cyrilzakka/clinical-trials huggingface dataset:
Nano Composites and Light Cure Composites - A Comparative Assessment of Bond Failure Rates

This randomized clinical trial is aimed to evaluate the bond failure rates of the brackets bonded with nano-hybrid composites (Filtek Z250) to that of conventional composites (Transbond XT)

Orthodontic brackets are attached to the teeth with a robust bonding material called composite resin, however sometimes the bond between the braket and the tooth surface may fail halting the desired tooth movement. Repeated bond failures like these are inconvenience both for the orthodontists as well as the patients. With each bracket loosening due to bond failure, treatment time is prolonged as the activation planned on eash visit is delayed resuling in increased treatment time.

Nanotechnology has recently made a breakthrough in dental materials through incorporation of nanoparticles. Composites containing nano-filler particles exhibit higher compression strength, flexural strength, elastic modulus and wear resistance (Rabia and Bilal). In vitro studies have shown that nanohbrid composites have shear bond stregnths similar to that of conventional composites however the environment of oral cavity is challenging and there are no long term clinical trials to validate these results.

The aim of this study is to compare the rate of bond failure between the brackets bonded with nano hybrid composites and that of the conventional composites over a period of six months.

Eligibility Criteria:
Inclusion Criteria:

* Patients having treatment with fixed metallic orthodontic appliances
* Patients in whom both upper and lower arches are bonded in single visit

Exclusion Criteria:

* Patients with variations in morphology of teeth
* Patients with defective enamel, dentine and cementum
* Patiens with parafunctioal habits
* Patients with restorations involving the facial surface of teeth
Incidence of Chronic Pain After Sternotomy

Chronic postoperative pain is a well-known problem. Chronic postoperative pain is defined as pain that begins following a surgical procedure and persists for more than 2 months without other obvious causes such as infection or underlying disease. Sternotomy causes significant postoperative pain, and patients with chronic pain after sternotomy are often referred to pain clinics. The incidence of chronic pain after sternotomy ranges from 17% to 56%; In approximately one-third of these patients, chronic pain after sternotomy can compromise their quality of life by affecting their sleep patterns and impairing their ability to work. However, epidemiological studies on chronic pain after sternotomy are scarce. The aim of this study is to examine the incidence and possible risk factors of chronic pain following sternotomy operations. In this study, it was aimed to analyze the chronic pain findings of the patients who underwent sternotomy in the postoperative 3rd month.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists' physical status I-II-III-IV
* Body mass index (BMI) between 18-35 kg/m2
* Patients undergoing elective sternotomy

Exclusion Criteria:

* History of chronic analgesic therapy
* Patients with previous sternotomy surgery
* Patients who were operated under emergency conditions
Predictors of Hospital-Based Care in Asthma

To identify clinical predictors of episodes of hospital-based care in people with asthma.

BACKGROUND:

This study was of great practical importance because asthma is a common condition (3-5 percent of the population) which has had a recent, unexplained rise in morbidity and mortality. Many previous epidemiological studies focused on predictors of hospitalization for people with asthma seen in the emergency room. These studies were of limited value for the practicing physician who sees the vast majority of patients with asthma.

Results from this study should, for the first time, enable a profile to be constructed of the high risk patient with asthma which includes identification of modifiable risk factors. These results can be used for physician and patient education programs as well as to target medical intervention.

DESIGN NARRATIVE:

The study developed a key piece of information needed for outpatient care of patients with asthma; a profile of patients at risk for severe, potentially life-threatening exacerbations of asthma. The experimental design was a prospective study of 800 patients with asthma drawn from a large, pre-paid health care plan. The key advantage of this population was that all the care occurred within the health plan. Characteristics identified included demographic factors, socioeconomic status; patient characteristics such as tobacco use, atopy, pattern of medication use, self-reporting of compliance/adherence, attitudes about asthma; historical assessment of indoor air quality; characteristics of asthma such as duration of asthma, lung function, and variation in asthma symptoms; and speciality of physician. The outcome measures were obtained over a three year period and included all episodes of hospital-based care including hospitalizations, emergency room visits, and urgency care clinic visits. Based on these data, models were developed which assigned relative risk to each of the independent variables. These models were validated in a subset of the population.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Taking Action Together- A Diabetes Prevention Program

The purpose of this study was to determine whether once-weekly exposure to a program that fostered self-esteem building, and improvements in nutrition and physical activity behaviors would reduce risk of type 2 diabetes in overweight, inner-city, African American children when compared to a control group.

In the United States and, indeed, worldwide the prevalence of overweight and obesity has increased at an unprecedented rate. Concomitant with this demographic change are increases in diseases including type 2 diabetes, cardiovascular disease and some cancers that are associated with body fatness. Strategies to reduce body weight have been largely unsuccessful, making it unlikely that our population will be made healthy simply by recommending that overweight people reduce their body fatness. There is evidence, however, that the impact of body fat on human health can be significantly attenuated by potentially achievable strategies. Such strategies require adequate intakes of essential nutrients, regular physical activity and strong self-esteem. The goal of the project is to reduce the risk of type 2 diabetes mellitus (T2DM) in overweight 9- to 10-year-old African American children through a multi-component community-based program. The specific objectives are to (1).Implement a randomly controlled 2-phase intervention involving a 2-week summer camp, and weekly \& monthly reinforcement sessions over 2 years, that include nutrition education, physical activity promotion, and self-esteem and self-efficacy building and (2) Test effectiveness of the program after 1 and 2 years of intervention on insulin sensitivity, the primary outcome, and on secondary outcomes including body fatness, dietary intakes, physical activity, and self-esteem. Identifying an effective, community-based program that could reduce risk of type 2 diabetes in high-risk children would promote health, reduce disease and reduce health-care costs in the future.

Eligibility Criteria:
Inclusion Criteria:

* Child age of 9-10 yr old at baseline
* Child BMI at least 85th percentile when matched for age and gender
* Able and willing to participate in normal daily activities
* Living in inner-city regions of Oakland CA

Exclusion Criteria:

* Fasting blood glucose of 120 mg/dl or higher
* Diagnosis of diabetes or other central metabolic disease
* Taking medications that interfere with or treat main study outcomes
The Effect of Sodium Bicarbonate (Nephrotrans®) on Calcification Propensity of Serum in Kidney Transplant Recipients

This is a single-center, prospective, open-label, randomized, cross-over study.

The primary hypothesis (H1) is that the T50 value will change between wash-out and high-dose (3000mg/d) sodium bicarbonate (Nephrotrans®) substitution.

The 0-hypothesis (H0) is that substitution of 3000 mg/d sodium bicarbonate (Nephrotrans®) has no effect on T50-values as compared to wash-out-phase.

Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between.

Patients will be randomized in a 1:1 ratio to either receive low-dose (1500 mg/d) sodium bicarbonate followed by high-dose (3000mg/d) sodium bicarbonate (sequence A-B) or to receive high-dose sodium bicarbonate followed by low-dose sodium bicarbonate (sequence B-A) with washout-phases in between. The study will start with an initial run-in wash-out phase, where all sodium bicarbonate or other alkalizing treatment taken by the patient as standard of care will be discontinued. Consequently, there will be a sodium bicarbonate treatment (high dose/low dose) phase, followed by a wash-out phase, followed by another sodium bicarbonate treatment (high dose/low dose) phase, followed by a final wash-out phase. Each study phase, including wash-out phases as well as low-dose and high-dose treatment phases will be 14 ±3 days of duration. Patients will be followed up to 12weeks after randomization until the last study visit of the final wash-out phase.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years old
* Prevalent (≥ 6 months after kidney transplantation) kidney transplant recipients
* eGFR (CKD-EPI formula) between 10 and 50 ml/min/1.73 m²
* Patient has provided informed consent prior to initiation of any study related procedure

Exclusion Criteria:

* Allergy to sodium bicarbonate or any component of Nephrotrans®, namely soy or peanuts (reported cross-reactivity to peanuts has been reported in patients with soy-allergy).
* Unstable clinical condition (e.g. uncontrolled heart failure, clinical uremia, uncontrolled hypertension, impending initiation of dialysis treatment...) as judged by the recruiting physician
* Pregnant and nursing (lactating) women
* Unwillingness to discontinue current medication with sodium bicarbonate
* Unwillingness to discontinue antacids containing aluminum, calcium carbonate, magnesium, lactate, citrate, bicarbonate or mixtures thereof
Biventricular Versus Right Ventricular Pacing

The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist devices (LVAD). Only patients are blinded. This is a small-scale study from which future larger scale randomized controls can be performed. The primary endpoint will be the effect of BiV and RV pacing setting on the 6-minute walk test.

Heart failure patients with reduced left ventricular systolic function and worsening clinical status are frequently treated with mechanical devices. Cardiac resynchronization therapy (CRT) and left ventricular assist devices (LVAD) are mainstays of advanced heart failure treatment and have independently been demonstrated to decrease mortality. However, minimal research documents the utility of these two modalities in unison. There have been recent investigations comparing Biventricular (BiV) versus right ventricular (RV) pacing suggesting better exercise performance and decreased left ventricular (LV) volumes with RV pacing. This discovery contrasts with prior meta-analysis that reports no difference between LVAD patients with and without CRT including mortality and hospitalizations. Investigators aim to compare BiV pacing and RV pacing in LVAD patients with CRT on patient's exercise tolerance and frequency of tachyarrhythmias. Additionally, research is required to form a conclusion on the role of CRT in LVAD patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with both an LVAD and CRT device with functional leads
* Age 18 years and older
* Ability to walk
* Ability to sign consent

Exclusion Criteria:

* Patients with permanent atrial fibrillation
* Patients who are pacemaker dependent
* Patients with sustained ventricular tachycardia
Mental Health Symptoms and Intimate Partner Violence

Using a touch screen computer, the researchers are screening emergency department patients for intimate partner violence and mental health issues.

Using a touch screen computer, the researchers are screening emergency department patients for intimate partner violence and mental health issues. The researchers are looking to see if those who participate in a computer screen and are given referral lists as well as having the computer printout placed on the physician clipboard, will increase physician awareness and recognition as well as patient use of resources compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

* Female patients between the ages of 18-55 who present to the waiting room of the emergency department during study time periods

Exclusion Criteria:

* Psychotic
* Acutely intoxicated
* Too ill to participate
* Unable to read
* Not English speaking
Evaluation of Dry Eye and Meibomian Gland Dysfunction After Cataract Surgery

Meibomian gland dysfunction (MGD) is a common and important disease has been investigated the pathophysiology, diagnosis, treatment modalities of MGD, however, the changes of MGD after the cataract surgery, the most popular surgery to ophthalmologist, had not been evaluated. The investigators evaluated parameters related with MGD including lid margin abnormalities, meibomian gland expressibility and meibography before and after surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for cataract surgery

Exclusion Criteria:

1. other comorbid ocular diseases such as ocular allergies.
2. continuous use of topical ocular medications before surgery
3. histories of ocular surgery, or ocular injury
4. Already had severe obstructive MGD before surgery, abnormal findings on lid margin (\> 3 positive findings), reduced meibum expression (\> grade 2), and obstructed gland dropout (meibography score \> 3)
A Study of Pregnancy Outcomes in Congenital Heart Disease

The purpose of this study is to determine if a biomarker assay obtained peripartum (1st-3rd trimester and post-partum) in patients with adult congenital heart disease can predict future risk of cardiovascular adverse events and determine if temporal changes in biomarkers levels throughout the peripartum period can provide a better risk prediction compared to samples taken at a single time-point.


Eligibility Criteria:
Inclusion Criteria:

* Congenital Heart Disease Diagnosis
* Currently Pregnant

Exclusion Criteria:

* Unable to consent
Effects of an Amino Acid and Chromium-picolinate Containing Drink on Glucose Metabolism

It has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose and insulin response. In this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in patients with early type 2 diabetes or prediabetes according to guidelines that are treated with dietary measures or metformin only. The study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. The primary endpoint of the study is the incremental area under the curve for plasma glucose (iAUCgluc) within 180 minutes after ingestion of the meal.


Eligibility Criteria:
Inclusion Criteria:

* Early Type 2 Diabetes (i.e. on Metformin or diet only)
* Prediabetes (i.e. FPG 100-125 mg/dl or IGT 2h PG in OGTT 140-199 mg/dl)
* HbA1c \< 7%
* BMI 28,0-39,9 kg/m²

Exclusion Criteria

* Any antidiabetic medication other than metformin
* Psychiatric Disease
* Acute Infections
* Alcohol or drug abuse
* Malignant tumors or hematologic disorders
* Heart failure NYHA III-IV
* Acute coronary syndrome
* Any macrovascular event within previous 3 months
* Chronic kidney disease \> Stage 3
* Pregnancy or Lactation
Enhanced Recovery After Surgery Protocol on Early Mobilization After Colorectal Surgery

Early mobilization is an important factor in increasing postoperative colorectal surgeries outcome. There are four components held by anesthesiologist in Enhanced Recovery After Surgery protocol for colorectal surgery in our hospital: post operative nausea and vomiting (PONV) prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and postoperative opioid-free pain management. Although early mobilization affected by postoperative pain, vomiting and nausea, and fluid balance management, nonetheless, there is no clear evidence of how much each of these components will affect early mobilization.

Early mobilization is an important factor in increasing postoperative colorectal surgeries outcome. There are four components held by anesthesiologist in ERAS protocol for colorectal surgery in our hospital: PONV prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and postoperative opioid-free pain management. Although early mobilization affected by postoperative pain, vomiting and nausea, and fluid balance management, nonetheless, there is no clear evidence of how much each of these components will affect early mobilization. This study was a retrospective cohort study by collecting secondary data from patients underwent elective colorectal surgery in our hospital from January 2020 to December 2022. The outcomes assessed were early mobilization rate and factors affecting it (PONV prophylaxis, intraoperative fluid management, intraoperative multimodal analgesia, and postoperative opioid-free pain management).

Eligibility Criteria:
Inclusion criteria

* Patient underwent colorectal surgery in Cipto Mangunkusumo Hospital from 2020 to 2022
* Age 18-60 years old
* American Society of Anesthesiologist (ASA) physical status 1, 2, and 3

Exclusion criteria

* Patients who were not intubated on postoperative period
* Patients who had physical limitation during preoperative mobility test
A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive

The study will evaluate the effect of oral contraceptive (birth control pill) on the blood level of lanabecestat when both are given together. Side effects will be monitored and documented. This study will last up to 27 days for each participant, not including screening. Screening is required within 42 days prior to first dose.


Eligibility Criteria:
Inclusion Criteria:

* Are healthy female participants
* Women not of childbearing potential; women of childbearing potential using a non-hormonal intrauterine device (IUD)
* Have a body mass index (BMI) of 17.5 to 32 kilogram per meter square (kg/m²)

Exclusion Criteria:

* Have a history of or current significant ophthalmic disease, which includes participants with clinically significant eye abnormalities, particularly any eye problem involving the retina, as determined by the investigator
* Have vitiligo or any other clinically significant disorder of skin or hair pigmentation, as determined by the investigator
* Have a history of or current neuropsychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state, or personality disorder
Impact of Calory Restriction and Biofeedback on Endocrine and Mental Health

Backgroup/relevance: Overweight and obesity, defined by a respective body mass index of above 25 and 30 kg/m2, are getting increasingly common in all regions of the world. Obesity is currently estimated to be present in more than 10% of the global population while overweight roughly reached an estimate of 40% in 2016.

Overweight dramatically increases the risk for a wide range of disorders such as diabetes mellitus and other metabolic and cardiovascular disorders subsumed under the term metabolic syndrome, increasing the risk for life-threatening cardiovascular events such as myocardial infarction and stroke. Similar to other chronic diseases such as mental health disorders, prescribing medication was oftentimes insufficient and should be complemented by patient empowerment to reach sufficient treatment adherence and control of lifestyle factors. Thereby, overweight and obesity can easily be challenged by patients themselves without pharmacological intervention.

Overweight may place central in the crossroad between metabolic and mental health for several reasons. Excessive body fat is known to cause subclinical inflammation that was also associated with many psychiatric disorders such as major depression. Similarly, the hypothalamic-pituitary-adrenal axis relevant for stress response was shown to be dysregulated in both metabolic and mental health disorders.

Study design: In this study, non-pharmacological interventions are applied in healthy women with overweight or obesity and self-perceived psychological stress. Women staying at the "la pura" women´s health resort (www.lapura.at/) are invited to partake in the study and receive a short-term intervention of calory restriction. Thereby, either F.X. Mayr or very-low-calory-diet (VLCD) will be applied, reducing calory intake to 700-800 kcal/die. Following random assigment to four treatment arms, half of the women also receive a 7-session clinical-psychological intervention consisting of biofeedback, individualized psycho-education on stress prevention and mindlessness training.

Women are assessed at baseline and after two weeks of interventions for metabolic parameters such as insulin functioning, anthropometric parameters such as body weight and body fat, blood parameters such as sex hormones, fat metabolism and liver function, parameters of neuroplasticity such as brain derived neurotrophic factor (BDNF), as well as psychological and biological stress correlates and mental health symptom dimensions.


Eligibility Criteria:
Inclusion Criteria:

* women willing to undergo two-weeks of calory restriction
* at least 18 years of age

Exclusion Criteria:

* currently pregnant
* any acute or a severe chronic illness
Evaluation of the Effectiveness of Aromatherapy on Anxiety, Vital Signs, and Postoperative Complications in Lower Impacted Wisdom Tooth Surgery

Dental anxiety is considered to be one of the fears and concerns associated with dental treatment. Lavender has a relaxing and anxiolytic aroma. The aim of this study was to evaluate the effects of aromatherapy on dental anxiety in bilateral impacted wisdom tooth surgery.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral wisdom tooth in mandible

Exclusion Criteria:

* Lavender oil allergy
* Systemic disease
* Off-study drug use
* Smoking
* Pregnancy or breastfeeding