cyrilzakka/clinical-trials huggingface dataset:
Family Cognitive Behavioral Therapy for Preventing Depression in Children

This study will determine the effectiveness of cognitive behavioral therapy (CBT) versus educational treatment in preventing depression in the children of parents with a history of depression.

Depression is a serious condition that can affect a person's work, relationships, and quality of life. Studies have shown that children of depressed parents are at a higher risk for developing depression than those whose parents have not experienced depression. Safe and effective treatments that can help prevent children of depressed parents from becoming depressed are needed. This study will compare CBT to depression education to determine which is more effective in preventing depression in the children of depressed parents.

Families will be randomly assigned to receive weekly sessions of either CBT or depression education for 12 weeks. Parents in the CBT group will be taught skills to more effectively raise their children and to better manage their depressive symptoms; their children will be taught skills to cope with the stress of their parents' depression. Families in the education group will be informed about the ways that depression can affect individuals with depression and their families.

Study visits will occur at study entry and at Week 12. Several follow-up visits will occur for up to 2 years after the interventional part of the study. At each visit, a clinician will make direct observations of the depressed parent's interaction with his or her children. In addition, families will be interviewed and will complete questionnaires about the parent's depressive symptoms and family interaction.

Eligibility Criteria:
Inclusion Criteria for Participating Families:

* Families with at least one parent with a history of depression during the life of his or her child
* Families with at least one child between the age of 10 and 15
* Parent or guardian willing to provide informed consent for participating children

Exclusion Criteria for All Participants:

* Parent with bipolar disorder or schizophrenia
* Child with conduct disorder or pervasive developmental disorder
Dexmedetomidine Versus General Anesthesia on the Diagnosis of Endobronchial US-Guided Transbronchial Needle Aspiration

The aim of this study is to compare dexmedetomidine as moderate sedation versus general anathesia on the diagnostic yield of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (EBUS-TBNA) has emerged as a highly effective, minimally invasive technique for sampling peribronchial, mediastinal, and lung masses for pathologic examination with low rate of complications, and costs.

Dexmedetomidine, is a high-affinity adrenergic agonist of the alpha 2 receptor, is a potential alternative sedative.

The use of dexmedetomidine does not lead to respiratory depression, or to a decline in cognitive skills or patient cooperation. This is because dexmedetomidine acts on the alpha-2 receptors in the locus coeruleus, in contrast to other sedatives (midazolam and propofol) which act on GABA receptors/cerebral cortex.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status classification II or III a requiring EBUS-TBNA based on suspicion of either benign or malignant disease in mediastinal or hilar lymph nodes (LNs) or masses or requiring EBUS-TBNA for mediastinal staging of lung cancer.

Exclusion Criteria:

* Suspected need for additional procedures other than EBUS-TBNA during planned bronchoscopy (e.g., need for navigational bronchoscopy, endobronchial biopsies, and therapeutic bronchoscopy)
* body mass index \> 35 kg/m2
* allergies to any of the involved sedatives or anesthetic agents
* comorbidities contraindicating the EBUS procedure
* pregnancy
Development of the Muscle Architecture Based Isokinetic Strength Assessment Position for Shoulder Rotator Muscles

Today, the most commonly used position is the seated position with 45° of shoulder abduction (Abd) in the scapular plane, known as the most functional isokinetic assessment of shoulder-rotator strength (1). However, considering the architectural feature of the rotator muscles, a position where the maximum sarcomere length is obtained, in which the maximum muscle strength is produced, has not been investigated. Ward et al. showed that the shoulder position, in which the sarcomere length of the muscles was between 2.0 - 2.6 µm, was 25⁰ Abd and 20⁰ external rotation (ER) as a result of their study on the rotator cuff muscles architecture (2). The test position selected in isokinetic measurements is the main factor for outcome measurements and the repeatability of the measurements directly depends on the selected position (3). This study was planned to investigate the effects of the position where the shoulder is at 25⁰ Abd and 20⁰ ER to develop the most suitable isokinetic strength evaluation position based on muscle architecture for shoulder rotator muscles.Using IsoMed 2000 device (D. \& R. Ferstl GmbH, Hemau, Germany) we conducted the isokinetic test of concentric (CON) and eccentric (ECC) shoulder internal (IR) and external (ER) strength at the angular velocity of 60˚/s in both Method I (scapular position) and Method II (25⁰ Abd and 20⁰ ER). There were seven days between the testing sessions, and both tests were conducted at the same time of day. The same examiner with experience in performing isokinetic testing with IsoMed 2000 tested all subjects in both testing sessions


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-25
* Body mass index (BMI) being between 18.5-24.9 kg / m 2
* Volunteering to participate in the study
* Having the skills to do the tests and exercises to be applied

Exclusion Criteria:

* Having a history of upper extremity injury within the past year
* Having a sensory problem that prevents participation in the study
* Have any musculoskeletal, neurological, respiratory, or cardiovascular risk factors that limit exercise
* Having a history of malignant disease
Identification of Pathophysiological Pathways and Therapeutic Targets in Primary Stomatodynia by Salivary Metabolomics

Burning mouth syndrome (BMS) is defined by a chronic oral pain affecting especially postmenopausal women. Its physiopathology is still unknown and several hypotheses have been put forward to explain this syndrome, such as neurological, hormonal or inflammatory process. The recent development of salivary metabolomic profiling in oral diseases has led to the identification of potential pathways in such disorders. The aim of this study is to analyze the salivary metabolomic in BMS patients compared to healthy controls.

Burning mouth syndrome (BMS) is defined by a chronic oral pain affecting especially postmenopausal women. Its physiopathology is still unknown and several hypotheses have been put forward to explain this syndrome, such as neurological, hormonal or inflammatory process. The recent development of salivary metabolomic profiling in oral diseases has led to the identification of potential pathways in such disorders. The aim of this study is to analyze the salivary metabolomic in BMS patients compared to healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* For cases : primary Burning Mouth Syndrome, based on the IHS diagnosis criteria
* For cases : being able to realise the salivary collection
* For controls : no primary BMS
* For controls : being able to realise the salivary collection

Exclusion Criteria for both groups:

* Treatment by antibiotics in the previous month
* New treatment in the previous two weeks
* Active smoking
* Active infectious or inflammatory oral disease
* Systemic disease that could have an impact on the salivary metabolome or on the neurological system
* Being under legal guardianship
* Opposition to the processing of personal data
Separation Versus Integrated Approach in Combining ECMO With CRRT

This investigation aims to evaluate the filter life time of CRRT membrane and complication of combining ECMO and CRRT.


Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years
2. Refractory acidosis (pH\<7.2 or HCO3\<15)
3. Refractory volume overload
4. Refractory hyperkalemia (K\>6.2mEq/L or EKG change)
5. Anuria or oliguria (urine output \<0.5 mL/kg/hr for 6-12hr)
6. High BUN \>100 mg/dL or uremic symptom
7. Increase intracranial pressure

Exclusion Criteria:

1. Pregnancy
2. Not use heparin in ECMO
3. Chronic kidney disease with CRRT
4. AKI with Glomerulonephritis, Interstitial nephritis, Vassculitis or Urinary tract obstruction
Factors Associated With Parental Observation of Side Effects Following the Child Flu Vaccine

This study investigates whether there are psychological predictors of parental perception of side-effects following vaccination with the child flu vaccine. We will also investigate whether the perception of side-effects affects parents' intention to vaccinate their child again in the following flu season, as well as whether there are underlying differences in parents' cognitive biases between those who do and do not re-vaccinate their child.

In 2012, the British Joint Committee on Vaccination and Immunisation (JCVI) recommended that the influenza vaccination programme be extended to include children aged 2 to 16. In the three flu seasons in which the child flu immunisation programme has been running (2013-14, 2014-15, 2015-16), uptake rates have been low (approximately 40%). Multiple factors are likely to underlie the poor uptake, including thinking the vaccine was unsafe and ineffective and having experienced side-effects related to the vaccine previously.

Although symptoms are commonly reported following vaccinations, their causes are not always straightforward. Although a minority may be directly attributable to the vaccine itself, others may reflect pre-existing or coincidental symptoms that are misattributed to the vaccine. Following vaccination, an expectation that the vaccine causes side-effects may also contribute to parents detecting symptoms in their child that might otherwise have gone unnoticed. Perception of side-effects may also influence the parent's decision to vaccinate their child again in following years.

Other possible factors influencing parents' perception of side-effects and their willingness to vaccinate their child again are their personal health beliefs and their interpretations of the information they are given about vaccination and side-effects. These cognitive processes can be measured objectively using experimental tasks, and can reveal characteristic patterns, or 'cognitive biases' which govern behaviour.

Eligibility Criteria:
Inclusion Criteria:

* Parents of guardians of children aged 2-4 on 31st August 2016 (i.e. born September 1st 2011 to August 31st 2014) who receive the flu vaccine at the GP
* Parents must be aged 18 or over
* Parents must be fluent in English

Exclusion Criteria:

-
Clinical, Immunological and Microbiological Evaluation of Experimental Gingivitis and Peri-implant Mucositis

The objective of this study is to evaluate, through clinical, microbiological and immunological tests, the changes during the experimental gingivitis and mucositis model, between teeth and implants, and between patients with a history of aggressive periodontitis and healthy individuals.

The objective of this study is to evaluate, through clinical, microbiological and immunological tests, the changes during the experimental gingivitis and mucositis model, between teeth and implants, and between patients with a history of aggressive periodontitis and healthy individuals. 20 patients will be include, 10 healthy and 10 with a history of aggressive periodontitis. All patients must present the same type of implant and abutments, with prostheses in function for more than 6 months. They should also have a tooth located in the contralateral hemi-arch in a similar position, allowing a comparison with the implant. They will be submitted to the plaque-induced inflammation by suspension of oral hygiene only in the tested areas (tooth / implant), protected by a personalized stent made of plastic, according to the experimental gingivitis and mucositis model of 21 days of duration.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years,
* History of aggressive periodontitis diagnosed according to the Armitage classification (1999) and verified by the dental chart and time of radiographic bone emission, being in periodontal maintenance for a little more than 6 months (Test group).
* Presence of teeth and implants (unitary prostheses) in the mouth; in a similar and counter-lateral position in the arch. The implants are the same system, including protective and dimensions.
* Probing Depth \<5mm, in the interest sites.
* Plaque Index ≤ 20% (Silness \& Löe, 1964),
* Healthy patients
* Signature of free and informed consent.

Exclusion Criteria:

* Probing Depth\> 5mm, in the interest sites.
* History of bone loss by peri-implantitis in the implant test.
* Smoking;
* Pregnancy;
* Presence of systemic disorders (diabetes, hypertension, heart disease or any other condition that could contraindicate periodontal surgery);
* Use of medications (immunosuppressants, phenytoin or anything else that might affect mucosal healing and repair);
To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Partial Seizures.

To evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.


Eligibility Criteria:
Inclusion Criteria:

* Must have met the inclusion criteria for preceding double-blind study
* Have received double-blind study medication and wish to receive open-label pregabalin.

Exclusion Criteria:

* Cannot have absence seizures
Cardiotoxicity in Locally Advanced Lung Cancer Patients Treated with Chemoradiation Therapy

This observational cohort will evaluate the cardiovascular effects of chemoradiation used to treat locally advanced, non-small cell lung cancer. Patients will be enrolled prior to the start of therapy and followed during and for at least 2 years after therapy with echocardiograms, nuclear stress tests, blood sampling, and quality of life surveys.

Lung cancer is both the most common malignancy worldwide and the leading cause of cancer death in the US. While radiation therapy is highly effective for many solid tumors, thoracic radiation therapy carries a risk of cardiovascular morbidity and mortality that limits critical gains in cancer control and survival. The investigators will perform detailed cardiovascular phenotyping using biologic and imaging markers to define functional and physiologic perturbations that occur with radiation therapy. The study will provide insights into how cardiovascular risk factors and disease impact these biologic and functional changes. The investigators will also determine which radiotherapy dose-volume metrics are indicative of subclinical cardiotoxicity.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Histologically confirmed or clinically diagnosed non-small cell lung cancer where the plan is for definitive treatment that includes radiation
* Able to give written informed consent

Exclusion Criteria:

* Pregnant or breast-feeding
* Prior treatment with anthracyclines
* Radiation treatment not expected to involve any heart exposure as determined by treating provider
* ECOG performance status greater than 2
* Vulnerable patients, including pregnant women and prisoners
* Contraindication to rest/vasodilator stress PET/CT, including: asthma with ongoing wheezing at time of enrollment; known Mobitz Type II AV block, 3rd degree AV block, or sick sinus syndrom, without a pacemaker; systolic blood pressure less than 90mmHg; known hypersensitivity to Regadenoson and adenosine; profound sinus bradycardia (heart rate less than 40bpm).
A Dose Ranging Vehicle Controlled Study to Determine the Safety and Efficacy of Permethrin Foam, 5% and Permethrin Foam, 4% for the Treatment of Scabies

To determine and compare the safety and efficacy of permethrin foam 4% and permethrin foam 5% with that of vehicle in subjects with scabies.

It is anticipated that a majority of subjects will require and receive a single treatment; however, those subjects not showing improvement at the follow-up visit 2 weeks after initial treatment will be treated a second time. Those subjects originally assigned to vehicle for the first treatment will receive a "re-treatment" with one of the active doses.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of active scabies infection.
* Subject is in good general health with normal appearing skin in noninfested areas.
* Females must be post-menopausal, surgically sterile or use an effective method of birth control with a negative pregnancy test (10 years of age and older) at study start.

Exclusion Criteria:

* Subject is pregnant, lactating, or is planning to become pregnant during the study.
* Subject has used any ectoparasiticide within the three weeks prior to study start.
* Subject has signs of systemic infection or is receiving systemic therapy for an infectious disease.
* Subject has severe cutaneous bacterial or fungal infections requiring therapy or heavily crusted lesions consistent with Norwegian scabies.
* Subject is currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days prior to study start.
* Subject whose close personal contacts will not comply with standard of care for fomite management.
Improving Search Strategy for Identifying Urgent Conditions on the Chest X-ray

Currently, teaching X-ray interpretation to medical students is not standardized, and is generally not very effective.

Objective: The goal of our study is to evaluate whether directly teaching an expert search strategy for x-ray interpretation to 3d year medical students is effective.

Methods:

* An expert's visual search strategy was recorded using a gaze-tracking device. The search strategy was then reproduced using a dynamic cursor moving across the corresponding chest x-ray, and incorporated into a teaching program accessible via the internet.
* Participants are 3rd year medical students who will be randomized into two groups. The experimental group will have access to the teaching program as described. The control group will have access to the same x-rays but not the expert's search strategy.
* At the end of the study period the investigators will collect performance data (the participants' accuracy at reading a series of chest x-rays) and process data (using gaze-tracking to evaluate the participants' search strategies); the experimental and control groups will be compared.

Expected results:

The investigators expect the group trained in expert search strategy to show improved accuracy at reading chest x-rays, and an improvement in their visual search strategy


Eligibility Criteria:
Inclusion Criteria:

* 3rd year medical students enrolled in medicine or surgery rotations during the planned study period
Effect of Post-stroke Discharge Training

The aim of this study was to determine the effect of post-stroke discharge training and telephone counseling service on patients' functional status and caregiver burden. The study was conducted with 69 stroke patients (34 in the intervention group and 35 in the control group) and their caregivers. In the study, data were collected before discharge and three months after discharge. Discharge training and telephone counseling (one week after discharge and once a month for three months) were given to the caregivers of the patients in the intervention group.

This study, which was planned as a randomised controlled study, was conducted university hospital neurology clinic in Turkey. A total of 80 participants who met the inclusion criteria were randomised to either the intervention and control groups.

In this study, Patient Information Form, Modified Rankin Scale and Barthel Index were used to collect data about patients, while Caregiver Information Form and Caregiver Burden Scale were used to collect data about caregivers Pre-tests were applied to patients and caregivers in the intervention and control groups before discharge. After the pre-tests were applied to the caregivers in the intervention group, discharge training was given.

Eligibility Criteria:
Inclusion Criteria:

* the age of 18 and over (for patients and caregivers)
* having undergone a hemorrhagic or ischemic stroke (for patients)
* being literate (for caregivers)
* being primarily responsible for the care of the stroke patient during the hospital stay and at home after discharge (for caregivers)
* using a mobile or home phone (for caregivers)
* being open to communication and collaboration (for caregivers)

Exclusion Criteria:

* Rankin Scale score of 4 above (for patients)
* Having problem in terms of hearing and understanding (for caregivers)
Immunogenicity and Safety Study of GSK Biologicals' GSK2202083A Vaccine in Healthy Infants at 2, 3 and 4 Months of Age

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine co-administered with GSK Biologicals' 10-valent pneumococcal conjugate (GSK1024850A) vaccine given as a three-dose primary vaccination course at 2, 3 and 4 months of age.

In accordance with the local recommended immunisation schedule, all subjects will receive 2 doses of GSK Biologicals' Human Rotavirus Vaccine (Rotarix) at 2 and 3 months of age.

Eligibility Criteria:
Inclusion Criteria:

* A male or female infant between, and including, 8 and 12 weeks of age at the time of the first vaccination.
* Born after a gestation period of 36 to 42 weeks inclusive.
* Subjects should have received one dose of hepatitis B vaccination at birth as per local recommendations.
* Subjects who the investigator believes that their parent(s)/LAR can and will comply with the requirements of the protocol.
* Written informed consent obtained from the parent/LAR of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
* Administration of any vaccine since birth, with exception of HBV and Bacillus Calmette-Guérin, or planned administration during the study period.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Hib, pneumococcal and/or MenC disease.
* History of seizures or progressive neurological disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Major congenital defects or serious chronic illness.

The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:

• Current febrile illness or axillary temperature \>= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.