cyrilzakka/clinical-trials huggingface dataset:
Olive Oil Massage Effect for Reduction of Preterm Sepsis (OMEPS)

The OMEPS trial is a randomized clinical trial in the western region of Saudi Arabia. Conducted to assess the safety and feasibility of olive oil as massage for preterm infants and if associated with reduced risk of Late-Onset sepsis.


Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants born at one of the participated centers.
2. Preterm Infants born at ≥24weeks gestation and ≤32weeks gestation
3. Birth weight ≥ 500gm up to 2000 gm.

Exclusion Criteria:

1. Outborn Infants.
2. Preterm infants \< 24wk or \> 32 wk
3. Preterm infants \< 500 gm or \> 2000gm
4. Critically ill patients, e.g., Hemodynamic unstable, culture-confirmed neonatal sepsis, Hydrops fetalis, Life-threatening congenital anomalies.
5. Congenital skin anomalies or infection
6. Major surgical procedure
7. Any patient whose parents refuse consent.
8. Death within 48 hours of life.
Risk Factor for Readmission and Death of Lower Respiratory Infections in Older Adults

Lower respiratory tract infection(LRTI) is a prevalent disease that threatens the health of older people worldwide. Anemia is also a common disorder in the elderly, and its prevalence increases significantly with age. Most factors that contribute to the development of anemia are improvable. Therefore, we investigated whether anemia was a risk factor for LRTI-caused readmission and death in the elderly occurring within 1 year of discharge from the hospital.

Objectives: To investigate the effect of anemia on readmission and deaths in the older adults following lower respiratory tract infection (LRTI)-caused hospitalization.

Design: A retrospective cohort study. Setting and Participants: Older patients (age: ≥ 80 years) hospitalized at the Department of Geriatrics, from March 2016 to December 2019 to undergo treatment for LRTIs were included.

Methods: The patients were divided into two groups (anemia and non-anemia) based on the level of hemoglobin. They were kept under observation till the occurrence of mortality event or 1 year after discharge. The primary follow-up outcome was LRTI-caused readmission and/or death.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 80 years
* lower respiratory tract infection

Exclusion Criteria:

* Died at the time of first admission
* Active malignancy
* Tuberculosis
* Anemia caused by gastrointestinal bleeding of unknown origin
* Achalasia of the cardia
* Could not be followed up after discharge
* Data were missing
Developing and Testing Culturally Based Educational Videos for Puerto Rican and African American Home Hospice Caregivers

The investigators hypothesize that culturally based educational videos for Puerto Rican and African American home hospice caregivers will better inform caregivers in managing symptoms, preparedness, self-efficacy, and competence.

The clinical trial for this project is a cross-sectional study conducted with VNS Health hospice, Hospicio Toque de Amor, and Hospicio Luz Celeste. Names of Puerto Rican and African American caregivers receiving home hospice care will be referred to the study team by the site leader/hospice leadership at each hospice. Demographic data will be collected from each caregiver participant. Prior to showing participants the culturally tailored videos, a research member will administer a set of Likert style questions developed by the research team around comfort in managing symptom related issues. The same questions will be administered again post video intervention. In addition, the preparedness scale, chronic pain self-efficacy scale, and caregiving competence scale will be administered to participants pre and post video intervention. The PI will not be involved in the administering the intervention for this study. After the culturally tailored videos have been shown to the participant, a research member will also conduct an open-ended interview about content, reactions, attitudes, usefulness and limitations around each video. Interviews will be conducted in either English and/or Spanish.

Eligibility Criteria:
Inclusion Criteria:

* Family caregivers who identify themselves as Puerto Rican or African American
* English and/or Spanish speaking
* 18 year of age or older
* Currently receiving home hospice services with a patient
S0007 - Combination Chemotherapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent head and neck cancer.

OBJECTIVES:

* Determine the overall survival of patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with paclitaxel, cisplatin, and fluorouracil.
* Determine response (unconfirmed, confirmed, complete, and partial) and time to treatment failure in patients with measurable disease treated with this regimen.
* Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 3 hours followed by cisplatin IV over 30 minutes on day 1 and fluorouracil IV over 24 hours on days 1-4. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 3 additional courses beyond CR.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed squamous cell carcinoma of the head and neck

  * Metastatic at diagnosis or persistent, metastatic, or recurrent after surgery and/or radiotherapy
  * Relapse after prior induction or adjuvant therapy allowed
* No newly diagnosed nonmetastatic disease
* Measurable or nonmeasurable disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No grade 2 or greater sensory neuropathy
* No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent biologic therapy

Chemotherapy:

* See Disease Characteristics
* At least 6 months since prior carboplatin or cisplatin induction or adjuvant chemotherapy
* No more than 1 prior induction or adjuvant chemotherapy regimen
* No prior chemotherapy for recurrent or newly diagnosed metastatic disease
* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent anticancer hormonal therapy

Radiotherapy:

* See Disease Characteristics
* At least 28 days since prior radiotherapy and recovered
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics
* At least 28 days since prior surgery and recovered
An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects

To characterize the pharmacokinetics of orally administered 3'-deoxy-3'-fluorothymidine (FLT), in a liquid formulation, after single doses in asymptomatic HIV-infected patients and to assess the safety and tolerance of the single oral doses of FLT.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Oral candida infection documented by morphology or by response to antifungal therapy within 2 months prior to study entry.
* Temperature \> 37.8 degrees Centigrade.
* Malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
* Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial.

Concurrent Medication:

Excluded:

-

Patients with the following are excluded:

* Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial.
* Unwilling to sign informed consent.
* Intolerant to zidovudine (AZT).
* Oral hairy leukoplakia at any time prior to study entry.

Prior Medication:

Excluded within 7 days of study entry:

* Antiretroviral drugs.
* Immunomodulators.
* Excluded within 30 days of study entry:
* Any investigational drugs.

Patients have the following:

* HIV seropositivity by licensed ELISA test, confirmed by Western Blot analysis.
* No symptoms as defined by:

  1. Normal neurological exam.
  2. Absence of the following:
* Unintentional weight loss of greater than 10 pounds or more than 10 percent of usual body weight within 2 months prior to study entry.
* Unexplained temperature \> 37.8 C on more than 5 consecutive days or on more than 10 days in any 30 day period in the one month prior to expected study entry.
* Unexplained diarrhea defined by = or \> 3 liquid stools per day persisting \> 7 days within 2 months prior to expected study entry.
Luteal Supplementation With Rec-LH After GnRH-agonist Triggering in In Vitro (IVF)

Our aim is to access whether we can achieve equivalent pregnancy rates by the addition of six doses of luteal support with recLH after agonist triggering for IVF cycles in the absence of OHSS.

Whether pregnancy outcome after GnRH-agonist triggering could be improved by adding luteal recLH support plus progesterone, compared to that observed after ovulation triggering with HCG in GnRH antagonist stimulated cycles.

Eligibility Criteria:
Inclusion Criteria:

* \< 36years,
* single blastocystET,
* FSH \< 12

Exclusion Criteria:

* endometriosis,
* 3 and 4,
* pco,
* frozen sperm
Quantitative Ultrasound to Assess Steatotic Liver Disease in Children

This research study is being conducted to find out more about advanced ultrasound techniques to non-invasively evaluate liver disease in children. The investigators are developing advanced techniques for analyzing ultrasound data and images of the liver, and they will compare it to other established methods used to evaluate the liver, including liver MRI.

The investigators plan to develop and test the advanced analysis techniques using conventional full-size ultrasound machines and, if possible, small handheld devices.

Our goals are:

* To assess the accuracy of the advanced ultrasound analysis techniques in children
* To implement and assess these advanced technique on small handheld ultrasound devices, if possible

Our broad long-term objective is to improve the health of children with metabolic dysfunction-associated steatotic liver disease (MASLD), a condition characterized by accumulation of fat in liver cells, by developing and validating accurate, precise, practical, and widely available tools to detect, measure, and monitor liver fat.

Our study aims to develop advanced quantitative ultrasound (QUS) analysis models for use with full-size US and, if possible, inexpensive point-of-care ultrasound (POCUS) systems in children at risk for MASLD to estimate liver fat fraction and classify presence/absence of fatty liver. We anticipate the models will incorporate technical innovations to improve QUS accuracy and efficiency. To develop and test these models, we plan to enroll 120 children who will undergo ultrasound exams using either full-size or POCUS devices. We plan to compare the performance of our QUS models with liver MRI.

Eligibility Criteria:
Inclusion Criteria:

* Age 9 to 18 years
* Presence of risk factors for having MASLD
* Ability and willingness of participant or legal guardian/parent to give written informed consent
* Participant is willing to give written assent
* Able and willing to undergo all study procedures

Exclusion Criteria:

* Known liver disease other than MASLD
* Pregnant or trying to become pregnant
* Inability to undergo an MR study: weight exceeding scanner table limit, waist circumference \> 140 cm, claustrophobie, and/or metal implants.
Postprandial Inflammation in Rheumatoid Arthritis

Patients with RA will be studied to see whether meals of different content will affect inflammation and metabolic variables in the postprandial state. Healthy controls will also be invited to examine potentially different responses to patients with RA.

The PIRA study aims to evaluate the metabolic and inflammatory effects after a vegan meal or a meal containing red meat or fish in patients with RA and matched controls. The study have a cross-over design and each participant will have one of three meals every week and then be compared to themselves. In addition healthy individuals will be included for the red meat meal so that the response from this meal could be compared between patients with RA and their matched controls. Blood samples will be collected before the meal (fasting) and every hour until 5h. Primary outcome will be high sensitive IL-6. Secondary outcomes will be additional inflammation markers such as area under curve for hs-CRP and gene expression in PBMC:s regarding genes related to inflammation and, glucose, blood lipids and metabolomics-profile in serum and urine.

Eligibility Criteria:
Inclusion Criteria for patients with RA:

* Diagnosed with rheumatoid arthritis
* BMI 18.5-30.0 kg/m2
* 2 years or more since diagnosis
* No DMARD changes during the last 3 months

Inclusion Criteria for healthy controls:

* Absence of diagnosis of RA
* BMI 18.5-30.0 kg/m2
* Self-assessed as healthy

Exclusion Criteria:

* Diagnosis of cancer, inflammatory bowel disease, celiac disease, diabetes
* Allergy or intolerance to any of the foods in the study
* Pregnancy or breastfeeding
* Use of any blood lipid lowering medication, glucocorticoids or IL-6-inhibitor during the last 4 weeks prior to enrolment
* Smoking
* Hemoglobin \< 100 g/L
COVID-19 Testing and Vaccination Among Spanish Speakers

Latinx communities are disproportionately affected by the COVID-19 pandemic, with Spanish-speaking Latinx communities carrying even heavier burdens of infection, hospitalization, and mortality. Major barriers to COVID-19 testing and vaccination exist, and a profound need remains to understand and address the social, ethical, and behavioral implications (SEBI) of COVID-19 testing and vaccination within Latinx communities. Our community-academic partnership proposes a rigorous mixed-methods, community-based participatory research study to better understand the SEBI of COVID-19 testing and vaccination and to refine and test a novel and culturally congruent intervention that integrates two evidenced-based strategies - peer navigation and mHealth - to increase COVID-19 testing and vaccination within Spanish-speaking Latinx communities.

A profound need remains to understand the social, ethical, and behavioral implications (SEBI) of COVID-19 testing and vaccination interventions within Spanish-speaking Latinx communities. The proposal is a conceptually integrated community-based participatory research (CBPR) study that includes systematic data collection on the multilevel factors that influence COVID-19 testing and vaccination; refinement of an efficacious intervention that uses complementary theory-based strategies (i.e., peer navigation and mHealth); intervention implementation and evaluation using a longitudinal group-randomized trial design; and dissemination of findings.

Eligibility Criteria:
Inclusion Criteria: To be eligible to participate in the in the NuestraSaludSegura intervention as a Navegante:

* participant must self-identify as Hispanic/Latinx
* participant must be Spanish speaking
* participant reports having been vaccinated against COVID-19
* participant must be ≥18 years of age
* participant must provide informed consent

Inclusion Criteria: To be eligible to participate in the interviews as a Social Network Member:

* participant must self-identify as Hispanic/Latinx
* participant must be Spanish speaking
* participant must be ≥ 18 years of age
* participant must provide informed consent

Exclusion Criteria:

* less than 18 years of age
Exploration of Safety and Efficacy of AzA 15% Foam Twice a Day in Rosacea

This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.


Eligibility Criteria:
Inclusion Criteria:

* male and female patient at least 18 years of age
* signed informed consent
* Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia
* Ability and willingness to accept and comply with treatment and required medical examinations

Exclusion Criteria:

* Known non-responders to azelaic acid
* Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea
* Presence of dermatoses that could interfere with the rosacea diagnosis
* Treatment with isotretinoin in the six months prior to randomization
* Treatment of the face with topical retinoids during the two weeks prior to randomization
* Treatment with oral antibiotics during the four weeks prior to randomization
* Treatment with topical antibiotics
* Treatment with systemic corticosteroids during 4 weeks prior to randomization
* Treatment of the face with topical corticosteroids during 2 weeks prior to randomization
* Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization
* Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization
* Use of a sauna during 2 weeks prior to randomization and during the study
* Facial laser surgery for telangiectasia during 6 weeks prior to randomization
* Planned concurrent use of any treatment other than study medication that affects rosacea
* History of hypersensitivity to propylene glycol or any other ingredient of the study drugs
* Participation in another clinical trial during the last 4 weeks
Evaluation of Safety of Levocetirizine in Routine Clinical Practice-non- Interventional Study

To evaluate over a period of 6 months the safety and the treatment satisfaction of newly prescribed levocetirizine in patients of age ≥ 2 years with persistent allergic rhinitis.

This is a non-interventional, prospective, post-authorization, multi-centre cohort study in patients treated with levocetirizine.

The baseline data will be collected at the visit to the physician when levocetirizine is prescribed for the first time for the patient for Persistent Allergic Rhinitis. The data will then be collected during 2 visits occurring within the first 6 months of treatment, as usually scheduled in normal clinical practice in the Czech and Slovak Republics. This is after approximately 4 weeks and 6 months of treatment or earlier, if the treatment is stopped

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of persistent allergic rhinitis
* first prescription of levocetirizine for this diagnosis for this patient
* age ≥ 2 years

Exclusion Criteria:

* indications other than those defined in inclusion criteria
* history of allergic or anaphylactic reactions to levocetirizine or other derivatives and excipients included
Integrating Metabolic and Vascular Sensors to Monitor Cardiometabolic Disorders After Nutrition Interventions

It is a 12-week study. The participants will follow three different diets, and during each diet period, and the participants will wear our device, and blood samples will be collected.

The investigators will conduct a randomized, controlled crossover intervention study. The investigators will enroll 54 participants, aged \>18 years, BMI \>25 kg/m2 with metabolic syndrome. During the first phase, all participants will consume their habitual diet for 2 weeks to establish baseline. Then participants will be randomized to either a Mediterranean diet (MED), high-fat/low carb diet (HF/LC), or low-fat diet (LF) for 14 days with 2 weeks washout between the different diets. The wearable system will monitor basal levels and the changes for glucose, cholesterol, TG, and NO through sweat analysis and HR, HRV, and PWV for carotid arterial stiffness during each diet intervention.

Eligibility Criteria:
Inclusion Criteria:

* United States Veterans
* Male or female, age 18-55 years at the time of signing informed consent.
* at least 2 of the following: waist circumference \> 40" for men and 35" for women, FBS \>100 mg/dl, triglycerides \> 150 but \< 500 mg/dL, HDL \< 40 mg/dL, Pre- hypertension or hypertension (BP\>120/80 mmHg but \<150/90 mmHg)

Exclusion Criteria:

* History of diabetes require medications
* History of alcohol intake ≥ 20g/day
* History of cirrhosis
* Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of \<30 mL/min/1.73 m2
* History of thyroid disease, but not taking medication or medication dosage changed one or more times over last 6 months. History of thyroid disease and on a stable dose of prescription medication for 6 months or longer is acceptable.
* Any unstable medical conditions or terminal diagnosis.
* Any participant who is unwilling to sign an informed consent form will not be admitted into the study.
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Eligibility Criteria:
Inclusion Criteria:

* Males in good general health and at least 50 years of age, with symptoms of moderate to severe benign prostatic hyperplasia.

Exclusion Criteria:

* Medical conditions that would confound the efficacy evaluation.
* Medical conditions in which it would be unsafe to use an alpha-blocker.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with this alpha-blocker.