cyrilzakka/clinical-trials huggingface dataset:
Aneurysms and Carotid Artery Block in Newborns

This study will determine the risk of brain aneurysm (abnormal outpouching of a brain artery) in young adults who had their carotid artery tied off as an infant as part of the extracorporeal membrane oxygenation (ECMO) procedure. This procedure is sometimes performed on newborns with lung problems so that they can have oxygen brought to their blood outside the body. ECMO operates similar to a heart-lung machine. Blood drained from the veins has the carbon dioxide removed and oxygen added. The oxygenated blood is then returned to the body through the arteries.

People 18 to 25 years of age who underwent ECMO as an infant at the Children's National Medical Center in Washington, D.C., may be eligible for this study.

Participants undergo the following procedures:

* Medical history and physical and neurological examinations.
* Magnetic resonance imaging (MRI) of the head and neck. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. The subject lies in the scanner (a metal cylinder surrounded by a magnetic field) for about 90 minutes, lying still for up to 15 minutes at a time. During part of the procedure, a contrast dye is injected into a vein through a catheter (thin plastic tube) to enhance the images.

Objective:

To assess whether the hemodynamic stress of long-term common carotid artery occlusion can lead to cerebral aneurysm formation in young adults.

Study population:

100 adults 18-25 years of age who underwent common carotid artery (CCA) occlusion as a neonate as part of the extracorporeal membrane oxygenation (ECMO) procedure performed in the setting of pulmonary insufficiency.

Design:

Patients who underwent CCA occlusion as a neonate for ECMO at Children's National Medical Center will be identified and contacted. The study will be explained and informed consent will be obtained. Subjects will undergo outpatient evaluation to include history and physical, magnetic resonance angiography and magnetic resonance imaging of the head.

Outcome measures:

* Cerebrovascular anatomic anomalies such as cerebral aneurysms and persistent fetal circulation pathways, etc.
* Cerebral perfusion asymmetry on MRI.
* Cerebral parenchymal abnormalities such as stroke.

Eligibility Criteria:
* INCLUSION CRITERIA:

Subjects must be 18-25 years of age.

Subjects had VA ECMO as a neonate at Children's National Medical Center.

Subjects must be in good health.

Subjects must provide informed, written consent for participation in this study.

EXCLUSION CRITERIA:

Subjects with a history or evidence of mental retardation precluding a written consent unless this consent could be obtained from a legal guardian.

Subjects with a history of reaction to MR contrast media or who are unable to have an MRI.

Subjects who underwent carotid artery reconstruction after neonatal ECMO.

Females who are pregnant or nursing.
Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes

Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance as well as glycemic control after transition from pediatric to adult diabetes care.

The purpose of this study is to determine if a structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance and management as well as glycemic control after transition from pediatric to adult diabetes care.

Eligibility Criteria:
Inclusion Criteria:

* Established T1D diagnosis for a minimum of one year (chosen to allow time for adjustment to a new diagnosis and more stable disease control).
* Between the ages of 17 and 20 years. It is left to the clinical judgment of the pediatric endocrinologist to determine individually the appropriate age of the transition for each subject
* At least 1 visit during the previous year with the pediatric endocrinologist at a Diabetes Clinic (aim is to minimize the non-adherence with the intervention).
* Ability to participate in all aspects of this clinical trial.
* Written informed consent/assent must be obtained and documented.
* Resident of Ontario.

Exclusion Criteria:

* Pregnant or lactating females or intent to become pregnant during the next 3 years.
* Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
* Prior enrollment in the current study.
* Current participation in another clinical trial or participation in another clinical trial in the 6 months prior to enrollment.
Nutritional Therapy in Patients With Post-extubation Dysphagia

The aim of this study is to evaluate the impact of the prescription of two doses of protein on the amount in kilograms of muscle mass and on the clinical evolution (time until safe swallowing, time until removal of the feeding stoma, number of hospital readmissions, feeding stoma infections, incidence of pneumonia, functionality, number of falls, fractures and mortality) at 6 months after hospital discharge in patients with enteral nutrition due to post-extubation dysphagia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who required invasive mechanical ventilation during their hospital stay with a diagnosis of post-extubation dysphagia diagnosed by fibroendoscopy evaluation of swallowing (FEES).
* Patients who discharged with a feeding tube.
* Patients with signed informed consent.

Exclusion Criteria:

* Patients with pre-existing dysphagia, or with neurological conditions that can cause dysphagia (e.g. multiple sclerosis, Parkinson's disease, Alzheimer's, myasthenia gravis).
* Patients with chronic kidney disease, defined as a glomerular filtration rate \<60 ml/min.
* Patients discharged with a terminal condition and/or life expectancy of less than 3 months.
* Diagnosis of HIV, upon receiving clinical follow-up by the team of specialists.
An Explorative Study of Treatment of Contact Dermatitis Due to DiabetesDevices

A feasibility study of treatment with a occlusive medical device or patch in pediatric patients with type 1 diabetes suffering from irritative contact dermatitis due to diabetes devices.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent, and for patients under the legal age consent by a legal guardian
* Clinically confirmed, active and evaluable irritant contact dermatitis (ICD)
* Age 6-20 at the time of signing the informed consent form (ICF)
* Ability to answer study questionnaires

Exclusion Criteria:

* Any type of skin irritation other than ICD
* Use of occlusive therapy for the treatment of their ICD, or unwilling to refrain from this treatment for duration of study
* For any other reason considered unsuitable by the investigator
* Pregnant or of child-bearing potential unwilling to use acceptable effective contraception
Point of Care UltraSound (POCUS) Use for Intravenous Catheter Placement During Pediatric Interfacility Transport

This study will determine the efficacy of POCUS (Point of Care UltraSound) for intravenous (IV) access during pediatric interfacility transport. The Butterfly iQ+ (Lightning) device will be used. Children requiring IV access for transport will be randomized to POCUS-Assisted IV placement or traditional IV placement. We will examine and compare first attempt success rates with each method.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients requiring IV access prior to transport by the Angel One Transport Team back to Arkansas Children's Hospital
* Age group: 2 weeks - 18 years

Exclusion Criteria:

* Adequate IV Access
* NICU transports
* Patients not needing IV access
Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)

The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the treatment of inflammation following ocular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral ocular surgery.

Exclusion Criteria:

* Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.
Impact of mHealth in Heart Transplant Management

The purpose of this study is to improve medication adherence, engagement and support to heart transplant patients through implementation of a new clinical care programme conducted by the clinical pharmacy service in cooperation with the heart transplant team and supported by mobile health (mHealth).

Non-adherence to immunosuppressive medications generally ranges from 20-40% and is associated with acute rejection episodes and graft loss. Many solid organ transplant centres have incorporated transplant pharmacists into the multidisciplinary transplant clinical team focused on improving outcomes and safety associated with drug therapy.

Mobile technology has undergone rapid advances in the past several years and the use of mHealth in pharmaceutical care is changing pharmacy practice. Several published reports have identified general mobile applications suited for improve adherence. But evidence supporting the benefits in clinical practice is limited.

This study expects to analyse the potential of mHealth to improve medication adherence and heart transplant patient management in real clinical practice.

The investigators asses a new multidisciplinary follow-up programme in heart transplant recipients supported by mobile health (mHealth) with the aim to improve medication adherence, prevent drug related problems and improve patient clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Heart transplant patients ≥ 18 years of age
* Give informed consent.
* Be able to use a mobile device (smartphone).
* Sign a confidentiality agreement (interventional group).

Exclusion Criteria:

* Do not meet all the inclusion criteria.
* Non-available to receive a minimum of one-year clinical follow-up by the heart transplant unit.
* Suffer severe mental disorders, other mental pathologies or conditions that can be a barrier to use the mobile application
Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma

To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and HLA-compatible unrelated donor in patients with Multiple Myeloma. In those with non complete remission DLI and/ or new agents such as Bortezomib, Thalidomid or Lenalidomide can be used to upgrade remission.


Eligibility Criteria:
Inclusion Criteria:

* Multiple Myeloma Stadium II / III acc. to Salmon and Durie
* signed informed consent
* adequate organ function prior autologous respectively allogeneic SCT
* availability of HLA-identical related or unrelated donor
* availability of at least 2 x 10\^6 CD34+ cells per kg BW of recipient for the autologous SCT and at least 3 x 10\^6 CD34+ cells for allogeneic SCT
* for MRD-SCT: 18-66 years; for MUD-SCT: 18-55 years
* at age \<55 years existence of risk factors that make an myeloablative allogeneic transplantation to risky
* consent of donor to give DLI

Exclusion Criteria:

* severe heart insufficiency
* cardiovascular diseases or severe concomitant diseases
* active infections that need antibiotic therapy
* positive for HIV or hepatitis
* malign secondary disease
* limited liver function with total bilirubin \> 1.5 ULN
* increased transaminase \> 3 ULN
* increased serum creatinine \> 2 mg/dl
* pregnant or lactating women
* known hypersensitivity to Fludarabine or Melphalan
* participation in another trial
Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma

This is a phase I, prospective, open label, dose escalation study of azacitidine in combination with rituximab, vincristine, and cyclophosphamide for the treatment of refractory lymphoma. The investigators expect to enroll 12-24 patients in this trial over a 2 year accrual period.


Eligibility Criteria:
Inclusion Criteria:

1. Patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.
2. Age ≥ 18 years and without a maximum age.
3. All patients of reproductive potential should not plan on conceiving children during the treatment program and must agree to use a medically accepted form of contraception.
4. Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of beginning treatment.
5. Patients must have relapsed lymphoma.
6. ECOG performance status of 2 or better.

Exclusion Criteria:

1. Pregnant or breast-feeding at the time of proposed study entry
2. Clinical AIDS or ARS or known positive HIV serology
3. History of malignant neoplasm, other than lymphoma, treated within two years prior to study entry (other than non-melanoma skin cancer or in situ cervical cancer) or where there is current evidence of recurrent or metastatic disease
4. Psychiatric or additive disorders that would preclude obtaining informed consent
5. Serum bilirubin \> 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these are attributed to active hemolysis
6. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) levels \> 2 times ULN
7. Serum creatinine levels \> 1.5 times ULN
8. Platelets \< 75,000/mm3
9. Absolute neutrophil count \< 1500/mm3
10. Active infection including viral hepatitis
11. Known or suspected hypersensitivity to mannitol, azacitidine, or rituximab
12. Grade 3 or 4 neuropathy
13. Advanced hepatic tumors
14. Uncompensated heart failure
Salivary Cortisol Measurements by Mass Spectrometry

Cortisol is a hormone critical for survival in times of stress. Currently most measurements are done with blood samples. The hypothesis of this study is cortisol measured from saliva using mass spectrometry can be used to replace measurements by blood.

Cortisol levels change depending on the time of day. Salivary samples were collected from health controls at bedtime, midnight and first morning waking on two consecutive nights and salivary cortisol levels were measured using mass spectrometry. In a patients with possible endocrine disorders who were going through an adrenocortiotropin stimulation test for adrenal insufficiency, salivary cortisol was measured prior to giving cosyntropin and 30-40 minutes after cosyntropin.

Eligibility Criteria:
Inclusion Criteria:

* Normal subjects
* Subjects with possible endocrine disorder

Exclusion Criteria:

* Tracheostomy or ventilator dependent
* Gastrotomy tubed dependent or unable to eat/drink by mouth
A Clinical Trial of Thread-embedding Therapy at Acupuncture Point for Simple Obesity

Thread-embedding Therapy has been used for treating Obesity in recent years. This research is aimed to observe the clinical effect of thread-embedding therapy in treating Simple Obesity. One hundred patients is planned to be enrolled in the research and receive a thread-embedding therapy. The level of BMI, serum triglyceride, cholesterol and fasting blood glucose will be adopted for evaluation before and after therapy.

Each participant will receive thread-embedding therapy every two weeks, and eight times in all.Blood test will be taken at the beginning of the first week of the whole therapy, and at the end of the 8th therapy. During the periods of whole therapy, the participants shall follow diets control and physical exercise as the protocol described.

Eligibility Criteria:
Inclusion Criteria:

* patients with age from 18 to 60 years old;
* patients with BMI≥ 24, meanwhile waist more than 85 cm (for male) or 80 cm (for female);
* patients with diagnosed as central adiposity and/or Simple obesity according to the diagnosis criteria；
* patients who is willing to cooperate with the test treatment and signed informed consent.

Exclusion Criteria:

* Pregnant or lactating women;
* patients who Syncope after acupuncture；
* patients who present hypersensitivity reactions after acupoint-embedding therapy;
* patients with serious heart, liver, kidney, brain and other diseases;
* patients with severe primary diseases;
* patients with psychiatric diseases；
* patients who did not meet the criteria for the inclusion criteria while investigators find out during the trial;
* participants who did not complete dietary control and physical exercise as the protocol described.
Copper Cu 64 TP3805 PET in Detecting Prostate Cancer in Patients With Persistently Elevated PSA

This pilot phase I trial studies how well copper Cu 64 TP3805 positron emission tomography (PET) works in detecting prostate cancer in patients with persistently elevated prostate specific antigen (PSA). The copper Cu 64 TP3805 PET scan uses copper Cu 64 TP3805, a compound made of a radioactive agent attached to a molecule that looks like a hormone that binds to cancer cells to detect prostate cancer during PET scans. Copper Cu 64 TP3805 PET may be able to see tumors at an earlier stage than the standard of care.

PRIMARY OBJECTIVES:

I. To assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect prostate cancer (PC), or absence thereof, within the prostate gland.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide signed informed consent and willingness to comply with protocol requirements
* Persistently elevated PSA
* Scheduled for magnetic resonance imaging (MRI) fusion/transrectal ultrasound (TRUS) biopsy, followed by histology
* Agree to use an acceptable form of birth control for a period of 7 days after the Cu-64-TP3805 injection

Exclusion Criteria:

* Participating would significantly delay the scheduled standard of care therapy
* Administered a radioisotope within 10 physical half-lives prior to study drug injection
* Have any medical condition or other circumstances that, in the opinion of the investigator, would significantly decrease obtaining reliable data, achieving study objectives or completing the study
A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.

This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet.

It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The remaining 27 patients received study drug and 25 patients completed the study.

The study was terminated due to slow enrolment. The final analysis included only safety analysis in the Safety population, due to the low number of randomized patients. No efficacy analysis was performed.


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to read and understood the language of the Informed Consent Form and Patient Information.
* International travelers with a duration of stay in host country long enough to attend schedules visits.
* Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization

Exclusion Criteria:

* Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug.
* Pregnant, breast feeding or planning pregnancy
* Acute diarrhea for \> 72 hours immediately prior to randomization.
* Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.
Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction

accelerated anterior teeth retraction with the help of microosteoperforation procedure and miniscrews.

the study contains 2 groups each contains 13 subjects, A control group (anterior segment retraction with the help of miniscrews) and an intervention group ( anterior segment retraction with the help of miniscrews and microosteoperforation)

Eligibility Criteria:
Inclusion Criteria:

* Females with an age ranging between 16-30 years.
* Malocclusion that requires bilateral extraction of the maxillary first premolars and anterior segment retraction; Angle class I mal-occlusion with bi-alveolar dental protrusions or class II division 1.
* Healthy dental and periodontal condition with a good oral hygiene
* Absence of degenerative conditions.
* Full set of permanent dentition.

Exclusion Criteria:

* Medically compromised patients.
* Previous orthodontic treatment
* Patients suffering from any congenital, hereditary or systemic diseases or asymmetries that might have an influence on tooth movement
* Chronic use of any medications affecting orthodontic tooth movement (eg: NSAIDs).
* Active periodontal affection or severe gingival inflammation.
Development and Piloting of a Just-in-Time, Personalized HIV Prevention Intervention for Youth Experiencing Homelessness and Unstable Housing

The purpose of this study is develop and pilot test a personalized HIV intervention with youth experiencing homelessness by creating and field testing prevention messages that address real-time predictors (e.g., sexual urge, use to use drugs, and substance use) of HIV risk behaviors,to evaluate the feasibility and acceptability of the intervention and to evaluate the intervention outcome effects on HIV risk behaviors (e.g., condomless sex, number of sexual partners, pre-exposure prophylaxis(PrEP) awareness, substance use during sex,Intravenous(IV)drug use)


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* HIV high risk: IV drug user or sexually active youth (sex in the past 3 months) who reports at least one of the following: condomless sex, concurrent sexual partners within 2 weeks,sex with a partner of unknown HIV status, or a bacterial STI in the last 6 months.
* Homelessness: staying on the streets or in a place not meant for human habitation, a shelter,hotel/motel, or some place they cannot stay for more than 30 days

Exclusion Criteria:

* Below 6th grade reading level:determined by the Rapid Estimate of Adult Literacy in Medicine Short Form (REALM)