cyrilzakka/clinical-trials huggingface dataset:
Methylene Blue Treatment of Chronic Hepatitis B Virus Infection

HBV infection is a global public health problem. It is estimated that there are more than 250 million HBV carriers worldwide, of whom approximately 600,000 die each year from HBV-related liver disease. Diagnosis and treatment depend on the stage of infection, the degree of liver inflammation, and the progression of fibrosis. Patients with HBeAg-positive or -negative hepatitis are usually treated with nucleos(-t)ide analogues. This treatment inhibits HBV reverse transcriptase and reduces viral replication, but does not affect HBsAg production. Treatment must be continued for life in most cases and is associated with high cumulative costs and the risk of development of resistance.

Recently, it has been shown that patients who show a decrease in their HBsAg levels are more likely to become HBsAg negative, seroconvert and be able to stop antiviral treatment, which is the ultimate goal of treatment, but unfortunately rarely achieved. Methylene blue (MB) has been shown to have an effect on HBsAg levels in vitro, making it a promising test for a new treatment for HBV.

This is an explorative pilot study, open label, dose-escalation, single center clinical trial on the efficacy of MB against HBV infection.

Primary objective is to assess the efficacy of incremental doses of MB against hepatitis B virus in patients with chronic hepatitis B assessed by the reduction of both the HBsAg and HBV DNA levels after 6 months of treatment and 6 months of follow-up.

Participant will be treated for 6 months with MB 100 mg capsules, and then followed up for a further 6 months. The initial dose of MB might be increased if the patient is a non-responder.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age ≥ 18 and \< 80 years
* Microbiologically confirmed chronic Hepatitis B Virus infection (according to the old terminology "inactive HBV carrier")
* HBsAg levels within 20-2'000 IU/ml measured at the at least twice at 6-18 months apart
* HBV DNA PCR levels within 1'000-20'000 IU/ml measured at least twice at 6-18 months apart
* Negative pregnancy test in women of child-bearing age

Exclusion Criteria:

* Documented refusal to participate in the study
* Known G-6-Phophatase deficiency
* Treatment with a serotoninergic drug
* Ongoing treatment with a nucleos(-t)ide treatment
* Clinically relevant concomitant liver disease
* GPT \> 2xULN
* Fibroscan of \> 8.0 KPa obtained ≤ 12 months before Visit 0/Screening
* HBeAg positivity
* Anti HDV antibody positivity
* Breastfeeding women
Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy

Pregnant and postpartum individuals often have difficulty sleeping and these sleep problems can negatively impact both the parent and infant. Research suggests that pregnant individuals prefer non-medication-based treatment for their sleep difficulties but there is a lack of research on the success of sleep treatment during pregnancy. Currently, there are two main non-medical treatments for sleep difficulties available. The first, cognitive behavioural therapy (CBT), is the first treatment recommended for insomnia and has been found to successfully treat insomnia during pregnancy and the postpartum period. In addition, shortened sessions of CBT for insomnia have also been found to successfully reduce sleep difficulties. The second option is sleep hygiene education which is the most commonly offered treatment for sleep difficulties and has been found to improve sleep problems. The present study will compare the effectiveness of a CBT for insomnia group workshop to a Sleep Hygiene group workshop.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years
2. First, second, or third trimester of pregnancy (up to 34 weeks gestation) to allow for early/proactive benefit of sleep intervention.
3. Subjective difficulties with sleep (a score of 8 or higher on the Insomnia Severity Index)
4. Fluent in English.

Exclusion Criteria:

1. Severe depression/active suicidal ideation or psychotic
2. Unstable general medical condition
3. Current use of sleep aids or if taking a prescriptive medication, it remains stable in dose and type for study duration
4. a sleep disorder other than insomnia (e.g., restless leg syndrome).
HELP Prevent Cancer Pilot Study

This pilot study is designed to adapt a community-based diabetes prevention program to reach adults at risk for cancer.

The Healthy Living Partnerships to Prevent Diabetes (HELP PD) study successfully translated the Diabetes Prevention Program (DPP) weight-loss lifestyle intervention in Winston-Salem, North Carolina by delivering the intervention via a partnership between a local diabetes education program with lay community health workers. This study documented a 7% weight loss and 4 mg/dl decrease in fasting blood glucose in patients with prediabetes in 1 year at promote healthy weight loss (1-2 pounds per week). These lifestyle strategies significantly lower costs than the DPP. The HELP PD lifestyle intervention focuses on restricting calories (while improving dietary quality) and increasing physical activity to allow participants to achieve an energy deficient state to are essential to reduce risk for type 2 diabetes but also for a multitude of chronic diseases where excess body weight plays a critical role in the development and exacerbation of the disease. In light of the community-based partnership on which HELP PD was based and the relatively low costs of program administration, the HELP PD model has the potential to be a highly effective and sustainable long-term approach to cancer prevention as well. This pilot study will be the initial step to determine feasibility of implementing the Healthy Living Partnerships to Prevent Cancer (HELP PC) in the Dan River Region of Southern Virginia through a partnership between researchers and colleagues from Wake Forest Comprehensive Cancer Center, Virginia Polytechnic Institute and State University, Danville Hematology and Oncology at the Danville Regional Medical Center, Resource Center of Southern Virginia in Danville, and Danville Regional Medical Center. Wake Forest will serve as the lead site in this study.

Eligibility Criteria:
Inclusion Criteria:

* English Proficiency: Able to read/understand English at or above a level sufficient to comprehend recruitment and intervention materials.
* Body Mass Index: BMI \> 25 kg/m2.

Exclusion Criteria:

* Weight Loss: Currently involved in a supervised program for weight loss.
* Medications: Use of insulin or other diabetes medications that would require additional medical monitoring during weight-loss; use of medications for weight loss or that may impact weight or glucometabolic function (e.g. corticosteroids).
* Recent History of Cardiovascular Disease: Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, transient ischemic attack (TIA), carotid revascularization, peripheral arterial disease, and congestive heart failure.
* Hypertension: Uncontrolled high blood pressure: BP \> 160/100. Persons can be re-screened after controlled.
* Pregnancy: Pregnancy, breast feeding, or planning pregnancy within 1 year.
* Other Chronic Conditions: Other chronic disease likely to limit lifespan to less than 2-3 years, including any cancer requiring treatment in past 5 years except non-melanoma skin cancer.
Australian Screening Mammography Decision Aid Trial (ASMDAT)

The purpose of the study is to develop and evaluate a decision aid to assist women aged 70 years and over to make an informed choice about whether to continue screening mammography.

The primary aims of the study are to assess the impact of the decision aid on (1) the proportion of women who make an informed choice about whether to continue screening mammography, and (2) the participation rates of screening among women aged 70 years and older.

There are two secondary aims of the study. First, to measure the effect of the decision support tool on women's decisional conflict, anxiety, and knowledge about the issues involved in screening mammography. Second, to compare relationships between a woman's objective and perceived risk of breast cancer with her decision to continue or stop screening mammography.

Screening mammography is recommended for women aged 50-69 years but there is no recommendation for women aged 70 years and older. Therefore the decision to continue or stop having screening mammograms are largely dependent on the importance women place on the perceived benefits and harms of screening.

The decision aid is a paper workbook and worksheet containing information on the outcomes of screening mammography for women aged 70 years and older (based on a published model- Barratt et al. 2005), steps to decision making and values clarification exercise. Currently it is not known if a decision aid with information about the benefits and risks of screening mammography can help women aged 70 years and older to make an informed choice. In addition to delivering benefits to individual women in assisting them to to make an informed choice the decision aid may lead to benefits for service providers such as improved efficiency and cost-effectiveness of screening women in this age group. Thus the impact of a decision aid in the efficiency and cost-effectiveness of screening mammography is an important but untested hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* Women who are due their FIRST screening mammogram over the age of 70, and who have previously participated in screening mammography at BreastScreen NSW.

Exclusion Criteria:

* Inability to complete a telephone interview in English.
* Personal history of breast cancer (invasive and pre-invasive).
Evaluation of Capsular Bag Shape Changes After Plate-haptic Intraocular Lens Implantation by SS-OCT

Evaluation of capsular bag shape changes after plate-haptic intraocular lens implantation by SS-OCT.

Eighty patients (80 eyes) with simple age-related cataracts were treated from December 2019 to December 2020 in the Wenzhou Medical University. Investigators specifically included patients who were bodily healthy and underwent a successful implantation of an IOL. Inclusion criteria for this study were patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

-patients who were older than 40 years old, had an axial length of 22-26mm, and could complete 4 follow-up visits.

Exclusion Criteria:

* people cannot cooperate with the check， corneal opacity, glaucoma, and other eye diseases
* any other previous intraocular surgery, and intraoperative complications including anterior or posterior capsulartears
* Continuous circular capsulorhexis is not centered and Mydriasis is less than 7mm.
Crossover Study of the Safety and PK Properties of Proellex®

Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.

This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be able to speak, read, and understand English and be willing and able to provide written informed consent in English on an Institutional Review Board (IRB)
* Premenopausal women aged 18-34, inclusive, with body mass index between 18 and 35, inclusive
* Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
* Must have a negative urine pregnancy test at screening
* Able to swallow gelatin capsules
* Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
* Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
* Other inclusion criteria may apply

Exclusion Criteria:

* Symptomatic uterine fibroids or endometriosis
* Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
* Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
* Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
* Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
* Other exclusion criteria may apply
Tumor Growth Factors in Hepatocellular Carcinoma

Malignant cells frequently produce many tumor growth factors to autocidal or endocrinal proliferate growth, metastasis,or angiogenesis about tumor cells. By studying tumor growth factors in hepatocellular carcinoma, one may know the tumor behavior, its relationship with clinical manifestation or invasion, and could be used as diagnostic or prognostic tools.This study aims to study the relationship between tumor growth factors in HCC ant its clinical relevance.

The clinical relevance of patients will be evaluated by the concentrations of tumor growth factors.

Eligibility Criteria:
Inclusion Criteria:

* Histology proven HCC

Exclusion Criteria:

* No definitely diagnosed tumor
INVITE Study: Invasive Instrumentation in Trauma Patients in the Shock Room

This study is an online survey asking for invasive instrumention in trauma patients of an emergency department

The INVITE study is an online survey for medical doctors asking for invasive instrumention (e.g., arterial line, entral venous line, etc.) in trauma patients of an emergency department

Eligibility Criteria:
Inclusion Criteria:

* Patients with multiple trauma
* treated in the emrgency department

Exclusion Criteria:

* none
Study of Role of Blood Microvescicles and Exosomes in Patients With Graft Occlusion After Aortocoronary Bypass Surgery

Coronary artery bypass graft (CABG) surgery is still the standard treatment of coronary revascularization for patients with severe coronary artery disease (CAD). Graft patency, together with completeness of revascularization, is a major determinant of long-term outcome following CABG. The surgical procedure elicits a persistent systemic inflammatory response associated with the activation of the hemostatic system leading to perturbation of endothelial and vascular function and activation of platelets and leukocytes. All of these events are the main players responsible for the early and late graft failure in a significant percentage of patients.

Circulating microvesicles (MVs) have received increasing attention during the last years as novel players in cardiovascular disease. MVs are small membrane vesicles involved in cell-to-cell communication acting as biological messengers. MVs of different origin are present in the circulation of healthy subjects, and their number increases in several pathological conditions contributing to the development, progression, and clinical outcome of diseases. They have been proposed as biomarkers of thrombosis, vascular injury, and inflammation in atherothrombosis and myocardial infarction, where elevated levels have been correlated with disease severity. Among the circulating MVs, those expressing phosphatidylserine are defined as procoagulant MVs. A subgroup of procoagulant MVs also express tissue factor (TF), the key activator of the blood coagulation cascade. These procoagulant MVs have a role in the prediction of cardiovascular events and are able to identify patients at high recurrence risk. Thus far, many studies have generated compelling data on the sensitivity of circulating MVs as biomarkers of cardiovascular disease progression and events. The usefulness of MVs in patients undergoing CABG, however, has only been tested in 1 study that highlighted their importance in surgical hemostasis. No information is so far available on the association between the amount or pattern of circulating MVs and CABG outcome.Thus, we carried out this study to investigate potential functional role of MVs and exosomes in graft occlusion based on their protein profile as well as their procoagulant potentia.l

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 40 and 80
* Ejection fraction\> 30%
* coronary artery bypass surgery
* informed consent
* Willingness to carry out the follow-up visits and the assessments required by the protocol

Exclusion Criteria:

* emergency intervention
* changes in liver or kidney function
* changes in coagulation factors
* associated interventions (valve replacement, carotid endarterectomy)
Sequential Versus Simultaneous Use of Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer (MBC)

The primary objective of this study is to evaluate the efficacy and tolerability of sequential use of vinorelbine and capecitabine as first line therapy in patients with MBC.

The administration of vinorelbine and capecitabine had been implied to be quite useful in metastatic breast cancer. This study was designed to explore whether sequential and simultaneous use of vinorelbine and capecitabine have similar efficacy and whether the sequential way has better tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Female, ≥ 18 and ≤ 70 years.
* Histologically confirmed invasive breast cancer.
* Metastatic breast cancer.
* ECOG Performance Status of 0 to 2.
* Life expectancy of more than 3 months.
* Subject must have adequate organ function.
* Normal laboratory values: hemoglobin \> 90g/dl, neutrophils \> 1.5×10\^9/L, platelets \> 80×10\^9/L, serum creatinine \< 1.5×upper limit of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN.
* Negative serum pregnancy test for women with childbearing potential.
* Good conditions for infusion and willing to have phlebotomy throughout whole study.
* Have ceased anti-tumor treatments including endocrinotherapy and bio-targeted therapy for more than 28 days.
* Have at least one target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

Exclusion Criteria:

* Pregnant or lactating females
* History of other malignancy. However, subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible
* Concurrent disease or condition that would make the subject inappropriate for study participation, or any serious medical disorder that would interfere with the subject's safety
* Active or uncontrolled infection
* Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure
* Concomitant with brain metastases
* Have received chemotherapy after metastasis
A Study to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203

The purpose of this study is to evaluate food effect on the pharmacokinetics of NVP-1203

This study is designed as randomized, open-label, crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1203 in healthy adult subjects

Eligibility Criteria:
Inclusion Criteria:

* healthy adult subjects who signed informed consent

Exclusion Criteria:

* Subjects has a history of allergy reaction of study drug ingredient
* Subjects participated in another clinical trial within 3 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
Female Sexual Dysfunction in Breast Cancer Patients

Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death among females world wide. breast cancer alone accounts for 25% of all cancer cases and 15% of all cancer deaths among females.

In Egypt, cancer breast is one of the commonest cancers among females representing 38.8%.cancer breast among females ranked the top with a high frequency in lower, middle, upper Egypt (33.8%,26.8%,38.7% resp.).

Women who developed breast cancer were more amenable than women who remained free of breast carcinoma to experience reduced physical function, vitality, social function.

Difficulties related to sexuality and sexual functioning were common and occurred soon after surgical and adjuvant treatment. addressing these problems is essential to improve the quality of life of young women with breast cancer.

Sexuality is a basic and important domain of human experience that can be damaged during and following cancer treatment. The risk of sexual dysfunction is even of greater importance among young cancer patients and survivors, with young breast cancer patients at particularly high risk.

In cancer breast patients, various factors can induce sexual dysfunction. Some of these factors; hormonal alterations induced by chemotherapy and radiotherapy, or physiological and functional disturbances are related to the deterioration of physical condition. These factors are strictly clinical.

Other factors which induce disturbances in sexual behavior, such as anxious\\ depressive reactions in adapting to illness and treatment and cancerophobic reactions and loss of self esteem that accompany any illness are more psychological\\ psychiatric in nature.

Having sexual problems (or dysfunction) includes experiencing disturbances in sexual desire and physiological changes associated with loss of sexual desire and arousal, reduction in sexual pleasure, difficulty achieving orgasm, anxiety about sexual performance and pain during intercourse.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40 years old.
* Social status: Married.
* (Performance status): Who 0-1

  * 0-Asymptomatic (fully active, able to carry on all predisease activities without restriction)
  * 1-Symptomatic but completely ambulatory (restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature. For example, light housework, office work)

Exclusion Criteria:

* Pregnant women.
* Comorbidities (Diabetes mellitus., Hypertension).
* Female genital tract disease.
Virtual Reality Before Pediatric Endoscopy

Brief Summary: Clinical Study

The purpose of this clinical study is to evaluate whether the use of virtual reality (VR) before endoscopy reduces anxiety levels and positively impacts vital signs in children. This study aims to answer the following key questions:

Does the VR application reduce pre-endoscopy anxiety in children? Does the VR application improve vital signs such as heart rate, blood pressure, and oxygen saturation in children?

Researchers will compare the effects of the VR application with standard care to assess its effectiveness.

Participants:

The experimental group will undergo a 15-minute VR session before the endoscopy.

The control group will receive standard care without VR. Anxiety levels and vital signs will be measured throughout the study.

This study aims to explore whether VR technology can serve as an effective stress management tool during pediatric medical procedure


Eligibility Criteria:
Inclusion Criteria:

* Children aged 8 to 17 years.
* Scheduled to undergo an endoscopy procedure.
* Able to provide assent, and their parents or legal guardians provide written informed consent.
* No prior exposure to virtual reality applications.
* Willing to participate in the study.

Exclusion Criteria:

* Presence of a chronic medical condition affecting cardiovascular or respiratory systems.
* Diagnosed with a severe psychiatric disorder.
* Known visual or auditory impairments that could prevent participation in a virtual reality session.
* History of seizures or epilepsy.
* Unwillingness to participate or inability to comply with study procedures.