cyrilzakka/clinical-trials huggingface dataset:
Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial

This study is a randomized control prospective study. The aim of this study is to establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC.

Surveillance of chronic hepatitis B and cirrhotic patients had been demonstrated to increase chances of curative treatment for hepatocellular carcinoma. However, the optimal surveillance interval for different risk patients is still controversial. The AASLD and EASL-EORTC guidelines recommend chronic hepatitis B patients undergoing ultrasound surveillance at a time interval of 6 months, but the Japanese HCC guideline recommend the very-high risk patients undergoing ultrasound surveillance at a time interval of 3 or 4 months.

The incidence of HCC is 0.3%-0.8% in the chronic hepatitis B patients and 2%-8% in cirrhotic patients, thus recalling a different follow-up strategy for different stage of chronic hepatitis B patients. Besides, ultrasound is the admitted surveillance tool for HCC for its convenience and cost-effectiveness. However, the sensitivity of ultrasound detecting HCC will remarkably decrease because of the influence of ribs, pulmonary and gastrointestinal gas, cirrhosis and fatty liver. So it is necessary to incorporate computed tomography (CT) or magnetic resonance imaging (MRI) into the follow-up strategy of very high risk patient such as patients with cirrhosis or history of HCC.

The aim of this study is to investigate whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC, ultimately establish an all-round and convenient follow-up strategy of Chronic Hepatitis B for early detection and diagnosis of HCC.

Eligibility Criteria:
Inclusion Criteria:

1. HBV-Ag positive( \>6 months)
2. age among 18 and 80 years

Exclusion Criteria:

1. patients with hepatocellular carcinoma
2. patients were diagnosis hepatocellular carcinoma within 3 months of inclusion;
3. patients with alcoholic hepatitis or autoimmune hepatitis
4. patients with severe uncontrolled disease resulting in estimated life expectance less than 1 year
5. coinfection with human immunodeficiency virus(HIV)
6. cannot undergo contrast-enhanced imaging
7. refuse attending the study
Simvastatin Treatment of Pachyonychia Congenita

Simvastatin and related statins, such as compactin, are able to inhibit the constitutive expression of inducible/repressible keratin genes such as K6a and K17. This effect is due to the reported ability of statins to inhibit STAT1 expression (Lee et al., 2007). The constitutive K6a promoter activity is dependent on STAT1 and blocked by simvastatin or siRNA against STAT1. This STAT1-dependent constitutive expression of K6a, is independent of JAK (Janus family of kinases).

Thus simvastatin is capable of down-regulating both the constitutive and interferon-inducible expression of PC-related keratins such as K6a and K17. Therefore, this class of molecule has potential for the treatment of PC or related inherited disorders where the causative mutation resides in an inducible/repressible keratin gene such as K6a or K17.

Simvastatin or other statins approved for human use might be delivered either orally, as is currently the case for cholesterol-lowering treatment or, if higher therapeutic doses are required in skin for reduction of hyperkeratosis in PC or in related keratinizing disorders, this might be achieved by topical formulations.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pachyonychia congenita with known mutations in keratin 6a. -

Exclusion Criteria:

* The use of concomitant medications known to interact with simvastatin.
* This would include itraconazole, ketoconazole, fluconazole, gemfibrozil, verapamil, diltiazem, mibefradil, erythromycin, clarithromycin, telithromycin, cyclosporine, ritonavir, nefazodone, danazol, amiodarone, Rifampin, and carbamazepine.
* During the study subjects must agree to avoid grapefruit juice.
* Also excluded are patients with a past history of myopathy, or impaired liver function.
Effect of Lifestyle on Caries and Apical Periodontitis

This study aimed to link lifestyle factors (Mediterranean diet adherence, stress, sleep quality, physical activity) to caries and apical periodontitis in 149 university-based individuals. Data included clinical and radiographic assessments and lifestyle questionnaires. Statistical tests and logistic regression were employed to analyze the relationships between these factors and oral health conditions.

The aim of this study was to evaluate the association between lifestyle (adherence to the Mediterranean diet, stress, sleep quality, and level of physical activity) with the presence of caries and apical periodontitis (AP) in a University-based cohort of individuals.

A total of 149 patients were included in this cross-sectional study. In addition to clinical (cold test, percussion test, evaluation of tooth mobility) and radiographic (bitewing Rx, periapical Rx, and OPT) parameters, validated questionnaires were used to investigate patient's lifestyle. Data on the number of decayed, missing, and filled teeth (DMFT score) and the severity of apical periodontitis (PAI score) were extrapolated from the available clinical and instrumental investigations. Shapiro-Wilk test was used to evaluate the normal distribution of data; Wilcoxon rank-sum test (Mann-Whitney) was used to compare continuous variables. Fisher's test was used to compare dichotomized variables. A logistic regression model was performed for the multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70
* Good general health status;
* Ability and willingness to give written consent;
* Presence of at least 6 teeth.

Exclusion Criteria:

* Age \<18 years;
* Pregnancy or lactation;
* administration of antibiotics within the last 6 months;
* Inability and unwillingness to give written consent
Comparison of Minimally Invasive Versus Open Spinopelvic Fixation for Unstable Sacral Fractures

The aim of this retrospective study is to evaluate patients with vertically unstable high-energy sacral fracture operated on at our institution with spinopelvic fixation, to compare the traditionally open method of fixation with the minimally invasive fixation. The aim of the research is to determine whether minimally invasive surgical techniques can achieve comparable fracture reduction and functional outcome as open surgical approaches. Another aim is to determine whether the minimally invasive surgical procedure leads to shorter patient hospitalization, lower perioperative blood loss, and lower postoperative complications.

This retrospective study included 51 patients with vertically unstable sacral fracture operated at our institution with open or minimally invasive spinopelvic fixation over a period of 11 years (2014-2024). The patients were divided into two groups. One group of patients underwent open spinopelvic fixation, the other group underwent minimally invasive spinopelvic fixation. Each patient underwent a CT scan before and after surgery. The degree of fracture dislocation and reduction was measured in three planes at each examination. The degree of reduction was divided into four groups according to residual dislocation. In the perioperative period, blood loss, the length of the surgical procedure from the first incision to the suture of the wounds, and radiation exposure were monitored. Intraoperative blood loss was calculated from the waste in the surgical suction system. Functional outcome was assessed one year after surgery. A standardized questionnaire according to the Majeed score was used to assess functional outcome.

Eligibility Criteria:
Inclusion Criteria:

* patient with high energy vertically unstable sacral fracture
* patients operated with open or minimally invasive spinopelvic fixation
* patients followed up for at least one year

Exclusion Criteria:

* patients with low-energy osteoporotic fractures of the sacrum
* patients with insufficiency fractures of the sacrum
* patients operated on using a method other than spinopelvic fixation
* patients who were not followed up for at least one year after surgery
The Effectiveness of a Recovery Program for People With Mental Illness.

Recovery-oriented approach has been the main trend in mental health field. However, few recovery-oriented programs are available in Taiwan, and many Taiwanese people with mental illness don't understand the concepts of recovery. A program which provides recovery knowledge and assists in setting recovery goals is beneficial for Taiwanese people with mental illness. Hence, this study aimed to investigate the effectiveness of a recovery program for people with mental illness.

This is a randomized control trial. Participants will be recruited from the psychiatric rehabilitation organizations in Taiwan. They will be randomly assigned to the intervention group or control group. The recovery program has 2 phases and consists of 20 classes, 1.5 hour per class and one class per week. We will introduce concepts of recovery and personal strengths in phase 1. Then, we will help participants to set goals and implement their plans in phase 2. Participants will fill out five questionnaires during the recruitment meeting, including Stages of Recovery Scale, Medical Outcomes Study Social Support Survey, The Hope Scale, Rosenberg Self-Esteem Scale and Brief Symptom Rating Scale-50. They will fill out the same questionnaires plus the course satisfaction survey in the end of phase 1 and 2. Six months later, participants will receive a follow-up interview and fill out the questionnaires again. The control group will receive a spiritual book and complete the questionnaires at the same time as the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mental illness
* lived in community

Exclusion Criteria:

-
Electrical Resynchronization and Acute Hemodynamic Effects of Direct His Bundle Pacing Compared to Biventricular Pacing

The aims are to compare Direct His Bundle Pacing (DHBP) with biventricular pacing (BiV) in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry. The study will be a randomized crossover design with acute measurements.

By recruiting native conducting tissue to relay electrical activation of the ventricles via the Purkinje fibre network, DHBP may potentially achieve greater electrical resynchronization and hemodynamic benefit compared to BiV where the electrical activation wavefronts propagate from two discrete pacing sites. Electrical synchrony achieved by these pacing modes have however never been compared. Furthermore, the acute hemodynamic effect of DHBP has been compared to BiV only in a small single study to date. The aims are to compare DHBP with BiV in terms of electrical resynchronization using electrocardiographic imaging (ECGI) and also in terms of acute hemodynamical effect using finger plethysmography and conduction velocimetry. The primary endpoint will be left ventricular activation time, with secondary endpoints including various electrical (right ventricular activation time, total ventricular activation time etc) and hemodynamic parameters (systolic pressure, cardiac output, cardiac contractility). It is expected that DHBP offers shorter left ventricular activation time (i.e. better synchrony) and hemodynamic benefit compared to BiV.

Eligibility Criteria:
Inclusion Criteria:

* Treatment of heart failure with a standard indication for CRT (NYHA III-IV, LVEF \< 35% and QRS \> 130ms; or LVEF\< 40% and requirement for frequent ventricular pacing, irrespective of baseline QRS duration) and optimal medical treatment.

  * Permanent atrial fibrillation (allowing connection of the DHBP lead to the atrial port).
  * Patients implanted with 1) a CRT pacemaker or CRT defibrillator 2) a His lead with selective or non-selective DHBP, connected to the atrial port of the generator 3) a functional right ventricular lead and 4) a functional coronary sinus lead.
  * DHBP with selective or non-selective His capture

Exclusion Criteria:

* Age \<18 years
* Pregnancy
* Inability to undergo CT or an MRI (e.g. due to severe claustrophobia)
* Inability or refusal to sign the patient informed consent form.
Plasma and Intracellular Concentrations of Raltegravir and Etravirine Administered Once Daily

Hypothesis: the intracellular concentrations of raltegravir (RAL) and etravirine (ETV) administrated as 800 and 400 mg once a day, respectively, are similar to those obtained with the standard doses of 400 and 200 mg/12h, respectively.

Objective: To analyze the plasma and intracellular concentrations of RAL and ETV administrated as 800 and 400 mg once daily respectively compared with standard doses of 400 and 200 mg/12h, respectively, and if they support its once daily administration.

Objective: To analyze the plasma and intracellular concentrations of RAL and ETV administrated as 800 and 400 mg once daily respectively compared with standard doses of 400 and 200 mg/12h, respectively, and if they support its once daily administration.

Method: Phase IV, prospective, open labelled clinical trial with a planned duration of 24 weeks in which 16 patients from Hospitales Universitarios Virgen del Rocío will be enrolled. A 12 hours pharmacokinetic profile (immediately before and after 1, 2, 3, 4, 6, 8, 10 and 12 h) will be obtained after a supervised drug intake while taking RAL or ETV bid. Afterwards,the patients will take RAL or ETV once a day for 7 - 10 days. Subsequently, a new pharmacokinetic profile (predose and after 1, 2, 3, 4, 6, 8, 10, 12, 16, 20 and 24 h after a supervised drug intake) will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Adult HIV-1-infected patients taking raltegravir- or etravirine-based antiretroviral regimens

Exclusion Criteria:

* Pregnancy
* Concomitant use of drugs that have potential interactions with raltegravir or etravirine pharmacokinetics
* Cirrhosis with clinical or analytic data of liver failure.
* Clinical history suggesting malabsorption or presence of diarrhea (\> 3 stools / day) that could interfere with the absorption of study drugs.
Carotid Artery Stenting With Cilostazol Addition for Restenosis

CAS-CARE study was conducted to evaluate the inhibitory effect of cilostazol, compared to that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting (CAS) in patients scheduled to undergo CAS. Study design is Multicenter Prospective Ranodomized Controlled Study, rondomized by cilostazol/non-cilostazol group prior to CAS. 900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS, evaluated by carotid ultrasound and angiography.

Restenosis after carotid artery stenting (CAS) is a critical issue. Cilostazol can reduce restenosis after interventions in coronary or femoropopliteal arteries. The investigators confirmed and published periprocedural cilostazol administration reduced incidences of in-stent restenosis (ISR) or target vessel revascularization (TVR) after CAS, retrospectively.

CAS-CARE study is Multicenter Prospective Ranodomized Controlled Study. Patients, scheduled for CAS within 30 days, 50% or more symptomatic carotid stenosis or 80% or more asymptomatic carotid stenosis, will enroll and randomize by cilostazol/non-cilostazol group. 900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS, evaluated by carotid ultrasound and angiography. And, evaluate cardiovascular events, including stroke, myocardial infarction, and hemorrhagic events in periprocedural period and followed period. In this study, ISR is diagnosed by ultrasound and DSA/CTA. Equivalence of CTA to ultrasound will be studied.

Eligibility Criteria:
Inclusion Criteria:

* 50% or more symptomatic carotid artery stenosis or 80% or more asymptomatic carotid artery stenosis
* scheduled for carotid artery stenting within 30 days
* 45 or more years-old and less than 80 years old
* antiplatelet agents can be administratered orally
* follow-up is anticipated possible for 2 years after CAS
* self-supporoted in daily activities (modified Rankin Scale 2 or less)
* patients who have given informed consent to participation in the study

Exclusion Criteria:

* received endovascular interevention
* scheduled for bilateral carotid intervention
* aortitis or cvasculitis
* congessive heart failure
* ischemic stroke within 48 hours
* hemorrhagic stroke within 90 days
* renal failure
CM082 Combined With Everolimus in Chinese Patients With Metastatic Renal Cell Carcinoma

This randomized, double blind, phase 2/3 study is aimed to evaluate the efficacy and safety of CM082 in combination with everolimus in Chinese patients with advanced renal cell carcinoma. The primary endpoint is progression-free survival.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of clear cell renal cell carcinoma
* Progressed on at least one standard therapy with VEGFR TKI
* Measurable disease per Recist v1.1
* Eastern Cooperative Group (ECOG) Performance Status score of 0 or 1
* Life expectancy of at least 12 weeks
* Adequate organ functions, and meet the following requirements:

Bone marrow: ANC ≥1.5\*109/L (1500/mm3), platelet ≥100\*109/L, and hemoglobin ≥9 g/dL Liver: Total bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5x the upper limit of normal (ULN) if no liver involvement or ≤5x the upper limit of normal with liver involvement Kidney: Creatinine ≤ 1.25 x ULN, urine protein \<1+ Heart: LVEF ≥ 50%

* Willingness and ability to comply with trial and follow-up procedures
* Ability to understand the nature of this trial and give written informed consent

Exclusion Criteria:

* Currently receiving anti-cancer treatment; currently or previously have received 2 or more systemic anti-cancer treatment
* Other tumors in addition to renal cell carcinoma
* Females who are pregnant or breastfeeding
* Known hypersensitivities to CM082 or everolimus
* Those with concurrent condition(e.g. psychological, neuronal, cardiovascular, respiratory conditions or infections) that in the investigator's opinion would jeopardize compliance with the protocol
* Patients with known central nervous system (CNS) metastases
* Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of CM082 or everolimus
* Any active infection
* Drug or alcohol abuser
Meta-analysis of Soluble Fiber Consumption on Body Weight, Glycemia, and Insulinemia in Overweight and Obese Adults.

Dietary fiber intake is protective against overweight and obesity; however, a significant fiber gap exists between consumption and recommended intake values. Soluble fiber beneficially impacts metabolism, and supplementation may be a feasible approach to improve body composition and glycemia in overweight and obese individuals. The investigators will evaluate results of randomized controlled trials (RCTs) of soluble fiber supplementation among overweight and obese adults for outcomes related to weight management (e.g. body mass index \[BMI\], body weight, body fat percentage, waist circumference) and glucose and insulin homeostasis (e.g. fasting glucose, homeostasis model assessment of insulin resistance \[HOMA-IR\], fasting insulin) through systematic review and meta-analysis.


Eligibility Criteria:
Inclusion Criteria:

Peer-reviewed randomized controlled trials (RCTs) will be included in the systematic review and meta-analysis if they involve participants who are:

1. Overweight or obese (BMI ≥ 25.0 kg/m2 for U.S. populations and ≥ 23.0 kg/m2 for Asian populations and/or waist circumference ≥ 40 inches (94 cm) in men or ≥ 35 inches (80 cm) in women and/or waist-to-hip ratio ≥ 0.90 in men or ≥ 0.85 in women).
2. Weight stable and not actively trying to lose weight at screening.
3. Without physician-diagnosed chronic conditions at screening (e.g., dyslipidemia, hypertension, type 2 diabetes, and cardiovascular disease).
4. Included studies will be soluble fiber supplementation interventions that are controlled feeding studies or conducted among free-living subjects that provide data for outcomes of interest.

Exclusion Criteria:

Studies will be excluded from the systematic review and meta-analysis if they meet any of the following criteria:

1. Studies conducted in animals.
2. Mechanistic research.
3. Human trials involving pregnant women, breastfeeding women, or children.
4. Conference proceedings.
5. Articles not published in English.
6. Studies less than 1 week in duration.
7. Studies that pool outcome measure data for healthy weight and overweight and obese individuals.
8. Studies involving whole food treatments or high fiber profile diets.
9. Weight loss interventions involving other tactics, such as counseling or energy restriction.
Physical Activity on Prescription in Overweight Older Adults

This randomized controlled study evaluates the effect of individualized physical activity on prescription (PAP) in older overweight adults. The primary hypothesis is that an individualized prescription of physical activity increases physical activity level in overweight older adults after 6 months. Secondary hypothesis are that the increased physical activity level will improve cardio metabolic risk factors and quality of life.

200 women and men, aged 65 with low physical activity level, overweight, and abdominal obesity, will be randomized to an intervention group or a control group. The control group receives general information about physical activity and registration of physical activity level for one week. The intervention group receives in addition an individualized physical activity on prescription with patient-centered counseling.

After six months both groups go through the same health check-up as at baseline and follow-ups take place after 12 and 24 months.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 40
* waist circumference over 88 cm for women and 102 cm for men
* basically healthy
* mostly sedentary in their leisure time

Exclusion Criteria:

* current heart disease
* tablet or insulin treated diabetes type 2
* cancer
* other chronic serious illness
The Effects of Low Dose Naltrexone (LDN) on Diseases of Aging

This retrospective, observational study will assess the health status of short- and long-term low-dose naltrexone (LDN) users.

Long-term (\>5 years), intermediate-term (1-5 years), and short-term low-dose naltrexone (LDN) users (\<12 months) will be contacted for a retrospective, observational assessment of their health status. Participants will be asked to complete a series of questionnaires assessing their quality of life, general physical and mental health, family history, the occurrence of age-related diseases, and immune status. Additionally, blood tests for immune and longevity markers will be optional for a subset of participants.

Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 18-120)
* Any sex
* Any ethnicity
* Taking LDN
* Willing to complete health questionnaires
* Technologically competent to complete web forms
* Subgroup: willing to undergo blood testing

Exclusion Criteria:

* LDN doses over 20 mg/day
* Terminal cancer patients (defined as stage IV and/or with a life expectancy of 12 months or less)