cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Zero Tolerance Program (SToP) on Child's Urine Cotinine Level According to Exposure Feedback

Although the ban on indoor smoking has greatly reduced secondhand smoke (SHS) exposure in public spaces, the home environment is still the primary source of exposure to SHS, particularly in children under the age of five. Although attempts are often made to prevent or reduce children's exposure to SHS, such as education, counseling, and exposure feedback to parents, exposure remains. Although using materials such as brochures, messages, posters and reminders that will minimize the harms such as protecting children from SHS will reduce the exposure, exposure continues in the long term.The aim of this study is to compare the effect of giving exposure feedback to the parents according to the zero tolerance program (SToP) on the urinary cotinine level of the children. In this study with active control group, single-blind (participant), randomized control, stratified block randomization (1:1) will be performed. Totally 58 participants including STOP intervention group (n:29) and the exposure feedback group (n:29), which is the active control group, were planned to be included in the study, which was planned to be conducted between January and September 2023. Cotinine-sensitive dipstick test kits will be used for the primary outcome (urine cotinine). Cotinine-sensitive dipstick test kit is a simple, cost-effective test to determine smoking status. It is an easy-to-read test strip that can be used with either a saliva or a urine sample. Secondary outcomes will be evaluated by information form on exposure to second-hand smoke, an attitude form on exposure to second-hand smoke, and a scale of beliefs towards third-hand smoke. This protocol will demonstrate whether SToP interventions, a sustainable program for children at high risk of secondhand tobacco exposure, are a viable intervention for parents on how to reduce exposure.


Eligibility Criteria:
Inclusion Criteria:

* Parents with children aged 5 and under, whose children are registered with the Family Health Center, and whose children are at high and very high risk of exposure to SHS according to the risk algorithm.
* Parents' willingness to participate in the study

Exclusion Criteria:

* Babysitter
* Those who do not speak Turkish.
* Parents of children with asthma will not be included on the grounds that it may be confusing as they may display more specific behavior.
Effect of an Advance Care Planning Intervention

The intervention being studied is an advance care planning intervention. The trial has two arms: usual care and information arm.

Eligible patients whose assisted living centers are randomized to the information arm will receive a letter from their clinician with links to informational video. Eligible patients whose assisted living centers are randomized to the usual care arm have advance care planning discussions with a clinician at admission, annually, and sometimes with a hospitalization or other change in condition.

Eligibility Criteria:
Inclusion Criteria:

* Partnering assisted living center with at least 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
* Patients not on hospice
* Patients who do not have comfort care or do-not-hospitalize orders at baseline

Exclusion Criteria:

* Partnering assisted living center with less than 20 patients with a dementia diagnosis (based on International Classification of Diseases, version 10 codes)
* Patients on hospice
* Patients with comfort care or do-not-hospitalize orders at baseline
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period.
* Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants.
* Mucosal ulceration on endoscopy.

Exclusion Criteria:

* Subject with ulcerative colitis or indeterminate colitis.
* Subject who has had surgical bowel resections in the past 6 months or is planning resection.
* Subjects with an ostomy or ileoanal pouch.
* Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
* Subject who has short bowel syndrome.
* Chronic recurring infections or active Tuberculosis (TB).
Color Dental Alteration Caused by Endodontic Treatment

The color change of endodontically treated teeth is a common concern in clinical practice. The objective of this study will be to evaluate, in vivo, the color change (ΔE00) caused by endodontic treatment. A randomized clinical trial (RCT) will be conducted with the objective of evaluating ΔE00 originated from epoxy resin (AH Plus) and mineral trioxide aggregate (MTA Fillapex) endodontic sealers, sectioned at the cervical level and 2 mm below, in a period between the immediate endodontic treatment versus after 3, 6 and 12 months.

The sample syze determined that 48 anterior teeth (incisors and canines) and posterior teeth (premolars) should be included in the study. The sealer and cut will be randomly determined at time of endodontic treatment, originating four groups (n = 12): AH Plus-Cervical, MTA Fillapex-Cervical, AH Plus-2mm and MTA-2mm. The endodontic access cavities will be sealed with resin composed of the color of the dental element. The mean, standard deviation and confidence interval (CI 95%) of the values of ΔE00 obtained for each sealer will be initially analyzed using the variable cut level (cervical or 2mm) using the T test. Indeed, the values of ΔE00 will be analyzed by two-way analysis of variance, where the level of the cut and the type of sealer will be the factors under study.

Eligibility Criteria:
Inclusion Criteria:

endodontically treated tooth, without intraradicular retainer and fixation;

* presence of homologous tooth to that treated, with pulp vitality and at least 1/3 of the crown;
* correctly patient's file showing the endodontic treatment day, the endodontic filler used, the pulp condition at the first consultation, and periapical radiography, obtained with the use of a radiographic positioner, preserved and with a clear apical image

Exclusion Criteria:

* dental elements submitted to retreatment;
* files with insufficient data, and absence of quality periapical radiography
Colonoscopy Motivation for Patients With Positive Immunochemical Fecal Test

Patients with an immunochemical fecal test positive, have to undergo a colonoscopy. Around 10% doesn't realize the colonoscopy. This study evaluate the impact of a motivational phone call (given by a doctor) to improve colonoscopy participation. And try to understand why this patients don't want to make this examination.


Eligibility Criteria:
Inclusion Criteria:

* immunochemical fecal test positive but no colonoscopy performed despite a full sequence of reminder (3 letters)

Exclusion Criteria:

* colonoscopy done
Quality of Life and Patient Needs in Advanced High Grade Gliomas

There is limited knowledge regarding the quality of life and needs of patients with advanced high grade gliomas, especially during the end of life. By doing this research, we are able to assess caregiver and patient symptoms and needs during the end of life phase of patients with brain tumors.

Purpose: This is a pilot study to prospectively assess the symptoms and quality of life of patients and with advanced high grade glioma and their care takers.

Specific Aims: The aim of this study is to investigate the symptoms of patients with advanced high grade glioma. Patients who failed 3rd line chemotherapy and who require at least occasional assistance will be prospectively followed and their symptoms will be prospectively assessed. Patient's caregiver will be interviewed following the death of the patient to assess clinical symptoms in the last weeks of life and around the time of death.

Methods: Patients will undergo clinical symptom assessment via questionnaire. Patients will be followed by regular semi-structured phone interviews.

Should a patient pass, four weeks following this, the patient's care giver will be interviewed.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Tissue proven diagnosis of a high grade brain tumor
* Disease progression by MRI
* Therapy resistant tumor to 2nd line chemotherapy
* Karnofsky Performance Scale (KPS) score of 60 or less
* Patient will need to assign caregiver

Exclusion Criteria:

* None
Transitional Care Program to Improve Risk Factors in Stroke Survivors

The goal of this clinical trial is to evaluate whether our transitional care program helps stroke survivors better manage their risk factors for stroke to lower the risk of a repeat stroke. The main question it aims to answer is:

- Does the program help participants meet the targets set by the American Heart Association clinical guidelines for control of risk factors associated with stroke?

Researchers will compare participants enrolled right after being discharged from the hospital to participants enrolled around 3-5 months after being discharged to examine whether timing differences in enrollment affect the efficacy of the program.

Participants will:

* Keep track of their medications, their exercise, and their health information using smart devices provided by the study
* Answer questions about their health and lifestyle
* Meet with our team of healthcare providers


Eligibility Criteria:
Inclusion Criteria:

All Cohorts:

* Age 30 or above
* Evidence of ischemic stroke documented on CT or MRI
* Modified Rankin score of 3 or less

Early Enrollment:

* Admission for ischemic stroke at a participating site
* Enrolled during their admission for ischemic stroke or within 24 hours of discharge

Late Enrollment:

* Stroke survivors previously admitted at the participating sites' inpatient stroke unit
* Enrollment date between 1 and 6 months after discharge for inpatient admission for ischemic stroke

Exclusion Criteria:

* Participants determined to have hemorrhagic or periprocedural stroke based on hospital EMR review will be excluded.
* Participants determined to have an ischemic stroke due to dissection based on hospital EMR review will be excluded.
* Participants who lack capacity determined by the care team during their hospitalization (for the early enrollment group) or their most recent clinical encounter (for the late enrollment group) will be excluded
* Participants with a diagnosis of dementia will be excluded.
* Participants who cannot perform the following will be excluded:

  1. offer a consistent choice about participating in the study
  2. demonstrate that they can comprehend and recall major features of the study including: participation is voluntary, the major procedures, the primary risk, and the primary benefit.
* Participants who are discharged to Long-term Acute Care Hospitals or Skilled Nursing Facilities because they are unable to meet the minimum threshold for daily rehabilitation therapy for an Acute Rehabilitation Facility will be excluded.
* Participants who are unable to read or communicate fluently in English will be excluded.
* Participants who do not have reliable internet access to complete telemedicine visits per self-report will be excluded.
Sun Protection Factor (SPF) Efficacy Assay

Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type I, II and/or 111 for UVB testing; Fitzpatrick Skin Type II, 111 and/or IV for UVA testing.
* Sex: Male or female.
* Age: 18-70 years.
* Good health as determined from the HRL SHF.
* Signed and dated lnformed Consent Form.
* Signed and dated HIPAA Form.
* An unambiguous MED or MPPD
Improved Gut Health Outcomes Associated With Probiotics Fortified With Hydrolyzed Whey Protein in Infant Formula

The goal of this interventional clinical trial is to test the effectiveness of improving gut health in terms of frequency of bowel movements in newly born infants fed with Feihe investigational formula product containing probiotics fortified with hydrolyzed hey protein. The main question it aims to answer is:

- whether the frequency of bowel movements (through 12 months) of participants in the study product arm is significantly better than participants assigned in the other two arms.

240 qualified participants will be randomized to 3 arms (investigational formula, control formula, and breast-feeding) to consume assigned formula or breast-feeding for 12 months according to protocol. There will be up to 6 site visits arranged for each participant during the study, and all relevant clinical and questionnaire data, including the most important primary outcome - frequency of bowel movements through 12 months, will be captured, recorded and entered to CMTS (Clinical Management Trial System) for statistical analysis and reporting.

Researchers will compare the three arms to validate the assumption that the consumption of Feihe investigational formula product containing probiotics fortified with hydrolyzed hey protein will improve gut health in newly born infants, along with physical development.


Eligibility Criteria:
Inclusion Criteria:

* Newborn baby, study entry before weaning (within 28 days of birth)
* Exclusively formula for at least 3 days fed prior to onset of study period.
* Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).
* Birth weight of 2500g (5 lbs. 8 oz.) or more.
* Signed informed consent obtained for infant's participation in the study.
* Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study.

Exclusion Criteria:

* History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.
* Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).
* Evidence of growth problems or concern for growth.
* Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.
* Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury.
* Use of probiotics/prebiotics before and during the study.
Determination of the Minimal Detectable Change of the Parkinson's Disease Questionnaire-8

This study is conducted to determine how many units of improvement the Parkinson's Disease Questionnaire-8 (PDQ-8), used to evaluate the quality of life of Parkinson's patients, should have to express a significant change in the quality of life. Patients for whom a 30-session physiotherapy program is recommended will be included in the study. Patients will be asked to express the change in their quality of life at the end of treatment. The PDQ-8 survey and Global Rating of Patient-Perceived Changes (GRP-PC) forms will be used to determine these changes. Evaluations will be repeated at the beginning of the treatment program and at the end of the 30th session.


Eligibility Criteria:
Inclusion Criteria:

* Having regular neurology follow-up and using medicine;
* Hoehn and Yahr Scale Stage between 1-3 points;
* Mini-Mental State Assessment Score \&gt;24 points;

Exclusion Criteria:

* Having a secondary neurological disease;
* Any surgery and/or trauma affecting the upper extremity
* Having complaints of pain before the treatment program;
* There was a change in medical treatment during the study;
* With symptoms of anxiety and depression;
* Those who use alcohol and drugs;
* Individuals with vision defects that cannot be corrected by the use of glasses and those with hearing loss
M3-JIA: Making Mindfulness Matter for Children with JIA

The investigator will evaluate the efficacy of M3©, an intervention for patients with JIA and their caregivers. Children with Juvenile arthritis and their parents will attend an 8 week online program called Making Mindfulness Matter (M3). This is a facilitator-led program that integrates knowledge and skills related to mindfulness, social-emotional learning, neuroscience, and positive psychology to promote coping and resiliency for children and families in context of the challenges of pediatric chronic disease. The child program is designed for children 4-12 years of age, with each lesson including a variety of concrete ways to teach children skills based on their age/developmental level.

This pilot RCT is essential to refine the implementation of the intervention to families with a child with JIA and collect information pertaining to the feasibility and effectiveness of the intervention in preparation for a subsequent multicentred trial across Canada. The investigator will propose to test if the M3© program improves the child's health related quality of life (HRQOL) and mental health for Children with JIA and caregivers. Additionally, to address the knowledge gap on the relationship between mental health and disease outcomes in JIA. M3 is a promising mindfulness-based intervention which may have mental health benefits for children with JIA and caregivers.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 to 12 years diagnosed with JIA
* Children have reasonable comprehension of spoken language and can follow simple instructions
* Children with JIA and their caregivers are willing to attend intervention sessions and have access to technology and internet to attend the online sessions.
* Children with JIA and their caregivers have an adequate understanding of English

Exclusion Criteria:

* Other major co-morbid disorders (e.g. Crohn's disease, diabetes, renal failure).
* Concurrent enrollment in other intervention trials or practicing any complementary health interventions such as yoga, meditation, or daily mindfulness practice.
Human Bone Graft for Hallux Valgus Correction According to the Austin Procedure

This observational study is to document the application of a human bone graft in the surgical repair of hallux valgus deformity and its subsequent healing process.

For the treatment of bone fractures metal screws have been used for decades. Removal of material is the major disadvantage of conventional osteosynthesis and requires a second intervention, with all the complications and risks for each patient. Moreover, the metal screw disturbs as foreign material in the bone and irritates the surrounding soft tissue.

In order to overcome the drawbacks of metal screws human bone screw grafts can be used instead representing a biodegradable osteosynthesis material with ideal material properties.

The bone graft helps to create a solid, bony connection. This connection leads to an extension, a bone remodeling, bone installation and optimal reparation process in the affected area.

This observational study is being conducted in order to overcome the lack of systematic research to objectively confirm the benefits of the product.

In total 50 patients will be enrolled in this study in several centers in Austria This observational study will use Shark Screw® grafts manufactured by two tissue banks, the Austrian Tissue Bank surgebright and the German Institute for Cell and Tissue Replacement (DZIG). The Shark Screw® grafts were approved by the competent Austrian authority (AGES) in 2016.

All patients participating in this observational study, due to a medical indication, undergo Hallux valgus correction according to the Austin procedure using the bone screws mentioned above.

A 12 month postoperative observation period is set. Five routine follow-up examinations including clinical examination and x-ray analysis will be performed. In case the an additional routine follow-up examination is necessary for clinical reason within 24 month post-operative, the patient remains in the study.

Eligibility Criteria:
Inclusion Criteria:

* Indication for the use of a human bone graft in the surgical treatment of Hallux valgus treatment using Austin procedure
* legal capability of adults
* Written consent to participation in the study after previous written and oral education
* Age ≥ 18 years

Exclusion Criteria:

* Insufficient knowledge of the German language
* Alcohol and drug abuse
* Pregnant or breastfeeding woman
* Foreseeable compliance issues
* Neoplastic diseases, malignant bone tumors, rheumatoid arthritis
* Active osteomyelitis
* Ulcerations in the area of the skin of the surgical area
* Revision surgery after primary Hallux valgus surgery
anti10a Levels in Women Treated With LMWH in the Postpartum Period

The aim of this study is to compare between anti-10a levels in postpartum women receiving different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's weight and the second group receiving 1mg/kg to a maximum dose of 120 mg

pregnancy and postpartum period are associated with increased risk of thromboembolism. this risk is further increased in women with thrombophilia.

This risk is higher in the postpartum period compared with pregnancy period, especially the risk for pulmonary embolism (PE). The American College Of Obstetrics and Gynecologists, The American college of chest physicians and The Royal College of obstetricians and gynecologists recommend using low molecular weight heparin during the postpartum period in women with thrombophilia and women with risk factor for developing thromboembolism. there is no specific guidelines regarding the best protocol based on the level of anti-10 a.

This study will compare between two protocols based on anti-10a levels.

Eligibility Criteria:
Inclusion Criteria:

* postpartum women supposed to receive LMWH according to obstetric indications

Exclusion Criteria:

* known allergy to clexane
* active bleeding postpartum
* thrombocytopenia \< 75000
* recent cerebrovascular accident / transient ischemic attack (\<4 weeks)
* glomerular filtration rate) \< 30 ml/min)
* active liver disease
* malignant hypertension (systolic \> 200 mmHg, diastolic\> 120 mmHg)
Vascular and Periodontal Disease - Microbial, Genetic and Histological Causalities

The purpose of this study is to analyze genetic polymorphisms in genes encoding pro-inflammatory cytokines, and study the genetic predisposition to chronic periodontitis (CP) in combination with atherosclerotic cardiovascular (ACD) and aneurysmal diseases. The investigators will also try to identify oral bacteria in atherosclerotic plaques and aneurysmal walls and thrombus. Histological analyses of atherosclerotic plaques and aneurysmal wall will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing vascular surgery at Oslo University Hospital, Aker, previously randomly collected patients with periodontitis,

Exclusion Criteria:

* patients whom undergone antibiotic treatment the past month.
* patients whom undergone periodontal treatment the past 6 months.
* patients with no teeth