cyrilzakka/clinical-trials huggingface dataset:
Comparison of Exparel to Marcaine in Post-Surgical Analgesia in Bariatrics

This study is designed to evaluate the use of bupivacaine liposome 1.3% compared bupivacaine 0.5% in pain control in post-operative laparoscopic bariatric surgery patient The purpose of this study is to evaluate two local anesthetics and determine if there is an advantage of administering one medication compared over the other. The intent is show that one local anesthetic.allows for improved pain control as per the pain scale ratings of the test subjects.


Eligibility Criteria:
Inclusion Criteria:

-Any patient scheduled to undergo Laparoscopic Roux en Y Gastric Bypass or Laparoscopic Gastric Sleeve with Dr. Stephen Fleischer

Exclusion Criteria:

* Patients with an allergy to either medications being studied any patient with neurological disorders that may be exacerbated by the use of either medication,including multiple sclerosis and amyotrophic lateral sclerosis or that may impact the perception of pain.
* Patients with complex medical conditions that may confound data analysis per the principal investigator's discretion.
* Any pregnant patient.Any patients that would not like to participate in the study.
* Any patient that is not able to read or understand English
Associated Genes With Atomoxetine Response in Attention Deficit Hyperactivity Disorder (ADHD)

Attention deficit hyperactivity disorder (ADHD) is the most common behavior disorder, with the prevalence of 3% to 6% in children and adolescents. The patients' academic achievements, professions and social livings are impaired. Comorbid antisocial behavior, substance abuse and delinquency burden family and society. Stimulants used to be the first line drug. But the medication compliance is poor because of strict drug administration. Atomoxetine is a new non-stimulant drug, which can effectively improve ADHD symptoms. But it achieves effect slowly, the drug responses differ significantly, and side effects interfere compliance. Since genetic factors is the most important cause for different drug responses, this project studies candidate genes potentially associated with atomoxetine medication, with the aim to find 2 to 3 gene polymorphisms influencing the drug response of ADHD. The study adopts cohort design. A sample of more than 100 ADHD cases with atomoxetine medication is to be collected. The rapid genotyping of large sample depends on high-through laboratory. New statistic method is to be used to improve the sensitivity of the target gene detection. There has been no such report in country and overseas. This project will provide basic information for forecasting drug response, improving clinical effects, tolerance and long-term compliance.


Eligibility Criteria:
Inclusion Criteria:

* The subject should meet with the DSM-IV ADHD criteria, confirmed by semi-structured interview.
* The subject has not accepted any treatment for ADHD before, or he/she received methylphenidate or atomoxetine treatment but has stopped for 1 or 4 weeks respectively.
* Han Chinese
* Parent sign the informed consent

Exclusion Criteria:

* Who are allergy to atomoxetine
* Who can not complete the titration procedure because of untolerable of the side effect
* Who combined other psychotropic drugs or non-drug intervention for ADHD.
* Children who can not be compliant with the blood withdraw.
A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh

This is a study assessing safety and efficacy of current national guidelines for the treatment of uncomplicated malaria in Bangladesh as well as to assess the G6PD status among the enrolled patients.

The national guidelines for the treatment of uncomplicated malaria in Bangladesh currently recommend a standard dose of artemether-lumefantrine followed by a single dose of primaquine for P. falciparum malaria and a three day course of chloroquine followed by 14 days of primaquine for vivax malaria.Currently the national treatment guidelines do not include any testing for G6PD deficiency before treatment with primaquine. In order to guarantee safe and efficacious treatment for all patients diagnosed with uncomplicated malaria in Bangladesh, it is essential to monitor the effectiveness and safety of the recommended treatment guidelines. This trial therefore evaluates the local efficacy and safety of the current first line treatment and assesses the G6PD status of the enrolled patients.

Patients with uncomplicated malaria attending the health care center, who meet the study inclusion criteria will be enrolled, treated on site and followed up for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. The study will provide efficacy data for both artemether-lumefantrine and chloroquine and will generate data on G6PD status in the region, which will provide vital information for policy makers in regards to the wider roll out of primaquine for the radical cure of vivax malaria.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 months
* P. vivax or P. falciparum monoinfection or P.v. / P.f. mixed infection
* Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs
* Ability to swallow oral medication.
* Ability and willingness to comply with the study protocol for the duration of the study
* Informed consent/assent from the patient or from a parent or guardian in the case of children.

Exclusion Criteria:

* Presence of general danger signs in children aged under 5 years or signs of severe malaria according to the definitions of WHO
* Presence of severe malnutrition
* Acute anaemia \<8g/dL
* Regular medication, which may interfere with antimalarial pharmacokinetics
* History of hypersensitivity reactions or contraindications to any of the drug(s) tested or used as alternative treatment(s)
* A positive pregnancy test or lactating
Efficacy and Safety of Metformin in Preventing Patients With Risperidone From Weight Gain and Amenorrhea

Some previous studies has demonstrated that Metformin can improve the weight gain which caused by antipsychotics. An our study, which will be published, also found that Metformin can improve the amenorrhea for patients with antipsychotics, approximately 60% patients recovery period. So the present study was designed to investigate the efficacy and safety of Metformin in preventing patients with Risperidone from weight gain and amenorrhea.


Eligibility Criteria:
Inclusion Criteria:

1. age 18-40 years.
2. diagnosis of schizophrenia (naive first-episode) as defined in DSM-IV axis I.
3. At screening, patients were required to have total score ≥60 on Positive and Negative Syndrome Scale (PANSS) and ≥4 on the Clinical Global Impression-severity scale (CGI-S).
4. treat with Risperidone.
5. Never participate in a diet control nor in other weight loss programs, and have a normal Period.
6. Written informed consents could be obtained from patients(or their Legal guardian).

Exclusion Criteria:

1. Female patients, those who were in the period of pregnancy and lactation, or plan pregnancy, were excluded.
2. Patients with serious physical disease patients, just like Epilepsy, liver and kidney dysfunction, diabetes, blood diseases, etc were excluded.
3. At screening, patients with abnormal results in physical examination, laboratory test, or electrocardiogram (ECG) were excluded.
4. Patients were also excluded if they met primary DSM-IV axis I psychiatric disorders other than schizophrenia, or ever used psychoactive substance.
Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy

To evaluate the effects of oral emixustat hydrochloride (emixustat) on aqueous humor biomarkers associated with proliferative diabetic retinopathy (PDR) from baseline to week 12.

This is a multicenter, randomized, double-masked, placebo-controlled study to evaluate the effects of emixustat in subjects with PDR. Subjects will be randomly assigned to either emixustat or placebo arms and treated once daily (QD) for 12 weeks. Doses of emixustat will be doubled on a weekly basis until week 4 after which all subjects will be held at a stable dose for the remainder of the 12-week dosing regimen. Subjects in the placebo group will be mock-titrated on the same schedule as those in the emixustat arm.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to provide written informed consent
* Documented diagnosis of type 1 or type 2 diabetes mellitus
* Meets specific ocular criteria for the study eye including but not limited to, the presence of PDR with or without diabetic macular edema in study eye for which treatment can be deferred for at least 4 weeks after Day 1 visit
* Media clarity, pupillary dilation, and subject cooperation sufficient to obtain adequate assessments

Exclusion Criteria:

* Any condition that would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease or glycemic control)
* History of myocardial infarction or other acute cardiac event
* History of chronic renal failure requiring dialysis or kidney transplant
* Prior participation in any clinical study of emixustat
* Treatment with any investigational study drug within 30 days of screening
* Known allergy to fluorescein sodium for injection in angiography
* Treatment with specific prohibited medications or therapy beginning 4 weeks prior to screening and throughout the duration of the study
* History of systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization
* Pre-specified laboratory abnormalities at screening
* Specific ocular characteristics in the study eye
* Male subjects who are not surgically sterile and are not willing to practice a medically accepted method of birth control with their female partner of childbearing potential from screening through 30 days following completion of the study
* Female subjects of childbearing potential who are not willing to practice a medically accepted method of birth control with their non-surgically sterile male sexual partner from screening through 30 days following completion of the study
* Female subjects who are pregnant or lactating
Long Term Safety of Immediate-release Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease

The purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (ADPKD).

This was a Phase 3b trial to evaluate and describe the long term safety of tolvaptan treatment in ADPKD participants with chronic kidney disease (CKD). Eligible participants could enroll into Trial 156-13-211 after completing the follow-up visit(s) of their previous trial (156-13-210, 156-08-271, 156-04-251, or 156-09-290). Renal function was assessed during screening by using historical laboratory values for serum creatinine levels to calculate the estimated glomerular filtration rate (eGFR).

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants ≥ 18 years with confirmed diagnosis of ADPKD (during participation in prior tolvaptan trials) who have completed and transferred from the double-blind Trial 156-13-210 (12-month period including post treatment follow-up, regardless of whether this was on-treatment or off-treatment), or completed Trial 156-08-271 or a prior tolvaptan trial, or interrupted or discontinued treatment in a prior tolvaptan ADPKD trial other than Trial 156-13-210. Participants may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the trial.
* eGFR ≥ 20 milliliter (mL)/minute (min)/1.73 meter squared (m\^2) within 3 months prior to the baseline visit. Participants who have an eGFR ≤ 20 mL/min/1.73 m\^2 may be enrolled with medical monitor approval.

Exclusion Criteria:

* Need for chronic diuretic use
* Hepatic impairment based on liver function abnormalities other than that expected for ADPKD with cystic liver disease
* Women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (IMP)
* Women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP.
* Participants with contraindications to required trial assessments (contraindications to optional assessments, for example, magnetic resonance imaging \[MRI\] are not a limitation).
* Participants who in the opinion of the investigator or the medical monitor, have a medical history or medical finding inconsistent with safety or trial compliance
Turkish Validity and Reliability of the Recovery Scale QoR-15

It is adapted and encouraged to a point to improve their quality of intervention for the purpose of the research.

This research was conducted as a methodological and descriptive study to evaluate the psychometric properties of the "Quality of Recovery Score" in patients who had surgery. The study was carried out with the participation of 150 patients over the age of 18 who were operated under general anesthesia in Samsun Training and Research Hospital between 8.11.2021 and 3.01.2022.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* operated under general anesthesia

Exclusion Criteria:

* non-operative under general anesthesia
* under 18 years old
International Survey of Acute Coronary Syndromes

The International Registry of Acute Coronary Syndromes registry study (ISACS) is both a retrospective and prospective study which was designed in order to obtain data of patients with acute coronary syndromes, and herewith control and optimize internationally guideline-recommended therapies in these countries

Aims of this survey study are (1) documentation of the characteristics of all patients presenting to the ISACS centers with STEMI or NSTEMI (2) documentation of in-hospital outcome, and outcome rates at 6 month and 1 year, (3) documentation of invasive procedures and procedure-associated complications (4) documentation of therapeutic regimens and investigation conformity of treatment with already established guidelines.

Investigators:

ISACS Administrative Committee:

Raffaele Bugiardini (Italy-Principal Investigator) Lina Badimon (Spain) Olivia Manfrini (Italy- Project Coordinator) Edina Cenko (Italy-Center Coordinator)

Steering Committee:

Mirza Dilic (Bosnia and Herzegovina), Asen Goudev (Bulgaria), Davor Milicic (Croatia), Raffaele Bugiardini, Edina Cenko and Olivia Manfrini (Italy) Gani Bajraktari (Kosovo), Andrejs Erglis and Ilja Zakke (Latvia), Remigius Zaliunas and Olivija Gustiene (Lithuania), Sasko Kedev and Marija Vavlukis (North Macedonia), Mihail Popovici (Moldova), Maria Dorobantu (Romania), Zorana Vasiljevic (Serbia), Eva Goncalvesova and Martin Studenkan (Slovakia) , Alexander N. Parkhomenko (Ukraine) , Christopher P Gale (United Kingdom).

Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndromes

Exclusion Criteria:

* under age or not able to give informed consent
HbA1c as an Early Serologic Marker for the Hemodynamic Progression of Stage A Heart Failure

In a retrospective community based cohort study from Pueblo County Colorado which has a higher population proportion of metabolic syndrome and diabetes mellitus, we hope to clarify and quantify an association of the AGE HBa1c elevation with the early subclinical hemodynamic changes of diabetic cardiomyopathy as measured by LAV, LVM, E/A ratio, E/e' ratio and BNP in patients with stage A heart failure.

The classic association of glycemic control, as represented by HBa1c, with progression or improvement of microvascular and macrovascular clinical complications has been well documented. Additionally, while the association of HBa1c elevation with a syndrome described as diabetic cardiomyopathy has also been well documented, the use of the advanced glycation end product axis (AGE/sRAGE/esRAGE which includes HBa1c) as markers for the early subclinical hemodynamic changes of diabetic cardiomyopathy has been suggested but less well characterized or utilized. Stage A heart failure is defined as persons with normal cardiac structure and function who have predisposing subclinical risks for cardiovascular disease. Estimates suggest that Stage A heart failure may comprise up to 56% of any community's patient population and are patients most commonly seen in non-specialty primary care clinics. In light of newer cardiometabolic agents which show promise in cardiovascular disease primary prevention, these patients may be an important target for preventative cardiometabolic care. In a retrospective community based cohort study from Pueblo County Colorado which has a higher population proportion of metabolic syndrome and diabetes mellitus, we hope to clarify and quantify an association of the AGE HBa1c elevation with the early subclinical hemodynamic changes of diabetic cardiomyopathy as measured by LAV, LVM, E/A ratio, E/e' ratio and BNP in patients with stage A heart failure.

Methods: Retrospective cohort analysis by chart review of patients presenting to Parkview Medical Center's inpatient service and outpatient clinics who obtained a full resting echo characterized by normal cardiac structure and function in conjunction with HBa1c and BNP levels within a 3 month time window. Using multiple regression analysis of the dependent variables LAV, LVM, E/A ratio, E/e' ratio and BNP, powered to detect a 5% change in LAV in conjunction with rising HBa1c levels characterized as normal (\<5.7), metabolic syndrome (5.7-6.4) or diabetic (\>6.4) after controlling for the presence of hypertension and coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Stage A heart failure on basis of metabolic criteria

Exclusion Criteria:

* LV dysfunction, valvular heart disease, hypertension and CAD
Polydextrose for Patients With Chronic Kidney Disease

Constipation is a common complication in patients with chronic kidney disease (CKD), especially in hemodialysis (HD) patients. Reduced intake of fibre-rich food is among the most important causes of constipation. The study aims to investigate the possible influence of polydextrose (PDX) supplementation on constipation in patients with CKD on HD.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Chronic Kidney Disease
* Hemodialysis patients for more than 6 months
* Aged 18 years or older

Exclusion Criteria:

* Patients pregnant
* Smokers
* Using antibiotics in the last 3 months
* Autoimmune diseases
* Clinical diagnosis of infectious diseases
* Clinical diagnosis of Cancer
* Clinical diagnosis of AIDS
INCIPAVE Study: Incidence of Ventilator Acquired Pneumonia in Children

Rationale : ventilator associated pneumonia (VAP) has been extensively studied in adults, however, few data exist regarding VAP in the paediatric intensive care population. The Centers for Disease Control (CDC) definition for VAP is regularly updated trying to homogenised practice, and the last version for paediatrics has been published in 2015. According to the latest CDC definition, the investigators aim to study incidence of VAP in different paediatric intensive care units (PICUs), diagnostic methods of identifying VAP, microbiology of VAP, and utilisation of empirical antimicrobial therapy.

Methods and population : a prospective multicentre observational study will be conducted in European PICUs for one year. All patients admitted to PICU aged more than 28 days and \< 18 years, mechanically ventilated either by endotracheal or tracheostomy tube are included. Clinical data, ventilation settings, and risk factors for VAP are inserted daily in an electronic database on the internet. The investigators are going to identify patients, who presented one or more episodes of VAP during PICUs stay, analysing onset circumstances, diagnostic methods, bacteria pathogens identified, and antibiotic treatment. VAP incidence will be reported as number of events per 1,000 ventilator-days. Risk factors associated to VAP will be identified by univariate and multivariate analysis.

Results and perspective : the investigators aim to define for the first time the incidence of VAP among European PICUs with a prospective and multicentre study. The identification of risk factors, diagnostic methods, epidemiology, treatment strategies will define the basis to start prevention manoeuvres and improve the clinical strategies for VAP in paediatric intensive care population.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to Pediatric Intensive Care Unit
* Aged more than 28 days and \< 18 years
* Mechanically ventilated either by endotracheal or tracheostomy tube

Exclusion Criteria:

-
Tools for Improving Colorectal Cancer Screening Rates: Multimedia Versus Print

The objective of this study is to compare the effectiveness of multimedia and print tools designed to provide patients at safety-net clinics with comprehensible information about colorectal cancer screening and motivate them to complete screening.The print and multimedia interventions were constructed with parallel content to allow valid comparison of format-related effects on knowledge and screening rates.These easy to use tools will provide under served patients at community health centers with clear and consistent messages about colorectal Cancer(CRC) and CRC screening, delivered immediately before the patients see a doctor.

Specific Aims

1. To determine if multimedia and print interventions that provide patients with information and motivational messages about CRC screening increase screening rates above usual care.
2. Determine whether showing patients a multimedia program achieves higher CRC screening rates than does a print booklet with equivalent messages.

   1. Examine if the effects of these multimedia and print interventions on CRC screening rates differ with literacy level.
   2. Examine if the effects of these multimedia and print interventions on CRC screening differ with race/ethnicity
   3. Examine if these multimedia and print interventions have differential effects on knowledge relevant to CRC screening.

Despite the clear benefits of screening for early detection and prevention of colorectal cancer, as many as half of eligible adults remain unscreened. Poor and under served populations, particularly African American and Latino/Hispanic adults, are at greatest risk for noncompliance with recommended tests. Health education strategies developed to date have led to relatively minimal gains, resulting in little translation to routine clinical practice. This is especially true in more difficult, resource-strained practice settings, such as community health centers.

The interventions in the proposed study draw on communication science to optimize message design, use communication technology to optimize message delivery and include parallel content in both print and multimedia versions to allow comparison of format-related effects on both knowledge and screening rates.The multimedia and print tools are based on patient education programs that we developed with extensive attention to theory as well as community member input.

Eligibility Criteria:
Inclusion Criteria:

* 50-80 years of age,
* Registered for an appointment at one of the target clinics,
* Speaks English or Spanish.

Exclusion Criteria:

* Patient has had CRC screening in the past 12 months,
* Unable to review the study materials because of language, physical condition or literacy.