cyrilzakka/clinical-trials huggingface dataset:
Validation of the Experience Sampling Dietary Assessment Method

A new dietary assessment method was developed based on the Experience Sampling Methodology. In order to use this newly developed Experience Sampling Dietary Assessment Method (ESDAM) in research and clinical practice as a valid and reliable method to measure dietary intake the ESDAM needs to be validated against objective biomarkers and reference methods.

The purpose of this research project is to advance nutritional research by delivering an improved, accurate, feasible and reliable method to assess dietary intake. Our newly developed approach to collate dietary intake based on experience sampling methodology (ESM) will serve this purpose.

Therefore, this research aims to validate the newly developed Experience Sampling Dietary Assessment Method (ESDAM) by assessing construct validity compared to blood and urine biomarkers representing dietary intake. This will eventually result in the newly developed dietary assessment method being evidence-based and validated and, thus, ready-to-use as a reliable method for research and clinical practice.

Therefore, the ESDAM will be validated against repeated 24-hour dietary recalls, the doubly-labelled water method, urinary nitrogen and blood biomarkers. The study has a duration of four weeks a. The first two weeks will be used to collect baseline data including socio-demographic, biometric data and three 24-hour recalls to assess dietary intake. During the last two weeks the Experience Sampling Dietary Assessment Method will be evaluated against urine biomarkers (Doubly-labeled water and urinary nitrogen), blood biomarkers (erythrocyte membrane fatty acid composition, beta-carotenoids) together with continuous glucose monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Having a smartphone and being capable of using the smartphone and apps
* Having a freezer at home
* Sufficient knowledge of the Dutch language to understand and participate in the study
* Having a stable body weight (body weight not changed by 5% last 3 months)
* Not aiming to gain or lose weight during the study period

Exclusion Criteria:

* Pregnant or lactating women
* Not following a specific diet for medical reasons (i.e. coeliac disease)
Cardiogenic Shock Working Group Registry

The Cardiogenic Shock Working Group is a multicenter registry where we collect de-identified clinical variables from the medical records and follow-up phone calls of shock patients from multiple institutions and centralize this data to a single registry for analysis of clinical outcomes.

The Cardiogenic Shock Working Group is an Academic Research Consortium involving multiple medical centers within the United States and includes a multicenter registry for patients with cardiogenic shock. De-identified clinical variables are collected from medical records and follow-up phone calls. There is currently no central database for cardiogenic shock, therefore analysis of cardiogenic shock on a larger scale is limited. A goal of the Cardiogenic Shock Working Group is to create a centralized registry, compiled of data from multiple institutions, to analyze clinical outcomes. The Cardiogenic Shock Working Group Registry will include a retrospective arm, where data is collected during the course of the hospital stay, and a prospective arm, where long-term outcomes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have cardiogenic shock.

Cardiogenic shock is defined by at least one of the two categories below:

1. At least 2 of the following concurrently at any point during the index hospitalization:

   * Cardiac Index \< 2.2
   * PAPI \< 1.0
   * Cardiac Power Output ≤ 0.6
   * MAP \< 60mmHg or a \>30mmHg drop in MAP from baseline
   * SBP \< 90mmHg or a \>30mmHg drop in SBP from baseline
   * Pulse \> 100
2. Require at least one acute mechanical circulatory support device, vasopressor or inotrope to maintain values above the above target.

Post-cardiotomy patients must meet the inclusion criteria 72 hours after their surgery to be included in this registry.
A Non-interventional, Observational Study for Targinact® Treatment in Patients With Chronic Severe Pain

This non-interventional, observational study is set up on request of the Belgian reimbursement authorities and evaluates the efficacy of Targinact with regard to pain relief and constipation in daily clinical practice in Belgium compared to the previous analgesic treatment with prolonged release oxycodone. Only patients eligible for Targinact® reimbursement in Belgium are included.

Patients are treated with Targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. Parameters assessed are pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of Targinact® treatment. These parameters, except for safety assessment, are compared between Targinact® treatment and previous analgesic treatment with prolonged release oxycodone.

Eligibility Criteria:
Inclusion criteria: patients included are patients who

* are eligible for Targinact® treatment according to the Targinact® SPC AND
* who have previously been treated with PR oxycodone during at least the last 30 days before study inclusion AND
* who are constipated (BFI \> 30) AND
* have used at least 2 laxatives with different modes of action during the previous PR oxycodone treatment

Exclusion criteria are based on Targinact® SPC.
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.

Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologic evidence of NASH based on liver biopsy obtained within 180 days
* NAS\> or = 5
* Able to swallow capsules intact

Exclusion Criteria:

* Symptoms of acute liver disease
* Cirrhosis on liver biopsy
* Positive HIV or Hepatitis tests
* Primary Biliary Cirrhosis
* Poorly controlled diabetes with HgA1C \>8.5%
* ALT \>4-fold upper limit of normal
* QTcF \>450 msec
* CrCl \<40 mL/min
Prospective Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Distal Lumen

Patients (female, male, or queer) with ureteral stones (smaller than 1 cm at the widest diameter of the stone) without pyonephrosis, urinary sepsis, or untraceable pain will be enrolled into the study. Ureteral width at the smallest area of the ureter (in most cases UV junction) will be noted during regular ultrasound scans. The ratio of ureteral width to the stone diameter will be correlated with the spontaneous stone passage.


Eligibility Criteria:
Inclusion Criteria:

Ureteral Stone smaller than 1 cm Volunteer to be enrolled

Exclusion Criteria:

Pyonephrosis Urinary Sepsis Untraceable Pain
Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho

The purpose of this trial is to determine if door-to-door is more effective than community gathering in providing voluntary HIV counseling and testing (VCT) in communities in rural Lesotho. The voluntary HIV counseling and testing will be proposed as an integrated part of a package of proposed services. The package consists of: Blood-pressure measurement, blood-glucose measurement, Body-mass-index (adults), weight for height (children), catch-up vaccinations, deworming (children) Vitamin A (children \& young women), family planning for eligible women, Tuberculosis screening and HIV counseling and testing.

12 health centers (clusters) in rural Lesotho are matched according to their routine performance in VCT and enrollment into chronic HIV/AIDS care (average numbers tested positive and enrolled into HIV/AIDS care per month per facility). After matching, 6 health centers are randomly assigned to perform door-to-door VCT, whereas the others perform the traditional community gathering approach (called "pitso" in Sesotho). Within the catchment area of each health center five campaigns in five different, randomly selected villages, are held (one day VCT campaign per village). Within each cluster another five villages are randomly selected who do not get a particular campaign and serve as a control for each cluster. In each matched cluster-pair, both health centers conduct the five campaigns during the same week (one conducting it as door-to-door, the other one conducting it through "pitsos" (community gathering)).

Both approaches receive the same resources in terms of finances, time spending doing the VCT-campaign and human resources.

Eligibility Criteria:
Inclusion criteria:

* Not already known to be HIV-positive
* Resident in the catchment area of the health center where the campaign is conducted
* Provision of written informed consent to participate (signed by writing or fingerprint)
* In case of children: Provision of written informed consent by an adult care-taker
The Effect of Video Information on Anxiety in Adolescents Having rRT-PCR Test During Corona Virus Pandemic

The Polymerase Chain Reaction (rRT-PCR) test is still the gold standard in the diagnosis of coronavirus disease. Health workers apply this procedure in a closed area, wearing personal protective equipment. Adolescents cannot be informed about the invasive procedure and it is difficult to communicate with them. Before the procedure, the effect on anxiety will be investigated by watching an informative video (containing information such as the materials used in the procedure, how long the procedure will take, how the sample will be taken, why healthcare workers wear personal protective equipment) prepared according to the developmental characteristics of the adolescents.

In the coronavirus pandemic, PCR testing is still the gold standard in the diagnosis of the disease. PCR with the right method can increase the sensitivity of the test. Adolescents' anxiety and anxiety levels may increase during invasive procedures such as PCR testing. In addition, in this process, factors such as the uncertainty created by the pandemic, disruption of routines, loss of school and peer social ties, and fear of getting sick bring along many mental disorders. The fact that the tests and treatments for the disease are new and that they are not informed about the procedures to be done cause the anxiety levels of the adolescents to increase. Nurses who treat adolescents with care and personal protective equipment may not be able to communicate verbally, sensorially, eye-to-eye with adolescents, and may have difficulty in conveying their voices and emotions. Likewise, by wearing a mask, it prevents nurses from observing their reactions to the hospital environment and procedures. Video education is one of the most effective ways for nurses to fulfill their educational roles during the epidemic when communication is limited. For this reason, it is very important to inform before the PCR sample collection process with a video prepared in accordance with the developmental stages of the adolescents. The aim of this study is to investigate the effect of the video that adolescents will watch before the procedure on their anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Applying to State Hospital for a PCR test
* Being literate in Turkish
* Not having a hearing or visual impairment, not having a mental disability.
* Not having had a previous PCR test sample taken
* To be in good general condition (clinically)
* Signing the informed consent form (child and parent)

Exclusion Criteria:

* Being illiterate in Turkish
* Hearing or visual impairment, mental disability
* Previous PCR test sample taken
* Absence of parents next to the adolescent
* Those who did not sign the informed consent form (child and parent)
The A-LIST WMM Insights Series

The main purpose of the Study is to develop an understanding over time and through multiple research projects, including surveys, interviews, online focus groups, and other primary research methodologies (A-LIST Research Projects) on what matters most to individuals concerned about brain health and those with and/or affected by Alzheimer's disease and other dementias, including caregivers.

To do this, UsAgainstAlzheimer's will identify and engage individuals who want to focus on brain health; individuals who are worried about their cognition; individuals who perceive themselves to be at risk for Alzheimer's disease (AD); individuals who may be at risk for AD due to self-identified confirmation of underlying disease pathology; individuals who self-identify as having a diagnosis of mild cognitive impairment (MCI) or of AD or another dementia; and those who self-identify as current or former caregivers of patients with Alzheimer's disease or another dementia to participate in the A-LIST Research Projects. Such participants will either already be - or will be invited to become - members of the A-LIST cohort, an online cohort of individuals ready and willing to engage in A-LIST WMM Insights Series (A-LIST members).

The A-LIST WMM Insights Series will enlist participants to offer insights into a range of issues relevant to Alzheimer's, including as examples issues pertinent to clinical trial design, regulatory submissions, other research strategies, payer value determinations, and care and services research. The A-LIST WMM Insights Series may seek information that in some instances will be marketing research or other research exempt from IRB oversight. However, when an individual A-LIST Research Project constitutes human subjects research consistent with governing law, IRB approval will be sought and obtained. Where questions exist whether an individual A-LIST Research Project constitutes human subject research, IRB determination will be solicited.

Eligibility Criteria:
Inclusion Criteria:

To be eligible to participate in the Study, an individual must meet all of the following criteria:

1. Age 18 years or older.
2. United States, Canada resident.
3. Self-report of cognitive difficulties, caregiver status or interest in brain health.
4. Have indicated willingness to participate by selecting "I Agree" option when joining the A-LIST. Additionally, will have clicked on link - invitation to take a specific survey
5. Able to speak, read, and understand English.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this Study:

1. Unable to comply with the Study requirements.
Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs

The purpose of the study is to evaluate the diagnostic value and safety of Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) Scope for peripheral pulmonary lesions (PPLs)

This study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (TCP-EBUS) Scope for the diagnosis of peripheral pulmonary lesions. The primary end point is to clarify the feasibility of using the thin convex probe EBUS scope to biopsy peripheral pulmonary lesions. The secondary objective is to evaluate operation time, sample adequacy and quality, factors affecting the diagnosis rate, etc. The safety, insertion ability, and operability of the thin convex probe EBUS would also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old.
* Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by pulmonary parenchyma and located below the segmental bronchus/located at least 2 airway generations from the main carina as seen radiographically.) suspicious of malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinical purposes, and the investigators consider it possible to be biopsied with BF-UC290F (the bronchus adjacent or leading to the PPLs are ≥5mm in diameter, thus BF-UC290F is able to arrival/access).
* Patients without contraindications of bronchoscopy.
* Patients have good medical adherence and signed informed consent.

Exclusion Criteria:

* Peripheral pulmonary lesion is pure ground-glass opacity.
* Visible lumen lesions during bronchoscopy
* The lesions were adjacent to the central airway (trachea, left and right main bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS Scope BF-UC290F were conducted without leaf bronchus entry
* The investigators believe that patient has other conditions that are not suitable for the study.
Impact of Starting Dose of Vasopressor on Hemodynamic Response in Shock

This study is designed to assess the effect of initial vasopressor dose on clinical outcomes. To date, there are no clinical guidelines or recommendations regarding the dose of vasopressor medication that should be initiated before titrating to a mean arterial pressure (MAP) in patients with circulatory shock. High heterogeneity and clinical equipoise regarding this variable exist in routine clinical practice. However, there is strong evidence that delays in achieving MAP goals lead to worse clinical outcomes. The study will randomize patients with circulatory shock to a low (5mcg/min of norepinephrine) or high (15mcg/min of norepinephrine) initial starting dose followed by the usual protocolized titration to MAP goal. The time to reach the goal MAP, organ dysfunction, hospital length of stay, and mortality will be measured for each group.


Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years old
* Patients who are diagnosed with shock (MAP \< 65 mmHg) require the initiation of vasopressors
* Care provided in the ED or admission to the Medical Intensive Care Unit (MICU)
* Norepinephrine chosen as first-line vasopressor by the treating clinician

Exclusion Criteria:

* Patients who are receiving vasopressors or inotropes prior to UI Health hospital presentation/admission
* Baseline MAP \>/= 65 mmHg
* Pregnant patients (checked as standard of care on admission)
* Prisoners.
* Immediate post-cardiac arrest patients
Tailored Bowel Preparation According to Bristol Stool Form Scale

The Bristol stool form scale ( BSFS) based tailored bowel cleansing regimen might be helpful to improve bowel cleansing quality before colonoscopy.

Colonoscopy is the standard approach for evaluating the colon currently. Thorough bowel cleansing is critical for adequate visualization of colonic mucosa during colonoscopy. Inadequate bowel cleansing results in adverse consequences for the examination, including lower adenoma detection rates, longer procedural time, lower cecal intubation rates, shorter intervals between examinations and an estimated 12-22% increase in overall colonoscopy cost.Unfortunately, despite advances in bowel preparation methods, up to one-third of all colonoscopies are reported to have an inadequate bowel preparation.

The Bristol stool form scale ( BSFS) was developed in 1988 by O'Donnell LJD et al and was widely applied in both gastrointestinal study and clinical practice. BSFS divides human stool into 7 different styles according to its moisture content. In our clinical work, we find that it is prone to gain poor bowel cleansing quality in patients who pass type 1or 2 stool. Unfortunately, there is lacking of study on tailored bowel preparation according to Bristol stool form scale. Thus, we intend to develop an easy, practical, BSFS based tailored bowel cleansing regimen, in order to serve clinical work and research.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older,
* scheduled to undergo elective outpatient colonoscopy,
* and were able to provide informed consent.

Exclusion Criteria:

* history of colorectal surgery
* severe colonic stricture or obstructing tumour
* dysphagia
* compromised swallowing reflex or mental status
* significant gastroparesis or gastric outlet obstruction
* known or suspected bowel obstruction or perforation
* severe chronic renal failure (creatinine clearance\<30 ml/min
* severe congestive heart failure (New York Heart Association class III or IV)
* uncontrolled hypertension (systolic blood pressure\>170 mm Hg, diastolic blood pressure\>100 mm Hg)
* inflammatory bowel disease or megacolon
* dehydration
* disturbance of electrolytes
* pregnancy or lactation
* haemodynamically unstable
* unable to give informed consent.
Study of ARO-APOC3 in Healthy Volunteers, Hypertriglyceridemic Patients and Patients With Familial Chylomicronemia Syndrome (FCS)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and in patients with severe hypertriglyceridemia and familial chylomicronemia syndrome (FCS).


Eligibility Criteria:
Inclusion Criteria:

* Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
* Willing to provide written informed consent and to comply with study requirements
* Normal electrocardiogram (ECG) at screening
* Hypertriglyceridemic patients must have a history of fasting serum triglycerides of at least 300 mg/dL (3.38 mmol/L) at screening or verifiable diagnosis of FCS

Exclusion Criteria:

* Clinically significant health concerns
* Regular use of alcohol within one month prior to Screening
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
* Recent use of illicit drugs
* Use of more than two tobacco/nicotine containing or cannabis products per month within 6 months prior to drug administration (applicable only to Normal Healthy Volunteers)

Note: additional inclusion/exclusion criteria may apply, per protocol
Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP

The study evaluates whether lung ultrasound monitoring could lead to earlier detection of ventilator associated pneumonia and influence outcome. Half of the participants will be diagnosed with VAP using a combination of lung ultrasound and clinical features and half will be diagnosed using the Johanson criteria, which is a combination of clinical features and chest x-ray.

The current guidelines recommend the use of chest x-ray or computed tomography of the chest to aid in the diagnosis of VAP. However many studies have shown that chest x-ray is neither very sensitive nor specific for pneumonia, and computed tomography, though has the highest diagnostic accuracy, is not routinely performed due to logistics, safety concerns, economics and radiation exposure.

Emerging studies including meta-analyses have shown high sensitivity and specificity of lung ultrasound in diagnosing pneumonia. When combined with clinical and microbiological features it has shown to be helpful in early diagnosis of VAP, but a study to show whether such early detection improves outcome is lacking.

Eligibility Criteria:
Inclusion Criteria:

* Mechanical ventilation for more than 48 hours
* Absence of pneumonia as the reason for mechanical ventilation (includes clinical, radiological or sonographic diagnosis)

Exclusion Criteria:

* Recent trauma or surgery to the thorax (including chest tube insertion)
* Presence of dressings or skin conditions restricting access to the thorax
* Confirmed pregnancy
* If already enrolled in the study
* Denial of consent