cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Vitrectomy With ILM Peeling in Myopic Macular Hole With Only Posterior Retinal Detachment

Retinal detachment (RD) resulting from the macular hole (MH), also known as MH-induced RD (MHRD), most commonly occurs in eyes with high myopia and results in irreversible visual disorders. Although ILM peeling for MHRD reportedly achieves a high retinal reattachment rate that ranges from 70% to 100%, the MH closure rate is relatively low, ranging from 10% to 70%.


Eligibility Criteria:
Inclusion Criteria:

* patients with high myopia (a spherical equivalent refractive error of at least -6.0 diopters (D) and an axial length of at least 26.5 mm).
* Macular hole and only posterior retinal detachment

Exclusion Criteria:

* Other causes of RD
* Patients with a history of trauma, choroidal neovascularization, coexistence with a peripheral retinal break or proliferative vitreoretinopathy
* History of any vitreoretinal surgery prior to MHRD and less than 36 months of follow-up after the surgery
MRI Split Scar Sign as a Predictor to Complete Pathologic Response After Neoadjuvant Chemoradiation in Rectal Cancer

Patients with middle or low rectal cancer who receive neoadjuvant chemoradiation and achieve complete clinical response while their pelvic MRI have split scar sign are included. Patients will have total mesorectal excision and pathologic complete response will be assessed

Patients with middle or low rectal cancer who have T3-4 and/ or N+ will be included. Patients will receive neoadjuvant chemoradiation in the form of pelvic irradiation by 50.4 thousands grays together with radio sensitization by 5-FU or oxaliplatin, 8 months after completion of neoadjuvant chemoradiation patients will be assessed clinically and radiologically. Complete clinical response is diagnosed if clinically no tumor is felt or just small scar and no tumor appears in MRI. Of these patients who achieve complete clinical response we will pick up cases who have split scar sign in the pelvic MRI. Patients will have total mesorectal excision 8-11 weeks after completion of neoadjuvant chemoradiation and pathologic complete response will be assessed. Correlation will be done between preoperative clinical response and postoperative pathologic response

Eligibility Criteria:
Inclusion Criteria:

middle and low rectal cancer

Exclusion Criteria:

* Distant metastasis
Food for Health Equity: Evaluation of a Nutrition Assistance Program

This study seeks to evaluate whether a nutrition assistance quality improvement program for patients with cancer and food insecurity receiving active treatment at Pacific Cancer Care will have reductions in food insecurity.

This study seeks to evaluate the effectiveness and patient satisfaction with a nutrition assistance quality improvement program in which a randomly selected 30 patients will receive a food voucher with $40.00 each month for 6 months for use in the produce section at local grocery stores in the county. The primary outcome is understanding whether this program is effective at reducing food insecurity among patients being treated for cancer and will provide key insights that may guide program expansion or improvement.

Eligibility Criteria:
Inclusion Criteria:

* Patient Participants must be undergoing or starting treatment for cancer at the Pacific Cancer Care clinic who screen positive for food insecurity using at 2-item screener, speak English or Spanish, have capacity to consent (e.g. no dementia or other cognitive impairment), are Latinx or another racial and ethnic minority group OR low income, have public insurance, OR are insured by an agricultural company sponsored health insurance

Exclusion Criteria:

* Patients will be ineligible if they do not have a current cancer diagnosis, cannot communicate in English or Spanish, are deemed ineligible to consent, are under 18 years of age, are not Latinx or another racial/ethnic minority OR are not low income OR are not publicly insured, uninsured, or do not have health insurance from an agricultural company
Inter-observer Reproductibility of Visual Estimation of Left Ventricular Ejection Fraction in Critical Care

Inter-observer reproductibility of visual estimation of left ventricular ejection fraction is known to be good in cardiology but has not been studied in ICU. The goal of the study is to determine if this reproductibility is good enough.


Eligibility Criteria:
Inclusion criteria:

* practitioners working in intensive care.
* age \> 18 years

Exclusion criteria:

- Age under 18
Early Detection of Coronary Artery Disease by Polygenic and Metabolic Risk Scoring

The overall goal of this study is to develop a combined polygenic risk score (PRS) and metabolic risk score (MRS) and determine its impact on selecting community members for CCS. The trial component of this study will compare the use of these scores to motivate people to adhere to therapy, an ongoing challenge for clinicians, by providing feedback in a meaningful form to both the clinicians and the patients.

Patients undergoing a polygenic risk score (PRS), metabolic risk score (MRS) and coronary calcium score (CCS) will be randomized to receive PRS and CCS information and followed for the reduction of risk over 12 months. This information will provide information about how to motivate people to adhere to therapy, by providing feedback in a meaningful form to both the clinicians and the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Asymptomatic subjects age 40-70y
2. Statin naïve
3. TC ≤ 6.5 mmol/L and LDLC \<5 mmol/L, and
4. 5 year Australian risk ≥2%.

Exclusion Criteria:

1. Symptomatic coronary, cerebrovascular, or peripheral vascular disease
2. Intolerance of statins or currently on statins for any length of time
3. Pre-existing muscle disease (eg polymyositis, fibromyalgia) - this may be confused with myalgia from statins
4. Patients on drugs that increase the risk of myopathy/rhabdomyolysis such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV/hepatitis C protease inhibitors)
5. Atrial fibrillation (interferes with CTCA)
6. Chronic kidney disease on haemodialysis (because of vascular calcification) or GFR \<50ml/min per 1.73m2 using the Modification of Diet in Renal Disease (MDRD) formula
7. Inability to provide informed consent
8. Major systemic illness eg. malignancy; rheumatoid arthritis
9. Women of child bearing potential (due to performance of CT)
10. Poorly controlled hypertension: SBP\> 200 and or DBP \> 100
11. Severe psychiatric disorder (eg bipolar depression; psychosis)
12. Patients eligible for treatment based on current Australian guidelines (5 year risk \>15%)
13. Patients eligible for treatment based on current PBS thresholds TC \>7.5 mmol/l and other criteria (see below).
Addressing Violence and HIV Care Among Transgender Women

This project seeks to adapt and pilot a trauma-informed combination intervention named 'Kickin' it with the Gurlz' that was designed with, for, and by transgender women of color to improve HIV care continuum outcomes. The intervention components include a violence and gender affirmation screening tool, a peer-led adaptation of Seeking Safety, and individual-level peer navigation sessions. The project will examine the feasibility, acceptability, and preliminary promise of the multicomponent by conducting a one-arm pilot with 30 transgender women of color who have a history of trauma. Participants will complete baseline, immediate post-intervention, and 3-month follow up assessments.

This project seeks to evaluate the feasibility and acceptability of the trauma-informed combination care intervention to improve HIV care continuum outcomes including the development of community-informed strategies for subsequent RCTs. We will conduct a one-arm pilot of the adapted multicomponent trauma-informed intervention named "Kickin it with the Gurlz." This project will collect feasibility and acceptability data related to identifying, recruiting, enrolling, intervening with, and retaining participants (i.e. recruitment length, screening procedures, feasibility of conducting sessions, intervention acceptability, retention rates, feasibility of verifying self-reported and medical chart review data on viral load and exit interviews with participants and staff at program conclusion). The study will recruit 30 participants into the pilot study. Participants will complete baseline, end of program, and 3-month post-intervention follow-up surveys. Exit interviews and interviews with key stakeholders will identify strategies for implementing trauma-informed HIV treatment efficacy trials with transgender women of color within close-knit communities, such as acceptable and feasible control conditions, acceptable and feasible violence and gender affirmation screening, biomedical confirmation methods, contamination concerns, and potential changes needed within existing health care systems.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Assigned male at birth; identifies as female, transgender woman, or another feminine gender identity
* Self-identifies as a person of color (any racial/ethnic identity except non-Hispanic white)
* Self-reports as HIV-positive
* History of trauma (i.e., endorses at least 2 items on the adapted Trauma History Screener which includes IPV and experiencing or witnessing other forms of violence for transgender women
* Living or willing to travel to Detroit
* English-speaking
* Willing and able to provide informed consent.

Exclusion Criteria:

• Evidence of severe cognitive impairment or active psychosis that may impede ability to provide fully informed consent
Trans-incisional Quadratus Lumborum Block Versus Caudal Analgesia in Pediatric Open Renal Surgeries.

There is scare literature about the usage of QLB in pediatric population, particularly the trans-incisional approach. Hence, the purpose of this study is to compare the postoperative analgesic efficacy of ultrasound-guided caudal epidural block versus ultrasound-guided QLB (trans-incisional) in combination with general anesthesia in pediatric patients undergoing elective open renal surgeries regarding pain scores, total analgesic consumption, and adverse effects.


Eligibility Criteria:
Inclusion Criteria:

1. patients who will be scheduled for indicated open pediatric renal surgery in the lateral decubitus position (nephrectomy, partial nephrectomy, pyeloplasty and nephrolithotomy for complex renal stones).
2. physical status American Society of Anesthesiologists (ASA) I or II.

Exclusion Criteria:

1. - patients whose guardians refuse to participate.
2. -ASA physical status \>II. 3-patients who have contraindications to regional analgesic procedures. 4-patients who have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological).

5-spine or chest wall deformity. 6-History of previous renal surgeries. 7-Coagulation abnormalities. 8-Infection at the injection site. 9-An allergy or contraindications to the drugs used in the study.
Patients With Co-occurrence of ANCA Vasculitis and Sjögren Syndrome

ANCA vasculitis and Sjögren syndrome are two rare diseases, and even more rarely associated. These two conditions have specific organ involvements, and specific follow-up.

The Investigators hypothesise that patients with co-occurrence of these two diseases may have a singular clinical course.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of ANCA vasculitis based on clinical, immunological and histopathological features.
* Diagnosis of Sjögren syndrom based on ACR/EULAR 2016 criteria.

Exclusion criteria:

* Age \< 18 years
* Insuffisant data during follow-up
Australian UCSF Concussion in Athletes

Analysis of cardiac induced brain forces using cranial accelerometry has been shown to diagnose concussion in high school athletes. This trial expands on this observation by recording headpulse signals in a recently concussed athletes playing Australian rules football.

Recently concussed athletes will have headpulse measurements obtained as soon after the clinically identified concussion as is feasible and at 1-3 day intervals over the course of a month. These recordings will pair with a self administered neurological symptom inventory (NSI) to track the athletes subjective concussion symptoms. Data will be used to confirm prior models of analysis and produce a tool to be confirmed in a future study.

Eligibility Criteria:
Concussion Subjects:

Inclusion Criteria:

* Diagnosed with sport related concussion
* first recording obtained within one week
* willingness to have multiple recordings in the month following concussion

Exclusions:

- head laceration

Control subjects:

Inclusion Criteria:

* athletes without concussion over the last year
* willingness to have single or multiple recordings

Exclusion Criteria:

- head laceration
Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer

RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA together with letrozole may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of DHEA when given together with letrozole in treating patients with metastatic breast cancer.

OBJECTIVES:

* To determine the maximum tolerable dose, dose-limiting toxicity, and pharmacokinetics of dehydroepiandrosterone (DHEA) when given together with letrozole in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer.

OUTLINE: Patients receive oral dehydroepiandrosterone and oral letrozole once daily. Physical exams and blood collections are performed every two weeks. Tumor assessments are performed once every three months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Metastatic disease
* Hormone receptor status

  * Estrogen receptor- and progesterone receptor-negative
  * Androgen receptor-positive

PATIENT CHARACTERISTICS:

* ECOG performance status 0-3
* Postmenopausal (\> 60 years of age)
* Leukocyte count \> 3,000/uL
* Absolute neutrophil count \> 1,500/uL
* Platelet count \> 100,000/uL
* Total bilirubin normal
* AST and ALT \< 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance \> 60 mL/min

PRIOR CONCURRENT THERAPY:

* At least 4 weeks since prior chemotherapy
* At least 4 weeks since prior biologic therapy
* At least 4 weeks since prior radiotherapy
* At least 30 days since prior investigational agents
* No concurrent dehydroepiandrosterone or androstenedione supplements
* No concurrent chemotherapy or radiotherapy
* No concurrent hormone therapy or immunotherapy (including trastuzumab \[Herceptin®\])
Liver Fat as a Dietary Target for Treating Cardiometabolic Disorders in Prediabetes and Type 2 Diabetes

The overall aim of this study is to investigate the long-term impact of a customized diet aimed at reducing liver fat specifically and a healthy Nordic diet on ectopic fat (liver, pancreatic and visceral) and cardiometabolic risk in individuals with prediabetes and type 2 diabetes (T2D).

Randomized controlled studies investigating the impact of replacing dietary carbohydrates with polyunsaturated fat (PUFA) on liver fat content and cardiometabolic risk in individuals with prediabetes and T2D are lacking. Also, the effects of a Healthy Nordic Diet on liver fat content and glycemic control have not be investigated. This study therefore aims to:

* Investigate the effects of the diets on liver fat content (primary aim)
* Investigate the effects of the diets on pancreatic fat, visceral fat, lean tissue, glycemic and lipid control
* Investigate the effects of the diets on plasma markers of de novo lipogenesis (DNL) and desaturation (i.e. stearoyl-Coenzyme desaturase 1, SCD-1) as well as on hepatic DNL using MRI spectroscopy
* Investigate gene-diet interactions, especially if common gene variants (e.g. in PNPLA3) known to increase liver fat and dyslipidemia, may modify the dietary effects.
* Perform lipidomic analyses to identify potential mechanistic pathways that may associate with diet-induced changes in liver fat, pancreatic fat, visceral fat, insulin sensitivity, dyslipidemia or DNL

Our hypothesis is that a customized diet will effectively reduce liver fat through suppression of hepatic DNL and SCD-1 activity, and thereby improve atherogenic dyslipidemia, insulin resistance and hyperglycemia in individuals with prediabetes and T2D.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* 30-75 years
* BMI 25-40
* T2D (duration ≤10 years, no insulin treatment) or prediabetes (ADA definition 2019) without diagnosed cardiovascular disease (CVD) during the last 2 years (e.g. myocardial infarction, stroke or angina pectoris)

Exclusion Criteria:

* BMI \>40
* Alcohol intake \>20 g/day
* Unwillingness to follow a new prescribed diet for 1 year
* Diet-induced weight loss (≥10%) the preceding 3 months of screening
* Malignant disease
* Severe kidney and liver disease
* Heart failure or other severe CVD
* claustrophobia or metal parts in the body (MRI)
Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding, Contraceptive Continuation, and Depression

The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants.

In the United States, depot medroxyprogesterone acetate (DMPA) is given to women after delivery and before hospital discharge with the belief that women who delay starting DMPA may be more likely to become pregnant when they are not yet ready to be pregnant and that giving DMPA before discharge has little to no negative effect on breastfeeding. Administering DMPA to breastfeeding women has not been widely questioned because the limited existing studies do not show any adverse impact of DMPA on breastfeeding. However, these studies used inappropriate control groups and did not control for prior lactation experience.

The investigators plan to enroll 184 women who are planning to breastfeed and use DMPA after delivery to find out whether the timing of postpartum administration of DMPA (prior to hospital discharge or 4-6 weeks after delivery) affects the duration or exclusivity of breastfeeding among women who plan to breastfeed their infants. The investigators will also look at rates of use of highly effective contraception (defined as DMPA, intrauterine device, implant, sterilization, or lactational amenorrhea) and postpartum depression.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old and \> 24 0/7 weeks pregnant at time of enrollment
* Planning to deliver at Magee-Womens Hospital and to breastfeed
* Plans to use DMPA for postpartum contraception for at least 6 months
* Willing and able to provide informed consent in English and to comply with study protocol

Exclusion Criteria:

* Intolerance of irregular vaginal bleeding
* Severe coagulation disorder
* Severe liver disease (LFTs \>2x upper limits of normal at time of randomization)
* Contraindications to breastfeeding: maternal HIV infection; active herpes simplex with breast lesions; active varicella; active, untreated tuberculosis; antineoplastic, thyrotoxic, or immunosuppressive medications; concern that the infant may have galactosemia
* History of breast cancer, reduction or augmentation surgery
* History of severe clinical depression
* Multiple gestation
Use of a Foot Length Card to Improve Careseeking Practices of Vulnerable Newborns in Sarlahi District, Nepal

This study will evaluate whether or not provision of a simple card ("footlength card") that allows identification of low birth weight and/or preterm babies through measurement of the length of a baby's foot, can improve basic newborn care behaviors in rural Nepal.

This study will evaluate a recently developed, simple, low-cost tool that can help recently delivered women and their family members identify whether or not their newborn baby needs extra care/attention. Some prior studies of the relationship between anthropometric measures (such as chest-circumference, footlength, head circumference, etc) and preterm birth or low birth weight, have shown that these measures can be used to identify high-risk/vulnerable babies. One such measure, foot length, has been shown to be a reasonable tool, and one that can be simply performed by mothers, without disturbing the newborn infant. With this in mind, Save The Children has developed a low cost card with an image of a baby's foot on one side, along with a toll-free number and some key messages on how to use the card. Specifically, pregnant women can be given this card during an antenatal contact, along with some basic instructions on its use. Then, after their baby is born, the newly delivered woman, other family member, or low-level facility provider can compare the length of the baby's foot to the image on the card, by lining the baby's foot up with the card. If the baby's foot is shorter than the image on the card, a toll-free number (provided on the card itself) can be used to access a set of standardized messages about how to take care of the baby.

In this proposed study, Save the Children, Johns Hopkins University (JHU), and the JHU-led Nepal Nutrition Intervention Project - Sarlahi (NNIPS) will give this card to women currently enrolled in the Nepal Oil Massage Study (NCT01177111), explain its use, follow up with the woman after delivery to determine if she used the card, and query her about her experience using the card, calling the toll-free number, and recalling the messages given. Additionally, one of the NNIPS staff workers will use the same card to measure the baby's foot. Ultimately, the study will summarize women's experience using this card, and provide guidance to Save the Children, the Ministry of Health and Population (MOHP), and other stakeholders regarding future programmatic scale up of the use of this card.

Eligibility Criteria:
Inclusion Criteria:

* Woman is pregnant
* Woman is enrolled in ongoing newborn oil massage study

Exclusion Criteria:

* Not pregnant
* Not enrolled in ongoing newborn oil massage study