cyrilzakka/clinical-trials huggingface dataset:
Hot Flash as a Marker of Cardiovascular Risk in Recent Postmenopause: Effects of Non-hormonal Treatments

Hot flashes, vasomotor symptoms that affect many postmenopausal women, are associated with cardiovascular disease and endothelial dysfunction. Estrogen therapy, associated or not with progestogens, is the standard treatment for vasomotor symptoms and improves the endothelial function of postmenopausal women with hot flushes, even those with cardiovascular risk factors, such as hypertension. It is not known whether hot flushes are a cause for the development of endothelial dysfunction or are markers of this dysfunction, evidenced by estrogen deficiency, thus representing primitive target organ (vessel) lesion. Paroxetine was approved by the FDA as a non hormonal treatment for menopausal hot flashes. In this double-blind randomized clinical trial, the vascular effects of paroxetine at a dose of 7.5 mg / day, compared to placebo, during 12 weeks are evaluated.

Paroxetine and placebo effects at baseline and after 12 weeks in endothelial, autonomic and pressure components of vascular function are evaluated.

Non invasive venous occlusion plethysmography is used to study endothelial function; ambulatory blood pressure monitoring is used to study blood pressure variations during daytime and nocturnal descent; autonomic function is studied following sympathetic and parasympathetic parameters through heart rate variability.

The effects of paroxetine and placebo are also evaluated on:

* daytime sleepiness (through Epworth Sleepiness Scale ),
* sleep quality (through Pittsburgh Sleep Quality Index),
* perceived stress (through Perceived Scale Stress).

Biochemical and hormonal profiles including complete lipid profile, fasting glucose, insulin, estradiol, follicle stimulating hormone (FSH), luteinizing hormone (LH); inflammatory and oxidative stress markers are also studied.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopause
2. Present hot flushes (note ≥ 3 on a scale of 0 to 10)

Exclusion Criteria:

1. \> 10 years of hypoestrogenism
2. Smoking
3. Diabetes mellitus or altered fasting glycemia in use of oral hypoglycemic agents or insulin
4. BMI ≥ 35 Kg / m2
5. Uncontrolled hypertension - blood pressure (BP) ≥ 140/90 mmHg
6. Users of glucocorticoids, phytoestrogens, β-blockers, selective serotonin reuptake inhibitors (SSRIs), selective noradrenaline reuptake inhibitors (SNRIs), clonidine, gabapentin, pregabalin, cinnarizine, alphamethyldopa or any drugs with effects on the central nervous system;
7. Uncompensated hypo or hyperthyroidism;
8. Previous cardiovascular event history.
Predicting Placental Pathologies by Ultrasound Imaging

Intrauterine growth restriction (IUGR) is caused when the placenta cannot provide enough nutrients to allow normal growth of the fetus during pregnancy. It is unclear why IUGR happens, but an increase in inflammatory T cells in the placenta known as villitis of unknown etiology (VUE) is observed in many IUGR infants. The investigators aim to develop ultrasound methods for diagnosing VUE to understand it's role in IUGR.

Intrauterine growth restriction (IUGR) occurs in 3-10% of all pregnancies and is associated with significant morbidity and mortality during pregnancy, after birth and throughout the child's lifespan. IUGR is caused by the inability of the placental vasculature to provide enough oxygen and nutrients to support the fetus; yet, the mechanisms leading to disruption of placental vasculature are unknown. The placenta of \~50% of IUGR fetuses are infiltrated with inflammatory cells, specifically maternal T cells, which destroy placental blood vessels that support the fetus. This infiltration of T cells is known as villitis of unknown etiology (VUE). The diagnosis of VUE is problematic because it occurs without clinical signs and symptoms of maternal (or fetal) distress and puts the fetus at significant risk of demise. Additionally, VUE commonly recurs in subsequent pregnancies putting future offspring at risk. Yet, the exact prevalence of VUE and its significance in IUGR pathogenesis and outcomes are poorly understood as VUE is only diagnosed after the infant is outside the womb. Therefore, the study aims to recognize risk factors and cellular mechanisms associated with VUE and develop methods for diagnosing and treating VUE in utero, in order to improve infant health.

Eligibility Criteria:
Inclusion Criteria for IUGR study cohort:

* Pregnancy \> 28 weeks gestation
* Diagnosis of Intrauterine Growth Restriction (IUGR) before admission for labor and delivery
* Weight \> 110 lbs (50 kg)
* Ability to understand and provide written informed consent

Inclusion Criteria for control cohort:

* Pregnancy \> 28 weeks gestation
* No known pregnancy complications at prenatal obstetrical visit (+/- 1 week gestational age of matched subject in IUGR cohort)
* Weight \> 110 lbs (50 kg)
* Ability to understand and provide written informed consent

Exclusion Criteria:

* Known immunodeficiency or pregnancy complication (i.e. preeclampsia or gestational diabetes)
* Known autoimmune disease (e.g., rheumatoid arthritis or systemic lupus erythematosus) or chronic hypertension
* Chronic, active viral infections, including HIV-1/2, HTLV-1/2, Hepatitis B or C
* Solid organ or transplant recipient
* Current smokers (tobacco exposure within 30 days of registration)
* Conceptions from assisted reproductive technology (prior Clomid use is allowed)
* Multiple gestation
* Ruptured membranes
* Pregnancy \<28 weeks gestation
* Not planning on delivering at Mayo Clinic
Development of a Tumor Molecular Analyses Program and Its Use to Support Treatment Decisions

The primary objective of this specimen correlative study is two-fold: to provide a mechanism for the association of known molecular alterations with clinical outcomes, and to provide rapid genetic profiling of alterations with known clinical utility using tumor and germline specimens to support treatment decisions.


Eligibility Criteria:
Inclusion Criteria:

1. Current or prospective cancer patients; current cancer patients must have histologically or cytologically confirmed diagnosis of cancer
2. Tumor tissue available and suitable for molecular analyses from at least one of the following sources:

   * Tissue previously stored in UNC's Tissue Procurement Facility (TPF)
   * Tissue previous stored at an institution other than UNC-CH, provided investigators can determine that the tumors were sampled and stored under appropriate conditions for inclusion in the study
   * Patient undergoing tissue collection as per clinical standard of care and willing to allow specimens from surplus tissue to be diverted for research purposes
   * Patient undergoing tissue collection as per clinical standard of care and willing to have additional specimens taken for research
   * Patient willing to undergo biopsy for purpose of research only
3. The following inclusion criteria apply only to patients undergoing biopsy for research purposes only under this protocol:

   * ≥18 years of age
   * Treatment options offer no expectation of cure, e.g., advanced solid tumor patients with metastatic disease. NOTE: This restriction applies to biopsy of vital organs only, e.g., lung, liver, etc.
   * Appropriate candidate for research biopsy based on institutional standards for target biopsy site

Exclusion Criteria:

1. Any condition that would make participation in the protocol unreasonably hazardous for the patient in the opinion of the treating physician
2. Dementia, altered mental status, or any psychiatric condition or co-morbid condition that would prohibit the understanding or rendering of informed consent.
3. The following exclusion criteria apply only to enrolled patients undergoing biopsy for research purposes only:
4. History of serious or life-threatening allergic reaction to local anesthetics (i.e. lidocaine, xylocaine) or any medications used for conscious sedation (if applicable).
5. Requires general anesthesia for collection of biopsy
6. Pregnant or lactating women
7. Active cardiac disease
8. Patients receiving bevacizumab less than 6 weeks prior to enrollment into this study should not undergo research core biopsies because of the concern for potential increased bleeding risk and delayed healing. (NOTE: Patients receiving bevacizumab who are undergoing a research biopsy of accessible organs (e.g. breast, lymph node, skin etc.) must be two weeks from the last dose of the angiogenesis inhibitor).
A Self-efficAcy Intervention to reDuce Injecting Risk behAviour and hePatitis c reinfecTion Rates

The study evaluates the use of implementation intentions to increase self-efficacy and reduce injecting risk behaviour in a sample of injecting drug users on treatment for hepatitis C (HCV). The overall aim is to reduce HCV reinfection rates. The primary objective is to identify lower injecting risk behaviour scores in patients on treatment for hepatitis C receiving the psychosocial intervention compared to the same patient group assigned to the control group.

The intervention will entail completing a volitional help sheet.This will create implementation intentions, which are self-regulatory strategies taking the form of "if-then" plans (i.e. situation-solution plan).

Injecting risk behaviour scores and self-efficacy scores will be analysed for differences between intervention and control groups.

To control for contact-time with the researchers, participants in the control group will spend approximately 20 minutes with the researcher exploring Zimbardo's time perspective constructs (ZTPI, Zimbardo \& Boyd, 1999) and completing the short Zimbardo's time perspective inventory (Orosz et al. 2017). The inventory was selected because the cognitive processes involved in accessing time constructs will also be activated in the intervention group for the planning of coping strategies and goal achievement during future injecting risk situations.

The study also aims:

* To assess the variability in injecting risk behaviour as explained by subjective norms, social connectedness and group identification constructs;
* To assess the variability in intervention effectiveness as explained by changes in mental health, illness perception subjective norms, social connectedness, and group identification.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female. (Over 18 years of age);
* Chronic HCV positive infection;
* Current illicit drug use established through participants' self-report;
* Current HCV treatment provided by the NHS;
* Informed consent, agreeing to study and monitoring criteria;
* English-speaking.

Exclusion Criteria:

* Inability to provide informed consent;
* Aggressive or violent behaviour;
* Not currently receiving HCV treatment;
* Inability to communicate in English.
The Effect of Rocking Bed on Preterm Newborns

The study was planned to determine the effect of rocking bed applied to preterm newborns on comfort, physiological parameters and cerebral oxygenase level (rSO2).

In most cultures, providing a newborn baby on the lap or in a rocking bed is mostly used to calm the baby. However, preterm babies who leave the uterus, which is their accustomed environment, in the early period, are positioned on a fixed bed such as an incubator or jeans in the NICU. These beds may reduce the infant's vestibular knowledge and the NICU environment may deprive infants of sensory stimuli. It has been suggested that because the vestibular system is one of the first systems to become functional, preterm infants may be more sensitive to stimulation of the vestibular system than other systems. When the studies were examined, it was seen that limited studies were conducted in the sample of preterm infants and the studies were not recent. Considering that babies are rocked in most cultures, it is thought that the evidence for the effects of the intervention on the baby is insufficient.

Eligibility Criteria:
Inclusion Criteria:

* Born at 32-37 weeks of postmenstruel age
* Not receiving mechanical ventilation support,
* Not receiving analgesia or sedative drug therapy,
* Congenital anomaly, intraventricular hemorrhage, meningitis, chromosomal anomalies, cyanotic congenital heart diseases, neonatal seizures and preterm infants without a diagnosis of sepsis

Exclusion Criteria:

• Infants with diseases that may decrease cerebral oxygenation such as cerebral edema, intraventricular hemorrhage, cerebral hypoxia will be excluded from the study.
PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants

The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU). By moving beyond the basic infant care tasks taught by parenting programs and instead comprehensively training parents to use evidence-based family management skills, we hypothesize that our intervention, called PREEMIE PROGRESS, will better equip parents to meet the chronic, complex healthcare needs of their preterm infant.

Increasing numbers of very preterm infants are surviving and have chronic, complex healthcare needs due to prematurity. These infants experience increased healthcare utilization, long durations of stay in the Neonatal Intensive Care Unit (NICU), and are at high risk of developing prematurity-related complications. As a result, their care is complex, and families need structured training to effectively understand, monitor, and manage their infant's care. PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant. This research aims to 1) refine a novel family management program, called PREEMIE PROGRESS, through iterative usability and acceptability testing and 2) test feasibility and acceptability of the refined intervention and study procedures in a pilot randomized controlled trial. This project will use implementation science tools and approaches to refine the intervention and study procedures to ensure that PREEMIE PROGRESS addresses key program elements that will be important for future adoption and implementation in NICU settings. We anticipate that the intervention will decrease parent anxiety and depression, increase infant weight gain and receipt of mother's milk, and reduce neonatal healthcare utilization. The long-term goal of this project is to develop, test, and translate into NICU practice an efficacious family management intervention for parents of preterm infants. Dr. Weber will significantly advance nursing science through this project by obtaining preliminary feasibility and acceptability data for a scalable and sustainable intervention to facilitate family management and improve parent-infant health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking parents
* Parents preterm infants born 25 0/7-31 6/7 weeks gestational age (GA)
* Parents who had a singleton or twin birth
* Parents 18 years of age or older

Exclusion Criteria:

* Mothers too ill (serious maternal complications, medications that impact alertness/ orientation) to provide informed consent
* Infants with imminent or probable death based on the healthcare team's judgement
Hearing Healthcare Assessment in Rural Communities

Adult hearing loss in is the third most common chronic health condition in the United States. Adults living in rural areas face a higher risk of experiencing hearing loss, and more difficulty receiving testing and treatment than adults in urban settings. The goal of this clinical trial is to develop and test a community-based hearing healthcare patient navigation program in rural Kentucky. The main question this study aims to answer is:

-Can the number of rural adults receiving diagnostic hearing tests be increased?

Investigators will pilot test the rural hearing health care patient navigation program (N=500 patients from 10 rural clinics). The program will be evaluated with the following outcome: number of participants obtaining a diagnostic audiogram within past 12 months after enrollment among rural adults

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older)
* Able to speak, understand, and read English.

Exclusion Criteria:

-Under 18
Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients

The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between the ages of 18 85 years, inclusive.
* Subjects with hyperuricemia and a history or presence of gout per American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2015 criteria.
* Subjects who are currently on urate-lowering therapies (ULT) with an sUA level ≥6.0 mg/dL at screening (Visit 1); or subjects who are currently not on ULT with an sUA level ≥7.0 mg/dL at screening (Visit 1). Subjects currently on ULT will undergo washout and must have an sUA level ≥7.0 mg/dL at Visit 3 to be randomized and participate in the study.
* Subjects with a Body Mass Index ≤50 kg/m2 and estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 at screening (Visit 1).

Exclusion Criteria:

* Subjects with secondary hyperuricemia and enzymatic defects.
* Subjects experiencing an acute gout attack (intense pain, swelling, or/and tenderness in the joint area) within 2 weeks prior to screening (Visit 1).
* Subjects who have received pegloticase to treat gout which has not responded to the usual treatments.
* Subjects who have not been receiving stable doses of drugs known to affect sUA levels for the last 3 weeks prior to screening (Visit 1).
* Subjects with a history of xanthinuria (elevated levels of xanthine in the urine).
Defeating Urinary Incontinence With Exercise Training (DUET) Feasibility Study

Pilot study to determine the feasibility and possible treatment effect of a multi-component intervention combining non-drug treatments for urinary incontinence and physical activity to improve urinary incontinence, toileting skills, physical function, and quality of life in frail older women without dementia living in senior housing facilities.

This was a single blinded, two-arm pilot randomized controlled trial designed to test the feasibility and potential treatment effects of a multi-component intervention that combined behavioral urinary incontinence treatments with physical activity to improve urinary incontinence, toileting skills, quality of life, and physical function in frail older women without dementia living in senior apartment buildings.The intervention included a 12-week program of tailored behavioral UI treatments delivered by a nurse practitioner during 4 home visits, 150 minutes of weekly walking, and twice weekly strength training classes.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 60 years or older
* Have urinary incontinence
* Not currently meeting national recommendations for physical activity (150 minutes of weekly moderate intensity aerobic exercise and twice weekly strength building exercise.
* At risk for functional decline per the Vulnerable Elders Survey (score of 3+)
* Free of dementia (pass mini-cog screening)

Exclusion Criteria:

* Cognitive impairment
* Grade 4 vaginal prolapse or pessary use
* Orthopedic surgery in past year
* Urinary retention (catheter use)
* Neurological cause for urinary incontinence (i.e. Parkinson's Disease, MS)
* Bladder cancer
* Bladder or incontinence surgery in past year
* Recipient of hospice or palliative care
* Ostomy
* New prescription or dosage change in past three months for anti-incontinence medication
Effect of Weekly Plyometric Training Frequency on Youth Female Basketball Players: A Comparison of Two vs. Four Sessions

Players were randomly assigned to a two-times-a-week (2PLYO, n = 15) or four-times-a-week (4PLYO, n = 15) PT (Plyometric Training) group. Both groups performed the same weekly total volume of jumps during PT in addition to regular basketball training and competition. The 2PLYO group performed 240 jumps over two sessions (120 jumps per session), and the 4PLYO group performed 240 jumps over four sessions (60 jumps per session). After the eight-week intervention, all players underwent a one-week detraining period with no PT training while basketball training and competitions continued. Testing was performed at baseline (pre-test), after intervention (post-test), and after the detraining period. Players were assessed for lower body power using jump tests (countermovement jump \[CMJ\], drop-jump \[DJ\] from a 20-cm box, and horizontal jump \[HJ\]; change of direction ability using a planned agility test; and speed using a 20-m sprint and a 5-m split.


Eligibility Criteria:
Inclusion Criteria:

* Minimum of four basketball training sessions with at least 90-min duration and one competitive game per week.

Exclusion Criteria:

* Musculoskeletal, neurological, or orthopedic injury that may impair their participation.
Generic Travoprost Versus Brand Name Travoprost in Patients With Primary Open Angle Glaucoma or Ocular Hypertension

The purpose of this study is to compare the efficacy and tolerance of generic travoprost with its brand name formulation. In this open label, randomized, crossover study, the primary outcome will be intraocular pressure and the secondary outcome will be tolerance to the drops, as measured by a subjective questionnaire. Patients will be randomized to receive either brand name or generic travoprost during the first visit. At the second visit 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the medication. Patients will then receive the other formulation of travoprost. At the third and final visit, another 3 weeks later, their intraocular pressure will be measured and a questionnaire will be completed on the tolerance of the second medication.


Eligibility Criteria:
Inclusion Criteria:

* Be apt to give consent
* Have a diagnostic of primary open angle glaucoma or ocular hypertension requiring treatment

Exclusion Criteria:

* Angle closure glaucoma or having benefited from a peripheral iridotomy
* Known allergies to travoprost or to one of the ingredients
* Current usage of other glaucoma drops other than travoprost
* Current usage of topical corticosteroids
* Pregnancy
* Breast feeding
* Monophthalmic
* Having benefited from glaucoma surgery including trabeculectomies, implant drainage devices, and selective laser trabeculectomies
* Active intraocular inflammation
* Ocular surface disease that interferes with accurate measuring of the intraocular pressure
* Any clinically significant ocular disease that could interfere with the study