cyrilzakka/clinical-trials huggingface dataset:
Bone Quality by vQCT and HR-pQCT:Translation to Multi-center Clinical Research

Our overarching aim is to set up a procedural, analytic and developmental framework to establish CT of the central and peripheral skeleton as a clinically useful biomarker for skeletal strength in the clinical research and ultimately in the clinical setting. To accomplish this, the investigators will develop and validate phantoms and scanning procedures to standardize strength and structure measurements between different vQCT scanners and develop standardized acquisition, analytical, and quality control techniques for HR-pQCT with an emphasis on optimization for multi-center studies.

The investigators will develop new calibration phantoms to address inter and intra scanner variability in vQCT and HRpQCT. Phantom sets to evaluate inter-scanner disparity and determine corrections to apply to in vivo scan data in the multi-center settings. These methods will be validated in a multi-center phantom study and in a 120 patients

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* must be able to lie down on bed

Exclusion Criteria:

* on wheel chair
* age above 80 years 0r less than 65 years
Botulinum Toxin Injection in the Treatment of Open Abdomen

Botulinum toxin has been widely approved and utilized in the treatment of complex abdominal wall hernias. Botulinum toxin has been only randomly studied in the treatment of open abdomen.

30 consecutive patients who have open abdomen for any indication, will have 300 IU botulinum toxin injected in three spots in either sides of the abdomen within 72 hours of the start of open abdomen. The hypothesis is botulinum toxin relaxes abdominal wall musculature to ensure better and faster closure of the open abdomen.

Eligibility Criteria:
Inclusion Criteria:

* Open abdomen

Exclusion Criteria:

* Previous incisional hernia in midline
* Patient is not in active treatment
Onsite Buprenorphine Treatment at Syringe Exchange Programs

This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.

In a 24 week randomized controlled trial based in a large urban area with high rates of opioid use disorder (OUD) and HIV, 250 out-of-treatment opioid users who utilize syringe exchanges will be recruited and randomize to receive an onsite treatment intervention (O-BMT) or enhanced referral to buprenorphine treatment. Over 2 weeks, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment. In the control arm, participants will receive enhanced referral to the community health center for maintenance buprenorphine treatment. Data collection will include urine drug tests, questionnaires, and medical and pharmacy record review. Key outcomes will include engagement in buprenorphine treatment, treatment outcomes, and programmatic costs. Buprenorphine diversion will be assessed by using electronic monitors that estimate medication adherence, testing urine samples for buprenorphine, and through sequential surveys regarding buying or selling illicit buprenorphine.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years
2. opioid use disorder
3. interest in buprenorphine treatment
4. motivation for opioid use disorder treatment
5. willingness to accept community health center referral
6. syringe exchange participant

Exclusion Criteria:

1. receiving opioid agonist treatment in the past 30 days (confirmed by New York Prescription Drug Monitoring Program);
2. inability to provide informed consent
3. unstable mental illness (e.g., suicidality, psychosis, etc.)
4. severe alcohol use disorder or benzodiazepine use disorder by the Diagnostic and Statistical Manual of Mental disorders, Fifth Edition (DSM-5) criteria
5. hypersensitivity to buprenorphine or naloxone.
6. pregnancy (confirmed via urine testing)
Transfusion Effects in Myelodysplastic Patients: Limiting Exposure

The goal of this study was to compare a restrictive RBC transfusion policy (a Hb transfusion trigger: 7.2 gr/dl) with a more liberal RBC transfusion policy (a Hb transfusion trigger: 9.6 gr/dl) on physical fatigue.

The goal of this study was to compare a restrictive RBC transfusion policy (a Hb transfusion trigger of 7.2 gr/dl) with a more liberal RBC transfusion policy (a Hb transfusion trigger of 9.6 gr/dl) on physical fatigue.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis myelodysplastic syndrome (primary or secondary) based on cytopenia in at least 1 cell line + dysplasia in 2 cell lines (and no other cause (especially deficiencies)) and a pathologic anatomic diagnosis after bone marrow punction.
* refractory anaemia (RA): blood: ≤ 1% blasts, ≤ 1 x 109 monocytes; bone marrow: \< 5% blasts, ringed sideroblasts ≤ 15% of the erythroid cells
* refractory anaemia with ringed sideroblasts (RARS): blood: ≤ 1% blasts, ≤ 1 x 109 monocytes; bone marrow: \< 5% blasts, ringed sideroblasts \> 15% of the erythroid cells
* refractory anaemia with excess blasts (RAEB): blood: \< 5% blasts, ≤ 1 x 109 monocytes; bone marrow: blasts ≥ 5 -≤ 20%
* chronic myelomonocytic leukaemia (CMML): blood: \>1 x 109/l monocytes, \<5% blasts; bone marrow: blasts \< 20%, increase of the monocytic component
* erythrocyte transfusion need
* working knowledge of the national language
* written consent for participating this study (informed consent)

Exclusion Criteria:

* candidate for bone marrow- or organ transplantation
* medication: growth factors (GM-CSF), or EPO
* patients who will receive an intensive chemotherapeutic treatment with a cytopenia, expected longer than 2 weeks
* refractory anaemia with excess blasts in transformation (RAEB-t): blood: ≥ 5% blasts or Auer rods; bone marrow: or blasts \> 20 - \< 30% or Auer rods
* pregnancy at the moment of inclusion
* patients with congenital severe haemolytic anaemia, like thalassemia or sickle cell anaemia
* patients with AIDS or a severe congenital or acquired (e.g. iatrogenic) immunological disorder
* severe active infections at the moment of inclusion
* severe cardiac, pulmonal, neurological, metabolic or psychiatric disease at the moment of inclusion
Exercise Effects on Brain Health and Learning From Minutes to Months

Given the accelerating growth of older adults worldwide and the decline in cognitive function with aging, therapeutics that remediate age-related cognitive decline are needed more than ever. The proposed research seeks to better understand and enhance the detection of exercise effects on hippocampal network function and learning and memory, which decline with aging and Alzheimer's. Success would lead to new ways to detect benefits of exercise on cognitive aging and would lead to mechanistic insight on how such plasticity is possible while also informing prevention strategies.

Animal models robustly support that exercise protects brain areas vulnerable to aging such as the hippocampus and that these benefits lead to better learning. In contrast, there are mixed findings from human studies on the cognitive benefits of exercise with healthy older adults. This contrast indicates there is still a lack of understanding for how exercise could change the course of cognitive decline in aging adults. However, no human studies have comprehensively tested exercise effects on cognition in older adults with learning tasks inspired from basic exercise neuroscience. The objective in the proposed research is to fill this translational gap by determining if different types of exercise improve the same kinds of learning in older adults that have been shown to improve in animal models by improving hippocampal function. This will bring the investigators closer to a long-term goal of determining how exercise protects the brain from adverse effects of aging in order to develop interventions that minimize age-related cognitive decline. The overall hypothesis is that exercise improves learning when it increases functional hippocampal-cortical communication that otherwise declines with aging. The investigators will test this in a sample of healthy older adults by determining if increases in functional hippocampal-cortical connectivity from exercise training improve learning on an array of tasks that require the hippocampus for acquisition of new relational memories compared to conditions of the same tasks that should not require the hippocampus for learning and memory.

Eligibility Criteria:
Inclusion Criteria:

* Eligible to participate in an aerobic exercise intervention based on the Physical Activity Readiness Questionnaire, and corrected vision of 20/40.
* Approval from a physician that monitored electrocardiography (ECG) response during a maximal aerobic fitness test that is part of the second study visit described below.
* Exercising less than 60 minutes a week for the past calendar year

Exclusion Criteria:

* Not between the ages of 55 and 80 years old
* Not fluent in English
* Score \< 20 (out of 30) on the Montreal Cognitive Assessment (MoCA)
* Inability to comply with experimental instructions
* Qualify as "high risk" for acute cardiovascular event by the published standards of the American College of Sports Medicine
* Previous diagnosis of neurological, metabolic, or psychiatric condition, and no previous brain injury associated with loss of consciousness
* Inability to complete an MRI
Comparing VR and Balance Exercises In Rehabilitation of Adolescent Athletes

Ankle sprains are common injuries in active young people. Most of these injuries recovery quickly on their own, do not require imaging, and do better with early motion and rehabilitation. High ankle sprains and fractures are much less common but more serious. They may require imaging and more treatment.

Phases of rehabilitation for ankle sprain Phase I treatment involves resting and protecting the ankle to permit healing, to prevent further injury, and to control pain and swelling.

Phase II treatment begins once pain and swelling have subsided to the point where the athlete can comfortably bear weight and walk from place to place.

Virtual reality (VR) is a simulated experience that can be similar to or completely different from the real world. Applications of virtual reality can include entertainment (i.e. video games) and educational purposes (i.e. medical or military training). Other, distinct types of VR style technology include augmented reality and mixed reality.

Biodex Balance Training is one of the main tool that used to assess dynamic balance and dynamic limits of stability also it can used as training tool to improve the participant balance training

Eligibility Criteria:
Inclusion Criteria:

1. Children will have sustained lateral ankle sprain (grade II).
2. Their age was ranging from 13-16 years
3. All children with stable medical and psychological status.
4. They will able to follow the verbal commands or instructions during testing.

Exclusion Criteria:

1. Children with ankle or foot deformity
2. Unstable medical and psychological status.
3. Children not able to follow the verbal commands or instructions during testing
4. Children with any disorder affecting balance.
Walking Program in Fatty Liver Children With Phenylketonuria

phenylketonuria (commonly known as PKU) is an inherited disorder that increases the levels of a substance called phenylalanine in the blood. PKU is usually associated with many metabolic complication including non-alcoholic fatty liver

this study will include PKU children sufferers 9n=40) with non-alcoholic fatty liver to be randomly assigned to group I (n=20) that will perform walking program (online supervised free walking that will be applied daily for eight weeks) or group II (N=20) that will act as waitlisted children

Eligibility Criteria:
Inclusion Criteria:

* PKU children
* obese children
* fatty liver children (non-alcoholic fatty liver)

Exclusion Criteria:

* cardiac children
* diabetic children
* neurogenic disorders
* respiratory and renal problems
Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)

The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva parameters with array - Comparative Genomic Hybridization (aCGH) results and ongoing pregnancy rates.

The present study was designed to determine if there is a correlation between the Eeva System parameters and aCGH testing results. Embryos will be selected for transfer based on aCGH results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≤43 years of age.
* Women undergoing IVF treatment with planned aCGH testing using her own eggs or donor eggs.
* Antral Follicle Count ≥ 6 at time of cycle start
* Baseline (day 2-3 of cycling) FSH ≤ 15 mIU/ml
* Antimüllerian Hormone level ≥ 0.5 ng/mL
* Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
* Willing to have all 2PN embryos monitored by Eeva
* Not previously enrolled in this study.
* Willing to comply with study protocol and procedures and able to speak English.
* Willing to provide written informed consent.

Exclusion Criteria:

* BMI ≥ 40
* Prior IVF cycle with \< 4 x 2PN
* Planned Day 3 Assisted Hatching
Evaluation of Serum Procalcitonin in Critically Ill Patients With Suspected Sepsis

Procalcitonin is a promising marker of sepsis in critically ill patients. Procalcitonin have better diagnostic accuracy compared to White blood cell count and C - reactive protein. Investigators propose that adding Procalcitonin to the list of standard laboratory work up of critically ill patients with suspected sepsis could increase diagnostic accuracy leading to better patient care.

Background: Sepsis is the leading cause of mortality in critically ill patients. Procalcitonin (PCT) is a promising marker for identification of bacterial sepsis. The aim of this study was to determine the diagnostic accuracy of serum PCT concentration in patients with suspected sepsis admitted to mixed medical-surgical Intensive care unit (ICU).

Material and Methods: A cross-sectional study conducted at section of Chemical Pathology, Department of Pathology and Laboratory Medicine and ICU. Patients with suspected sepsis were included, serum PCT cut off ≥0.5 ng /ml was taken for diagnosing sepsis. Diagnostic accuracy was measured in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) taking blood culture as gold standard. Furthermore, different cut offs were compared by using receiver operating characteristic curves (ROC). Data analysis was done on SPSS version.

Eligibility Criteria:
Inclusion Criteria:

1. Both male and female patients less than 70 and greater than 18 years of age
2. Patients full filling the sepsis definition (American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference)
3. Patients were recruited within 24 hour of ICU admission

Exclusion Criteria:

1. Patients discharged before 24 hours
2. Patients who had blood transfusion before ICU stay
3. Patients with organ failure
Dyadic Neurofeedback for Development of Healthy Emotion Regulation in Youth

This study will examine the effect of a real-time functional magnetic resonance imaging (fMRI) dyadic neurofeedback protocol with mothers and their adolescent daughters. Mothers in the experimental condition will view a moving bar showing their daughters' brain activity on a computer screen while talking to their daughters.

Adolescents with a family history of adverse childhood experiences (ACEs) are at heightened risk for depression and other mental health problems related to poor emotion regulation (ER). The proposed study will test the efficacy of a real-time fMRI dyadic neurofeedback (DNF) protocol to promote healthy ER-related neurodevelopment in female adolescents with a maternal history of ACEs. The proposed study will use DNF to provide neurofeedback from the adolescent's anterior insular cortex (aIC) to the adolescent's mother as the mother and adolescent engage in an emotion discussion task together. Parents and adolescents (n=35 active DNF; n=35 control) will communicate via microphones and noise-canceling headphones while the adolescent is undergoing fMRI scanning. Specific aims of the current study are to determine: 1) the effects of aIC DNF on the developing ER network in adolescents with a history of maternal ACEs, 2) associations between parenting practices during DNF and reduced adolescent aIC activation, and 3) longitudinal effects of aIC DNF on adolescent internalizing symptoms.

Eligibility Criteria:
Inclusion Criteria:

All participants inclusion criteria:

* Biological female
* Sufficient English fluency to complete tasks
* Co-residing at least 4 days per week

Inclusion criteria for adult participants:

* Primary caregiver for more than 50% of child's lifespan
* History of at least two adverse childhood experiences
* Biological parent of adolescent participant

Inclusion criteria for adolescents:

* Eligible for fMRI
* Body mass index between 16 and 40 (inclusive)
* Age 14-17 years

Exclusion Criteria:

Exclusion criteria for adolescent participants:

* Current or past psychiatric disorder
* Neurodevelopmental delay
* Medications influencing fMRI
* Medical conditions influencing fMRI
A Study of an Oral Nutrition Supplement (ONS) in Children.

To assess the effect of oral nutritional supplementation with dietary counseling versus dietary counseling alone on growth of preschool children over a period of 90 days.


Eligibility Criteria:
Inclusion Criteria:

1. Age of 24-72 months (inclusive), both genders.
2. Diagnosed with current acute upper respiratory tract infection.
3. Weight-for-age between 3rd - 15th percentile according to WHO Growth Charts.
4. Identified as a picky eater.
5. Able to consume foods and beverages orally.
6. Willing to abstain from additional non-study provided protein supplements or nutritional supplements throughout the study period.

Exclusion Criteria:

1. Current illness requiring hospitalization.
2. Gastrointestinal infection and/or acute diarrhea at the time of inclusion in the study.
3. Currently taking medication that could affect absorption/metabolism of study product or weight of the child.
4. Diagnosed with recurrent respiratory infections due to cystic fibrosis, immunodeficiency syndromes, and congenital abnormalities of the respiratory tract, congenital lung and ciliary abnormalities, an unsuspected foreign body and asthma.
5. Active tuberculosis, acute hepatitis B or C, or HIV, malignancy.
6. History of diabetes mellitus.
7. Received antibiotic therapy within the last two weeks before start of the study.
8. Dysphagia, aspiration risk, difficulty in swallowing due to acquired / congenital abnormalities that would hamper oral intake of the study product.
9. Clinically significant nutritional deficiency requiring specific treatment with any other nutritional supplement (not study product).
A Study to Evaluate the Effect of Lycomato on Skin Attributes in Healthy Participants.

The study will be performed with oral gels, with up to 55 study subjects who meet the inclusion and non-inclusion criteria required. Study subjects will be instructed to use the products during 12 weeks and they will be assessed and supervised throughout the study by clinic technicians, in order to check for possible adverse events. Efficacy documentation through digital photography, instrumental measurements with the devices Cutometer® MPA 580 and Tewameter®, image acquisition with Visia-CA® as well as self-assessment through questionnaires will be carried out.


Eligibility Criteria:
Inclusion Criteria:

1. Females in good general health, and between ages of 35 and 55 years old, inclusive at enrollment;
2. 50 subjects: 20 Caucasians + 10 Asians + 10 African Americans + 10 Latinos;
3. All Fitzpatrick skin types being II, III and IV for Caucasian/Asian;
4. Subjects to have Glogau skin classification of photoaging, Type 2;
5. Subjects with baseline signs of facial skin aging as conformed by visual expert grading of photographs

Exclusion Criteria:

1. Subjects participating in any other clinical studies;
2. Subjects that underwent beauty injections/ deep pealing/ cosmetic surgery/ tanning- for 3 months before study starts and for all the study duration.
3. Subjects having an acute or chronic disease or medical condition, including dermatological problems, which could put her at risk in the opinion of the Principal Investigator or compromise study outcomes. Typical uncontrolled chronic or serious diseases and conditions which would prevent participation in any clinical trial are cancer, AIDS, diabetes (insulin dependent), renal impairment, mental illness, drug/alcohol addiction;
4. Unreliable or unlikely to be available for the duration of the study;
5. History of allergic reactions, skin sensitization and/or known allergies to cosmetic ingredients, toiletries, sunscreens, etc.;
6. Immunocompromised subjects
A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)

Background: Mild Cognitive Impairment (MCI) is a risk factor for dementia and represents a critical window of opportunity to intervene and alter the trajectory of both cognitive and functional decline. Emerging life-logging technologies has shown a tremendous potential to increase autobiographical memory.

Objective: The main goal of the present study is to develop a Cognitive Training program (CT) for MCI based on life-logging captured by a Wearable Camera (WeC) recording specific autobiographical episodes for stimulating posteriorly episodic memory. The challenge is to create an application to manage this large collection of images, which can be easily retrieved as events by users in a therapeutic context as a multimodal cognitive stimulation. The investigators will conduct a quasi-experimental design with non-equivalent control group, evaluating the effectiveness of the life-logging re-experiencing program immediately and 3-month follow-up period.

Methodology: The design is a pretest, posttest and follow-up design, where 30 adults with MCI were sequentially allocated to one of two conditions: intervention or control group. All subjects wore a lifelogging WeC during two weeks, and subsequently they were generated several videos with the most relevant information of each event. Subjects in the Intervention Group will attend 1-hour individual training sessions 2 times per week for 14 8 weeks. Main outcomes measures will be cognitive, functional, emotional and quality of life measures, as well as biochemical measures (BDNF).

Expected results: The investigators expect the outcomes to provide preliminary evidence that autobiographical experimentation CT programs can positively impact cognitive functioning and may represent an effective strategy to improve memory and functionality in those who begun to experience cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* 65-90 years of age
* Meet definition criteria for MCI (Petersen, 2004)
* Be receiving CT at least three month in Day Hospital during three months or more; c) having memory complaint, usually verified by an informant
* Having memory complaint, usually verified by an informant
* Memory performance below the mean score for the corresponding age and education group
* Having normal general cognitive functioning as determined by a Mini-Mental State Examination (MMSE) score \> o = 24
* Having a reliable caregiver who can supervise the patient's daily activities
* Having Global clinical dementia rating scale score of 0.5
* Granted written informed consent accepting to participate in the study

Exclusion Criteria:

* Neurological, psychiatric or unstable medical disorders
* Intellectual deficiency (Premorbid Intellectual Quotient (IQ) -Vocabulary- less 85)
* Relevant hearing, vision, motor or language deficits
* Less than 4 years of education e) acquisition of Catalonian or Spanish languages after 15 years old