cyrilzakka/clinical-trials huggingface dataset:
Empowering Adolescents and Young Adults With Sickle Cell Disease as Partners in Treatment Decision Making (EMPOWER-AYA)

This study will evaluate the acceptability, feasibility, and preliminary efficacy of a shared decision making intervention for adolescents and young adults (AYAs) with sickle cell disease (SCD). 60 AYAs with SCD ages 15-25 and their caregivers and 8 SCD providers will participate in the pilot pragmatic trial. AYAs, caregivers, and providers will be recruited from Nemours Children's Hospital, Delaware (NCH-DE), Nemours Children's Hospital in Orlando, FL (NCH-ORL), and Nemours Children's Health at Wolfson Children's Hospital in Jacksonville, FL (NCH-JAX). NCH-DE participants (n=30) will receive the SDM intervention including a virtual reality patient health education component, whereas NCH-ORL and NCH-JAX participants (n=30) will receive the SDM intervention with standard patient education materials (print, video). SCD providers will be trained to use the toolkit components and will introduce decision aids during an outpatient clinic visit for AYAs who are candidates for one or more disease-modifying therapies.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with SCD ages 15-25 years receiving treatment at Nemours and their caregivers will be included. Patients must be deemed candidates for initiation of one or more disease-modifying therapies by their SCD healthcare provider.
* Nemours SCD healthcare providers will also be included.
* English language fluency is a requirement for all participants.

Exclusion Criteria:

* Patients/ caregivers who previously participated in usability testing of the intervention will be excluded.
* Patients will also be excluded if they have history of seizures, if their medical status or cognitive functioning preclude completion of interviews, or if no legal guardian is available to provide consent (for patients \< 18 years).
* Providers still completing training will be excluded.
Measuring and Monitoring Patient Informed Clinical Outcomes In Psychological Therapy Supervision

Providing feedback on patient progress to therapists improves clinical outcomes for patients, particularly those who are failing to improve with therapy. The encouraging research has been carried out by a small group of researchers, largely working in the United States health care context. The samples studied have been young people attending university counselling services, suffering from mild mental health disorders. The group studies are therefore not similar to patients seen for psychological therapy in the NHS. Also given that therapists are not necessarily alert to treatment failure, have an overly optimistic view of their patients progress even when provided with evidence to the contrary, clinical supervision may be a more effective method through which to provide patient informed clinical outcomes than directly to therapists themselves.

We will assess if providing feedback through the supervision process is more effective than providing this information to therapists themselves in terms of improving clinical outcomes, particularly for patients who are failing to improve with routine NHS Psychological therapy.

As above

Eligibility Criteria:
Inclusion Criteria:

Patients

Able to give informed consent Male or female (\>18 years of age) Requiring psychological treatment or therapy in routine Mental Health Services Able and competent to understand and complete CORE questionnaires

Supervisors and their therapists

Able to give written informed consent Any NHS Greater Glasgow and Clyde applied psychologist who is supervising therapists offering routine psychological therapy to patients in NHS Greater Glasgow and Clyde and whose therapists agree to take part in the study.

Exclusion Criteria:

Patients

Below the age of 18 years Inability to give written informed consent Inability to understand and complete CORE questionnaires

Supervisors and their therapists

Those supervisors and therapists who are unlikely to be able to stay in the study for its duration.
Open-label Study of IMGN779 in Adult Patients With Relapsed/Refractory CD33-positive Acute Myeloid Leukemia

This is an open label, multicenter Phase 1 study to determine the MTD, dosing schedule and RP2D of IMGN779 when administered as mono-therapy to adult AML patients with CD33 -positive disease.

In the Dose Escalation Phase, patients will be assigned to one of three schedules. The MTD for all schedules will be determined from the assessment of Dose Limiting Toxicities (DLTs). The Dose Expansion Phase will consist of one cohort based on patients response to prior therapy according to the MTD selected.

Eligibility Criteria:
Inclusion Criteria:

* Dose Escalation: Patients with relapsed or refractory AML
* Dose Expansion: Patients with relapsed AML or patients who refuse, or are not suitable candidates for induction therapy

Exclusion Criteria:

* Dose Escalation: Acute Promyelocytic Leukemia
* Any concurrent anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, biologic or any investigational agents (with the exception of hydroxyurea or leukapheresis for control of hyperleukocytosis) within 14 days or five half-lives of drugs, whichever is shorter, prior to Cycle 1 Day 1
* AML patients with known, active leptomeningeal/central nervous system (CNS) involvement
* Prior treatment with IMGN779
* Women who are pregnant or breast feeding
Effectiveness of a mHealth Application as a Family Supportive Tool in Pediatric Otolaryngology Perioperative Process

Tonsillectomy and/or adenoidectomy are common surgeries in children. Authors report how distressed children and their families are by perioperative processes. Fear of the unknown can put a strain on the preoperative period, while pain and other possible complications such as fever, vomiting, restricted oral feeding or bleeding can create difficulties in postoperative home management. Parental anxiety has been found to worsen the perception of pain, perioperative discomfort and recovery of operated children. Providing children and families with preparation for hospitalisation, surgery and postoperative home management has been shown to improve perioperative outcomes. However, not all individuals can understand and benefit from the information provided by healthcare professionals: higher levels of anxiety in the perioperative process have been associated with individuals with low health literacy. Furthermore, unmet information needs may lead parents to expose themselves to health-related misinformation through autonomous investigations on the Web and common social media resources. Patient- and family-centred education and support is a complex and time-consuming care practice, while some surgeries such as tonsillectomy are characterised by short hospitalisations that limit the amount of time health professionals can devote to this programme. Health systems have been testing different types of formats, content and ways of delivering health information/education in order to meet the requirements of clients, time availability and effectiveness. MHealth apps in particular are an essential element of e-health and consist of medical information that is available via mobile phones or other wireless devices and can be used by patients or health professionals. Their use is growing and evolving into a variety of functionalities and positive outcomes related to improving the wellbeing of individuals, including diagnostics and clinical decision-making; interventions on healthy behaviours and lifestyles; patient disease management and self-care. Findings from literature highlight the need for further randomised controlled trials to confirm positive results.


Eligibility Criteria:
Inclusion Criteria:

* Caregivers of children aged 2-10 scheduled for tonsillectomy and/or adenoidectomy with or without tympanostomy tubes insertion;
* Caregivers who are capable of oral and written communication without any impairment;
* Caregivers who guarantee access to a smartphone and internet connection.

Exclusion Criteria:

* Caregivers with cognitive deficits;
* Caregivers of children with cognitive impairment
* Caregivers with visual impairment;
* Caregivers of children affected by chronic pain;
* Caregivers of children who had another surgery operation in the previous month.
* Caregivers who never used at least one smart phone application
Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes

The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D insufficiency.

There is increasing evidence that vitamin D affects the risk of diabetes. The role of vitamin D in type 2 diabetes is suggested by cross sectional studies, where an inverse association between vitamin D status and the development of type 2 diabetes has been found. Moreover supplementation with calcium and vitamin D may attenuate increases in glycemia and insulin resistance in healthy older adults with IFG. However further research is needed to confirm these findings and to determine possible mechanisms of the preventive effect from vitamin D against diabetes. The aim of this study is to examine the effect on metabolic parameters such as glycemic control, lipid status, inflammatory markers, insulin resistance and insulin secretion in patients with type 2 diabetes and vitamin D insufficiency before and after a 12-week period of treatment with high doses of vitamin D.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Type 2 diabetes
* Patients of Danish extraction
* Vitamin D insufficiency (1,25OHvitD \< 50 nmol/l)

Exclusion Criteria:

* Nephropathy (Urea \> 12 mmol/l)
* S-calcium \> 2,52 mmol/L
* Primary hyperparathyroidism
* Serious disease
* Malabsorption
* Sarcoidosis
* Pregnancy
Gestational Weight Gain and the Electronic Medical Record

Less than one third of pregnant women actually achieve the Institute of Medicine's (IOM) recommended weight gain. To date, there are no randomized controlled trials studying the use of the electronic medical record to alert providers to initiate the counseling of patients on the IOM gestational weight gain recommendations.

In the investigator's planned study intervention, using the EPIC EMR system, an electronic alert (Best Practice Advisory) will appear for providers at each prenatal care visit. This alert will remind providers to counsel patients on the recommendations for gestational weight gain. The control group will receive standard prenatal care, without electronic alerts generated regarding BMI and gestational weight gain.

The investigators hypothesize that a higher percentage of patients who receive the intervention will meet the IOM guidelines for weight gain.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant with a single intrauterine gestation
* Present for new OB visit up to 13 weeks and 6 days gestation

Exclusion Criteria:

* They have a multiple gestation pregnancy
* They are under the age of 18
* They do not speak English
Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis

Determine if the addition of a specific acupuncture protocol to a standard of care prescribed exercise program is more effective at improving pain and function in adult patients with plantar fasciosis.

This is a randomized, controlled, multi-site trial investigating whether a specific acupuncture protocol can improve pain and function in adults with plantar fasciosis when added to standard of care treatment. The investigators hypothesize that there will be a significant improvement in both pain and functional outcomes, both acutely and over time, in the experimental group compared to the control group.

Eligibility Criteria:
\*\*Patients must be able to get care at Nellis Air Force Base, Scott Air Force Base, or Eglin Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Male and female DoD beneficiaries, aged 18 to 74 years, who have been diagnosed with plantar fasciosis (in one or both of their feet) OR
* Patients meeting criteria of pain in the bottom of the foot/heel with first steps in the morning \& tender to palpation over the medial calcaneal tubercle (where the plantar fascia inserts).

Those with acute and chronic diagnoses will be included.

Exclusion Criteria:

* Pregnant
* Any of the following in the foot being included into the study:

  * Active cellulitis of lower extremity
  * Prior surgery for plantar fasciosis
  * Steroid injections in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subjects will be offered to be involved in the study after they have completed a 12 -week wash out period.
  * If they have every had any prior acupuncture for plantar fasciosis using the defined Deep Ankle Local Periosteal points, any regenerative therapy to include proliferation therapy or platelet rich plasma therapy in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed a 12-week wash out period.
  * Botox injections for plantar fasciosis injections in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed.
Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans

Pectus excavatum is the most common anterior chest wall deformity that affects up to 1:400 of newborns. If an operative correction is indicated, patients are often operated via the Ravitsch or Nuss bar procedure. The latter (i.e. the Nuss bar procedure) is the most commonly performed procedure. During this procedure one or more metal bars are inserted behind the sternum to push the sternum back into its normal position. These bars remain in situ for two-to-three years before being removed. Despite the fact that the Nuss bar procedure is regarded as an effective procedure, retraction may occur after removal. A recent study has investigated this phenomenon, utilizing three-dimensional (3D) optical surface scans acquired before and after Nuss bar removal. The authors found statistically significant changes to occur in chest wall dimensions directly after, as well as between 2 and 8 weeks after Nuss bar explantation, in comparison to the situation just prior to bar removal. They, moreover, found the time the bar was in situ to be predictive for retraction. However, the authors also stressed that further studies are needed to reinforce their preliminary findings and perform long-term assessments. Subsequently, a similar study with long-term assessments will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Patients that received 1 or more Nuss bar(s) to treat pectus excavatum and is/are scheduled to be removed due to the end of treatment.

Exclusion Criteria:

* Patients in which the Nuss bar(s) or its stabilizers are or have been dislocated.
* Patients that received a second operation to treat any complications regarding the initial Nuss bar implantation.
* Patients with proven connective tissue diseases (e.g. Marfan's syndrome).
* Patients with a diagnosis of epilepsy (as the 3D scanner utilizes flashing light to acquire the torso topography)
* Patients that are not fit to remain in a standing position with their arms above shoulder level for a maximum of 60 seconds.
A Coordination Card of Care Relative to the Medicinal Treatments Got Out of it From Hospitalization

The continuity of the medicinal care between the city and the hospital stays a major organizational stake and of safety of patients' therapeutic care.This takeover is more complex when it concerns pathology needed lots of hospitalization and included the intervention of multiple healthcare practionners. This is clearly the case of cancer coverage.

The optimization of the therapeutic suppor in town is based on pharmaceutical advice strengthening but also on the pharmaceutical analysis to check the entire treatments' prescription and eventual medicinal interactions which ensue from it.That's why it's important to have a medicinal conciliation that takes into account all the medecine taken or have to be taken by the patient.

A specific support was developped by nurses , doctors and pharmacist ; it's a care coordination card that can be put easely in a pocket by the patient.

The aim of the study is that this card can be also used as a communication tools by sharing the prescription done at the release of hospital by using an IT link (flea datamatrix) for the patients Via the use of an IT link (flea datamatrix) for the patients whose pathology is complex in term of extra hospital coverage.

The aim of this strudy is to evaluate with community pharmacists the impact of a new information system on the prevalence of dispensing difficulties reported by pharmacies when hospitalized patients leave the city. This information system will be based on the care coordination card implemented by a secure computer link allowing the use of information on treatments prescribed at the end of hospitalization. Patient management is not changed by this protocol. Only the information of the pharmacist, which is the object of the study, is increased.

Eligibility Criteria:
Inclusion Criteria:

* all patient admitted in onco-thoracic service
* Handled by an anticancer agent
* Having frequented the same city pharmacy for at least 3 months

Exclusion Criteria:

* hospitalization above 21 days
* refusing participation
* palliative care
* misunderstanding of french language
* frequenting several pharmacy
Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases

Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries. This study will evaluate the efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary immunodeficiency diseases.

The primary objective of the study is to investigate the safety of Octagam 10% in replacement therapy in PID and to compare the pharmacokinetic profile of Octagam 10% with that of the previously used Octagam 5%.

The secondary objective is to investigate the efficacy of Octagam 10% in replacement therapy in PID by monitoring the rate of occurence of serious bacterial infections, the rate of other infections, the trough (pre-next-dose) levels of total serum IgG and IgG subclasses (IgG1, IgG2, IgG3 and IgG4), the trough (pre-next-dose) levels of selected antigen specific antibodies, the use of antibiotics, the rate of absence from school/ work, and the number of days in hospital.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of primary immunodeficiency (acc. WHO)
* Previous treatment with commercial Octagam 5% every 3-4 weeks for at least 6 infusions intervals
* Documented IgG trough levels of the two previous infusions before enrollment with a value of at least 5.5 g/L for both

Exclusion Criteria:

* Acute infection requiring intravenous antibiotic treatment within two weeks before screening
* Exposure to blood or any blood product or derivative other than commercially available Octagam 5%, within the past 3 months
* History of hypersensitivity to blood or plasma derived products
* Requirement of any routine premedication for IGIV treatment
* History of congenital impairment of pulmonary function
* Severe liver function impairment
* Severe renal function impairment or predisposition for acute renal failure
* History of autoimmune haemolytic anaemia
* History of diabetes mellitus
* Congestive heart failure NYHA III or IV
* Non-controlled arterial hypertension
* History of DVT or thrombotic complications with IGIV treatment
* Known infection with HIV, HCV or HBV
* Treatment with steroids, immunosuppressive or immunomodulatory drugs
* Planned vaccination during study period
* Pregnant or nursing woman
RQC for the Prevention of Alzheimer's Disease and Retinal Amyloid-β

The goal of this clinical trial is to evaluate whether oral resveratrol, quercetin, and curcumin (RQC) can prevent the accumulation of retinal amyloid-β and/or cognitive decline over 24 months in adults aged 50-90 with Stage 1 or 2 Alzheimer's disease as described in FDA-2013-D-0077. The trial will also evaluate the safety and tolerability of RQC. Curcumin, which binds to amyloid-β, will act as a fluorescent label to identify retinal amyloid-β in vivo using optical coherence tomography (OCT)-autofluorescence imaging. The investigators will longitudinally evaluate the effect of RQC on retinal amyloid-β load cognitive outcomes including the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and the Mini Mental State Examination (MMSE), and potential microvascular biomarkers. The investigators will also evaluate associations between retinal amyloid-β and progression to early Alzheimer's disease (mild cognitive impairment). The investigators will compare RQC, taken daily for 24 months, with curcumin alone, taken only during the 7 days preceding each of the six study visits to see if RQC can prevent (or reduce) amyloid-β and prevent the onset of mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* 50-90 years of age at screening.
* Male or female
* Any race or ethnicity.
* Provide written informed consent.
* Availability for the duration of the study.
* Ability to speak, read, and understand English.
* Ability to take oral medication and be willing to adhere to the RQC regimen.
* Have adequate literacy, vision, and hearing for neuropsychological testing at screening

Exclusion Criteria:

* MMSE score 0-25, indicating more than subtle cognitive abnormalities
* CDR-SB score \> 0, indicating functional impairment
* Clinical diagnosis of any non-Alzheimer's disease (AD) type of mild cognitive impairment (MCI) or dementia
* Taking pharmaceutical anti-Aβ monoclonal antibodies (i.e., Leqembi, Aduhelm).
* Participation in another clinical study with an investigational product during the last 90 days.
* Presence of hepatic disease or kidney disease
* Clinically significant or unstable hematologic, cardiovascular, pulmonary, gastrointestinal, endocrine metabolic, or other systemic disease.
* Diagnosis of gastrointestinal or stomach condition including but not limited to irritable bowel syndrome (IBS), ulcerative colitis, peptic ulcers, Crohn's disease, gastroesophageal reflux disease, gastritis, severe dyspepsia, and intestinal malabsorption.
* Clinically significant abnormal values in hematology, coagulation and platelet function, clinical chemistry, or urinalysis at screening (such as those with prolonged prothrombin time (PT), anemia, low neutrophil or platelet count, elevated liver function tests, low glomerular filtration rate).