cyrilzakka/clinical-trials huggingface dataset:
New Technologies to Help Manage ADHD

Cluster randomized controlled trial to evaluate the general effectiveness of intervention compared to control on medication continuity as measured by prescriptions written and other more proximal outcomes during the first six months of treatment.

This cluster randomized controlled trial will evaluate the general effectiveness of the intervention (e.g. enhanced myADHDportal.com), compared to control (e.g. treatment as usual standard portal), on medication continuity as measured by prescriptions written and other more proximal outcomes during the first six months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Parents of children are eligible to participate if

  1. their child receives ADHD care at one of the pediatric primary care practices that is partnering to conduct this trial
  2. child being registered on myADHDportal.com to initiate child assessment of ADHD
  3. child age 6-10 years
  4. child must not have been previously treated with ADHD medication
  5. child prescribed ADHD medication within 12 months of enrolling in the study

Exclusion Criteria:

* Unable to read and speak English
Autologous Tolerogenic Dendritic Cells (ATDC) for Highly Sensitized Kidney Transplant Recipients

The ATDC-PICI study is a Phase Ib, single-arm, prospective, non-randomized, multicentric trial, to evaluate the safety of ATDC cell product as adjunctive therapy to standard of care (SOC) in highly sensitized kidney transplant recipients.

The study population is sensitized kidney transplant candidates (cPRA ≥ 90%) between 18 and 65 years.

An algorithm has been designed to rank highly sensitized patients on the waiting list for kidney transplantation according to their likelihood of obtaining a suitable donor within the upcoming 12 months. The algorithm was designed based on an analysis of an immunologically matched historical cohort using data from the OCATT registry.

Patients will be selected in accordance with the algorithm and proposed for inclusion in the study in a sequential manner until the required number of patients has been reached (n=30). Given the unpredictability and reduced likelihood of obtaining a compatible deceased kidney donor within an acceptable time frame for this study, the total number of patients to be included will be 2x superior to those who will receive treatment with ATDC (n=15).

* 30 highly sensitized patients will be pre-included in the study.
* The first 15 highly sensitized patients that obtain a compatible deceased kidney donor will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Highly sensitized (cPRA ≥ 90%) kidney transplant candidates between 18 and 65 years old.
2. To be selected by the algorithm according to probability of kidney transplantation in the upcoming 12months.
3. Adequate venous access and absence of contraindications for leukoapheresis.
4. Women of childbearing age must take contraceptive measures.
5. Must have given written informed consent

Exclusion Criteria:

1. Subjects with active TB.
2. Patients on the waiting list multiple organ transplants.
3. A significantly abnormal general serum screening lab result defined as WBC\<3.0x103/ml, Hgb\<8.0 g/dL, platelet count \<100x103/ml, SGOT\>3x upper limit.
4. HIV-positive subjects.
5. Subjects who test positive for HBV infection \[positive HBVsAg or HBVeAg/DNA\] or HCV infection \[RNA+\].
6. Subjects with active CMV or EBV infection as defined by positive PCR.
7. Subjects with a known history of previous myocardial infarction within one year of screening.
8. Subjects with a history of clinically significant thrombotic episodes, and subjects with active peripheral vascular disease.
9. Patients with a kidney disease with high risk of recurrence and/or complement-associated kidney disease (aHUS, etc).
10. Pregnant and lactating women.
Evaluation of My Future Self, an New Teen Pregnancy Prevention Group Intervention for Youth in Non-traditional Settings

Children's Hospital Los Angeles and ETR will implement and test the effectiveness of a pregnancy prevention intervention, My Future Self, targeting youth ages 16-19 in Los Angeles and San Diego Counties who, for a variety of reasons, are receiving education or training in non-traditional settings. These youth typically experience a combination of needs related to unstable or no housing, extreme poverty, involvement with child welfare or juvenile justice, historical trauma, and/or learning differences. My Future Self is a 5 week program consisting of 5 group sessions. Our study will enroll up to 704 highly mobile youth from various sites in Los Angeles and San Diego. Youth will be randomized to receive the My Future Self intervention in conjunction with their regular services or just their regular services. All youth enrolled will complete baseline, 6 month and 12 month surveys.

Children's Hospital Los Angeles and ETR will implement and test the effectiveness of a pregnancy prevention intervention, My Future Self, targeting youth ages 16-19 in Los Angeles and San Diego Counties who, for a variety of reasons, are receiving education or training in non-traditional settings. These youth typically experience a combination of needs related to unstable or no housing, extreme poverty, involvement with child welfare or juvenile justice, historical trauma, and/or learning differences.

Currently, there are a few evidence-based interventions that focus on sub populations of these youth in alternative schools (All4You!, All4You2!), those at risk for dropping out of school (Crossroads/TCAP), and those coming from out of home care settings (Power Through Choices). However additional interventions are needed as these youth represent a vulnerable population with unique needs and barriers to pregnancy prevention requiring approaches that are tailored to nontraditional educational settings, familial circumstances, developmental trajectory, and that are synergistic with the generational reliance on technology.

Eligibility Criteria:
Inclusion Criteria:

Youth will be eligible for enrollment in the evaluation if they:

* Are served, or identified on outreach, by one of our partner youth-serving agencies or schools
* Are ages 16-19 years
* Are English-language speakers
* Are not currently pregnant
* Have no immediate travel plans (i.e., are planning on being in the area for the length of the intervention)
* Have not previously enrolled in the study, and
* Answer the baseline survey items related to our primary outcome (which will be assessed after completion of the baseline survey).

Exclusion Criteria:

* Outside of age range
* Currently pregnant
* Not planning to be in the area for the length of the intervention)
* Previously enrolled in the study
Study to Gather Information on the Kidney Function of Patients With Non-valvular Atrial Fibrillation (Irregularly Heart Beats Which is Not Caused by a Heart Valve Problem) Treated With Rivaroxaban or Vitamin K Antagonists

By evaluating routine clinical practice data from the UK primary care database, researchers in this study want to gather information on the kidney function of patients with non-valvular atrial fibrillation (NVAF, irregularly heart beats which is not caused by a heart valve problem) who are treated with Rivaroxaban (non-vitamin K antagonist, brand name Xarelto) or vitamin K antagonists (VKAs). The study planned to enroll about 25,000 male or female patients who were at least 18 years old and were new users of Rivaroxaban or VKAs between 01 January 2014 and 30 September 2019. Researchers are especially interested in whether patients experienced under treatment any worsening in kidney function, the onset of acute kidney diseases or injuries. In addition, risk of worsening in kidney function in patients with or without diabetes or heart failures are of interest to the researchers.


Eligibility Criteria:
Inclusion Criteria:

* aged ≥18 years in the IMRD-UK database
* a first prescription for either rivaroxaban or a VKA between 01 January 2014 and 31 March 2019. The date of the first rivaroxaban/VKA prescription will be set as the start date (start of follow-up for that patient). The follow-up will be extended until 30 September 2019 to ensure that each patient has at least 6 months of potential follow-up.
* a diagnosis of AF recorded any time before start date or within 2 weeks after start date.
* registered with their general practice at least 1 year before the start date and have a recorded prescription of any drug at least 1 year before the start date.
* registered with a general practice with data considered to be up-to-standard quality.

Exclusion Criteria:

* a prescription for any OAC before the start date - all first-time rivaroxaban/VKA users will therefore be OAC naïve
* a record of heart valve replacement or mitral stenosis any time before the start date or in the 2 weeks after the start date.
* a record of deep vein thrombosis, pulmonary embolism, or hip/knee surgery in the 3 months before the start date (because these are all alternative reasons for NOAC initiation).
* a record of ESRD (including renal transplant patients) on/before the start date
Pelvic Floor Physical Therapy-Biomarkers Project

This study is collecting serum and urine samples at various time points during pelvic floor physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and proteomics at various time points.

Collection points will be baseline, and at the last PT visit.

Eligibility Criteria:
Inclusion Criteria:

* Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic floor PT in our center.

Exclusion Criteria:

* all others
Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers

An observational study to generate a long-term outcome database from medical records for infants who completed protocol SS-101-18 or infants who are breastfed, fed commercial formula, or fed a marketed ByHeart formula.

The first Cohort (Cohort 1) goals of the registry include: to compile a clinical database of children who were fed in SS-101-18 by breastfeeding, commercial formula, or ByHeart formula; to investigate any difference in demographics, growth, development, medical diagnoses, and outcomes between the feeding groups, and in particular to compare ByHeart formula-fed infants against commercial formula-fed infants, and referenced against breastfed infants.

The second Cohort (Cohort 2) goals of the registry include: to compile a clinical database of children who were fed by breastfeeding or commercial formula (including ByHeart formula); to describe any difference in growth, development, medical diagnoses, and outcomes based on early nutritional intake; and to inform or facilitate development of future ByHeart products.

Eligibility Criteria:
Inclusion Criteria Cohort 1:

* Active participation in SS-101-18 through Visit 9
* Provision of signed and dated informed consent form (ICF) by parent or legally authorized representative (LAR)
* Stated willingness to comply with all study procedures by parent or LAR.

Exclusion Criteria Cohort 1:

* Did not participate in SS-101-18
* Participated in SS-101-18 that withdrew from the study for any reason prior to Visit 9
* Anything that in the opinion of the Investigator is likely to interfere with participation in the registry.

Inclusion Criteria Cohort 2:

* Be less than 120 days old at the time of enrollment
* Provision of signed and dated informed consent form (ICF) by parent or legally authorized representative (LAR)
* Stated willingness to comply with all study procedures by parent or LAR.

Exclusion Criteria Cohort 2:

* Participation in SS-101-18
* Anything that, in the opinion of the Investigator, is likely to interfere with participation in the registry.
* In the opinion of the investigator, has a diagnosed medical condition or genetic abnormality known to impact growth or development.
ChordArt System for Mitral Regurgitation

The ChordArt System is a novel catheter based technology for mitral chordal replacement that enables controlled implantation of artificial mitral chords to treat mitral regurgitation with a minimally invasive approach. The implant is designed to allow transfemoral antegrade implantation.

ChordArt utilizes a minimally invasive catheter based approach by which multiple artificial chordae are precisely positioned into the papillary muscle and then secured to the pathological leaflet.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Mitral Regurgitation due to degenerative mitral leaflet prolapse or flail
* Left Ventricular Ejection Fraction \>20%
* New York Heart Association functional class II to IV
* Able and willing to give informed consent and follow protocol procedures.

Exclusion Criteria:

* Life expectancy \<1 year
* Hemodynamic instability
* Severe untreated ischemic disease
* Pulmonary Hypertension
* Any prior mitral valve surgery or transcatheter mitral valve procedure
* Stroke or transient ischemic event within 30 days before randomization
* Patient is pregnant (urine human chorionic gonadotropin (HCG) test result positive), planning to be pregnant or lactating.
* Renal insufficiency
* Acute anemia
* Chronic obstructive pulmonary disease
* Severe right ventricular dysfunction
* Hepatic insufficiency
* Patient is participating in other investigational studies
HPV Integration Testing for Cervical Cancer Screening

The primary objective is to determine the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.


Eligibility Criteria:
Inclusion Criteria:

Women aged 30-65 years old Attending the China population-based organised cervical screening program

Exclusion Criteria:

1. Not providing informed consent
2. previously confirmed CIN, cervical cancer, or other malignancies
3. previous therapeutic procedure to cervix
4. pregnancy
Administration of Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Vocal Cord Paralysis

The study tries to see the effect of using a combination of platelet-rich fibrin (PRF) and autologous fat as a filler for injection laryngoplasty procedures to treat unilateral adductor vocal cord paralysis.

The vocal cord in humans is essential in producing voice used in communication and interaction between us. Vocal cord paralysis causes dysphonia, which interferes with communication, causing disruptions towards social activity and daily activities. One of the managements for vocal cord paralysis is medialisation and augmentation of the vocal cord through injection laryngoplasty. Autologous fat is one of the best fillers that can be used in this procedure, but it is highly absorbable and can be reabsorbed very quickly when injected to body tissues. Platelet Rich Fibrin (PRF) is a biomaterial consisting of growth factors that are thought to improve fat tissue longevity through increase of adipogenesis and angiogenesis. Improvement in fat longevity will improve clinical outcomes after laryngoplasty procedure potentially reducing number of repeated injections needed to achieve satisfactory resolution to vocal cord paralysis. The study evaluates a combination of PRF and autologous microlobular fat compared with autologous microlobular fat alone on laryngoplasty. Subjective evaluation was done by using Voice Handicap Index (VHI-30) questionnaire, while objective evaluation was conducted via computerized acoustic analysis/Multidimensional Voice Program (MDVP), videostroboscopy, and maximum phonation time.

Eligibility Criteria:
Inclusion Criteria:

* Subject is diagnosed with unilateral vocal cord paralysis in paramedian position or 3 months lateral onset without movement and mucosal waves of the vocal cords on videostroboscopy.
* Willing to give consent

Exclusion Criteria:

* Has a history of malignancy of the larynx or lung
* Subject isn't able to undergo injection laryngoplasty procedure under general anesthesia
* Subject with thrombositopenia
Effects of Natural Sourdough Fermentation Duration and Acid Development on Postprandial Blood Glucose in Prediabetic Adults

The primary intervention for management of prediabetes is lifestyle changes. Eating healthier and increasing physical activity was found to slow the progression of prediabetes into diabetes, reduce the risk of other diseases like cardiovascular disease and hypertension, and have a lasting impact even after the intervention is discontinued. Studies found that increasing the intake of fiber, pre- and probiotics, and fermented foods have been linked to improved glycemic biomarkers. The goal of this crossover randomized trial is to assess the relationship between lengthened fermentation time of sourdough bread, e.g., an increased amount of lactic acid and acetic acid in the bread product, and postprandial glycemic response in healthy adults with prediabetes.

Sourdough bread has been proven to have higher fiber content and contains beneficial microorganisms from the fermentation process and has been linked to reduced risk of various diseases like diabetes, cardiovascular disease, and dyslipidemia. The fermentation of sourdough bread products converts starch and sugar in the dough into resistant starches and other slower digesting compounds. Sourdough bread products also have a lower glycemic index value, meaning they do not cause the blood sugar to rise as quickly, thus slowing the release of insulin in the body, leading to reduced risk of insulin resistance. However, very few studies exist studying the effects of naturally fermented sourdough products in individuals with prediabetes. It is worth exploring if increasing the fermentation time of naturally fermented sourdough bread increases the effects on relevant biomarkers relating to postprandial glycemia and insulinemia in prediabetic adults.

This study examined the acute effect of varying lengths of sourdough fermentation times on postprandial blood glucose levels over a 4-week period in adults with prediabetes (as evidenced by fasting glucose ≥100 or diagnosis by physician), but not taking diabetic medications. For each trial, the sourdough bread was ingested after an overnight fasting period in order to evaluate the effects of the bread when incorporated into the diet in place of breads made with baker's yeast. The goal of this crossover randomized trial was to assess the relationship between lengthened fermentation time, meaning an increased amount of lactic acid and acetic acid in the bread product, and glycemic and insulinemic response.

Eligibility Criteria:
Inclusion Criteria:

* prediabetes; not on metformin; no known food allergies or sensitivities; not supplementing pre/post biotics

Exclusion Criteria:

* following diet that restricts carbohydrates; medication use affecting blood glucose; acute illness; smoker; pregnant; lactating; GI tract surgery; not willing to follow protocol
Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease

Study participants who have been clinically diagnosed with Parkinson disease will receive no treatment, treatment with either levodopa, or treatment with Mirapex for a period of 12 weeks. Over the course of the study subjects will travel to the Institute for Neurodegenerative Disorders (IND) in New Haven, Connecticut for brain imaging.

Brain imaging will be conducted three times during this study. Study participants will travel to IND for \[123I\]ß-CIT and SPECT imaging (scan 1). Subjects will be randomized to no treatment, treatment with either levodopa, or treatment with Mirapex and undergo treatment for a period of 12 weeks. Subjects will return to IND for \[123I\]ß-CIT and SPECT imaging (scan 2) after 12 weeks of treatment and withdraw from the medication following the scan. Eight to 12 weeks after medication withdrawal, a final \[123I\]ß-CIT and SPECT imaging study (scan 3) will be performed at IND. The imaging outcome, striatal uptake of \[123I\]ß-CIT, from scan 1 (untreated) and scan 2 (treated with levodopa or pramipexole) will be compared to determine if there is a significant change in the uptake of the marker that may be attributed to levodopa or pramipexole treatment. In addition, scan 3 will be compared to scan 2 to determine the duration and reversibility of any regulatory effect that occurs. The subjects will be randomized, but not blinded to study drug assignment. The imaging technologist and all imaging analyses will be performed by investigators blinded to study drug assignment.

Eligibility Criteria:
Inclusion Criteria:

* 30 years or older at time of Parkinson Disease (PD) diagnosis
* clinical diagnosis of PD of equal to or less than 7.5 years
* Normal laboratory screening

Exclusion Criteria:

* Participant is pregnant
* Participant has atypical or drug induced PD
* Participant has significant dementia
Prebiotic Intervention for Autism Spectrum Disorders

The purpose of this study is to determine the effect of a prebiotic (BGOS) on gut microbiota and metabolites in children with autism spectrum disorders.

Children with ASD have a higher incidence of dietary and/or bowel problems than typically developing children. it has been postulated that imbalances in the gut bacteria and/or metabolites present in the gut may be a contributing factor to these symptoms, with potentially bad (toxin-producing) bacteria colonising the gut. Certain carbohydrates (so-called 'prebiotics') are not digested by the human gut and they provide food for beneficial bacteria and thus they improve the composition by preventing the growth of bad bacteria. Individuals could therefore benefit from these safe and effective dietary interventions to maintain the healthy gut bacteria and overall health. This study is being carried out to establish the effect of one such prebiotic, called galactooligosaccharide (B-GOS) on the relative balance of gut bacteria and metabolites in children with ASD. The aim is to enrol 42 children, ages 5-10 with formal ASD diagnosis and with signed informed consent from their parents, into double-blind, placebo controlled, parallel study. The trial will last 10 weeks in total (2 weeks run in period, 6 weeks treatment and 2 weeks follow up). Children will be required to take food supplement daily during the treatment period and their parents will collect stool, saliva and urine samples. Various questionnaires will also be used for assessments. Children will not be required to make other extra changes to their diet, medication or lifestyle.

Eligibility Criteria:
Inclusion Criteria:

* children aged 5-10 years with formal ASD diagnosis
* children's parent or guardian has given written informed consent to participate and is willing to participate in the entire study

Exclusion Criteria:

* consumption of antibiotics, prebiotic or probiotics in the last 4 weeks prior to or during the study
* participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
* undergone surgical resection of any part of the bowel