cyrilzakka/clinical-trials huggingface dataset:
Dario Blood Glucose Monitoring System - Android Devices Altitude Evaluation Study

This study evaluates the performance of a blood glucose monitoring system at high altitudes (approximately 10,000 feet). The performance is assessed via a reference method for glucose analysis (Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer).

This study will be a non-randomized study conducted to assess the accuracy and performance of the Dario Blood Glucose Monitoring System at an elevated altitude. 50 subjects will be enrolled in this study. Participation includes a 15-20 minute visit to the clinical site where they will be consented. The participant will then receive a fingerstick to obtain capillary blood used to test the performance of the BGMS and to obtain a comparative glucose measurement on the reference method, the Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak and read English

Exclusion Criteria:

* Pregnant
* Has any condition that the principle investigator believes may interfere in the subject's participation in the trial.
Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring

The first 1,000 days of life, from the conception to 24 months, are crucial to achieve long-term health outcomes and represent a strategic period to intervene under prevention and public health perspective. Nutritional exposures during this critical period of life can influence the future disease susceptibility. Maternal diet during pregnancy has been linked to offspring overweight/obesity risk and it could represent a potential target for overweight/obesity prevention. The Mediterranean Diet (MD) is considered one of the healthiest dietary models, which impacts beneficially the gut microbiome (GM), providing high amounts of fiber, antioxidants polyphenols and vitamins, and a balanced ratio of essential fatty acids (ω6:ω3). Notably, the MD beneficial effects are due to the synergistic and interactive combinations of nutrients, and the modulation of gene expression through epigenetic changes. Unofrtunately, the MD mechanisms during pregnancy in the prevention of childhood overweight/obesity are not yet fully known.

The PREMEDI study has been designed to evaluate the effects of Mediterranean Diet during pregnancy on the occurrence of overweight/obesity at 24 months in the offspring.

Eligibility Criteria:
Inclusion Criteria:

* women
* caucasian ethnicity
* aged between 20 and 35 years

Exclusion Criteria:

* proven presence of infections during pregnancy and at delivery,
* twin pregnancy,
* ongoing malignancies,
* major gastrointestinal tract malformations,
* immunodeficiencies,
* diabetes and other chronic diseases at each organ or apparatus level,
* chronic intestinal inflammatory diseases,
* gastrointestinal function disorders,
* celiac disease;
* history of abdominal surgery with intestinal resection,
* neuropsychiatric disorders,
* central nervous system disorders,
* vegan diet.
Lesinurad Tablet Bioequivalence

This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.

This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
* Subject has a Screening serum urate level ≤ 7 mg/dL. ˗ Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

* Subject has any gastrointestinal disorder that affects motility and/or absorption.
* Subject has a history or suspicion of kidney stones.
* Subject has undergone major surgery within 3 months prior to Screening.
* Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.
Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress

Use of caffeine citrate in late-preterm infants with respiratory distress is questionable. Oliphant and colleagues found in a recently published study that caffeine therapy use in late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20 mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively.

The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea, shorten the hospital stay and improve arousal state in late preterm infants.

The investigators aim to study the effect of caffeine citrate on late preterm babies as regard duration of respiratory support, duration of hospital stay, respiratory morbidity, incidence and frequency of apnea.

late preterm infants will be randomized in a blinded manner to receive either caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) in Caffeine treatment group, or equivalent volume of saline in the placebo group. Caffeine will be continued until infants get off all forms of respiratory support.

Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.

Eligibility Criteria:
Inclusion Criteria:

* Newborn infants at gestational age 34 0/7 through 36 6/7
* Presented with respiratory distress
* Require respiratory support in the form of any of the following :

A) Invasive mechanical ventilation, B) Non-invasive positive pressure ventilation, C) Nasal cannula with FIO2 requirement over 50% to keep pre-ductal saturation between 90-95%.

Exclusion Criteria:

1 - Late preterm admitted for non-respiratory etiologies 2- Late preterm infants requiring nasal cannula on less than 50% FIO2 by 4 hours of age as they are less likely to require respiratory support for a long time.

3- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with echocardiographic evidence of PPHN requiring medical intervention.

5- Late preterm with history of maternal substance abuse
Mindful Coloring to Reduce Nurses' Stress

The purpose of this study was to investigate whether nurses who did mindful coloring for at least five working days during a 10-day period experienced stress reduction afterwards.

Enrolled participants who met inclusion criteria (full-time clinical nurses working for at least five days during a specified 10-day period) were randomized in 1:1 ratio to the coloring or control groups. A third party did the allocation sequence and concealment. After giving informed consent, participants completed the baseline questionnaire and the coloring group watched an instructional video on mindful coloring. The coloring group were asked to color for any length of time on at least five working days during a 10-day period (period A) while the control group were asked to do it on a subsequent 10-day (period B). The post-intervention questionnaire was completed by both groups at the end of period A. The study was completed after period B.

Eligibility Criteria:
Inclusion Criteria:

* Full time clinical nurses working under the Hospital Authority who would be working for at least 5 days during a specified 10-day study period.

Exclusion Criteria:

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Comparison of Pain Level During Intrauterine Device (IUD) Insertion Between Conventional and Direct Method

The so-called "direct" method of intrauterine device (IUD) and intraintuerine system (IUS) insertion is increasingly used. A study has shown that it is technically simpler and assumes less painful than the classic pose.

It seems interesting to compare the pain felt by the patients during IUD / IUS insertion in these two methods of placement and also to confirm that there is no more malposition with the direct method.

The classic method uses: a Pozzi for pulling the uterus to horizontalize it and a hysterometer to visualize the axis of the uterus and to measure the distance between the external orifice of the cervix and the uterine fundus in order to deploy the IUD / IUS.

In the so-called direct technique, the operator does not measure the depth of the uterus thanks to a hysterometer and does not draw the cervix with a Pozzi forceps, the IUD / IUS is deployed as soon as the orifice passes. inside the cervix and the inserter tube does not enter the uterine cavity. With this method the Pozzi forceps is only used as a second line, especially in case of a fleeing neck.

Eligibility Criteria:
Inclusion Criteria:

* The study population will concern all women aged 18 to 50 who want IUD or SIU contraception regardless of whether they are nulliparous, primiparous or pluriparous, whether or not they have had an IUD or IUS.
* Having signed informed consent.
* Being affiliated to a social security scheme (excluding AME)

Exclusion Criteria:

* Can not express their consent
* Not mastering French
* With a contraindication to the chosen IUD or IUS.
* Having had local anesthesia of the cervix (in case of Voluntary Interruption of Pregnancy on the day of insertion)
* Having received analgesic treatment within four hours
* Patient without social security
* No consent of the patient
* Minor patient
HyperArc Registry Study

The HyperArc registry is designed to collect data from which the efficacy of the HyperArc procedure can be assessed and compared to alternative treatments.

A significant percentage of newly diagnosed cancer patients will develop brain metastases. For many of these patients, stereotactic radiosurgery (SRS) is recommended as a primary treatment option. Concerns about complexity, patient safety, cost, and human resources can make SRS challenging. HyperArc radiotherapy addresses these challenges by introducing key technology and workflow elements to streamline multi-leaf collimator-based, non-coplanar SRS. HyperArc is designed to deliver SRS treatments from the TrueBeam linear accelerator platform. The HyperArc registry is designed to collect data from which the efficacy of the HyperArc procedure can be assessed and compared to alternative treatments.

Eligibility Criteria:
Inclusion Criteria:

* Received or scheduled to receive treatment using the HyperArc treatment method
* Age of legal adult according to local law
* Signed informed consent form, or, informed consent waived by the local ethics board/institutional review board

Exclusion Criteria:

* None, apart from not meeting Inclusion Criteria
The Effect of Toremifene Treatment to the Magnetic Resonance Imaging (MRI) Findings in Premenstrual Mastalgia

The purpose of this study is to determine the effect of toremifene treatment to the MRI findings of the breast in women suffering from premenstrual mastalgia.

Benign breast pain is a common complaint of women in western countries. As many as 41-69% of women reported having mastalgia sufficient to interfere with their daily routines. Approximately 8-10% of premenopausal women suffer monthly from moderate to severe breast pain.Tamoxifen has previously been found to be effective in reducing premenstrual mastalgia. We showed that another triphenylethylene derivative, toremifene, significantly alleviated cyclical breast pain as compared to placebo. In this study women suffering from cyclical breast pain are randomly allocated to receive toremifene (20mg) or placebo during the luteal phase for three consecutive cycles. The patients are then crossed over after a wash-out period to placebo or toremifene, respectively. The MRI investigations are made at two occasions during the premenstrual period after three cycles of toremifene and after three cycles of placebo.

Eligibility Criteria:
Inclusion Criteria:

* Premenstrual mastalgia
* Age 20-45 years
* Reliable non-hormonal contraception

Exclusion Criteria:

* Pregnancy
* Breast cancer or uterine corpus cancer
* Unexplained menstrual disorders
* Serious health problems
* Hormonal contraception, including hormonal IUD trade name Mirena
* Oestrogen and/or progestin treatment
* Hysterectomy and/or oophorectomy or radiation therapy
* Artificial cardiac pacemaker/metallic prostheses
A Study of Cytomegalovirus (CMV) Infection After Kidney Transplant in Adults in the United Kingdom

This observational study intends to retrospectively gather information on cytomegalovirus (CMV) infection management in the United Kingdom (UK) over a period of 7 years (2017-2024). The main aims of this study are the following:

* To estimate the overall prevalence and annual rate of adults with refractory CMV infection after a kidney transplant and describe how such CMV infections are treated
* To describe how effective and well-tolerated the treatment was.
* To describe the demographic and clinical characteristics of adult participants with CMV infection (refractory and non-refractory).

In this study, already existing data will be reviewed and analysed from a UK database called the Registry of Rare Kidney Diseases (RaDaR) (NCT06065852). The study will only review data collected as part of routine clinical practice. The study will not impact the standard medical care and treatment of participants.


Eligibility Criteria:
Inclusion Criteria:

Refractory CMV group:

1. Participants aged greater than or equal to (\>=) 18 years at index date
2. Kidney transplant recipients on or subsequent to June 2016.
3. CMV viraemia or disease identified as requiring treatment and which was refractory to previous CMV management (at least one course of therapy), with or without confirmed resistance.
4. At least six months follow up time (except for participants who have died earlier).

Reference cohort of non-refractory CMV group:

1. Participants aged \>=18 years.
2. Kidney transplant recipients.
3. Received initial CMV management (at least one course of therapy).
4. At least six months follow up time (except for participants who have died earlier).

Exclusion Criteria:

Refractory CMV group:

1. Multi-organ transplant recipients.
2. Participation recorded in an anti-CMV prophylaxis or treatment clinical trial from 2010 onward.

Participants with non-refractory CMV are to be included as a reference to indicate impact of refractory CMV not responding to initial therapy on resource use and other outcomes.

Reference cohort of non-refractory CMV group:

1. Multi-organ transplant recipients.
2. Participation recorded in an anti-CMV prophylaxis or treatment clinical trial from 2010.
3. CMV viremia or disease refractory to any previous anti-CMV therapy.
4. Treatment for CMV viremia or disease refractory to initial therapy during the follow up period.
Study of Hemodynamics of Neonates by Echocardiography and USCOM

The purpose of this study is to evaluate the hemodynamic values of neonates that are healthy and those with various congenital heart diseases and sepsis by using echocardiography and USCOM.

Echocardiography is a diagnostic tool for congenital heart disease.However,it requires skilled specialists to perform it and is a little expensive.Besides,it is too big to move to the bedside easily.USCOM is another newly choice to evaluate hemodynamic values in recent years.This study will compare the hemodynamic values of neonates that are healthy and those with congenital heart diseases and sepsis by using echocardiography and USCOM.

Eligibility Criteria:
Inclusion Criteria:

* neonatal
* congenital heart disease
* sepsis

Exclusion Criteria:

* aged more than thirty days
Pharmacokinetics and Safety Study of Omecamtiv Mecarbil in Healthy Japanese Adults

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of omecamtiv mecarbil in healthy volunteers in Japan.

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Eligibility Criteria:
Inclusion Criteria:

* No history or evidence of clinically relevant medical disorders as determined by the Investigator, and in good health as determined by a pre-study physical examination and medical history with no clinically significant abnormalities, normal vital signs and no history or presence of a clinically significant abnormal electrocardiogram finding
* Subjects' pre-study clinical laboratory findings (including creatine phosphokinase) should be within normal range or if outside of the normal range, are deemed not clinically significant by the Investigator.

Exclusion Criteria:

* A clinically significant disorder/disease, including gastro intestinal abnormalities that might interfere with absorption
* An unstable medical condition, defined as having been hospitalized within 28 days before day 1, major surgery within 6 months before day 1, or otherwise unstable in the judgment of the Investigator
* History or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the Investigator or Medical Monitor would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
* History of malignancy of any type other than surgically excised non-melanomatous skin cancers or in situ cervical cancer within 5 years before the day of dosing
* Use of any prescription or over-the-counter medications within 14 days or 5 half-lives (whichever time period is greater), prior to receiving the first dose of omecamtiv mecarbil (acetaminophen up to 2 grams per day for analgesia and hormone replacement therapy (e.g., estrogen) will be allowed
* Use of any known inhibitors of CYP3A4/p-glycoprotein (P-gp) or CYP2D6 within 14 days or 5 half-lives, whichever is longer; or use of grapefruit juice or grapefruit containing products within 7 days prior to receiving the first dose of omecamtiv mecarbil
* Use of any known CYP3A4 inducers within 30 days or 5 half-lives, whichever is longer, before receiving omecamtiv mecarbil
Effect of Mother's Supplementation Omega-3 in the Dynamics of Fetal Ductus Arteriosus: a Randomized Clinical Trial.

The effect of anti-inflammatory substances on the dynamics of the fetal ductus arteriosus is well documented, but the anti-inflammatory property of polyunsaturated fatty acid omega-3 about changing this dynamic is not established. This study evaluate the relationship between supplementation of omega-3 in the dynamics of the fetal ductus arteriosus in the third trimester. Women with gestational between 28 to 32 weeks will receive capsules of omega-3 or placebo, to be consumed daily for 3 weeks.

The omega-3 features similar the statins to be antioxidants and anti-inflammatory drugs and their derivatives have the function of slowing the neuro-inflammation, oxidative stress and apoptotic cell death anti-inflammatory properties. Also, they have antithrombotic effects, being related to prevent disease. Studies show that supplementation with omega-3 has a positive impact on several outcomes like cardiovascular disease, asthma, rheumatoid arthritis and Alzehimer. Objective: Evaluate the relationship between supplementation of omega-3 in the dynamics of the fetal ductus arteriosus in the third trimester. Methodology: randomized double blind clinical trial. Women with gestational age between 28 to 32 weeks, literate, over 18 years will be invited. Pregnant women with anti-inflammatory drugs, they have a higher intake of dietary polyphenols to 127mg / day or using drugs that may interfere with the absorption of omega-3 are excluded. The selected women will be randomized to receive capsules of omega-3 or placebo, to be consumed daily for 3 weeks. In the first interview, and after 3 weeks, they will respond the Questionnaire Food Frequency (QFF) to quantify polyphenols and omega 3 in their diet, weight and height will be measured and the examination of fetal echocardiography is performed.

Eligibility Criteria:
Inclusion Criteria: Women between 28 - 32 weeks pregnancy who accept participate in the study.

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Exclusion Criteria: hypertensive , diabetic , who use anti-inflammatory drugs , HIV positive , do not take mate, black or green tea, had inflammation in the last 5 days, allergic to fish or soy.

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Financial Support in an Underserved and Low-Income Population With Heart Failure

The goal of this clinical trial is to test whether financial support in the form of a one-time $500 stipend would improve medication adherence and quality of life in low-income, socially-needy patients with heart failure with reduced ejection fraction in the post-discharge setting. The main questions it aims to answer are:

* Will financial support improve heart failure quality of life?
* Will financial support improve medication adherence?

Participants will complete surveys on quality of life, social stress, and spending habits at their baseline visit. Participants will be randomly assigned to receive $500 at their baseline visit or $0 at their baseline visit. At their one month visit, quality of life and medication adherence will be assessed. These results will be compared between groups. The group that received $0 at their baseline visit will be provided $500 at their one-month visit and return for a two-month visit. At that visit, quality of life and medication adherence will be assessed. These results will be compared to their one-month results.

Researchers will compare the 1-month quality of life scores and medication adherence scores between the immediate financial support vs delayed financial support. Researchers will also compare 1-month vs 2-month quality of life and adherence data for participants who were randomized to the delayed financial support group.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* English speaking participants who completed SOCIAL-HF study surveys
* Ejection Fraction \<=40% and eligible for at least one component of GDMT
* Has at least some difficulty paying monthly bills (Somewhat Difficult and Very Difficult)
* Annual household income \<130% Federal Poverty Limit
* Have at least two additional social needs based on the following domains:

  * Cost-related nonadherence
  * Food Insecurity
  * Housing Instability
  * Transportation Difficulty
  * Unemployment
  * Household Crowding: Person/Room Ratio \>1
  * Rent Burden: Rent/Income Ratio \>30%
  * Low social support
  * Interpersonal Violence
  * History of Discrimination

Exclusion Criteria:

* Unwilling to return for 1 and 2-month follow-up visits.
* Currently in jail or prison
* Primary residence outside Dallas County
* Legal Blindness
* Systolic blood pressure \<90 mmHg on screening
* Contraindications or Intolerance all medications available for therapeutic drug monitoring (metoprolol, losartan, lisinopril, valsartan, and spironolactone)
* Unable to answer orientation questions.