cyrilzakka/clinical-trials huggingface dataset:
89Zr-atezolizumab PET Scan and Lobular Breast Cancer

The exploratory single center feasibility ImaGelato study is conducted as an imaging side study to the Dutch GELATO trial (Assessing efficacy of carboplatin and atezolizumab in metastatic lobular breast cancer). Ten patients with lobular metastatic breast cancer, who are included in the GELATO trial at the UMCG, are eligible for the ImaGelato study.

All patients will undergo two Zirconium-89 (89Zr)-atezolizumab positron emission tomography (PET) scans, one at baseline and one after two doses carboplatin induction treatment. The 89Zr-atezolizumab PET scan will be performed 4 days after tracer injection. Procedures within the ImaGelato study will be completed after the two 89Zr-atezolizumab PET scans, but patients will continue treatment with carboplatin combined with atezolizumab in the GELATO trial.


Eligibility Criteria:
Inclusion Criteria:

1. A patient must meet the inclusion criteria of the GELATO trial
2. Able to give written informed consent and to comply with the ImaGelato protocol

Exclusion Criteria:

1. Contra-indication for 89Zr-atezolizumab PET scan
2. Any approved anti-cancer therapy, including chemotherapy or hormonal therapy within ≤14 days prior to the first 89Zr-atezolizumab injection. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to the first 89Zr-atezolizumab injection.
Enduring Exercise Habits: Trending Norms

Learning that most people engage in an activity can be a powerful motivator to adoption. But are there instances in which people can similarly find motivation from learning that only a minority of others engage in a behavior? Evidence suggests this may be possible when the message is that the size of the minority has been growing in recent years. In this study, we first examine how gym members' exercise patterns shift when they are informed that the minority versus the majority of (a subpopulation of) other Americans exercise frequently. We also test how gym members are affected by learning that the number of frequent exercisers has increased in recent years.

Gym members register online to participate in a 28-day workout program. Upon registration, participants are assigned to one of five conditions (a 2 x 2 study design plus a control group). Participants are assigned to receive information about majority exercise norms or minority exercise norms, and are informed that these norms are trending up or receive no information about trends in these norms. Participants are then prompted to create a workout schedule. Over the 28-day intervention period, participants are sent text messages with information about exercise depending on their condition (i.e., majority trending exercise norms, majority exercise norms with no information about trends, minority trending exercise norms or minority norms with no information about trends), workout reminders before their scheduled workouts, and weekly emails with additional exercise information related to their assigned condition and their schedule. Participants assigned to the control condition are prompted to create a workout schedule and receive text message reminders, information about exercise that is unrelated to social norms, and weekly emails with exercise information unrelated to social norms or trends and their workout schedule. All participants earn points for participating and for each day that they go to the gym which can be redeemed for an Amazon cash gift card after the end of the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* Has 24 Hour Fitness gym membership

Exclusion Criteria:

-
Construction of a Model for the Differential Diagnosis of SArcoma/myoma Based on the RAdiomics Features: Single-center Observational Study

Uterine sarcomas are rare and aggressive tumors originating from the muscular wall of the uterus. They have a high risk of recurrence and death, regardless of the stage of the disease at diagnosis. The therapy is surgical and involves hysterectomy preferably via laparotomy in consideration of the high risk of neoplastic dissemination through the rupture and fragmentation of the neoplasm as occurs through removal by other surgical routes which involve core drilling of the mass (laparoscopic, vaginal , hysteroscopic).

Uterine myoma represents a very frequent benign pathology in women, with an incidence of approximately 70%-80%. Asymptomatic cases do not require treatment, while symptomatic cases can be treated through the administration of generally antiestrogenic drugs to block growth and symptoms. Only a small part is removed surgically.

Currently the diagnosis of uterine sarcoma is almost always defined in the post-operative setting with the definitive histological examination, due to the lack of typical sonographic and radiological characteristics of certainty capable of differentiating benign neoplastic forms (myoma) from malignant ones of the uterus (sarcoma).

Magnetic resonance imaging is currently the most reliable imaging modality for characterizing such uterine masses. Unfortunately, although it offers useful information, it is not able to discriminate with good precision a benign uterine lesion from a malignant one.

CT is a method widely used in the staging of oncological diseases and therefore also in sarcomas. It is usually prescribed when there is an ultrasound doubt of a sarcoma before proceeding with surgery.

However, although it is important in the definition of secondaries, it has very low sensitivity (60%) and specificity in the differential diagnosis between sarcoma and myoma.

Radiomics is a novel approach that translates medical images into data by extracting a large number of quantitative features describing tissue characteristics, shape and texture, combining quantitative data analysis with biological and clinical endpoint.

Capturing information from imaging that goes beyond the different biomedical imaging formats themselves is the great promise of this growing field.

The application of radiomics analysis to CT with the aim of preoperatively discriminating between sarcoma (malignant) and myoma (benign) could be a valid support in the preoperative evaluation and therapeutic decision-making process in order to personalize the most appropriate therapeutic approach .


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of uterine sarcoma or myoma
* Patients with pre-operative CT performed for diagnostic suspicion no more than 30 days before surgery
* Age between 18 and 80 years
* Patients followed in the clinical care path in our center
* Obtaining informed consent

Exclusion Criteria:

* Low quality of CT images.
* Patients affected by other active neoplasms or diagnosed less than 5 years before the diagnosis of uterine sarcoma or myoma.
Using the Visualization for Lifestyle Change in Patients At Risk of Cardiovascular Diseases

In the framework of PhD research, the investigators will present a visualization of estimation of CVDs risk and the possibility of monitoring blood glucose levels in real-time. Based on the results, the investigators will assess the association of these with lifestyle change. The findings highlight the need for sufficiently reliable and high-quality evaluations of visualizations, technologies or applications used in the family medicine.

The investigators reviewed the existing literature and found little research on the use of Continuous Glucose Monitoring (CGM) and visualization of SCORE2 prognostic model in healthy populations and how they can influence lifestyle change. The investigators will conduct a randomised control trial with 3 intervention groups and 1 control gropu. The investigators also found that primary care nurses are still using paper-based methods to calculate CVDs by using colour-coded charts. Therefore, the investigators will use the visual tool of the SCORE2 scale to identify possible increased participants motivation using visualization. The investigators will also confirm or refute lifestyle change by calculating biological age.

Eligibility Criteria:
Inclusion Criteria:

* individuals ages more than 40 years
* without serious disease progression
* at least one risk factor for CVDs

Exclusion Criteria:

* individuals younger than 40 years
* with serious disease progression
* without risk factor for CVDs
Effect of Probiotics on Gut-Liver Axis of Alcoholic Hepatitis

Background/Aims:

The investigators explored the therapeutic effects of probiotics in patients with AH.

Methods:

Between December 2012 and January 2015, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis were checked at baseline and again after therapy.

Background/Aims: Alcoholic hepatitis (AH) is one of the leading causes of liver diseases. Gut-derived microbial lipopolysaccharide (LPS) has been known as a central role in the pathogenesis of AH. Some animal studies suggested an emerging role of probiotics in restoration of the bowel flora and improving liver enzymes. We explored the therapeutic effects of probiotics in patients with AH.

Methods:

Between December 2012 and January 2015, the investigators conducted a 7-day, double-controlled, randomized, prospective clinical trial comparing the efficacy of probiotics in improving liver enzymes, LPS, pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis. AH was defined as an aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 2 and elevated AST (ALT) level with an alcohol consumption history within 48 hours. Patients were randomized to receive 7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day) or placebo. The levels of liver enzymes, modified Discriminant Function (mDF), LPS, and pro-inflammatory cytokines, stool culture, and stool Polymerase chain reaction denaturing gradient gel electrophoresis were checked at baseline and again after therapy.

Eligibility Criteria:
Inclusion Criteria:

* Alcoholic hepatitis (AST/ALT \>2 \& elevated AST (ALT) level
* Alcohol \>60 g/day (M), \>40 g/day (F) during 7 days before screening
* Last drinks: within 48 hours prior to admission)

Exclusion Criteria:

* viral hepatitis,
* autoimmune hepatitis,
* pancreatitis,
* hemochromatosis,
* Wilson's disease,
* Drug-Induced Liver Injury,
* cancer,
* infection need for antibiotics,
* severe AH, or
* obesity (BMI \>30 kg/m2)
Stem Cell Therapy in Duchenne Muscular Dystrophy

The purpose of this study was to study the effect of stem cell therapy in patients with Duchenne Muscular Dystrophy.


Eligibility Criteria:
Inclusion Criteria:

* age group of 3-25 years
* Duchenne muscular dystrophy diagnosed on the basis of clinical presentation

Exclusion Criteria:

* presence of respiratory distress
* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \< 30%
* pregnancy or breastfeeding
A Study of Chinese Congenital Bicuspid Aortic Valve

Pervious studies indicated that the prevalence of bicuspid aortic valve（BAV） might be higher in China. There is a familial predisposition to the development of BAV. The study analyzed epidemiological data on selected BAV and established a BAV cohort to observe disease progression and treatment outcomes.

There is no recognized comprehensive epidemiological data on congenital BAV in China, although findings of BAV is common in clinical practice. In the course of the Venus-A registry clinical study, which was the first Aortic Valve Replacement (TAVR) trial in China, the investigators concluded about 40% of the final enrollment of BAV patients. Since then, an increasing number of scholars have figured out that the prevalence of BAV may be much higher in China than abroad. This study was designed to investigate Gene backgrounds, pathological progress, imaging characteristics of young health BAV participants and their relationships in long-term follow-up. These findings may help to identify high risk individuals with specific gene expression or other features in clinical observation.

Eligibility Criteria:
Inclusion Criteria:

* The patients were aged 14-60 years;
* Definitive diagnosis of BAV by imaging (echocardiography, aortic CTA, cardiac magnetic resonance, etc.)
* Patients were informed about the nature of the study and agreed to participate in all the terms of the study and signed an informed consent form approved by the ethics committee.

Exclusion Criteria:

* Poor patient compliance and inability to complete follow-up visits as required;
* Rheumatic heart valve disease, other organic valve disease.
* Hyperthyroidism, severe anemia, and other factors that significantly affect hemodynamics.
* Other circumstances that the researcher believes should be excluded.
Stereotactic Radiosurgery After Surgery in Treating Patients With Brain Metastases

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating patients with brain metastases.

OBJECTIVES:

Primary

* To estimate the rate of recurrence at the surgical site in patients with brain metastases treated with adjuvant stereotactic radiosurgery (SRS) compared with historical data documenting recurrence at the surgical site after surgery and whole brain radiotherapy (WBRT).

Secondary

* To estimate the rate of salvage WBRT, SRS, or surgery in patients treated with adjuvant SRS alone.
* To estimate the rate of new brain metastases outside of the adjuvant SRS site.
* To estimate patient quality of life after adjuvant SRS alone.
* To assess the effect of surgical intervention and SRS on the preservation of neurocognitive functioning in these patients.
* To determine the clinical significance (if any) of locally recurrent brain metastases at the time of their occurrence (mass effect, cognitive functioning, and other symptoms) in these patients.
* To estimate the rate of death due to neurologic causes, defined as death attributable to the progression of neurological disease.
* To estimate the overall survival of these patients.

OUTLINE: Patients undergo stereotactic radiosurgery over 30-90 minutes.

Quality of life and neurocognitive function are assessed periodically.

After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years of age.
2. Gross total resection (as verified by the lack of any enhancement in the resection cavity on post-operative MRI) of single brain metastasis confirmed by histology. Patients with up to 4 metastases are eligible if the largest mass is amenable to surgical resection and all non-resected masses are amenable to SRS.
3. Patient must be Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) Class 1 or 2.
4. Life expectancy of at least 3 months.

Exclusion Criteria:

1. Radiographic or cytologic evidence of leptomeningeal disease.
2. Patient with incomplete or partial resection.
3. Primary lesion with radiosensitive histology (i.e., small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma).
4. Patients with a resection cavity \> 4 cm in maximal extent in any plane on contrasted MRI scan.
5. Lesion located in anatomic regions which are not amenable to SRS including the brain stem and optic apparatus.
6. Pregnant or need to breast feed during the study period.
7. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness.
8. Brain surgery other than for resection of metastasis.
9. Previous brain radiotherapy.
10. Contraindication to SRS, WBRT, or MRI.
Longitudinal FolloW-up of Antimicrobial Resistance From Perinatal Acquisition (LWAPA): A SHARE Study ASSESSING AND PREVENTING Antimicrobial Resistance in the Perinatal Period

In 2022, in collaboration between the Botswana Ministry of Health (MOH), the U.S. Centers for Disease Control \&amp; Prevention, and the Botswana-UPenn Partnership (BUP), a program was launched called, "Surveillance of Healthcare-associated infections \&amp; Antimicrobial Resistance", or "SHARE". The aims of SHARE are to 1) enhance laboratory capacity to detect emerging AMR patterns; 2) strengthen hospital epidemiology programs, leveraging data to prevent, detect, and contain emerging AMR threats; 3) deploy study teams to answer critical public health surveillance questions, and 4) to build a national network of hospital infection prevention and control (IPC) resources to prevent, detect, and contain emerging infectious disease threats.

The Longitudinal FolloW-up of Antimicrobial Resistance from Perinatal Acquisition (LWAPA) study will assess the extent of perinatally-acquired MDROs and GBS, exploring factors influencing both maternal and neonatal colonization and better understanding the long-term outcomes in families affected by MDRO colonization.

By collecting samples at critical time points (e.g. during labour, after delivery, sequentially in the hospital, and then 3, 6, 9, and 12 months of age, the LWAPA study aims to identify modifiable factors influencing colonization risk. The results from this study can help inform and operationalize infection prevention measures which are poised to reduce the incidence of healthcare-associated infections and other poor health outcomes.

In Setswana, 'lwapa' means 'home' or 'family', which captures how this study aims to understand healthcare-associated AMR is impacting households and communities.

Eligibility Criteria:
Inclusion Criteria:

Pre-partum mothers will be eligible for recruitment if they have been admitted to the pre-partum ward (2F) at PMH. This includes mothers with:

* Pre-term labor (24-36 weeks gestation)
* Pre-eclampsia
* Post-dates (\&gt;41 weeks gestation)-

Exclusion Criteria:

Mothers/babies who have been admitted for more than 96 hours will be excluded
Rosuvastatin in the Long-term Treatment of Hypercholesterolaemic Subjects With Coronary Heart Disease

The primary objective of this study is to evaluate that 76 weeks of treatment with rosuvastatin calcium 2.5-20 mg results in no progression of coronary artery atherosclerotic volume as measured by intravascular ultrasonography (IVUS) imaging in hypercholesterolaemic subjects with coronary heart disease (CHD).


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent,
* 20 to 75 years old,
* Plan to undergo coronary angiography (CAG) or Percutaneous coronary intervention (PCI) and LDL-C ≥ 140 mg/dL (untreated patients) or LDL-C ≥ 100 mg/dL (treated patients)

Exclusion Criteria:

* Acute myocardial infarction within 72 hours after the onset,
* Heart failure of New York Heart Association (NYHA) Class III or above,
* Serious arrhythmia,
* Being treated with LDL-apheresis
* History of serious reaction or hypersensitivity to other HMG-CoA reductase inhibitors.
The 10/7 HIIT Shock Cycle Study: Effectiveness of 10 HIIT Sessions in 7 Days

A randomized, controlled trial to evaluate the effects of two versions of 10 high intensity interval trainings (HIIT) within a 7-day shock microcycle on endurance performance, well-being, health, stress and recovery in trained athletes.

Thirty-six trained endurance athletes will be recruited and randomly assigned to either a "high volume (HIIT-HV)" group, a "low volume (HIIT-LV)" group, or a control group. All participants will be monitored before (9 days), during (7 days), and after (14 days) a 7-day training intervention, for 30 days. Participants in both intervention groups will complete 10 HIIT sessions within the period of 7 days, with an additional 30 minutes of low-intensity training exclusively in HIIT-HV. HIIT sessions consist of aerobic HIIT, i.e., 5x4min at 90-95% of maximal heart rate interspersed by 2.5 min active recovery periods. To determine the effects of the intervention, performance diagnostics, and a 5 kilometer time trial will be conducted before and after the intervention. In addition, participants are closely monitored for general health, stress, fatigue, recovery, neuromuscular performance, executive functions and sleep.

Eligibility Criteria:
Inclusion Criteria:

* Female or male
* aged 18-45 years
* Proof of physical fitness (e.g. sports medical examination required) for measurements with higher intensities (e.g. endurance tests, competition simulation)
* Competition experience at the national or international level in an endurance sport
* VO2max ≥50ml/kg/min for females; ≥55 ml/kg/min for males or a 5-kilometer (km) time trial performance of ≤ 20:00 min (female), or ≤ 18:30 min (male)

Exclusion Criteria:

* Systemic disease or other known pathology in the organs: heart, lungs, kidney, stomach, spleen, liver, gall bladder, and intestines.
* Evidence of pulmonary disease: forced expiratory volume in one second/forced expiratory volume \< 70% with/without symptoms (cough, sputum) or other evidence of pulmonologic disease.
* Diabetes II.
* Neurological or psychological disease of any kind.
* Currently undergoing medical or psycho-therapeutic treatment.
* Health condition that does not allow regular participation in the training forms (e.g. acute illnesses such as fever or other flu-like infections within the last 7 days before the start of the study), orthopedic diseases, injuries to the muscular, bone, joint or tendon apparatus within the last three months.
* Alcohol or drug abuse.
* Already high training volume with high intensity training (more than 2 weekly training sessions of high-intensity training)