cyrilzakka/clinical-trials huggingface dataset:
Quantification of Breast RadioTherapy Associated Late Toxicity Using Novel UltraSound Techniques

Around 20% of women who receive breast radiotherapy (RT) experience moderate to severe breast hardening and shrinkage. These side-effects have been shown to be important factors influencing quality of life after breast radiotherapy. It is thought that the likelihood of developing these side-effects is related to the presence of underlying genetic differences in patients. In order to identify these genetic differences, the severity of side-effects needs to be accurately measured. Currently, clinical assessments are conducted by a clinician but this is not specific enough to be able to relate development of breast shrinkage and hardening to genetic differences. For example, clinical assessment often fails to distinguish between hardness due to swelling (known as oedema) and hardness due to generalised radiation-induced scarring (known as fibrosis). Ultrasound techniques, however, may be able to help quantify and characterise radiotherapy-associated changes in breast tissue allowing for better correlation with genetic abnormalities. Once genetic changes can be identified, adjustment of breast RT treatments (or add drugs) to help reduce side-effects in women at higher genetic risk of side-effects may be possible.

This study tests the ability of two forms of ultrasound, shear-wave elastography (USE) and ultrasound backscatter spectroscopy (UBS), to quantify and characterise breast shrinkage and firmness with a view to using these techniques to measure the late side-effects of breast RT to study the underlying causes of radiotherapy toxicity.

Principle research question: Can a new ultrasound technique (shear wave elastography) measure radiation-induced side-effects in women who have received breast radiotherapy?


Eligibility Criteria:
Inclusion Criteria:

Two patient groups will be included:

1. IMPORT or FAST trial patients who received breast RT previously and have received four (or more) year follow-up assessment which found moderate or severe induration.
2. Patients who are (1) undergoing, or undergone recently, breast RT (general population) and have undergone a clinical assessment that found moderate or severe oedema, or (2) IMPORT HIGH patients who have received RT and have received one or two year follow-up which found moderate or severe oedema.

Exclusion Criteria:

* Patients with bi-lateral breast cancer.
* Patients who have undergone surgery to the contralateral breast for either benign or malignant conditions.
Adherence to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients

This is a non-interventional cohort study using existing administrative data from the U.S. Medicare program.

This study has two objectives:

* Identification of adherence trajectories of nintedanib among Idiopathic Pulmonary Fibrosis (IPF) patients.
* Understanding characteristics of patients within each nintedanib adherence trajectory among IPF patients.


Eligibility Criteria:
Inclusion criteria:

* Newly initiated nintedanib during 10/01/2014 to 12/31/2018
* Were at least 66 years old as of the date of their first nintedanib prescription claim (index date)
* Qualified for Medicare based on age
* Had at least 12 months (365 days) of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months (360 days) after the index date (follow-up period)
* Had at least one inpatient or two outpatient claims (\>14 days apart) with a diagnosis code for Idiopathic Pulmonary Fibrosis (IPF) during the baseline period

Exclusion criteria:

* Had any history of pirfenidone or nintedanib use during the baseline period
* Had any history of lung transplant during the baseline, index date or follow-up periods
* Had any claims for skilled nursing facility, long-term care facility or hospice during the baseline, index date or follow-up period
* Had evidence during the baseline period of any of the following conditions: lung cancer, autoimmune, or connective tissue diseases (i.e. rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's, and mixed connective tissue disease (CTD)) during the baseline period
* Had dual eligibility of Medicare and Medicaid
* Had history of using pirfenidone at the same time with nintedanib during follow-up
Evalution of Optical Enhancement With Magnification for Polyop Histology

When a polyp is found, it woulf be recorded by a white-light and OE1 model with magnification for assessing and predicting its histology. After that, its really histology will be reported by an pathologist.

When a polyp is found, OE mode 1 with magnification was first used with near focus the polyp and an endoscopist made a real-time prediction of polyp pathology. After that, high-definition mode and OE mode 1 without magnification were used to observe polyp sequencely. The video of all procedure was recorded.

After bowel cleansing with 2L polyethylene glycol, patients received colonoscopy under propofol intravenous anesthesia. When a polyp was found, we began to wash it and record the video. OE mode 1 with magnification was first used with near focus the polyp and an endoscopist made a real-time prediction of polyp pathology. After that, high-definition mode and OE mode 1 without magnification were used to observe polyp sequencely. Biopsy of the polyps were taken after observation, and the size of polyps was estimated by the biopsy forceps. The information of patient age, gender polyp morphology and location were recorded. After a video transcoding and clipping, the pathology type of each video clip was predicted by an endoscopist. The sensitivity, specificity, positive predicting value (PPV), negative predicting value (NPV) and accuracy were calculated. The pathology types of polyps were classified by non-neoplastic polyps and neoplastic polyps according to Vienna Classification. Statistics were performed by NCSS 11 and R software (Version 3.3.2).

Eligibility Criteria:
Inclusion Criteria:

* Patients will be included if they are found polyps during endoscopy procesure.

Exclusion Criteria:

* Inflammatory bowel disease
* Biopsies were not available.
* Unable to provide informed consent.
Dysphagia and Vocal Cord Injury Following Cardiac Surgery

Aiming to determine the incidence and contributing risk factors of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients and evaluate the impact of VFMI on health-related outcomes.

This is a retrospective study to determine:

1. the incidence and contributing risk factors of vocal fold mobility impairment (VFMI) and dysphagia in postoperative cardiovascular patients
2. evaluate the impact of VFMI on health-related outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All cardiac surgery patients January 2010-April 2020 at Shands Hospital
* Patients aged between 18 and 90 years
* Undergone an elective, urgent, and/or emergent cardiovascular surgery via endovascular or open (sternotomy and/or extended thoracotomy) technique at the University of Florida Health.

Exclusion Criteria:

* Under 18 years old or over 90 years old
A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGS

The main purpose of this study is to evaluate the efficacy and safety of baricitinib in adult and pediatric Japanese participants with Nakajo-Nishimura Syndrome/chronic atypical neutrophilic dermatosis with lipodystrophy and elevated temperature (NNS/CANDLE), STING-associated vasculopathy with onset during infancy (SAVI), and Aicardi-Goutières Syndrome (AGS).


Eligibility Criteria:
Inclusion Criteria:

* Have systemic signs and symptoms of inflammation as manifested NNS/CANDLE, SAVI, AGS
* Have been diagnosed with genetic diagnosis
* Men must agree to use a reliable method of birth control during the study
* Women not of child-bearing potential or nonbreastfeeding
* Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
* NNS/CANDLE and SAVI patients who are ≥17.5 months of age
* AGS patients who are ≥6 months of age
* Are ≥ 5kg in body weight

Exclusion Criteria:

* Have received immunosuppressive biologic agent/monoclonal antibody/oral JAK inhibitor/OAT3 inhibitor and cannot discontinue prior to investigational product initiation. Note: A washout period is required to each drug.
* Have diagnosis of current active tuberculosis (TB) or, latent TB who did not receive appropriate treatment.
* Have had a serious infection within 12 weeks prior to screening.
* Have a history of lymphoproliferative disease
* Have any history of venous thromboembolic event (VTE) (deep vein thrombosis \[DVT\]/pulmonary embolism \[PE\]) prior to screening.
* Have had any major surgery within 8 weeks prior to screening.
* Have previously been enrolled in any other study investigating baricitinib.
Database Study to Provide Information on Pregnancy and Infant Outcomes Among Women Exposed to QUVIVIQ (Daridorexant)

Healthcare claims database study to provide safety information on maternal, fetal and infant outcomes among women exposed to QUVIVIQ (daridorexant) during pregnancy

This is a longitudinal observational cohort study using an electronic database of healthcare claims data. Safety information will be retrospectively collected from the database and pre-specified diagnostic codes will be used to identify pregnancy and infant outcomes. The study will include two phases, a patient accrual phase (Phase 1) and an analysis phase (Phase 2).

Descriptive statistics will be conducted to characterize the patient population and to support the interpretation of comparative analyses. Comparative analyses will be performed to estimate the effect of QUVIVIQ exposure during pregnancy on the study outcomes. Approximately 419 mother-infant pairs with exposure to QUVIVIQ and 1676 mother-infant pairs with exposure to non-orexin receptor antagonist insomnia medication are expected with a 1:4 ratio of exposed:active comparator patients.

Analysis of the prevalence of each specific pregnancy or infant outcome will comprise: (1) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia exposed to any non-orexin receptor antagonist insomnia medication during or shortly prior to pregnancy (active comparator group); (2) a comparison between women with insomnia exposed to QUVIVIQ during or shortly prior to pregnancy (QUVIVIQ-exposed group) and women with insomnia unexposed to any insomnia medication during or shortly prior to pregnancy (unexposed comparator group).

Eligibility Criteria:
1. Evidence of a singleton end of pregnancy event during the intake period.
2. ≥ 1 insomnia diagnosis during the period which begins 12 months prior to the date of conception and ends at the end of pregnancy.
3. Date of conception ≥ 42 weeks before the end of the intake period.
4. Age 15 to 50 years at the date of conception.
5. Continuous medical and pharmacy insurance coverage during the period which begins 6 months prior to the date of conception and ends at the end of pregnancy.
6. No dispensing of known or suspected teratogenic medications during the period which begins 5 half lives of that medication prior to the date of conception and ends at the end of pregnancy.
7. No exposure to other orexin receptor antagonists during the exposure period, i.e., suvorexant, lemborexant, and any orexin receptor antagonists newly approved during the intake period.
TMC125-C223: TMC125 in HIV-1 Infected Subjects

The purpose of this study is to investigate the ability of TMC125, a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), to lower the amount of virus in your blood when administered twice daily for 48 weeks.

TMC125 will be given in addition to a combination of anti-HIV drugs that have been selected specifically for you by your doctor. There are three treatment groups in the study. One group will be given a dosage of TMC125, 400 mg twice daily. Another will be given 800 mg twice daily. The third group, a control arm, will not receive TMC125 (formulation TF035). The safety, tolerability and pharmacokinetics (determinations of the concentration of drug in your blood and its evolution over time) of TMC125 will also be evaluated in this study. Patients who have known resistance to NNRTIs and 3 or more protease inhibitor (PI) mutations may be eligible to participate. One-hundred-fifty (150) patients will be enrolled into this study. TMC125, 400mg twice daily for 48 weeks; TMC125, 800mg twice daily for 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 plasma viral load at screening \>1000 copies/ml
* Documented genotypic evidence of resistance to currently available NNRTIs
* Previous NRTI experience for at least 3 months
* 3 primary PI mutations at screening

Exclusion Criteria:

* Chronic HBV and/or HCV with elevated liver function tests \> 3x upper normal limits
* Any grade 3 or 4 toxicity according to the ACTG grading severity list (except for grade 3 glucose and asymptomatic triglyceride/cholesterol grade 3 or 4 elevation)
* Previous permanent discontinuation of any NNRTI due to cutaneous events.
Transobturator Verus Single Incision Slings

A randomized control trial to compare the efficacy of the single incision mini-sling to the transobturator sling

Transobturator slings are one type of sling that has become standard treatment for stress urinary incontinence. However, this procedure involves a total of 3 incisions to perform.

In contrast, single incision slings have been developed to treat stress urinary incontinence by using only one incision.

However, to date the success and complications of these two procedures have not been compared or studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients with urodynamically proven stress urinary incontinence who were planning on undergoing surgery for treatment.

Exclusion Criteria:

* Patients with prior incontinence surgery, a urodynamic diagnosis of intrinsic sphincter deficiency and mixed incontinence with a predominance of detrusor overactivity were excluded.
Measurement of MRP2 Function Using Urinary Coproporphyrins

Human Multidrug Related Protein 2 (MRP2) excretes several drugs and could therefore modulate their elimination. Individual's MRP2 activity is under genetic control. Thus it would be very useful to get an easily measurable biomarker reflecting individual's MRP2 activity. We aimed to investigate the ratio of urinary coproporphyrins I and III (UCP(I/I+III), known to be increased in patients with mutations in MRP2/ABCC2 gene.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* \> 18 y
* Affiliated to an health insurance

Exclusion Criteria:

* Patient not able to understand or to comply to the protocol
Testing of a Navigation Intervention for Hepatitis C and HIV

This study will evaluate the efficacy of navigation for hepatitis C treatment in people living with both HIV and HCV with criminal justice involvement.

Hepatitis C (HCV) is the most common chronic, blood-borne infection in the U.S. and, untreated, can result in liver failure and liver cancer. Despite advances in treatment and remarkable improvements in cure rates, very few persons with chronic HCV infection are receiving this treatment, especially among people who use drugs, who are also disproportionately HIV-infected and incarcerated. Existing efforts to ensure linkage to and retention in medical care following release from incarceration among people living with both HIV and HCV are generally insufficient. Increasing treatment engagement following release from incarceration can drastically reduce HCV and HIV in the blood, which can limit transmission to sexual and injection drug use partners.

The goal of this study is to evaluate the effect of a novel navigation intervention to improve HIV/HCV treatment engagement among HIV/HCV co-infected adults with criminal justice involvement. The investigators hypothesize that the navigation intervention is more effective than the current standard-of-care approaches to link this population of adults to HIV/HCV treatment. All participants, regardless of study arm, will complete one baseline interview around the time of study enrollment. Follow-up interviews are done at 3 months and 8 months following enrollment (if enrolled in the community) or after release from jail (if enrolled in the jail).

Blood samples to analyze the HCV RNA will be collected or requested from participants' clinics both for the baseline assessment and the assessment conducted 12 weeks after completion of the HCV treatment course (if the HCV RNA result cannot be obtained at 12 weeks, it will done at the 8-month follow-up interview). HIV RNA will be collected from the clinics.

In addition to the interviews and the HCV/HIV RNA assessments, participants assigned to the intervention arm will engage in a six- or seven-session navigation intervention. Participants will be in the study for about 12 months but no more than 3 years.

Eligibility Criteria:
Inclusion Criteria (if recruited in jail)

1. Diagnosed HIV+/HCV co-infection;
2. 18 years of age or older;
3. non-cis women;
4. Fluent in speaking English;
5. Have an anticipated sentence of no more than 12 months;
6. Have detectable Hepatitis C viral load
7. Going to live in LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County

If recruited outside of jail:

1. Diagnosed HIV+/HCV co-infection;
2. 18 years of age or older;
3. non-cis women;
4. Fluent in speaking English;
5. Incarceration history within the last 12 months of enrollment;
6. Have detectable Hepatitis C viral load
7. Going to live in LA County, Kern County, San Diego County, Riverside County, Ventura County or San Bernardino County

Exclusion Criteria:

1. Inability to give informed consent
2. CD4 count\<200
Correlating In Vitro Fertilization Outcomes After Euploid Blastocyst Transfer With Sperm DNA Fragmentation

The purpose of this study is to determine if sperm DNA fragmentation is associated with in vitro fertilization (IVF) outcomes when euploid embryos are transferred.

The purpose of this study is to determine if sperm DNA fragmentation is associated with in vitro fertilization (IVF) outcomes when euploid embryos are transferred. Euploid embryos are those that have a complete set of chromosomes (46, XX or 46, XY). Sperm DNA fragmentation refers to sperm DNA that is damaged or has an altered structure. The sperm chromatin structure assay (SCSA) is a method to evaluate sperm DNA Fragmentation.

Couples will undergo a routine IVF cycle at Reproductive Medicine Associates of New Jersey. Semen specimens collected on the day of ICSI will undergo semen analysis as per routine. An aliquot of semen (0.5- 1mL) will be collected for subsequent evaluation of DNA fragmentation by the Sperm Chromatin Structure Assay (SCSA) testing at SCSA Diagnostics. All embryo biopsies will undergo CCS analysis in the genomics laboratory, Foundation for Assessment and Enhancement of Embryonic Competence.

Eligibility Criteria:
Inclusion Criteria:

* Completing first IVF/ICSI cycle at Reproductive Medicine Associates of New Jersey
* Couple undergoing CCS (Comprehensive Chromosome Screening)
* Female age 35-40 years
* Male will have to refrain from ejaculation no less than 2 days but no greater than 5 days prior semen specimen production on day of oocyte retrieval

Exclusion Criteria:

* Known genetic abnormality
* Use of sperm donation or cryopreserved sperm
* Use of Oocyte donation
* Use of gestational carrier
* Use of testicular aspiration or biopsy procedures to obtain sperm
* Presence of varicosele
* Presence of hydrosalpinges that communicate with endometrial cavity
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
Adiponectin and Circulating Macrophage Phenotypes in Non-alcoholic Fatty Liver Disease (NAFLD)

In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes. M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus.

In peripheral blood; monocytes and macrophages are found in two phenotype; proinflammatory M1 and anti-inflammatory M2 phenotypes.

M2 form is converted (or polarized) to M1 phenotype in various metabolic disorders such as obesity and type 2 diabetes mellitus. In addition, these forms also are related to insulin resistance and inflammation in adipose tissue.

Today, there is no study that investigate the role of adiponectin an anti-inflammatory adipokine, on macrophage polarization in non-alcoholic fatty liver disease.

Eligibility Criteria:
Inclusion Criteria:

* Persistently (at least 6 months) elevated aminotransferases
* Ultrasonographic presence of bright liver without any other liver or biliary tract disease
* Liver histology compatible with a diagnosis of NASH or SS

Exclusion Criteria:

* A history of alcohol consumption \>40 g/wk, as assessed by a detailed interview extended to family members
* Morbid obesity \[body mass index (BMI) ≥40 kg/m2\], hypertension
* Positive blood markers of viral, autoimmune, or celiac disease
* Abnormal copper metabolism or thyroid function tests
* A diagnosis of T2DM and systemic arterial hypertension
* Total cholesterol (TC) ≥250 mg/dL, triglycerides (TG) ≥400 mg/dL, exposure to occupational hepatotoxins or drugs known to affect glucose and lipid metabolism
Mhealth for PrEP Adherence by Young Adult MSM, Phase 2

This Phase 2 project aims to enhance and test a mobile health intervention designed to increase adherence to the daily PrEP pill among culturally-diverse young adult men who have sex with men. The intervention will include: a) personalized PrEP pill reminders b) culturally- and developmentally-sensitive text messages targeting patient education, motivation, and stress c) a gamification avatar and d) a linked online community of peers. Effectively promoting PrEP adherence would reduce new HIV infections in this at-risk population, which is subject to health disparities

The project is to develop and test the effectiveness of an individually-tailored, developmentally- and culturally-sensitive, mobile health (mhealth) PrEP adherence intervention called DOT. The intervention will target culturally-diverse, young adult men, ages 18-35, who have sex with men (YMSM). The recent rise in HIV infection among young people, particularly minority YMSM, points to the value of PrEP uptake and adherence support for YMSM. In PrEP efficacy trials, younger age was the most consistent correlate with low PrEP adherence. Our DOT mhealth intervention reflects a developmental understanding of young adult decision-making, and is uniquely combined with principles from social cognitive theory, positive psychology and behavioral economics. The proposed project is based on Dr. Weitzman's successful Phase 1 trial of DOT, which led to significant improvements in PrEP adherence, PrEP treatment self-efficacy, and intention to follow PrEP treatment guidelines among the YMSM that used DOT for six weeks. Our proposed Phase 2 DOT mhealth intervention is directly responsive to Phase 1 findings by adding: 1) texts targeting motivation, patient education, and stress burden 2) online community for social support 3) linkage to the federal crisis text line 4) virtual avatar 5) cloud-based platform to view user engagement 7) calendar for clinic appointments and pharmacy refills 8) enhanced personalization of pill reminders and 9) enhanced adherence graphing. In Phase 2, we will test the effectiveness of DOT at improving PrEP adherence in a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria: (self report) Individuals who self-identify as a male, age 18-35, who has sex with men or who self-identify as a bisexual male or a gay male; currently taking PrEP; own a smartphone and desirous of adherence support.

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Exclusion Criteria: (self report) Males who do not meet the above criteria and/or currently use I.V. drugs.