cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschools

Socioeconomic disparities in early childhood place low-income children at 1.5 to 2 times higher risk for obesity compared to middle- to upper-income children. Obesity interventions have turned toward the promotion of family mealtimes. This study will test the effects of 6 intervention components reflecting differing levels of supports to ultimately reduce childhood obesity prevalence and increase the frequency of healthy family mealtimes and improve dietary quality. The investigators will test 6 intervention components in Phase 1 (Screening Phase), resulting in the implementation and evaluation via a randomized controlled trial of a "final" intervention model in Phase 2 (Confirming Phase). The investigators hypothesize that providing low-income families with effective supports to enhance family capability to plan and implement family mealtimes will lead to improvements in children's adiposity indices, dietary quality and frequency of family meals.

This study is comprised of two phases. In the first phase of the study, we will test associations between participation in combinations of 6 intervention components reflecting differing levels of practical resources to increase the frequency of healthy family mealtimes, improve children's dietary quality and ultimately reduce childhood obesity prevalence. Phase 1 utilizes the Multiphase Optimization Strategy (MOST) design to test combinations of the 6 intervention components which include: (1) Meal Delivery: the home delivery of pre-made healthy family meals including recipes weekly (2) Ingredient Delivery: the home delivery of ingredients and recipes to make healthy family meals weekly; (3) Community Kitchen: community kitchen sessions in which families prepare healthy meals with recipes to take home weekly; (4) Didactics: nutrition education classes using the Preschool Obesity Prevention Series (POPS) curriculum (5) Cooking Lessons: cooking lessons/demonstrations with recipes weekly; and (6) Cookware/Flatware: delivery of flatware/ cookware to utilize for family meals delivered at the beginning of the intervention. The goal of Phase 1 is to identify the intervention components most robustly related to decreased BMI z-score, increased dietary quality and frequency of family meals. Phase 1 will enroll approximately 500 parents of preschoolers. The goal of Phase 2 is to test the selected intervention components (identified in Phase 1) in a randomized controlled trial with approximately 250 participants. Participants in both phases will be enrolled through Head Start programs and/or university research recruitment platforms, social media, and posted flyers. The intervention period in Phase 1 will be 8 weeks, and the intervention period in Phase 2 will be expanded to 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Preschool aged child

Exclusion Criteria:

* Significant feeding/eating disorders that would preclude participation in the interventions
* Child is a foster child
* Parent is non-English speaking
Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery

The goal of this interventional clinical trial is compare between two different dose regimens of bisoprolol (beta-blocker) in CABG patients in terms of efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients: 18 to 65 years old
* Diagnosed with coronary heart disease or myocardial infarction and scheduled for coronary artery bypass surgery

Exclusion Criteria:

* History of Ventricular arrhythmia, atrial fibrillation, atrial flutter, left bundle block, AV block grade II/III
* History of Sick sinus syndrome, sinoatrial heart block
* History of valve replacement
* Permanent Pacemaker
* LVEF less than 30%
* Unstable Heart failure
* Cardiogenic shock
* Sustained systolic blood pressure less than 100 mmHg or HR less than 50 bpm at recruitment
* Severe chronic obstructive airway disease
* Severe asthma unless was on previously tolerated bisoprolol dose
* Uncontrolled diabetes mellitus unless was on previously tolerated bisoprolol dose
* Pregnant/Lactation
* Previous recent stroke
* Creatinine clearance less than 30 ml/min
* End stage liver disease (liver cirrhosis)
* Drug dependance history
* Untreated phaeochromocytoma
* Vasospastic angina
* Thyrotoxicosis
* History of advanced staged of peripheral vascular disease
* Hypersensitivity
* Patients on any other beta-blocker other than bisoprolol
* Patients on bisoprolol higher than 5 mg/day.
Use of High Sensitivity Cardiac Troponin in Ruling Out Emergency Patients with Acute Myocardial Injury and Infarction

Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

Background: Studies addressing the clinical performance of the Siemens Healthineers High-Sensitivity Troponin I assay (TnIH) on the Atellica IM analyzer for the diagnosis and rule out of acute myocardial injury and myocardial infarction in consecutive patients presenting to a United States (US) emergency department are lacking.

Study objective: Examine the analytical and clinical performance of Atellica IM TnIH assay for the diagnosis and rule out of acute myocardial injury and myocardial infarction in patients presenting to the emergency department in whom serial cTnI measurements are obtained on clinical indication.

Hypothesis: The Atellica IM TnIH assay will offer an excellent diagnostic performance for acute myocardial injury and acute myocardial infarction, as well as expedite the risk stratification of patients for early discharge from the emergency department.

Eligibility Criteria:
Inclusion Criteria:

1. Baseline cTn measurement and at least one additional cTn measurement within 6 hours after initial measurement.
2. At least one 12-lead electrocardiogram

Exclusion Criteria:

1. Less than 18 years old
2. Pregnancy
3. Trauma
4. Decline to participate
5. Did not present through the ED
6. Transferred from an outside hospital or clinic.
The Qingdao Port Health Study

China, efforts are underway to respond to an unprecedented epidemiologic transition, with soaring rates of cardiovascular disease (CVD), including heart disease and stroke. Yet there may be limitations in translating observations and findings derived from Anglo-based population studies. As such, there is a critical need for population-based studies that provide insight into the risk factors, incidence, and outcomes of CVD in China. The Qingdao Port Health Study is a population-based prospective cohort study of employees of the Qingdao Port Group, China, designed to investigate the burden of CVD and risk factors (e.g., sociodemographic, biological, environmental and clinical factors) associated with disease onset and outcomes.

In Qingdao Port, annual health assessments are offered at 3 on-site health clinics. The annual health assessment consists of a questionnaire, physical examination, laboratory tests, bio-sampling, and imaging examinations.In each year, demographics information, medical history, medication use and adherence, family history,lifestyles (e.g., nutritional intake; physical activity; smoking; alcohol use/abuse), menopause (including hormone use) and quality of life were collected by trained researchers.In 2013, blood and saliva samples were collected. Follow-up health assessments are performed every year. The outcomes of cardiovascular disease (angina, myocardial infarction, heart failure, stroke, revascularization), non-communicable diseases (chronic obstructive pulmonary disease, renal failure, liver disease and cancer), and all-cause death are collected from local medical insurance database.This study aim to surveillance of cardiovascular and other non-communicable diseases (risk factors, health outcomes and trends) and investigate of socio-cultural, biological, behavioral, social, and environmental factors on work performance, cardiovascular disease onset and cardiovascular health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All employees and retirees in Qingdao Port Group
* Aged over 18 years old

Exclusion Criteria:

-
Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke Before and After Thrombectomy

This proposal is a prospective, single-center, dose-escalation safety, tolerability, feasibility and potential efficacy study of transcranial direct current stimulation (tDCS) in acute stroke patients with substantial salvageable penumbra due to a large vessel occlusion before and after endovascular therapy.

This is a single-center, sham-controlled, dose-escalation study where cathodal tDCS is delivered to threatened but not yet irreversibly damaged (penumbral) tissue in patients with large vessel occlusion who are undergoing recanalization procedure. Patients will be randomized in a 3:1 design, to cathodal versus sham (control) stimulation, at each six designed dose tiers. The dose tiers will be increasing in both intensity and duration of the stimulation. All patients will be receiving the first dose (stimulation cycle) after the recanalization procedure and patients at dose tiers 5-6 will also be receiving stimulation cycles before the recanalization procedure begins.

The occurrence of symptomatic intracranial hemorrhage will determine the pace of the escalation through the dose tiers.

Eligibility Criteria:
Inclusion criteria

* New focal neurologic deficit consistent with AIS
* Age≥18
* NIHSS ≥ 4
* ICA or M1 or M2 MCA occlusion on pre-thrombectomy MRA or CTA
* Onset (last-seen-well) time to randomization time within 24 hours
* Pre-stroke modified Rankin Scale≤ 3.
* Patient ineligible for IV tPA, per national AHA/ASA Guidelines.
* Having undergone endovascular thrombectomy with less than a complete reperfusion (\<TICI 2c, 3) for receiving post-thrombectomy adjunct C-tDCS.
* Undergoing endovascular thrombectomy, per national AHA/ASA Guidelines for patients who are assigned to pre-thrombectomy bridging session at Tiers 5, 6.
* A signed informed consent is obtained from the patient or patient's legally authorized representative

Exclusion criteria

* Acute intracranial hemorrhage
* Evidence of a large Ischemic core volume (ADC \< 620 µm2/s or rCBF\< 30%) ≥ 100 ml
* Presence of tDCS contraindications - electrically or magnetically activated intracranial metal and non-metal implants.
* Pregnancy
* Severe contrast allergy or absolute contraindication to iodinated contrast preventing endovascular intervention.
* History of seizure disorder or new seizures with presentation of current stroke
* Evidence of any other major life-threatening or serious medical condition that would prevent completion of the study protocol including attendance at the 3-month follow-up visit
* Concomitant experimental therapy
* Preexisting scalp lesion at the site of the stimulation or presence of skull defects (may alter current flow pattern)
* Preexisting coagulopathy, consist of a platelet count of ≤ 100, INR ≥ 3, PTT ≥ 90.
Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study

Targeted population:

Sleep apnea patients at low cardiovascular risk newly treated by CPAP

Hypothesis:

Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP care.

Main goal:

To compare 6-months CPAP compliance when Sleep Apnea patients at low cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and coordinated follow-up based on a telemonitoring web platform.

Study procedures:

The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of oximetry, CPAP compliance, side effects and residual events.

Secured data transmission to medical staff computers and secured websites will allow easy telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP treatment in case of side effects, leaks and persistent residual events.

An interim analysis will be performed when 200 patients will be included.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 78 years
* Men and women
* AHI \> 30 / hour
* Patient with low cardiovascular score (\<5% defined by European SCORE)
* Patient affiliated to the national health insurance
* Willingness to use a telemonitoring system

Exclusion Criteria:

* Known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
* Central sleep apnea syndrome
* Previous CPAP treatment with respiratory support for sleep respiratory trouble
* Cardiac failure
* Hypercapnic chronic respiratory failure (daytime PaCO2 \> 50 mmHg)
* Terminal disease
Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)

Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)

The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture above) in order to stiffen and stabilize the soft palate, which may reduce the severity of airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea). Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction. The System is labeled for use by physicians only.

The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up.

Study hypothesis: Reduction of initial AHI ≥20%

Eligibility Criteria:
Inclusion Criteria:

Study patients must meet all of the following inclusion criteria:

* Socially disturbing snoring with/without obstructive sleep apnea syndrome
* Predominantly retropalatal obstructions established by ApneaGraph ≥60%, sleep nasendoscopy or successful application of the Velumount palatal device
* Findings for predominantly retropalatal obstructions in ENT-examination:
* No tonsils or tonsils grade I - II
* Normal finding of larynx and tongue base
* No lingual tonsil hypertrophy
* ASA (American Society of Anaesthesiology, 1963) criteria I or II
* Body mass index (BMI) \< 33 kg/m2
* Age \> 18 yrs
* Fix bed partner
* Ability to read and understand the patient's information

Exclusion Criteria:

* Previous Pillar implants
* Previous airway surgery other than nasal, adenoid, tonsil or UPPP
* Presence of other sleep disorders
* Psychiatric disorders
* Neurological disorders (e.g. Cerebrovascular injury)
* Dysmorphia of the cranial skeleton
* Pregnancy or breastfeeding
* Known hypersensitivity to nitinol
* Participation in another clinical study
Validation of the Utility of Myopia Intelligent Diagnostic System

The screening of myopia via artificial intelligence represents an challenge in computational medicine. Here, the investigators use "deep learning" to create an automatic diagnostic system for myopia screening using ocular appearance images. The investigator also use this system and conduct clinical trial to validate its performance.


Eligibility Criteria:
Inclusion Criteria:

* Student aged 6-18

Exclusion Criteria:

-
Improving Tolerability of Bowel Preparation Laxative for Colonoscopy

The purpose of this study is to determine whether the pattern of flavoring and drinking of laxatives for colonoscopy can improve the experience of patients when they are undergoing bowel preparation for the test.

Investigators hypothesize that patients will have a better experience if patients taste the bowel preparation laxative with and without flavoring and then decide how they want to drink the rest of the laxative since taste preferences vary widely from person to person.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and older) referred for outpatient colonoscopy

Exclusion Criteria:

* Patients with history of bowel resection
* patients with history of inflammatory bowel disease
* History of polyposis syndrome
* History of colorectal cancer
* History of poor taste perception from any cause
Evaluation of Thymidine Kinase Activity in the Serum of Patients With Solid Tumors

This study aimed to evaluate serum thymidine kinase 1 (TK1) activity as a marker for solid tumors and more specifically in: preoperative testing for prediction of disease recurrence and survival; follow-up after surgical removal of the original tumor for early detection of disease recurrence and in monitoring therapy as a surrogate marker of tumor response.

Thymidine kinase 1 (TK1) is a metabolic enzyme catalyzing the ATP-dependent phosphorylation of thymidine to thymidine monophosphate followed by its utilization in DNA synthesis. It has been demonstrated that activity of TK1 in the serum of cancer patients corresponds to the amount of dividing tumor cells. Several clinical investigations clearly showed that abnormal TK1 levels indicate tumor growth. In breast cancer, serum TK1 was shown to predict increased risk of recurrence following surgery and may be a good marker for monitoring the response to therapy. The measurements of TK1 were useful as a prognostic and monitoring factor in patients with NSCLC. Unfortunately, all previously used assays measuring TK1 activity showed relatively low analytical sensitivity. Recently, the novel high sensitive non-radioactive TK1 assay (DiviTum) has been developed. With this assay tumour growth may be detected at an earlier stage of disease and smaller amounts of residual disease may be detected during and after therapy.

Eligibility Criteria:
Inclusion Criteria:

* patients with colon, breast, prostate and lung cancer before and during treatment

Exclusion Criteria:

* pregnant women;
* patients with generalized CMV and HZV infections;
* patients with severe rheumatoid arthritis
Castror Oil for Labor Induction in Women With Previous Cesarean Section

Nowadays, more and more women embark on pregnancy with previous Caesarean scar. One in five pregnancies requires induction of labour. The use of non-pharmacological methods (methods without using medication) has been gaining popularity for women who are not good candidates, such as women with previous Caesarean scar, for induction with medications such as prostaglandin. Labour induction with prostaglandin carries a higher risk of uterine rupture and thus it is not routinely offered to women with previous Caesarean delivery in Cairo University Hospital. Non-pharmacological methods of induction of labour appear to be safe in women with previous Caesarean delivery. However, various methods are available and the efficacy among them remain in doubt.

In Cairo University Hospital, castor oil, which is a type of induction methods, is routinely offered to women with previous Caesarean delivery who require induction of labor. However, castor oil may not exert its labor induction effect immediately and the delivery may be delayed by up to 8 days. This may render a proportion of women resort to repeated Caesarean section for failed induction. Castor oil is traditionally given by midwives in order to induce labor.

The investigators are intent to recruit 70 healthy pregnant women with a history of previous one cesarean section and with no contraindication to trial of labor after cesarean . Women will be randomly and blindly divided into equal-sized intervention group and control group. Intervention group will be given a single dose 60 mL of castor oil in 140 mL of orange juice, while control group will be given a placebo with similar texture. Primary outcomes to be tested are the percentage of women entering active labor within 24 hours of castor oil or placebo administration and the number of successful vaginal deliveries after cesarean.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with one previous lower segment Caesarean section who are admitted to Cairo University Hospital for induction of labor (IOL) will be recruited. The inclusion criteria are age at least 20 years old, gestational age at recruitment from 36 weeks to 38 weeks ±6 days, gestational age at induction= 39 weeks, singleton pregnancy, reassuring fetal status, and Bishop score ≤ 6.

Exclusion Criteria:

* Prior high-risk uterine scar; uterine rupture, classical CS, hysterotomy, or myomectomy
* Short inter-delivery interval (\<12 months)
* Complications in the previous CS (e.g. puerperal sepsis)

Obstetric indication for CS (either elective or emergency):

* Placenta praevia
* Placental abruption
* Documented evidence of cephalopelvic disproportion
* Fetal macrosomia (estimated fetal weight \>4 kg)
* Fetal anomalies interfering with vaginal delivery e.g. hydrocephalus
* Fetal distress or non-reassuring Cardiotocography pattern
Neural and Cognitive Correlates of Pragmatic Abilities

Pragmatics of language refers to the set of abilities that allow one to use and interpret language according to context and, in general, to communicate effectively. Disorders in the pragmatics of language are prevalent in various clinical populations. They are a cause of social withdrawal and worse quality of life, both for patients directly affected and for their family members. Despite this, this type of disorder is rarely considered in neuropsychological assessment and rehabilitation.

This study's objective is to characterize pragmatic deficits in various neurological populations, allowing for the most accurate diagnosis possible and leading to the planning of personalized and effective Rehabilitation Plans.

To delineate the pragmatic deficit profile for each pathology group, eligible participants will undergo a neuropsychological assessment, subdivided into as many sessions as per the participant's availability and tolerance.

Assessment tools will include:

* APACS (A test for the Assessment of Pragmatic Abilities and Cognitive Substrates; Arcara and Bambini, 2016)
* SET (Story-based Empathy Task, Dodich et al., 2015)
* COAST (Communication Outcome After Stroke, Bambini et al., 2016)
* PWB (Psychological Well-Being scales, Sirigatti et al., 2009)
* other neuropsychological assessment tools depending on the participant's pathology and routinely used in the clinical practice within the Institution.

Resulting test scores will be statistically analyze to provide pragmatic and cognitive profiles for each pathology.

Eligibility Criteria:
Inclusion Criteria:

* Presence of objective neuropsychological assessment using standardized tests used in clinical routine.
* Ability to knowingly provide written informed consent and , therefore preserved comprehension skills and good understanding of simple verbal requests (for the experimental phase).
* Being a native speaker of Italian.

Exclusion Criteria:

* Presence of disability that impairs participation in research.
* Insufficient knowledge of the Italian language.
* Refusal to participate in the research.
* Other relevant prior neurological or psychiatric conditions (other than those determining membership in the experimental group).
* Comorbidity of multiple conditions that would determine membership in more than one experimental group.
* Comorbidity with other neurological conditions.
* Presence of prior psychiatric conditions.