cyrilzakka/clinical-trials huggingface dataset:
Prospective Double Arm Randomized Trial: WBRT Alone and WBRT Plus Silibinin

The occurrence of brain metastases (BMs) is increasing given the availability of a more accurate radiological imaging such as MRI for detecting also small brain lesions and the most effective systemic therapy able to control extracranial disease. Although, the new target therapy and immunotherapy has proven to be effective on brain metastasis too, a subgroup of patients shows prove themselves unresponsive to medical treatment. A further subgroup of patients exhibit diffuse brain disease for the presence of multiple brain lesion (\>10 BMs) or leptomeningeal carcinomatosis. Among these patients the most treatment employed is represented by whole brain RT. Since the 1950s, whole-brain radiation therapy (WBRT) has been the most widely used treatment for patients with multiple brain metastases, given its effectiveness in palliation, widespread availability, and ease to delivery. However, the median overall survival recorded is restricted to 3 months, on the average. A better understanding of the molecular and cellular mechanisms underlying brain metastasis might be expected to lead to improvements in the overall survival rate for these patients. Recent studies have revealed complex interactions between metastatic cancer cells and their microenvironment in the brain. Priego et al. describe that brain metastatic cells induce and maintain the co-option of a pro-metastatic program driven by signal transducer and activator of transcription 3 (STAT3) in a subpopulation of reactive astrocytes surrounding metastatic lesions. In patients, active STAT3 in reactive astrocytes correlates with reduced survival from diagnosis of intracranial metastases. Blocking STAT3 signaling in reactive astrocytes reduces experimental brain metastasis from different primary tumor sources, even at advanced stages of colonization. Silibinin (or silybin) is a natural polyphenolic flavonoid isolated from seed extracts of the herb milk thistle (Silybum marianum). Silibinin has been shown to impair STAT3 activation. Preclinical studies show that Silibinin has an anticancer effects in vitro and in vivo.

Based on this background, the investigators designed a double arm randomized trial evaluating the benefit of Silibinin (in the form of marketed supplement) associated to WBRT respect to WBRT alone.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Histological or cytological confirmation of solid tumor malignancy
* Clinical indication for whole brain radiotherapy
* Karnofsky performance status (KPS) ≥60
* Written informed consent

Exclusion Criteria:

* Prior WBRT
* KPS \< 60
* Diagnosis of Lymphoproliferative disease
* Pregnant women
Probiotics Improve Gastrointestinal Symptoms After Roux-en-Y Gastric Bypass: A Prospective Randomized Trial

Obesity has been a global epidemic. Currently, bariatric surgery has been recognized as the only successful treatment for morbid obesity. Laparoscopic gastric bypass (LGB) is the leading bariatric surgery worldwide including Taiwan, it's resulted in significant weight loss and resolution of metabolic co-morbidities in morbidly obese patients .

However, annoyed Gastro-Intestinal (GI) symptoms are a common complaint after gastric bypass like foul smell flatus, oil flatus and over flatus. The aim of this study was to determine whether probiotics would improve annoyed GI symptoms after gastric bypass.

Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial microorganisms found in the human gut. They are also called "friendly bacteria" or "good bacteria." Probiotics are available to consumers mainly in the form of dietary supplements and foods.

Probiotics are available in foods and dietary supplements (for example, capsules, tablets, and powders) and in some other forms as well. Examples of foods containing probiotics are yogurt, fermented and unfermented milk, miso, and some juices and soy beverages. In probiotic foods and supplements, the bacteria may have been present originally or added during preparation. In this study, we investigate the efficacy of probiotics for alleviating the annoyed GI symptoms after LGB.

Clostridium butyricum Probiotics is a novel microecological feed additive, it has the characteristic of heat tolerance, acid tolerance and antibiotic resistance and is general used to treat the intestinal tract disease in the clinical treatment. Its potential function in the situation that feed has been added universally with antibiotics will make it have a good development.

This randomized, placebo-controlled, double blind, prospective clinical trial was conducted among 60 patients undergoing gastric bypass for morbid obesity who had annoyed GI symptoms. Patients were randomized to the clostridium butyricum MIYAIRI group (80 mg daily , n=20,), bifidobacterium Longum BB536 group (2 packs daily, n=20),and biotase group(4 tablets daily, n=20). Control group (Biotase per day). Quality of life was measured and compared by the gastro-intestinal quality of life index (GIQLI) before and two weeks after in both groups. The higher score means that they have better quality of life. Through this study, we hope that we can find a effective probiotics can help all the patient received gastric bypass and bothered by their gastrointestinal problems also can improve their satisfaction of this operation.

Eligibility Criteria:
Inclusion Criteria:

* morbid obesity patients after gastric bypass with annoyed intestinal symptoms

Exclusion Criteria:

* cannot obey the orders to take medicine
Real-world Effectiveness of Asciminib and Treatment Patterns in Patients With Chronic Myeloid Leukemia With T315I Mutation - a Chart Review Study of Patients Treated in the Asciminib Managed Access Program (MAP)

This non-interventional study (NIS) was a retrospective chart review analyzing existing data from patients participating in the asciminib MAP.


Eligibility Criteria:
Study Population: Key Inclusion/Exclusion Criteria Inclusion criteria

* Diagnosis of CML (chronic phase, accelerated phase or blast crisis).
* Confirmed presence of T315I mutation prior to asciminib initiation.
* Patients enrolled in the asciminib MAP and received their first dose of asciminib between 01 November 2018 and 30 April 2022. Patients must have received at least one dose of asciminib.
* Appropriate approval was obtained for the patient chart review including:

  * Patient signed the informed consent form (ICF) or,
  * Individual ICF waiver was granted by an institutional review board/ Independent Ethics Committee (IRB)/ IEC.

Exclusion criteria

• Age less than 18 years old at the time of initiating asciminib treatment.
Epidemiological Investigation of Malocclusion in China

Malocclusion is a kind of craniomaxillofacial complex deformity caused by heredity, environment, bad habits, trauma, inflammation, tumor and aging. Notably, the last comprehensive national prevalence data on malocclusion in China, which encompassed a significant sample size, dates back over two decades. Given the evolving nature of these epidemiological metrics, such as prevalence rates, it is imperative to update our understanding. Consequently, there is an urgent need for China to undertake a unified, standardized epidemiological survey of malocclusion with a substantial sample size to ensure accurate and timely data collection.

With the improvement of our country's living and cultural level, orthodontic treatment for malocclusion has emerged as a critical need that significantly impacts individuals' physical and mental wellbeing, as well as their social life in contemporary society. To obtain the prevalence rate, demand index and risk factor analysis of malocclusion in China serves as a fundamental prerequisite for effective diagnosis, identifying the optimal treatment window, and devising tailored treatment plans.

The purpose of this study is as follows:

1. Obtaining epidemiological data such as the prevalence rate of malocclusion is the cornerstone of prevention and treatment of malocclusion, and is also the prerequisite of carrying out a series of studies;
2. Establishing China's orthodontic treatment demand index offers vital support for the advancement of orthodontics and oral healthcare.;
3. Updating and enhancing X-ray head image measurement normal reference value provides a more scientific and objective foundation for orthodontic planning, improves the level of diagnosis and treatment, and fosters the development of related disciplines.

The implementation of this project will not only foster an improvement in the overall oral health of the populace but also establish a scientific foundation for oral medicine research and the development of prevention and treatment strategies.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals with all genders;
2. Individuals with good general health;
3. Individuals with no history of orthodontic treatment or other maxillofacial surgical interventions;
4. Individuals who agree to and are willing to sign the informed consent form.

Exclusion Criteria:

1. Individuals diagnosed with genetic or systemic disorders;
2. Individuals with a recent (within the past 3 months) history of maxillofacial trauma;
3. Individuals who are incapable of undergoing oral examinations or completing the necessary questionnaires.
Pulsatility Aneurysmal Evaluation Process by Cerebral Dynamic CTA (Computed Tomography Angiography)

Intracranial aneurysm are frequent with a prevalence estimated over 2-5% in the general population. These are focal dilatations occuring in the cerebral vessels. They usually remain silent until complications occur. Complications associated with intracranial aneurysms include mass effect on adjacent structures and rupture. Rupture is the most severe complication with a mortality rate of 35-50% and a high rate of morbidity including long-term disability. It incidence is estimated about 1% per year for aneurysm smaller than 1 cm.

However, preventative treatments have their own risk of complication and morbi-mortality rate including stroke and hemorrhage. Actual guidelines for treatment planning are mainly designed with the size, the location and the age of the patient. This is why working on the identification of imaging markers of aneurysmal instability is relevant.

Dynamic CTA (Computed Tomography Angiography) acquisition allow to study the variation of metrics such as dome height, dome length, ostium width, ostium area, and volume during the cardiac cycle. The goal of this study is to assess different aneurysmal metrics to determine those which may vary the most during the cardiac cycle and to assess it as an imaging marker of aneurysmal instability.


Eligibility Criteria:
Inclusion Criteria:

* Patient with an intracranial aneurysm assessed with a 4D CTA

Exclusion Criteria:

* Minor
* Refusal to participate
Spinal Fusions Steroid Study

Current efforts to improve pain alleviation focus on non-opioid pharmaceuticals. Intravenous perioperative corticosteroid administration has been suggested as an alternative method for post-operative pain control. The evidence regarding perioperative intravenous corticosteroids to help alleviate post-operative pain is mixed. Some meta-analyses report decreased opioid consumption and decreased pain intensity after a variety of surgical procedures. However, a study of larger orthopedic procedures found no benefit. The catabolic and immunosuppressant effects of corticosteroids also pose issues with wound healing and infection, which can have severe consequences after spine surgery. There is limited data on the effect of perioperative intravenous steroid administration on pain alleviation in children having surgery to address spine deformity. A recent retrospective review demonstrated that perioperative corticosteroid administration was associated with a statistically significant decrease in opioid medication utilization among children and adolescents after spinal deformity surgery. While not increasing the risk of postoperative complications. The investigators hypothesize that the administration of perioperative intravenous dexamethasone will demonstrate a clinically meaningful and statistically significant decrease in postoperative pain intensity, need for opioid medications, time to ambulation, and length of stay in children recovering from surgery for spine deformity.


Eligibility Criteria:
Inclusion Criteria:

* Meets operative criteria for posterior spinal instrumented fusion for AIS
* Parental consent

Exclusion Criteria:

* Revision procedure
* Other associated conditions which may alter the postoperative course
Imaging in Clinical Trials - a Questionnaire Study to Assess Impact of Imaging Regimes on Patient Participation

This research is aimed at finding out what may influence the decision of patients to participate in trials involving imaging so that the investigators may improve our future studies so they are more patient focused and acceptable in regards to scan schedules.

This is a questionnaire study aimed at gaining a greater understanding of the patient perspective on undertaking imaging procedures, MRI and PET/CT, for research purposes. The study is to evaluate the patient opinion and perceptions of the burden of imaging associated with research. We will look at different scanning procedures of varying duration, intensity, frequency and scheduling; this will enable us to have a better understand of the factors that influence participation in research and thus help us develop protocols that are more patient focused and acceptable.

Eligibility Criteria:
Inclusion Criteria

* Being treated at The Royal Marsden Hospital
* Over the age of 18
* Having imaging (MRI or PET/CT) as part of research or clinical care.
* Group 1

  * Currently enrolled in a research project that involves imaging (either MRI or PET/CT)
* Group 2

  * Previously enrolled in a research project that involved imaging (either MRI or PET/CT), where the patients involvement in the research project has now ended.
* Group 3

  * Patients attending the MRI or PET/CT departments for imaging as part of their standard clinical care.

Exclusion Criteria -

* Inability to complete the questionnaire.
* Previously completed questionnaire.
Seroquel for Frequent, Heavy Drinkers

The purpose of this study is to examine the effects of quetiapine in reducing percent heavy drinking days and increasing percent abstinent days in alcohol dependent patients who are frequent heavy drinkers.

This trial is a phase 2, randomized, double-blind, placebo-controlled, parallel group trial intended to assess the efficacy of quetiapine compared to placebo in alcoholics who are frequent heavy drinkers.

Eligibility Criteria:
Inclusion Criteria:

1. Male and females, 18-70 years old.
2. Meets DSM-IV criteria for current diagnoses of alcohol dependence, determined by the MINI/SCID-IV {First, 1996 #34}.
3. Meets the drinking criteria, measured by TLFB and the Addiction Severity Index {McLellan, 1992 #37}:
4. Three consecutive days of abstinence from alcohol immediately before randomization
5. Lives a commutable distance from the TRC and agrees to attend all research visits including follow-up visits.
6. Speaks, understands, and prints in English.

Exclusion Criteria:

1. Has evidence of dependence on a substance other than alcohol (except nicotine and marijuana).
2. Tests positive on the urine drug screen during the screening weeks (one retest allowed). Subjects whose urine drug screen tests positive for benzodiazepines will be allowed to randomize, at the discretion of the PI, if they are known to be physician-prescribed for detox purposes.
3. Has hepatocellular disease indicated by elevations of SGPT (ALT) and SGOT (AST) of at least 4.5 times normal after the required 3 days of abstinence, or elevated bilirubin (\>1.3), with associated elevations of AST and ALT above normal limits.
4. Meets diagnostic criteria for a current unstable or serious psychiatric or medical illness.

   Has serious heart, lung, kidney, immune system, GI tract (ulcerative colitis, regional enteritis, or gastrointestinal bleeding) disease.
5. Has taken any psychotropic medications (including disulfiram, naltrexone or acamprosate) regularly within the last 2 weeks or needs immediate treatment with a psychotropic medication.
6. Tests positive on a pregnancy test, is contemplating pregnancy in the next 12 months, is nursing, or is not using an effective contraceptive method if the patient is of child-bearing potential, meaning has not had a hysterectomy or is in menopause, meaning 50 or over and has not had a menstrual cycle in 12 months.
7. Has known hypersensitivity to antipsychotics.
8. Has taken any investigational drug as part of an investigational trial within 30 days prior to the randomization.
9. A history of seizure disorder.
10. The presence of cataracts.
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)

The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.

The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.


Eligibility Criteria:
Key Inclusion Criteria:

* NYHA Classification ≥ III
* Left Ventricular Ejection Fraction ≥ 30%
* Mitral regurgitation ≥ Grade 3+
* Subject meets anatomical eligibility criteria for the investigational device
Virtual Reality (VR) -Directed Brain Gut Behavioral Treatment (BGBT) for Inflammatory Bowel Disease (IBD) Inpatients

The research is studying virtual reality (VR)-directed brain-gut behavioral therapy (BGBT) as a pain treatment option for hospitalized patients with inflammatory bowel disease (IBD). This study is being done to learn if VR-directed BGBT is feasible and acceptable for patients with IBD in addressing pain in the hospital setting.

The study hypothesizes that:

* At least 75% of enrolled participants will complete the VR-directed BGBT inpatient program
* Hospitalized patients with IBD will find VR-directed BGBT acceptable as a pain treatment option in the inpatient setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Inflammatory Bowel Disease and self-reported pain
* Hospitalized for management of IBD (inpatient medicine services at Michigan Medicine)

Exclusion Criteria:

* Patients that do not report pain
* Anticipated length of hospital stay is less than 72 hours
* Patients that have previously had a seizure, loss of awareness, or other symptoms linked to an epileptic condition
* Patients with binocular vision loss
* Patients with an uncontrolled cardiac condition such as an arrhythmia, coronary artery disease, or neurological/cerebrovascular disease.
* Patients that are currently pregnant
Fibrillatory Factor in Ventricular Tachycardia

This study involves recording electrical signals inside the heart during an ablation procedure. It is thought that by studying these electrical signals in detail the investigators may be able to better identify and treat patients at risk of Ventricular Tachycardia (VT).

VT is where the lower chambers (ventricles) of your heart beat fast and this condition can be life-threatening. An ablation procedure is performed in patients who have VT despite the best treatment available with tablets.

Cardiac ablation involves interrupting the abnormal electrical signals, which cause VT, by applying a type of electrical energy through a catheter. An important part of the ablation procedure is the identification of the exact part of the heart muscle responsible for causing the VT. This typically involves sampling the electrical signals in lots of different areas of the heart, which allows the construction of computer generated 3 dimensional pictures of the structure and the electrical circuits inside the ventricle. Recent research has identified a new method to interpret these electrical signals (called Fibrillatory Factor - FF), which may allow better identification of the area within the ventricle that should be ablated.

A standard VT ablation will often involve us controlling the heart-beat by pacing the heart through 1 of the investigators catheters within the heart. The electrical response to pacing at different heart rates can often provide your doctor with information to help the ablation. This study will involve an additional period of pacing at different heart rates, during which the electrical response is measured in different areas around the ventricle. This will allow us to calculate areas of the ventricle, which the investigators new measure FF would predict to be the source of the VT. In the future this may then allow us to better identify patients who are at risk of VT, and to better locate the area that needs to be ablated.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or above, and capable of giving informed consent
* Scheduled for a clinically indicated cardiac ablation for the treatment of ventricular tachycardia

Exclusion Criteria:

* Moderate or severe aortic stenosis or mitral stenosis
* Active infection
* Presence of thrombus, cardiac tumour, interatrial Baffle patch (a specific form of congenital cardiac surgery) or prior septal occluder device
* Subjects who cannot be anticoagulated of infused with heparinized saline
* A history of heparin induced thrombocytopenia
* Pregnant or actively breast feeding