2 or \< 18 kg/m2
maintenance metronomic chemotherapy for metastatic colorectal carcinoma

Conditions: Colorectal Cancer Metastatic

Summary: colorectal cancer patients with metastases (mcrc) at response under expensive chemotherapy which may be toxic +/- exhausting are candidates for an effective and more convenient maintenance treatment. objectives: 1. to define the efficacy of maintenance chemotherapy by a low-dose metronomic (ldm) regimen, in metastatic crc patients responding under folfiri + bevacizumab. 2. to discover predictive factors for response to this ldm regimen. hypothesis: 1. the re-growth of residual metastases can be slowed by the anti-angiogenic effects of ldm chemotherapy. 2. serial measurements of angiogenic/ inflammatory factors in the plasma and/or evaluation of certain enzymes in the tumor may discover predictive factors of response to ldm chemotherapy in metastatic crc patients.

at entry to the research protocol the up-till then administered treatment with intra venous folfiri+bevacizumab will be stopped.instead, the research oral treatment will be initiated to be taken daily on an ambulatory basis and under once monthly re-evaluation. if and when disease progresses the original folfiri+bevacizumab treatment will be considered for re-institution.

Eligibility criteria:
inclusion criteria: 1. histologic (or cytologic) proof of colorectal carcinoma (crc). 2. age: between 18 and 80. 3. sex: both sexes. 4. previous treatment for metastatic disease is limited to folfiri+ bevacizumab. 5. prior adjuvant chemotherapy, with a fluoropyrimidine and/or oxaliplatin, is allowed. 6. prior radiotherapy, either as adjuvant treatment or palliation of metastatic sites is allowed, provided that there are other non-irradiated foci of disease for evaluation. 7. persistent remission, either complete, partial or minimal response (cr, pr or mr) or stable disease (sd), one year+/-one month from initiation of first line treatment for mcrc. 8. asymptomatic patients at break from chemotherapy. 9. intact organ function, including complete blood counts (cbc) showing normal values or any toxicity limited to grade 1 and blood chemistry (sma) showing liver and renal functions \< 1.5 upper normal limit (unl). 10. capability to understand and to sign the informed consent. exclusion criteria: 1. concurrent any other cancer (except bcc or squamous cell carcinoma of skin). 2. inability to adhere to monthly visits to the oncology unit for evaluation. 3. presence of brain metastases. 4. any current or recent (within the last month) continuous treatment by steroids or by nsaids, or with therapeutic doses of anticoagulants for any reason. 5. previous radiotherapy to the only site of measurable disease. 6. evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac including arrhythmias, hepatic or renal disease), and/or existence of active peptic ulcer (clinically and/or by gastroscopy).

Keywords: metronomic chemotherapy anti-angiogenic maintenance treatment colorectal cancer metastatic
skin iam: an exploratory clinical trial to evaluate changes in skin appearance, colour, and/or texture following the induction of a local inflammatory skin response

Conditions: Skin Inflammation

Summary: this trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.


Eligibility criteria:
inclusion criteria: * male aged \>25- \<40 years. * healthy, non-smoker. * in the opinion of the investigator, the subject will be able to comply with the requirements of the protocol, including ability to present for all required visits. * subject is capable of understanding and signing an informed consent form. * white origin (limit skin fitzpatrick i to iii). exclusion criteria: * male aged \ 40 years. * female of any age. * tattoos on or within 5 cm of the area to be assessed. * scars on or with 5 cm of the area to be assessed. * current, active inflammatory skin disease, or past history of any inflammatory skin disease (other than acne) such as psoriasis, atopic dermatitis. * suffered from any significant allergies (i.e. food, environmental, contact). * subjects who are immunocompromised (i.e. hiv positive, hepatitis c, transplant, etc.), based on clinical history. * subjects who currently have an activated immune system (e.g from current infection or recent vaccination). * subjects who have a history of chronic disease such as diabetes. * use of investigational therapy in the preceding month prior to screening visit. * use of g-csf, gm-csf, il-2, ifns, erythropoietin, systemic or inhaled steroids within one month of the screening visit. * use of oral analgesics/anti-inflammatories (e.g. paracetamol, ibuprofen, aspirin, codeine) or topical anti-inflammatories (e.g., ibuprofen) within 5 days of the screening visit. * concurrent disease or conditions that may present a risk to the subjects.
obesity heterogeneity study

Conditions: Obesity

Summary: the investigators will assess the heterogeneity of obese individuals in the united states to help researchers, clinicians and policymakers to establish goals for obesity treatment and identify whether differing interventions may be needed.

guidelines for obesity set common targets for interventions and goals around weight loss, and randomized trials and epidemiologic studies of obesity tend to consider obesity to be a homogeneous entity . the investigators will analyze data from the 2011-2012 wave of the nhanes. obesity will be defined as having a body mass index greater than or equal to 30 kg/m2. the investigators aim to identify obese sub-groups according to demographic factors, clinical conditions and behavioral characteristics. results of this type of analysis will shed light on an important gap in the way that obesity interventions and guidelines are developed and will be an important step in beginning the discussion towards this important area.

Eligibility criteria:
inclusion criteria: * all exclusion criteria: * pregnant