cyrilzakka/clinical-trials huggingface dataset:
Ambulatory Liver Fat Monitoring in Patients With Non-alcoholic Fatty Liver Disease

Non-alcoholic fatty liver disease (NAFLD) affects 25% of the global population and causes serious complications, including cirrhosis, hepatocellular carcinoma or mortality. Unfortunately, there are not yet any approved drugs to treatment NAFLD. The only effective means to improve NAFLD is by weight reduction via lifestyle modifications, i.e., diet and physical activity. Most NAFLD patients lack the motivation to initiate and maintain lifestyle modifications. The investigators hypothesize that ambulatory monitoring of liver fat can help NAFLD patients lose more liver fat by motivating them to gain a sense of control over their condition.

As NAFLD is a chronic medical illness, NAFLD patients are not able to receive timely feedback from their effort, and they are often frustrated. Also, living with NAFLD may not cause major perturbations to their usual life, as NAFLD is mostly asymptomatic and patients can easily forget the significance of this condition in the long run. The investigators plan to design a randomized, controlled, non-blinded, multi-centre study to compare the effects of ambulatory liver fat monitoring and standard of care in reduction of liver fat in NAFLD patients. Fibroscan and MRI-PDFF will be used for quantification of hepatic steatosis. Apart from the effect on liver fat, the investigators will also investigate whether ambulatory liver fat monitoring promotes more weight loss and improvement in liver biochemistry.

Eligibility Criteria:
Inclusion Criteria:

* patients with known NAFLD (diagnosed by ultrasonography or other forms of imaging; transient elastography with controlled attenuation parameter \>248 dB/m; or liver biopsy) who are managed in the Liver Clinics of Queen Mary Hospital or Tung Wah Hospital
* aged 18-65 years
* without major cognitive impairment - since these subjects would be given simple instructions on using the ambulatory device to measure liver fat at home by themselves

Exclusion Criteria:

* on SGLT-2 inhibitors, GLP-1 agonists, or thiazolidinediones due to their prominent effects on body weight changes
* patients with cirrhosis (defined by imaging features of nodular liver and evidence of portal hypertension, liver stiffness \>13 kPa, endoscopically proven gastroesophageal varices, or histological features), with or without ascites
* patients who are pregnant
* patients on special diet or with special dietary requirement (e.g., vegan, gluten free) heavy alcohol use (≥20 grams/ day for women or ≥30 grams/ day for men)
* history of HCC, hepatic resection, or LT
* patients with damaged skin on the abdomen, as this will affect the assessment by the ambulatory liver fat device
* patients with implanted electronic devices
* patients with spinal diseases/ discomfort
* patients with metallic implants
Assessment of Frailty in Patients With Advanced Hepatocellular Cancers

This study is looking at the feasibility of performing frailty assessments on patients with advanced hepatocellular cancer.

This study is primarily looking to see if it is feasible to assess frailty in patients with advanced hepatocellular cancer. It is also evaluating whether there may be any correlation between these assessments and toxicity of treatment and outcome.

The assessments include: Frailty score, nutritional assessment, comorbidity score and quality of life. In addition sarcopenia will be assessed measuring muscle mass from imaging performed as part of routine clinical care.

The assessments will be performed at baseline on entry into the study, at week 9 and week 18.

There is the option for patients to also donate a blood samples for research purposes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of hepatocellular cancer not suitable for curative treatment
* Seen by an oncologist or hepatologist for consideration of palliative treatment and a decision regarding management already made
* WHO Performance status 0-2
* Childs Pugh Score A or B
* Written informed consent

Exclusion Criteria:

N/A

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Clinical Impact of Red Cell Storage Age

The recent four RCTs evaluating effects of RBC storage age on morbidity and mortality found no statistically significant adverse effects of longer stored RBC compared to shorter storage ages. Unfortunately, none of these RCTs had sufficient numbers of subjects receiving RBC at either storage age extreme to identify consequences of RBC transfusion at these limits. To better investigate effects of RBC storage age on clinical outcomes, this study will perform secondary meta-analyses of merged common patient data elements -individual patient data (IPD) meta-analysis (IPDMA) - from the nearly 33,000 subjects enrolled in the four RCTs.


Eligibility Criteria:
Inclusion Criteria:

* Received at least one RBC transfusion
* \>=18 years of age

Exclusion Criteria:

* N/A
FOODS: Food shOppers' sOcial meDia Study

This study aims to assess the effects of a new approach to food labelling called physical activity calorie equivalent (PACE) labelling. PACE food labelling provides the public with information about how many minutes (or miles/kilometres) of physical activity (e.g. walking or running) are equivalent to the calories contained in foods.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old.
* BMI of ≥ 18.5 kg/m2.
* ≤ 3kg weight loss in previous 6 months.
* Access and ability to use personal Twitter and/or Instagram account via own smartphone, computer or tablet device.
* Access to the internet.
* Access to a set of weighing scales.

Exclusion Criteria:

* Unable to read and understand English.
* Experienced in the last 12 months or currently undergoing any of the following conditions or illnesses: coronary heart disease (CHD), hypertension, heart failure, stroke/transient ischaemic attack, atrial fibrillation, type 2 diabetes, chronic obstructive pulmonary disease (COPD), painful condition, dementia and cancer.
* Had bariatric surgery.
* Pregnant, lactating or planning to become pregnant in the next 12 months.
* Parallel participation in another weight, dietary or physical activity intervention study.
Neonatal Intensive Care (NICU) Course and Hospital Outcome of Infants With BPD Treated Using Inhaled Nitric Oxide

This is a chart review study of neonates admitted to Primary Children's Medical Center or University of Utah NICU who had or developed a diagnosis of bronchopulmonary dysplasia (BPD) and were treated for this condition with inhaled nitric oxide (iNO) beginning after the 4th week of life. For this study BPD will be defined as need for supplemental oxygen on day 28 of life. The data collection from the medical record will gather demographics on admission (birth weight, gestational age, etc); past medical history from transferring hospitals; admission diagnoses; hospital respiratory care treatment course and laboratory/xray findings; nutrition and growth; and discharge diagnoses including all major neonatal morbidities such as absence or severity of intraventricular hemorrhage, retinopathy of prematurity, or hearing deficits. The data will be compiled and compared to data previously published on similar infants with BPD but not treated with iNO.

Recent studies (e.g. Schreiber 2003)1 have prompted several large current clinical trials on the use of inhaled nitric oxide (iNO) for the prevention of bronchopulmonary dysplasia (BPD) in preterm infants. Results of these studies are not yet published and will be forthcoming Spring 2006. However, there is evidence to suggest that for patients with BPD, treatment with iNO may improve oxygenation2 and improve pulmonary blood flow by relaxing pulmonary vascular tone. 3 Also, there is a recent primate study that suggests in the face of existing BPD, treatment with iNO may decrease oxygen and ventilation requirements through a mechanism that helps preserve surfactant protein.4 Taken together, this preliminary work suggests there may be clinical benefit in treating established BPD with iNO. However, as few data exist on the clinical course of BPD patients treated with iNO, further description is necessary to evaluate iNO as a potential treatment modality for BPD. Since iNO has been used as adjunctive therapy for neonates at PCMC with serious respiratory disease, useful information on the relationship between BPD and iNO treatment may exist within our own patient population

Eligibility Criteria:
Inclusion Criteria:

* Any patient who at 28 days of life was requiring oxygen therapy in the Neonatal Intensive Care Unit and who was then treated with iNO would be eligible for chart review. Since iNO therapy has only been available for a few years, this study will attempt to capture all patients who qualify.

Exclusion Criteria:

* Any patient who received iNO treatment under an IRB study protocol after 28d of life would not be eligible for chart review.
Evaluation of the Vi Polysaccharide Vaccine Against Typhoid Fever

This study is part of the International Vaccine Institute's (IVI's) typhoid Vi demonstration project that aims to accelerate the rational introduction of Vi vaccines in typhoid endemic countries. The purpose of this study is to determine the effectiveness of the Vi vaccine following a mass typhoid immunization campaign in an endemic area in Kolkata, India. The cost-effectiveness of the Vi vaccination and the logistic feasibility of a mass typhoid immunization campaign will also be evaluated.

Typhoid fever is a major cause of morbidity worldwide. The disease predominantly affects school-aged children, is more prevalent in urban areas, may last for several weeks and can lead to serious complications. Management of this disease is further complicated by the emergence of multi-drug resistant strains. Vaccination of high risk populations is considered the most promising strategy for the control of typhoid fever. The Vi polysaccharide vaccine has been targeted for accelerated introduction into public health programs since it has been shown to have consistent efficacy results even in areas of high typhoid incidence, is given as a single dose, lacks patent protection and requires less strict cold chain requirements.

This project attempts to evaluate a new vaccination strategy for residents of endemic areas. A cluster-randomized trial involving the Vi polysaccharide vaccine and an active control (Hepatitis A) was designed to determine the effectiveness and the feasibility of providing Vi vaccine under actual programmatic conditions in 2 contiguous urban wards in Kolkata. The vaccines used in this study are internationally produced and locally licensed. A 1 year pilot phase will precede the actual Vi-demonstration project. Surveillance for typhoid fever cases will continue after the mass immunization campaign. A passive surveillance system to evaluate adverse events following immunization will be implemented. Socio-economic studies will be conducted in parallel to the effectiveness evaluation. The knowledge, attitudes, beliefs and practices among parents and health care providers regarding typhoid illness, treatment and prevention will be assessed. Logistic, feasibility and vaccine costs will also be determined.

Eligibility Criteria:
Inclusion Criteria:

* Registered in the project census
* Age \>=2 years
* Provide informed consent to receive vaccine

Exclusion Criteria:

* Fever (\>37.5 degrees Celsius)
* Pregnancy
* Lactating
Pharmacokinetic Interaction Study in Indonesian Tuberculosis Patients Indonesia

Pharmacokinetic study in TB patients to determine the effect of rifampicin on the pharmacokinetic profile of moxifloxacin.

Tuberculosis is an infectious disease that still causes many victims in the developing world, especially in Indonesia. Rifampicin, isoniazid and ethambutol are the cornerstone of the current treatment. The disadvantage of the current treatment is the long, six-months, duration of the treatment. This long duration contributes to suboptimal adherence to the TB drugs.Thus, there is a very urgent need to evaluate drugs that may help shortening TB treatment. The fluoroquinolone moxifloxacin has shown early bactericidal activity (EBA) in patients with pulmonary TB, and has shown rapid and reliable sterilization. Rifampicin is a strong inducer of the CYP enzymes, but it also induces phase II metabolism. As moxifloxacin is metabolized by phase II metabolism, rifampicin could cause a decrease in the plasma concentrations of moxifloxacin. Therefore, a pharmacokinetic interaction study is warranted.

Eligibility Criteria:
Inclusion Criteria:

* Indonesian AFB negative tuberculosis patients who are in the last two months of the continuation phase of their six-month-antituberculosis treatment.
* Subject is 18-55 years of age at the day of the first dosing of study medication.
* Subject has a normal ECG
* Subjects bodyweight is \>35kg
* Use of rifampicin and isoniazid

Exclusion Criteria:

* Pregnant or lactating
* History or condition that might interfere with drug absorption, distribution, metabolism or excretion, including ileus, gastric paresis, liver and renal dysfunction, diabetes mellitus.
* Presence of contraindications for moxifloxacin or use of drugs that are known to interact with moxifloxacin.
* Subject is not able and/or not willing to sign the informed consent form.
Vitamin D Levels in Stage IV Colorectal Cancer Patients

The purpose of this study is to find out what effects, good and/or bad, vitamin D blood levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to increase low vitamin D levels into normal range using vitamin D supplements taken by mouth. Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given would be considered standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Stage IV (metastatic) colorectal cancer
* Baseline 25-hydroxy vitamin D level \< 30 ng/ml
* Age ≥18 years of age

Exclusion Criteria:

* Current or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \> 3 years
* Albumin \< 3.2
* Patients on concurrent chronic steroids, other than those allowed for routine antiemetics, or inhaled steroids
* Patients receiving phenobarbital, phenytoin, orlistat and cholestyramine
* Hypercalcemia (Calcium \>10.5 mg/dl)
* Calcium x Phosphorus \> 70 mg2/dL2
CFT-focused Mental Health Intervention With Exposure Training for Youngsters

The aim of this study is to explore if individual CFT-based intervention with exposure training in virtual reality decreases conduct disorder symptoms and callous-unemoitonal traits , as well as increases subjective emotional welbeing among 15-to-20 year-old male prisoners and boys placed to state's residential schools. We will also study factors that may predict adherence to the intervention. These factors include mental well-being, motivation, and working alliance. In addition, we will evaluate the costs of the program.


Eligibility Criteria:
Inclusion Criteria:

* Express conduct disorder psychopathology and psychopathic personality traits
* Are placed to a prison or a state residential school for at least 9 months

Exclusion Criteria:

* Females
* Non-Finninsh-speaking
* Remaining in the institution facility less than 9 months
* Intellectual dissability
* Presence of psychotic symptoms
* Autism
* History of epilepsy
* Currently participating another psychotherapeutic intervention
Search for Noninvasive Markers of "Graft Injury" in Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Transplantation

This clinical tissue-based, drug-free, single-center, longitudinal study aims to validate a new diagnostic method, namely, to evaluate whether plasma levels of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA), in patients undergoing orthotopic heart transplantation, can be predictive of the presence of acute myocardial rejection with the same sensitivity as immunohistochemical analysis on endomyocardial biopsy specimen, the current gold standard for the diagnosis of acute cell-mediated myocardial rejection, in a population consisting of pediatric patients and adult patients with congenital heart disease undergoing orthotopic heart transplantation.

To achieve the study objective, approximately 20 patients of all ages, both pediatric and adult with congenital heart disease and undergoing orthotopic heart transplantation, followed at our center will be enrolled. Whenever a patient enrolled in the study undergoes endomyocardial biopsy, either as part of surveillance of acute myocardial rejection or for clinical suspicion of rejection, concomitantly a blood sample will be taken and analyzed for the presence of dd-cfDNA. In patients with biopsy evidence of acute rejection, a new dd-cfDNA sampling will be performed approximately three months after treatment at the next clinical follow-up. The data collected for each patient will be both baseline anthropometric data and imaging and laboratory variables collected in the normal follow-up provided by clinical practice, as well as data related to the endomyocardial biopsy result and those related to blood sampling for donor DNA.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with congenital heart disease undergoing cardiac transplantation at our center or other centers, followed in follow-up at our center (Unit of Pediatric Cardiology and Developmental Age, IRCCS Azienda Ospedaliero-Universitaria di Bologna)
* Pediatric patients undergoing cardiac transplantation at our center or other centers but followed in follow-up at our center
* Obtaining informed consent from the adult patient or parent/guardian in case of minor

Exclusion Criteria:

* Failure to obtain informed consent from the adult patient or parent/guardian in case of minor
Efficacy and Safety of Silodosin on Nocturia for Patients With Benign Prostatic Hyperplasia

The objective of this study is to determine safety and efficacy of silodosin, which is a treatment for benign prostatic hyperplasia with high selectivity to α1A-receptor, on patients with benign prostatic hyperplasia accompanied by nocturia.

This study is designed as a multi-center, prospective, open-label and single-arm study. Subjects who are willing to provide written informed consent will be enrolled after screening for eligibility criteria. The subjects will be administered with investigational product for 12 weeks and visit as outpatients for evaluation of safety and efficacy at baseline (visit 2) and 4 weeks (visit 3) and 12 weeks (visit 4) after baseline.

Eligibility Criteria:
Inclusion Criteria:

* Males of at least 50 years of age, with current diagnosis of benign prostatic hyperplasia
* Symptoms of nocturia evidenced by ≥2 episodes per night in average according to 3-day voiding diary
* More than total of 8 points on IPSS and 3 points on QoL
* Able to provide written informed consent and to comply with all study procedures

Exclusion Criteria:

* PSA level \> 10 ng/㎖ (except patients who had 4 ng/㎖ \< PSA level ≤ 10 ng/㎖ 6 months prior to screening and identified as negative from biopsy)
* Symptoms of postural hypotension
* Severe renal disorders or creatinine clearance ≥ 2.0 mg/dL
* Severe hepatic disorders or AST or ALT ≥ 3 x upper limit of normal (ULN)
* Severe cardiac disorders or development or diagnosis of vascular disorder (unstable angina, myocardial infarction, cerebral infarction, cerebral hemorrhage, coronary artery bypass graft, etc) 6 months prior to enrollment
* Any disorder of the gastrointestinal system which could result in altered digestion or absorption, history of gastrointestinal tract surgery except ecphyadectomy
* Patients with bladder cancer, cystolith or urethral stricture
* Patients with neurogenic bladder
* History of acute urinary retention
* Indwelling catheter or self intermittent catheterization
* Patients with pyuria 1 month prior to screening
* History of prostatic cancer
* History of prostatic surgery
* Patients with uncontrolled chronic disease
* Alcoholism or sustained drug dependent abuse 1 year prior to screening
* Hypersensitivity to α1A-receptor blockers
* Administration of following drugs within according periods prior to screening - 2 weeks: Antimuscarinic agents (Tolterodine, Trospium, Solifenacin, Fesoterodine, Propiverine, Oxybutynin, Flavoxate, etc), Anticholinesterase agents (Neostigmine methylsulfate, etc), Cholinergic agonists (Bethanechol Cl, etc), Benign prostatic hyperplasia agents (Tamsulosin HCl, Prazosin HCl, Terazosin HCl, Doxazosin mesylate, Silodosin, Naftopidil, etc), Tricyclic antidepressants (Amitriptyline, Clomipramine, Dosulepin, Doxepin, Imipramine, Quinupramine, etc), 6 months: 5-α-Reductase Inhibitors (Finasteride, Dutasteride)
* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
Smoking While on Transdermal Nicotine Replacement Therapy: Effects on Craving and Cessation

Smoking while on nicotine patches will help subjects to reduce their expired carbon monoxide levels from the levels they were before they started using the patch. Subjects will also decrease their daily consumption of cigarettes.

Subjects who smoke while on an individually dosed tNRT will reduce their expired carbon monoxide levels from pre- to post-treatment conditions. They will also decrease their daily consumption of cigarettes.

Eligibility Criteria:
Inclusion Criteria:

* at least 19 years of age
* male or female
* have intention to quit smoking within the next 6 months
* smoke 10 or more cigarettes per day

Exclusion Criteria:

* Pregnant or not using an adequate enough method of birth control to ensure that they are not at risk of becoming pregnant
* breastfeeding
* have any generalized skin disorders
* are in an immediate post-myocardial infarction period or have life-threatening arrhythmias, have severe or worsening angina pectoris or have had a recent cerebral vascular accident
* are using additional nicotine replacement therapies or any other smoking cessation pharmacotherapy
* any clinically significant ECG abnormalities
* any known hypersensitivity to components of the transdermal system