cyrilzakka/clinical-trials huggingface dataset:
MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD

The purpose of this study is to compare the efficacy of CD25 monoclonal antibody and calcineurin inhibitors with or without mesenchymal stem cells (MSCs) in treating patients with steroid-resistant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective therapy for several hematological disorders. Although good progress has been made in the prevention and treatment of side effects associated with transplantation, aGVHDremains a common and life-threatening complication with poor prognosis. Corticosteroids are still acted as the first-line treatments of aGVHD, with a response rate of 50-80. However, those who failed to initial therapy only have 10-30% long-term survival.

Mesenchymal stromal cells (MSCs) are a form of multipotent adult stem cells that can be isolated from many tissues, such as bone marrow (BM), adipose tissue and umbilical cord. Such cells possess the capacity to suppress immunological responses, support hematopoiesis and repair tissues. Clinical applications of human MSCs are evolving rapidly for preventing and treating GVHD. Although the results are still controversy, most prospective and retrospective data suggest that MSCs are effective to aGVHD.

In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded BM-derived MSCs from third-party donors combined with CD25 monoclonal antibody and calcineurin inhibitors in treating patients with aGVHD.

Eligibility Criteria:
Inclusion Criteria:

* age of 14-65 years
* steroid-resistant aGVHD
* subjects (or their legally acceptable representatives) must have signed an informed consent document

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
Azithromycin Versus Erythromycin For Preterm Prelabor Rupture of Membranes

Aim 1. To examine the latency period according to antibiotic regimens (erythromycin iv for two days followed by orally for 5 days vs. azithromycin iv for 2 days followed by 5 days orally).

Aim 2. To examine the latency period according to races stratified by antibiotic regimens.

Aim 3: To examine if there is a difference in neonatal morbidity and mortality stratified by antibiotic regimen.

Significant differences exist in the pharmacokinetics and pharmacodynamics pathways of macrolide antibiotics between different races and ethnicities. Erythromycin compared to azithromycin interacts with more proteins and is likely affected by genetic variation. Therefore, the investigators hypothesize that the optimal latency antibiotic regimens for PPROM could potentially differ between races.

Due to the paucity of data regarding the use of an azithromycin regimen for latency antibiotics, the Eastern Virginia Medical School MFM team uses an erythromycin regimen even though azithromycin requires less frequent dosing, has lower rates of side effects, and is more cost effective. The Center for Maternal and Child Health Equity at Eastern Virginia Medical School was developed to address health disparities for mothers and their children, and the investigator team is committed to working with the center to address this research gap regarding latency antibiotic use in PPROM.

The aim is to determine the optimal antibiotic regimen for women with PPROM. The hypothesis to be tested are 1) The antibiotic regimen with azithromycin (iv for 2 days followed by 5 days orally) is associated with a longer latency period compared to the antibiotic regimen with erythromycin, and 2) The antibiotic regimen with azithromycin reduces disparity in latency period compared to the antibiotic regimen with erythromycin.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* PPROM from 22 weeks 0 days to 31 weeks 6 days at Sentara Norfolk General Hospital
* Membrane rupture within 36 hours of randomization, cervical dilation 3 cm or less, and 4 or fewer contractions in the 60-minutes monitoring before randomization

Exclusion Criteria:

* Non-reassuring fetal heart tracing
* Vaginal bleeding
* Indications for delivery
* Received any antibiotic therapy within 7 days other than initiation of Ampicillin treatment as part of latency antibiotics prior to transfer to Sentara Norfolk General Hospital
* Allergy to penicillin, erythromycin, or azithromycin
A RCT to Assess the Performance of CytoSorb for Shock Reversal in Patients With Vasoplegic Septic Shock

To assess the performance of the CytoSorb® 300 mL device for shock reversal in patients with vasoplegic septic shock.


Eligibility Criteria:
Inclusion Criteria:

1. Patients treated with standard of care (SOC) according to guidelines for sepsis/septic shock for \> 6 and \< 30 hours prior to randomization
2. Vasoplegic septic shock\*, requiring NA ≥ 0.2 µg/kg/min at the time of randomization, despite adequate fluid resuscitation to maintain MAP ≥ 65 mmHg after at least 6 hours of guideline-oriented initial therapy, including continuous NA administration
3. Lactate \>2 mmol/l and \<8 mmol/l at baseline
4. IL-6 ≥ 1000 ng/l at screening
5. Minimum 18 years of age
6. Provide voluntary consent to participate in the study either directly or via a legally authorized representative (LAR) or in accordance to the procedure after determination of an emergency situation according to Art. 68 (1) MDR, as applicable

   * (Septic shock is defined according to the SCCM / EISCM task force Sepsis-3 definition \[Singer 2016\])

Exclusion Criteria:

1. Patients with an abdominal source of infection without a source control intervention at the time of randomization OR a planned additional surgical intervention within the first 28 hours after randomization
2. Administration of any other vasopressors than NA at time of randomization and within the first 28 hours after randomization
3. Indication for va-ECMO at baseline OR a planned va-ECMO within the first 28 hours after randomization
4. Patients with a steroid therapy above Cushing-threshold dose (e.g. 30 mg hydrocortisone/d or 6 mg prednisolone/d) for more than 30 days prior to baseline
5. Cytokine-specific antibody therapy before inclusion
6. Anticipated interruption of CytoSorb® therapy for more than 2 hours within the first 26 hours after start of intervention
7. Conditions with a poor 90-day chance of survival because of an uncorrectable medical condition such as poorly controlled neoplasm, or other moribund end-stage disease states in which death was perceived to be imminent
8. Cancer patients currently on chemotherapy with cytostatics, tyrosine kinase inhibitors, or a treatment with antibodies (e.g. PD-1-inhibitors)
9. Acute traumatic brain injury
10. Decision to limit or withdraw treatment within the study and/or observation period in the ICU
11. Pregnancy / breast feeding
12. Participation in another interventional study
Platelet Rich Plasma in Women With Urinary Incontinence

Stress urinary incontinence (SUI) is defined as involuntary loss of urine on effort or physical exertion or on sneezing or coughing. Platelet-rich plasma (PRP) is an autologous solution of human plasma containing various growth factors witch enhance regeneration and healing process. The aim of this study is to evaluate the efficacy and safety of PRP in the treatment of the female SUI.


Eligibility Criteria:
Inclusion Criteria:

* Adult women with stress urinary incontinence

Exclusion Criteria:

* pregnancy,
* history of active malignant pathology,
* mental disorders making them unable to give consent,
* undiagnosed abnormal uterine bleeding,
* genitourinary fistula,
* anti-incontinence surgery,
* pelvic organ prolapse stage \> 2 according to POP-Q system
An Assessment of an Attenuated Live Listeria Vaccine in CIN 2+

Cervical cancer is associated with Human Papilloma Virus. About 57% of cervical cancer is the result of infection by Human Papilloma Virus strain 16 (HPV-16). HPV is a very common virus that can affect the cells of the cervix. E7 is a substance that is made by the HPV virus which causes cervical cancer. The purpose of the study is to test the safety, tolerability (how the drug makes you feel), immunology (effects on the immune system) and efficacy (disease curing effects) of a vaccine called Lovaxin C against E7. The vaccine is designed to cause the immune system to react against the E7 substance in a manner that is intended to reverse the changes to the cervix and prevent cervical cancer from occurring.

Worldwide, many women carry HPV and cervical cancer is the leading cancer killer of women under the age of 50. Although its consequences are considerably less severe in the US, it leads to considerable morbidity. Many published clinical trials describe the immunotherapeutic treatment of early stage, pre-invasive, cervical cancer. It is widely recognized that immunotherapies are most effective in early stage disease because the immune system is least debilitated and disease burden is lowest. Invasive cervical cancer is preceded by a long, slowly progressive, pre-invasive phase termed Cervical Intraepithelial Neoplasia (CIN), which allows for this therapeutic approach. An ideal therapy would result in the remission of CIN 2/3 without damage to cervical tissue. A National Institute of Cancer panel charged with achieving consensus on this issue concluded that a non-surgical medical treatment for this indication would be valuable

The primary objectives of this trial are to test three doses of Lovaxin C to determine if vaccination with Lovaxin C in women with CIN 2/3 for whom surgery is indicated can safely reverse the disease compared to placebo treated control patients.

An earlier Phase 1/2 trial of Lovaxin-C in late stage metastatic cervical cancer used a regimen of two doses given with a 28-day interval. That regimen was shown to be safe and to generate reduction in tumor burdens in some patients. In this trial we will treat earlier stage disease in healthier patients with better immune systems, will use the same and lower doses as given before, but add an additional dosing to the regimen by administering the lowest dose that we assessed previously and by adding a third vaccination to the prior regimen. Unlike the phase 1 trial in which 2 doses were given with a 3 week separation, dosing in the proposed trial will be separated by 4-week intervals.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed CIN 2/3 that requires surgical intervention

Exclusion Criteria:

* Previous history of listeriosis
* Steroid use
* Antibiotic use
* Negative anergy panel
* HIV positive
* Pregnant or actively trying during the treatment period
* Intercurrent disease
Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)

The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) \<= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).

The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.


Eligibility Criteria:
Inclusion criteria:

* Male or female patients aged \>=18 years
* Patients with Non Valvular Atrial Fibrillation
* Patient presenting with:

An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI \[NSTEMI\] or unstable angina \[UA\]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)

* The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.

Exclusion criteria:

* Patients with a mechanical or biological heart valve prosthesis
* Cardiogenic shock during current hospitalisation
* Stroke within 1 month prior to screening visit
* Patients who have had major surgery within the month prior to screening
* Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated
* Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
* Anaemia (haemoglobin \<10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count \<100 x 109/L) at screening
* Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) \<30mL/min at screening
* Active liver disease
Evaluate the Efficacy and Safety of HL151 Versus Talion Tab. in Pruritus Cutaneus

a Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of HL151 versus Talion Tab. in Pruritus cutaneus.

- Endpoint: VAS Score Change, Investigator's assessment of overall treatment


Eligibility Criteria:
Inclusion Criteria:

1. Both gender, 19 years ≤ age
2. Patients with pruritus due to the following diseases

   ① acute eczema, chronic eczema, monetary eczema, sebaceous deficiency eczema

   ② contact dermatitis, atopic dermatitis, seborrheic dermatitis, neurodermatitis

   ③ Acute prurigo (Strofus, Urticaria, lichen urticatus), subacute prurigo, chronic prurigo (nodular prurigo)

   ④ systemic skin pruritus, focal skin pruritus
3. In visit 2, during the run-in period previous week the VAS score of day and night time were 2 or more average points per day (maximum 4 points)
4. Those who can ability to record subject diary
5. Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial

Exclusion Criteria:

1. Patients with pruritus due other medical causes (liver disease, heart failure, etc.)
2. Among patients with skin disease, malignant tumors and patients with chronic urticaria skin disease
3. Patients with systemic infection symptoms at the time of clinical trials
4. Asthmatic patients requiring steroid treatment
5. Patients with Spastic diseases such as epilepsy
Image-guided Brachytherapy for Vaginal Cancer (EMBRAVE)

The goal of this clinical study is to improve clinical outcomes of patients with vaginal cancer who are treated with curative intent by primary radio(chemo)therapy and image-guided adaptive brachytherapy (IGABT).

Being an observational, prospective registration study, wherein neither an experimental treatment is compared to the standard treatment, nor groups of patients are compared.

The specific aims are:

* to develop evidence-based recommendations for curative intent treatment with primary radio(chemo)therapy and IGABT.
* to identify prognostic parameters for oncological outcomes, morbidity and quality of life.

The study aims to enroll at least 300 patients. Oncological events will be evaluated at 2 and 5 years of follow-up. Acute and late morbidity events will be evaluated at end of treatment, 2 and 5 years of follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven primary vaginal cancer or carcinoma in situ, per WHO classification
* Histological types: main cohort: squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the vagina; parallel cohort: other epithelial carcinomas and carcinoma in situ/vaginal intraepithelial neoplasia, as per WHO classification
* Primary vaginal cancer are treated following the protocol target concept.
* Primary vaginal cancer: Stage I-IVA; para-aortic lymph node metastasis below L1-L2 interspace are allowed
* Planned IGABT treatment with MRI-guided adaptive brachytherapy (at least the 1st fraction contouring and planning on MRI; CT for later fractions is allowed); main cohort: External beam radio(chemo)therapy followed by IGABT; parallel cohort IGABT alone
* IGABT alone for stage I \<2 cm or carcinoma in situ will be registered in a parallel cohort in this study
* Treatment with curative intent
* Written informed consent

Exclusion Criteria:

* Vaginal cancers with involvement of the ostium of the cervix or vulva (these should be classified as cervical cancer or vulvar cancer, respectively)
* Metastatic disease beyond para-aortic region L1-L2 interspace
* Sarcomas and melanomas.
* Treatment only by external beam radiotherapy
* Treatment by primary surgery or debulking surgery
* Treatment with neo-adjuvant radiotherapy and/or neo-adjuvant chemotherapy followed by surgery
* Treatment including neo-adjuvant or adjuvant chemotherapy
* Previous pelvic or abdominal radiotherapy
* Pregnancy
Businesses That Care - Zacatecas

The purpose of this study is to develop and implement a community-based prevention initiative to prevent youth alcohol use and abuse in Zacatecas, Mexico.


Eligibility Criteria:
Inclusion Criteria for Parent Participants:

* Must be 18 years or older who are actively working at one of the four BTC participating companies in Zacatecas, Mexico.
* Must be residents of the Cities of Zacatecas or Guadalupe, in the state of Zacatecas, Mexico.
* Workers who are illiterate or otherwise literary challenged are included.
* Must have at least one child (biological, step or adopted) between the ages of 8 and 16 years of age.

Exclusion Criteria for Parent Participants:

* Doesn't speak Spanish.

Inclusion Criteria for Children Participants:

* Must be a child (biological, step or adopted) of a BTC employee who participated in the study.
* Must be between the age of 11 to 16 years.

Exclusion Criteria for Children Participants:

* Doesn't speak Spanish.
Gallbladder Stones in Children and Correlation With Etiological Factors

Aims of the Study:

The objective of this study is to estimate the correlation between etiological factors and postoperative histochemical analysis of pediatric gallbladder stones.

Study design:

A prospective, cohort study. Duration of the study: The study starts from October 2024 to August 2025.

Place of the study:

The study will be held in Department of Pediatric surgery in Sohag University Hospital.

Inclusion and exclusion criteria:

Inclusion criteria:

Age \<18 years . Symptomatic gallbladder stones (biliary colic, fever, vomiting, positive Murphy sign ) .

Congenital hemolytic anemia with gallbladder stones. Asymptomatic patient with gallbladder stones \<5mm after medical treatment (Ursodeoxycholic acid ) for 1year .

Imaging criteria ( large gallbladder stone \< 1cm diameter , gallbladder thickness \>3mm ) either symptomatic or asymptomatic .

Exclusion criteria:

Age \>18 years. Asymptomatic patients who improved after follow up and medical treatment . Biliary anomaly as choledochal cyst , biliary stricture. Common bile duct stones .

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria:

Age \<18 years . Symptomatic gallbladder stones (biliary colic, fever, vomiting, positive Murphy sign ) .

Congenital hemolytic anemia with gallbladder stones. Asymptomatic patient with gallbladder stones \<5mm after medical treatment (Ursodeoxycholic acid ) for 1year .

Imaging criteria ( large gallbladder stone \< 1cm diameter , gallbladder thickness \>3mm ) either symptomatic or asymptomatic .

Exclusion Criteria:

* Age \>18 years. Asymptomatic patients who improved after follow up and medical treatment . Biliary anomaly as choledochal cyst , biliary stricture. Common bile duct stones .
Digital Literacy and Emotional Intelligence and Professional Burnout Among Doctors

The role of digital technologies in healthcare is growing. Therefore, the roles and responsibilities of medical professionals are constantly changing and there is a need for continuous professional development. However, according to some authors, today's generation of doctors can be considered as "digital aborigines" \[Aungst, Patel, 2020\]. Low literacy in the field of e-health has become a major obstacle to digital transformation in developed countries, so digital skills training for healthcare professionals has gradually been introduced in the USA \[Adler-Milstein, et al., 2014\], Europe \[Schreiweis, et al., 2019\], Australia \[Evolution of eHealth in Australia, 2016\].

However, in our opinion, the digital competence of a doctor is not only the ability to work at a computer and use software. The successful development of the digital world is preceded by some psychological and emotional processes.

Computerization and automation of the healthcare system began relatively recently, traditional (paper) document management in medicine is familiar to everyone, but not optimal from the point of view of system management. Therefore, universal digitalization is perceived as something artificially imposed, increasing the workload of doctors, distracting from their main work and shifting the focus from truly therapeutic activities to filling out documentation. As a result, doctors have a range of negative emotions: fear, annoyance, anxiety, despondency, refusal of further contacts, etc., which lead to an aggravation of emotional burnout. The ability to recognize and live through these states, to come to an inner balance, to accumulate an internal resource for further development of new technologies - all this is possible under the condition of the development of emotional intelligence. By developing so-called soft skills, the doctor will be emotionally stable, capable of further advancement and learning new skills, and will easily cope with temporary difficulties and setbacks.

And the final stage, having gained the opportunity to overcome internal obstacles, the doctor is ready to begin mastering specialized digital skills directly related to medical activities: work in medical information systems, remote monitoring, artificial intelligence, medical decision support systems.

The result of the development of a doctor within this model will be not only digital literacy, but also the development of an internally stable personality that easily overcomes any obstacles not only in training, but also in communication with patients and colleagues.


Eligibility Criteria:
Inclusion Criteria:

* respondent has higher medical education
* he is an employee of the any medical department at this moment

Exclusion Criteria:

* There is no higher medical education
* Does not work in medicine at this moment
Impact and Utility of PET Versus Clinical Score for the Assessment of Inflammatory Activity in Takayasu Arteritis

The purpose of this study is to demonstrate that \[18F\]FDG PET is a a better method than clinical and laboratory values for the identification and assessment of inflammatory activity in patients with Takayasu Arteritis (TA), allowing long-term follow-up with a precise evaluation of response to therapy.

Inflammatory activity and fibrosis are the main causes of morbidity and mortality in patients with Takayasu arteritis. The investigators objective is to determine the utility of using 18F-FDG PET in the basal evaluation and follow-up of patients and compare the results with Dabague's clinical score.

Eligibility Criteria:
Inclusion Criteria:

* TA was diagnosed if the patient met 3 or more ACR criteria.