cyrilzakka/clinical-trials huggingface dataset:
Cough Sensitivity and Taste Preferences

This single-site, within-subject, experimental study is designed to test the hypothesis children who live in a household in which one or both of their parent smoke will exhibit a higher cough threshold and will prefer more intense sweet tastes than children who live in a household where neither parent smokes. Subjects will include at least 50 racially and ethnically diverse, healthy children aged 10 to 17 years (a critical time for experimenting with tobacco) and a parent. The sample will comprise two groups: Non-Environmental Tobacco Smoke (ETS) Exposed (neither the child nor parents has ever smoked or been exposed to environmental tobacco smoke (ETS) in the home), and ETS-Exposed (the parent has smoked at least 3 cigarettes per day for at least five years in the home, with the child living in the home continuously). Cough sensitivity will be measured using a standard single-inhalation challenge, a test of the minimum concentration of capsaicin (the spicy chemical in hot peppers) needed to elicit cough. Sweet taste preferences will be measured using a forced-choice paired comparison method of liquids which differ in sucrose content. Measures of breath carbon monoxide will validate the smoking status of parents and their adolescent children. The key comparison will be between Non-ETS Exposed and ETS-Exposed children, with the difference between smoking and non-smoking parents as a positive control. Because smoking and non-smoking families may differ in ways besides tobacco exposure, the investigators will obtain health histories (with a focus on respiratory illness), smoking histories, measures of body weight, diet, and responses to personality tests (including susceptibility to addiction). The investigators will also obtain genomic DNA from saliva samples. Genes for chemosensory receptors that are part of the cough reflex pathway and genotype may account for aspects of cough sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults and children of both genders will be studied.
* Ages of children will range from 10 to 17 years.

Exclusion Criteria:

* Subjects with a current respiratory illness of any type (including current infection or infection within the last month, asthma, chronic obstructive pulmonary disease, bronchitis of any type, or any other breathing issue).
* Subjects who report that they have a history of asthma or other chronic respiratory condition.
* Subjects who report unusual sensitivity to environmental odors (e.g., reactive airways, multiple chemical sensitivity).
* Subjects who report that they have a history or allergic reactions to foods and/or chemicals.
* Subject who report that they are diabetic, or on any medication, with exception of birth control pills (for mothers only).
Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis

The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.


Eligibility Criteria:
Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis
Psychometric Properties of Sit-to-stand Test in Spinal Cord Injury

1. Do different arm placements (including arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) influence outcomes of sit-to-stand test (STST) in ambulatory individuals with spinal cord injury (SCI)?
2. What are the factors associated with ability to perform STST in ambulatory individuals with SCI?
3. Are the single-time sit-to-stand test (STSST) and five-time sit-to-stand test (FTSST) reliable, valid and responsive to determine functional alteration in ambulatory individuals with SCI?

* To cross-sectionally compare characteristics (duration and amount of lower limb loading) of STS movements among 4 arm placement conditions (arms on armrests/devices, arms on knees, arms free, and arm crossed over chest) in ambulatory patients with SCI.
* To investigate reliability (inter-rater, intra-rater, and test-retest), standard error of measurement and minimal detectable changes of the STSST and FTSST in ambulatory patients with SCI.
* To investigate concurrent validity and factors associated with ability of the STSST and FTSST in ambulatory patients with SCI.
* To investigate the ability of the STSST and FTSST to predict the risk of falls over 1, 3 and 6 months in ambulatory patients with SCI.
* To investigate internal and external responsiveness of the STSST and FTSST to detect changes on walking ability over 1, 3 and 6 months in ambulatory patients with SCI.
* To estimate the minimal clinically important difference or clinical significance of the FTSST in ambulatory patients with SCI.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 - 29.9 kg/m2
* Having an incomplete SCI from traumatic or non-traumatic causes
* Ability of independent standing up from a chair with or without hand support
* Ability of independent walking with or without walking device over at least 10 meters continuously.
* Ability to follow commands used in the studies

Exclusion Criteria:

Any ambulatory individuals with incomplete SCI who present signs and symptoms that might affect ability to perform STST will be excluded from the study such as

* Pain in the muscles or joints with an intensity of pain more than 5 out of 10 on a numeric rating scale (NRS)
* Joint deformities that affect mobility
* Other neurological disorders such as having brain lesions
* Unstable medical conditions
* Pregnancy
Impact of Using Mini-Bronchoalveolar Lavage as a Diagnostic Test for Ventilator-Associated Pneumonia

The proposed study will evaluate adult patients admitted to the medical or surgical intensive care units (ICUs) at San Francisco General Hospital (SFGH). On admission, patients will be randomized in a 1:1 manner to the mini-bronchoalveolar lavage (BAL) quantitative culture arm in the setting of suspected ventilator-associated pneumonia (VAP) versus the tracheal aspirate culture arm, which is the current test available at SFGH.

Patients will be randomized to either Mini-Bal or tracheal aspirate then samples will be taken to the lab for culture. Comparative analysis will then be performed based upon lab results.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (\> age 18) admitted to 5E, 5R, and 4E intensive care units and are on the ventilator for greater than 48 hours and expected to remain on the ventilator for awhile
* Study procedures would be performed only in patients clinically suspected of having VAP.

Exclusion Criteria:

* Severe respiratory distress at the time of suspected VAP defined by:

  * FiO2 ≥ 0.7
  * PEEP ≥ 12
Assessing Ocular Surface Changes After Changing Glaucoma Medications

Hypothesis: Changing to Travatan Z therapy increases the tear film break up time of subjects on Xalatan therapy presenting with ocular surface disease.

Patients who have been taking Xalatan monotherapy to treat their glaucoma and presenting with ocular surface disease will be advised to switch their medication to Travatan Z. Test results will be recorded at the day that the medication was changed and at follow-up to determine if there is a measurable change in tear film break up, corneal staining and in the Ocular Surface Disease Index.

Eligibility Criteria:
Inclusion Criteria:

* on Xalatan monotherapy from 1 to 18 months
* 18 years of age or older
* has been diagnosed with ocular surface disease

Exclusion Criteria:

* special populations such as children, pregnant females, prisoners, etc.
The Esbjerg Cohort - A Cross-sectional Study About Work Ability and Musculoskeletal Pain in 55 to 70 Years Old Workers

The overall aim of this study is to investigate how work with physical demands affects the physical capacity, work ability, labor market affiliation, pain and self-reported health in the oldest group of workers.

Following research questions are to be answered:

1. How high physical work demands affects muscle strength in 55-70-year-old workers and how obesity in combination with high physical work exposure influences muscle strength, work ability, cardiac function, and self-reported health?
2. Which parameters are important for work ability and how does the exposure of high physical workload affect the work ability over time in 55-70-year-old workers?
3. By exploring the underlying mechanism of pain among 55+ year old workers, how is pain associated with work ability, BMI and physical capacity?

This study is a population-based cross-sectional study conducted in the municipality Esbjerg, Denmark. This study wants to investigate how ergonomic exposure in relation to physical capacity has an effect on work ability and musculoskeletal pain in workers between 55 and 70 years old. This Ph.D. is a clinical study including physical tests, questionnaires, and long-term evaluation of work ability. The study population consists of 336 citizens divided into 12 groups stratified for gender, age (\< 60 years, 60-64 years and above 64 years) and occupational group (white-collar or blue-collar worker).

The study population will be recruited to uncover the physical workload among citizens 55+ years and compare the physical work demands to their health status, pain and physical capacity. The intention is to provide knowledge of the consequences of high physical workload on the musculoskeletal system in the oldest group of workers. This knowledge is necessary for better treatment and counseling to the oldest group of workers and for improved guidelines on how to optimize the balance between the physical work demands and the capacity of the workers.

Eligibility Criteria:
Inclusion Criteria:

* Men and women born between 1952 and 1966
* Living in the Esbjerg municipality
* Able to write, read and understand Danish

Exclusion Criteria:

* Injuries to arms or legs (e.g arm in plaster, acute trauma on ACL)
* Just had a surgery (e.g an operation in the abdominal region or in the brain)
Parental Perceptions and Acceptance of Silver Diamine Fluoride in Italy

Parental perceptions on staining due to Silver Diamine Fluoride (SDF) could affect its implementation in pediatric dentistry. This study represents the second part of a wider project focused on SDF aesthetic acceptability among Italian parents.

The aim of this survey was to assess the parental acceptance of Silver Diamine Fluoride (SDF) staining in Italy, and to examine wether the level of acceptability depends on location, child's behavior, or demographic background. A cross-sectional study was undertaken, involving 234 Italian parents whose children were attending two university dental clinics. Using a validated Italian version of the questionnaire 'Parental Perceptions of Silver Diamine Fluoride Dental Color Changes', researchers administered a series of closed-ended Likert-type questions to parents. The questionnaire included sets of colored photographs showing both anterior and posterior teeth before and after SDF treatment. Respondents were requested to provide their assessments based on the presented visual stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Italian-speaking parents
* Parents of healthy children or children with mild systemic disease. American Society of Anesthesiologists (ASA) status 1-2
* Parents of children under the age of 12 years
* Parents of children with previous caries experience in primary teeth
* Parents who consented to participate

Exclusion Criteria:

* No Italian-speaking parents
* Parents of children with ASA status ≥ 3
* Parents of children over the age of 12 years
* Parents of children without previous caries experience in primary teeth
* Parents who no consented to participate
Vaccine Against Atherosclerosis in Patients With Overweight Problems or Obesity

Atherosclerosis vaccine, V6, has been through two small-scale Phase II open label clinical trials. It has shown significant improvement in lipid profile in patients with overweight or obesity

The proposed study will evaluate daily dose of one V6 pill administered for one month in placebo-controlled, randomized, double-blind phase 3 trial in men and women with baseline waist diameter over 90 and 80 cm respectively. The effect of V6 will be assessed by changes in lipid profile, i.e., LDL, HDL, TG and TC; anthropomorphic indices, i.e., circumference of waist, mid-arm, and hips; arterial blood pressure and fasting glucose levels at baseline versus post-treatment timepoint.

Eligibility Criteria:
Inclusion Criteria:

* Baseline waist diameter over 90 and 80 cm for men and women, respectively

Exclusion Criteria:

* Pregnant and lactating women
* Individuals with clinical symptoms or diseases who in opinion of study investigators are not eligible to participate
Critical Respiratory Events in Children Requiring Naloxone: Naloxone Use as Opioid Safety Measure

Opioids are the mainstay of analgesia in hospitalized children but opioid therapy is associated with life-threatening respiratory depression requiring antagonism with naloxone. Hence, it is hypothesized that naloxone requirement can be used as a quality measure of opioid safety. A retrospective medical chart review of 95 patients, who received naloxone for life threatening events, from June 2006-2012, is planned, to identify significant factors associated with risk for opioid induced respiratory depression and formulation of preventive strategies.


Eligibility Criteria:
Inclusion Criteria:

* any gender, age or race
* administered naloxone for opioid induced respiratory depression

Exclusion Criteria:

* Any one who did not require naloxone for opioid induced respiratory depression
Effect of Low GI/ Glycemic Load (GL) Diet in Diabetic Nephropathy Patients

low GI and low GL diet have more beneficial effect for diabetic nephropath patients compared with conventional diet.

low GL may have more favorable effect than low GI diet.

According to body weight status of participants, the investigators considered a slight calorie restriction ranged from 200 to 300 Kcal/d. Planed meals and exchange list prescribed for all volunteers. Dietary records forms were given to all subjects and they were educated how to record their dietary intakes. The investigators asked subjects not to change their physical activity level during the study and monitored them for their physical activity level by 3 days physical activity records monthly.

Eligibility Criteria:
Inclusion Criteria:

* diabetic nephropathy, medication stable

Exclusion Criteria:

* poor adherence of dietary recommendations, any changes in kind or dosage of medications
Long-Term Outcomes in Patients With Three-Vessel Disease

The long-term outcome of coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), and medical therapy (MT) alone for triple-vessel disease (TVD) patients is controversial. The aim of this study is to evaluate the long-term outcome of TVD patients among these three treatment strategies, to find out the most appropriate treatment methods for these patients.

The present study was a retrospective observational study. Patients who underwent diagnostic coronary angiography from January 2013 to December 2018 were eligible for this study if they had three-vessel disease, which was defined as more than 50% stenosis in three major epicardial coronary arteries, left anterior descending, left circumﬂex, and right coronary artery. There were no pre-specified exclusion criteria. The choice of PCI, CABG, or MT was mainly followed the guidelines and based on clinical and angiographic features, physical condition (comorbidities, malignant tumor, frailty, etc.), complexity, and was discussed by physicians and surgeons, combined with the choice of patients. The PCI strategy and stent type were left to the physician's discretion.

The primary endpoint were major adverse cardiac and cerebrovascular events (MACCE), which were a composite of all-cause death, myocardial infarction (MI), repeat revascularization, or stroke. Clinical information of in-hospital outcome was obtained by reviewing medical records. Follow-up was completed by survey via telephone, letter, or hospital visit. All patients had at least one follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients were diagnosed as having three-vessel disease (defined as angiographic stenosis of ≥ 50% in all three main epicardial coronary arteries, with or without left main artery involvement) and age \>18 years.

Exclusion Criteria:

* None
Participatory Research for Suicide Prevention in Autism

The goal of this study is to pilot test a new educational intervention for organization members focused on suicide prevention for autistic people. The main questions it aims to answer are:

* Does participating in the intervention increase participants' knowledge, skills, and actions to support suicide prevention for autistic people?
* What feedback do participants have to help improve the intervention?

Participants will:

* engage in a four-part virtual educational intervention
* answer questions via online survey before, after, and 3-months after the intervention
* participate in an optional interview to provide feedback

This study will pilot test a new four-part virtual educational intervention called Forming Love around Autistic People to Prevent Suicide (FLAPS).

Participants will be active members of an organization (e.g., paid employee, volunteer, stakeholder) whose work impacts autistic people. They will participate in four virtual educational sessions led by trained facilitators.

The educational intervention will provide current research evidence and community-informed information about suicide risk and prevention, and engage participants in active discussions to expand their knowledge and skills as well as to promote action planning to support suicide prevention for autistic people in their community.

Participants will provide demographic and descriptive information and complete the Steps Toward Prevention (Autism Community Suicide Prevention) measure at three time-points (Pre-intervention, post-intervention \[approximately 2 months after baseline\], and 3-months after intervention). The Steps Toward Prevention (Autism Community Suicide Prevention) measure will assess participants' knowledge, skills, and actions to support suicide prevention for autistic people. They will also be provided an option to complete a short interview to provide feedback about the FLAPS intervention.

Eligibility Criteria:
Inclusion Criteria:

* Active member of an organization whose work impacts autistic people
* Age 18+
* Fluent English language to participate in virtual educational intervention

Exclusion Criteria:

* No access to an internet-connected device
* Unable to participate in a virtual educational intervention
Covid-19 Infection in After Vaccination

Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified in Wuhan, China. It rapidly spread, resulting a global pandemic in March 2020. Globally, till 27 August 2021, there have been 214,468,601 confirmed cases of COVID-19, including 4,470,969 deaths, reported to WHO.

With the absence of curative treatment for COVID-19 infection the development of safe and effective vaccines is critical to ending the COVID-19 pandemic. The Pfizer/BioNtech Comirnaty vaccine was listed for WHO Emergency Use Listing (EUL) on 31 December 2020. The SII/Covishield and AstraZeneca/AZD1222 vaccines (developed by AstraZeneca/Oxford and manufactured by the State Institute of India and SK Bio respectively) were given EUL on 16 February. The Janssen/Ad26.COV 2.S developed by Johnson \& Johnson, was listed for EUL on 12 March 2021. The Moderna COVID-19 vaccine (mRNA 1273) was listed for EUL on 30 April 2021 and the Sinopharm COVID-19 vaccine was listed for EUL on 7 May 2021. The Sinopharm vaccine is produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG). The Sinovac-CoronaVac was listed for EUL on 1 June 2021. As of 25 August 2021, a total of 4,953,887,422 vaccine doses have been administered. In large, randomized-controlled trials, vaccines were found to be safe and efficacious in preventing symptomatic, laboratory-confirmed COVID-19.

However, a small percentage of fully vaccinated persons will develop symptomatic or asymptomatic infections with SARS-CoV-2, the virus that causes COVID-19. A vaccine breakthrough infection is defined as the detection of SARS-CoV-2 RNA or antigen in a respiratory specimen collected from a person ≥14 days after receipt of all recommended doses of an FDA-authorized COVID-19 vaccine. A total of 10,262 SARS-CoV-2 vaccine breakthrough infections had been reported from 46 U.S. states and territories as of April 30, 2021. Among these cases, 6,446 (63%) occurred in females, and the median patient age was 58 years (interquartile range = 40-74 years). Based on preliminary data, 2,725 (27%) vaccine breakthrough infections were asymptomatic, 995 (10%) patients were known to be hospitalized, and 160 (2%) patients died.


Eligibility Criteria:
Inclusion Criteria:

* • Patients 18 years old and above of both genders.

  * Received at least one dose of COVID-19 registered vaccines.
  * Diagnosed COVID-19 positive after vaccination by real time PCR (confirmed case) or combined clinical and radiological diagnosis (possible case).

Exclusion Criteria:

• Children less than 18 years.

* Cases non vaccinated with COVID-19 registered vaccine
Positive Feeding of the Preterm Infant

The goal of this feasibility study is to assess the feasibility to implement a feeding strategy for preterm infants.

The main questions it aims to answer are:

* Is it feasible to implement the PoP-intervention in a level 3a category Neonatal intensive care unit?
* Is the PoP-intervention acceptable for parents of preterm infants and health care personnel working in Neonatal intensive care unit?

Parents of preterm infants and health care personnel will be asked to follow a protocol of a feeding strategy based on the preterm infants development and cues throughout the NICU-stay.

The parents will be recruited before or as soon as possible after birth. The intervention will start as soon as the parents have given written consent for themselves and behalf of their infant.

The intervention is developed in line with the MRC framework of developing and evaluating complex interventions in an iterative and dynamic way. The intervention will be based on parents counseling and an infant feeding protocol.

Eligibility Criteria:
Inclusion Criteria:

* gestational age of 28 weeks
* post menstrual age of 28 weeks after transition from regional hospital

Exclusion Criteria:

* diagnoses or malformations that makes eating difficult
* triplets or more
* parents not speaking/understanding Norwegian or English
* parents with challenges or special needs for follow up