cyrilzakka/clinical-trials huggingface dataset:
Customized Approaches for Evaluating and Reducing Chemical Exposures From Home Building Materials

This project will evaluate new approaches to quantify and reduce chemical exposures from common building materials, with an emphasis on plastic additives, pesticides, flame retardants and lead in addition to other environmental contaminants. The objective of this project is to develop methods to quantify and reduce chemical exposures from the home environment using approaches that are adaptable and customizable to individuals and households. To achieve this goal investigators will: 1) Identify the types of building materials and housing characteristics associated with higher levels of exposure to different classes of contaminants; 2) Assess the effectiveness of a simple robotic vacuuming intervention for reducing exposure to a range of indoor contaminants; and 3) Evaluate a new wearable silicone wristband for monitoring exposure to lead and other metals.

This study will leverage Project HOPE 1000 (Duke University Health System IRB Pro00100000), an existing longitudinal pregnancy cohort study. Investigators will invite a subset of women participating in HOPE 1000 (n=150) to participate in an environmental assessment involving home visits by a research team. Separate informed consent will be obtained from all participants. During home visits, environmental samples will be collected (e.g. dust and water) and participants will complete a questionnaire. A smaller subset of participants (n=50) will be asked to wear a silicone wristband to monitor ambient exposure to metals. Finally, to evaluate whether robotic vacuums can reduce exposure to environmental chemicals in the home, investigators will deploy robotic vacuum cleaners (i.e., Roomba) in 50 participants' homes. Investigators will measure a range of environmental contaminants and chemicals in environmental samples. This information will be combined with data and samples collected under the HOPE 1000 protocol. In particular, investigators will analyze maternal blood samples which have already been banked for metals and will analyze previously collected silicone wristbands for the same environmental chemicals targeted in previously collected samples.

Investigators will evaluate statistical associations between contaminants in the home and occupants' exposure. Investigators will also investigate changes in exposure before and after the intervention program. Risk to study participants includes the potential loss of confidentiality.

Eligibility Criteria:
Inclusion Criteria:

* Participants enrolled in Project HOPE 1000, a pregnancy cohort study at Duke University Medical Center.
* Any enrolled HOPE 1000 participants planning to remain in their homes for at least the following 12 weeks will be eligible for our sub-studies.

Exclusion Criteria:

* Individuals not planning to remain in their homes for at least 12 weeks.
* Those not able to communicate in fluent English will be excluded.
Effects of Corticosteroid Use on Restoration of Spontaneous Circulation in Cardiac Arrest Patients

We aim to investigate the effects of pre-arrest corticosteroid use for any reason on the time of return of spontaneous circulation in patients experiencing witnessed cardiac arrest, either in-hospital or out-of-hospital. Additionally, we plan to study the effects of corticosteroid use on post-ROSC administration of vasoactive agents, required dosage of vasoactive agents and number of vasoactive agents needed in order to reach targeted blood pressure levels.

Patients will be collected from Etlik City Hospital Emergency Medicine Department. Patients presenting with witnessed cardiac arrest, either in-hospital or out-of-hospital, will be enrolled in our study.

Inclusion Criteria:

Age 18 and above Witnessed cardiac arrest

Exclusion Criteria:

Traumatic cardiac arrest Forensic cases Cardiac arrest secondary to ST-elevation myocardial infarction Patients in whom spontaneous circulation could not be achieved despite cardiopulmonary resuscitation lasting more than 20 minutes Patients with inaccessible past medical records or unknown medication history Patients without identification Unwitnessed cardiac arrest Pregnant patients

Patients will be divided into two groups:

The first group will consist of 23 patients who used corticosteroid medications for any reason before experiencing cardiac arrest.

The second group will consist of 23 patients who did not use corticosteroid medications before cardiac arrest.

Following successful cardiopulmonary resuscitation and restoration of spontaneous circulation, the following parameters will be recorded for both groups: need for vasopressor support, number of vasopressor agents used, maximum dose of vasopressor agent(s) required to maintain mean arterial pressure (MAP) \>65 mmHg, duration of stay in intensive care unit/emergency department, mortality rate, length of hospital stay, patients' medical histories, age, and gender.

These parameters will be compared between the corticosteroid-using and non-using groups, and statistical analysis will be conducted to evaluate differences between the two groups

Eligibility Criteria:
Inclusion Criteria:

Age 18 and above Witnessed cardiac arrest

Exclusion Criteria:

Traumatic cardiac arrest Forensic cases Cardiac arrest secondary to ST-elevation myocardial infarction Patients in whom spontaneous circulation could not be achieved despite cardiopulmonary resuscitation lasting more than 20 minutes Patients with inaccessible past medical records or unknown medication history Patients without identification Unwitnessed cardiac arrest Pregnant patients
Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas.

Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. Because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated.

Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas by conducting a randomized, placebo-controlled, prospective clinical.

Eligibility Criteria:
Inclusion criteria

* Individuals aged 18-75 years
* Individuals who had at least one and no more than 6 histologically confirmed CRAs removed within 6 months before recruitment
* Individuals who are able to swallow pills
* Individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of this study, characters of the disease, effect of medication, methods of related examinations, and potential risk/benefits of the study 4.2 Exclusion criteria
* Individuals whose adenoma was not completely removed during previous colonoscopy
* Individuals with a history of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome)
* Individuals who are taking regularly aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D
* Individuals with a history of subtotal/total gastrectomy or partial bowel resection
* Individuals who are intolerant to another colonoscopy examination
* Individuals who are hypersensitive or intolerant to the drugs
* Individuals with severe heart, liver or kidney disease, or any cancer history
* Individuals presenting severe constipation
* Pregnant women, women during breast-feeding period, or women with expect pregnancy
* Individuals with mental diseases who are not able to cooperate
* Individuals who are involved in designing, planning or performing this trial
Intermediate-Size Patient Population Expanded Access Program for Intravenous Difelikefalin

This is an intermediate-size patient population expanded access protocol for the use of intravenous (IV) difelikefalin for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult patients undergoing hemodialysis.

Visits during the expanded access program will consist of a Baseline Visit to confirm eligibility and an End of Treatment visit. Patients will receive IV difelikefalin at a dose of 0.5 mcg/kg after each dialysis session, generally 3 times per week. The End of Treatment visit will be defined as the first dialysis visit following the last dose of IV difelikefalin under the intermediate-size patient population expanded access protocol.

Eligibility Criteria:
Key Inclusion Criteria:

* Adults ≥ 18 years old;
* Has end-stage renal disease (ESRD) and is currently receiving in-center hemodialysis;
* Has moderate-to-severe pruritus attributed to ESRD which is significantly impacting the patient's quality of life;
* Has no comparable or satisfactory alternative therapy for the treatment of moderate-to-severe pruritus, as determined by the sponsor-investigator.

Key Exclusion Criteria:

* Has severe hepatic impairment (Child-Pugh class C), as the influence of severe hepatic impairment on the pharmacokinetics of difelikefalin has not been evaluated;
* Is pregnant or nursing;
* Has been exposed to any other investigational medication in the past 60 days;
* Present any other reason which may lead to an unfavorable risk-benefit ratio for treatment with difelikefalin, as determined by the sponsor-investigator;
* Has a known or suspected allergy to difelikefalin or any component of the investigational product.
The Critical Care Response to the COVID-19 Pandemic in Madrid

Description of the adaptation of ICUs in the region of Madrid to que surge in demand of critical care due to COVID-19

Background

The worldwide SARS-CoV-2 pandemic has put healthcare systems under the extreme pressure, with intensive care units being faced with a previously unseen number of patients with severe respiratory failure requiring admission for endotracheal intubation and mechanical ventilation.

Methods

The study describes how the critical care resources adapted to the sudden surge of severe Covid-19 in the province of Madrid, which developed at the beginning of March 2020. The response consisted of a swift increase in ICU capacity and the relocation of patients. ICU beds were mounted outside the usual intensive care areas. Transfer of critically ill intubated patients with COVID-19 was managed in an instant messenger service group composed of representatives of 53 intensive care units and performed by the Madrid Emergency Medical Systems (EMS). The investigators will compare transferred with non-transferred patients matched for risk factors for cardiovascular and respiratory complications.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to ICU in Madrid with COVID-19

Exclusion Criteria:

* Admitted to ICU without COVID-19
Metformin in Older Adults With Type 2 Diabetes (AMEMET)

Multicentric, observational, cross-sectional study in Italy. The aims are to evaluate the daily metformin prescribed dose and the impact of renal function and concomitant medication in diabetic patients over 65 years.

The study was commissioned by the Italian Association of Clinical Endocrinologists (Association of Medical Endocrinologists - AME) and approved by the Ethical Committee of Cuneo Hospital. The research was open to all specialists taking care of patients with diabetes in Italy.

The primary endpoint was the evaluation of metformin dosage. Secondary endpoints were the relationship between the metformin dosage and the renal filtration rate and the relationship between the metformin dosage and the concomitant medication.

An ad hoc form was developed and used to record all medical findings. The form was emailed to all participating centers who then emailed or faxed it back to the investigator's data manager. Data were checked for accuracy.

The following data were required: age, gender, body weight and height, diabetes duration, type of metformin (classical/slow), daily dosage of metformin, reported side effects,concomitant medications.

Serum creatinine and HbA1c levels obtained within the previous two months were also required.

Each participating center recruited about 50 diabetic outpatients. Inclusion criteria were as follows: adult outpatients ≥ 65 years with T2 diabetes mellitus, using metformin for at least six months, usually assuming three daily meals, and capable of informed consent.

Eligibility Criteria:
Inclusion Criteria:

* adult outpatients (≥65 years);
* T2 diabetes mellitus;
* Taking metformin for at least six months;
* assuming three daily meals;
* capable of informed consent.

Exclusion Criteria:

* severe liver or renal failure (eGFR \<30 mL/min/1.73 m2);
* hospitalization for any cause in the last six month;
* glucocorticoid treatment in the last six month;
* oncologic treatment in the last six month;
* Ramadan in the last six months.
Continuous Intravenous Lidocaine Infusion Versus Placebo for Rib Fracture Analgesia

The current cornerstone of pain control for rib fractures is oral and intravenous opioids, especially in the form of patient-controlled analgesia (IV PCA), which are are associated with multiple adverse effects including sedation, respiratory depression, cough suppression, and increased risk of delirium.

In the past few decades, intravenous lidocaine infusion (IVL) has emerged as a new tool in the arsenal of multimodal analgesia. Multiple randomized clinical trials have indicated that IVL is overall well tolerated and have shown other beneficial effects such as anti-inflammatory properties. To this date, there have been no published randomized clinical trials (RCT) evaluating the effectiveness of IVL in management of traumatic rib fracture pain.

Therefore, the purpose of this study is to evaluate whether IV Lidocaine infusion can provide improved pain control as demonstrated by decreased OME consumption at 24 and 48 hours compared to placebo in adult patients with acute traumatic rib fractures.


Eligibility Criteria:
Inclusion Criteria:

* all adult patients admitted to Stanford Health Care with two or more acute traumatic rib fractures

Exclusion Criteria:

* hemodynamically instability
* mechanical ventilation
* polytrauma (defined as bone or organ injury outside the thorax)
* pregnancy
* incarceration
* local anesthetic allergy or contraindications to lidocaine (Stokes-Adams syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular block)
* chronic opioid use.
18613 - Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Measuring Omalizumab Responses Using Real-world Evidence (MORRE) Study

Develop new real-world evidence indicators of worsening and improving asthma. Scientists will measure (1) steps per day, (2) duration and intensity of exercise per day, (3) sleep duration and the number of awakenings per night using Fitbit activity trackers. Scientists will measure asthma symptoms using a once-monthly custom survey delivered to participant smartphones via Twilio. Scientists may measure rescue medication use and adherence to maintenance medications using digital inhaler devices. Scientists will correlate the above measures to participant-reported significant asthma exacerbations (SAEs), lung function (FEV1), and standardized surveys (i.e. the asthma control test (ACT) and global evaluation of treatment effectiveness (GETE)(4)) collected in clinic every 3 months. Coordinators will record any medication changes or reported medication side effects.

Determine response to omalizumab therapy. After participants are placed on omalizumab therapy as part of standard medical care, scientists will determine whether and how real-world evidence can be used to gauge responses to omalizumab. Then, scientists will determine which features, or combination of features, are the best indicators of disease control in the real world.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of uncontrolled or difficult-to-treat asthma, defined as 1 course of systemic corticosteroids (e.g. oral prednisone) in the last 12 months OR an asthma control test (ACT) score less than or equal to 19 despite regular use of inhaled corticosteroids (ICS) therapy (at least 176 mcg of fluticasone/day or the equivalent) for at least 1 month prior to enrollment.
* Participants will need access to a smartphone.

Exclusion Criteria:

* Active smoking and any significant comorbid conditions that could inadvertently interfere with study results as determined by the study investigators (i.e. any terminal illness, cancer, HIV, end-stage renal disease, congestive heart failure, severe autoimmune disease or inflammatory bowel disease)
* Conditions that require bursts of oral corticosteroids
* Other significant lung diseases (cystic fibrosis, pulmonary hypertension, interstitial lung disease, pulmonary fibrosis among others)
* Other disease that may mimic asthma, including vocal cord dysfunction, hypersensitivity pneumonitis, or tracheobronchomalacia.
Clinical Implications of Three-vessel Ultrasonic Flow Ratio Measurement in Patients with Coronary Artery Disease

This is a prospective, observational, single-center study. The main purpose of this study is to evaluate the diagnostic accuracy of offline computational ultrasonic flow ratio (UFR) in predicting functionally significant three coronary stenosis with conventional pressure wire-based fractional flow reserve (FFR) as the standard reference. The study will be conducted in Fuwai Hospital, and a total of at least 495 patients with all the three coronary vessel diameter stenoses ≥30% are planned to be recruited. Participants who meet the inclusion criteria and do not meet the exclusion criteria will undergo intravascular ultrasound (IVUS) followed by FFR examination. IVUS imaging will be sent to an independent core laboratory for UFR calculation. UFR analyses were performed offline in a blinded fashion without awareness of FFR measurement. Using FFR≤0.80 as the gold standard, the sensitivity and specificity of UFR in the functional significance of all the three coronary artery stenoses will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

Stable angina pectoris, unstable angina pectoris, or after the acute phase of myocardial infarction; Age ≥18 years; Written informed consent; Angiographically confirmed ≥30% diameter stenosis in all three major epicardial coronary arteries (left anterior descending, left circumflex, and right coronary artery); Patients with clinical indications for revascularization who have successfully completed percutaneous coronary intervention (PCI) prior to study enrollment.

Exclusion Criteria:

Ineligible for diagnostic IVUS examination; Prior coronary artery bypass grafting (CABG); Myocardial infarction within 72 hours of coronary angiography; Severe heart failure; Serum creatinine levels \>150 umol/L, or glomerular filtration rates \<45 ml/ kg/1.73 m2; Allergy to the contrast agent or adenosine; Life expectancy \< 2 years; Severe coronary artery disease requiring CABG identified during angiography; Extreme vascular tortuosity precluding IVUS catheter advancement; Suboptimal IVUS image quality impairing quantitative analysis.
Dental Attire Effect on Children's Dental Anxiety

The aim of this study is to evaluate the effect of friendly attire on dental anxiety among children visiting dental office in comparison with conventional attire. All of the children who will be experienced maxillary dental anesthesia with/without distraction will be assessed by using a combination of measures: Wong-Baker faces and the Children's Fear Scale (self-report), heart pulse rate, and behavior (using Anxiety levels using Face - Legs - Activity - Cry - Consolability "FLACC" scale "external evaluator") Acceptance will be measured using a two-point Likert scale.

This study will evaluate the effect of dental attire on children's acceptance of different dental treatments that include dental anesthesia. pain and anxiety will be evaluated during buccal and palatal infiltration using five behavioral scales, Wong-Baker pain scale, Children's Fear Scale and Children's Anxiety Questionnaire (self-report), pulse rate (physiological) and behavior (using FLACC behavior rating scale "external evaluator".

Heart pulse rate measurement will be recorded firstly when the patient is seated comfortably in the reception area, on dental chair prior to the injection, and finally after the procedure is done and the child patients will be asked to choose a face that describe their status from one of both Wong Baker faces scale, Children's Fear Scale and Children's Anxiety Questionnaire.

Body responses of all child patients will be recorded during the whole procedure and then will be evaluated by an external evaluator to determine the children behavioral score according to FLACC scale.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 6 and 10 years.
2. No previous dental experience.
3. Definitely positive or positive according to Frank scale.
4. Need of maxillary anesthesia for any dental treatment.

Exclusion Criteria:

1. Previous dental experience
2. Systematic or mental disorders.
3. Definitely negative or negative according to Frankel scale
Comparison of Face to Face Lecture, Interactive Internet Based and Computer Based Teaching

The investigators carried out a randomized controlled trial comparing three methods of teaching. These three instructional methods consist of face to face lecture, interactive internet based teaching and computer based teaching (lecture synchronized with presentation).

The hypotheses tested were: a) whether there is a difference between these three methods in knowledge achievement and b) whether there is a difference between Students satisfaction in three groups.


Eligibility Criteria:
Inclusion Criteria:

* 3rd year medical school's students

Exclusion Criteria:

* It must be their first experience of the course and they must have no previous elective or obligatory study about teaching topic (multiple myeloma).