cyrilzakka/clinical-trials huggingface dataset:
Percutaneous Sclerotherapy of Symptomatic Liver Hemangioma With Bleomycin

Percutaneous sclerotherapy is currently a widely used treatment for subcutaneous low-flow vascular malformations. Considered as a low-flow vascular malformation, symptomatic liver hemangiomas could also theoretically be safely and effectively treated by percutaneous sclerotherapy with a mixture of Bleomycin and Lipiodol. The safety and efficacy of percutaneous sclerotherapy was firstly introduced by the investigator's investigators in 5 patients in a pilot study. The aim of this study is to design and conduct a study to evaluate the safety and efficacy of percutaneous sclerotherapy in a larger sample size with a long term follow-up.

Twenty-five patients with symptomatic liver hemangioma will be enrolled after an informed consent being obtained. Patients' symptoms related to liver mass, including the pain severity being measured by visual analogue scale, discomfort, early satiety, or nausea will be recorded. Liver function tests, coagulation tests, and complete blood count will be checked before the intervention. A triple phase abdominal CT scan with the administration of intravenous contrast medium will also be performed before the procedure. Exclusion criteria include hepatic or renal impairment, abdominal symptoms unrelated to a liver mass, uncorrectable coagulopathy, lung fibrosis, allergy to contrast media, systemic infection, liver abscess, and biliary obstruction.

Patients will be sufficiently hydrated with normal saline before the procedure. Corticosteroid and prophylactic antibiotics will be administered before the procedure. Antibiotics will be continued for 3 days after the procedure.

The liver mass will be punctured under guidance of ultrasonography with a 20- or 22-gauge Chiba needle. Contrast medium will be injected under fluoroscopy guidance to assess any possible communication with the biliary tree and to evaluate the amount of sclerosing agent which could be safely injected. Then, the mixture of Bleomycin (Bleocin-S; Korea United Pharm Inc., South Korea) and Lipiodol (Ultra-Fluid, Guerbet, France) will be slowly injected under continuous guidance of fluoroscopy. No more than 45 units of Bleomycin and 15 cc of Lipiodol will be injected in a single session.

Any complication taking place during and within 30 days after the procedure will be recorded. Liver function tests, coagulation tests, and complete blood count will be repeated the day after the procedure, and 6 months after the procedure. Also, a triple phase abdominal CT scan will be repeated in 6 months, and 12 months after the intervention. The patients' symptoms will be asked by phone after 12 months. The changes in lesion size on CT scan and in patients' symptoms will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic liver hemangioma

Exclusion Criteria:

* hepatic or renal impairment
* abdominal symptoms unrelated to a liver mass
* uncorrectable coagulopathy
* lung fibrosis
* allergy to contrast media
* systemic infection
* liver abscess
* biliary obstruction
Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability Study

This study will evaluate the safety and tolerability of a dietary fiber, resistant maltodextrin, in people with Parkinson's disease. It will also evaluate the fiber's effect on the gut microbiome and potential effects on motor function and non-motor functions. Half of the participants will receive resistant maltodextrin and the other half will receive a control substance, maltodextrin.

Intestinal microbiota may play in important role in Parkinson's disease (PD). Colonic bacteria play roles in multiple functions including gut motility and secretion of metabolites which can have systemic effects on the body. Recent evidence has shown that people with PD have an altered distribution of gut bacteria that healthy controls. These changes are associated with differences in various metabolites, including butyrate, that are involved in maintaining the gut barrier integrity and even gait and balance function. Microbiota dysbiosis could potentially exacerbate or even contribute to the pathogenesis of PD. Probiotic and dietary interventions may improve gut function and the motor symptoms in PD, but neither have been examined for their effect on the gut microbiome. Prebiotic treatments have been shown to order the microbiome in some populations, but have not been assessed for tolerability or efficacy in PD.

The objective of this study is to examine the safety and tolerability of resistant maltodextrin (RM), a prebiotic non-digestible fiber, and its effect on the microbiome and motor in non-motor symptoms and PD. The investigators will conduct a randomized, parallel-group double-blinded controlled trial assessing RM 50 g daily compared to maltodextrin (an easily digestible glucose polysaccharide) over 4 weeks. Patients will be dosed with 25 g daily for 1 week and then titrated to 50 g daily for the remaining 3 weeks.

The goals of this study include: 1) To determine the safety and tolerability of RM compared to maltodextrin in patients with PD; 2) To determine if RM will remodel the gut microbiome in patients with PD; 3) (exploratory) To determine if RM administration will improve motor and non-motor symptoms in PD.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age ≥60 years
* Diagnosis of PD based on United Kingdom PD brain bank criteria, Hoehn and Yahr stage 1-3.
* Stable dose of PD medications for 30 days prior to study and for duration of study
* If used, stable dose of melatonin, sedative/hypnotic or stimulant medications

Exclusion Criteria:

* use of other prebiotic or probiotic treatment for 30 days prior to or during the study
* unstable medical or psychiatric disorder
* history of diabetes mellitus or current use of medication for diabetes
* cognitive impairment based on Montreal Cognitive Assessment (MoCA) \<25.
* current or recent (within previous 3 weeks) use of laxatives
* use of antibiotics in the past 30 days
* participation in another clinical trial in the past 30 days.
The Effects of Fertility Management Counseling Supported With Telehealth on Contraceptive Use

Fertility management refers to the entirety of practices that allow families to have as many children as they want and when they want, prevent unwanted pregnancies, regulate the time between two births and receive help in having children in the case of infertility.

According to the Turkey Demographic and Health Survey 2018 data, 70% of women in Turkey who are currently married do not use any contraceptive method. Based on the same data, the rate of the unmet need for fertility management is 12% nationwide, 14% in eastern provinces, and 17% in women at the ages of 20-24. These rates show that the rates of unmet fertility management needs in Turkey are still not on the desired level.

The fact that eastern provinces of Turkey have the lowest rate of modern contraceptive method use as 43% and a high rate of unmet fertility management needs as 14% suggests that it is needed to increase the effectiveness of fertility management counseling and reach more women. In these eastern provinces, especially women living in rural areas do not have easy access to these services due to the high prevalence of adolescent marriages, lack of transportation opportunities, healthcare personnel and healthcare services, and unpredictable weather conditions.

To eliminate these obstacles to a relative extent, fertility management counseling will be provided through using the telehealth method. The World Health Organization states that telehealth practices will make access easier, eliminate geographical obstacles, increase the quality of healthcare, and allow the cost-effective management of the resources of the healthcare sector. The telehealth system increases the quality of healthcare, and thus, it has a significant role in managing the resources of the healthcare sector.

The Participant Information Form created by the researcher based on the review of the relevant literature includes questions about the sociodemographic characteristics of the participants (age, education level, employment status, income level) and pregnancy-related questions. The Contraceptive Method Usage Status Form (for the experimental and control groups) will be utilized to determine the contraceptive methods that are used by women in the 7th month of the postpartum period.The data that will be obtained in the study will be statistically analyzed using the International Business Machines Statistical Package for the Social Sciences Subscription Trial version. The analyses will include independent-samples t-test, ANOVA, and Cochran test. In cases of significant differences identified in ANOVA, Tukey's test will be used to identify the source of the difference in pairwise comparisons. The level of statistical significance is accepted as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* volunteer
* be between the ages of 18-45
* to be primiparous
* have a smart phone
* complete education

Exclusion Criteria:

* refuse to research
Detection of Early Idiopathic Pulmonary Fibrosis

The purpose of the study is to determine if miR200 family may serve as a biomarker of IPF.


Eligibility Criteria:
Inclusion Criteria for IPF Patients:

* Informed consent
* Subjects ≥ 40 y.o.
* Naive patients with no IPF treatment
* IPF diagnosis based on the ATS/ERS/JRS/ALAT criteria

Inclusion Criteria for non-IPF ILD Patients:

* Informed consent
* Subjects ≥ 18 y.o.
* ILD diagnosis

Exclusion Criteria:

* HIV
* Hepatitis B
* Hepatitis C
* Pregnant or lactating women

inclusion criteria for controls: informed consent \>18 years old; no lung diseases
Interventions to Decrease Financial Toxicity

Financial distress affects 30-70% of cancer patients and describes the burden that patients experience due to the costs of care (CoC). One reason may be because patients lack the appropriate information on CoC that would help them better plan for and manage their CoC. Therefore, the investigators plan to test a Proactive CoC intervention which includes a discussion with a trained educator on CoC information and a Cost Tracking tool to help patients deal with their CoC.

The investigators will recruit 60 patients diagnosed with gynecologic (ovarian, uterine, cervical, or vulvar cancer), breast or colorectal cancer who are starting a new line of treatment at the O'Neal Comprehensive Cancer Center. Participants will be randomized to Proactive CoC intervention versus Usual Care. Usual Care consists of the current care processes at the cancer center where information on CoC and financial assistance are only provided once a financial need is identified. The main goal is to compare the change in financial distress from baseline to 6 months to see if patients who received any of the Proactive CoC intervention have improved financial distress compared to those in Usual Care.

All participants will complete two main surveys at 0 and 6 months that will ask questions to measure the study outcomes, self-efficacy (patient reported confidence managing certain situations, such as dealing with CoC), depression, anxiety, and insurance knowledge. Participants randomized to any of the Proactive CoC intervention groups will complete three additional phone interviews at 2, 4, and 6 months to check how participants utilized the materials, reasons why they have or have not, and what sections were helpful or not. This study is important to determine whether the Proactive CoC intervention can be successfully delivered, whether the intervention is useful to help patients decrease financial distress, and to inform the design of a future larger study that will include different cancer types and health systems.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed ovarian cancer (i.e., stage II-IV epithelial histology receiving surgery and chemotherapy), or newly diagnosed cervical cancer (i.e., locally advanced stage IB3-IVA receiving chemoradiation), or newly diagnosed uterine cancer (i.e., high-risk histology likely to receive chemotherapy; serous/clear cell), or newly diagnosed stage I-III breast cancer (i.e., high-risk histology), or newly diagnosed stage III-IV Colorectal Cancer
* Receiving systemic therapy or radiation at University of Alabama at Birmingham O'Neal Comprehensive Cancer Center
* With health insurance coverage
* With reliable access to a phone, mobile device, or Internet

Exclusion Criteria:

* Unable to read English
* Does not agree to complete surveys
Effects of Whole Body Vibration Therapy on Cognitive Function, Balance, and Quality of Life in Older Adults With Mild Cognitive Impairment

This is a double-blind, randomized controlled trial comparing WBV therapy with a placebo intervention and standard care. A total of 150 participants will be recruited and investigated from Prince Mutib Hospital. Participants will be randomly allocated to one of three groups: WBV therapy, placebo (non-vibrating platform), or control (standard care). The study duration will be 12 weeks, with assessments conducted at baseline, post-intervention (12 weeks), and at a 6-month follow-up.

Protocol Parameters Summary

* Session Frequency: 3 times per week.
* Session Duration: 25 minutes per session.
* Vibration Frequency: 30 Hz.
* Amplitude: 1-2 mm.
* Program Duration: 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 60 years and older.
* Diagnosed with mild cognitive impairment (Montreal Cognitive Assessment (MoCA) score of 18-25). One point is added if years of education are less than 12 years\[2\].
* Able to stand independently or with minimal assistance.
* No contraindications for WBV therapy or exercise.

Exclusion Criteria:

* Diagnosis of dementia.
* Severe musculoskeletal or neurological disorders.
* Implanted electronic medical devices (e.g., pacemaker).
* Inability to comprehend study instructions.
PRostate Cancer Individual Signature Evaluation Trial in Patients Undergoing Scheduled Prostate Biopsy

The purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will serve to reduce the number of unnecessary prostate biopsies.


Eligibility Criteria:
Inclusion Criteria:.

1. Male over the age of 40.
2. Patient is scheduled for prostate biopsy for one or more of the following reasons:

   * PSA \> 2.5 ng/ml
   * Rising PSA (\>0.5 ng/ml/yr)
   * Lower PSA value with other risk factors for prostate cancer (e.g.; family history)
   * Abnormal DRE
   * Percent free PSA \<15%
3. No prior history of prostate cancer or prostate biopsy.

Exclusion Criteria:

* Unable or unwilling to provide informed consent
Thoracic Fluid Content by Electrical Cardiometry Versus Lung Ultrasound in Mechanically Ventilated Patients

This study aims to compare the accuracy of the total thoracic fluid content (TFC) measured by electrical cardiometry with accuracy of lung ultrasound score in prediction of weaning outcome in mechanically ventilated patients.

Weaning of patients from mechanical ventilation remains one of the critical decisions in the intensive care unit. Earlier patient weaning from mechanical ventilation is recommended to avoid complications of prolonged mechanical ventilation; however, premature weaning might result in extubation failure which is, independently, associated with poor outcomes.

Screening for eligibility is the first step in the weaning process, followed by the spontaneous breathing trial (SBT). Various indices should be checked carefully before starting a spontaneous breathing trial to ensure adequate oxygenation, ventilation, and airway reflexes. However, nearly one-third of patients fail and are reintubated despite fulfillment of all the current weaning pre-requisites.

Eligibility Criteria:
Inclusion Criteria:

* 85 mechanically ventilated patients for ≥ 48 hours
* Aged 18-65 years
* Both sex
* Fulfilled the weaning readiness criteria
* Scheduled for spontaneous breathing trial (SBT) using pressure support ventilation.

Exclusion Criteria:

* Acute respiratory distress syndrome (ARDS) patients.
* Interstitial lung fibrosis.
* Patients with lung resection.
* Pulmonary embolism.
* Patients with fluid overload due to heart, renal or hepatic failure.
* Cardiac patients with ejection fraction less than 40%, cardiomyopathy, congenital or valvular heart diseases.
* Pneumothorax.
* Pleural or pericardial effusion.
* Pregnancy.
* Patients with injuries, burns, or wounds which precluded the proper application of the device electrodes or the ultrasound transducer.
Cardiovascular Disease in Black Versus White Physicians

To examine the natural histories of coronary artery disease and hypertension in cohorts of Black and white men of identical education and occupations.

BACKGROUND:

Prior studies of Black-white differences in hypertension and coronary disease have compared racial groups from markedly different socioeconomic and educational backgrounds. This study represented one of a few, if any, long term prospective studies of cardiovascular disease in middle-class Blacks and whites of similar education and occupation, in whom both youthful and midlife risk factors were assessed.

DESIGN NARRATIVE:

In this prospective study, the prevalence and incidence of coronary artery disease, hypertension, and other cardiovascular diseases were compared using standardized endpoint criteria. The prevalence of cardiovascular risk factors in midlife were compared between cohorts, and included smoking, diabetes, family history, dietary factors, and lipoprotein cholesterol levels. The youthful predictors of midlife cardiovascular risk factors were determined using baseline data collected by identical protocols in the two cohorts between 1957 and 1965. The youthful risk factors were related to the incidence of disease in midlife in two cohorts to identify differences in significance, independence, and relative importance of risk factors in Blacks versus whites.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Effect of Positive Airway Pressure Therapy on Hospitalization and Mortality in SDB Patients With Comorbid Chronic Obstructive Pulmonary Disease (COPD) or/and Heart Failure (HF)

The aim of the study is to test the hypothesis that treatment of sleep disordered breathing (SDB) in patients with comorbid chronic obstructive pulmonary disease (COPD) and/or heart failure (HF) with positive airway pressure (PAP) is associated with reduced risk for hospitalizations and death, lower health care utilization, and greater cost-effectiveness.

In this retrospective analysis the health care utilization in patients with COPD and HF will be quantified. Data of patients who additionally underwent a polysomnography or polygraphy between 2012 and 2015 are taken into consideration. The data (risk for hospitalization and death, comorbidities, diagnosis and therapy of SDB, costs of health care utilization) will be collected 12 months before and 12 months after diagnosis of SDB.

The patients' medical records will also be reviewed for compliance to treatment for SDB, and the patients will be classified as treated or untreated. The treated group will be divided into two subgroups: those with "good adherence" to PAP therapy (≥ 4 hours PAP use per night) and those with "poor adherence" to PAP therapy (\< 4 hours PAP use per night). Healthcare Utilizations, HF or COPD exacerbations and mortality will be identified by reviewing medical records, National database when available, or self-reported by patient or patient's family through phone interview or questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* subjects between 21 to 75 years;
* consecutive patients who underwent polysomnography or polygraphy during the period of 01/01/2012 to 31/12/2015.
* diagnosis of COPD and/or HF

Exclusion Criteria:

* age \<21 or \>75 years
Effect of Acupressure on Fatigue in Hemodialysis Patients

OBJECTIVE: To investigate the effect of acupressure on fatigue in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD) as well as assess sleep quality and psychological status HYPOTHESIS TO BE TESTED: Upon intervention completion, the experimental group will exhibit lower severity of fatigue and depression/anxiety and improved sleep quality compared to the control group.

DESIGN AND SUBJECTS: A randomized controlled trial with experimental and control groups. A total of 116 patients with ESRD who screen positive for fatigue severity ≥ 4 (using a single-item indicator of fatigue, which ranges from 0 to 10 points) will be recruited.

STUDY INSTRUMENTS: Brief Fatigue Inventory (BFI), Pittsburgh Sleep Quality Index (PSQI), and Hospital Anxiety and Depression Scale (HADS) INTERVENTION: A 4-week acupressure intervention was performed by the principal investigator (PI) for every subject by applying the rate of two rotations per second, three times a week.

MAIN OUTCOME MEASURES: Primary: fatigue. Secondary: sleep quality, depression, and anxiety.

DATA ANALYSIS: Multiple regression was used to analyze between-group differences in BFI and PSQI, while ordinal logistic regression was used to analyze the subscales of the HADS.

EXPECTED RESULTS: The proposed acupressure intervention is useful for alleviating fatigue and related symptoms (sleep quality, depression, and anxiety) experienced by patients with ESRD.

The prevalence and impact of fatigue and related symptoms in patients with ESRD have been clearly demonstrated in the literature, which also emphasizes the need for evidence-based interventions targeting symptom management in such patients. The main challenge is identifying an intervention that is not only effective in managing hemodialysis-related symptoms, but also feasible, acceptable, and safe for this patient group. The proposed study primarily aims to test the effects of acupressure intervention on fatigue in ESRD patients receiving HD using the robust study design of a randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≧ 18 years
* 2. HD therapy for at least 3 months
* 3. Experience of fatigue (fatigue severity ≥ 4, using a single-item indicator of fatigue, ranging from 0 to 10 points)
* 4. Absence of lower limb wounds
* 5. Did not receive any complementary treatment

Exclusion Criteria:

* 1. Diagnosis of major depression or psychiatric disorders
* 2. Wound or amputation of the lower extremities, rheumatoid arthritis, or limb fracture