cyrilzakka/clinical-trials huggingface dataset:
Pathogenesis of Adverse Drug Reactions

The purpose of the study is to examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine identities of the reactive metabolites or, alternatively, the identities of those metabolites that serve as potential precursors to reactive species.

Adverse drug reactions can be broadly defined as any undesirable response associated with therapeutic drug use. A simple and clinically useful classification is to divide adverse events into those that are dose-dependent and largely predictable from the known pharmacologic properties of the compound in question, and those that are dependent on characteristics unique to susceptible individuals, or idiosyncratic in nature.

The long term objective of this research is to characterize the mechanisms responsible for the pathogenesis of idiosyncratic hypersensitivity reactions in children, particularly those involving carbamazepine and other aromatic anticonvulsants.

The study is divided into two phases. Phase 1 of the study involves collecting urine from 50 patients taking CBZ therapeutically. Participants will be asked to provide a spot urine sample during routine health visits. The urine will be analyzed for the presence of CBZ and its metabolites. In Phase 2 of the study, urine will be collected from patients taking either CBZ or VPA therapeutically. If blood samples are drawn from these patients for medical purposes not related to this study the residual blood sample will be recovered before it is discarded for use in genotyping analysis. Participants will be asked to provide a urine sample covering one complete dosing interval of CBZ or VPA (preferably overnight). Patients will also be followed longitudinally, with urine collections at each clinic visit over at least a two year period.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients of both genders between 1 and 16 years of age receiving CBZ or VPA mono-therapy will be recruited for this study. Additionally, for those patients who are receiving drugs other than CBZ or VPA to control their seizures, if CBZ or VPA are subsequently added to their treatment regimen, then these patients will also be recruited for this study.

Exclusion Criteria:

* None
Whole-Exome Sequencing (WES) of Intraductal Neoplasms of the Bile Duct (IPNB)

Intraductal papillary neoplasm of the bile duct (IPNB) is a distinct type of biliary tumor characterised with delicate fibrovascular stalks (papillary of villous) covered at biliary epithelium. The typical pathologic feature is dramatical dilation of affected bile ducts due to obstruction by mucin production. IPNB has a better prognosis than bile duct carcinoma, but the current proposed entity contains multiple definitions or categories, thus confused in pathology.

Although mutations of several genes on IPNBs (such as GNAS, KRAS, APC, CTNNB1, and RNF43) identified in previous studies, there is still an unification at gene expression signature.

This research trial will use whole exome sequencing and subsequent bioinformatic analysis in finding causative mutations in deoxyribonucleic acid (DNA) samples from IPNBs patients.

Using production-scale platform, this study will carry out whole exome sequencing from archival (FFPE) material to Identification and classification of significantly mutated genes, determine the somatic genomic alterations that may be relevant to the development or treatment of cancer, establish classification of IPNBs gene mutation signature. Next, analysis of gene mutation signature and IPNBs clinicopathologic outcomes, including the association between pathologic type, long-term oncological outcomes and gene mutation signature. Last, the determination of involved signal pathways at IPNB patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of IPNBs
* ECOG Performance status of 0, 1, or 2
* Adequate liver function, bilirubin \< 1.5 times ULN, ALT or AST \< 2.5 times ULN
* Adequate renal function: creatinine \< 1.8
* Must be at least 18

Exclusion Criteria:

* Diagnosis of hepatic mucinous cystadenoma (MCN)
* Complicated with other Malignancy
* Pregnancy
Effectiveness of the Pilates Method to Prevent and Reduce Falls in Older People

The present research aims at evidencing the effect of one of the training methodologies increasingly demanded by the older adult, and used to promote, maintain and enhance physical and biopsychosocial aspects. Consequently, we intend to base the evidence supporting Pilates as an effective method in the following specific aspects: balance, prevention and reduction of falls, and improvement of the quality of life in the older adult


Eligibility Criteria:
Inclusion Criteria:

* Subjects +60 years.
* Subjects without cognitive impairment that prevent from performing interventions. A score in the Mini-Cognitive Examination of Lobo has to be equal or greater than 20 points.
* Subjects without physical impairment that prevent from performing interventions, or can directly influence the evaluation of the balance abilities (i.e., vestibular pathologies, amputated limbs, etc.)
* Subjects willing to participate, and have read, understood and signed an informed consent.
A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide \[2 milligrams (mg), 8 mg, or 16 mg\] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.


Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* Aged 18-64 years (both inclusive) at the time of signing informed consent.
* Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening.
* Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) \[53 - 91 millimoles per mole (mmol/mol)\] (both inclusive).
* Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m\^2).
* Stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations.

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (\<) 30 milliliters per minute (mL/min)/1.73 meter square (m\^2) at screening.
Validation of Procalcitonin as a Biomarker Diagnosing CDI

Cardiac device infections (CDI), especially pocket infections, are difficult to be diagnosed. Device pocket infections are not associated with elevated white blood cell count. CRP is only assoziated with a low sensitivity. The diagnosis of a local pocket infection is challenging and relies primarily on the clinical presentation. The prospective DIRT study identified procalcitonin (PCT) among 14 biomarkers as the most promising biomarker to aid the diagnosis of pocket infection.

The study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection


Eligibility Criteria:
Inclusion Criteria:

• device associated infections

Exclusion Criteria:

* malignancy
* cytostatic or immunomodulating therapy
The Protective Effect of Prostaglandin on Coronary Microcirculation and Ventricular Remodeling After Reperfusion Therapy in Acute ST-segment Elevation Myocardial Infarction

To explore the protective effect of prostaglandin sodium on coronary microcirculation function and ventricular remodeling after reperfusion treatment of acute ST-segment elevation myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* 1) Meet the diagnostic criteria for acute ST-segment elevation myocardial infarction: ①The onset of ischemic chest pain lasts for more than 30 minutes and cannot be relieved by taking nitroglycerin; ②The ECG has two or more ST-segment elevations in adjacent leads , Limb leads ≥ 1mm, pectoral leads ≥ 2mm; or newly-appearing left bundle branch block; ③The increase in serum markers of myocardial necrosis is at least twice the normal value; (2) Coronary angiography confirmed acute myocardial infarction; (3) Direct PCI treatment within 12 hours of onset; (4) Complete clinical and radiographic data.

Exclusion Criteria:

* (1) Those who do not cooperate in the inspection, have poor compliance, and cannot guarantee the completion of the test; (2) Persons with consciousness impairment, obvious intellectual impairment and mental abnormality; (3) With metal foreign bodies, such as metal prostheses, intraocular metal foreign bodies, intracranial aneurysm clamps, etc.; (4) Those who suffer from closure phobia; (5) Those who have had a history of myocardial infarction, PCI treatment, or coronary artery bypass graft; (6) Factors affecting the changes in the ST segment of the electrocardiogram: complete left bundle branch block, pre-excitation syndrome, pacemaker electrocardiogram
T-score Comparability Between GE Lunar Prodigy and Norland Excel Densitometers

Differences in determining bone density scores have been found when comparing different bone density machines. Reducing differences between machines will improve diagnostic agreement for patients measured at different clinics. This study will test if this difference exists between the Norland Excel, such as the one at Wildwood Clinic, and the GE Healthcare Lunar Prodigy at the UW Osteoporosis Clinical Research Center.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory women age 40 years and older
* Recent spine and hip DXA at Wildwood clinic in Madison, WI
Health Status and Its Socio-economic Covariates of the Older Population in Poland - the Nationwide PolSenior2 Survey.

The PolSenior2 survey is aimed to characterise health status of old and very-old adults in Poland.

One of the goals is assessing the prevalence and control of age-related diseases and of the "geriatric giants" (immobility, instability, incontinence, sensory deficiency, cognition and mood disorders) which lead to frailty, disability and dependence. Monitoring of health status, health behaviors and identifying socio-economic factors favoring successful aging will be significant. As the polypragmasy and adverse drug reactions remain a significant issue in the geriatric care, pharmacotherapy and medical adherence will also be examined.

The additional purpose of the study is to evaluate the utilization and access to health care and social services in respect to needs for assistance and long-term care, as well as the level and different forms of these needs.

The project is planned as a cross-sectional survey of representative sample of 6000 people aged 60 years and over. The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, anthropometric and blood pressure measurements and laboratory tests. The data are collected by well-trained nurses during three visits at respondents homes.

Eligibility Criteria:
Inclusion Criteria:

* over 60 years of age,
* randomly selected from database of all Polish citizens,
* consent to participate in the study.

Exclusion Criteria:

* under 60 years of age,
* no consent to participate in the study.
The Effect of Motivational ınterviewing on ıntention to Quit Smoking in Lung Cancer Patients

The effect of online video conferencing on smoking cessation intention in patients diagnosed with lung cancer was investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18,
* diagnosed with lung cancer, who had smoked at least 100 cigarettes in their lifetime and had smoked at least one cigarette in the last month,
* who volunteered to participate in the study,
* who had no communication problems, and who had internet access were included in the study.

Exclusion Criteria:

* Occasional smokers,
* Those using a different type of nicotine than cigarettes,
* Those actively participating in other smoking cessation programs, and those reporting dependence on any medication were excluded from the study.
Organ Protection by Remote Ischemic Preconditioning for Surgical Treatment of Pediatric Congenital Heart Disease

Cardiac surgery is associated with risk of perioperative inflammation and ischemia leading to cerebral and myocardial morbidity and mortality. Ischemic preconditioning by repetitive ischemic episodes at an organ can reduce damage resulting from consecutive prolonged ischemia in that organ. Remote ischemic preconditioning is defined as ischemic preconditioning by repetitive ischemic episodes of an organ remote from the organ to be protected, e.g. ischemic episodes of a limb can reduce ischemic damage of the heart. Animal studies as well as human studies have shown that ischemic preconditioning can protect the heart from intraoperative ischemia. Remote preconditioning by repetitive limb ischemia has been applied in humans in some studies.12-14 However, the published data is not yet sufficient to support evidence based recommendations for clinical practice. In particular, available data regarding the influence of remote preconditioning on inflammatory and ischemic damage of brain and heart in children following surgery of congenital heart disease are limited. Hence, this prospective, controlled and randomized study was designed to perform remote ischemic preconditioning in children after induction of anesthesia for pediatric heart surgery and to investigate the effect on postoperative organ function in comparison to a control group.

Arterial blood flow to the right leg of the patients is interrupted by inflating a cuff around the thigh up to a pressure of 15 mmHg above the systolic blood pressure for five minutes. Thereafter the pressure is released for another five minutes and the procedure is repeated fourfold. Cerebral and myocardial damage are examined by postoperative laboratory exams in comparison to preoperative baseline values. In addition to this, systemic immune response, renal function, duration of intensive care and time to discharge from hospital are compared between groups. Mechanisms of remote preconditioning are investigated by analyzing gene expression in human heart tissue obtained during surgery and in leukocytes.

The investigation is not associated with any known risks for the children.

Eligibility Criteria:
Inclusion Criteria:

* congenital heart surgery

Exclusion Criteria:

* hypoplastic left heart syndrome
Evolution® Biliary Stent System Clinical Study

The Evolution® Biliary Stent System Clinical Study is a clinical trial on a commercially available device to gather physician experience with the Cook Evolution® Biliary Stent System for the palliation of cancer in the biliary tree. Patients will be treated as per usual medical practices.


Eligibility Criteria:
Inclusion Criteria:

* Patient is considered a candidate for stent placement based on institutional guidelines and product IFU.

Exclusion Criteria:

* Patient is less than 18 years of age.
* Patient is unable or unwilling to provide written informed consent.
* Patient is unable or unwilling to comply with the follow-up schedule.
Study of the ENTact Septal Staple System for Tissue Approximation During Septoplasty

The purpose of this research study is to learn more about the ENTact™ Septal Staple System device performance and to collect information to support its premarket application.

The ENTact™ Staple System is a device that inserts a small staple or tack to hold mucosa (moist tissues) in place instead of using stitches. The staple gradually dissolves and does not need to be removed. This clinical study will evaluate:

* surgical performance of the ENTact Septal Staple System
* one week post op clinical evaluation of gross tissue appearance at implantation site(s)
* ENTact™ Septal Staple functionality based on maintained coaptation

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, between the ages of 18 and 65 years, with a clinically significant deviation of the nasal septum
* Patient is able to provide a signed informed consent form
* Patient will agree to comply with all study related procedures
* Patient is not pregnant at this time. If patient is of child-bearing age and capable of bearing children, a pre-operative pregnancy test confirmation is required to show that patient is not pregnant on the day of surgery
* Patient does not plan on becoming pregnant and is not breast feeding during the course of the study

Exclusion Criteria:

* Patients who do not meet the inclusion criteria
* Patients who have had previous septoplasty
* Patients with uncontrolled diabetes
* Presence of infection at the site
* Smokers and severe drug and alcohol abusers
* Patients with autoimmune disease deemed clinically significant by Principal Investigator
Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428
* Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study
* Willing to continue to abstain from use of disallowed medications as defined per protocol

Exclusion Criteria:

* Has newly diagnosed impaired renal function identified at the Screening Visit \[i.e., serum creatinine concentration \> 1.8 milligrams per deciliter (mg/dL)\]
* Has experienced an unexplained and/or clinically significant weight loss defined as \> 5% within 90 days prior to Screening Visit.
* Has plans to participate in another trial with an investigational drug or device during the course of the extension study
Erector Spinae Plane Block for Congenital Hip Dislocation Surgery

Developmental dysplasia of the hip (DDH) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. Open surgical reduction of congenital hip dislocation (CHD) is typically performed after an ineffective closed reduction or older than 18 months. Multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain. The aim of this study was to evaluate the analgesic effect of ultrasound guided erector spinae plane block (ESP) in pediatric patients undergoing CHD surgery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-II patients undergoing hip dislocation surgery

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
* Incomplete patient forms
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* ASA III-IV
Point-of-care Ultrasound to Assess Hydronephrosis in Patients With Acute Kidney Injury in the Emergency Department

Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic management. This observational study aims at assessing the accuracy of point-of-care ultrasound (POCUS), performed by the emergency physician (EP) for the detection of dilatation or distension of the kidney secondary to urinary tract obstruction, in emergency department patients presenting with acute kidney injury (AKI). Participants will undergo a bedside POCUS of the urinary tract by the EP followed by central imaging evaluation by a radiologist (either ultrasound or renal computed tomography (CT) or both). Researchers will compare both diagnosis. Study hypothesis is that trained emergency physicians can rapidly and reliably diagnose renal tract obstruction at POCUS in the context of AKI.

Acute kidney injury (AKI) is a common diagnosis in the emergency department (ED), and urinary tract obstruction is a contributing cause that requires rapid diagnosis and therapeutic management. Hydronephrosis is a dilatation or distension of the kidney secondary to urinary tract obstruction. It can be diagnosed at ultrasonography or computed tomography. Assessment of the renal tract and detection of hydronephrosis is a core component of the emergency medicine Point-of-Care Ultrasound (Pocus) curriculum. The primary objective of this study is to compare the performance of point-of-care ultrasound performed by the emergency physician to that of central radiology imaging (US or CT) by a radiologist, to diagnose hydronephrosis in patients presenting with AKI in the ED. All imaging exams will be performed as part of routine evaluation, Pocus will be carried out by a trained EP blinded from radiology imaging results.

Eligibility Criteria:
Inclusion Criteria:

* Patient with acute kidney injury defined by changes in serum creatinine (sCr) level between the index sCr at ED admission and pre and/or post sCr controls (Kidney Disease Improving Global Outcome criteria)
* Patient who does not oppose to the use of their data

Exclusion Criteria:

* Vesical globe
* Polycystic kidney disease
* Known renal tumor
* Horseshoe kidney
Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs.Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate.

Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants.

The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.


Eligibility Criteria:
Inclusion Criteria:

1. Infants with age range from 1-30 days.
2. Unilateral complete cleft lip and palate
3. Medically free subjects.
4. Both males and females.

Exclusion Criteria:

1. Patients older than 30 days.
2. Syndromic patients with other defects in addition to cleft lip and palate.
3. Patients with bilateral cleft lip and palate.
4. Incomplete cleft lip.
5. Patient with previous surgical lip repair or adhesion.
6. Patients with previous presurgical infant orthopedic treatment.
7. Medically compromised patients.