cyrilzakka/clinical-trials huggingface dataset:
Integrated Smart Speaker Promoting Positive Parenting Among Caregivers of Youth With Challenging Behaviors

This project will develop and evaluate the feasibility of an integrated smart speaker and mobile/web-based application, "FamilyNet" (FN) to assist parents in implementing empirically supported behavioral parenting strategies to promote positive behavior change in their children. The FamilyNet system will help parents to create a positively framed, individualized behavioral plan for their child(ren), and then provide prompts, reminders, and tracking tools to help them effectively implement that plan. Once developed, FamilyNet will be field tested for usability and usefulness with a group of parents who have children ages 10-17 years exhibiting challenging behaviors. Establishing feasibility of this innovative parenting tool will have important implications for harnessing smart speaker and mobile/web technologies to provide parents in-situ support with parenting challenges; parents' effective implementation of empirically supported parenting strategies is likely to increase children's prosocial behaviors and reduce problematic behaviors, thus reducing their risk for long-term behavioral problems.

This project will develop and establish feasibility of an integrated smart speaker and mobile/web application, FamilyNet, designed to help parents utilize best practices in behavioral parent training to create and implement personalized behavior plans for their children. The FamilyNet system will integrate mobile app, smart speaker technology, and website technologies to assist families in creating their behavior plan, and then will track compliance, timelines, incentives, and other details to assist parents in following through and maintaining the behavior change program that they have created. After development, the intervention program will be pilot-tested with up to 35 families of youth ages 10-17 with challenging behaviors.

Primary parents will complete measures of parenting practices and child behavior prior to using the FamilyNet system, and again after having access to the program for 4 weeks. During the intervention period, user information will be tracked. Post-intervention measures will also include primary parents' perceptions of usability and acceptability of and satisfaction with the FamilyNet system. Children will also complete satisfaction questionnaires at the post- intervention assessment. Data will be analyzed to determine the degree to which families are able to utilize the FamilyNet interface and report finding it helpful.

Eligibility Criteria:
Inclusion criteria:

1. Primary parent/caregiver who has a child ages 10- to 17-years-old who lives with them at least half the time
2. Has a smartphone and access to email
3. Speaks English

Exclusion criteria:

a. The target-age child has a developmental disability severe enough that the child is unable to speak and/or follow simple directions.
OCT and Early Cognitive Impairment in Multiple Sclerosis

The aim of this study is to investigate the relationship between cognitive impairment and retinal nerve fiber layer \& ganglion cell inner plexiform layer in MS.

Cross-sectional study design, including 60 patients and 30 healthy controls. Subjects were investigated clinically, underwent retinal optical coherence tomography (OCT) and comprehensive cognitive assessments. The correlation between these modalities was evaluated by Spearman correlation.

Eligibility Criteria:
Inclusion Criteria:

* 60 MS patients diagnosed according to the revised McDonald criteria 2010 were included
* 30 healthy subjects with age and sex match control group.

Exclusion Criteria:

* Medical disorder other than MS that may grossly affect cognitive functions
* Pregnancy,
* Previous neurological or neuropsychiatric disorders,
* Alcohol or drug abuse,
* MRI findings which could not be attributed to MS.
* Severe visual disorders (\> ± 6.0 dpt.)
* History of ocular surgery, glaucoma or diabetes.
Evaluate the Efficacy and Safety of Multiple Roxadustat Dosing Regimens for the Treatment of Anemia in Dialysis Participants With Chronic Kidney Disease

This is a randomized, open-label, multi-center study in dialysis chronic kidney disease (CKD) participants to evaluate the efficacy and relative safety of different dosing regimens of roxadustat over a 36-week treatment period.

There are 3 study periods:

* Screening Period (up to 4 weeks)
* Treatment Period (36 weeks)

Part 1: Correction/Conversion Period (Weeks 1-20)

Part 2: Hemoglobin (Hb) Maintenance Period (Weeks 21-36)

* Follow-up Period (4 weeks)

Approximately 102 erythropoiesis stimulating agents (ESA)-naïve participants and 204 ESA-treated participants will be enrolled and randomized respectively in a 1:1 ratio to receive roxadustat at one of 2 starting doses as below:

* Low weight-based dosing: 70 milligrams (mg) 3 times a week (TIW) for body weight \<60 kilograms (kg) or 100 mg TIW for body weight ≥60 kg
* Standard weight-based dosing: 100 mg TIW for body weight \<60 kg or 120 mg TIW for body weight ≥60 kg

After 20 weeks of treatment, all eligible participants whose last 2 Hb levels ≥105 grams (g)/liter (L) and change in Hb over the most recent 4 weeks is \> - 10 g/L will switch to receive roxadustat for another 16 weeks to evaluate the efficacy and safety of new dosing regimens.

At the end of Week 36, all participants will discontinue roxadustat and enter a 4-week Follow-up Period.

Eligibility Criteria:
Inclusion Criteria:

1. CKD with end-stage renal disease (ESRD) on either hemodialysis (HD) or peritoneal dialysis (PD)

Exclusion Criteria:

1. Positive for any of the following: human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus antibody (anti-HCV Ab).
2. Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thromboembolic event (for example, deep venous thrombosis or pulmonary embolism) within 26 weeks prior to Day 1.
3. History of malignancy, myelodysplastic syndrome, and multiple myeloma.
4. Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis (for example, systemic lupus erythematosis \[SLE\], rheumatoid arthritis, celiac disease).
5. Clinically significant gastrointestinal bleeding.
6. Women of childbearing potential and men with sexual partners of child bearing potential who are not using adequate contraception.
Assessment of Collagen Plug for Alveolar Socket Sealing With Simultaneous Implant Placement in Maxillary Esthetic Zone

Following tooth extraction alveolar ridge will undergo dimensional changes and soft tissue may collapse. These changes may complicate the subsequent restorative procedure especially in the esthetic zone.

It was observed that socket-healing process may be divided into three sequential, and frequently over-lapping phases: inflammatory, proliferative and modeling/remodeling.

Implants placed in fresh extraction sockets alone wasn't found to prevent the resorption of the alveolar bone.

Alveolar socket preservation using primary flap closure technique utilizing free gingival graft in conjunction with bone substitutes didn't produce the desired effect on ridge preservation compared with bone substitutes alone. A clinical trial showed that achieving primary closure didn't present additional beneficial effect on preserving ridge width, however, the mucosa was significantly thicker and more coronally positioned.

Also soft tissue graft has its limitations on covering graft material and socket preservation due to the higher morbidity given that the soft tissue graft has to be harvested from a donor site of the patient.

Another options for socket seal are coronal advancement of buccal flap or rotating grafts from tissue adjacent to cover the defect but they have limitations such as altering the mucogingival line and creating a shallow vestibule.

Lekovic et al. investigated the use of a non-resorbable polytetrafluroethylene membrane but it was found also to have its limitations as 30% of the membranes became exposed and as a result loss of bone height and width occurred.

Also studies have found that using bone substitutes together with collagen membrane with primary closure of the socket has shown clear effects on preserving alveolar ridge height as well as ridge width, however, its limitation are flap dehiscence and subsequent membrane exposure and the increased cost.

Eligibility Criteria:
Inclusion Criteria:

* Patients with maxillary teeth in the esthetic zone (incisors/premolars) requiring extractions.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Uncontrolled periapical infections
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Safety and Tolerability of E5555 and Its Effects on Markers of Intravascular Inflammation in Subjects With Acute Coronary Syndrome

This is a multi-center, randomized, double-blind, placebo-controlled study to determine the safety and tolerability of E5555 in subjects with Acute coronary syndrome (ACS).


Eligibility Criteria:
INCLUSION CRITERIA:

1. Males or Females, 45 - 80 years of age
2. Presenting with features of non-ST segment elevation ACS (unstable angina or Myocardial infarction without persistent ST elevation). and at least one of the following two criteria on admission: Cardiac enzymes≥ ULN for the local institution OR ECG changes compatible with ischemia
3. Randomisation possible within 24 hours of the onset of the most recent symptomatic episode.

EXCLUSION CRITERIA:

1. History of acquired or congenital bleeding disorder, coagulopathy or platelet disorder, or history of pathological bleeding within the last 6 months
2. History of intracranial bleeding, history of hemorrhagic retinopathy, history of recent ischemic stroke or transient ischemic attack, or known structural cerebral vascular lesion
3. Recent trauma, major surgery, Percutaneous coronary intervention or coronary artery surgery
4. Clinically significant haematological, hepatic or renal abnormalities
5. Patients with some specific ST-segment changes, severe congestive heart failure or uncontrolled cardiac arrhythmias at baseline
6. Recent significant (as determined by the investigator) cardiovascular events
Climbing Lifestyle Intervention for Modifying Physical Activity Behaviors: Pilot Study

The aim of this pilot study is to determine the effects of a 12-week indoor rock climbing training program on heart health, mental health, and behavioral health in generally healthy adults aged 18-35 years old who do not exercise. Participants will learn to rock climb using ropes on an indoor rock climbing wall and participate in the training program 2-3 days per week for 60 minutes each session over 12 weeks. Health outcomes will be measured at 4 time points over the course of the study (pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, and 24-weeks post-intervention).

The purpose of this study is to determine the effects of a 12-week progressive, supervised indoor rock climbing intervention on physical, mental, and behavioral health outcomes in physically inactive adults. This will be a pilot study used for informing a larger, randomized controlled trial. Measurements include: cardiometabolic disease risk factors (e.g., blood pressure, fasting glucose and lipids, hemoglobin a1c), health-related components of physical fitness (e.g., cardiorespiratory fitness, muscular fitness, dynamic balance, body composition), health-related quality of life, and behavior change variables (e.g., attitudes toward physical activity, self-efficacy for exercise, objective physical activity and sedentary behavior). The majority of rock climbing-related studies focus on enhancing performance in high-level climbing athletes and very little research has examined the specific impact of climbing physical activity on cardiovascular health parameters. Indoor climbing has demonstrated to be an activity that is safe for many individuals and does not require a high level initial fitness to partake in the activity. This study will engage generally healthy, physically inactive adults (aged 18-35 y) in an indoor rock climbing program 2 times per week for 60 minutes for the first 4 weeks and progressing to 3 times per week for 60 minutes for the last 8 weeks. Participants will partake in top-rope style rock climbing and bouldering. Data collection will occur over three visits to the School of Health and Human Performance Research Lab at four time points throughout the course of the study (baseline/pre-intervention, 6-weeks/mid-intervention, 12-weeks/post-intervention, 24-weeks post-intervention; total of 12 data collection visits).

Eligibility Criteria:
Inclusion Criteria:

* Physically inactive
* Membership to Physical Education Instructional Facility at Northern Michigan University
* No/very little experience with rock climbing
* No diagnosed cardiovascular, metabolic, renal disease
* No current injury

Exclusion Criteria:

* Physically active
* Experience with rock climbing
* No current membership with Physical Education Instructional Facility at Northern Michigan University
* Pregnant and/or breastfeeding
* Diagnosis of cardiovascular disease, metabolic disease, renal disease
* Current or previous injury that would be exacerbated by rock climbing
* Other diagnosed conditions in which rock climbing would be contraindicated
Development of an Instrument That Monitors Behaviors Associated With OCD

To support the discovery of new means for revealing the presence of Obsessive Compulsive Disorder (OCD), facilitating detection through new technology-based metrics, and attempt to automate existing diagnostic procedures allowing for more efficient diagnostic methods that would broaden clinical scope and outreach.

Aim 1: To observe and compare childhood behaviors regarding handwashing in OCD and control populations

Hypothesis 1: Control participants will spend less time washing their hands, will wash them less frequently, and will be less preoccupied with the sink when doing other activities.

Aim 2: To observe and compare childhood behaviors regarding organizing a cluttered area.

Hypothesis 2: OCD participants will be more disturbed by the presence of clutter and more compelled to organize the items than control participants

Aim 3: To observe and compare childhood behaviors regarding turning on/off light switches

Hypothesis 3: OCD children will be more likely to exhibit compulsive repetitive behaviors regarding the light switch than control participants

Eligibility Criteria:
Inclusion Criteria:

* Male and female children
* Aged 5 to 17

Exclusion Criteria:

* Inability or unwillingness to provide written informed consent/assent
Low VW Activity in Adolescent HMB

This is a research study for patients diagnosed with heavy menstrual bleeding (HMB) and low Von Willebrand Factor (VWF). Menstruation, also known as a period, is the regular discharge of blood and tissues from the uterus. HMB is having a heavier amount of discharge during menstrual period. Low Von Willebrand Factor means that the participant has lower level of a blood protein that is important for clotting of blood and so, the participant is at a higher risk for bleeding.

The purpose of this project is to study the genetic differences of adolescent females with HMB and low VWF activity and compare the genetic differences with their bleeding manifestations, response to medications and outcome.

One hundred and twenty subjects will be enrolled. Adolescent females with heavy menstrual bleeding (HMB) and low Von Willebrand Factor (VWF) will be recruited.

Data collection will occur from participant's medical records in regards to their low VWF activity and HMB medical history.

Participants will be asked to complete symptom questionnaires in regards to their HMB.

A blood sample will be collected to analyze how many participants have the disease causing sequence variation in the VWF gene and other genes affecting bleeding, clotting and blood vessel biology and correlated with their bleeding history.

The blood sample will be deidentified and stored indefinitely for future research.

Eligibility Criteria:
Inclusion Criteria:

* Post-menarchal females less than 21 years of age
* HMB defined as PBAC score greater than 100
* VWF:Activity more than or equal to 30 and less than or equal to 50 IU/dL x 2
* VWF: Activity /VWF:Ag ratio greater than or equal to 0.6
* Normal VW multimers, if performed

Exclusion Criteria:

* Post menarchal females age greater than or equal to 21 years
* VWF: Activity less than 30 or greater than 50 IU/dL consistently, type 2 or type 3 VWD
* Presence of other bleeding disorders (thrombocytopenia, platelet function defect, coagulation factor deficiency, fibrinogen defect or deficiency)
A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia

This trial aims to prospectively assess the feasibility, complications and functional results of free-hand transperineal image fusion targeted biopsies under local anesthesia in a large group of patients.

12-core transrectal ultrasound (TRUS) biopsy is one of the most performed urological procedures and remains the standard method for prostate cancer (PCa) histological diagnosis according to the most recent Guidelines. During the last decade, the transperineal prostate biopsy has attracted renewed interest. However, only a few studies and no large prospective studies investigated complications of the transperineal approaches.

Image fusion of Multi-parameter MRI (mpMRI) and TRUS guided prostate targeted biopsy had equivalent results with standard 12-core biopsy. Combination of targeted and standard biopsy was recommended in recent Guidelines. Image fusion targeted biopsy needs satisfactory anesthetic effect, and no prospective studies investigated feasibility in this approach under local anesthesia.

The scientific urological community is focusing on detection rate and concordance with final pathology of the radical prostatectomy specimen, which remain the cornerstones to assess the accuracy of a prostate biopsy technique. In this study, the investigators will additionally assess the functional results of erectile function and urinary function.

Together, the investigators will perform free-hand image fusion targeted biopsies plus standard biopsies under local anesthesia in patients recruited in this study. Then, Feasibility, such as peri-procedural pain, changes in patients quality of life; complications, such as infection rate and bleeding rate; functional results, such as erectile function and urinary function; and concordance with final pathology will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Men more than 18 years old with clinical suspicion of prostate cancer;
* Serum PSA ≤ 20 ng/ml within the previous 3 months;
* Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) within the previous 3 months;
* No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
* Able to provide written informed consent.

Exclusion Criteria:

* Prior prostate biopsy or prostate surgery;
* Prior treatment for prostate cancer;
* Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
* Contraindication to prostate biopsy.
Effect of Intralymphatic Immunotherapy

The investigators want to investigate whether specific immunotherapy can be delivered directly into a lymph node. The investigators think that a direct introduction of allergen to the antigen presenting cells in the lymph node a give a strong immune response and that this can change the number of injections needed in allergen immunotherapy. The investigators do measurements of clinical effect and a variety of paraclinical test to see if the investigators can find af biomarker of successful specific immune therapy of grass allergy.

Patients are injected with 3 or 4 doses of alk 225 Phleum Pratense 1000 standard quantity units/ml in a lymph node in the groin.

The investigators monitor clinical response and use of medication during the grass pollen season. SMS (Symptom and Medication Score) will be used.

The investigators count the number of immunoglobulin E grass producing plasma cells in blood one week after each injection. The investigators also do basophil activation tests, nasal provocation tests and titrated skin prick test to monitor effect.

Adverse events will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years.

Exclusion Criteria:

* Uncontrolled asthma.
* Severe asthma with post bronchodilator test forced expiratory volume at 1 second less than 70% of expected.
* Severe co morbidity. Allergy to Fenol or Aluminium hydroxid.
* Any autoimmune diseases. Treatment with beta blocking medicine.
* Any heart diseases.
* Severe arterial hypertension. Kidney failure.
* Known malignancy. Known pregnancy.
Exendin-9,39 and Satiety After Bariatric Surgery

The overall aim of the application is to determine the contribution of the elevated incretin hormone concentrations seen after certain types of bariatric surgery to the regulation of food intake and satiety.

Both Sleeve Gastrectomy (SG) and Roux-en-Y Gastric Bypass (RYGB) increase GLP-1 concentrations, although this is of lesser magnitude in SG compared to RYGB. Data suggests that endogenous GLP-1 is at least partially responsible for reducing free-choice caloric intake after RYGB, providing a mechanism underlying differences between procedures. Inhibition of GLP-1 action with Exendin-9,39 after RYGB accelerates gastric emptying. These observations suggest that factors other than anatomy regulate the upper gastrointestinal response to food ingestion. It is therefore reasonable to consider that the postprandial rise in GLP-1 might affect feeding behavior after RYGB, and to a lesser extent SG, where the increase in GLP-1 is less marked.

Eligibility Criteria:
Inclusion Criteria:

* Undergone either sleeve gastrectomy or Roux-en-Y Gastric Bypass surgery within prior 2 years
* Healthy, with no active systemic illness

Exclusion Criteria:

* Pregnancy
* Functional or organic bowel symptoms
* Systemic illness
* Diabetes
* Bariatric surgery \> 2 years