cyrilzakka/clinical-trials huggingface dataset:
Octreotide LAR in the Induction of Immunologic Response in NENs Patients

Evaluating the impact of OCTREOTIDE LAR on the immune response by studying Regulatory T-cell (T-Reg) and Myeloid-derived suppressor cells (MDSC) and the immunoregulatory cell population in peripheral blood of NET G1 / G2 patients treated with Octreotide LAR

MDSCs and T-Regs will be evaluated at baseline pre-treatment with octreotide, after 15 days, at three and at six months and before each octreotide LAR administration for 12 months. MDSC cells will be detected by surface receptors LIN-, CD11b, CD14, CD15, CD33, CD124-IL4-Ra, CD184-CXCR4, CD279-PD1, HLA-DR and T-reg cells from CD3, CD4, CD8 receptors , CD25, CD39, CD45RA, CD45R0, CD62L, CD127, CD152-CTLA-4, CD184-CXCR4, CD278-ICOS, CD279-PD-1. Briefly, CD4 + cells will be separated by negative selection, using the mixture of human CD4 antibodies. Octreotide is currently a registered drug to the FDA, EMA and AIFA with the indication for the treatment of well and moderately differentiated NETs functioning and not working on the front line. .

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to initiation of any study-specific procedures or treatment, as confirmation of the patients awareness and willingness to comply with the study requirements.
* Patients ≥18 years of age.
* Patients with histologically confirmed well and moderately differentiated Neuroendocrine Tumors with Ki67 ≤ 20% (Ki67 must be quantified in percentage) and candidates for treatment with octreotide.
* ECOG performance status (PS) of 0-2.
* At least 28 days since prior the last radiation therapy or surgery.
* Estimated life expectancy of ≥12 weeks.

Exclusion Criteria:

* Patients \< 18 years of age.
* According to the current SmPC of the prescribed drug agent.
* Previuos treatment with octreotide.
* Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would prevent the patient from meeting the study requirements.
* Serious active infection requiring i.v. antibiotics and/or hospitalization at study entry.
* Patients who are treated with any medicinal product that contraindicates the use of the study drug, may interfere with the planned treatment, affects patient compliance or puts the patient at high risk for treatment-related complications.
* Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days with a confirmatory urine pregnancy test within 7 days prior to study treatment start. Women of childbearing potential (defined as inferior to 2 years after last menstruation and not surgically sterile) not using effective, non hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly). Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential
* Patients with meningeal carcinomatosis
* Patients with known positive HIV status
Cytoreductive Prostatectomy in Treating Patients With Newly Diagnosed, Metastatic Prostate Cancer

This phase I trial studies the side effects of cytoreductive prostatectomy in treating patients with newly diagnosed prostate cancer that has spread from the primary site to other places in the body. Cytoreductive prostatectomy is a type of surgery that removes the prostate and as much of the tumor as possible. When combined with hormone therapy, robotic assisted radical prostatectomy (RARP) or conventional open retropubic radical prostatectomy (RRP) may prolong survival in patients with prostate cancer that has spread.

PRIMARY OBJECTIVES:

I. To determine the safety and feasibility of cytoreductive prostatectomy (to remove as much of the primary cancer as possible) in men with newly diagnosed clinical T1-3N1M0 or T1-3N0M1a-b prostate cancer (herein, collectively referred to as metastatic prostate cancer).

SECONDARY OBJECTIVES:

I. Time to prostate specific antigen (PSA) nadir and castration resistance following cytoreductive prostatectomy and subsequent standard systemic therapy, androgen deprivation.

OUTLINE:

Patients undergo RARP or conventional open RRP. Immediately following surgery, patients receive standard systemic androgen deprivation therapy.

After completion of study treatment, patients are followed up every 90 days for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the prostate
* Evidence of lymph node or bone metastasis by magnetic resonance imaging (MRI)/computed tomography (CT), bone scan, or biopsy (N1Mx or NxM1)
* Give informed consent
* Clinical stage T3 or less (pelvic MRI shows no rectal and ureteral invasion)
* Cleared by the primary medical doctor for surgery
* No prior systemic therapy for metastatic prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Refuses to give informed consent
* Refuses or is unable to have pelvic MRI
* Clinical stage T4 (pelvic MRI shows rectal and/or ureteral invasion)
* Deemed a poor surgical risk per primary medical doctor
* Received prior therapeutic intervention for metastatic prostate cancer
* Known spinal cord compression or brain or liver metastasis
* Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months
Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patients With Tracheostomy

This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

The safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge. Nasogastric tube feeding has been the mainstream choice in China but with the risk of complications. Intermittent Oro-esophageal Tube Feeding is an established modality of enteral nutrition support that can be used with routine treatment. This study reports the clinical outcomes of Intermittent Oro-esophageal Tube Feeding vs. nasogastric tube feeding, in patients receiving routine treatment. This was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding (n=50) or the control group with Nasogastric tube feeding (n=48) for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of severe Traumatic Brain Injury, confirmed through MRI
* score of Glasgow Coma Scale (GCS) \<8;
* presence of no contraindication for enteral nutrition;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
* informed consent form was obtained from the patient\&#39;s family members, indicating their full understanding of the study and agreement to participate.

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
* complicated with other intracranial lesions, such as stroke;
* with severe consciousness disorders caused by other diseases.
Sex and Gender Differences in Ischemic Heart Disease - Endocrine Vascular Disease Approach

The application of sex-gender medicine is strongly recommended by World Health Organization and other international organization. In fact, it is emerging that, although men and women are affected to the same cardiovascular diseases (CVD), however they have different risk factors, disease progression and response to pharmacological and not-pharmacological treatments. Consequentially, the identification of biomarkers and therapeutic approaches taking into account sex gender differences (SGD) is relevant to develop a really evidence-based medicine.

With the aim of translate in clinical setting the more recently available basic research evidences on estrogens and androgens balance involvement in modulation of ischemia-reperfusion myocardial damage, the investigators planned to conduct a research study on patients, affected by suspected or known ischemic heart disease (IHD) undergoing angiography and/or percutaneous coronary interventions (PCI), aged more than 18 years of both sex in ratio 1:1. Thus, in this setting, the goals of this proposal are:

1. To assess the sex-gender difference in entity of microvascular reperfusion damage in patients with IHD undergoing urgent or elective PCI;
2. To evaluate estrogen/androgen-dependent and -independent effects in gender-related differences on myocardial ischemia reperfusion damage occurring during PCI;
3. To investigate the differences in terms of platelet biology between men and women affected by IHD undergoing urgent or elective PCI, matched for age and clinical cardiovascular and metabolic characteristics;
4. To verify sex-driven interplay between response to PCI procedure, platelet function, sex hormones and entity of reperfusion and myocardial damage, as well as, the impact on clinical outcomes during a 1-year follow up.

This research study wants to explore and consequently elucidate biological mechanisms responsible for sex-based differences in vivo human models of ischemia reperfusion myocardial damage. Moreover, the investigators expected to clarify the impact of biological variables evaluated on clinical outcomes after reperfusion therapeutic intervention.


Eligibility Criteria:
Inclusion Criteria:

* patients with ischemic heart disease (acute or chronic) undergoing percutaneous coronary intervention (urgent or elective)
* written informed consent
* both sex
* aged more than 18 years

Exclusion Criteria:

* patients with expectancy of life less than 12 months
* active cancer
* pregnancy
COVID-19 Post-Vaccination Observation

The study started after the second COVID-19 vaccination of the participant with blood spots appearing on the skin with severe arthritis. The study continued to the third-dose full vaccination of the participant with the recombined COVID-19 vaccination and afterwards. The study completed until intervention.


Eligibility Criteria:
All COVID-19 vaccinated are eligible for inclusion.
Antibiotic Therapy in Treating Patients With Low Grade Gastric Lymphoma

RATIONALE: Antibiotics may stop the growth of Helicobacter pylori which may be associated with gastric lymphoma.

PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy in treating patients with low grade gastric lymphoma that has not been previously treated.

OBJECTIVES: I. Determine the rate of eradication of Helicobacter pylori using omeprazole, colloidal bismuth subcitrate, tetracycline, and metronidazole in patients with low grade gastric lymphoma. II. Determine the macroscopic/endoscopic and microscopic healing/remission rate after eradication of Helicobacter pylori in this patient population. III. Determine the natural history of low grade gastric lymphoma after eradication of Helicobacter pylori.

OUTLINE: This is a nonrandomized, open label, multicenter study. Patients receive oral omeprazole bid on days 1-10, oral bismuth subcitrate and oral tetracycline qid on days 4-10, and oral metronidazole tid on days 4-10. Patients are evaluated at 8 weeks. Patients who experience complete remission and are H. pylori negative proceed to follow up. Patients with complete remission or no change but who are H. pylori positive proceed to a second course of therapy with the previous schedule or with omeprazole bid, amoxicillin qid, and clarithromycin tid for 14 days. Patients who experience no change but are H. pylori negative are followed at 6 and 9 months and restaged. Patients are followed at 6, 9, 12, 18, and 24 months, then annually thereafter.

PROJECTED ACCRUAL: Approximately 60-96 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven, previously untreated, low grade gastric lymphoma Clinical stage I and II1 No bulky disease No high grade component (grade 5 and 4, if monoclonality proven, allowed) Documented presence/absence of H. pylori infection Measurable and/or evaluable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or lactating Fertile patients must use effective contraception No prior or concurrent malignancies unless: At least 1 year remission Low risk or recurrence No prior gastric malignancy No nonmalignant disease causing poor medical risk No allergy to omeprazole

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the abdomen Surgery: No prior gastric surgery except simple closure of perforated ulcer with or without wedge excision of the ulcer Other: No prior therapy for gastric lymphoma At least 30 days since experimental therapy No other concurrent experimental therapy At least 30 days since antibiotics with activity against H. pylori
Comparison of Circular(Soave) and Heart-shaped Anastomosis in Hirschsprung's Disease

Comparison of Circular(Soave)and Heart-shaped Anastomosis in Hirschsprung's disease.

At present, the treatment for children with HSCR is still surgery. The basic treatment principles of all surgical procedures commonly used in the world include confirming the location of the transitional zone between the intestinal tube with and without ganglion cells, removing the intestinal segment without ganglion cells, and reconstructing the digestive tract by anastomosis of the intestinal segment with ganglion cells with the anus or rectum. Intact anal receptors and autonomic internal sphincter control are essential for autonomic bowel control, and the integrity of the internal sphincter directly affects the occurrence of soilage and fecal incontinence after surgery. Therefore, how to deal with the internal sphincter during the operation, so as to avoid the recurrence of constipation caused by the spasm of the internal sphincter after the operation, and to retain the function of the internal sphincter for defecation control has been the focus of research.

In the 1980s, Professor Wang Guo, based on the experience of previous researchers, innovated the "heart-shaped anastomosis", which is a surgical procedure in which the dorsal rectum is split longitudinally to the dentate line without removing the internal sphincter, and then the normal colon is drawn out to make an oblique anastomosis with the rectoanal canal. A retrospective single-center follow-up of nearly 100 cases of "heart-shaped anastomosis" over a period of 20 years found that compared with traditional end-to-end colorectal anastomosis, patients with "heart-shaped anastomosis" had a significantly lower rate of fecal fouling and a long-term Bowel function score (Bowel function score, bowel function score). BFS) and Quality of Life-BREF (QLB) were also significantly improved compared with the traditional operation (P\<0.05), and no other adverse events occurred. This study aims to determine the optimal surgical procedure for HSCR by a prospective, multicenter controlled study comparing the "heart-shaped anastomosis" with the commonly used Soave procedure.

In summary, this project will compare the application of "heart-shaped anastomosis" and traditional surgery for children with HSCR before operation, and comprehensively evaluate the advantages of "heart-shaped anastomosis" for defecation control from morphology to electrophysiological function through postoperative follow-up, combined with anorectal manometry.

Eligibility Criteria:
Inclusion Criteria:

1. Age\<14 years
2. Hirschsprung's disease diagnosed by biopsy
3. Surgical indication

Exclusion Criteria:

1. Age\>14 years
2. Not Hirschsprung's disease
3. Surgical contraindication
Comparative Effectiveness of CET vs. SST in SMI (Serious Mental Illness)

To compare two evidence-based treatments, Cognitive Enhancement Therapy (CET) and Social Skills Training (SST) that have been shown in meta-analyses and in our own research to be effective to improve community functioning. The investigators will test the impact of CET and SST on community functioning, with special attention to their relative effectiveness for patients differing in baseline cognitive skills and age. The research uses a cluster design in which different mental health service centers are randomized to one of the two treatments.

Aim 1. We will test our hypothesis that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (NIH Toolbox, PennCNB, and MSCEIT) and social skills (SSPA). For study Aim 1, we hypothesized that CET will be associated with greater improvements than SST in both the primary outcome: community functioning (SAS, QLS), and the secondary outcomes of neuro- and social cognition (selected NIH Toolbox and Penn CNB measures, and MSCEIT) and social skills (SSPA). Aim 2: We will explore differential effectiveness of the two interventions by baseline cognitive functioning and age. For Aim 2, we hypothesize that patients with less impairment in cognitive functioning at baseline will demonstrate relatively larger treatment gains in SST compared to those in CET than those who are initially more cognitively impaired, and that younger patients will benefit more from CET compared to those in SST than those who are older. The results of this study will address a key knowledge gap in the field and a decisional dilemma for clinicians. A pilot study at four treatment sites will be used to test the feasibility and acceptability of telementalhealth delivery of these two treatments, as compared to in-person delivery.

Eligibility Criteria:
Inclusion Criteria:

1. age 18 to 65;
2. DSM-5 diagnosis of schizophrenia or schizoaffective or schizophreniform disorder (confirmed via the MINI diagnostic interview);
3. estimated IQ of \> 70 (established via WTAR).

Exclusion Criteria:

1. the presence of a current organic brain syndrome;
2. intellectual disability (DSM-5);
3. participation in either CET or SST within the prior year.
Clinical Pathway With "Fast-Track" In Uncomplicated Acute Appendicitis

The aim of this study is to reduce the postoperative hospital stay, without increasing morbidity and mortality postoperative, expressed in terms of rate of complications and readmissions.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with uncomplicated acute appendicitis urgently.
* Signing the consent of participation and commitment to attend reviews.

Exclusion Criteria:

* Suspected liver disease.
* Coagulation disorders.
* Patients in septic shock.
* Pregnant patients.
* Patients with symptoms compatible with acute uncomplicated appendicitis (plastron appendix, perforated appendicitis or diffuse peritonitis), or had 5 to more days of evolution).
* No sign consent for participation in it.
Effect of the Enriched Environment on the Risk of Relapse

This clinical study investigates the effects of enriched environment on the risk of relapse in alcoholic patients.

135 patients hospitalized for an alcoholic addiction will be recruited and randomized in two groups: one group will receive standard of care, the other group will receive a treatment with enriched environment.

The enriched environment consists of six sessions of virtual reality (20 minutes) in a multi-sensory pod and six sessions (20 minutes) of bike activity with cognitive tasks while pedalling.

The multi-sensory virtual reality pod allows mindfulness practice and allows patients to be in immersive situations that may trigger cues in order to help them in craving management.

The bike consists in the combination of a pedal set and a touch pad on which cognitive training games are offered. This tool thus makes it possible to simultaneously stimulate motor skills and cognition by means of bicycle-game coupling.

Patients are then followed during 3 months and a half.


Eligibility Criteria:
Inclusion Criteria:

* Any patient hospitalized at the Henri Laborit Hospital for alcohol addiction, on an opened unit for at least 48 hours;
* Woman or man aged between 18 and 65 inclusive
* Severe alcohol use disorder according to the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders
* Benefit from social security or benefit from it through a third party in accordance with French law on research involving the human person
* Have signed the informed consent form after receiving written information.

Exclusion Criteria:

* Disabling cognitive disorders
* Cardiological pathologies that could compromise the participation of patients, detected by an ECG.
* Advanced pulmonary, renal, and hepatic diseases, or any unstable and serious medical conditions that could compromise the patient's participation in the study, subject to the judgment of the doctor
* Hypertension
* Ataxia
* Uncompensated and unstable psychiatric pathology
* Susceptibility to cybersickness
* Pregnant or breastfeeding woman
* Simultaneous participation in another trial
* Any other current addiction, except addiction to tobacco and benzodiazepines
* Employee of the investigator or of the clinical study site
* Patients protected by law
* People not covered by state health insurance
* Patients who in the opinion of the investigator are unable to complete the questionnaires
Evaluation of Carebot AI MMG Medical Device for Breast Lesion Detection and Density Assessment

Comparison of accuracy of clinician and DLAD image evaluation (Carebot AI MMG v2.2)

1. Comparison of the Accuracy of Density Assessment by Clinician and DLAD (DENS)
2. Comparison of Accuracy of Lesion Assessment by Clinician and DLAD (MASS, CLASS)

The mammography studies were acquired from three independent sites: Site 1 (EUC Mamocentrum Brno) and Site 2 (Hospital Šumperk, a.s.) specialise in routine screening mammography, and Site 3 (Masaryk Memorial Cancer Institute) is a comprehensive oncology facility primarily dedicated to diagnostic mammography, i.e. performing additional examinations in case of a suspicious finding (recall).

The ground truth was obtained by consensus of two board-certified radiologists with expertise in radiology and diagnostic methods, and 13 and 27 years of experience with mammography image interpretation, respectively.

For comparative analysis, a team of five independent radiologists with clinical experience in interpreting mammography images was established. Three of the clinicians were junior (2, 2, and 4 years of experience, respectively) without board-certification; two physicians were senior (7 and 8 years of experience, respectively), board-certified.

Eligibility Criteria:
Inclusion Criteria:

* The medical device is intended for use in women over 18 years of age who are indicated for screening mammography using digital mammography.

Exclusion Criteria:

* The medical device cannot be used in patients with breast implants.
* The medical device cannot be used in male breast examination.
* The medical device cannot be used in patients under 18 years of age.