cyrilzakka/clinical-trials huggingface dataset:
Study on the Staging and Prognosis Model of Bladder Cancer

Firstly, we retrospectively gathered the patient information who compliant with the criteria from 2012 to 2023, encompassing basic information, clinical information, along with MRI images, blood/urine samples, and tissue samples, for conducting relevant analyses of radiomics. Subsequently, based on artificial intelligence technology, deep learning and machine learning models were established on the basis of MRI radiomics and pathological histomics. Ultimately, the following research aims were accomplished: 1. Primary research objective: To explore the role of artificial intelligence and multimodal omics features in the staging and prognosis monitoring of bladder cancer. 2. Secondary objective: To explore the correlations among radiomics, case histomics, and test omics.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with bladder cancer in preoperative examination; 2. Gender is not limited; 3. Age≥ 18 years old; 4. Be able to provide MRI images, pathological data and laboratory examination data before the operation; 5. Agree to provide basic personal clinical information and pathological and imaging data for scientific research use, and sign the informed consent form; 6. Agree to provide monitoring results during follow-up recurrence monitoring;

Exclusion Criteria:

* 1. Incomplete clinicopathological data; 2. Combined with upper tract urothelial carcinoma or previously diagnosed upper tract urothelial carcinoma; 3. Is participating in the rest of the clinical studies; Unable to cooperate with the relevant examinations of this project, and do not agree to sign the informed consent form.
Preterm Infant Growth

The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.


Eligibility Criteria:
Inclusion Criteria:

* Born AGA
* Exclusively formula-fed
* 28-34 weeks GA at birth
* Intact GI tract, tolerating full oral feeds
* Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days

Exclusion Criteria:

* Severe respiratory disease defined as needing mechanical ventilation at discharge
* Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
* Major congenital malformation, history of GI surgery, severe postnatal complications
* Daily or routine diuretic use at time of discharge
* Receiving more than 10% of daily kcals from food additives such as thickeners
* Currently participating or having participated in another conflicting clinical trial.
Intraoperative Nociception and Postoperative Pain

If the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. Therefore, investigators try to evaluate the relation intraoperative nociception response with postoperative pain score.

In similar anesthetic depth(End tidal sevoflurane 3%) , changes of surgical pleth index values for stimulus of skin incision are thought to reflect the individual nociception characteristics.

Patients who undergoing upper abdominal laparotomy surgery usually experience severe postoperative pain. Previous studies were reported that preoperative pain, young age, high-dose remifentanil, and depression were associated with severe postoperative pain.

However, anesthesia-related studies were either retrospective studies or injected with anesthetic agents in excess of clinical doses to differentiate between groups. There is no objective indicator for prediction severe postoperative pain.The purpose of this study was to investigate the relationship between intraoperative pain response and postoperative pain on standardized surveillance devices.

To maintain the depth of anesthesia, an EEG monitoring device bispectral index (BIS) is used. Also, surgical pleth index (SPI, GE healthcare, Freiburg, Germany) is a noninvasive pain-analgesia balance monitoring device that is commercially available to evaluate the state of pain during general anesthesia. SPI = 100- (0.3 \* heart beat interval + 0.7 \* photoplethysmographic pulse wave amplitude) is automatically and continuously calculated from the waveform of peripheral oxygen saturation.

In similar anesthetic depth(End tidal sevoflurane 3%) , changes of SPI values for stimulus of skin incision are thought to reflect the individual nociception characteristics. The investigators hypothesized the higher analgesics consumption can predict with high SPI response following incisional stimuli.

Thus, investigators try to evaluate the comparison of two groups ( high fentanyl consumption group vs. low fentanyl consumption group) with intraoperative SPI value (incision and before aurosal) and hemodynamic parameters under End tidal sevoflurane 3%(anesthesia depth, hemodynamically stable and appropriate anesthetic depth based on previous studies were confirmed at the time of skin incision). And the characteristics and emotional status of patients in two groups are compared.

Eligibility Criteria:
Inclusion Criteria:

-undergoing laparotomy gastrectomy

Exclusion Criteria:

* cardiac arrythmia
* allergic history for drugs
* renal failure (Cr\> 1.5 mg/dl)
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for CKD

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Chronic Kidney Disease.

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Chronic Kidney Disease (CKD). This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of CKD. Patients with CKD will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chronic Kidney Disease
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
Research on Improving Sleep During Pregnancy

The overarching goal is to utilize a randomized control design to examine acceptability, feasibility, and adherence of mindfulness-based stress reduction plus prenatal sleep supplement (MBSR+PS) compared to treatment as usual among pregnant people with poor sleep quality (n=50).

Poor sleep quality is highly prevalent during pregnancy, with important implications for maternal and infant health and well-being. Despite this, there is limited research on interventions to improve prenatal sleep, and prior research did not target the specific factors contributing to poor sleep quality in this population. Specifically, pregnant people report that physical symptoms, including discomfort and pain, disturb their sleep. In non-pregnant populations, this pain-sleep relationship is bidirectional, and maladaptive psychological responses to pain further exacerbate poor sleep. Theory and empirical evidence indicate that mindfulness-based interventions may be effective for targeting these psychological responses. The overarching goal is to utilize a randomized control design to examine acceptability, feasibility, and adherence of mindfulness-based stress reduction plus prenatal sleep supplement (MBSR+PS) compared to treatment as usual among pregnant people with poor sleep quality (n=50). Participants will be recruited to complete study questionnaires at two timepoints during pregnancy. Participants randomized to MBSR+PS will receive usual care, will be asked to attend 8 weekly group MBSR sessions (in addition to the MBSR orientation session, 1:1 interview with the instructor, and daylong retreat) and 6-8 PS sessions individually or in small groups, and will complete daily sleep and home practice diaries. Participants randomized to treatment as usual will receive usual care.

The specific aims are:

1. To determine acceptability of MBSR+PS.
2. To determine feasibility of MBSR+PS.
3. To determine adherence to MBSR+PS.
4. To explore evidence of change in psychological mediators.
5. To explore between-group differences in sleep.
6. To explore group differences in other critical clinical outcomes (e.g. depressive symptoms, anxiety symptoms, stress).

There is strong conceptual basis to predict the potential benefit of this approach for pregnant people. Targeting psychological responses to poor sleep during pregnancy may have significant public health benefits.

Eligibility Criteria:
Inclusion Criteria:

* Pregnancy 12-28 weeks gestation at time of intervention start
* 18 years of age or older
* Regular access to a web-enabled computer, phone or tablet
* Ability to read and speak English, and to provide informed consent
* Poor sleep quality (PSQI \> 5)

Exclusion Criteria:

* Self-reported sleep disorder (e.g. sleep apnea, narcolepsy, parasomnia, circadian rhythm disorder)
* Shift-work or nighttime caregiving responsibilities
* Psychological, medical, or other issues that necessitate priority treatment (e.g. active suicidality, probable depression (PHQ-9 ≥ 10), psychosis, on bed rest, multiple gestation)
* Current regular mindfulness practice (\>20 minutes/week)
Open Surgical, Modified Seldinger's and US Techniques for Jugular Central Line Insertion in Infants

The aim of this study was to compare the three approaches: open technique, modified Seldinger's technique and closed ultrasound-guided Central venous catheterization insertion for central line insertion in infancy as regards safety, success of cannulation, technique time, and preservation of the patency of the internal jugular vein.

Central venous catheterization is an essential technique in the intensive care units , for the administration of life-saving treatments including total parenteral nutrition, nutritional support, and intravenous medication. The internal jugular vein is often chosen because of its relatively larger size than the subclavian vein, lower risk of complications, and easy compressibility in case of bleeding. To facilitate Central venous catheterization, ultrasound guidance over anatomical guidance in closed techniques has been introduced bringing increased success rates, decreased catheterization times, and reduced complications.

Open surgical insertion is a common method of tunneled catheter implantation in the past, but the percutaneous approach has recently gained more popularity . The modified Seldinger's insertion technique is a catheter over guide wire technique, based on the original Seldinger's technique, and has not been widely adopted in Intensive care units. However, the modified Seldinger's technique has been successfully introduced into Intensive care units, and it is now used as the only technique for peripherally inserted central venous catheter insertion .

Central venous catheterization have become a mandatory part of clinical management in a variety of clinical circumstances in pediatric age groups. It allows resuscitation for intravascular fluid depletion and access for vasoactive medications and antibiotics, and it provides a means for hemodynamic monitoring and pacing. US guided closed technique is the updated use for insertion of IJV catheterization because it can both increase the success rate and decrease the complications related to Central venous catheterization placement

Eligibility Criteria:
Inclusion Criteria:

- 1-patients needed Central venous catheterization insertion in the internal jugular vein for medical or surgical causes.

2- patients with age ranging from birth till two years

Exclusion Criteria:

* 1- femoral or subclavian Central venous catheterization insertion. 2- patients with thrombosed internal jugular vein . 3- patients with previous Central venous catheterization insertion. 4- those with malignant conditions
ENdothelial DysfUnction in Renal Disease and Exercise Training

Chronic kidney disease (CKD) is a prevalent disorder and a major health concern. Cardiovascular disease is the most prevailing and life-threatening complication observed in patients with CKD. The diagnosis of CKD places a patient at the highest cardiovascular risk level irrespective of the stage of renal decline. Therefore, fatal cardiovascular events are more likely to occur than the evolution to final stages of kidney disease with the need for dialysis. Counter intuitively, treatment of classical cardiovascular risk factors does not affect cardiovascular prognosis in CKD, which suggests that the missing link between these two entities has not been elucidated yet.

In the present project, the investigators focus on endothelial dysfunction in patients with CKD. Endothelial dysfunction precedes overt atherosclerotic changes by many years. In the absence of structural changes, endothelial dysfunction is still reversible, which offers therapeutic perspectives to tackle the progression towards atherosclerosis in an early stage.

The purpose of this study is to determine whether an exercise training program is effective in ameliorating endothelial dysfunction in patients with chronic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* patients with CKD stage 3-4 (eGFR (15-59 ml/min/1.73m2) without cardiovascular disease.

Exclusion Criteria:

* patients \< 18 years
* pregnancy
* warfarin therapy
* glucocorticoid therapy
* clinically active malignant disease
* heart failure (ejection fraction \< 50%)
* peripheral vascular disease, defined as a history of intermittent claudication, abnormal peripheral angiography or Doppler ultrasound, lower limb artery bypass surgery/angioplasty/stenting or non-traumatic lower extremity amputation
* cerebrovascular disease, defined as a history of transient ischemic attack (TIA) or stroke, significant stenosis of the A. carotis on ultrasound/CT angiography or carotid endarterectomy/stenting
* coronary artery disease (CAD), defined as a history of myocardial infarction, coronary artery angioplasty/stenting/bypass surgery, significant structural coronary lesions on angiography or high suspicion of CAD on a maximal exercise test
Impact of Severe Tricuspid Regurgitation Correction on Gut Microbiota and Gastrointestinal Function

Tricuspid regurgitation (TR) is gaining increasing attention within the cardiological community due to its poor prognosis, challenging clinical presentation and difficult treatment.

TR causes decreased forward cardiac output and increased intravascular pressure upstream, which lead to peripheral oedema, ascites, hepatic congestion and kidney failure.

The microbiota is also getting increasing attention and changes in microbiota have been already associated with cardiovascular disease.

The impact of hemodynamic effects of TR on the gut microbiota however is still unknown.

Patients affected by TR frequently complain abdominal distension and anorexia. We hypothesize that, due to increased venous congestion, TR may induce impaired gut function with modification in the microbiota and that TR correction may induce reverse changes.

This study will enroll patients treated with Transcatheter Tricuspid Edge-to-Edge Repair (T-TEER) at the Valve Center of San Raffaele Hospital due to severe TR.

In addition to the standard of care, before T-TEER, for all patients 2 additional blood samples, 1 urine and 1 fecal sample will be collected.

3 months after the procedure, all patients will be re-assessed at the Valve Center outpatient clinic as standard of care. At this stage for all patients 2 blood samples, 1 urine and 1 fecal sample will be collected again for the purpose of the study. The microbiota metabolites of patients after 3 months from the procedure will be compared to those at baseline according to the degrees of residual TR.

To assess the reproducibility of the microbiota results and to explore an intrinsic short-term variation in microbiome composition within single patients, a subgroup of 30 patients will undergo a low intervention substudy repeating the measurements (2 blood, 1 urine and 1 fecal) within 10 days, both at baseline and at follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, able to sign the Informed Consent Form, admitted to OSR Heart Valve Center with TR ≥ severe treated with T-TEER.

Exclusion Criteria:

* Concomitant ≥ severe MR. Such patients may be treated with M-TEER and be re-evaluated after 3 months: if TR is ≥ severe and MR is ≤ moderate the patient may then be enrolled.
* Surgical candidates
* Recent \< 6 months cardiac coronary or structural procedure
* CAD requiring intervention
* other valvular disease \> moderate
* Treatment with transcatheter tricuspid replacement
* Age \<18 years
* Inability or unwillingness to sign informed consent
* Kidney dialysis
* Acute infection
* Inflammatory bowel diseases
* Gastrointestinal diseases
* Previous gastrointestinal surgery
* Active cancer
* Active autoimmune or inflammatory diseases
* Treatments with antibiotics or probiotics within one month
* Emergency procedures
* Patients enrolled in interventional studies that may confound study results
The Effects of Elliptical Cross Training Bike for Stroke Patients

To investigate the effects of elliptical cross bike exercises combine conventional physical therapy on gait, postural control, balance, muscle tone, spasticity, quality of life, motor functioning, functional activity, and ADL in post stroke patients.

In a single-blind, randomized controlled intervention, patients were randomly assigned to an active cycling group (ACG, n=25) five times a week combine with conventional al physical therapy or a control group (CG, n=25) with conventional physical therapy 3 weeks of training in the center.

All outcome measures were administered at the beginning of the study, at the end of the 1st, 2nd, and 3rd week.

All participants will be divided two groups. One group will be experiment with conventional physical therapy as control group (CG), the other group will active cycling as active cycling group (ACG) with elliptical Cross Trainer \& Exercise Bike after conventional physical therapy.

Baseline assessment of muscle tone by Myoton-3, Modified Ashworth Scale used as a simple measure of spasticity; Barthel Index scale for performance in activities of daily living; Berg Balance Scale to measure balance; the upper and lower limb subscale of the Fugl-Meyer assessment for motor function of extremities; and BTS G-WALK was used to measure gait parameters. The data will be collect before session.

Eligibility Criteria:
Inclusion Criteria:

* First-ever stroke (World Health Organization ,1978).
* Joint mobility ranges of lower extremity that would not preclude pedaling(Ambrosini, Ferrante et al. 2011).
* Unilateral hemiplegia.
* Able to carry out simple instructions.
* Able to sit independent at least 20 minutes and pedal an elliptical cross bike.

Exclusion Criteria:

* Neurologic disorders with impaired functionality existing pre-stroke.
* Patients could not follow instructions.
* Cardiovascular disease or other risk factor which precluded participation in aerobic exercise.
* Peripheral neuropathy that could potentially interfere with this study.
Effect of Aromatherapy on Postoperative Nausea, Vomiting

The aim of this study is to evaluate the effect of the aromatherapy with lavender, rose or ginger essential oils on nausea, vomiting and postoperative quality of recovery scores in patients with postoperative nausea and vomiting.

Postoperative Nausea and Vomiting (PONV) relief is still challenge for the anesthesiologist. Pharmacological therapies is also cornerstone for treatment of PONV. Although future researches are needed, there is some proofs about the aromatherapy could provide an inexpensive, noninvasive and effective treatment for PONV.

Eligibility Criteria:
Inclusion Criteria :

* Be scheduled for elective surgery
* Have a postoperative nausea and vomiting

Exclusion Criteria:

* Age \> 65years or \<18 years
* Not accepted to inhale lavender, rose or ginger oil
* Preoperative predications with anti emetic drugs
* Pregnancy or breastfeeding
* Asthma, Chronic obstructive pulmonary disease
* Poor sense of smell
* Allergy to the lavender, rose or ginger oil
Defining the Clinical Role of Topiramate in the Treatment of Alcohol Dependence in Australia

To compare the clinical effectiveness, tolerability, and cost-effectiveness of topiramate to active control (naltrexone) on treatment outcomes for alcohol dependence in a double-blind randomised controlled trial.

Clinicians urgently require new treatment strategies for the treatment of alcohol dependence. Although alcohol use disorders are a leading cause of preventable death in Australia, their treatment is generally not evidence based. The medications currently approved for use in Australia for the management of alcohol dependence have limited efficacy, and existing research does not address the heterogeneity of treatment response.

Targeted personalised medicine addresses this heterogeneity with better medicine selection for patients based on their genotype and clinical comorbidities.

Members of our research team have recently demonstrated findings that support the use of topiramate (TOP) 200 mg/day to reduce heavy drinking and pharmacogenetic findings that implicate the GluK1 receptor subunit in the mechanism of these effects.

This project will evaluate the clinical effectiveness and tolerability of topiramate relative to the active control naltrexone (NTX) in heavy drinkers.

Investigators hypothesise that topiramate treated patients will be better able to achieve a reduction in heavy drinking and predict that, based on prior research, that the effects would be moderated by a single nucleotide polymorphism (rs2832407) in GRIK1.

Research personnel will utilise an innovative prospective pharmacogenetic randomisation approach to a double-blind, randomised, controlled trial.

Individuals will receive 12 weeks of titrated treatment with topiramate (200 mg/day) or naltrexone (50mg/day) and medical management.

Eligibility Criteria:
Inclusion Criteria:

* Alcohol Use Disorder according to the Diagnostic and Statistical Manual of Mental Disorders Version V criteria
* Age 18-70
* Average weekly alcohol consumption of \>30 standard drinks for men and \>25 standard drinks for women, with a weekly average of \> 2 heavy drinking days during the month before screening
* Adequate cognition and English language skills to give valid consent and complete research interviews
* Willingness to give written informed consent
* Willingness to provide a blood sample for genotyping
* Written informed consent

Exclusion Criteria:

* Active major psychological disorder associated with psychosis, significant suicide risk, and signs of impaired cognitive functioning
* Pregnancy or lactation
* Concurrent use of any psychotropic medication other than antidepressants
* Currently taking any tricyclic antidepressant
* Use of antiretroviral dolutegravir
* Any substance dependence other than nicotine
* Opioid abuse, opioid dependence, or on opioid maintenance treatment
* Clinically significant liver disease
* History of nephrolithiasis
* History of glaucoma
* Lack of stable housing and/or contact phone number
* Previous hypersensitivity to TOP or NTX
* Any alcohol pharmacotherapy within the past month