cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy of MACitentan in the Treatment of CoronaryMICrovascular Angina (MACMIC)

Coronary microvascular angina (MVA) significantly reduces quality of life and increases the risk of heart problems in patients with angina. Unfortunately, there are no effective treatments available yet. The endothelin-1 (ET-1) - endothelin receptor (ETRs) system plays a critical role in MVA. Preclinical studies demonstrate that ETRs antagonists or pericyte-specific knockdown of ETRs can improve coronary microvascular function in myocardial ischemia/reperfusion mice and diabetic mice. Foreign clinical drug trials have shown that ETRs antagonists may alleviate patients' symptoms. However, these studies predominantly rely on conventional coronary angiography rather than direct assessment of coronary microvascular function. Early experimental trials using ETRs antagonists reported a high incidence of side effects, such as sodium retention and headaches, which negatively impacted treatment satisfaction.

To address these limitations, a pilot study is proposed to evaluate the efficacy of macitentan in MVA treatment. This investigation will implement thermodilution-based coronary microcirculation function testing to precisely characterize the severity and subtype of coronary microvascular lesions in MVA patients. By administering macitentan - a safer ETRs antagonist - the study aims to systematically assess improvements in coronary microvascular function, angina symptom relief, and adverse event incidence. The findings are expected to provide critical evidence regarding the therapeutic potential and safety profile of macitentan, while establishing foundational data for subsequent large-scale clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years old.
* With typical angina symptoms.
* Excluding obstructive coronary lesions (coronary stenosis ≤50% or FFR ≥0.8) by CAG.
* Coronary microcirculatory function CFR\<2.5 and/or IMR\>25 assessed by temperature dilution method.

Exclusion Criteria:

* Pregnant or lactating women.
* History of heart attack within the last 90 days.
* Severe heart disease (e.g., moderate to severe heart failure, severe heart valve disease).
* Severe renal impairment (GFR \<30 ml/min/1.73m2).
* Severe liver disease (Child-Pugh class C).
* Moderately severe anaemia (haemoglobin concentration \<90 g/L).
* Participation in another drug intervention trial study within the last 90 days.
The Effect of On-Line Hemodiafiltration Versus High Flux Hemodialysis on Hemodynamic Parameters in Patients With Intra-Dialytic Hypotension

Rationale and objectives

1. Patients on On Line Hemodiafiltration (OL- HDF) are more stable hemodynamically with less Intra Dialytic Hypotension (IDH) episodes compared to conventional hemodialysis (HD). The investigator will follow the hemodynamic parameters during the dialysis sessions (HD and OL-HDF) by using the new non invasive technology, the NICAS device.
2. By switching each patient with IDH from HD to OL- HDF, the investigators will evaluate the hemodynamic parameters and compare the two renal replacement treatment modalities, and prove the superiority of OL-HDF over HD regarding the hemodynamic measures.

Intradialytic hypotension (IDH) or a significant fall in blood pressure (BP) is the most common complication that occurs during hemodialysis (HD) treatment, occurring in up to 20-33% of sessions.

Different mechanisms are involved in the pathogenesis of IDH including acute central hypovolemia, may be precipitated by rapid or excessive ultrafiltration that lead to intravascular volume depletion beyond the level of hemodynamic compensatory response. Other proposed mechanisms of intra vascular depletion are volume shift into the extra-vascular space due to rapid reduction in plasma osmolality, slow and incompatible vascular refilling rate and incorrectly low prescribed dry weight.

Autonomic dysfunction occurs in considerable amount of dialysis patients up to about 50% . This dysfunction reduces the ability to produce an adequate sympathetic response in the setting of acute volume diminution.

Due to the complexity of the dialysis treatment and absence of non- invasive technology, few studies followed the hemodynamic changes which occur during a dialysis session especially during IDH episodes.

OL- HDF is a relatively new method of therapy that allows a larger volume of blood filtration during a single dialysis therapy compared with standard hemodialysis.

Compared to conventional HD treatment, OL-HDF treatment was associated with lower incidence of IDH and better hemodynamic stability.

Bioelectrical impedance analysis is a method for estimating body composition in most of the cases. The Non-Invasive Cardiac System (NICaS) device (non-invasive cardiac system) applies the principle of Whole Body Bio-Impedance and provides continuous data regarding the hemodynamic status (i.e. heart rate, stroke volume, cardiac output, cardiac index, and total peripheral vascular resistance) as well as respiration rate and total body water.

Following the hemodynamic changes, the NICaS device will allow to shed light on the physiological mechanisms underlying the IDH phenomenon and prove the superiority of OL-HDF over regular hemodialysis regarding the hemodynamic measures.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by IDH during one or more dialytic sessions every week

Exclusion Criteria:

* Patients with recent change in chronic medications, chronic liver disease, recent acute coronary event, cardiac arrhythmias and acute infection.
Study of VIR-2218, VIR-3434, And/or PEG-IFNα in Subjects with Chronic Hepatitis B Virus Infection

This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy


Eligibility Criteria:
Inclusion Criteria:

* Male or female ages 18 - \<66 years
* Chronic HBV infection for \>/= 6 months
* On NRTI therapy for \>/= 2 months at the time of screening

Exclusion Criteria:

* Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation
* Significant fibrosis or cirrhosis
* History or evidence of drug or alcohol abuse
* History of chronic liver disease from any cause other than chronic HBV infection
* History of hepatic decompensation
* History of anaphylaxis
* History of allergic reactions, hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments, or any excipients of VIR-3434
* History of immune complex disease
* History of known contraindication to any interferon product
To Evaluate the Characteristics of a Breast Cancer

The purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the breast cancer tumor microenvironment. The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1 and VEGF, which we term the HRHV axis. Fifty breast cancer patients with planned surgical excision will be administered the hypoxia marker drug, EF5, 24-36 hr prior to surgical excision. EF5 is a non-therapeutic drug and provides no direct benefit to those patients enrolled in this pilot study. Tissues obtained intra-operatively will be snap frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will be examined. The association of the markers with the presence of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in breast cancer. This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed Stage 0 - III invasive carcinoma of the breast
* Tumor size greater than 1-cm by radiological (mammogram/ultrasound or MRI) evaluation
* KPS status ≥ 70
* Bilirubin ≤ 1.5x normal
* Creatinine ≤ 1.8
* WBC \> 3000/mm\^3 and platelets \> 100,000/mm\^3

Exclusion Criteria:

* Pregnant or breast-feeding women
* Neoadjuvant chemo or hormonal therapy for existent breast malignancy
* Allergy to IV contrast dye
* History of grade III or IV peripheral neuropathy as defined by the NCI CTC
* Previous history of any malignancy treated with radiotherapy and/or chemohormonal therapy
Observational Study to Evaluate, Under Real-world Practice Conditions, the Safety and Effectiveness of Regorafenib in Patients Diagnosed With Unresectable Hepatocellular Carcinoma (uHCC)

Observational study to evaluate, under real-world practice conditions, the safety and effectiveness of regorafenib in patients diagnosed with unresectable hepatocellular carcinoma (uHCC)


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed diagnosis of unresectable HCC
* Physician-initiated decision to treat with regorafenib (prior to study enrollment)

Exclusion Criteria:

* Participation in an investigational program with interventions outside of routine clinical practice
* Past treatment with regorafenib
Correlation of Timing of Pegfilgrastim Administration and PIBP.

According to the National Comprehensive Cancer Network (NCCN) guidelines, patients receiving high-risk or moderate-risk febrile neutropenia (FN) chemotherapy with at least one risk factor should receive prophylactic granulocyte colony-stimulating factors (G-CSFs). However, pegfilgrastim-induced bone pain (PIBP) remains a common and significant clinical issue without a satisfactory solution. Studies have reported that the incidence rate of PIBP is 71.3%, with severe bone pain occurring in 27.0% of cases. Currently, the available data on PIBP treatment are limited to case reports, reviews, and small randomized controlled trials.

The NCCN guidelines recommend preventive oral non-steroidal anti-inflammatory drugs or antihistamines as the treatment for PIBP. However, even with these preventive measures, the incidence rate of PIBP remains high at 61.1%, with severe bone pain occurring in 19.2% of cases. Severe bone pain can significantly impact the patient's health-related quality of life (HRQol), leading to potential refusal of pegfilgrastim administration and subsequent dose reduction in effective chemotherapy. Ultimately, this may have negative implications for tumor cure rates and patient survival.

Based on previous literature, it appears that delaying the administration of pegfilgrastim may be associated with a lower incidence of PIBP. Therefore, our study aims to investigate the correlation between the timing of pegfilgrastim administration and the occurrence of PIBP.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years and less than or equal to 70 years.
2. Pathologically or histologically confirmed diagnosis of primary breast cancer.
3. Able to receive the chemotherapy regimen as scheduled.
4. Able to understand Chinese and fill out the study-related questionnaires independently.
5. Given written informed consent.
6. There is no need to use prescription or over-the-counter drugs regularly because of pre-existing chronic pain.

Exclusion Criteria:

1. Suffering from bone pain due to other diseases currently.
2. Allergy or contraindication to chemotherapeutic agents or pegfilgrastim.
3. Previous use of pegfilgrastim.
4. Previous received chemotherapy.
5. Pregnancy or breastfeeding.
6. Concurrently accompanied by other primary malignant tumors.
Citicoline for Alcohol Dependence

The purpose of this study is to determine if citicoline, as an add-on therapy, will help reduce alcohol use in outpatients with alcohol dependence.

A total of 62 outpatients with alcohol dependence will be enrolled in a 12-week, randomized, placebo-controlled trial. Participants will be randomized to receive either placebo or citicoline.

Throughout the study, participants will be asked about their alcohol use and any withdrawal or craving symptoms. Depressive symptoms will be measured as well. Cognition and memory will be measured as well with a neurocognitive battery. Blood will be drawn at study start and week 12 to measure liver enzyme levels.

Appointments will be weekly for the entire study. Participants will have a physician follow-up at every study appointment.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18-75 years old with diagnosis of alcohol dependence
* Average alcohol use of at least 28 drinks per week and at least 7 heavy drinking days (defined as 4 or more drinks/day for women, 5 or more drinks/day for men) in the past 28 days
* No alcohol use within 72 hours of randomization (maximum abstinence 7 days)
* CIWA-Ar (withdrawal scale) score less than or equal to 8 at randomization (consistent with minimal or no withdrawal symptoms and medication probably not needed)

Exclusion Criteria:

* Vulnerable populations including individuals with intellectual disability or dementia, prison or jail inmates, pregnant or nursing women, or women of childbearing age who will not use acceptable forms of birth control
* History of arrhythmias
* Myocardial infarction or coronary artery bypass graft surgery in the past 6 months
* Active angina or blood pressure \>170/105
* High risk for suicide (defined as suicide attempt in past 6 months, or current suicidal ideation with plan and intent)
* High risk of violence toward others (defined as assault in past 6 months, or violent thoughts with evidence of plan and intent)
* Intensive outpatient treatment for substance abuse (AA, NA meetings or weekly therapy/counseling for substance use for at least 28 days prior to randomization will be allowed)
* Dependence (not just abuse) on substances other than alcohol or nicotine
* History of delirium tremens or other sever alcohol withdrawal symptoms, history of cirrhosis or AST or ALT \>3 times normal, or other unstable medical condition (e.g. uncontrolled diabetes)
* History of bipolar disorder or schizophrenia
* Current major depressive episode (past episodes and current milder depressive symptoms allowed) or other psychiatric disorder that should be a major focus of treatment
Development and Evaluation of a Cognitive Enhancement Product Made From Selected Thai Herbs for Menopausal Women

This study is set up to determine the cognitive enhancing effect and consumption safety of the novel cognitive enhancement product made from the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) in menopausal volunteer.

Memory impairment is one of the common health problems in menopausal women. Due to the therapeutic efficiency limitation, the searching for the protective intervention for this condition is required. Based on the previous findings that the combined extract of Z. mays (purple color) and P. amaryllifolius based-drink (MP1) could attenuate memory impairment in animal model of menopause, the investigators aimed to investigate the effect of MP1 functional drink on working memory, psychological fitness, possible underlying mechanism and the consumption safety in menopausal volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy perimenopausal and postmenopausal women (\<5 years menstruation cessation) who live in Northeastern of Thailand.

Exclusion Criteria:

* Subject who is diagnosed with one of the following: cardiovascular diseases, respiratory diseases,neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease and hematological disorder are excluded.
* Hysterectomy and/or Oophorectomy
* Subject who use hormone or any drug exerts the influence on Hypothalamic Pituitary Gonadal axis and nervous system.
* Body mass index \>27
* Athlete or subject who has a regular exercise.
* Smoker or heavy drinker
Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With Nanobone Versus Xenograft

Immediate implant placement has a success rate from 94-100 % . After tooth extraction there is a loss in the horizontal and vertical dimension by about 3-6 mm and 1-2 mm respectively and alveolar crest resorption of about 44% especially through 6 months after extraction.

After immediate implant placement there is usually a void between the implant and the socket walls which is called jumping distance or gap which may heal spontaneously or need bone graft to bridge the space. If the gap is 1-2 mm it may heal spontaneously more than that this will need bone graft. There is no evidence that the graft impairs osseointegration Development of artificial bone has increasingly progressed in the last few years. Nanobone "nanocrystalline hydroxyapatite embedded in a porous silica gel matrix bone graft is introduced which has osseoconductive and biomimetic properties .the sub-micron modification in the bone substitute will enhance osteogenic property. It bind to the bone by stimulation of osteoblast activity and enhance growth factors which improve bone healing and provide more strength and stability to the implant.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with badly broken teeth in upper esthetic zone indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
* Both sexes.
* No intraoral soft and hard tissue pathology.
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
* Heavy smokers more than 20 cigarettes per day .(24)
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
Compositional Shift of Gut Microbiome According to the Complications in Patients With Liver Cirrhosis

Change in gut microbiome is closely associated with liver cirrhosis diseases initiation, progression, establishment, and severity. Nevertheless, compositional alterations in gut microbiome during cirrhosis development still not been evaluated, comprehensively. Here, investigators compared the gut microbial composition in cirrhosis patients to encompassing the gut microbial role in whole spectrum of disease.

Stool samples were collected prospectively from 240 participants (Healthy Control (HC=52) + Alcoholic Control (HC=46) + cirrhosis patients (n=142)). 16S rRNA (ribosomal ribonucleic acid) gene sequencing were performed using the MiSeq sequencer on the illumine platform and based on the phylogenetic relationship,16S-based Microbiome Taxonomic Profiling was performed to discovery gut microbial compositional shift along with cirrhosis severity progression.

Eligibility Criteria:
Inclusion Criteria:

1. Registered in the Hallym University Hospital
2. Presented initially sign of liver cirrhosis
3. Patients must have the following laboratory parameters at screening:

   1. Alanine aminotransferase (ALT) ≤10 × upper limit of normal (ULN)
   2. Aspartate aminotransferase (AST) ≤10 × ULN
   3. Hemoglobin ≥12 g/dL for male, ≥11 g/dL for female patients
   4. Platelets ≥ 50,000/mm3
   5. International normalized ratio (INR) ≤1.5 × ULN unless patient has known haemophilia or is stable on an anticoagulant regimen affecting INR.
   6. Albumin ≥3g/dL.
   7. Direct bilirubin ≤1.5 × ULN h) HbA1c ≤10.0%

   i) Creatinine clearance (CLcr) ≥60 mL/min, as calculated by the Cockcroft-Gault equation.

   -

   Exclusion Criteria:
   * Pregnant Female
Why Wait? Initiating Contingency Management in Traumatically Injured Patients During Hospitalization

This clinical trial is to implement contingency management (CM) as an intervention tool to address methamphetamine use and will be initiated during inpatient acute hospitalization in trauma injured patients.

The goals are:

* Gather effectiveness data on a CM program for participants in Hawaii who use methamphetamine during hospitalization and following discharge due to trauma injury
* To assess participant perspectives on engaging with a CM program based at a Level 1 Trauma Center. Researches will assess both patient-reported and biologically-confirmed medium-term program effectiveness and conduct qualitative interviews with participants post-program.
* To assess the rate of leaving against medical advice (AMA) and treatment completion in acute hospital setting in participants.
* To assess the optimal timing of CM initiation for traumatically injured hospitalized patients by comparing patient outcomes (i.e. duration of CM participation and rates of CM program completion and providing negative urine samples) to NCT06532370 where CM was initiated after discharge from the hospital.

For total of 12 weeks, participants will:

* Be visited on Mondays, Wednesdays and Fridays by the research team to complete urine analysis during the hospitalization
* Visit a follow up clinic up to 3 times per week on Mondays, Wednesdays and Fridays to complete urinalysis following discharge from the hospital
* Complete Treatment Effectiveness Assessments at 6 and 12 weeks
* Engage in qualitative interview at the end of the CM program


Eligibility Criteria:
Inclusion Criteria:

* Admitted trauma patients
* Age greater than 18 years old
* Urine drug screen positive for methamphetamines during the current hospitalization
* Report at least weekly methamphetamine use
* First methamphetamine use greater than 6 months prior to injury
* Report at least 4 Diagnostic and Statistical Manual of Mental Disorders 5th Edition, Amphetamine-Type Substance Use Disorder symptoms (at least moderate disease)
* Glasgow Coma Scale ≥13 upon arrival to the emergency department
* Ability to understand and participate in study procedures
* Ability to communicate in English
* Expected discharge date within 45 days on the day of screening / recruitment

Exclusion Criteria:

* Active psychosis (reporting auditory or visual hallucinations)
* Under ongoing cardiorespiratory monitoring
* Evidence of moderate or severe traumatic brain injury
* Patients who are known to be pregnant
* Prisoners
* Individuals incarcerated at the time of their hospitalization
* Individuals lacking capacity to provide, or are otherwise unable or unwilling to provide written informed consent
Effectiveness of Squatting Position on Constipation Severity and Defecation Problems

One of the most common nursing care problems after surgery is defecation problems and the risk of constipation. The aim of the study was to determine the effectiveness of the squatting position with footstool on the constipation severity and defecation problems in the postoperative period in patients with hernia surgery.

In this study, after the surgical procedure, the patients were placed in a squatting position by placing a stool under their feet in the toilet.

Eligibility Criteria:
Inclusion Criteria:

* Hernia surgery in the general surgery clinic
* Between 18 and 65 years of age
* BMI between normal and overweight (18.50-24,99 kg/m2: Normal,25-29,99 kg/m2: Overweight)
* Being able to establish verbal communication
* Volunteering to participate in the study
* Absence of mental confusion
* Having full consciousness and orientation
* Having no communication difficulties
* Having a constipation risk between moderate to high
* Using a water closet type toilet at home

Exclusion Criteria:

* Having a low risk of constipation
* Patient who declined to participate in the study