cyrilzakka/clinical-trials huggingface dataset:
Turkish Version of Back Pain Knowledge and Beliefs Survey

Low back pain (LBP) is a globally prevalent health issue, affecting the majority of individuals at some point in their lives. Misconceptions about LBP can prolong its chronicity, highlighting the importance of educating patients with accurate information. The Back Pain Knowledge and Beliefs Survey (BacKS), introduced in 2024, aims to measure individuals' knowledge about LBP based on updated scientific evidence. Given the high prevalence of LBP in Turkey and the lack of validated tools in Turkish, adapting BacKS to Turkish is essential. This study aims to conduct its cross-cultural adaptation, validation, and reliability analysis for clinical and community use.

Low back pain (LBP) is one of the most prevalent health issues worldwide, with approximately three-quarters of individuals experiencing this condition at some point in their lives. Misconceptions, beliefs, and misinformation about LBP can prolong the duration of pain and contribute to its chronicity. Clinical guidelines emphasize the importance of educating patients with evidence-based information to remove potential barriers to recovery.

The Back Pain Knowledge and Beliefs Survey (BacKS) was introduced in October 2024 to assess individuals' knowledge and beliefs about LBP based on the most recent scientific evidence. Several tools in the literature aim to measure knowledge and beliefs related to LBP, including the Back Beliefs Questionnaire (BBQ) and the Back Pain Knowledge Questionnaire. However, these tools were developed in previous decades and may not reflect the current scientific literature. Additionally, the Turkish versions of some of these questionnaires have not yet undergone validation and reliability studies.

According to the 2016-2022 Turkish Health Survey conducted by the Turkish Statistical Institute (TÜİK), back-related problems rank first among all reported health issues, with a prevalence rate of 24.6%. Despite the high prevalence of LBP in Turkey, there is currently no systematically validated tool available in Turkish to measure the public's knowledge and beliefs regarding this condition.

The adaptation of BacKS into Turkish will help address this gap by providing a valid and reliable tool for both clinical and community-based research. Measuring and evaluating patient-reported outcomes accurately is crucial in managing LBP effectively. Therefore, the aim of this study is to conduct the cross-cultural adaptation, validation, and reliability analysis of the Turkish version of BacKS.

Eligibility Criteria:
Inclusion Criteria:

* Having low back pain or having a history of low back pain in the last 12 months
* To be able to read and write Turkish

Exclusion Criteria:

* Having cognitive impairment that prevents communication
* Pregnancy
* Malignite
* Infections
* Fractures,
* Inflammatory diseases
Safety, Tolerability and Pharmacokinetics of Single Doses of TS-134 in Healthy Volunteers

This is a Phase 1a study involving single oral dose of TS-134 in healthy male and female subjects. The safety, tolerability and pharmacokinetics of single dose of TS-134 will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and female participants between 18 and 55 years of age
* Body weight greater than or equal to 45 kg
* Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m\^2

Exclusion Criteria:

* Female participants who are pregnant, intend to become pregnant, or are breastfeeding
* Clinically significant abnormal physical examination, 12-lead electrocardiogram (ECG) OR cardiac telemetry prior to dosing.
* Significant history or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, locomotor, immunologic, ophthalmologic, metabolic or oncological disease.
* History or presence of psychiatric or neurologic disease or condition
* History of alcohol or drug abuse
* Any participant who currently uses or has used tobacco or tobacco-containing products for at least one month prior to screening
* Participated in strenuous exercise within 48 hours prior to study start (initial dosing) and/or are unwilling to avoid strenuous exercise at any time throughout the study.
Upper Limit for TSH of First and Second Trimester Pregnancy in Turkey

Physiological changes necessitate the use of pregnancy-specific reference ranges for TSH and FT4 to diagnose thyroid dysfunction during pregnancy. Although many centers use fixed upper limits for TSH of 2.5 or 3.0 mU/L, this may lead to overdiagnosis or even overtreatment.

The new guidelines of the American Thyroid Association have considerably changed recommendations regarding thyroid function reference ranges in pregnancy accordingly. Any hospital or physician that is still using the 2.5 or 3.0 mU/l cut-off for TSH during pregnancy should evaluate their own lab-specific cut-offs.

The investigator's objective is to establish a rational reference range of serum TSH for diagnosis of subclinical hypothyroidism in the first and second trimester of pregnant women in west Black Sea region in Turkey.

Serum thyroid function tests (including T3, T4, TSH, Anti-TPO) will be obtained from the singleton pregnancies in first and second trimester to determine the local specific normal ranges.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Free of pre-existing thyroid disease
* That do not use thyroid interfering medication
* That did not undergo IVF treatment
* TPOAb negative

Exclusion Criteria:

* Adolescent pregnancy
RNFL Thickness Measurements Obtained Using SD-OCT and SLP Using GDx Variable Corneal Compensation

The aim of this study is to evaluate the correlation of retinal nerve fiber layer (RNFL) thickness measured using spectral domain optical coherence tomography (SD-OCT) and scanning laser polarimetry (SLP) in uveitic eyes compared to healthy eyes.

A descriptive, observational, prospective, consecutive, cross-sectional, controlled, mono-center case series was conducted from May to October 2015. Clinical characteristics, best-corrected visual acuity, intra-ocular pressure, RNFL thickness measurement with SD-OCT and SLP using GDx variable corneal compensation (GDx VCC) were performed for each patient. An evaluation of anterior chamber inflammation with laser flare cell meter was also carried out. Correlations between SD-OCT and GDx VCC RNFL measurement were evaluated by linear regression analysis.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years,
* best-corrected visual acuity better than or equal to 20/40,
* spherical refraction between -6.00 and +3.00 diopters,
* no retinal disease or non-glaucomatous neuropathy, and no ophthalmic surgery in the past 6 months.

Exclusion Criteria:

* Healthy eye were excluded in case of consecutive and reliable abnormal standard automated perimetry with abnormal Glaucoma Hemifield Test and pattern standard deviation outside 95% of normal limits, and optic nerve damage (asymmetric cup-to-disc ratio ≥ 0.2, rim thinning, notching, excavation, or retinal nerve fiber layer defect).
* any history of ophthalmic disease.
Heel Warming Before Capillary Blood Sampling

Capillary blood sampling from the heel is often used in the treatment of infants admitted to neonatal intensive care (NICU). In Danish NICUs a heated blanket, a heated gel pad or a disposable glove with warm water are the methods most often used.

The purpose of this randomized controlled study is to investigate which of the mentioned heating methods ensures the best quality of the blood sample and provides the most gentle blood sampling for the infant.

Some infants experience a difficult and painful blood sampling which can lead to bruised or swollen heels and a blood sample of poor quality. To minimize the risk of that, the infant's heel is heated before the procedure as described in standard GP42-A6 from The Clinical and Laboratory Standards Institute. However, no consensus exists on which heating method to use. The aim of this study is to compare three different heating methods in terms of which method can help reduce pain experienced by infants as well as increase the quality of the blood samples.

Infants (postmenstrual age ≥ 28 + 0) admitted to the NICU, Kolding Hospital and having a blood sample taken by a Biomedical Laboratory Scientist are invited to participate. A parental informed concent must be signed by both parents before participation.

Infants are randomized to one of the three heating methods: glove, blanket or gel pad.

The following blood sampling procedure is closely monitored to register data corresponding to the five outcome measures.

Furthermore the infants personal data, location of the infant during the procedure, surface temperature of the heel before and after heating, volume of sampled blood, sign of bruises and swelling as well as hematocrit are registered.

Data registration, web-based block randomization, data storage and statistical analysis are supported by OPEN (Open Patient data Explorative Network, University of Southern Denmark).

The study is registered as public research at the Region of Southern Denmark (journal no. 20/1316) and is approved by The Regional Committees on Health Research Ethics for Southern Denmark (ID S-20200082).

Eligibility Criteria:
Inclusion Criteria:

* PMA (postmenstrual age) ≥ 28+0
* Blood sampling performed by a Biomedical Laboratory Scientist

Exclusion Criteria:

* GA (gestational age) ≥ 44+0
* Weight \> 6000 g
* Coagulation related disorder
* Severe illness/disorder
* Heel is bruised or swollen
* Parents not understanding written Danish language
Guanfacine to Treat Borderline Personality Disorder

This study is designed to investigate whether guanfacine (Tenex) is an effective treatment for borderline personality disorder (BPD), an illness often characterized by unstable mood and impulsive aggression. Guanfacine stimulates activity in the front portion of the brain, a region associated with attention and the control of behavior. We believe that guanfacine may improve symptoms of BPD by improving attention and aiding regulation of behavior.

This is an 8-week treatment study designed to test whether guanfacine is an effective treatment for borderline personality disorder (BPD). Prior to taking the study medication, subjects will have medical and psychiatric evaluations, complete self-report questionnaires, do a functional MRI scan, and complete a set of cognitive tests. While taking the study medication, participants will meet weekly with a study doctor and be administered interviews and questionnaires. At the end of the 8-week trial, participants will be asked to repeat the MRI scan and cognitive tests.

Eligibility Criteria:
Inclusion Criteria: This study includes men and women between the ages of 18 and 55 who meet criteria for borderline personality disorder with impulsive aggression.

Exclusion Criteria: Subjects must not currently be taking any psychiatric medications. Subjects must not meet criteria for current substance dependence, current major depression, bipolar disorder, or schizophrenia-spectrum disorders.
Effectiveness and Cost-Effectiveness of Depression Treatment for Individuals With TB in South Africa

This hybrid type I effectiveness-implementation trial will increase understanding of the effectiveness and cost-effectiveness of integrating a brief evidence-based treatment for major depressive disorder (MDD) within the tuberculosis (TB) care platform to improve TB and MDD. Findings from this R01 are likely to inform policy and treatment guidelines for the integrated management of TB and MDD in low- and middle-income countries globally.

TB and depression are the leading infectious cause of death and the leading cause of disability, respectively. Furthermore, they are commonly co-occurring and negatively synergistic. TB and depression comorbidity is associated with a 2.85 greater chance of death and 8.70 higher risk for loss to follow up (LTFU) from treatment, which has a cascade of negative individual-, community-, societal-, and health system-level implications. As a treatable condition, depression is a remediable driver of the TB epidemic. The WHO has called for a global policy framework for TB and mental health integration, recommending brief psychological interventions to address mental disorders in primary care settings. Interpersonal counseling (IPC) is a brief version of one such evidence-based intervention that has demonstrated efficacy and effectiveness in treating depression when delivered by non-mental health specialists, including in South Africa. The purpose of this study is to assess the effectiveness and cost-effectiveness of integrating IPC (for depression) into the TB care platform to improve TB and depression outcomes, as well as mitigate TB-related catastrophic costs. As the country with the highest TB burden in the world, nearly 60% of whom are co-infected with HIV, South Africa is the ideal setting for this study. This 3-year hybrid type I effectiveness-implementation trial will be implemented in eight clinics (n\~1410 individuals with TB/depression) in the Eastern and Western Capes of South Africa to integrate IPC to treat depression comorbidity within the TB care platform with the following aims: Aim 1) To evaluate the effectiveness and implementation outcomes of integrating IPC treatment for depression into the existing TB care platform to improve TB and depression outcomes; Aim 2) To determine the influence of theoretically based intervention mediators and moderators on TB treatment outcomes; Aim 3) To assess the cost-effectiveness of integrating depression treatment into the TB care platform from the patient and health system perspectives. This research will provide critical clinical, programmatic, and economic data to inform the WHO global policy framework for TB and mental health integration, and cost-effective clinical practice to improve TB outcomes, especially in low-resource settings.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or over
* initiating treatment for TB
* ability to provide informed consent

Exclusion Criteria:

* unable or unwilling to provide informed consent
Cardiopulmonary Exercise Tests in Patients With Long COVID

The value of clinical cardiopulmonary exercise testing (CPET) within healthcare settings has been established in the last decade. CPET methods remain highly relevant in the COVID-19 endemic phase and should be used to assess those recovering from COVID-19 (SARS-CoV-2) infection. This diagnostic tool could play an integral role in disease prognostication and evaluate the integrative response to incremental exercise. Date from such assessments can enable practitioners to characterise cardio-respiratory fitness and identify reasons for physical impairment or abnormal cardio-respiratory function. More than 50% of patients admitted to hospital will experience cardiorespiratory issues and significant morbidity during their recovery and will require significant rehabilitative support. In this context, measurements obtained from an assessment of cardio-respiratory responses to physiological stress could provide insight regarding the integrity of the pulmonary-vascular interface and characterisation of any impairment or abnormal cardio-respiratory function. Current approaches to rehabilitation are being developed on existing knowledge from Severe Acute Respiratory Syndrome (SARS) and Acute Respiratory Distress Syndrome (ARDS) related illness. These provide important insight but do not provide insight into the novel challenges provided by COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* • Aged 18 to 65 years old

  * Diagnosed with COVID-19
  * Still suffering from symptoms of COVID-19, 3 months after initial infection
  * Sufficient English language comprehension and cognitive ability to understand the study protocol, give informed consent and follow instructions.

Exclusion Criteria:

* • \<18 years of age

  * Admitted to or received treatment from Intensive Care Units
  * Unconfirmed COVID-19 test diagnosis
  * Unable to understand verbal or written information in English
  * Achieving a grade 0 or 1 on the PCFS.
  * Unstable angina
  * Uncontrolled hypertension, that is, resting systolic blood pressure (SBP) \>180mmHg, or resting diastolic blood pressure (BP) (DBP) \>110mmHg
  * Orthostatic blood pressure drop of \>20 mmHg with symptoms
  * Significant aortic stenosis (aortic valve area 120 bpm)
  * Acute pericarditis or myocarditis
  * Decompensated HF
  * Third degree (complete) atrioventricular (AV) block without pacemaker
  * Recent embolism
  * Acute thrombophlebitis
  * Resting ST segment displacement (\>2 mm)
  * Uncontrolled diabetes mellitus
  * Severe orthopaedic conditions that would prohibit exercise
  * Other metabolic conditions, such as acute thyroiditis, hypokalaemia, hyperkalaemia or hypovolaemia (until adequately treated)
  * Severe grade 3 rejection (cardiac transplantation recipients Appendix N).
Quantifying New Heart Muscle Cells

Regenerative therapies could provide new ways of treating heart failure. Unlike many organs in the human body, such as the skin and the GI tract, the ability to regenerate heart muscle decreases after birth, but the precise timing of this decrease and how this decrease is altered in heart disease are uncertain. The investigators will use an innovative approach to quantify cellular heart regeneration in pediatric patients, an appropriate population for determining this decline as well as the potential for reactivating heart muscle regeneration.

The study has now been registered on ClinicalTrials.gov, despite its initiation on July 23, 2015, as registration was not mandated at the original study site, the University of Pittsburgh Medical Center. However, following the transfer of the study to Weill Cornell Medicine, adherence to institutional requirements necessitated its registration on ClinicalTrials.gov.


Eligibility Criteria:
Inclusion Criteria:

* Patients at 30 days of age to 1 year of age undergoing scheduled elective cardiac surgery will be eligible for study inclusion.
* The investigators will recruit patients at 30 days of age to 1 year of age with those types of heart disease whose surgical approach has a high probability of myocardial resection.
* Diagnosis of ToF/PS or other types of heart disease that have a high likelihood of requiring surgery that involves routine resection of myocardium that becomes available for research

Exclusion Criteria:

* Patients with low chance of having resection of myocardium as part of their surgical care.
Intervention in Informal Caregivers Who Care Older People After a Stroke: a Pilot Study in Northern Portugal

Background: More than 42% of older people (aged +65) have a stroke and most of them require some type of help to self-care at home. Informal caregivers have reported different types of need and have shown dissatisfaction with technical and emotional support delivered by community health teams. Furthermore, empowering informal caregivers who care after older stroke survivors is an important challenge, preventing them from negative outcomes such as burden, anxiety and depression or loss of physical function or hospitalization in older people.

Objectives: This pilot study aims to implement and evaluate the impact of an intervention based on training and telephone support delivered to informal caregivers who care after older people post-stroke.

Setting: Community health units in Northern Portugal region. Design/Methods: This single blinded randomized trial will be delivered by a community nursing team to informal caregivers 1 week, 1 and 3 months after a hospital discharge.

Study outcome(s): The primary outcomes will be informal caregivers´ empowerment. Secondary outcomes will include burden and health quality of life in caregivers; functionality, hospital readmission and institutionalization of older people stroke survivors, measured 1 and 3 months after intervention.

Results/Conclusion: Data collection started in February and will be concluded in August 2014. First results will be published at the beginning of 2015. The InCARE programme will be the first pilot in informal caregivers study ever conducted in Portugal. It will highlight new ways to support caregivers who take care of older people after a stroke. If successful, this study will be translational and it will also allow to disseminate the results in Portugal and abroad and implement it as best practice.

InCare study has a purpose to implement and evaluate an intervention delivered to informal caregivers who care for older people after a stroke.

Eligibility Criteria:
Inclusion Criteria:

Informal caregivers are eligible to participate in the InCARE programme if they meet the following inclusion criteria: (i) to be able to communicate and learn (2) not to have a cognitive disease; (3) to live in the Cávado Region covered by ACES I, II and III; (4) to return the informed consent. In addition, older stroke survivors will enter in this study if they had a stroke for the 1st time and which have become dependent for activities of daily living.

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Exclusion Criteria:

Involvement in the InCARE programme requires to communicate frequently, face to face or on the phone, with the nursing staff. Informal caregivers will also be excluded in all the situations in which the provision of older people care is taken by formal support.
Non Invasive Positive Pressure Ventilation to Minimize Aerosolization for COVID 19

Patients presenting to the emergency department, or needing hospitalization, for a variety of medical conditions often require non-invasive ventilation (breathing support). For example, for a person with shortness of breath as a complication of COPD (Chronic obstructive pulmonary disease) the gold standard of care requires application of a BiPAP machine. However, in the current environment of COVID-19, the aerosols produced by this machine in a COVID-19 positive patient pose serious potential harms to healthcare providers and other patients. All patients with similar symptoms to COVID-19 need to be treated as positive until definite testing determines otherwise. The best test available for COVID-19 takes up to 4 hours to determine the patients status, which is too long to delay application of a BiPAP. This could lead to either a delay in care or the need for invasive breathing measures (intubation), which requires intense resource utilization, may not be in line with a patient's goals of care, and could cause serious harms (i.e. infection, medication reactions, etc.) in patients who do not need it. The use of a closed-loop BiPAP machine in which no expired air is released into the environment would solve these problems. Building off the failures of a similar approach that was trialed in Italy in response to the COVID-19 crisis, this project will develop and test a novel closed-loop BiPAP system.


Eligibility Criteria:
Inclusion Criteria:

* Patient with respiratory failure due to primary pulmonary pathology.
* Patient who is selected for BiPAP or CPAP by the health care provider

Exclusion Criteria:

* Age \<18 years.
* Respiratory failure due to non-pulmonary pathology.
* Impaired consciousness (Glasgow coma scale \<10).
* Patients with contraindications of NIV.
* Severe upper gastrointestinal bleeding.
* Chest trauma.
* Agitated or violent patient.