cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Outcomes of Bronchopulmonary Dysplasia in Young Adulthood

Preterm birth alters the normal sequence of lung development with lasting respiratory consequences. It is still unclear whether observed respiratory morbidities in preterm born individuals reflect sequelae from a non-progressive lung disease that occurred early in life or result from ongoing active disease that, if left undiagnosed and untreated, could increase the risk of a COPD-like phenotype. We propose to examine micro-structural abnormalities of the lung using innovative non-invasive imaging technologies in relation to pulmonary function and markers of inflammation and oxidative stress in young adults born preterm.


Eligibility Criteria:
Inclusion Criteria:

* 20-29 years old
* For the pre-term subject: \<29 weeks gestational age, with or without BPD
* For the matched term control: ≥37 weeks gestational age with birth weight appropriate for gestational age i.e. between the 10th and 90th percentile
* Subject understands the study procedures and is willing to participate in the study as indicated by the signature on the informed consent
* Subject is judged to be in otherwise stable health on the basis of medical history
* Subject is able to perform reproducible pulmonary function testing (i.e., the 3 best acceptable spirograms have FEV1 values that do not vary more than 5% of the largest value or more than 100 ml, whichever is greater)

Exclusion Criteria:

* Patient is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand the written material
* Patient is unable to perform spirometry or plethysmography maneuvers
* Subject has an implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants)(at the discretion of the MRI Technologist/3T Manager)
* In the investigator's opinion, subject suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
A Comparison of 122-0551 Foam Versus Vehicle Foam in Subjects With Plaque Psoriasis (Study 306)

This Phase 3 study (Study 306) has been designed to determine and compare the efficacy and safety of 122-0551 Foam and Vehicle Foam applied twice daily for two weeks in subjects with plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 12% affected body surface area.
* Subject has an Investigator's Global Assessment (IGA) score of at least three (moderate) at study start.
* If subject is a woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control for the duration of the study.

Exclusion Criteria:

* Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
* Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis.
* Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, or which exposes the subject to an unacceptable risk by study participation.
* Subject has used any phototherapy (including laser), photo-chemotherapy or other forms of photo based therapy for the treatment of their psoriasis within 30 days prior to study start.
* Subject has used any systemic methotrexate, retinoids, systemic corticosteroids \[including intralesional, intra-articular, and intramuscular corticosteroids\], cyclosporine or analogous products within 90 days prior to study start.
* Subject has used any systemic biologic therapy (i.e., FDA-approved or experimental therapy) within five half-lives of the biologic prior to study start.
* Subject had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to study start or is intending to have such exposure during the study.
Effects of Emicizumab vs. Factor VIII Prophylaxis on Joint and Bone Health in Severe Hemophilia A

The investigators propose to study longitudinal joint and bone density changes in patients with severe Hemophilia A. Per current standard of care, most patients are on prophylactic FVIII replacement therapy intravenously several times weekly with a goal of keeping the trough \>1% FVIII. Recent phase 3 data suggest superior bleed protection with emicizumab prophylaxis every 1-2 weeks. It is the purpose of this study to longitudinally assess joint health and bone density over 3 years and to compare the effect of routine factor VIII prophylaxis with emicizumab prophylaxis.

Summary: This retrospective/prospective, non-randomized controlled study, whereby patients will be included in 1 of 2 groups depending on their current treatments as outlined below. Patients will be assigned to a specific group by the clinician/PI based on their current regimen with the intent to stay on this regimen for the next 3 years.

Duration of Study and Subject Participation: Study subject enrollment is anticipated to occur over about 12 months and study duration per subject will be 3 years. Thus a total study duration of 4 years is anticipated.

Intervention: By using musculoskeletal ultrasound, the investigators will measure joint health among participants and assess joint health changes over 3 years compared between group A (factor prophylaxis) vs. group B (emicizumab prophylaxis) as assessed by MSKUS at baseline and after 3 years. Other outcomes such as bone density, comparative assessment of joint and overall health status, and exploration of potential biomarkers for joint and bone health will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Severe hemophilia A (factor VIII \< 1%)
* Age ≥ 16 year
* Either on prophylaxis with factor VIII or emicizumab with the intention to stay on the current regimen for the next 3 years
* Willing and able to give written informed consent/assent
* Willing to undergo MSKUS, DEXA scan +/- collection of blood sampling for repository biomarkers
* Willing to come in for baseline and 3 yearly visits
* Willing to answer phone survey for bleeding and safety every 3 months

Exclusion Criteria:

* Current FVIII inhibitor of \> 0.6 BU
* Unable to take FVIII replacement
* Other known bleeding disorder
* Other rheumatologic disorder affecting joints
* Other known neuromotor defect (making physical exam difficult)
The Genetics of Diabetes in Southern California Chinese Americans

The purpose of this research study is to investigate the genetic causes of diabetes. Specifically, we are interested in the mitochondrial genome and how variants in the mitochondrial genome influence a person's risk to develop diabetes and metabolic syndrome.

Since our laboratory's initial linkage of Type 2 diabetes to a mtDNA rearrangement in a three generation maternal pedigree 13 years ago, there has been increasing support for our hypothesis that mitochondrial dysfunction plays an important role in the etiology of Type 2 Diabetes Mellitus (DM) and the overlapping Metabolic Syndrome (MS). With this study we are planning an extensive investigation of defects in mitochondrial oxidative phosphorylation (OXPHOS) caused potentially by deleterious sequence variants in the mitochondrial DNA (mtDNA). As the primary objective we are trying to further substantiate 2 hypotheses: 1) that these diabetogenic mtDNA variants, which are proposed to range from recent, relatively severe, mutations will result in substantial OXPHOS defects with familial DM \& MS and 2) that ancient, relatively mild polymorphisms result in partial OXPHOS defects and an increase in the risk to develop DM \& MS.

Eligibility Criteria:
Inclusion Criteria:

* Chinese or Taiwanese ancestry
* Resident of Southern California
* Age between 40 and 65
* Both people with and without diabetes are welcome to enroll.

Exclusion Criteria:

* Younger than 40 years or older than 65 years
* Ancestry is not Chinese or Taiwanese
* Not a resident of Southern California
The Role of Ultrasound in Cholecystitis

The aim of this study is:

1. To describe the natural course of acute cholecystitis, by performing repeated ultrasound examinations from day of admission to hospital until day of surgery or discharge.
2. To investigate if there is anything in the ultrasound picture that can predict a difficult operation.

Patients will be prospectively enrolled. The ultrasound picture (ultrasound variables: gallbladder volume, gallbladder wall thickness, and presence of oedema in the gallbladder wall), will be compared to clinical variables (tenderness in right upper quadrant, WBC, CRP and temperature) and to the time (hours) from onset of symptoms. Statistical analyses will be made to see if statistically significant, and clinically relevant, associations between variables exist.

Furthermore, for participants receiving acute surgery, an upper GI surgeon will evaluate the operation as easy, intermediate or difficult. In extension, investigators will look at associations between difficult surgery and all the variables previously mentioned (both ultrasound variables, clinical variables and time).

Patients admitted to Stockholm South General Hospital's Surgery Department, with a confirmed diagnosis of acute cholecystitis (according to the Tokyo Guidelines 2013) will be considered eligible for the study and asked to participate. Informed consent will be obtained from all participants. Participants will be examined with ultrasound of the gallbladder daily, while receiving regular care for acute cholecystitis, which means either waiting for acute surgery or being treated conservatively for as long as inpatient care is needed.

The ultrasound examinations will be performed by a radiologist or a specialised certified ultrasound trained nurse as well as by an ultrasound trained surgeon. Measures of gallbladder volume (measured in cm3), gallbladder wall thickness (measured in mm:s) and presence of oedema in the gallbladder wall (noted as a binomial variable 'yes/no') are recorded in a case report form (no.1) together with body temperature, labs and information about onset of symptoms.

The operating surgeon (a specialist in surgery) will evaluate the operation and grade it from easy to difficult and fill in a case report form (no.2).

Data will be collected from the forms and analysed using a regression model (generalised estimated equation or a mixed model).

Eligibility Criteria:
Inclusion Criteria:

* Acute cholecystitis according to the Tokyo Guidelines 2013 criteria

Exclusion Criteria:

* Difficulties to communicate
The Effect of Remifentanil Infusion During Emergence on the Incidence of Emergence Delirium

The aim of the present study is to assess the effect of postoperative remifentanil infusion on the incidence of emergence agitation in preschool-aged children undergoing strabismus surgery with sevoflurane anaesthesia.

Patients are randomly assigned to one of two groups. Anesthesia is maintained with sevoflurane and remifentanil infusion. All patients received a predetermined concentrations of remifentanil according to their group assignments (control group, remifentanil 0 ug/kg/min; remifentanil group, remifentanil 0.05 ug/kg/min) from 10 minutes before the end of surgery to discharge from postanesthetic care unit. emergence agitation is assessed during the emergence phase.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I and II
* preschool-aged children undergoing strabismus surgery

Exclusion Criteria:

* psychological disorders
* emotional disorders
* abnormal cognitive development
* developmental delay
* allergy to the drugs in our protocol
A Phase Ib Study of YY-20394 in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma

A single-arm, open, multicenter study to investigate the efficacy and safety of YY-20394, an oral small molecular inhibitor of PI3K-delta, in patients with relapsed or refractory peripheral T cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically or cytologically confirmed diagnosis of relapsed or refractory peripheral T cell lymphoma.
3. Eastern Cooperative Oncology Group performance status of 0 to 2.
4. Life expectancy of at least 3 months.
5. At least one measurable lesion according to IRWG.
6. Adequate organ function.
7. Had anti-tumor treatments greater than or equal to 2 weeks prior to the first dose of investigational product (including TKI, chemotherapy, radiotherapy, immunotherapy and major surgery).
8. Men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose.
9. Volunteers did not participate in other clinical trials within 1 month prior to study entry.
10. Able to comply with the protocol judged by investigator.
11. Provision of signed and dated, written informed consent prior to any study- specific evaluation.

Exclusion Criteria:

1. Previous treatment with any PI3K-delta ihinibitors. 2. Uncontrolled pleural effusion and ascites. 3. the dosage of steroid hormone ( prednisone equivalent ) was greater than 20mg/day, and lasted for more than 14 days. 4. Medical conditions in swallowing, malabsorption, or other chronic gastrointestinal disease that may hamper compliance and/or absorption of the investigational agent. 5. During the study period, drugs that may prolong the QT (such as anti arrhythmic drugs) could not be interrupted. 6. Evidence of central nervous system involvement of the malignancy, including invasion of brain parenchyma and meninges, or spinal cord compression. 7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy(such as pneumonia). 8. Active infection with hepatitis B and C virus ( Volunteers with HBsAg or HBcAb positive and HBV-DNA greater than or equal to 1000 coRpies/ml or 200IU/ml; HCV antibody and HCV-RNA positive ). 9. History of immune deficiency ( acquired or congenital ), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation. 10. Presence of severe or uncontrolled cardiovascular disease. 11. The baseline pregnancy test was positive in pregnant women, lactating women or fertile women. 12. According to the judgement of the investigator, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (such as severe hypertension, diabetes, thyroid diseases, etc.). 13. Medical history of other primary malignant tumors in the past 5 years except for the following: clinically cured cervical in situ, local basal cell carcinoma of the skin.

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Using Bluetooth Beacon Technology to Reduce Distracted Pedestrian Behavior

Over 4,800 American pedestrians die annually, a figure that is current increasing. One hypothesized reason for the increasing trend in pedestrian injuries and deaths is the role of mobile technology in distracting both pedestrians and drivers. The investigators propose to develop and then evaluate Bluetooth beacon technology as a means to alert and warn pedestrians when they are approaching dangerous intersections, reminding them to attend to the traffic environment and cross the street safely rather than engaging with mobile technology. One aspect of the research will involve a crossover research trial to evaluate efficacy of the program.

Bluetooth beacons are very small (about the size of a dime) and inexpensive (\~$20 range) devices that broadcast information unidirectionally (beacon to smartphone) within a closed proximal network. The investigators propose placing beacons at intersection corners (e.g., on signposts) frequently trafficked by urban college students. The beacons will transmit to an app installed on users' smartphones, signaling users to attend to their environment and cross the street safely. The app will be developed to be flexible based on user preferences; for research purposes, the app also will download data concerning the users' behavior while crossing the street. The crossover trial will evaluate the app with a sample of about 411 young adults whose behavior is monitored for: (a) 3 weeks without the app being activated, (b) 3 weeks with the app activated, and then (c) 6 weeks without the app activated to assess retention of behavior. Throughout the 12 week period, the investigators will monitor user behavior at multiple intersections around campus, along with gathering self-report questionnaire perceptions and behavior at baseline and 12-week post-intervention assessments.


Eligibility Criteria:
Inclusion Criteria:

* individuals who cross streets on the UAB campus at least twice daily
* ownership of an Android phone
* willingness to install the app on phone
* ability to communicate in English

Exclusion Criteria:

* none
A Prospective Observational Registry of Primary Headache Patients Treated With Ausanil

This study is an observational study with the primary objective to assess the safety and tolerability of Ausanil in the treatment of primary headache disorders. The secondary objective is to assess headache pain, functional outcome, time loss to headache and patient satisfaction with Ausanil treatment.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 80 years
* Primary Headache disorder as per International Classification of Headache Disorders-11
* Ausanil naive
* Signed dated informed consent
* Females of childbearing potential must be using adequate contraception during study period.
* Willing and able to comply with registry requirements to document headache response

Exclusion Criteria:

* Known allergy to Ausanil or any of its ingredients
* Active bronchial asthma that in the opinion of the investigator would interfere with use of Ausanil
* Nasal obstruction due to any cause or extensive nasal surgery resulting in scarring or other such impact on nasal mucosa that might lead to heightened sensitivity to Ausanil in the opinion of the investigator.
* Pregnant or breast feeding females
* History of addictive behavior
* Any severe or chronic unstable medical or psychiatric condition
* Active nasal infection or inflammation
* Unable or unwilling to provide informed consent
* Suffer from atypical, basilar or hemiplegic migraine that is new onset or unstable.
Standardizing Method and Development of Normal Values to Measure Human Small Intestinal and Colonic Permeability

To develop a test to measure small bowel and colonic permeability.

The study consists of a physical examination, standardized meals and 3 oral sugar tests with 24 hour urine collections. It requires the participants to visit the Clinical Research Trials Unit in the Charlton Building and Domitilla Building. Remuneration will be offered.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Non-Obese
* Non-pregnant
* Caucasian
* BMI \<30kg/m2

Exclusion Criteria:

* Diabetes
* Hypertension
* BMI ≥30kg/m2
* Chronic NSAID use (\>3 days/week)
Paricalcitol in Treating Patients With Myelodysplastic Syndrome

RATIONALE: Paricalcitol is a form of vitamin D that may help myelodysplastic cells develop into normal bone marrow cells.

PURPOSE: Phase II trial to study the effectiveness of paricalcitol in treating patients who have myelodysplastic syndrome.

OBJECTIVES:

* Determine the clinical effects of paricalcitol in patients with myelodysplastic syndromes.
* Determine whether this drug can improve RBC, WBC, or platelet counts in these patients.
* Determine whether this drug can decrease the risk of development of leukemia without causing undue toxicity in these patients.

OUTLINE: Patients receive oral paricalcitol daily for 4 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 8 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Clinical diagnosis of myelodysplastic syndromes according to the modified FAB classification

  * Confirmed by bone marrow aspiration showing blast and promyelocyte count no greater than 30% of the bone marrow differential
* Patients with refractory anemia with ringed sideroblasts are eligible provided there was no response to a 3-week course of prior high-dose pyridoxine

PATIENT CHARACTERISTICS:

Age

* 25 to 100

Performance status

* Karnofsky 60-100%

Life expectancy

* At least 12 weeks

Hematopoietic

* See Disease Characteristics

Hepatic

* Bilirubin less than 2.0 mg/dL

Renal

* Creatinine less than 2.5 mg/dL
* Calcium normal

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior sensitivity to paricalcitol or any component of its formulation
* No prior cholecalciferol toxicity
* No other concurrent acute illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* More than 5 weeks since prior chemotherapy

Endocrine therapy

* Not specified

Radiotherapy

* More than 5 weeks since prior radiotherapy

Surgery

* Prior recent surgery allowed, if fully recovered

Other

* More than 5 weeks since prior megadose vitamins
* No concurrent cholecalciferol, phosphate, calcium, or cholestyramine
* No concurrent digoxin
Enhancing Use of Hydroxyurea In Sickle Cell Disease Using Patient Navigators

Multi-phase, patient navigator-based program in the Richmond and Tidewater regions of Virginia to demonstrate:

1. the feasibility of using patient navigators to improve the percentage of children and adult (age 15 and older) patients with sickle cell disease (SCD) in SCD specialty care
2. the efficacy of using patient navigators to improve hydroxyurea (HU) (re-)initiation and adherence among adult patients with SCD eligible for HU

(Patient navigators may also be known as public health workers.)

The state of Virginia, including the Virginia Department of Health and three academic medical centers and one federally qualified health center, plans a two-phase demonstration, first of improvement in the percentage of adults with SCD who are in SCD specialty care (Phase I), then of improvement in adherence to HU of eligible SCD adults (Phase II). Both phases will use existing academic SCD providers, and an innovative, multimodal strategy, featuring specially trained SCD patient navigators (PNs), that addresses barriers to care and to HU use. In Phase I we will demonstrate the feasibility of utilizing PNs to overcome patient access barriers to SCD care. In Phase II we will test the efficacy of PNs for overcoming barriers to acceptance of and adherence with HU therapy. Patients will be randomized to a PN arm or to a usual care arm. Providers will implement NIH guidelines for HU eligibility and prescribing in both arms. All HU eligible patients will be offered HU at each clinical visit. Among patients prescribed HU, if a maximum tolerated dose (MTD, defined in end points) has not been reached, providers will dose escalate every 8-12 weeks to MTD, rather than to clinical effect, before declaring treatment success or failure.

This project will be critically important and impactful by demonstrating the feasibility of a statewide community-based strategy to assist vulnerable SCD adults in obtaining SCD specialty care and likely prolonging life, a model that other states could adopt.

Eligibility Criteria:
PHASE I:

Inclusion Criteria:

* Patient Self Report of Sickle Cell Disease (Genotypes: Hb SS, SC, SBoThal, SB+Thal)
* 15 years or older
* Virginia resident

Exclusion Criteria:

-Visited one of a pre-selected list of sickle cell specialists in Virginia within the last 6 months

PHASE II:

Inclusion Criteria:

* Sickle Cell Disease (SCD) patient (Genotypes: SS or SBoThal)
* Eligible for Hydroxyurea (according to NIH guidelines)
* 15 years or older
* Virginia resident

Exclusion Criteria:

* Pregnancy
* Enrollment in scheduled chronic transfusion program
* SCD Genotype: Hb SC and SB+Thal)