cyrilzakka/clinical-trials huggingface dataset:
Optimizing Care for Patients With Dementia

Of the 1.4 million nursing home (NH) residents in long term care facilities, more than half have Alzheimer's disease or dementia. Due to changes in their familiar daily routines, difficulty expressing their thoughts or asking for what they need, and overstimulation (such as noise) or under stimulation (such as lack of activity), individuals with dementia often display disruptive behaviors like resisting help or continually repeating the same phrases. Medications are often prescribed to reduce agitation and aggressive behavior; however, these medications may not be effective and can have a negative impact on the individual. Therefore, families and other stakeholders strongly advocate the use of other types of approaches that focus on minimizing the cause of the behavior. Two facility-based methodologies include the transdisciplinary approach for integrated dementia care, which combines the expertise of all NH staff, who work together to build a common language and approach for each resident, and the multidisciplinary approach for problem-based dementia care, in which each staff member conducts individual assessments and makes discipline-specific recommendations. While prior research suggests that both of these facility-based approaches are useful, the circumstances under which each approach is most effective are not clear. This project will prospectively randomize 80 nursing homes to one of the two treatment arms to compare the effect of the transdisciplinary approach versus the multidisciplinary approach.

This study will examine the difference between the two comparators with respect to facility rates of medications dispensed to residents with dementia, leading to enhanced quality of life for the resident.

This project is important because it will address a key clinical dilemma NH staff face as they strive to optimize the use of alternative approaches to reduce disruptive behaviors in residents with dementia. Transforming the quality of dementia care in NHs and enhancing the quality of life of residents with dementia are high priorities for families and other advocates.


Eligibility Criteria:
Inclusion Criteria:

Eligible nursing home facilities will

* lack any existing dementia program targeting reduction of off-label psychotropic medication use
* each serve \>60 long-term care residents with Alzheimer's or dementia
* meet Center for Medicare \& Medicaid Services' minimum requirements for NHs (e.g., meeting the mandated number of hours of staff training on dementia care, performing regularly scheduled resident assessments).

Exclusion Criteria:

Facilities will be excluded if they have

* less than 60 long-stay residents
* an existing formal dementia care program in place
* an off-label psychotropic medication reduction program
* is located in a state that requires more than the Center for Medicare \& Medicaid Services' minimum for staff training requirements on the topic of dementia care
Evaluation on the Proper Size of the Nasotracheal Tube and Depth in Nasotracheal Intubation: a Preliminary Study

The nasotracheal intubation is preferred for oral surgery; it provides an easier view of the surgical field. However, nasotracheal tubes are produced by foreign countries. Tubes are often not fitted in anatomy of Korean people because of small nostril. When the size of the tube is chosen by nostril size, the length of nasotracheal tube is not appropriate to the glottis. The aim of this study is to evaluate on the proper size of the nasotracheal tube and depth in nasotracheal intubation in Korean. Forty patients (20 males and 20 females) who are scheduled for nasal intubation for general anesthesia will be enrolled. The primary outcome is the proportion of patients who are in inappropriate insertion of nasotracheal tube; the proximal end of tube's cuff is less than 2 cm below vocal cord. The size of nostril, length from the nare to the carina and vocal cord are measured.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled for nasotracheal intubation for general anesthesia

Exclusion Criteria:

* age \< 20 years and age \> 70 years
* ASA(American Society of Anesthesiologist) class III or more
* pregnancy
* emergency surgery
* nasal airway disease
* expected difficult intubation (difficult intubation history, Modified Mallampati score 4, mouth opening \<2cm, facial anomaly)
* unstable teeth
Effect of Genetic Alterations Affecting the Genes Encoding the Major Enzymes of the Kynurenine Pathway on Suicidal Behavior

Current research has shown that an imbalance in the Kynurenine pathway plays a role in the physiopathology of neurogenerative and mental disorders (with a decrease in neuroprotective metabolites and an increase in neurotoxic products). So far the research has concentrated on the enzymes IDO 1/2, KAT (1-4), KMO and ACMSD which are the key players in this pathway. Several polymorphisms affecting these enzymes have been associated with certain disorders characterized by a deregulation of the inflammation and immune response (McCauley et al 2009,Tardito et al 2013, Lee et al 2014), but the link between these enzymes and suicidal behavior is not yet clear. The investigators hypothesize that people with history of suicide attempt would have a genetic alterations of the kynurenine pathway specific for suicidal behavior.


Eligibility Criteria:
Inclusion Criteria:

* For the "Sucide attempters" group: Any patient aged 18 or over who has made at least one suicide attempt.
* For the two control groups: Any patient aged 18 or over, suffering from depression but has never attempted to commit suicide and any healthy subject who has never had any mental disorders.

Exclusion Criteria:

* Any patient who has expressed opposition to the use of his/her data.
Trichuris Suis Ova (TSO) Suspension Versus Placebo in Active Crohn's Disease

This study will run in centers in Germany, Denmark, Austria, Czech Republic, and Switzerland, only.

This proof-of-concept study aims to evaluate the efficacy of three doses of oral TSO suspension vs. placebo for the induction of remission in Crohn's disease.


Eligibility Criteria:
Major Inclusion Criteria:

* Signed informed consent,
* Man or woman between 18 and 75 years of age,
* Established diagnosis of Crohn's disease (CD) since at least 3 months prior to screening confirmed by endoscopic and histological, or endoscopic and radiological criteria,
* Negative pregnancy test in females of childbearing potential.

Major Exclusion Criteria:

* Bowel surgery within the last 3 months prior to baseline,
* Resection of more than 50 cm of the ileum,
* Ileostomy or colostomy,
* Septic complications,
* Evidence of infectious diarrhoea (i.e., pathogenic bacteria or Clostridium difficile toxin in stool culture),
* Abscess, perforation, fistulas, or perianal lesions,
* Immediate surgery required (e.g., major stenosis, serious bleeding, peritonitis, ileus),
* Clinical signs of stricturing disease,
* Parenteral or tube feeding,
* Abnormal hepatic function (ALT or ALP \> 2.5 x upper limit of normal \[ULN\] at screening), liver cirrhosis, or portal hypertension,
* Abnormal renal function (Cystatin C \> ULN) at screening,
* Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient's compliance or the interpretation of the results,
* Any condition associated with significant immunosuppression,
* Active malignancy or treatment with anticancer drugs during the last 5 years.
* Existing or intended pregnancy or breast-feeding,
* Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial.
Healthy Juntos Pilot Study

The purpose of the study is to assess the feasibility, acceptability, and preliminary effects of a digital (web and mobile phone-based) program to improve physical activity levels and quality dietary intake among Hispanic parent-adolescent dyads.


Eligibility Criteria:
Inclusion criteria:

1. Female and male adolescents whose primary caregiver self-identifies as Hispanic
2. Adolescent is between the ages of 12-15;
3. Adolescent lives with an adult primary caregiver willing to participate;
4. Both parent and adolescent have smartphone/mobile device with internet access;
5. Adolescent does not meet recommendations for fruit and vegetable intake (proxy for overall diet quality) as determined by a validated two-item screener;
6. Adolescent does not meet physical activity guidelines as determined by responses on a validated two-item screener AND self-reports engaging in \>2 hours/day of screen time (proxy for overall sedentary behavior) using three items.

Exclusion Criteria:

1. Adolescent's body mass index for age and gender is ≥ 95th percentile ("obese" range);
2. Adolescent has a chronic medical condition (e.g., type 2 diabetes) that requires intensive lifestyle modification;
3. Adolescent has a diagnosed developmental delay that would interfere with understanding program materials;
4. Parent or adolescent has a diagnosed medical or psychiatric condition and is currently taking medications that would interfere with changes to physical activity or diet (e.g., adolescent is diagnosed with Attention Deficit Hyperactivity Disorder and is currently on stimulant medication);
5. Family is planning to move out of the South Florida during the study follow-up period
Prevalence of Fuctional Heartburn in Patients With IBS .

The purpose of this study is to assess prevalence of functional heartburn in IBS patients.

Functional heartburn (FH) and IBS are functional digestive disorders that may occur in the same patients (1).

Heartburn is a burning sensation in the chest, radiating toward the mouth, as a result of acid reflux into the esophagus. However, only a small percentage of reflux events are symptomatic. Heartburn is also often associated with a sour taste in the back of the mouth with or without regurgitation of the refluxate.(2) Definition of FH has been greatly modified from the Rome II criteria (in which the definition of FH included all NERD patients with negative pH-manometry) to the Rome III criteria (in which FH is defined as a functional esophageal disorder unrelated to GERD and characterized by negative pH-manometry, the lack of a relationship between symptoms and reflux events, and the lack of symptom improvement after a trial of PPI therapy)(2).

However, data establishing a solid link between FH and IBS are lacking, because the clinical definition of FH has undergone substantial changes over the years(3). the prevalence of IBS varied from 5 to 65% and the incidence varied from 1 to 36% , Its frequency in women is more than men.(4). Psychological problems were strongly associated with prevalence and incidence of IBS. (5) Distinguishing between irritable bowel syndrome (IBS) and functional dyspepsia can be challenging because of the variations in symptom patterns, which commonly overlap.(6) Currently, The criteria for diagnosis of Functional heartburn (FH) rest not only on compatible symptoms but also on exclusion of structural and metabolic disorders that might mimic the functional disorders, Patients have to have a normal X_ray ,normal upper endoscopy and 24-hour PH monitoring test that is normal, and the absence of any evidence of a correlation between physiologic reflux events, either weakly acidic or acidic, and heartburn symptoms.(7,8)

Eligibility Criteria:
Inclusion Criteria:

1. Age above 18 years.
2. Patients diagonsed as IBS (according to the Rome criteria of the lV revision) and presented with heartburn with a normal X_ray, normal upper endoscopy and normal 24-hour PH monitoring.

Exclusion Criteria:

1. Patients who refuse to contribute in this study.
2. Presence of duodenal or gastric ulcer or cancer on upper endoscopy.
3. cardiac patients.
4. Pregnancy and breastfeeding
Detection and Characterization of Anti-SARS-CoV-2 Salivary Antibodies After COVID-19 Booster Vaccines

The investigators aim to evaluate the ability of a COVID-19 (Coronavirus disease) booster vaccine to induce a salivary antibody response and investigate a possible correlation with the serum antibody response and the cellular response.

The investigators will conduct a prospective single center cohort study including fully vaccinated probands.

The investigators will conduct a prospective single center cohort study including fully vaccinated probands.. The study will take place at the Medical University of Graz. Blood and saliva samples will be obtained before the third booster vaccination, 3-8 weeks, and 6 months after the third booster vaccination.

The total duration of the study is 15 months, starting in November 2021 with a recruiting period until June 2022 and termination of all scheduled visits until January 2023.

In order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent).Scheduled vaccination for the booster vaccination with Comirnaty or Spikevax will allow recruitment.

At Visit 1, after informed consent, inclusion and exclusion criteria will be checked to include or exclude the subject in the trial. Clinical history will be assessed and blood (32ml - Serology, T cell immunity) and saliva (1.5ml) will be taken. At visit 2, 3-8 weeks after after 3rd vaccination, vaccination reactions and clinical history will be assessed. Blood (32ml - serology, T cell immunity) and saliva (1.5ml) will be taken.

At vist 3,6 Month (±3 weeks) after 3rd vaccination, clinical history will be assessed. Blood (8ml - serology) and saliva (1.5ml) will be taken.

Antibody tests and T cell assays will be performed according to protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine and decided to receive a booster vaccination as recommended by national guidelines. -

Exclusion Criteria:

1. Presence of diseases or therapies that are likely to interfere with the immune response to booster vaccination.
2. Any contraindications to the vaccine planned to receive as listed in the product characteristics.
3. Lack of willingness to undergo serial blood draws and attend follow-up appointments.
4. Having already received a third (booster) vaccination with any COVID-19 vaccine.
5. Women who are pregnant or breastfeeding.
6. Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent) -
Inducing Children's Emotional Eating

Background: Children's emotional eating is related to greater BMI and less healthy diet but little is known about the early development of this behavior.

Objective: This study aimed to examine the relationships between preschool children's emotional eating and parental feeding practices using experimental manipulation of child mood and food intake in a laboratory setting.

Design: 25 3-5 year old children and their mothers sat together and ate a standard meal to satiety. Mothers completed questionnaires about their feeding practices. Children were assigned to a control or negative mood condition. Children's consumption of snack foods in the absence of hunger was measured.


Eligibility Criteria:
Inclusion Criteria:

* Child age between 3 years and 5 years
* No disease/disorder affecting eating
* No learning disability

Exclusion Criteria:

* Any child brought in by a (non-primary care-giving) grandparent
* Child BMI at extreme of sample
* Incongruous mood shift to condition
* Child of non-english speaking/reading parent
Cardiovascular Screening for Family Members of People With Acute Coronary Disease

Over a 12-month period, patients admitted with acute coronary disease to the cardiovascular care unit at the Jewish General Hospital (JGH), an academic tertiary care referral center in Montreal, Quebec, will be approached to refer first-degree relatives and/or household members age 18 years or older to an outpatient cardiovascular (CV) risk factor screening and treatment program. Relatives and household members will undergo a focused history, physical, and CV risk factor assessment and will receive evidence-based guideline-recommended treatment as indicated. Participants will be referred to nutritionists, smoking cessation programs, and to other allied healthcare professionals as needed. A follow-up visit at 6-months will assess treatment adherence and improvement in CV risk factors. All family and/or household members including the index patient will be encouraged to attend all healthcare visits together.

The effectiveness of the screening strategy will be measured by the total number of participants identified as intermediate or high modified Framingham 10-year risk of cardiovascular disease. The effectiveness of the primary prevention intervention will be measured by the change in percentage of the mean modified Framingham 10-year risk score for participants between the initial visit and 6-month follow-up. The value of the referral, screening, and treatment program, as well as participant engagement and satisfaction will also be systematically evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patient age ≤70 years old admitted with an initial diagnosis of an acute coronary event (such as acute coronary syndrome or myocardial infarction)
* At least 1 first-degree family or household member age ≥ 18 years old

Exclusion Criteria

* No eligible family or household members
* Inability to contact family or household members
* Distance to study centre too far as determined by the patient
* Family or household members who have been screened for CV disease in the previous 2 years.
* Family or household members with known coronary disease.
"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms. MP-376 is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery using the PARI electronic eFlow® nebulizer. Preclinical and early clinical studies in adults show that aerosol doses of MP-376 appear to be safe and well tolerated, and exert an antimicrobial effect when administered once or twice daily. High concentrations of levofloxacin in the lung delivered using MP-376 are expected to be active against CF pathogens such as P. aeruginosa and S. aureus, including those resistant to aminoglycosides (such as TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using the PARI eFlow® nebulizer system. This Phase 1 study is being performed to obtain safety, tolerability and PK data in children ages 6-16 in order to determine if MP-376 is safe, prior to enrolling children of these ages in the planned pivotal Phase 3 studies.

A Phase 1B, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution given Daily for 14 Days to Stable Pediatric Cystic Fibrosis Patients.

Study acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria (selected):

* 6 to 16 years of age (inclusive) at Visit 1
* Weight is greater than or equal to 14 kilograms (kg)
* Confirmed Diagnosis of Cystic Fibrosis
* Patients are able to elicit an FEV1 \>/= 25% of predicted value (Wang criteria)
* Clinically stable with no changes in health status within the last 14 days
* Able to reproducibly undergo spirometry testing

Exclusion Criteria (selected):

* Use of any nebulized or systemic antibiotics within 7 days prior to baseline
* History of intolerance or hypersensitivity to fluoroquinolones or intolerance with aerosol medications including bronchodilators
* CrCl \< 50mL/min/1.73m2, AST, ALT or total bilirubin \>/= 3 x ULN at Screening or evidence of severe liver disease
Criticality Analysis of Diabetic Gait Within a Primary Care Pediatric Clinic for Obese Children (PAIDOS)

One of the difficulties with diabetes care is the problem of predicting progression to more severe stages using current measures (for example blood glucose, HbA1c). This feasibility study aims to use Criticality Analysis (CA) of gait to monitor the progression of the condition as well as identifying individuals at risk of developing diabetes among children in Mexico.The study will investigate whether gait analysis can be used as a fast, reliable and cost effective way to detect individuals at risk of developing Type 2 Diabetes (T2DM) as early treatment could reduce the number of cases that develop into full T2DM.

This feasibility study aims to the do the following:

1. To evaluate the use of Criticality Analysis of Gait as means of Diabetes assessment.
2. To design and set up a clinical feasibility study in a hospital (Hospital Infantil de Mexico) with adolescent patients on different clinical stages of type 2 Diabetes mellitus (DM).
3. To analyse the collected data and validate Gait data analysis as mechanism for identifying and monitoring pre-diabetic teenagers.
4. To use the feasibility study conducted in Mexico to develop a robust method using Gait analysis for diabetes prevention and management.

Participants will be selected from the Primary Care Pediatric Clinic for Obese Children (PAIDOS) in the Hospital Infantil de México Federico Gómez, Mexico City, Mexico. Sixty participants will be selected and divided into three groups: 40 obese non-diabetic subjects, 10 with Type 2 Diabetes and 10 healthy subjects as controls. Obese participants within the Paidos clinic will undergo standard clinical care that includes dietary prescription of caloric intake according to height, 150 min weekly physical activity, group cognitive-behavioural intervention, 6 session of obesity awareness and educational program.

Gait will be recorded in all groups using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility. The study will be repeated after 3-6 months as a follow up.

Data analysis will be performed in a semi-blind manner in order to test the efficacy of the criticality analysis Rate control of Chaos (RCC) model. In order to provide an objective measure of analysis, the anonymised data will be presented to the nonlinear RCC models, where results can be extracted and compared afterwards to known states.

Eligibility Criteria:
Inclusion Criteria:

* BMI over 95 th percentile for age
* Living in Major Mexico City area

Exclusion Criteria:

* Diabetic patients
* major physical disability