cyrilzakka/clinical-trials huggingface dataset:
Turkish Adaptation of Segmental Assessment of Trunk Control Scale

In infants with Down syndrome at risk in terms of neurosensory motor development retardation, the level of trunk control can determine the level of trunk control towards motor development in infants with down syndrome.

For this reason, the purpose of this study is to adapt the segmental assessment of trunk control scale to Turkish by evaluating the motor development in children with Down syndrome. It is the investigation of validity and reliability.

Independent sitting of babies with Down syndrome is very important because sitting is the primary position on improving play activities. It is a known fact that late acquisition of sitting posture has negative effects on gross motor skills such as crawling and walking as well as fine motor skills. The extent to which trunk development affects the developmental stages of the child and his performance in motor behaviors and skills should be evaluated. At the same time, trunk control should be evaluated at various periods in order to determine early intervention and treatment strategies in babies with Down syndrome who are at risk for motor development.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer parents who have;
* Infant with down syndrome

Exclusion Criteria:

* Have a serious medical history (serious cardiac problems, infantile spasm, leukemia)
* Presence of MSS and PSS-related problems
* Those with visual and auditory problems
* Having epileptic seizures
* Presence of musculoskeletal problems
Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of CDX 6114 in PKU Patients

The primary objective is of this Phase 1 study is to evaluate the safety and tolerability of daily, multiple, oral doses of CDX-6114 when administered to patients with PKU for 14 days. The aim is to check if administration of daily, multiple, oral doses of CDX-6114 to patients with PKU for 14 days shows a clinically acceptable safety and tolerability profile.


Eligibility Criteria:
Inclusion Criteria

1. Male and female patients between the ages of 18 and 65 years, with a diagnosis of classical PKU
2. Patients with a blood phenylalanine concentration \> 600mol/L at screening as an indicator of sub-optimal dietary management
3. Body mass index (BMI) between 18 and 35 kg/m2 at screening.
4. Male patients must agree not to donate sperm starting at screening and continuing throughout the clinical study period up to 90 days after last study drug administration
5. Female patients of childbearing potential and their spouse/partner
6. Female patients of non-childbearing potential:
7. Female patients must agree not to breastfeed. This includes the period starting at screening and continuing throughout the clinical study period up to 90 days after last study drug administration.
8. Female patients must agree not to donate ova. This includes the period starting at screening and continuing throughout the clinical study period up to 90 days after last study drug administration.
9. Patients must be deemed competent to understand the nature of the study and capable of giving written informed consent. Patients must also be willing to attend scheduled study visits in person and to reliably communicate to study personnel on adverse events and concomitant medication use.
10. Patients must agree not to participate in another interventional study while participating in the present clinical study.

Exclusion Criteria

1. Presence or history of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease/condition (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies and childhood asthma).
2. Presence or history of gastrointestinal illness or conditions interfering with normal gastrointestinal anatomy. Examples include gastrointestinal bypass surgery, cholecystectomy, partial or total gastrectomy, gastric band surgery, small bowel resection, vagotomy, malabsorption, Crohn's disease, ulcerative colitis, or coeliac disease.
3. Active treatment with any platelet aggregation inhibitor and/or active treatment (or within the last 4 weeks) with anticoagulant medication.
4. Presence or history of specific food intolerance. Examples include coeliac disease, severe lactose or dairy food intolerance.
5. Positive result for serum hepatitis B surface antigen (HBsAg), hepatitis A virus antibodies (HAV), hepatitis C virus antibodies (HCV), or antibodies to human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) at Screening.
Early Feasibility Study - Edwards APTURE Transcatheter Shunt System

The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System.

The early feasibility study of the Edwards Transcatheter Atrial Shunt System is a multi-center, prospective, early feasibility study to evaluate initial clinical safety, device functionality, and effectiveness of the Edwards Transcatheter Atrial Shunt System.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Heart Failure (HF):

  * NYHA class II with a history of \> II; III; or ambulatory IV AND
  * ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; OR an NT-pro BNP value \> 150 pg./ml in normal sinus rhythm, \> 450 pg./ml in atrial fibrillation, or a BNP value \> 50 pg./ml in normal sinus rhythm, \> 150 pg./ml in atrial fibrillation within the past 6 months prior to study entry.
* On stable Guideline Directed Medical Therapy (GDMT) for heart failure
* At rest: elevated LAP (or PCWP) of \> 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by \> 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of \> 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by \> 10 mmHg
* Left Ventricular Ejection Fraction (LVEF) ≤ 40%
* Pulmonary Vascular Resistance (PVR) \< 4.0 WU

Exclusion Criteria:

* Severe HF:

  * Stage D, non-ambulatory NYHA Class IV, transplant list
  * If BMI \< 30, Cardiac index \< 2.0 L/min/m2
  * If BMI ≥ 30, cardiac index \< 1.8 L/min/m2
  * Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm
  * LVEF \< 20%
* Valve disease: MR \> 3+ or \> moderate MS, TR \> 2+, AR \> 2+ or \> moderate AS
* MI or therapeutic invasive cardiac procedure \< 3 months
* TIA, stroke, CRT implanted \< 6 months
* RV dysfunction \> mild by TTE OR TAPSE \< 1.2 OR RV size ≥ LV size by TTE, OR right ventricular fractional area change (RVFAC) ≤ 25%
* Dialysis OR renal dysfunction (S-CR \> 2.5 mg/dl OR eGFR \< 25 ml/min/1.73m2)
* 6MWT \< 50m OR \> 600m
* Active endocarditis or infection \< 3 months
* Mean Right Atrial Pressure (mRAP) \> 15 mmHg at rest
* Body Mass Index (BMI) ≥ 45 kg/m2
Cyclophosphamide and Busulfan as Conditioning Regimen Before Allogeneic HSCT

The aim of this study is to test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.


Eligibility Criteria:
Inclusion Criteria:

* Patients planned to undergo an allogeneic HSCT with myeloablative conditioning
* Age 18 - 65 years
* Myeloid leukemia respectively related precursor neoplasms (acute myeloid leukemia, chronic myeloid leukemia, myelodysplastic syndrome), or lymphoid neoplasms (acute lymphoblastic leukemia/lymphoma, mature B-/T-/natural killer (NK)-cell neoplasms).
* Human Leukocyte Antigen (HLA)-identical sibling donor or matched unrelated (min. 10/10 Ag matched)
* Patients with a history of hepatitis might be included, if no contraindication for HSCT exists.
* Patient must give written informed consent

Exclusion Criteria:

* Indication other than myeloid leukemia respectively related precursor neoplasms, or lymphoid neoplasms.
* Severe liver damage for \> 2 weeks (bilirubin \> 3xupper limit normal (ULN) or ASAT/ALAT \> 5xULN)
* HIV infection
* Donor other than HLA-identical sibling or min. 10/10 matched unrelated donor
* Pregnant or lactating women
* Lack of written informed consent
An Observational Study of Predictors and Outcomes of Lung Cancer in Never-smokers in the UK

The goal of this observational study is to improve the early detection of lung cancer in adults who have smoked less than 100 tobacco cigarettes ("never-smokers") in the United Kingdom. The main questions it aims to answer are:

* To describe characteristics such as demographics, co-morbidities and environmental exposures
* To describe participant pathways including presentation mode and symptoms to understand if earlier diagnosis would be possible
* To describe participant outcomes such as cancer stage, treatment and mortality
* To quantitatively or qualitatively measure modifiable and non-modifiable factors that may be associated with LCINS including environmental measures, blood tests and genomic data.

Participants will currently have no change to their usual care.


Eligibility Criteria:
Inclusion Criteria:

* All adult participants from age of 18 who are diagnosed or treated with primary lung cancer through radiology or histology at any participating study site

Exclusion Criteria:

* Participants who have ever smoked cigarettes or tobacco will be excluded; this is defined as:

  * More than 100 cigarettes or 75g tobacco in their lifetime
  * Those who have received a prescription for nicotine replacement therapy
* For prospective participants, those who cannot consent will be excluded
Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage

Robotic Assisted Evacuation of Subacute and Chronic Supratentorial Deep Hypertensive Intracerebral Hemorrhage for Accelerating Functional Rehabilitation (RESCUE-CHAIN): a Multi-center Randomized Controlled Trial

Background: Hypertensive intracerebral hemorrhage (HICH) is a devastating neurological disorder with high mortality and disability rates. Secondary injury following HICH may worsen motor function rehabilitation in subacute and chronic hematoma. Hematoma evacuation has the potential to reduce mass effect and mitigate the neurotoxic effects. A per-protocol analysis identified a significant functional improvement in patients with minimally invasive surgery with thrombolysis achieving end of treatment (EOT) goal ≤ 15mL. However, no surgical management of stabilized subacute or chronic HICH have been reported before. Therefore, we design this study in which we hypothesize this robotic assisted approach to hematoma EOT goal ≤ 15mL would accelerate functional rehabilitation in subacute and chronic HICH patients.

Eligibility Criteria:
The inclusion criteria are HICH patients who: (1) are ≥ 18 and ≤ 75 years old of either gender; (2) have evidence of supratentorial, deep-seated on CT scan with a volume of between 15 mL and 30 mL; (3) are within 24 h of ictus (\<24 h between symptom onset and initial imaging); (4) have stable hematoma (hematoma growth\<5 mL) for at least 12 h after diagnostic CT; (5) have no brain herniation and no needs for emergency surgery (clinical decisions made by 2 attending neurosurgeons); (6) have had no previous surgery on HICH or traumatic brain injury; (7) have GCS\>8, NIH Stroke Scale (NIHSS)\>5, Modified Rankin Scale (mRS) 3-5, and FMA scale\<85; (8) fully understand the nature of the study and have signed informed consent.

The exclusion criteria are: (1) HICH caused by aneurysms, cerebrovascular malformations, tumors or trauma; (2) any pre-existing physical or mental disorder that could interfere with the functional assessment; (3) severe abnormal coagulation function, hematologic diseases or multiple hemorrhagic lesions; (4) excessive hematoma extending into the ventricular system with ventricular dilation; (5) concomitant diseases such as liver, kidney and heart failure; (6) rebleeding\>5 mL or with surgical indications before allocation; (7) poor adherence or other unsuitable situations for the trial as determined by the investigators; (8) pregnant female.
Effect of OSA Resulting From Chronic Tonsillitis on Pregnancy Outcomes

This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) resulting from chronic tonsillitis on pregnancy outcomes. The hypothesis posits that chronic tonsillitis-induced OSA may exacerbate pregnancy complications and increase the risk of adverse pregnancy outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women confirmed with chronic tonsillitis by clinical diagnosis and presenting symptoms.
* Pregnant women with a confirmed diagnosis of OSA based on polysomnography or other validated sleep monitoring techniques.
* Pregnant women who are willing to participate in the study and provide informed consent.

Exclusion Criteria:

* Pregnant women with other respiratory or sleep disorders that may confound the diagnosis of OSA.
* Pregnant women with severe comorbidities or medical conditions that may significantly impact pregnancy outcomes.
* Pregnant women who have undergone surgical treatment for chronic tonsillitis or OSA during the study period.
* Pregnant women who refuse to participate in the study or are unable to provide informed consent.
Utility of Bedside Ultrasound in the Prediction of Difficult Airway

The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.

A variety of pre-intubation clinical screening tests have been advocated to predict difficult laryngoscopy, but their usefulness is limited in emergency department, intensive care unit, pre-hospital and combat settings. Patients in these settings are often confused, lethargic, obtunded, uncooperative and common screening tests for difficult laryngoscopy cannot be applied in a large number of emergency intubations. In the recent past, there has been growing interest in upper airway ultrasound. The purpose of this study is to assess the utility of bedside ultrasound to predict difficult airway in patients requiring emergency intubation.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for any surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* Upper airway pathologies (facial fractures, tumours, etc)
* Cervical spine fractures
* Tracheostomy tube
* unable to give consent
Rosuvastatin in Rheumatoid Arthritis (RORA)

Patients with rheumatoid arthritis are at increased risk of having cardiovascular deaths. The investigator's study is aimed at looking at the effects of proven cholesterol lowering treatment drug called rosuvastatin in rheumatoid arthritis patients on few cardiovascular markers. Endothelial behaviour improved on treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be selected from a high risk population of hospital clinic attendees, defined as RA greater than 5 years' disease duration, and all will be RA latex seropositive or IgM RF ELISA \>14iu/ml. The subjects will be of either sex and \>40 years of age.
* Patients should have both tender and swollen joint counts \>4 each and either a CRP \>10mg/l, ESR \>25mm/h or PV \>1.78.
* Patients on cyclosporine or other medications known to be contraindicated with this form of drug will not be enrolled.

Exclusion Criteria:

* The patient's hospital and general practice records will be scrutinised for evidence of symptomatic vascular disease.
* Any patient not free from vascular disease symptoms will be excluded.
* In addition to evidence of symptomatic vascular disease (either previous or current), the exclusion criteria consist also of those already taking lipid-lowering therapy or those with contraindications to these therapies.
* Also excluded will be subjects with a total cholesterol level of \>7.5mmol/L as it might be argued that such patients merit primary prevention on the basis of dyslipidemia alone.
Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI)

The trial aims at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)

The purpose of this trial is to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred for contrast-enhanced MRI of body regions.

This is a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial.

This trial will be conducted in approximately 50 centers worldwide. During the course of the trial, two MRIs will be obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations will be assessed by independent off-site blinded readers.

Eligibility Criteria:
Inclusion Criteria:

* Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.

Exclusion Criteria:

* Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent administration.
Trial of Cocoa-based Food in Children

Today, there is an important lack of knowledge on child metabolism and the effects of phytochemical-rich foods, which includes fruits and vegetables and plant-derived foods. Here, the investigators will monitor the metabolism of children using minimally invasive techniques at rest, and with physical/mental activities and assess the changes associated with the intake of cocoa-based food.


Eligibility Criteria:
Inclusion Criteria:

All subjects must comply with all the following inclusion criteria:

* Healthy and physically active, and no diabetes or metabolism related disorders in their first degree relatives (as determined by medical and activity questionnaire)
* Caucasian, with English as a first language and an adequate standard of literacy.
* BMI adjusted for age and gender which falls between the 9th and 91st as shown in the Child Growth Foundation BMI growth charts
* 8-13 years of age
* Having obtained his/her informed assent
* Having obtained his/her legal representative's informed consent
* Willing to allow their family doctor (GP) to be informed about their participation in this study

Exclusion Criteria:

Subjects representing one or more of the following criteria are excluded from participation in the study.

* Post-pubertal
* Taking any medication
* Smoker
* Undergoing medical treatment or investigations
* Body mass index \> 24
* Suffer from chronic diseases (with regular intake of drugs, medical history)
* Vegetarians
* Vaccination in the last 4 months
* Any know food allergies or intolerance
* Pregnancy
* Special diet or weight loss program (e.g. Atkins diet)
* Acute illness
* Fever, cold, flu
* Participation in a cholesterol management program with functional foods like food supplement enriched in omega-3 fatty acids, dairy products enriched with phytosterols (margarines, yoghurts).
Effect of Patient Education Videos on Perioperative Anxiety in Patients Undergoing Endoscopic Sinus Surgery

Chronic rhinosinusitis treatment consists of medical management and surgical intervention. Improving patient education can positively impact perioperative patient experiential outcomes such as anxiety, pain and satisfaction. However, online education materials are often too complex, inaccurate or misleading. The objective of this study was to determine if patient education videos at an appropriate reading level would improve perioperative anxiety in patients undergoing endoscopic sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* English speaking
* diagnosed with CRS according to Canadian Guidelines
* computer or mobile phone access were included

Exclusion Criteria:

* immunocompromised
* had sinonasal tumours
* history of anxiety, depression, bipolar, or any other mental illnesses
Adult Broad Learning Experiment (ABLE): Feasibility Study

This study evaluates the feasibility of enrolling and retaining older adults in a 15-week intervention that will implement six factors from early childhood experiences: individualized scaffolding (having a responsive teacher), forgiving environment (allowing the learner to make and learn from mistakes), growth mindset (believing that abilities can develop with effort), open-minded learning (exploring new experiences), serious commitment to learning (adopting a "learning" lifestyle), and learning multiple skills simultaneously. These six factors will be implemented via concurrent classes at the UCR Extension center (OSHER Lifelong Learning Institute).


Eligibility Criteria:
Inclusion Criteria:

* 55 years of age or older
* Fluent in English
* Have not been diagnosed with a cognitive condition (e.g., Mild Cognitive Impairment, Alzheimer's, and Dementia)
* Currently not experiencing a mental health disorder (e.g., anxiety, depression, Schizophrenia)
* Have normal eye vision or corrected-to-normal eye vision
* Not proficient in any of the three skills that will be taught during the intervention. Proficiency of skills will be determined by participants' self-report of their experience with each skill. Only potential participants who self-report having less than one or more years of experience with any of the three skills in the past 10 years or as having less than 5 years of experience more than 50 years ago will be considered as being "unfamiliar" with that skill (or skills) and will be qualified to participate in the study.

Exclusion Criteria: n/a
Physical Activity and Screen-Time Regulations in Childcare Centers - Aim 3

The objective is to establish community priorities for strategies to improve young children's health behaviors based on focus groups of stakeholders in the greater Baton Rouge area.

Pause and Play (Aim 3) objective will be achieved through a series of taskforce and focus group meetings administered by the Mayor's Healthy City Initiative (MHCI). Meetings will include monthly meetings of the MHCI advisory boards composed of community stakeholders and focus groups of childcare center directors and parents. Stakeholders will create dissemination and implementation plans to leverage the findings of the project. We plan to conduct 2-3 focus groups of 8-10 parents and childcare directors, for a total of 16-30 participants. Participation in the focus group part of the study will last approximately 1 day.

Eligibility Criteria:
Inclusion Criteria:

* Either a director of a licensed childcare center in East Baton Rouge Parish OR a legal guardian and/or primary caretaker of a child aged 3 to 5 years who is enrolled in a licensed childcare center
* Able to understand and speak English
* Willing to be audio-taped during the focus group (for transcription purposes)

Exclusion Criteria:

* Being affiliated with 1 of the 10 childcare centers being assessed for Pause and Play Aims 1 or 2, either as a director/teacher or as a parent of a student
* Cognitive impairments that interfere with participation in a group discussion