cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Collagen, Propolis Plus Quercetin (Proqutin®), Bacillus Coagulans, Hyaluronic Acid and Chondroitin Sulphate and D-Mannose to Avoid Symptoms and Prevents Recurrence in Women With Recurrent Urinary Tract Infections

The aim of this study is to evaluate whether a dietary supplement based on D-mannose, collagen, hyaluronic acid, chondroitin sulphate, enhanced by the properties of quercetin plus propolis (Proqutin ®) and Bacillus Coagulans, eventually associated with antimicrobial prophylaxis, could be effective in preventing recurrent UTIs and improving related quality of life.


Eligibility Criteria:
Inclusion Criteria:

* a history of rUTIs (defined by EAU guidelines as a frequency of at least three UTIs per year, or two UTIs in the past six months in the last 12 months, confirmed by positive urine cultures
* not undergone any previous treatment for their condition.

Exclusion Criteria:

* age under or over limit
* concurrent antimicrobial treatment
* any ongoing treatment that could influence study outcomes,
* congenital or post-surgical urinary tract anomalies
* immunodeficiency or HIV infection
* ongoing pregnancy.
Adapted Physical Activity for Children Treated With Cancer and Insulin Sensitivity

The main objective of this study is to evaluate the evolution of the sensitivity to insulin, a hormone that acts on sugar in the body, as well as other metabolic, motor and nutritional elements of children with cancer, according to the practice of intense physical activities or stretching. In view of the scientific work on this subject, it is expect to observe that the practice of intense physical activities will improve the results of the children in the metabolic, motor and nutritional evaluations, compared to the stretching program.

The protocol consists of 6 months of intense physical activity and stretching programs for children with solid cancer or haematological disease, starting at diagnosis. Evaluations will be performed at the first, third and sixth month of the programs and then six and eighteen months after they are stopped. The physical activity sessions will take place in the hospital during hospitalizations or by videoconference when the children are at home. The sessions are adapted to the needs, desires and abilities of the children and will take place two to three times a week. They will be mediated by various activities such as soccer, rugby, darts, muscle strengthening. Inclusion lasts two years.

Eligibility Criteria:
Inclusion Criteria:

* age between 5 and 18 years old;
* have a solid cancer or hematological disease;
* be treated for the first time in pediatric oncology and hematology department;
* have an estimated life expectancy at diagnosis of more than 6 months.

Exclusion Criteria:

* present a physical and/or psychological impossibility to follow an adapted physical activity program;
* have a pre-existing heart disease that is not suitable for adapted physical activities;
* have a known type 1 diabetes
* have an obesity defined by a body mass index greater than or equal to the International Obesity Task Force 25 threshold
ProMRI PROVEN Master Study

This investigation is designed to provide supporting evidence for the clinical safety of the Ilesto/Iforia ICD (implantable cardioverter-defibrillator)system and the Evia/Entovis HF-T (Heart Failure) triple chamber pacemaker system when used under specific MRI (magnetic resonance imaging) conditions.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Able and willing to complete MRI testing
* Able and willing to activate and use the Cardio Messenger
* Able and willing to complete all testing required by the clinical protocol
* Available for all follow-up visits at the investigational site
* Standard indication for single, dual, or triple chamber ICD or CRT-P.
* ICD or CRT-P system to be implanted in the pectoral region
* Patient body height ≥ 140 cm
* Age ≥ 18 years

Exclusion Criteria:

* Standard contraindication for single, dual, or triple chamber ICD or CRT-P.
* Systems with an atrial lead: The patient has persistent (lasting longer than 7 days or requiring cardioversion) or permanent atrial arrhythmia
* Patient has other medical implants that may interact with MRI, e.g. abandoned pacemaker/ICD leads, lead extensions, mechanical valves, other active medical devices, non-MRI compatible devices
* Patient has other metallic artifacts / components in body that may interact with MRI
* Life expectancy of less than eight months
* Cardiac surgery in the next eight months
* Pregnant or breastfeeding
* Enrolled in another non-observational cardiac clinical investigation
Locking Compression Plate Fixation Versus Revision- Prosthesis of Vancouver-B2, B3 and C Periprosthetic Femoral Fractures After Total Hip Replacement

The purpose of this study was to compare the clinical (range of motion, weight bearing, quality of life) and radiographic outcome (boney consolidation) between open reduction and internal fixation using locking compression plates with revision prosthesis using a non-cemented long femoral stem in a group of patients with a Vancouver type-B2, B3 and C periprosthetic fracture after primary total hip replacement.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Vancouver type- BlI, BIII and C fractures and unstable femoral prosthesis stem.

Exclusion Criteria:

* Patients with pathological fractures,
* Vancouver type-A, Bl, and
* stable femoral prosthesis stem,
* Patients with hemi - prosthesis and periprosthetic femoral fractures were excluded from final analysis.
Dynamic Contrast Enhanced Computed Tomography to Assess Radiation Therapy in Liver Cancer Patients

This is a pilot study that uses a standard of care technique, Stereotactic Body Radiation Therapy (SBRT), in combination with Dynamic Contrast Enhanced Computed Tomography (DCE-CT) to determine if perfusion changes from SBRT of liver cancer may be used for outcome assessment and prediction of prognosis.

Patients will undergo standard of care SBRT while also receiving DCE-CT, also known as perfusion CT, pre-treatment, 6 hours post-treatment and 6 weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Provision to sign and date the consent form
2. Stated willingness to comply with all study procedures and be available for the duration of the study
3. Be a Male or Female aged 18-100
4. Diagnosed with Liver HCC or metastases
5. Must be receiving or will plan to receive SBRT for Liver HCC or metastases

Exclusion Criteria:

1. Allergy to iodine contrast
2. CT with contrast not offered as a Standard of Care
3. Pregnant women
Assessment of Seminal Levels of Cystatin C and Endoglin in Infertile Men With Varicocele

Varicocele is a major contributor in male infertility. The improvement of sperm parameters after varicocelectomy supports this contribution. The pathophysiological mechanisms of varicocele-induced male infertility are still under investigation. Cystatin C (Cys C) and endoglin are secreted glycoproteins that recently linked to several cellular changes common in varicocele like apoptosis and autophagy.

Subinguinal varicocelectomy under general anesthesia and complete aseptic condition was done to infertile men with varicocele

Eligibility Criteria:
Inclusion Criteria:

* Infertile men
* Varicocele
* Poor sperm parameters

Exclusion Criteria:

* Men with systemic diseases
* Infertile men due to other causes than varicocele
Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients

This study evaluates whether objective compliance monitoring can increase mandibular advancement device (MAD) usage in obstructive sleep apnea (OSA) patients. Half of participants will be assigned to objective compliance monitoring group (experimental group), while the other will be assigned to subjective compliance monitoring group (control group). A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.

The design of this study is a randomized controlled trial. Total 40 participants are randomly divided into 2 groups: objective compliance monitoring (n=20) and subjective compliance monitoring (n=20). Both groups wear the same MAD (commercial name: SomnoDent Flex with DentiTrac). They visit Seol National University Hospital at 1, 3, and 6 month after the initiation of MAD. A research coordinator acquires data by downloading from the MAD or by asking the patients, and then transfer the information to the physician. If the patient belongs to objective compliance group, data from the MAD will be transferred to the physician. But if the patient belongs to subjective compliance group, data acquired by asking patients will be transferred to the physician. A physician will prescribe and explain to patients based on data from objective or subjective compliance monitoring.The primary aims is to examine the effectiveness of SomnoDent Flex with DentiTrac, in terms of compliance.

Eligibility Criteria:
Inclusion Criteria:

* obstructive sleep apnea patients without a history of soft palate surgery and moderate to severe periodontal disease.

Exclusion Criteria:

* central sleep apnea
* active mandibular disease
* tooth grinding
* moderate to severe periodontal disease
3D-Printed Personalized Metal Implant in Surgical Treatment of Ankle Bone Defects

This study aims to use 3D-printed personalized metal implants for bone defect surgeries in order to reduce pain of the patients.

Bone defects are common in ankle disease, and the conventional treatment includes autologous or allogeneic bone grafts. However, autologous bone graft may cause complications and its source is rather limited; allogeneic bone graft may cause disease transmission and the mechanical strength of the graft is low after processing.

The 3D printing technology has provided a new way of solving this problem. It has the following technical advantages: wide range of graft sources, high mechanical strength, and can be prepared in advance according to various shapes.

Preparation procedure: first, establish the individualized ankle model according to the patient's ankle CT scan data and then prepare the implant model; second, conduct surgery rehearsal and place the implant model in the ankle model for observation; third, after confirmation, use titanium alloy in the 3D printing machine to prepare the individualized metal implant, which is in line with the Chinese National Standard "Wrought titanium and titanium alloy for surgical implants" (GB/T 13810-2007); fourth, implant the individualized metal implant into the bone defect area after sterilization.

Eligibility Criteria:
Inclusion Criteria:

* Receive ankle or subtalar arthrodesis;
* Refuse to use autologous bone graft or allogeneic bone graft.

Exclusion Criteria:

* The local defect area is small;
* Refuse to use permanent metal metal implant.
Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)

This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS).

We carried out a randomized, double-blind placebo-controlled trial of allogeneic bone marrow derived human mesenchymal stromal cells for treatment of moderate to severe ARDS in 60 patients, 40 MSC and 20 placebo, in a 2:1 randomization. This trial is the extension of the Phase 1 pilot trial (NCT01775774). Patients were followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. Vital status was collected at 6 and 12 months after study enrollment.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for inclusion if they meet all of the below criteria. Criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment:

Acute onset (defined below) of:

1. A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio \< 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP)
2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
3. No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.

Exclusion Criteria:

1. Age less than 18 years
2. Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS
3. Pregnant or breast-feeding
4. Prisoner
5. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years
6. Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
7. Moderate to severe liver failure (Childs-Pugh Score \> 12)
8. Severe chronic respiratory disease with a PaCO2 \> 50 mm Hg or the use of home oxygen
9. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
10. Major trauma in the prior 5 days
11. Lung transplant patient
12. No consent/inability to obtain consent
13. Moribund patient not expected to survive 24 hours
14. World Health Organization (WHO) Class III or IV pulmonary hypertension
15. Documented deep venous thrombosis or pulmonary embolism within past 3 months
16. No arterial line/no intent to place an arterial line
17. No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol
18. Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)
Postoperative Patency of Internal Jugular Vein After Neck Cannula Insertion

The number of patients undergoing Minimally Invasive Cardiac Surgery (MICS) is increasing each year. MICS procedures on atrioventricular valves are usually performed without conventional sternotomy, an alternative approach is from right anterolateral minithoracotomy. This surgical approach has essential impact both on anesthesia techniques and cardiopulmonary bypass (CPB) settings. Specific anesthesiological procedure is an insertion of neck venous cannula of CPB through the right internal jugular vein into the superior vena cava both for partial and total bypass. The size of neck cannula is between 15 and 21 French depending on the type of surgical procedure and patient's weight. Central venous catheter and eventually sheath are also inserted into the right internal jugular vein. Thus, there is a relevant question regarding postoperative patency of right internal jugular vein in patients undergoing MICS procedures requiring an insertion of neck cannula of CPB. The investigators hypothesize, there is no significant difference in postoperative patency of internal jugular vein assessed by ultrasound in patient undergoing cardiac surgery with and without neck cannula of CPB


Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing cardiac surgery

  1. conventional sternotomy without neck cannula as planned operating approach
  2. right minithoracotomy with neck cannula as planned operating approach

Exclusion Criteria:

* Any pathology of right internal jugular vein on preoperative ultrasound (vein not fully compressible, hypoplastic jugular vein, preoperative invasion on right jugular vein)
Prediction of Neoadjuvant Chemotherapy Efficacy in Locally Advanced Gastric Cancer

This study intends to explore the value of 68Ga-FAPI-04 and 18F-FDG PET/CT in the evaluation of treatment response to neoadjuvant chemotherapy(NAC) for patients with locally advanced gastric cancer(LAGC).

Before the start of NAC, baseline 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT scans will be scheduled in all enrolled patients. Next, the patients with resectable LAGC will receive NAC treatment, surgery will follow 3\~6 weeks after finishing NAC. Abdomen 68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT will be scheduled after one cycle of NAC treatment or before surgery. Imaging response measurements will be compared with the histopathological tumor regression grade (TRG) of the resection specimen as gold standard.

Eligibility Criteria:
Inclusion criteria

1. Age between 18-75 years.
2. Histologically confirmed gastric adenocarcinoma through gastroscopy.
3. Resectable gastric cancer.
4. ECOG performance status 0-1.
5. White blood count \>4x109/L, Absolute neutrophil count (ANC) \>2x109/L, Hemoglobin (Hb)\>90g/L, Platelets \>100x109/L.
6. Ejection Fraction\>50%.
7. Serum bilirubin \<1.5x ULN; ALT and AST \<1.5x ULN.
8. Serum creatinine ≤1.5x ULN, or GFR\> 60ml/min.
9. Agreement to participate in this study with informed consent form.
10. Willingness and ability to comply with the protocol for the duration of the study.
11. No children bearing petential in the next six months before enrollment.

Exclusion criteria

1. With second primary malignant diseases in past five years, exceptions include basal cell and squamous cell carcinoma of the skin that have been cured.
2. Known hypersensitivity reaction to chemotherapy drugs or with contraindications.
3. With severe disease or other unsuitable conditions determined by investigators. Inadequate organ function.
4. With uncontrollable diabetic or fasting blood glucose level ≥11 mmol/L on the test-day.
5. With severe mental symptoms, unconscious or unable to complete the examination.
6. Pregnancy or possibly pregnant woman, breastfeeding woman.
7. Lack of compliance.
Phenotyping Patients With Alcohol and Cannabis Use Disorders Using the Addictions Neuroclinical Assessment

This 2-arm study will recruit participants with 1) alcohol use disorder and 2) cannabis use disorder for a 12-week cognitive behavioral therapy, following a thorough baseline assessments on executive function, incentive salience, and negative emotionality.

Although effective evidence-based interventions have been developed for alcohol and cannabis use disorders, it is still unclear which individuals respond best to treatment. A recent model known as the Addictions Neuroclinical Assessment (ANA) proposes that assessing for differences in three neurofunctional domains (executive function, incentive salience, and negative emotionality) could allow for a stronger neuroscience-based framework for understanding heterogeneity in response to addiction treatments but this has never been tested prospectively. In this study, we will recruit two groups: (1) participants with alcohol use disorder (AUD) and (2) participants with cannabis use disorder (CUD). Participants will undergo thorough baseline assessments of each of the three ANA domains prior to evidence-based treatment for their respective disorders. Individuals with AUD will be treated with 12 weeks of cognitive behavioral therapy (CBT) for AUD plus optional pharmacotherapy guided by a pharmacotherapy algorithm. Individuals with CUD will be treated with 12 weeks of CBT + motivational enhancement therapy for CUD. The primary objective of the study is to assess whether baseline ANA measures are associated with changes in drug consumption and craving over treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has been referred to or intends to participate in either the AUD or CUD Integrated Care Pathway (and is therefore willing to participate in group psychotherapy).
2. Able to communicate and provide informed consent in English.
3. 18 years of age or older.
4. Willing and able to safely abstain from substances (other than nicotine or tobacco products), including alcohol and cannabis, for 12 hours prior to the eligibility and task-based assessments.
5. Meets DSM-5 diagnostic criteria for AUD (AUD group) or CUD (CUD group)
6. Meets criteria for risky drinking, defined as \> 10 drinks per week for females and \> 15 drinks per week for males on average over the past 30 days (AUD group) or daily or near-daily cannabis use over the past 30 days, defined as ≥ 4 days of cannabis use per week on average (CUD group)

Exclusion Criteria:

1. Active suicidal ideation at time of assessment.
2. Suicide attempt within the past month.
3. Unstable psychiatric or medical status (e.g., acute psychosis or mania) or unstable use of another substance that may interfere with participation in groups (e.g. active fentanyl use).
4. Enrollment in another study that conflicts with the procedures or scientific integrity of this study.
5. Individuals planning to be out of the province for a substantial amount of time during the treatment period will not be permitted to enroll.
The Role of ctDNA Testing Plus AI-based Pathology in Resectable LSCC

The goal of this observational study is to explore whether ctDNA dynamic monitoring plus AI-based pathology can more effectively predict the therapeutic effect of neoadjuvant chemoimmunotherapy for resectable lung squamous cell carcinoma, so as to accurately guide clinical diagnosis and treatment.

This study is a single-center, observational, non-interventional, prospective study. 50 patients diagnosed with lung squamous cell carcinoma receiving neoadjuvant chemoimmunotherapy (ranging 2 to 4 cycles) will be planned to be enrolled in the study. Pre-treatment biopsy tissues of enrolled patients will be collected for whole exon sequencing (WES) testing, and personalized detection panel will be customized based on WES testing results. Peripheral blood will be collected 1 day before each cycle of neoadjuvant therapy, 1 day before surgery, 3 days after surgery, and 3 weeks after surgery for ctDNA testing. In addition, the prediction model of AI-based pathology will be constructed by AI deep learning based on pathological sections of pre-treatment biopsy tissues. All inclued patients will be regularly followed up for at least 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histopathology or cytology confirmed the lung squamous cell carcinoma
* Age ranging from 18 to 75
* Agree to participate in this study and sign an informed consent form
* Treatment-naive tumor
* According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is stage II-IIIb resectable or potentially resectable tumor
* Sufficient tissue/blood samples are available to meet research requirements
* The ECOG PS score is 0-1

Exclusion Criteria:

* Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form
* Non-squamous NSCLC
* Unresectable IIIa-IIIb tumor
* Patients with solid organ or blood system transplantation
* Previous use of CTLA-4, PD-1, or PD-L1 immune checkpoint inhibitors
* Patients with interstitial lung disease
* Patients with acute or chronic infectious disease
* Pregnant and lactating women
* Patients who have undergone other clinical drug trials