cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Cardiac Biomarkers and Ventricular Function in Asthmatic Children

Evaluation of cardiac biomarkers and the left and right ventricular systolic and diastolic function in asthmatic children in Assuit university hospital

Severe acute asthma which is defined asthma that is uncontrolled despite maximal optimized therapy and treatment of contributory factors, or that worsens when high dose treatment is decreased(1) and it is characterized by severe respiratory distress because of increasing bronchoconstriction, leading to ventilation perfusion mismatch, hypoxia, respiratory muscle fatigue, carbon dioxide retention and respiratory acidosis(2) In acute severe asthma, the use of beta 2 agonists, together with hypoxia and tachycardia might cause increased myocardial workload further leading to myocardial infarction(3).

Cardiac biomarkers including Brain Natriuretic Peptide (BNP),Troponin I (TnI) and Creatine kinase muscle/brain(CK-MB) are used to detect myocardial injury(4).

The objective of the present study was to find out the incidence of myocardial dysfunction in patients of acute severe bronchial asthma based on cardiac biomarker levels at admission and to see whether the myocardial dysfunction was transient or persistent even after the stabilization of the patient. As far as it could be reviewed, no study relating BNP levels in pediatric asthma patients could be found in literature.

Echocardiographic changes in bronchial asthma regarding RT ventricular and Ltventricular function will be assessed According to some studies right ventricular (RV) systolic and diastolic dysfunction were detected, even in mild cases, by echocardiography. On the other hand, left ventricular (LV) dysfunction usually presents itself in severe asthmatic cases which may be reversible in acute conditions (5).

Some studies showed that there were no differences in echocardiographic findings regarding the ventricular function with the exception of RV wall thickness (6).

Asthma affects ventricular contractility in children. Although cardiac systolic function was found to be impaired in asthmatic patients, contrary to the literature diastolic dysfunction didn't observed in these patients even by tissue Doppler imaging, may be due to using inhaled corticosteroid(7). This was one of the most comprehensive studies among asthmatic patients. Further studies with larger sample sizes or without using corticosteroid treatment war ranted to better elucidate the cardiac function.

Eligibility Criteria:
Inclusion Criteria:

* all pediatric cases between the age of 5 -15years with acute severe bronchial asthma who were admitted in pediatric emergency care unit

Exclusion Criteria:

* Children with congenital or acquired heart diseases
* Foreign body aspiration .
* Chest infections
* Tuberculosis or pneumonia
Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort

Ongoing prospective cohort of type 2 diabetes individuals.

The study population included individuals with type 2 diabetes aged between 40 and 70 years old, living in the metropolitan area of Campinas, Brazil. The volunteers were recruited between 2016 and 2020 through radio, newspaper, television and social media advertisements. A total of 1046 participants were enrolled into the study so far.

All participants were firstly invited to an interview with the physician-researcher for medical story register and physical examination. Afterwards, all participants were submitted to the following procedures: blood and urine samples collection, dual-energy X-ray absorptiometry, 6 minutes walk test, hand strength test, bone densitometry test, diabetic polyneuropathy evaluation, advanced glycation end-product measurement, electrocardiogram, echocardiogram, carotid doppler ultrasound, flow-mediated dilation, diabetic retinopathy assessment, ambulatory blood pressure monitoring and cardiac computed tomography for calcium scoring. After full examination, patients were contacted every year for 5 years for endpoints registration. The primary endpoint was a composite of all-cause mortality, myocardial infarction, stroke and myocardial revascularization. Secondary endpoints were end-stage kidney disease requiring dialysis and limb amputation. Study data were collected and managed using REDCap electronic data capture tools.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed type 2 diabetes
* Age between 40 and 70 years old

Exclusion Criteria:

* Unconfirmed diagnosis of diabetes
* Intellectual disability
Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation will be up to 22 days.

Eligibility Criteria:
Inclusion Criteria:

* Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
* Any spherical monovision and multifocal lens wearers.
* Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.
* Other protocol-defined exclusion criteria may apply.
Seasonal Variations and Different Treatment Protocols of Intussusception in Children: Our Centers Experiences

Intussusception remains a common cause of bowel obstruction in children and results in significant morbidity and mortality if not promptly treated. There is a paucity of prospective studies regarding childhood intussusception. This study describes the seasonal variation and management outcomes of childhood intussusception

Intussusception is the invagination of a segment of bowel into an adjacent segment resulting into an intestinal obstruction. It is the most common acquired cause of intestinal obstruction in children aged four months to two years with a peak of incidence between four and nine months of age. Etiology of intussusception is reported to be idiopathic in about 90% of cases and rarely is it associated with pathological lead points such as Meckel's diverticulum, appendix, solid bowel lesions, intestinal polyp, and intestinal lymphoma. It is an occlusive-strangulation type of intestinal obstruction, and all necessary measures should be taken early to ensure prompt diagnosis and treatment to avoid ischaemia and necrosis of bowel. The term comes from two Latin words, intus, which means "inside" and suscipere, which means "to receive". It has been reported in neonates and adults . The ancient Greeks, treated intestinal obstruction with enema or insufflations of air into the anus. Abdominal pain, vomiting and blood in stools are the classic triad and are uncommon and seen in less than one-third of the children affected. Cases often present with non-specific symptoms, including vomiting, pain, irritability, decreased appetite and lethargy, and this may render diagnosis of intussusception difficult. Abdominal ultrasound is considered the standard choice for its diagnosis. Non-surgical management with Pneumatic reduction (PR) by air, hydrostatic reduction by saline or contrast enema is the best procedure.Surgical management by exploratory laparotomy with simple reduction while some cases may require a bowel resection and reanastomosis for gangrenous bowel.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria: The verified diagnosis of intussusceptions in patients by clinical examination and ultrasonography

Exclusion Criteria:

* Patients were excluded if the diagnosis of intussusceptions was not validated or patients who were above 12 years of age.
Bone Augmentation Using Calvarial Versus Iliac Crest Bone Blocks.

This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones

Although the calvarial bones represent a nearby donor site for maxillary augmentation of matching bone origin, the excessive volume of bone needed to reconstruct a severely deficient arch, the limited cancellous bone volume, and the arciform pattern of the skull cap that yield the curvatures of the harvested cortical blocks incompatible with the topography of the maxillary arch, all represent limitations for the calvarial graft.

The anterior iliac crest is frequently used for free bone grafting by being subcutaneous and generous to afford ample bone blocks of favorable curvatures. However, the minute cortical overlay and its endochondral origin contribute to excessive graft resorption. Pikos et al. demonstrated that a reasonable amount of graft resorption could occur with atraumatic surgical intervention and intimate graft fixation.

This study aims to evaluate and compare the quantity of the radiographic horizontal bone gain of severely deficient complete maxillary ridges reconstructed by bone block harvest from the iliac crest versus the calvarial bones.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the clinical and radiographic interpretation of horizontal maxillary ridge deficiency of less than 5 mm

Exclusion Criteria:

* Any previous maxillary reconstructive or dental implant treatment.
* Any local pathologic lesion or systemic disease that would affect the typical pattern of bone healing.
To Determine the Gait and Functional Improvement in Total Knee Arthroplasty

This is an observational study to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty

The primary objectives of this study are to understand the effects of soft-tissue balancing on Gait, function and rehabilitation potential after sensor-assisted Total Knee Arthroplasty and to correlate Intra-operative subjective feel with OrthoSensor Outputs

Secondary objectives are to quantify and observe pain medication use, swelling, muscle strength and girth, gait efficiency, patient satisfaction, activity levels, functional return (i.e., back to work, resume normal activities) and patient perception of a balanced knee

Eligibility Criteria:
Inclusion Criteria:

* Subject must be a candidate for a primary PCL retaining total knee arthroplasty
* Subject must be diagnosed with one or more of the following conditions:

  1. osteoarthritis
  2. avascular necrosis
  3. rheumatoid or other inflammatory arthritis
  4. post-traumatic arthritis Minimum age: 45 Maximum age: 80
* Subject is likely to be available for all study visits
* Subject is able and willing to sign the informed consent and follow study procedures

Exclusion Criteria

1. Prior total knee arthroplasty
2. ligament insufficiencies
3. prior surgeries such as:

   1. ACL or PCL reconstructions
   2. posterolateral reconstructions
   3. osteotomies
   4. tibia plateau fractures
   5. Range of Motion less than 90 degrees f ) flexion contracture of more than 20 degrees
Evaluation of Sleep Quality in Head and Neck Cancer Patients Throughout Treatment Course

This study examines how head and neck cancer treatment affects quality of sleep over time and factors that contribute to sleep quality. Sleep plays a critical role in healing and quality of life, and recent studies investigating sleep disorders in head and neck cancer patients reveal sleep quality is a major determinant of post-treatment outcomes. Information from this study may help researchers better understand how treatment impacts sleep quality so that they can make changes that may help improve patient sleep quality.

PRIMARY OBJECTIVES:

I. To describe the five (5) components of sleep quality in head and neck patients under different stages of post-op treatment and different environment.

II. To evaluate the effect of surgery, treatment and environment on the five (5) components of sleep quality in head and neck cancer patients.

SECONDARY OBJECTIVES:

I. To evaluate the association between the five (5) components of sleep quality and comorbid obstructive sleep apnea (STOP-BANG and Epworth Sleeping Scale) and depression (Patient Health Questionnaire-2 \[PHQ-2\]), under different stages of post-op treatment and different environment.

II. To evaluate the association between Fitbit actigraphy data (i.e. the 5th component of sleep quality) and the first 4 components of sleep quality for inpatients.

III. To compare the inpatient versus the outpatient responses on sleep hygiene at different time points of measurement.

EXPLORATORY OBJECTIVE:

I. To assess whether survey results warrant additional counseling or patient education.

OUTLINE:

COHORT 1-TP1: Patients complete surveys over 20 minutes on post-op day 3 and on day of discharge (or within 1 week).

COHORT 1-TP2: Patients complete surveys over 15 minutes at all regularly scheduled follow-up appointments (approximately 1 month, 3 months, 6 months, 12 months).

COHORT 2: Patients complete surveys over 15 minutes once.

Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Adult at least 18 years old
* Capable of giving informed consent
* Diagnosed with head and neck cancer (previously untreated, any stage)
* Treatment plan involves surgery
* Willing to comply with all study procedures and be available for the duration of the study
* English-speaking

Exclusion Criteria:

* Non-English speaking
* Pre-existing sleep disorder defined below:

  * Obstructive sleep apnea
  * Insomnia
  * Narcolepsy
  * Restless leg syndrome
  * Rapid eye movement (REM) sleep behavior disorder
Varying the Energy Density and Portion Size of the Main Course After a First-course Salad

The purpose of this research is to determine whether varying the energy density and portion size of the main course will affect meal energy intake after consumption of a first course that has previously been shown to enhance satiety. It is hypothesized that increasing either the energy density or portion size of the main course will increase meal energy intake after consumption of the first course. It is also hypothesized that compared to when a first course is consumed, not consuming a first course will increase meal energy intake.


Eligibility Criteria:
Inclusion Criteria:

* Adults from Penn State and the surrounding community

Exclusion Criteria:

* Currently dieting
* Food allergies
Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia

The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes.

Neonatal hypoglycemia is a leading cause of admission to the neonatal ICU (NICU) and is associated with increased costs, separation from mothers, and when severe, long term neurological sequelae. Prior research has suggested an association between intrapartum maternal glucose and the risk of neonatal hypoglycemia, so current insulin administration protocols aimed to maintain the blood glucose close to 100mg/dl.

However, recent studies have found inconsistent evidence of a relationship between intrapartum maternal glucose and neonatal hypoglycemia, Furthermore, on review of previously established protocols, improved maternal glucose control came with an increased frequency of neonatal hypoglycemia. Thus, these findings have suggested that relaxing the intrapartum goals for maternal glucose may be associated with improved neonatal outcomes.

Few randomized controlled trials (RCTs) exist in evaluating neonatal outcomes comparing liberal versus tight intrapartum glycemic control. Recent RCTs have found that tight maternal glucose control in labor was associated with lower mean neonatal blood glucose levels in the first 24 hours of life. While another recent RCT found that a permissive blood glucose (up to 180mg/dl) threshold was associated with equivalent neonatal blood glucose levels when compared to the standard, strict thresholds (up to 110mg/dl).

In this study, participants will be recruited at delivery planning outpatient visits or at admission to labor and delivery and stratified by type of diabetes into two groups, either Type 1 Diabetes or Gestational Diabetes(GDM)/Type 2 diabetes. They will then be randomized to one of two intervention groups. The liberalized treatment group will have a target Glucose Range 70 - 160mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound. The standard treatment Group will have a glucose target Glucose Range 70 - 110mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound.

The specific aim of this project is to determine the effectiveness of liberalized intrapartum glycemic targets in reducing the incidence of neonatal hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients with Pre-gestational (Type 1 or Type 2) or Gestational Diabetes
* Singleton Gestations
* Greater than or equal to 35 weeks gestation
* Planned for vaginal delivery at the University of Pittsburgh Medical Center Magee-Womens Hospital (UPMC MWH)

Exclusion Criteria:

* Major fetal anomalies anticipated to require NICU admission
* Planned Cesarean delivery
Multidimensional Individualized Nutritional Therapy for Individuals with Severe COPD

Individuals with severe chronic pulmonary disease often life isolated with a high burden of symptoms. Nutritional risk and low quality of life are common, and both associated with increased societal cost and poor prognosis. COPD is a complex and progressive disease with changing clinical states that influences nutritional status and quality of life in different ways. The primary aim is to improve quality of life for individuals with severe COPD.

120 individuals are recruited from the outpatient clinic at Nordsjællands Hospital in Denmark to a randomized controlled trial with two parallel groups (intervention and control). The intervention will last for 3 months comprising four elements including nutritional plan, regular contact, informal caregiver/friendly reminder and a weight dairy.

We expect that the intervention will improve quality of life, nutritional status and prognosis.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 35 years
* Severe COPD defined as GOLD grade 2 group B or D OR GOLD grade 3 and 4 group ABCD
* Able to eat orally
* Live in own home
* Speak Danish or English
* Undernourished OR at risk of undernutrition defined as BMI ≤ 21 kg/m2 if \< 70 years and BMI \<22 kg/m2 if ≥70 years OR BMI 21-25 kg/m2 plus nutritional risk (nutritional risk screening score ≥3) if \<70 years and BMI 22-25 kg/m2 plus nutritional risk if ≥70 years
* Stable phase

CHANGE: Undernourished OR at risk of undernutrition (a maximum BMI of 25 kg/m2) determined by Nutritional Risk Screening 2002 or Mini Nutritional Assessment Short Form according to the protocol published in Trials.

Exclusion Criteria:

* Active solid cancer" defined as cancer diagnosed within the previous six months, recurrent, regionally advanced, or metastatic cancer, cancer for which treatment had been administered within six months or hematological cancer that is not in complete remission
* Unable to sign informed consent e.g. due to severe dementia.
* Severe chronic renal failure defined as estimated glomerular filtration rate \< 30 mL/min./1.73 m2 (ICD-10 codes N18.4 and N18.5
* Severe alcohol abuse (ICD-10 codes F10.2 and K70.x).
Clinical Accuracy of Patient-specific Implants in Genioplasty

The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique for genioplasty.

Chin plays an important role in the lower facial harmony and balance. With the advances in computer-aided surgical simulation (CASS) technology, surgeons are now able to simulate surgical procedures in the computer to achieve the best possible surgical plan. However, CAD/CAM surgical templates do not maximize the potential of CASS technique. Patient specific implants (PSI) has rapidly developed in cranio-maxillofacial surgery in the past few years. However, few studies have introduced PSI technique in osseous genioplasty. The purpose of this study is to assess the accuracy and clinical validation of patient specific implants (PSI) technique in genioplasty for positioning and fixation of the chin segment.

Anticipated 30 patients with chin deformities are enrolled. Virtual planning is performed with the computer-aided surgical simulation method. The 3D printing titanium cutting guide and patient specific plate is involved in this PSI method. The cutting guide is designed to guide the osteotomy and screw holes drilling for the following patient specific plate. And the patient specific plate is used to simultaneously complete the reposition and fixation of the chin. The outcome is evaluated by comparing the plan with actual outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. patients who were scheduled to undergo genioplasty;
2. patients who were scheduled to undergo CT scan as a part of their diagnosis and treatment;
3. patients who agreed to participate in this study

Exclusion Criteria:

1. craniofacial syndrome;
2. segmental osseous genioplasty;
3. previous osseous genioplasty;
4. previous mandibular trauma;
5. systemic disorders.
iUni G2+ Prospective Study

This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement

The study subjects will be followed for 10 years post implant. The follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.

Eligibility Criteria:
Inclusion Criteria:

* Clinical condition included in the approved Indications For Use
* Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
* Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
* \> 18 years of age

Exclusion Criteria:

* Simultaneous bilateral procedure required
* BMI \> 35
* Treatment for cancer within the past 5 years, with the exception of skin cancer
* Poorly controlled diabetes
* Neuromuscular conditions which prevent patient from participating in study activities
* Active local or systemic infection
* Immunocompromised
* Fibromyalgia or other general body pain related condition
* Advanced tricompartmental osteoarthritis
* Symptomatic patellofemoral disease
* Rheumatoid arthritis or other forms of inflammatory joint disease (excluding Gout unless it is in the treated knee or limiting overall function)
* Loss of bone or musculature, osteoporosis, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified. Osteoporosis is defined by more than -2.5 standard deviations from the T score as measured on a Dual Energy X-Ray Absortiometry Scan (DEXA) within 2 years of surgery.
* Advanced loss of osteochondral structure on the affected femoral condyle
* Compromised ACL, PCL or collateral ligament
* Severe (\>15º) fixed valgus or varus deformity
* Extension deficit \> 15 º
* Prior history of failed implant surgery of the joint to be treated
* Unwilling or unable to comply with study requirements
* Participation in another clinical study which would confound results