cyrilzakka/clinical-trials huggingface dataset:
Cardiac Dysfunction in Adolescents With Type 1 Diabetes: Contribution of Daily-life Glucoregulation and Impact on Cardiorespiratory Exercise Capacity

During the course of type 1 diabetes mellitus (T1DM), several complications can occur. One of these is the development of diastolic and systolic dysfunction (even in the absence of ischemic, valvular or hypertensive heart disease). Such cardiac dysfunction and adverse remodeling is more common in adolescents with T1DM with a worse glycemic control (as evidenced by higher blood glycated hemoglobin HbA1c) concentrations. Even though an association has been observed between higher blood HbA1c concentrations and a worse cardiac function/structure in adolescents with T1DM, less is known about the specific characteristics of the glucoregulation (e.g. number and duration of hyperglycemic or hypoglycemic episodes, age of onset of T1DM,..) in relation to cardiac function/structure in this population. Therefore, the first aim of this study is to identify specific parameters related to glucoregulation which correlate with cardiac function and structure in adolescent with T1DM.

In T1DM, exercise training is generally recommended and included in the guidelines for the care of T1DM (due to beneficial effects on HbA1c levels, cardiovascular risk profile,..). However, as exercise training may increase the risk of hypoglycemic events, many patients may fear exercise, leading to inactivity or sedentarism. Logically, physical activity volumes are diverse in cohorts of this patient population, in which the long-term physically active T1DM patient will display an optimal or preserved cardiopulmonary exercise capacity, while a suboptimal cardiopulmonary exercise capacity will be noticed in mostly sedentary T1DM patients. The second aim of this study is to evaluate the association between cardiac function/structure and cardiopulmonary exercise capacity in adolescent T1DM patients (in the perspective of their physical activity behavior). This study thus may provide greater insights in the etiology and consequences of a disturbed cardiac function/structure in adolescents with T1DM.


Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes mellitus

Exclusion Criteria:

* chronic diseases (except type 1 diabetes mellitus)
* disorders hindering exercise
Hygiene Protocol of Complete Dentures

Adequate denture hygiene is important to patient's oral health maintenance in particular because of Candida albicans, responsible for the development of denture stomatitis. The aim of this study is to conduct a randomized controlled trial seeking for the best hygiene protocols to be used in removable denture wearers. The null hypothesis tested is that there will be no difference among the denture hygiene protocols tested.


Eligibility Criteria:
Inclusion Criteria:

* Complete denture wearer
* healthy
* ability to comply with the experimental protocol

Exclusion Criteria:

* Candidiasis (thrush)
* use of antifungals, antibiotics or mouthwashes in the prior 3 months
* limited motor activity
* unhealthy
Testing A Couple-based Program for Alcohol Risk Reduction in the National Guard

The purpose of this project is to develop and test indicated prevention intervention to harness support and health promoting endeavors to address use of alcohol to cope with reintegration challenges in Massachusetts National Guard (MANG) service members.

Specific Aim 1: To modify the existing, efficacious Alcohol Behavioral Couple Therapy (ABCT) manual into a 6-session prevention protocol, called Alcohol Behavioral Couple Prevention (ABCP) that will be developed for delivery via in-person and telehealth platforms. The goal of the new ABCP is for individuals or family dyads to learn to work together to minimize hazardous drinking in order to effectively address other problems often present among returning service members.

Specific Aim 2: To field test feasibility and preliminary efficacy of a prevention protocol using a successive cohort design. First, an in-person protocol will be tested with 4 National Guard (NG) members and then adapt and test the protocol for 4 NG members via an analog telehealth design. Again, the manual and accompanied materials will be revised.

Specific Aim 3: To conduct a small Randomized Controlled Trial (RCT) to compare 2 conditions with 22 NG Members in each: (1) In person (ABCP_P; 11 individual, 11 dyad), and (2) Telehealth (ABCP_T; 11 individual, 11 dyad).

Eligibility Criteria:
Inclusion Criteria for NG member:

* Age 18 and older and a member of the MANG.
* Have a SO or trusted friend who is 18 or older
* Service member endorsed one item on the 10-item Alcohol Use Disorders Identification Test within their lifetime

Exclusion Criteria:

* unable to give consent
* Prisoners
* Principal Investigators determined the participant requires a higher level of care (based on unstabilized psychiatric disorder, and/or high drinking or drug use severity, and/or inability to attend to adl's and/or agitated behavior
* Service Member is unable to read or comprehend English at the 7th grade education level
Effectiveness of a Web-based Prevention Program for Postpartum Depression

The original trial will evaluate the effectiveness of a Web-based program in preventing postpartum depression. The site has been modified to provide materials from both conditions.

Depression is a mental health condition in which symptoms such as sadness, inability to feel pleasure, and loss of energy interfere with a person's normal life. Postpartum depression is a type of depression experienced by women after giving birth to a child. In this study an intervention for preventing postpartum depression that has been adapted for use over the Internet will be tested. Administering a depression-prevention program over the Internet has several advantages: after the initial investment is made to develop the program, costs are lower for treating each patient; online treatment is more accessible to a greater number of people than any given clinic; and participants who may be worried about a stigma associated with mental health problems often feel more comfortable seeking information through the Internet. Previous research has shown that symptoms of depression can be reduced through Internet-based interventions, but no research has examined such interventions specifically for postpartum depression. The program tested in this study is not aimed at replacing in-person mental health care-in fact, people who have signs of serious depression will be directed to in-person mental health care. Instead, the program is aimed at providing an additional mental health service among the range of available options.

The original trial was a two-arm pilot prevention of postpartum depression trial comparing the Internet-based course called "Mothers and Babies/Mamás y Bebés" (M\&B) to informational materials on postpartum depression. In the original trial, 1088 pregnant women were recruited and randomized (as anticipated) to either condition. The study Website has therefore been modified such that all participants who consent to participate will now receive materials from both conditions. We have eliminated the randomization procedure.

As in the original study, participants be allowed to enroll at any time during their pregnancies and will be followed for 6 months after the birth of their children, so the length of participation will vary between 6 and 15 months. After undergoing a screening process, participants will now have access to both the Internet-based course called "Mothers and Babies/Mamás y Bebés" (M\&B) and the informational materials. The informational materials will include information about postpartum depression and depression that may occur before childbirth. All participants will be invited via email to complete monthly assessments for the duration of the study. These assessments will measure mood, depression, and satisfaction with the assigned intervention.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Fluent in English or Spanish
Web-based Breastfeeding Education for Adolescent Mothers

The present study was conducted as a randomized controlled trial to evaluate the effectiveness of web-based and face-to-face breastfeeding education given to primipara adolescent pregnant women. The study was conducted between March 2023 and December 2023 at the University of Health Sciences Van Training and Research Hospital Obstetrics and Gynecology Polyclinics. A total of 135 primipara adolescent pregnant women who met the inclusion criteria were included in the study, including 45 in the Booklet Supported Face-to-Face Breastfeeding Education Program (KİDYEP), 45 in the Web-Based Video Supported Breastfeeding Education Program (WEBVİDEP) and 45 in the control group. Pre-test data were collected in the third trimester by applying socio-demographic data form, breast milk and breastfeeding information form, and breastfeeding self-efficacy short form scale (antenatal form) to the groups. After the pre-test data were collected, a face-to-face breastfeeding education program with a breastfeeding education booklet was administered to the KİDYEP group, and a web-based video-assisted breastfeeding education program was administered to the WEBVİDEP group. Data were collected by applying breast milk and breastfeeding information form, LATCH breastfeeding identification and evaluation scale and breastfeeding self-efficacy short form scale (postnatal version) to the groups at the first (midtest) and sixth (posttest) weeks after delivery. As a result of the present study, the rate of exclusive breastfeeding, the total duration of considering breastfeeding, breast milk and breastfeeding knowledge levels, breastfeeding self-efficacy levels and breastfeeding success of the mothers in the KİDYEP and WEBVİDEP groups were found to be higher than the control group, and both the booklet-supported face-to-face breastfeeding education program and the web-based video-supported breastfeeding education program were found to be similarly effective.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 15 and 19 years
* Being 19 years old and above
* Being literate
* Being primigravida
* Having a single baby (not twins or more)
* Being a volunteer to participate in the study
* Having no health problems for the mother and the baby
* Having a computer, tablet or smart phone and the ability to use it
* Having regular internet access

Exclusion Criteria:

* The mother being 18 years of age or younger
* Being multigravida and/or multiparous
* Having a health problem related to the mother or the baby
* Not having a smart phone or wireless internet during the study period
* Not filling out the survey forms incompletely and not watching videos about hygienic care of the newborn
Improving Self Management Skills of Older Adults With Diabetes

The study will help determine if the Better Choices Better Health Diabetes program (community-based or online, also known as the Diabetes Self-Management Program) improves the hbA1C of people with Type-II diabetes. The investigators will also examine 1) symptoms (fatigue, sleep, low blood sugar symptoms, depression, shortness of breath), 2) healthy behaviors (blood sugar monitoring; taking medications as prescribed; getting eye, foot, kidney and cholesterol exams; and activity), 3) the use of health care services. This project is a translational study to demonstrate the effectiveness of the intervention in the context of a major insurer.

Self-report questionnaires and hbA1c capillary blood collection kits will be administered at baseline (prior to the intervention), six-months and twelve-months. Differences between baseline and followup scores will be used to determine if participants have benefited from the intervention, using intent-to-treat methodology. Subgroups and delivery method (small-group or on-line) will be compared using repeated measures and analyses of covariance.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* WellPoint insurance or medicare supplement plan participant
* 18 years or older

Exclusion Criteria:

* Treatment for cancer in past year
* Pregnant
* Under 18
* Previously taken a Stanford self-management program
Lactate to Treat Hypoglycemia

Tight glucose control in intensive care has become a major concern, allowing a reduction in morbidity and mortality. However, its use is limited by the percentage of hypoglycemia which can have severe consequences on the brain. The bispectral index (BIS) is derived from the EEG and measures of brain electrical activity noninvasively. It has already been shown that its value changes according to hypoglycemia and its correction. Furthermore, if the hormonal response to hypoglycemia is well known in healthy and diabetic subjects, it is not the case in ICU patient. The usual treatment of hypoglycemia is based on parenteral infusion of glucose. Btu this can lead to a hyperglycemic rebound that can be deleterious. Lactate is a substrate for gluconeogenesis and an energy substrate during critical situations. It has been shown to improve neurological tests during hypoglycaemia and had cerebral protective properties after a severe head injury. The hypothesis of this study is that sodium lactate is superior than the 30% glucose to correct hypoglycemia in the ICU in terms of glycemic variation, brain function and hormonal response.


Eligibility Criteria:
Inclusion Criteria:

* hypoglycemia under 0.6 g/L

Exclusion Criteria:

* hepatic failure
* hyperlactatemia above 5 mmol/L
Pharmacogenetics of Antidepressant-Induced Disinhibition

The purpose of this study is to identify pharmacogenetic profiles associated with selective serotonin reuptake inhibitors (SSRI)-induced behavioral disinhibition in children with Major depressive disorder (MDD), anxiety disorders and/or obsessive-compulsive disorder (OCD) that could be used clinically to reduce the incidence of this adverse event and improve health outcomes.

Background and Rationale:

Antidepressants such as serotonin-selective reuptake inhibitors (SSRIs) are frequently prescribed to children to manage major depressive and anxiety disorders. Although SSRIs are thought to be generally effective and well-tolerated in children, 10%- 20% of children treated with SSRIs experience behavioral disinhibition (i.e. activation, hyperactivity, impulsivity, insomnia) that can lead to devastating consequences (e.g. suicidal impulses, violence). There are currently no tools available to assist healthcare providers in predicting which children will experience behavioral disinhibition as a result of SSRI treatment.

Research Question:

Do children who experience SSRI-induced behavioral disinhibition (SIBD) have a distinct pharmacogenetic profile relative to children who do not have these adverse experiences?

Methodology:

Using a retrospective cohort study design, 120 SSRI-treated children diagnose with major depression, anxiety and OCD, aged 6 to 17 years of aged will be recruited from Child and Adolescent Addiction, Mental Health \& Psychiatry (CAAMHP) Program in Calgary. Children with a current or past history of SSRI use will be identified via recruitment advertisements and by CAAMHP treatment teams operating within community clinics as well as inpatient units within the Alberta Children's Hospital and Foothills Medical Centre.

Clinical data will be collected from the participant's medical record as well as information provided by the child's healthcare provider and caretaker using a customized data collection form. Saliva will be collected, processed and genotyped in accordance with standard procedures. Participants and their parents will complete self-report measures to gather information regarding demographics, SIBD, and other adverse side effects and drug reactions.

Using machine learning (i.e. the construction of algorithms that can learn from and make predictions on data) we will identify and validate a panel of genetic variants that could be used to pre-emptively detect children at-risk for developing SSRI-induced behavioral disinhibition.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 6 - 24 years
2. Medical records available
3. Diagnosis of MDD, anxiety disorder, or OCD
4. Current or past history of SSRI therapy

Exclusion Criteria:

1. Inability of parent/legal guardian to give informed consent
2. Inability of the child to give informed assent
3. Unwillingness of child to provide saliva sample for genetic analysis
4. Current, past or suspected diagnosis of attention deficit hyperactivity disorder, oppositional defiant disorder, conduct disorder, bipolar disorder, psychotic disorder, or pervasive developmental disorder.
A Prospective Cohort of Obinutuzumab and Chlorambucil (GC) Chemotherapy for the Treatment of Elderly Patients With Chronic Lymphocytic Leukemia Including Next- Generation Sequencing (NGS)-Based Assessment

This study is prospective, open-label, single arm observational study to assess efficacy of obinutuzumab plus chlorambucil (GC) chemotherapy in treatment naïve CLL, and prognostic impact of genetic alterations for CLL using NGS.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects will be considered for inclusion in this study if they meet all of the following criteria:

  1. Newly diagnosed chronic lymphocytic leukemia
  2. Age≥ 70 years
  3. Satisfy the one of indications for starting treatment guideline

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  1. Evidence of progressive marrow failure (anemia, thrombocytopenia)
  2. AIHA, thrombocytopenia refractory to steroids
  3. Massive (\>6cm, LCM) or symptomatic splenomegaly
  4. Massive nodes (\>10 cm) or symptomatic
  5. Progressive lymphocytosis
  6. 50% increase over 2 months or LDT \< 6 months
  7. Constitutional Symptoms : weight loss \> 10% in 6 months, significant fatigue, fever \>38 over 2 weeks, night sweat \> 1month 4. ECOG performance status 0-2 5. Total bilirubin ≤ 1.5 x ULN (upper limit of normal) 6. Aspartate aminotransferase (AST) ≤ 5 x ULN, (ALT) ≤ 5 x ULN 7. Creatinine ≤ 3.0 x ULN 8. Provide informed consent Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information

Exclusion Criteria:

1. Unmet NGS samples by bone marrow biopsy or peripheral bloods at diagnosis
2. Hairy cell leukemia or prolymphocytic leukemia
3. Uncontrolled infection
4. Therapy history with combined chemotherapy or biologic therapy prior to registration
5. History of thromboembolic episodes ≤ 3 months prior to registration
6. Active hepatitis B or C with uncontrolled disease
7. Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
8. Any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study
9. Concurrent participation in another therapeutic clinical trial.
The Effect of Electro-Hyperthermia in Preoperative Radiotherapy for Locally Advanced Rectal Cancer

Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of complete resection and anal sphincter preservation. However, a treatment period of from 5 to 6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is confronting challenges for maximizing the therapeutic effect and minimizing the side effects. Electro-hyperthermia is appropriate treatment method to solve these kinds of problems. In this clinical trial, therapeutic effect of the high-frequency electro-hyperthermia is to be verified during preoperative radiotherapy for locally advanced rectal cancer. The ultimate goal is to establish a safe and effective treatment protocol.

Preoperative radiotherapy in locally advanced rectal cancer increases the possibility of complete resection and anal sphincter preservation. However, a treatment period of from 5 to 6 weeks is an obstacle of proper surgical intervention. Also, radiotherapy itself is confronting challenges for maximizing the therapeutic effect and minimizing the side effects. Electro-hyperthermia is appropriate treatment method to solve these kinds of problems. In this clinical trial, therapeutic effect of the high-frequency electro-hyperthermia is to be verified during preoperative radiotherapy for locally advanced rectal cancer. The endpoint of the trial is treatment safety and non-inferiority of tumor regression to conventional schedule of preoperative radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically-proven rectal adenocarcinoma within 15 cm from anal verge
* Clinically T3-4 stage or positive lymph nodes
* Performance status 0-2
* Proper function of bone marrow, kidney, and liver

Exclusion Criteria:

* Past disease history of rectum
* Hereditary colorectal cancer
* Chronic inflammatory bowel disease
* Bower stenosis
* Active infection
* Myocardial infarction, uncontrolled arrhythmia, angina pectoris, or cardiac insufficiency within 6 months
* Pregnancy, nursing
* Unresected contemporary colon cancer
* Thermal hypersensitivity
* Too much subcutaneous fat in the abdominal and pelvic area
Identification of Entamoeba Spp. in Assuit Governorate Hospitals.

1. Determination the prevalence of Entamoeba histolytica infections among patients at Assiut University Hospitals presented with diarrhea/dysentery.
2. Evaluatation the role of different cultures in diagnosing Entamoeba .
3. Molecularly differentiation between Entamoeba species to monitor the true prevalence of E.histolytica .

Entamoeba histolytica is a common pathogenic protozoan widely distributed throughout the world (10% of the world's population), with 50,000-100,000 deaths reported annually(1) .It is a health problem both in Egypt and worldwide (2) The disease is more prevalent in densely populated areas with poor hygiene requirements and lacking sanitary water supply, especially in rural areas(3). It causes many digestive complications including diarrhea , and fever(2). it transmits through bloodstream forming abscesses in the brain, eye, liver and other vital organs and tissues or even lead to death in some cases . Some individuals have no symptom of the disease but transmit the infection to others(4) It is well- established that E. histolytica leads to invasive disease in humans. Although both E. dispar and E. moshkovskii are still considered to be non pathogenic and free-living amoebas, respectively, some reports suggest their potential role in provoking disease in humans (5) Cysts of E.dispar , E.moshkovskii and E.hartmanni can be confused with E.histolytica. cysts in the parasitological examination(6) The molecular assays, is preferable as it detects E. histolytica , differentiates it from other species and monitors its true prevalence for better treatment and effective control (2)

Eligibility Criteria:
Inclusion Criteria:

* : Male and female patients of different age groups with diarrhea/dysentery attending the outpatient clinics at Assiut University Hospitals .

Exclusion Criteria:

* No exclusion criteria .