cyrilzakka/clinical-trials huggingface dataset:
A Trial Comparing the Pharmacokinetic Properties of Faster-acting Insulin Aspart (FIAsp) After Different Injection Regions and Routes of Administration in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to compare the pharmacokinetic properties (the exposure of the trial drug in the body) of faster-acting insulin aspart (FIAsp) after different injection regions and routes of administration in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-64 years both inclusive at the time of signing informed consent
* Considered generally healthy upon completion of medical history, physical examination,analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator
* Body mass index 20.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period
The Effect of Uroshield on Sputum-specimen Bacterial Growth

The investigators retrospectively register the conduct of this study after its completion.

Background: Ventilator-associated pneumonia is a frequent complication of mechanical ventilation, caused by bacterial proliferation and biofilm formation on endotracheal tubes. The UROSHIELDTM is a small device that generates low-energy surface acoustic waves, which transmit energy to the endotracheal tube through a thin cable attached to the tube. Laboratory studies using catheterized urinary tract models have shown a significant reduction in microbial colonization and reduced development of antimicrobial resistance in UROSHIELDTM device treated individuals.

Purpose: To evaluate the impact of a UROSHIELDTM device, adapted for endotracheal tube diameter, on the development of positive sputum cultures in intubated patients.

Methods: The study was prospective, double-blind, interventional and randomized. Included were newly intubated patients, who were randomized at a rate of 1:1 by a physician not involved in the study. Patients, treating staff and study investigators were blinded to whether the patients received true or sham devices. Sputum cultures were taken at baseline and every three days for 15 days.

Eligibility Criteria:
Inclusion Criteria:

Mechanically ventilated patients

Exclusion Criteria:

Less than 18 years of age, pregnant women
Optimizing Treatment of Adhesive Small Bowel Obstruction

Small bowel obstruction (SBO) is one of the most common causes of serious gastrointestinal disease in the US. Adhesion-related SBO (aSBO) is usually treated by the placement of a nasogastric tube (NGT) to decompress the stomach, administration of intravenous (IV) fluids and observation by a surgical team.

The purpose of this feasibility study is to determine the potential for implementation of treatment protocols for aSBO and determine the feasibility of randomizing patients with aSBO to receive or not receive NGTs or water-soluble contrast (WSC). The investigators will also determine the ability to measure HRQOL as a main outcome for the treatment of aSBO. The studies outlined in this research program intend to address gaps in knowledge about how to determine who benefits from NGT placement, who can be managed without them, how to objectively determine when a bowel obstruction has resolved, how to reintroduce feeding to patients with aSBO, what criteria should be used for hospital discharge and what role cathartics such as WSC contrast have in the management of aSBO.

This feasibility study will enroll a limited number of patients (n=40) who will be followed for up to 30 days.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age.
2. Documentation of aSBO as evidenced by one or more clinical features meeting the following criteria: Nausea, emesis, abdominal pain, distended abdomen CT evidence of aSBO

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
2. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
3. Unstable angina or recent myocardial infarction (MI)/stroke within 6 months
4. Nonadhesive SBO

   1. Paralytic Ileus
   2. Incarcerated hernia
   3. Fecal impaction
   4. Intra-abdominal malignancy Early aSBO within 4 weeks of a prior abdominal operation
Clinical Performance of Masimo Rad-GT

The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy of temperature measurements.

Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05779397, NCT05787782, and NCT05674344).

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 to 80 years of age.
* Subjects are able to read and communicate in English as well as understand the study and the risks involved.

Exclusion Criteria:

* Subject is pregnant or nursing.
* Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. \*
* Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

(\* = Per study staff discretion)
Perfusion Index in Assessment of Postoperative Pain in Children.

The aim of this study will be to examine the validity of perfusion index in predicting pain and evaluation of its severity in the postoperative period.

\* Hypospadias repair is a common surgery that is accompanied with significant postoperative pain. The largest group of children usually undergo this type of surgery are infants and pre-verbal children who cannot verbally report pain, and their treatment depends typically on behavioral and observational tools. Although these tools are valid and reliable measures in assessment of pediatric pain, they are still hindered by their subjectivity, which consequently could result in inadequate pain treatment that in early childhood may lead to negative behavioral and neurophysiological sequalae.

That is why recent studies have focused on developing more objective measures to evaluate pain especially when self-report is not possible.

\* Changes in perfusion index(PI) caused by sympathetic stimulation refers to possible correlation between pain and PI which forms the basis of our study proposing that the PI is a non-invasive easy method that can be used in evaluating pain in infants

Eligibility Criteria:
Inclusion Criteria:

1. patients aged \<3 years
2. Sex:- both male and female.
3. ASA I-II
4. Informed written consent obtained from parents or guardians of all patients.
5. Undergoing hypospadias repair surgery

Exclusion Criteria:

1. Patients outside the selective age range
2. Parents or guardians refusing to enroll their child in the study.
3. ASA III or VI
4. Children with behavioral changes or physical developmental delay
5. Children treated with sedatives or anticonvulsants.
Clinical Study of Diazoxide Choline Controlled-Release Tablet (DCCR) in Patients With Prader-Willi Syndrome

• This is a single-center, open-label, single-arm study with a double-blind, placebo-controlled, randomized withdrawal extension. Patients are initiated on a DCCR dose of about 1.5 mg/kg (maximum starting dose of 145 mg) and are titrated every 14 days to about 2.4 mg/kg, 3.3 mg/kg, 4.2 mg/kg, and 5.1 mg/kg (maximum dose of 507.5 mg). These DCCR doses are equivalent to diazoxide doses of 1.03, 1.66, 2.28, 2.9, and 3.52 mg/kg. The administered dose will be as close to the mg/kg dosing as can be achieved by the available dose strengths of DCCR. Patients will be up-titrated at each visit at the discretion of the investigator. All patients will be continued in the double-blind, placebo-controlled, randomized withdrawal extension. Any patient who showed an increase in resting energy expenditure and/or a reduction in hyperphagia from Baseline through Day 55 or Day 69 will be designated a responder, whereas all others will be designated non-responders. Responders will be randomized in a 1:1 ratio either to continue on active treatment at the dose they were treated with on Day 69 or to the placebo equivalent of that dose for an additional 4 weeks. Non-responders will continue open label treatment during the extension.


Eligibility Criteria:
Inclusion Criteria:

* Children. adolescents and young adults with genetically confirmed Prader-Willi syndrome
* Ages at ≥ 10 years and ≤ 22 years
* Generally healthy as documented by the medical history, physical examination, vital sign assessments, 12-lead electrocardiogram (ECG), and clinical laboratory assessments
* BMI exceeds the 95th percentile of the age specific BMI value on the CDC BMI charts
* Fasting glucose ≤ 126 mg/dL
* HbA1c ≤ 6.5 %

Exclusion Criteria:

* Administration of investigational drugs within 1 month prior to Screening Visit
* Anticipated requirement for use of prohibited medications
* History of allergic reaction or significant intolerance to: diazoxide, thiazides or sulfonamides
* Anticipate transitions in their care from family home to group home or other similar potentially disruptive changes
* Congestive heart failure or known compromised cardiac reserve
* Any other clinically significant endocrine, cardiovascular, pulmonary, neurological, psychiatric, hepatic, gastrointestinal, hematological, renal, or dermatological disease interfering with the assessments of the investigational drug, according to the Investigator
Investigate the Effect of Food on the Pharmacokinetic of JLP-1207 in Healthy Male Volunteers

The purpose of this study is to investigate the pharmacokinetic drug interaction between Solifenacin and Tamsulosin in healthy male volunteers.

A randomized, open-label, single dose, two-way crossover study

Eligibility Criteria:
Inclusion Criteria:

* 19\~45 years healthy male
* Body weight is over 55kg, BMI measurement 18.0kg/m\^2\~ 27.0kg/m\^2
* Signed informed consent form from to participate voluntarily and to comply with the trial requirements.
* Researchers determined suitable volunteers through physical examination, laboratory tests

Exclusion Criteria:

* History of clinically significant liver, kidneys, nervous system, immune system, respiratory, endocrine disorders or tumor or blood disorders, cardiovascular diseases, mental disorders (mood disorders, obsessive-compulsive disorder, etc.)
* Sitting SBP\>150mmHg or \<100mmHg, sitting DBP\>100mmHg or \<60mmHg, after 3 minutes break
* An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
* Have a gastrointestinal disease history that can affect drug absorption (Crohn's disease ulcers, etc) or surgery (except simple appendectomy or hernia surgery)
* History of drug abuse
* Positive urine drug screening
* Administrated investigational product in a previous clinical trial within 90 days of the first administration day in this study.
* Donated blood within 60 days prior to the first administration day in this study.
The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial

We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy (HD-WLE).

We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI. Patients will undergo tandem colonoscopy, the second colonoscopy with either HD-WLE or an AI- assisted device.

We will include patients with a known pathogenic variant (PV) / likely PV in one of the MMR genes, who are undergoing endoscopic screening and surveillance in our institute. Patients will undergo a first colonoscopy with HD-WLE, and will be randomized at 1:1 ratio to undergo a second colonoscopy with either HD-WLE or an AI- assisted device. All visualized polyps will be removed and size, histology and numbers of polyps detected on each exam will be recorded. We will evaluate the adenoma detection rate and polyp detection rate in each arm and the number of adenomas / polyps in each arm.

Eligibility Criteria:
Inclusion Criteria:

* patients with a known pathogenic variant in one of the mismatch repair genes, who are undergoing endoscopic screening and surveillance in our institute

Exclusion Criteria:

* patients \< 18 years old
* lack of informed consent
* concomitant inflammatory bowel disease
* previous total colectomy
* inadequate bowel cleansing (Boston Bowel Preparation Scale (BBPS) ≤5 or \< 2 in one of the 3 segments)
The Development of Child Development Checklist Multimedia System and Its Clinical Evaluation

【Background\& Purpose】In order to early detect the problems a child might have during his/her development, an effective screening tool is of great needs. The \[Taipei City Child Development Screening checklist\] is often used to serve this process. This text version is mainly distributed to the parents to fill out during their child regular check-ups to the hospitals and clinics. The drawbacks of this checklist is that it lacks of active participation of the target population, and the text version limits its usage to people who are not familiar with Chinese characteristics, such as those new inhabitant. These lead to low screening rates therefore causing delayed early intervention. 【Purpose】The purpose of this study was to design and develop the multi-media graphic version of the \[Taipei City Child Development Screening checklist\] based on its original text version.【Method】The developed muti-media system will be checked for is validity. Thirty parents/legal guardians of children in each target age groups will be recruited randomly for the clinical reliability evaluation.


Eligibility Criteria:
Inclusion Criteria:

* For parents/primary caregivers whose children are between 3 months and 7 years old can participate.

Exclusion Criteria:

* Any visual impairment.
mHealth for Prevention of Childhood Obesity in Mexico

Background: The sending of text messages (short messaging service, SMS) has been proven as an effective strategy in behavior change. In Mexico, the Strategy of Comprehensive Care for the Nutrition (EsIAN for its acronym in Spanish ) focuses on improving access to information for the main caregivers of child beneficiaries on the practice of infant feeding and healthy physical activity.

Objective: To assess whether the mHealth (or mobile health) strategy or the sending of SMS has an effect on knowledge, attitudes, intentionality, perceived control and practices to prevent childhood malnutrition in a population living in poverty.

Design: Randomized effectiveness trial by conglomerates. Participants: 400 primary caregivers of children \<59 months and health personnel working in the health units included in the study.

Control group: Healthy child care in standard health units plus exposure to EsIAN.

Intervention group: In addition to the control group, the SMS are sent through a cell pone through the RapidPro platform on practices related to prevention of child malnutrition (in primary caregivers) and the reinforcement of counseling for the prevention of infant malnutrition (with health personnel).

Randomization: The first level health units were stratified by state (Morelos or Yucatan); rural and urban area and affiliation institution (Secretary of Health or Mexican Institute of Social Security); and randomized to be assigned to the control or intervention group; 400 primary caregivers of children \<59 months in total will be included for the study.

Main measures of interest: State of nutrition and knowledge, attitudes or practices on breastfeeding, physical activity, adoption and preparation of healthy foods and beverages in primary caregivers of children\<5 years old; and advice on the key messages of EsIAN by health providers.

RapidPro is a tecnological platform of programming of short messaging service (SMS) for cell phone.

Morelos is the name of one of the central states of Mexico Yucatan is the name of one of the south states of Mexico

Eligibility Criteria:
Inclusion Criteria:

* Primary caregivers whose beneficiaries children are cared in the health units selected for the study and who have a cell pone in home
* Health personnel who provides services to Prospera population in the health units selected for the study and that have a cell pone
* Primary caregiver, must care for at least one child under 60 months users of the health units selected for the study

Exclusion Criteria:

* Primary caregivers and health personnel who do not have a cell pone or who do not have connectivity in their communities
* Health personnel, who have been in office for a least 3 months
PeerNaija: A Mobile Health Platform Incentivizing Medication Adherence Among Youth Living With HIV in Nigeria

The PEERNaija application will feature routine medication reminders, along with individual adherence monitoring with adherence scores, anonymized peer adherence scores (from peers attending the same clinic; social incentive), and a monthly lottery-based prize for youth with the highest adherence scores (financial incentive). The Investigators will recruit a cohort of 50 HIV-infected adolescents and young adults (AYA) to pilot the app and assess feasibility, acceptability, adoption, and preliminary efficacy of important clinical measures (including adherence and virologic suppression). The proposed study will provide important preliminary data for the role of mobile health (mHealth) platforms to harness and deliver social and financial incentives to promote adherence efforts, especially for vulnerable youth, and for a larger intervention trial evaluating this app among HIV-infected AYA in Nigeria.

The use of digital health solutions, especially medication reminders delivered via mHealth platforms, have shown promise as adherence support tools in sub-Saharan Africa (SSA). Importantly, the proliferation of mobile phones in resource-limited settings and the early adoption of communication technologies by young people make mHealth technologies an ideal platform for this age group. The Investigators propose to pilot a novel, mHealth peer-based intervention for AYA living with HIV in Nigeria that will utilize social and financial incentives to promote medication adherence. In addition to medication reminders and peer support, the proposed intervention will innovate within the mHealth arena to leverage the currency of social incentives through daily adherence monitoring with the provision of adherence scores for individual users in relation to their peers, and financial incentives through a monthly lottery for youth with the highest adherence scores with the prize delivered through the mHealth application itself. This proposal builds on the Investigator's successful research collaborations in Nigeria with APIN Public Health Initiatives, (APIN, a multi-site non-governmental organization with solid President's Emergency Plan For AIDS Relief-funded HIV infrastructure), the investigators expertise in building capacity for implementation research, and proficiency in developing and deploying mHealth-based interventions in SSA. This will be accomplished through the following specific aim:

To establish the feasibility, acceptability, and preliminary efficacy of PEERNaija, an mHealth intervention designed to harness peer influence as an incentive to promote medication adherence among a pilot cohort of 50 AYA living with HIV in Nigeria. Hypothesis: PEERNaija will be feasible, acceptable, and show preliminary efficacy in improving antiretroviral (ART) adherence.

Eligibility Criteria:
Inclusion Criteria:

* Own a smartphone (on which they are willing to download PEERNaija),
* 16-27 years of age,
* on ART, and
* demonstrate the ability read simple text language in English.
Generation of Marfan Syndrome and Fontan Cardiovascular Models Using Patient-specific Induced Pluripotent Stem Cells

Medical researchers of National Heart Centre Singapore will carry out a state-of-the-art study that examines the possibility of changing patients' own cells into multi-functional and potent stem cells called iPS cells. These iPS cells can subsequently give rise to functional cardiac cells (myocytes) and other cardiovascular cells which might give further clues into the manifestation of the structural heart disease. This study involves blood sample collection for pre-screening and skin biopsies to establish skin cell culture.

Participants are invited to participate in this study because they have been diagnosed with Marfan's syndrome whereby a gene mutation is suspected to have affected major blood vessel of their heart or have a Fontan procedure that was carried out to re-direct blood flow in their heart. This study will recruit 30 subjects from National Heart Centre Singapore over a period of 1 year.

For clinically diagnosed Marfan disease, a genetic test in a gene called FBN1 will be carried out to confirm the presence of gene mutation that is suspected to cause the disease. It is important for them to know that any research finding that indicates the presence of this gene mutation may only suggest a pre-disposition to Marfan disease, but it does not definitely ascertain that gene has caused the disease or predict that they will develop the disease. Further independent clinical genetic testing may be made available, should they so desire after consulting their doctor or genetic counsellor.

The skin obtained during the course of this study will be used for this study only and will be stored and analysed for the purposes of this study only, for a period not exceeding 5 years for research studies and experimental transplant studies, and will be destroyed after completion of the study, unless they agree to donate the samples to National Heart Centre Singapore for continuous storage for future studies that are approved by Institutional review board. The blood will however be stored indefinitely in National Heart Centre for future research on molecular, imaging and outcome studies of cardiovascular health and disease.

Eligibility Criteria:
Inclusion Criteria:

* Patient that are under the care of the cardiologist and diagnosed with Marfan's syndrome or who had underwent Fontan palliation

Exclusion Criteria:

* No