cyrilzakka/clinical-trials huggingface dataset:
Breaking Down Barriers to Diabetes Self-Care

Performance of self-care recommendations is key to the successful treatment of diabetes. However, many patients have difficulty adhering to diabetes self-care recommendations. Recent results from our own studies and others have identified specific barriers to diabetes self-care. To evaluate the efficacy of a diabetes educator-led group intervention, the Breaking Down Barriers Program, that addresses barriers and therefore leads to improved adherence to diabetes self-care recommendations, we will randomize 222 (111 type 1 and 111 type 2) diabetes patients to one of three conditions: 1) the Breaking Down Barriers Program, 2) a cholesterol attention control condition, or 3) a 'usual care' control condition. We hypothesize that those assigned to the Breaking Down Barriers group will improve self-care behaviors and glycemic control more than those in the two control groups. We will follow study subjects for one year to determine whether their self-care behaviors and glycemic control improved and if the improvement was maintained over time.


Eligibility Criteria:
Inclusion Criteria:

For Patients With Type 1 Diabetes

* Aged 18-65
* Presence of type 1 diabetes mellitus.
* 2-25 year duration.

For Patients With Type 2 Diabetes

* Aged 25-65 years
* presence of type 2 diabetes mellitus.
* 2 years since initial diagnosis.

Exclusion Criteria:

* Renal disease, microalbumin \>300 ug/mg)
* Severe peripheral diabetic neuropathy and/or severe peripheral vascular disease
* Symptomatic severe autonomic neuropathy who may be at risk when increasing activity levels.
* Women who are currently pregnant
* proliferative diabetic retinopathy based on dilated eye examination within one year of study entry. Patients whose eye disease is successfully treated will be included.
* HbA1c levels less than 7.0% (normal range 4.0 - 6.0%).
* HbA1c levels greater than 14.0%
* patients who underwent intensive insulin treatment within one year
* a history of severe, unstable myocardial infarction, congestive heart failure or other severe cardiac disease, severe hypertension (systolic more than 160 mmHg or diastolic 90 mmHg) who may be at risk when mildly increasing physical activity
* a DSMIV diagnosis of eating disorders including anorexia nervosa, bulimia, and severe weight-related insulin omission.
* Patients with recent diagnosis (past 6 months) of bipolar disorder, schizophrenia, mental retardation, organic mental disorder, and alcohol or drug abuse
* Patients whose diabetes diagnosed cannot be clearly classified as type 1 or type 2.
Prevalence of Periodontitis Based Upon Principles Presented by the 2017 Classification: A Hospital-based Cross-sectional Study on a Sample of Young Egyptian Dental Patients

The study aims at determining the Prevalence Of Periodontitis based upon principles presented by the 2017 Classification: A Hospital-Based Cross-Sectional Study on A Sample of Young Egyptian Dental Patients


Eligibility Criteria:
Inclusion Criteria:

1. Patients whose age from 12 to 39 years old .
2. Patient consulting in the outpatient clinic
3. Provide informed consent.

Exclusion Criteria:

1. Patients having problem in opening their mouth or undergoing inter maxillary fixation where oral examination will not be possible.
2. Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs
Group Treatment for Adolescents With Depression

Youth with depressive symptoms are at risk for a range of problems later in life. This includes problematic interpersonal relationships, occupational stress, and the occurrence of adult mental disorders. The main purpose of this study is to test how effective two types of group therapy are at reducing depressive symptoms in youth. A focus on group therapy is important because group therapy allows for many youth to be treated in a short amount of time. Group therapy is also helpful because youth can get social support and feel less alone in their symptoms when they participate in group. This study compares two groups, one that targets skills for managing difficult emotional experiences (dialectical behavior therapy skills group) and another group focuses on psychoeducation and is based on a publicly available treatment manual from the Services for Teens At Risk (STAR) Center at the University of Pittsburgh. The results of this study will provide insights regarding the comparative efficacy of these two treatments, and regarding predictors of treatment response.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* male or female, ages 14 to 19, all races and ethnicities
* Current depression as assessed by an ALIFE - PSR score equal to or greater than 4
* Has a treating psychiatrist at Sunnybrook Health Sciences Centre

Exclusion Criteria:

* Current manic episode
* current psychosis
Effect of a Visual Nutrient Profiling System on Recall of Nutrition Information

The objective of the study is to validate a visual method of presenting nutritional information by determining if users of the visual method remember food properties better than users given the same information in a non-visual form with texts and tables.


Eligibility Criteria:
Inclusion Criteria:

* Current student at University of Illinois at Urbana-Champaign

Exclusion Criteria:

* N/A
Clinical Impact of an Antibiotic Stewardship Program in a Neonatal Intensive Care Unit

Antimicrobial resistance is one of the biggest and most urgent threat to global health. Initiating antimicrobial stewardship programs is one of the main efforts to control antimicrobial resistance. Implementing these programs in neonatal intensive care units (NICU)is very important and crucial despite of its difficulty, where antibiotics are used extensively. The aim of present study was to assess the clinical impact of implementing antibiotic stewardship program interventions at NICU.

Background:

Implementing an antimicrobial stewardship program is one of the main efforts to control antimicrobial resistance. The present study aimed to assess the clinical impact of the antibiotics stewardship program (ASP) in the neonatal intensive care unit (NICU) of Assiut University Children's Hospital.

Methods:

The study was conducted in two phases from January 2019 to June 2020. The pre-ASP phase (603 patients) included making NICU-specific antibiograms, choosing the antibiotic use evaluation measures, conducting antibiotic use evaluations, and designing the ASP. The ASP intervention phase (597 patients) included implementation of the ASP, which involved modifying the neonatal sepsis treatment protocol according to the local antibiotic susceptibility patterns and measuring its clinical outcomes.

Results:

The ASP intervention phase showed a significant increase in the number of C-reactive protein tests, microbiological cultures/patient, the number of patients taking definitive therapy, and the number of pharmacist interventions/patient. The prescribing rates of antibiotics and their consumption levels were changed according to the NICU-specific antibiogram. There was a significant reduction in the 14-day and 28-day mortality of patients with late-onset sepsis after modifying the neonatal sepsis treatment protocol in the ASP intervention phase.

Conclusion:

ASP implementation was successful in improving antibiotic prescribing and patients outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Received antibiotics for more than 72 hours.

Exclusion Criteria:

* Hospital stay was less than 72 hours.
* Did not receive any antibiotics during hospital stay.
Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life

Pulmonary hypertension (PH) leads to impaired physical condition (PC), body composition (BC) and health-related quality of life (HRQOL). We hypothesized that a 3 week inpatient pulmonary rehabilitation (PR) improves PC, BC and HRQOL.

Pulmonary hypertension (PH) impairs physical condition (PC), body composition (BC) and health-related quality of life (HRQOL).

Specific pharmacological treatment and - in selected patients, refractory to agents - lung or combined heart and lung transplantation can improve physical functioning and long term survival. Initial trials with limited numbers of patients were encouraging. Investigation of larger cohorts is essential to assess the efficacy of rehabilitation programmes in PH.

We hypothesize that a 3 week inpatient pulmonary rehabilitation (PR) improves PC, BC and HRQOL in patients with PH in functional classes (FC) II and III. Critical ill patients with a functional class IV are excluded. All patients with PH undergo a 3-week inpatient rehabilitation program (interval bicycle and strength training, physiotherapy, psychological support, education). Exercise testing (peak work load (PWL) 6-min-walk distance), body composition (bioimpedance analysis BIA: lean body mass (LBM), body cell mass (BCM), BCM/LBM ratio, phase angle (PA)) and HRQOL (SF 36 questionnaire) are assessed at baseline and completion of PR.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of pulmonary hypertension
* Functional class II-III

Exclusion Criteria:

* Functional class I and IV
* Right heart decompensation
Safety and Efficacy of Six Months Dual Antiplatelet Therapy After Drug-Eluting Stenting

The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.

Drug elution from stent struts is associated with less smooth muscle cell proliferation and delayed stent strut re-endothelialization. Thus it seems conceivable that a longer duration of dual antiplatelet therapy (aspirin and clopidogrel) after DES implantation is needed. However, no studies have been done to investigate which is the optimal antiplatelet therapy duration after DES implantation. Therefore, the objective of the randomized, double-blind, placebo-controlled ISAR-SAFE study is to evaluate the safety and efficacy of a 6 month versus a 12 month duration of clopidogrel therapy after DES implantation.

Patients on clopidogrel therapy at least 6 months after DES implantation, who do not require a reintervention will be randomized to an additional 6 month period of clopidogrel or placebo. The patients will be followed-up for 9 months after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Patients on clopidogrel therapy at 6 months (-1/+2 months) after DES implantation
* Informed, written consent by the patient

Exclusion Criteria:

* Age ≤18 years
* Clinically symptoms, proof of ischemia and/or presence of angiographic lesions requiring revascularization
* Previous stent thrombosis
* DES in left main coronary artery
* ST-elevation and non-ST-elevation myocardial infarction during the last 6 months
* Malignancies or other comorbid conditions with a life expectancy of less than one year or that may result in protocol noncompliance
* Planned major surgery within the next 6 months with the need to discontinue antiplatelet therapy
* Active bleeding; bleeding diathesis; history intracranial bleeding
* Oral anticoagulation therapy with coumadin derivatives
* Known allergy or intolerance to the study medications: aspirin and clopidogrel
* Pregnancy (present, suspected or planned) or positive pregnancy test (In women with childbearing potential a negative pregnancy test is mandatory)
* Patient's inability to fully comply with the study protocol
* Prior enrollment in the same clinical trial.
Diagnosis and Treatment of Sleep-Disordered Breathing in the Homes of Patients With Transient Ischemic Attack

Generalist physicians in the outpatient setting care for 80% of the 300,000 patients who have transient ischemic attacks (TIA) annually in the United States. Despite existing secondary prevention therapies, recurrent ischemic events are common following a TIA. Given the risk of poor outcomes and the important role of the generalist, new therapeutic approaches for patients with TIA are needed that can be applied by generalists to outpatients. This research will develop and evaluate a new therapeutic approach that centers on the observations that sleep-disordered breathing is a risk factor for cerebrovascular and cardiovascular disease, is common in patients with cerebrovascular disease, and is associated with poor outcome following a stroke or TIA. We posit that diagnosing and treating sleep-disordered breathing in the home of TIA patients can improve cerebrovascular and cardiovascular outcomes.

The primary aims are to determine in TIA patients: 1) the prevalence of sleep-disordered breathing, 2) the feasibility of diagnosing and treating sleep-disordered breathing using an auto-titrating continuous positive airways pressure (auto-CPAP) machine within 24-hours of TIA symptom onset, 3) adherence to auto-CPAP, and 4) the effect of auto-CPAP on blood pressure.

We will recruit 80 TIA patients to be randomly assigned to either the intervention or the control groups. Each patient in the intervention group will use an auto-CPAP machine for up to 90 days and will then receive an unattended sleep study using a sleep monitor. Each patient in the control group will receive two unattended sleep studies, one upon enrollment and another after 90 days.


Eligibility Criteria:
Inclusion Criteria: transient ischemic attack - Exclusion Criteria:age \<45 years; respiratory distress or known sleep-disordered breathing; chronic obstructive pulmonary disease (COPD) requiring oxygen; pregnancy; time from symptom onset to beginning of study intervention 72 hours; life expectancy \<6 months; cognitive impairment (Mini-Mental Status Exam\<20); inability to provide informed consent; inability to communicate in English; residence outside the greater New Haven area; or any condition where the monitoring required by the study would constitute a risk to the patient or impair his or her care.

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Sevoflurane Protective Effect on Ischemia-reperfusion Injury. Multicenter, Randomized Controlled Trial

This study aimed to evaluate the possible protective effect of anesthetic technique balanced(with sevoflurane) compared with total intravenous anesthetic technique (propofol,remifentanil). The hypothesis is that the Sevoflurane may exert protective effect in regard to the ischemia-reperfusion injury induced on the microsurgical breast free flap during transfer to receiving area. The investigators will evaluate the continuous flap tissue oximetry and the level of biochemical markers.


Eligibility Criteria:
Inclusion Criteria:

Patient selected for plastic breast surgery With microsurgical Free flap Over 18 y Asa I/II

Exclusion Criteria:

Unusual reaction to anesthetic drugs Suspect for malignant hyperthermia Vasculopathic disease Coagulation disease
HIFEM Technology for Post-Radical Prostatectomy and Post-Holmium Laser Prostate Surgery

The purpose of this study is to evaluate the efficacy of High-Intensity Focused Electromagnetic (HIFEM) technology in improving the recovery time of urinary control and quality of life for male patients after radical prostatectomy (RP) and Holmium laser prostate surgery (HoLEP).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are male
* Post-radical prostatectomy or post HoLEP
* Experiencing urinary incontinence one-month post-RP
* Have the capacity to make their own medical decisions
* Able to complete the questionnaires and visits required.

Exclusion Criteria:

* Subjects who are not male
* Not post-radical prostatectomy or post HoLEP
* Neurologic disease
* Atonic or hypofunctional bladder (bladder contractility index (BCI) \< 100; BCI = pDetQmax+5Qmax)
* Status post pelvic radiation
* Past surgical history of other GU surgeries
* Gross hematuria
* Concomitant use of medications that cause muscle relaxation or inhibition
* Indwelling foley catheter at time of treatment
* Documented urine leak
* Not experiencing urinary incontinence
* Do not have the capacity to make their own medical decisions
* Unable to complete the questionnaires provided.
Menopausal Health Training for Husbands on Women's Quality of Life and Marital Satisfaction

The investigators conducted a clinical trial to evaluation the effect of a menopausal health training for Husbands of 45-60 years women on the women's quality of life and marital satisfaction during transitional period to menopause.

The investigators applied a menopausal health training program for Husbands of 45-60 years women. The content of menopausal health training program was about the nature of menopause, signs and symptoms, complications, treatment option and health behavior during transitional period. Training program lasted 3 sessions. The investigators assessed quality of life and marital satisfaction using Hildich marital satisfaction questionnaire and Menopause Quality of Life questionnaire(MENQOL), respectively, three month after intervention.

Eligibility Criteria:
Inclusion Criteria:

* living with their spouse
* no history of premature menopause
* no history of hysterectomy
* no history of oophorectomy
* no history of acute disease
* no history of burden chronic disease

Exclusion Criteria:

* no participation of spouse in all of training session
* uncompleted all of equation
* favorite to exclude from study
Membrane Sweeping in Early Labor and Delivery Outcomes

Membrane sweeping is a routine procedure in obstetrics in term patients. It has been shown to be effective in decreasing post term gestation and in increasing rate of spontaneous vaginal delivery when used in setting of induction of labor in nulliparous patients. The goal of this study is to determine if membranes sweeping in early labor is effective in improving delivery outcomes including decreasing rate of cesarean section.

This is a non-blinded randomized controlled trial. Participants will be recruited at time of presentation to triage for labor evaluation after cervical exam. Patients with a term, singleton pregnancy who present with regular, painful contractions and a Bishop score \< 7 will be recruited to the study. A random number generator will be used to create a list of random binary numbers. If the patient agrees to the study, the random number list will be used to assign the participant to membrane sweeping or no membrane sweeping. Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise. Those not assigned to membrane sweeping will not have an additional exam. Patients will then be managed as per their primary Obstetrics (OB) provider with the exception of no further membrane sweeping throughout the labor course.

Participants are only required to participate during initial evaluation and randomization. No extra study visits are required.

Due to the nature of the intervention, which requires a provider to perform a procedure, blinding will not be possible for this trial.

No therapy will be withheld for any patients. Their labor course will be managed as per their primary provider using standards of care.

Non-treatment group is necessary in order to exam the difference of effects between membrane sweeping and no membrane sweeping.

Patients will be removed from the study if they chose to withdraw their participation.

Participants will resume care as normal regardless of withdrawing study participation.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy at or after 39 weeks gestation, intact membranes, cephalic presentation, nulliparous, Bishop score \<7, English or Spanish speaking

Exclusion Criteria:

* Prior uterine surgery precluding vaginal delivery, maternal condition precluding vaginal delivery, fetal anomaly, prior membrane stripping
The Effects of Polyunsaturated Fatty Acids (PUFA) on Allergic/Atopic Dermatitis

This clinical trial will study the effects of PUFA supplementation during pregnancy and lactation period on fatty acid composition in human milk and plasma of the mothers and the clinical outcome of atopic dermatitis in infants at increased risk.


Eligibility Criteria:
Inclusion Criteria:

* Woman is pregnant between 16 and 20 weeks
* Mother delivers after 36 weeks
* Mother is willing to breast-feed for four months
* Mother has potential to deliver a child with increased risk of atopic dermatitis
* Signed Informed Consent

Exclusion Criteria:

* Mother is smoking
* Disease with influence on breast feeding
* Complicated pregnancy
* Allergic to seafood
* Allergic to soy
* Allergic to marine fish
* Mother has more than two salmon or tuna meals per week
* Mother is undergoing treatment with anticoagulants
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone

To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic kidney disease or kidney disease alone. These treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years and older. The lower age limit may be higher if legally required in the participating country
* Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active
* Subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital
* Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non ischemic, New York Heart Association (NYHA) functional class II-IV
* Subjects with type 2 diabetes mellitus and / or
* Subjects with 30 mL/min/1.73m\^2 \</= eGFR \</= 60 mL/min/1.73m\^2 (MDRD, Modification of Diet in Renal Disease Study Group) at screening
* Left ventricular ejection fraction (LVEF) \</= 40%
* Blood potassium \</= 5.0 mmol/L at screening
* Systolic blood pressure \>/= 90 mmHg without signs and symptoms of hypotension at the screening visit

Exclusion Criteria:

* Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis
* Acute coronary syndrome (ACS) in last 30 days prior to screening
* Cardiogenic shock
* Valvular heart disease requiring surgical intervention during the course of the study
* Stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit
* Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin inhibitor, or potassium-sparing diuretic
Optimization and Clinical Study of Early Prediction Model for Neonatal Acute Respiratory Distress Syndrome

The goal of this observational study is to learn about neonatal acute respiratory distress syndrome in describe participant population. The main question it aims to answer is: using perinatal factors to predict early neonatal acute respiratory distress syndrome and reduce its mortality.

Participants' umbilical cord blood will be collected for testing, but will not receive any intervention.


Eligibility Criteria:
Inclusion Criteria:

* A newborn born alive

Exclusion Criteria:

* Stillborn newborn
* Respiratory distress syndrome(RDS), transient tachypnoea of the neonate (TTN), or congenital anomalies as a primary current acute respiratory condition
* Hereditary endocrine and metabolic diseases
* Incomplete records