cyrilzakka/clinical-trials huggingface dataset:
Incentives and Glucose Adherence in Diabetes

Diabetes in pregnancy carries significant pregnancy specific risks and requires frequent glucose monitoring to reduce these risks. This project compares the effect of two incentive schemes on adherence rates of glucose testing in pregnancy.

Diabetes in pregnancy is associated with increased risks of maternal and fetal complications and can be challenging to manage due to increasing insulin requirements with advancing gestational age. Based on standard of care guidelines, patients with diabetes check their blood glucose at least 4 times per day. Optimal management requires frequent glucose self-monitoring and active management of abnormal blood sugars and medications by clinicians. Poorly controlled diabetes has both significant maternal and neonatal consequences: Improving test adherence could benefit both the pregnant woman and her fetus. In this study, we propose to test the effect of two incentive schemes on rates of glucose monitoring on pregnant women with diabetes requiring medication.

Pregnant women with diabetes requiring medication are invited to participate if they meet specific inclusion criteria (\<28 weeks) and followed in our outpatient clinic. Participants are randomized into one of three groups:

1. control group - receive compensation at time of enrollment,
2. positive incentive group - receive compensation per test completed
3. loss aversion group - receive between a range of compensation depending on their overall level of adherence.

Primary outcome of the study is frequency of prescribed glucose testing in pregnancy

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with insulin dependent diabetes prior to 28 weeks gestation.

Exclusion Criteria:

* incarcerated, not English speaking
HAIC Plus Toripalimab vs. HAIC Plus Sorafenib for HCC With PVTT: a Non-comparative, Prospective, Randomized Trial

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus toripalimab versus hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib in patients with hepatocellular carcinoma (HCC) with portal vein tumor thrombus.

Our previous study showed that hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin plus sorafenib was more effective and safe than sorafenib for hepatocellular carcinoma with portal vein tumor thrombus. Programmed cell death protein-1 (PD-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has compared HAIC plus toripalimab with HAIC plus sorafenib. Thus, the investigators carried out this prospective, randomized, non-comparative study to find out it.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Patients with portal vein tumor thrombus
* Eastern Cooperative Oncology Group performance status of 0 to 2
* With no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

Platelet ≥75,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 32 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

• Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
A Study Comparing The Bioequivalence Of Ciclesonide Nasal Spray (Apotex, Inc.) To That Of Omnaris™ Nasal Spray (Sepracor, Inc.) In The Treatment Of Seasonal Allergic Rhinitis

This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of the marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic ciclesonide nasal spray compared with Omnaris™ nasal spray.


Eligibility Criteria:
Inclusion Criteria:

* If female of childbearing potential, is not pregnant (confirmed by negative urine pregnancy test) or lactating and must have used reliable birth control measures throughout the study.
* At least a 2-year reliable medical history consistent with SAR
* Positive skin test within 12 months of screening to at least one seasonal allergen present in the geographical area
* Capable of tolerating intranasal application of the IMP, willing and able to comply with the requirements of the protocol
* No clinically significant findings in physical and nasal examinations, and medical history.
* A reflective TNSS of at least 6 (out of 12) in the 24 hours prior to placebo lead-in visit.
* Successfully complete the placebo lead-in period.

Exclusion Criteria:

* - Signs or symptoms of nasal polyps, deviated septum, or any other condition which, in the opinion of the Investigator, could resulted in erroneous study data.
* Undergo nasal surgery or had nasal trauma within 3 months of screening.
* Active respiratory conditions or respiratory tract infection that require antibiotic treatment within 2 weeks of screening
* Persistent allergic rhinitis (PAR) that does not require or not expected to require active PAR treatment during the study period.
* Evidence of any unstable or clinically significant conditions that would place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives.
* Presence or history of clinically significant conditions which in the opinion of the Investigator would have compromised the safety of the subject or the conduct of the study.
* Use of corticosteroids, intranasal cromolyn, Leukotriene inhibitors, long or short acting antihistamines, intranasal or systemic decongestants prior to the start of the single-blind, placebo lead-in visit within the time periods specified in the protocol or receiving immunotherapy.
* Use of an investigational drug within 30 days before screening or during the study.
* Known or suspected hypersensitivity to corticosteroids.
* Inability to avoid exposure to chicken pox or measles.
* Infection requiring oral antibiotic treatment 2 weeks prior to screening.
* Previously identified as a placebo responder or known as a non responder to corticosteroids.
* History of alcohol, drug, or substance abuse in the 12 months prior to Visit 1 (screening).
* Positive for hepatitis B or C, or human immunodeficiency virus (HIV).
* Uncooperative or non compliant.
* Female subjects who planned to become pregnant during the conduct of the study.
* Current smoker (former smokers had to be 6 months smoke free).
Metabolic and Endocrine Status in Women With Prior Preterm Birth

The prevalence of preterm birth is rising in most western countries. The causes of preterm birth is not fully understood and seem to be multifactorial. The endocrine and metabolic aspects are scarcely investigated.The main purpose of this study is to test the hypothesis that endocrine and metabolic factors associate to preterm births.


Eligibility Criteria:
Inclusion Criteria:

* One or more preterm birth in the given period of time
* Having Namsos Hospital as their local Hospital during pregnancy

Exclusion Criteria:

* Moved from the region of Mid- Norway at the time of the study
* Lack of communication skills in Norwegian or English
* Ongoing pregnancy
* Ongoing breastfeeding
A Study to Evaluate a Computerized Stethoscope Called ©Voqx to Diagnose Heart Disease

The purpose of this study is to determine whether recording heart sounds with an acoustic stethoscope, combined with artificial intelligence (computer information), will show similar abnormalities to an echocardiogram or cardiac catheterization.

In the current study the plan is to recruit 600 patients who have been referred to the echocardiogram laboratory for routine clinically indicated echocardiography, or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures. Individuals with normal heart structure and sounds, isolated aortic stenosis (of varying severity), and isolated mitral regurgitation (of varying severity) will be included, while excluding individuals who have multiple valve involvements or combined valve pathologies. Each patient will have baseline testing using the ©CompuSteth device, which will be used to auscultate and record each patient's heart sounds at the bedside prior to the index echocardiogram or cardiac catheterization procedure. This process will take less than 10 minutes and is outlined below. Patients will then proceed with their clinically indicated echocardiograms or cardiac catheterization procedures.

Amongst the first 200 study participants, the results of the echocardiograms and invasive cardiac catheterization procedures will be used to train the ©VoqX device to identify normal heart and to screen and grade for various cardiac structural pathologies, aortic stenosis, and mitral regurgitation, diagnosed by gold-standard testing. Subsequently, after the ©VoqX device has been trained how to characterize and identify sounds that correspond to various structural cardiac pathologies, the next step is to prospectively 'test' how well the ©VoqX device is able to screen normal heart from cardiac pathologies, such as aortic stenosis, and mitral regurgitation, and identify the severity of the valve disorder in the subsequent 200 participants of the study. This will be done by comparing the results obtained from auscultation with the ©VoqX device against the results obtained from gold-standard testing with echocardiography or invasive cardiac catheterization.

Eligibility Criteria:
Inclusion Criteria

* Aged 18 years of age or older.
* Referred to the echocardiogram laboratory for routine clinically indicated echocardiography, or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures
* Individuals with normal heart sounds, isolated aortic stenosis (any degree of severity), or isolated mitral regurgitation (any degree of severity)

Exclusion Criteria

* Patients with unstable cardiovascular or pulmonary disease
* Patients with mixed valvular heart disease, corresponding to more than one type of valve pathology (i.e.: Aortic stenosis and Aortic Regurgitation), or more than 1 valve involved (i.e.: aortic stenosis and mitral regurgitation)
Does Saxagliptin Reduce the Risk of Cardiovascular Events When Used Alone or Added to Other Diabetes Medications

The purpose of this study is to determine whether saxagliptin can reduce the risk of cardiovascular events when used alone or added to other diabetes medications

A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* HbA1c ≥6.5%. (based on the last measured and documented laboratory measurement within 6 months)
* High risk for CV events -Established cardiovascular disease and/or multiple risk factors

Exclusion Criteria:

* Current or previous (within 6 months) treatment with DPP4 inhibitors and/or GLP-1 mimetics
* Acute vascular event \<2months prior to randomisation
Using Telemedicine to Optimize Teamwork and Infection Control of Critical and Highly-infectious Patients in an Emergency Department

Since 2000, various emerging infectious diseases have repeatedly caused serious impact on the health of the global population and the healthcare systems. With the growing international transportation and improving accessibility of the healthcare systems, hospitals have been inevitably the first sentinels dealing with emerging infectious diseases. The biological disasters, such as the Severe Acute Respiratory Syndrome (SARS) in 2003, the Middle East Respiratory Syndrome (MERS) outbreak in South Korean in 2015, and the Coronavirus disease 2019 (COVID-19) outbreak this year, challenged our vulnerable healthcare systems and caused great loss of lives.

Regarding the ongoing global epidemics and possible community outbreaks of the COVID-19, the management of biological disasters for an overcrowded emergency department should be planned. In the early 2020, the emergency department used a double-triage and telemedicine method to treat non-critical patient with suspected COVID-19. This application reduced the exposure time of the first responders and reserve adequate interview quality. However, for the critical patients treated in the isolated resuscitation rooms, the unique environment limited the teamwork and communication for the resuscitation team. These factors might led to poorer quality of critical care.

The investigators designed a telemedicine-teamwork model, which connected the isolation room, prepare room and nursing station by an video-conferencing system in the emergency department. This model try to break the barriers of space between the rooms and facilitate the teamwork communications between each unit. Besides, by providing a more efficient workflow, this model could lower the total exposure time for all workers in the contaminated area. This study was conducted to evaluate the benefits of the telemedicine-teamwork model and provide a practical, safe and effective alternative to critical care of the patients with suspected highly infectious diseases.


Eligibility Criteria:
For patients:

1.Patients triaged as highly-infectious patients, needed to be treated in isolation rooms in the emergency department.

For healthcare providers:

1. Those providers who participates in the critical care for the patients included in the study accordingly
Effect of Spacer in Extrafine Formoterol-Beclomethasone Treatment to Asthma

Combined inhaled treatment with long acting adrenergics and steroids in an unique inhaler plays an important role in the management of non-mild asthma. Some studies have demonstrated that the use of spacers achieve better lung deposition and decrease the number of side effects. Recently a new combined treatment for asthma has been developed (extrafine formoterol plus beclomethasone dipropionate). The small size of the extrafine particles of this new combination get the small airway and theorically improve their positive effect. Some authors have stated that the use of a spacer with extrafine particle could decrease the effectiveness of this treatment due to the adhesion of particles on the walls of the spacer because of the electrostatic characteristics of plastic spacers. However, there are no clinical or functional studies demonstrating the role of this phenomena in the control of asthmatic patients. The investigators' hypothesis is that the benefit of using spacers with this new treatment is at least equal in magnitude than the loss of efficacy because of the adhesion of particles on the wall of the spacer and then the investigators hypothesized that the use of spacer with extrafine formoterol-beclomethasone do not suppose a decrease in clinical or functional control in stable moderate-severe asthma patients.


Eligibility Criteria:
Inclusion Criteria:

* Moderate-severe asthma
* Stable asthma
* 18-75 years old

Exclusion Criteria:

* Exacerbation of asthma
* Instability with the study treatment
* Other cardiopulmonary disease
Gastrodin Prevents Cognitive Decline Related to Cardiopulmonary Bypass

The incidence of cognitive decline related to CPB ranges from 20% to 80%, which may affect length of hospital stay, quality of life, the rehabilitation process, and work performance.However, there is no method to prevent the decline.Gastrodin,the active constituent of gastrodia elata, has been widely used for the treatment of paralysis, hemiplegia, headache, vertigo, and Alzheimer's disease. Gastrodin is safe. No severe side-effect has been observed in the treatment. We postulate that gastrodin would attenuate the causative parameters of cognitive dysfunction related to CPB and would be an effective drug to prevent the decline as a result.

Cardiac surgery with cardiopulmonary bypass (CPB) is one of the most frequently performed operations. Neurobehavioral disorders, including neuropsychiatric and neuropsychological deficits, are a very frequently reported sequela of valve replacement or coronary artery bypass grafting (CABG) surgery. CPB is associated with significant cerebral morbidity. The incidence of cognitive decline related to CPB ranges from 20% to 80%, which may affect length of hospital stay, quality of life, the rehabilitation process, and work performance. Neurocognitive decline can present days to weeks after surgery and may remain a permanent disorder. Many pharmacologic strategies have been proposed or investigated for preventing post-CPB cognitive decline, but to our knowledge, none of these drugs has been systematically evaluated for efficacy in preventing post-CPB cognitive decline.

The causative parameters of cognitive dysfunction associated with CPB include cerebral ischemia secondary to either microemboli or hypoperfusion, intraoperative cerebrovascular risk factors such as the duration of CPB, inflammatory response, cerebral glutamine release, free radicals, and NO release.

Gastrodia elata, a famous Chinese medical herb, has effects on preventing ischemic brain injury, neuronal cell damage or apoptosis, suppressing inflammatory response, inhibiting glutamine receptors and nNOS, and scavenging free radicals. Gastrodin (4-\[hydroxymethyl\]phenyl-β-D-glucopyranoside), the primary active constituent of gastrodia elata, has been widely used for the treatment of paralysis, hemiplegia, headache, vertigo, and Alzheimer's disease. Based on its pharmacological effects, we postulated that gastrodin would attenuate the causative parameters of cognitive dysfunction related to CPB and would be an effective drug to prevent the decline as a result.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients undergo mitral valve replacement surgery.

Exclusion Criteria:

* Thrombi in left atrium, a history of symptomatic cerebrovascular disease, diabetes, psychiatric illness, renal disease, or active liver disease, less than a seven-grade education, or who cannot read.
Effects of Active Reminders and Motivational Techniques on Oral Hygiene and Gingival Health in Orthodontic Patients

This study will compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements.

Orthodontic treatment (i.e. braces) makes it hard to keep good oral hygiene. The purpose of this research study is to compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements. Participation in this study will last up to 6 months and will consist of 4 study visits to the VCU Orthodontic clinic which are also regular visits for treatment. Measurements to assess participant's oral health will be taken during these visits. Participants will be randomly assigned to 1 of 4 groups which may include receiving different types of text messages, repeated in-person oral hygiene instructions, or both, or neither.

Eligibility Criteria:
Inclusion Criteria:

1. Age 11-20 that have their own mobile device
2. Patients have cellular plan that allows them to receive text messages at no extra cost
3. Patients that will undergo treatment with full fixed appliances

Exclusion Criteria:

1. patients with significant medical or dental history, including patients with bleeding disorders that would require antibiotic prophylaxis
2. Pregnant women
Aortic Dissection With 4-dimensional Phase-contrast Magnetic Resonance Imaging

We prospectively collected information on consecutive patients who had been evaluated using 4D PC-MRI for aortic pathology in a tertiary hospital between April 2018 and Feb 2020. Patients were eligible for inclusion in the study if they had a clinical indication for CTA of aortic dissections.

The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In addition, patients with poor compliance and with unstable status that prevented them from lying down for the MRI protocol were excluded. Initially, 26 patients evaluated. One patient was excluded due to fever at the scheduled time, and another was unable to lie down due to complicated spine disease. All patients underwent CTA scan on a 64-slice multidetector scanner (Somatom Sensation 64; Siemens Healthcare, Erlangen, Germany) with the intravenous administration of contrast media, followed by 4D PC-MRI to assess aortic pathology

Eligibility Criteria:
Patients were eligible for inclusion in the study if they had a clinical indication for CTA of aortic dissections. The exclusion criteria were non-MRI-compatible ferromagnetic devices and pregnancy. In addition, patients with poor compliance and with unstable status that prevented them from lying down for the MRI protocol were excluded.
Prevention of Surgical Site Infections

The primary research question is whether interventions to prevent caregiver and system errors will increase the proportion of laparotomy patients who receive recommended measures to prevent surgical site infections.

Background: Surgical site infections (SSIs) cause significant and largely preventable morbidity, mortality, and resource use due to failure to comply with evidence-based guidelines. Quality improvement programs report increased compliance with these guidelines, but are subject to a variety of biases.

Hypothesis: The primary hypothesis is that a targeted intervention program will increase the proportion of patients in a county hospital who receive recommended interventions to prevent SSIs, when assessed in the most rigorous feasible clinical trial. The specific aims of the trial are to establish practical surveillance measures to determine the percentage of patients whose care complies with 5 major guidelines to prevent SSIs; to use chart review, direct observation, attitude surveys, and focus groups to identify, quantify, and address latent and active errors linked to non-compliance, and to develop, implement, and assess the effectiveness of an intervention program to increase guideline compliance.

Study Design: An innovative trial design will be performed with 3 staggered phases in the two major county hospitals in Houston, TX. This design allows for adjustment for temporal trends and hospital differences in assessing the intervention program in a large, high-risk, disadvantaged urban population. Based on a compliance goal of 95%, this design has adequate power to detect even a small absolute increase ( \>= 5%) above baseline in the percentage of patients receiving all 5 recommended preventive measures.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing laparotomy at either Ben Taub Hospital or Lyndon Baines Johnson Hospital in Houston, Texas

Exclusion Criteria:

* None