cyrilzakka/clinical-trials huggingface dataset:
Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia

This study will evaluate the effect of atomoxetine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)


Eligibility Criteria:
Inclusion Criteria:

* patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD)
* patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient
* child or adolescent patients must be 10 to 16 years old
* must be able to communicate in English
* must be able to swallow capsules
* be reliable to keep appointments for clinic visits and all related tests

Exclusion Criteria:

* patients who weigh less than 25 Kg or greater than 70 Kg
* patients with a history of alcohol or drug abuse on a repeated basis within the past 3 months
* patients with documented history of autism, Asperger's syndrome or pervasive developmental disorder
* females who are pregnant or breastfeeding
* patients with a history of severe allergy to more than one class of medications
* patients with documented history of bipolar I or bipolar II disorder, or psychosis
Prenatal Ultrasonographic Assessment of Fetal Thyroid in Patients with Thyroid Pathology

The goal of this observational study is to evaluate the possibility to use prenatal ultrasonography for diagnosis and prognostic guidance in cases of suspected fetal thyroid changes in fetuses belonging to women with thyroid disease and women with low obstetric risk (i.e., pregnancy not complicated by maternal and/or fetal pathology) between 14 and 37 gestational weeks.

The main question it aims to answer is:

Is it possible to diagnose thyroid disease in fetuses early using measurable parameters of the fetal thyroid through ultrasonography?

Current knowledge about fetal thyroid anatomy and the association between ultrasonographic alterations and maternal thyroid disease is not yet comprehensive. A number of observational studies have been conducted describing the possible changes found in fetal thyroid parenchyma in mothers with dysthyroidism. In addition, there are interventional studies that have attempted to modulate anti-thyroid therapy in hyperthyroid mothers depending on the ultrasound changes of the fetal thyroid found. However, to date, the possibility of ultrasound study of the fetal thyroid has not been established, and there are no universally recognized reliable nomograms for the assessment of fetal thyroid biometry.

The present study will provide more information about the possibility to use prenatal ultrasonography for diagnosis and prognostic guidance in cases of suspected fetal thyroid changes. In the latter case, we will be able to more accurately delineate the indication for serious prenatal ultrasound checks, guide counseling with the parental couple, addressing them to possible consultation with pediatric specialist.

Women will be asked to undergo a single ultrasound scan, as per normal clinical practice. With the ultrasound scan it will also be possible to assess parameters that will allow the study of the biometry, morphology and volume of fetal thyroid.

Eligibility Criteria:
Inclusion Criteria:

* Participants between 14 and 37 gestational weeks, who will be followed for the entire period of pregnancy, up to delivery, at the same enrolling center
* Obtaining informed consent for participation in the study
* Maternal age between 18 and 45 years (extremes included)
* Participants with good understanding of the Italian language

Exclusion Criteria:

* Smoking participants
* Patients with BMI\>30
* Absence of correct dating of pregnancy within the first trimester
* Pathological conditions (e.g., malabsorptive or socioeconomic conditions that may interfere with fetal growth)
* Twin pregnancy
* Only for the low obstetric risk group of patients: Fetus with malformative pathology
Flexibility: A Study to Assess the Impact of Darbepoetin Alfa in Subjects withNon-Myeloid Malignancies With Anemia Due to Chemotherapy

This study will compare the efficacy (non-inferiority) of darbepoetin alfa (Aranesp®) extended dose schedule administration (EDS) versus darbepoetin alfa administered once per week (QW) in the treatment of anemia in subjects with non-myeloid malignancies receiving multi-cycle chemotherapy.


Eligibility Criteria:
Inclusion Criteria: - Subjects with active non-myeloid malignancy(ies) including lymphocytic leukemias - Receiving chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy anticipated to be on a QW, every other week (Q2W) or every three weeks (Q3W) schedule - Anemia due to cancer and/or chemotherapy (screening Hb less than 11.0 g/dL) - Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: - Subjects with acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML), or myelodysplastic syndromes (MDS) - Other underlying hematologic disorder, which could cause anemia, other than a non-myeloid malignancy - Active bleeding - Severe, unstable, active chronic inflammatory disease (e.g., ulcerative disease, peptic ulcer disease, rheumatoid arthritis) - Active, unstable systemic or chronic infection - Planned elective surgery during the study where significant blood loss is expected - Known iron deficiency (to be considered iron deficient a subject must have both of the following: a saturated transferrin less than 15% and ferritin less than 10 ng/mL at screening) - Unstable angina, or uncontrolled cardiac arrhythmia - Hypertension (diastolic blood pressure greater than 100 mmHg) - Inadequate renal and/or liver function (e.g., creatinine greater than 2 X upper limit of normal (ULN) and/or transaminase greater than 5 X ULN) - History of pure red blood cell aplasia - Known positive human immunodeficiency virus (HIV) test or acquired immune deficiency syndrome (AIDS) status - Known positive antibody response to any erythropoietic agent - Subject has known sensitivity to any erythropoietic agents, the study drug, or its excipients to be administered during this study
Pro-active Fecal Calprotectin Monitoring PROMOTE-UC

Hypothesis:

Pro-active home fecal calprotectin testing in patients with Ulcerative Colitis will allow early detection and treatment of inflammation to prevent symptomatic flares. This will result in less steroid use, fewer hospitalizations and a reduced risk of surgery, as well as improved quality of life and adherence to medication.

Previous studies have shown that fecal calprotectin (FC) may be useful to predict relapse of inflammatory bowel disease and response to treatment. Current methods for measurement of FC require bringing stool samples to the laboratory or physician's office. The test is either not readily available or is expensive for patients. Some patients also find it inconvenient to collect, transport and travel to return the sample.

A prior study in our institution showed that only 77% of patients returned samples for processing. Therefore, a home-based kit may offer greater uptake by patients as samples do not need to be returned to a lab or physician's office. Regular monitoring of patients at home may allow the detection and prediction of flares before the appearance of symptoms. With earlier treatment, the risk of complications may be minimized and the quality of life for people living with this disease may be improved.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 19 years or older with Ulcerative Colitis
* Symptomatic remission defined as a modified Partial Mayo score ≤ 2 with a rectal bleeding score = 0
* Able to use IBDocTM test kit which requires a smart phone with a camera and internet access to download the CalApp® which interprets the measurement
* Able to give informed consent to the study protocol

Exclusion Criteria:

* Patients experiencing a symptomatic flare
* Patients currently receiving therapy as part of a clinical trial
* Pregnancy
Prediction of Extubation Success by the Patient

The evidence-based approach to wean and consecutively extubate patients is based solely on objective criteria/tests. The introduction of subjective criteria could further improve the actual method.


Eligibility Criteria:
Inclusion Criteria:

* all intubated patients ready for a spontaneous breathing trial

Exclusion Criteria:

* not awake
* not collaborative
Evaluation of an Internal Hospital Practice: The Effect of Altered Test Tubes Sampling Order on Blood Culture Contamination Rates

Implementation of the initial specimen diversion technique, in which the first milliliter of the venipuncture sample is not injected into the culture bottle, led to a significant reduction in blood culture contamination rates. This technique is based on the assumption that the skin plug aspirated during venipuncture is a major source of contaminating bacteria. One such diversion method is aspirating the first blood volume into a blood collection tube. It has, however, been suggested that regular blood collection tubes carry contaminants from the tube's stopper into the blood cultures drawn afterwards, thereby increasing contamination rates. The aim of this trial is to examine the effect of aspirating the first blood volume into a regular blood collection tube on blood culture contamination rate.


Eligibility Criteria:
Inclusion Criteria:

* Adults evaluated in the emergency room or as inpatients for suspected sepsis or having sepsis and from whom the treating physician plans to take, in the same venous puncture, blood cultures and additional blood tests (blood count and/or blood chemistry).

Exclusion Criteria:

* None
Adoption-specific Treatment Prevention Pilot Trial

This study seeks to pilot a manualized adoption-specific intervention aimed at providing a preventive intervention for families adopting children ages 5-14 years where family reunification has been terminated and the family is moving toward adoption or who have adopted children from foster care in the last three years. This work will fill a major gap in services to children and families and is developed to improve mental health and family functioning of children adopted from foster care, as well as decrease adoption disruptions. President Clinton's 1997 adoption initiative, The Adoption and Safe Families ACT (ASFA), along with subsequent Congressional initiatives, have provided incentives to States and subsidies for adopting older children with a resultant increase in rates of adoption from foster care from 26,000 in 1995 to 53,000 (stabilized annual rate) beginning in 2002. The mean age at adoption from foster care is now 6 years old. These older children have histories of physical and sexual abuse, neglect, and multiple placements, all factors that predict behavior problems over time. To address this gap in our knowledge of providing care for this vulnerable group, we have developed a manualized adoption-specific intervention for families adopting children from foster care. Because adoptive children generally enter homes with stable, well-functioning parents, interventions may be particularly effective in helping the children adjust and their parents learn to understand and manage children with difficult past histories.

The aim of this current pilot trial is to test this intervention designed to improve the outcomes for children adopted from foster care through a randomized trial. Our hypothesis is that this manualized adoption-specific intervention will be more effective than care as usual in improving child mental health and family functioning outcomes; specifically, families and children who have been randomized to the manualized adoption-specific intervention will show better outcomes on the post-treatment measures and the 3 month follow-up than on the pre-treatment measures than the care as usual families and children.


Eligibility Criteria:
Inclusion Criteria:

* Children being adopted from foster care, ages 5-14
* Children (within above age range) who have been adopted in the last three years
* Family reunification services have been terminated

Exclusion Criteria:

* Children with the following Diagnostic and Statistical Manual psychiatric disorders will be excluded from study participation: Pervasive Developmental Disorders (e.g. Asperger's, autism, mental retardation, or psychotic disorder as known to the parents
* Children will be excluded if the child has a major neurological disorder or a major medical illness that would interfere with participation in the study
* Children who pose a significant risk for dangerousness to self or others that makes participating inadvisable
* Children and/or parents who are non-English speaking and unable to complete treatment without a translator will not be included
Effect of Curodont Repair in Patients With Early Approximal Carious Lesions

The purpose of this study is to evaluate the therapeutic benefit of Curodont Repair for the treatment of early approximal carious lesions compared to no treatment.

All study participants must have two early approximal carious lesions in need of a treatment but not of an invasive treatment (split-mouth design). One lesion will be treated with Curodont Repair and the other will not undergo a treatment as control. Study duration is 12 months. For assessment x-ray pictures are used.

Eligibility Criteria:
Inclusion Criteria:

* Two approximal carious lesions on different teeth with at least one tooth in between
* Both study lesions must not require an invasive treatment
* Size and form of the lesions: the lesions must be fully visible and assessable on radiographs
* The two carious lesions must fall into classes:

D1 (outer half of enamel) D2 (inner half of enamel) D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction)

* Able and willing to observe good oral hygiene throughout the study
* Age ≥ 18 years and ≤ 65 years
* Willing and able to attend the on-study visits
* Willing and able to understand all study-related procedures
* Written informed consent before participation in the study

Exclusion Criteria:

* The two study test lesions are located on adjacent teeth
* Fluoride varnish application \< 3 months prior to study treatment
* Tooth with numerous carious lesions
* Evidence of tooth erosion
* History of head and neck illnesses (e.g. head/neck cancer)
* Any pathology or concomitant medication affecting salivary flow or dry mouth
* Any metabolic disorders affecting bone turnover
* Patient suffers from diabetes
* Concurrent participation in another clinical trial
* Women who are breast-feeding, pregnant or who plan a pregnancy during the study
* Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner
Virtual Mantram Program for Patients With PTSD and SUD

The purpose of this study is to evaluate a virtual Mantram repetition program for adults with PTSD and substance use disorders. The program involves repetition of a personalized Mantram, which is a word or short phrase with spiritual meaning that is frequently repeated throughout the day. The program also involves slowing down thoughts and have one-pointed attention that help with stress.

The purpose of this study is to evaluate a virtual Mantram repetition program for adults with PTSD and substance use disorders. The program involves repetition of a personalized Mantram, which is a word or short phrase with spiritual meaning that is frequently repeated throughout the day. The program also involves slowing down thoughts and have one-pointed attention that help with stress.

The study starts with an eligibility and baseline assessment, which involves completing a series of questionnaires. Following these assessments, enrolled participants will be placed into a Mantram repetition program group led by two facilitators. This group will consist of 5 to 8 participants who will meet virtually every week for ninety minutes over an 8-week period. During this time, participants will also be asked to complete weekly self-reported questionnaires on their own. Additionally, at weeks 4 and 8, the participants will complete assessments and questionnaires with a member of the study team. The program will end after week 8. At week 12, participants will be invited to participate in a focus group to complete additional assessments, as well as be asked open-ended questions assessing the impact of the program on PTSD symptoms, substance use, and substance use cravings.

In summary, the Mantram group program will take 8 weeks to complete and the assessments will take approximately 12 weeks to complete. Participants will receive compensation of up to $200 for their participation.

Eligibility Criteria:
Inclusion Criteria:

* participants 18-years old or older
* fluent in English
* diagnosed with PTSD by a healthcare practitioner confirmed with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5 past month version)
* diagnosed with past-year substance use disorder other than tobacco or caffeine by a healthcare practitioner confirmed by Structured clinical interview for DSM-5 (SCID-5)
* agreed not to participate in other therapies during the program (mindfulness, yoga, biofeedback, self-hypnosis or tai chi)
* willing to commit to attend all sessions

Exclusion Criteria:

* diagnosis of a severe or unstable medical illness that precludes safe participation in the study by a healthcare practitioner
* diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder; or current acute psychosis or mania by a healthcare practitioner
* participants with moderate or high risk of suicide upon screening by the Columbia Suicide Severity Rating Scale (C-SSRS)
* have an inability to communicate in English fluently enough to complete the questionnaire.
Measuring Cortisol Levels in Persons With Parkinson's (PD)

The objective of this study is to evaluate the cortisol awakening response with persons with Parkinsons Disease (PD), Huntingtons Disease (HD), and controls. These data are desired so experience can be gained with measuring stress levels subjectively and objectively in persons with PD, HD, and controls.

Telephone consent will be obtained.

Participants will collect saliva at twelve time points - four times a day for three days.

Visits will be conducted virtually (over the internet).

The virtual visit is to assess Parkinson's or Huntington's disease status, stress, mood, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

Group (3) Inclusion:

* No significant neurological disorder
* PSS score of greater than or equal to 13.

Group (5) Inclusion:

* HD diagnosis or HD gene carrier
* a Perceived Stress Scale (PSS) score higher than or equal to 13.

Group (6) Inclusion:

* HD diagnosis or HD gene carrier
* PSS score lower than 13

Group (7) Inclusion:

* PD diagnosis
* Prior completion of the study.

Exclusion Criteria:

* The use of medications known to effect cortisol levels (estrogen, synthetic glucocorticoids, androgens, phenytoin, spironolactone, prednisone, prednisolone, and hydrocortisone).
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II

The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.

Objective: The aim of this study is to provide high quality data and give a comprehensive overview of characteristics, clinical features, management and prognosis during exacerbations and stable periods among inpatients with acute exacerbation of chronic obstructive pulmonary disease in real-world China.

Eligibility Criteria: Details are shown in the Eligibility Criteria part.

Procedures and Measurements: At admission, each eligible subject will be given an in-depth interview to collect the demographics, smoking history, medical history, management of disease during stable period, etc. During hospitalization, treatment and auxiliary examination results including laboratory and lung function tests will be recorded if available. To ensure the quality and uniformity of spirometry data, training on performing spirometry will be provided to each study site by professional doctors from central site. At discharge, physicians will record the discharge diagnoses and clinical outcomes including death, intensive care unit admission, chronic obstructive pulmonary disease assessment test (CAT) score and total direct cost for each participant. During follow-ups, clinical outcomes including death and exacerbation events, change of medication, new-developed complications, auxiliary examination results, and economic burden will be collected.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* hospitalized with main diagnosis of acute exacerbation of chronic obstructive pulmonary disease (AECOPD)

Exclusion Criteria:

* refusing to sign informed consent forms
* participating in clinical trials or intervention studies of drugs
* diagnosed as active pulmonary tuberculosis, or acute left heart failure
Developing Nursing Students' Intercultural Sensitivity Levels

This study; This is a randomized controlled experimental type study designed to improve the intercultural sensitivity levels of nursing students.

Cultural sensitivity is extremely important for healthcare professionals. Understanding cultural differences can help build a trusting relationship between patients and healthcare professionals. This increases patient satisfaction and improves the quality of health services.

This work; This is a randomized controlled experimental type study designed to improve the intercultural sensitivity levels of nursing students.

Intercultural sensitivity training does not affect the intercultural sensitivity level of nursing students.

Eligibility Criteria:
Inclusion Criteria:

* Being a student of Aydın Adnan Menderes University Nursing Department
* Having successfully completed the basic practical courses of the first three classes
* Being enrolled in one of the Public Health Nursing or Mental Health and Diseases Nursing courses from the fourth year
* Volunteer to participate in the study

Exclusion Criteria:

• Not completing the training sessions of the research