cyrilzakka/clinical-trials huggingface dataset:
Acute Whole Body Vibration Change the Glycemic and Lactate Levels

The type II diabetes is characterized by high levels of blood glucose followed by excessive insulin release so that the target cells become less sensitive and develop insulin resistance, maintaining hyperglycemic levels. The Whole body vibration session may improve the glucose metabolism in diabetic patients by reducing the peripheral blood sugar. Ten healthy elderly women and eight diabetic elderly women were allocated into two groups, and have made an acute whole body session.


Eligibility Criteria:
Inclusion Criteria:

* elderly between 60 to 74 years,
* sedentary according the International Physical Activity Questionnaire (IPAQ- short form)
* For diabetic group, were considered who those medical diagnoses of type II diabetes for at least 02 complete years, who had used only oral hypoglycemic agents of biguanides class (Metformin extended release - XR) in dosage between 500 to 850 mg.
* For healthy elderly group were considered elderly women without self-reported diseases

Exclusion Criteria:

* diabetic volunteers who have ingested the breakfast less than 02 hours or more than 03 hours and those who have taken Metformin less than 02 hours before the intervention.

For all volunteers, the complementary exclusion criteria were:

* the current or past smoking or alcoholic habits;
* the cardiovascular, liver or neuromuscular diseases;
* subjects with prior labyrinthitis or embolic events;
* who have had any surgery in last year;
* volunteers with metallic prosthesis as pacemaker, pins or plates;
* volunteers with advanced osteoporosis;
* which had difficulties during the evaluation or acute protocol.
Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis

This study aimed to evaluate the acute physiological effects of expiration with the glottis open in lateral posture (ELTGOL) and Flutter valve in dynamic and static lung volumes in patients with bronchiectasis and, secondarily, to study the effect of these techniques in sputum production.


Eligibility Criteria:
Inclusion Criteria:

Patients with clinical and radiological criteria of bronchiectasis

Exclusion Criteria:

* heart failure
* pneumonia
* chest pain
* inability to perform the procedures
* asthma
* cystic fibrosis
Effectiveness of Sulfamethoxazole-trimethoprim in the Treatment of Chronic Otitis Media

Chronic suppurative otitis media is one of the most common chronic infections in children worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries, it is treated primarily with antibiotics; in other countries such as the Netherlands a surgical approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes or a tympanomastoidectomy is preferred. There is however, no agreement on the management of this disease.

The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim for 6-12 weeks in children suffering from chronic otitis media and otorrhea.

Chronic suppurative otitis media is one of the most common chronic infections in children worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries it is treated primarily with antibiotics; in other countries such as the Netherlands a surgical approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes or a tympanomastoidectomy is preferred. There is however, no agreement on the management of this disease.

Co-trimoxazole is an inexpensive antibiotic and tolerated well by children, also when long treatment regimens or prophylaxis is necessary. A previously performed retrospective study of 48 children who were referred to the pediatric department of otorhinolaryngology in the UMC Utrecht because of "therapeutic resistant" otorrhea showed promising results; after 3 months follow-up, 52% of the patients were otorrhea free, 25% had otorrhea incidentally and 23% showed no signs of improvement. Therefore, the treatment of chronic otitis media with sulfamethoxazole-trimethoprim for a minimum of six weeks is promising and might be a good alternative to surgical treatment.

The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim during 6-12 weeks in children with chronic otitis media and otorrhea for more than 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* age between 1 and 12 years
* otorrhea for more than 3 months

Exclusion Criteria:

* cholesteatoma
* known immune deficiency other than IgA or IgG2
* Down's syndrome
* craniofacial anomalies
* cystic fibrosis
* immotile cilia syndrome
* allergy to sulfamethoxazole-trimethoprim
* continuous use of sulfamethoxazole-trimethoprim for more than six weeks in the past six months
Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

Accurate preservation of neuro-vascular bundles is crucial in guaranteeing erectile function recovery after robot assisted radical prostatectomy (RARP). However, the nerve sparing approach is associated with higher rates of positive surgical margins (PSM) at final pathology. Augmented reality (AR) RARP was previously associated with a 10-15% reduction in the rates of PSMs in two retrospective series. However, prospective studies are needed to demonstrate clinical utility and to validate these technologies. The hypotheses of this study are that: 1) AR RARP reduces the rates of PSMs, if compared to standard approach; 2) AR RARP can guarantee a more accurate preservation of neurovascular bundles and, in consequence, a greater recovery of erectile function; 3) the lower rates of PSMs will translate in greater oncological control of the disease.

This is a Phase III, monocentric, prospective trial in which patients will be randomized to AR RARP vs. standard approach (standard RARP). Patient population is defined as: patients≥18 years old, untreated biopsy-proven adenocarcinoma of the prostate classified as European Association of Urology (EAU) low or intermediate risk (PSA≤20 ng/ml and cT≤2b and International Society for Urological Pathology \[ISUP\] grade group≤III), pre-operative International Index of Erectile Function-5 (IIEF-5)≥20, no contraindications for multiparametric magnetic resonance imaging (mpMRI). The primary objective of this study is to compare the rates of PSMs with AR RARP vs. standard RARP. Secondary objectives are the rates of nerve sparing approaches and erectile function recovery at 3-, 6- and 12-months after surgery in AR RARP vs. standard RARP. Subgroup analyses will tested for a specific subgroup of patients in which AR RARP should be particularly indicated. Longer-term follow-up will also assess the percentages of biochemical recurrences (BCR) in the two groups.

Eligibility Criteria:
Inclusion Criteria:

Untreated, biopsy-proven adenocarcinoma of the prostate Age ≥18 years

European Association of Urology (EAU) low or intermediate risk prostate cancer:

* PSA≤20 ng/ml
* cT≤2b
* International Society for Urological Pathology \[ISUP\] grade group≤III Written informed consent provided for participation in the trial International Index of Erectile Function-5 (IIEF-5)≥20 No contraindications for multiparametric magnetic resonance imaging (mpMRI)

Exclusion Criteria:

Any prior therapy for prostate cancer

European Association of Urology (EAU) high risk prostate cancer:

* PSA\>20 ng/ml or
* cT\>2b or
* ISUP grade group\>III International Index of Erectile Function-5 (IIEF-5)\<20 Prostate cancer with sarcomatoid or spindle cell or neuroendocrine small cell components Morbidity that would limit compliance with study protocols Controindications to perform mpMRI
Influence of Chemotherapy on Gamma-delta T Cells in Patients With Epithelial Ovarian Cancer

In patients with an ovarian cancer, the treatment is currently based on surgery and chemotherapy.

The impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.

The long term goal is to give a rational to combine conventional treatment of ovarian cancer with immunotherapy based on Vgamma9Vdelta2 T cells.

Ovarian cancer is associated with a high mortality rate. Treatment of ovarian cancer is currently based on surgery and chemotherapy.

The first surgery is a radical surgical procedure aiming to achieve no residual disease. Patients who could not benefit from the first surgery may be offered neoadjuvant chemotherapy with a new surgical procedure after 3 or 6 chemotherapy cycles. Chemotherapy is currently based on Taxol and Carboplatin. Immunotherapy based on Vgamma9Vdelta2 T cells could provide a promising therapeutic strategy, however, the impact of chemotherapy on the expansion and functional abilities of Vgamma9Vdelta2 T cells has never been evaluated.

We want to study the effect of chemotherapy of ovarian cancer on Vgamma9Vdelta2 T cells rates in the peripheral blood of patients with ovarian cancer.

Functional abilities of the Vgamma9Vdelta2 T cells will be studied: expansion after chemotherapy and their cytotoxic abilities in an autologous context before or after chemotherapy.

The long term goal is to give a rational to combine conventional treatment of ovarian cancer with non-conventional treatment such as immunotherapy based on Vgamma9Vdelta2 T cells.

Eligibility Criteria:
Inclusion Criteria:

* Patients with proven epithelial ovarian cancer
* Patients receiving carboplatin and / or taxol chemotherapy.

Exclusion Criteria:

* Minor patient
* Protected adult
* Lack of invasion to the final histological checking
* Absence of chemotherapy in the therapeutic plan of treatment
Incretin and KATP Channels

This study aims to examine the involvement of KATP channels on the microvascular actions of the incretin GLP-1 and its analogues in healthy individuals and to determine whether the acute oral administration of different KATP channel blockers which are oral medications for Type 2 diabetes such as Glibenclamide and Glimepiride differentially modulate the microvascular responses in these individuals.

In addition to the glucose lowering effect, incretin based therapies have also an effect on the vascular system. Previous animal work and initial human studies suggest that incretins may be cardioprotective and act as vasodilators through opening of KATP channels.

Initial evidence suggests that beneficial vascular effects of incretin modifying agents may be nullified by the co-current treatment of the sulfonylurea (SU) drug glibenclamide. The investigators hypothesis is that the GLP-1 and SUs may have conflicting effects on the KATP channels and thus vascular function.

Interestingly the vascular actions of GLP-1 were not modified by a different treatment SUs called glimepiride, thereby raising the possibility that SUs differentially modulating the vascular actions of GLP-1 though this remains controversial.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≤ 25 kg/m2

Exclusion Criteria:

* current or past history of diabetes (HbA1C more or equal 45mmol/mol)
* history of postprandial hypoglycaemia and dumping syndrome
* established cardiovascular disease
* established cerebrovascular disease
* blood pressure ≥ 140/85 mmHg
* Raynaud's disease
* severe impairment of renalhepatic, thyroid or adrenocortical function
* current treatment with any anti-hypertensive treatment
* lipid lowering therapy or systemic steroids
* lactation, pregnancy
* established vascular disease
* bariatric surgery
* significant weight change within the last 3 months
Accountable Care Organizations/ Public Health Collaborative

This study focuses on implementing and evaluating an evidence-based collaborative method of increasing immunization rates among preschool children, adolescents and adults within an Accountable Care Organization-Public Health collaborative. The infrastructure we will create through this project will serve as the framework for future collaborative delivery of other preventive services.

The current project leverages newly formed Regional Care Collaborative Organizations (RCCO) in Colorado that are charged with providing comprehensive care for children and adults insured by Medicaid. With a new RCCO-public health collaborative we will implement a randomized controlled trial to test the effectiveness of 1) evidence-based collaborative centralized method of increasing immunization delivery using reminder/recall techniques versus 2) traditional practice-based reminder/recall techniques that are done by individual practices (not centrally) or usual care from their provider. These interventions have been previously developed by the study team in different clinical settings. The project will examine the collaborative centralized approach, implemented within the new RCCO-public health collaborative first among preschool children, the group in which it has been previously studied. We will then extend the method to new populations, including adolescents and adults within the RCCO and Denver Health (adults only), and will evaluate the effectiveness of the intervention in each population.

Eligibility Criteria:
Inclusion Criteria:

* Patients enrolled in Regional Care Collaborative Organizations (RCCOs) study practices in the regions covered by Colorado Access,
* Age 19-35 months,
* Age 11-17 years, or
* Age 18 years and older.
* Require an immunization according to Advisory Committee on Immunization Practices (ACIP) guidelines,
* Adult (18 and older) patients at 8 primary care sites who are enrolled in Denver Health and patients at 6 primary care RCCO study practices

Exclusion Criteria:

* Any child whose parents have requested removal from the immunization registry;
* Any adult who has requested removal from the immunization registry;
* Any child or adult with hypersensitivity to any component of one of the recommended vaccines;
* Any child or adult who has moved to a primary care provider other than one at the study practices.
Diagnostic Study of Tumor Characteristics in Patients With Ewing's Sarcoma

Diagnostic trial to study genetic differences in patients who have Ewing's sarcoma. Genetic testing may help predict how cancer will respond to treatment and allow doctors to plan more effective therapy.

PRIMARY OBJECTIVES:

I. To develop a mechanism to collect and distribute tumor specimens to various investigators, and a system to prioritize and develop quality-control measures for central data reporting of studies undertaken.

II. To determine the prognostic significance of translocation subtype in Ewing sarcoma; to determine the prognostic significance of translocation negative Ewing sarcoma.

III. To determine the prognostic significance of MRD detection in bone marrow specimens by RT-PCR determination of EWS-ETS fusion genes.

IV. To determine whether serum levels of IGF1, IGFBP3 are of significance in the outcome of patients with Ewing sarcoma.

V. To determine whether RNA expression profiles performed on diagnostic specimens will allow for the identification of newer prognostic categories and potentially new molecular targets for treatment in Ewing sarcoma.

VI. To identify new treatment targets for therapy. Further testing of these potential targets will be carried out in hopes of expediting translation of these findings to the clinic.

VII. To establish a bank of Ewing sarcoma xenografts in SCID/Beige mice. VIII. To establish clinical proteomics as a resource for investigations of altered signaling molecules in the pathogenesis of Ewing sarcoma.

OUTLINE: This is a multicenter study.

Patients undergo various specimen collections, including bone marrow aspirate, paraffin-embedded blocks of tumor tissue or slides of tumor tissue, and blood specimens. These specimens are collected before, during, and after any chemotherapy regimens, during follow-up, and at time of recurrence. Translocation studies are performed on specimens to identify fusion genes, specifically EWS-ETS. Serum IGF1 and IFGBP3 levels are determined. Bone marrow is assessed for minimal residual disease using reverse-transcriptase polymerase chain reaction.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed or recurrent Ewing's sarcoma
* Availability of the following specimens:

  * Paraffin-embedded block or 20 unstained slides and 1-3 thick (50 micron) sections from initial biopsy
  * Pretreatment serum and whole blood
* Concurrent therapy is not required
Unraveling the Role of Extracellular Vesicles-driven Senescence in Myeloproliferative Neoplasms

In this study the aim is to investigate the pathogenetic role of extracellular vesicles and senescence in Myeloproliferative Neoplasms. In particular, the goal of this project is to identify possible EV-based biomarkers of senescence according to gender, which are disease-specific, biology-related, and predictive of short-term outcome in terms of Event-Free Survival and to define personalized targets for new therapeutic approaches.

This is a 3-year multi-centre prospective in vitro study. 120 patients with MPN (ET (n=45), PV (n=45), and MF (n=30)) will be enrolled for a period of 22 months. Follow-up: 12 months. Patients (ET=Group A; PV=Group B; MF=Group C) will be enrolled at the Complex Operative Unit of Haematology-IRCCS Azienda Ospedaliero-Universitaria di Bologna and at the Haematology Centres of Reggio Emilia, Brescia, Meldola, and Ravenna. Peripheral blood samples from patients with ET, PV, and MF (Group A-C; 40 ml) and/or bone marrow samples from patients with ET and PV (Group A, B; 5 ml) will be collected at diagnosis as part of normal clinical practice. The samples will be analysed at the Complex Operative Unit of Haematology-IRCCS Azienda Ospedaliero-Universitaria di Bologna in collaboration with the Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori' - IRST IRCCS (analysis of EV size and concentration) and with the University of Perugia (analysis of EV lipid cargo). The data analysis will be carried out in collaboration with the Department of Physics and Astronomy of the University of Bologna.

Eligibility Criteria:
Inclusion criteria for patients:

* age ≥ 18 years.
* patients with WHO2017-defined diagnosis of Myeloproliferative Neoplasms.
* patients at first diagnosis.
* Informed consent signed.

Exclusion criteria for patients:

- patients with concomitant second neoplasia

Inclusion criteria for Healthy Donors:

* age ≥ 18 years.
* Informed consent signed.

Exclusion criteria for Healthy Donors:

- Healthy Donors with neoplasia.
[68Ga]DOTATATE-PET/MRI in Hepatocellular Carcinoma

There is great need for new therapeutic options for patients with hepatocellular carcinoma (HCC). This proposal will assess the feasibility of a novel theranostic approach to HCC using \[68Ga\]DOTATATE, a recently approved positron emission tomography (PET) ligand for imaging somatostatin receptor (SSTR) positive tumors. In this study, we will use \[68Ga\]DOTATATE to determine the percentage of HCCs that express adequate levels of SSTR for treatment with targeted radionuclide therapy (TRT) using the therapeutic SSTR ligand \[177Lu\]DOTATATE. This radionuclide therapy was FDA approved in January 2018 for treating neuroendocrine tumors (NETs) arising from the gastrointestinal tract, but its use in HCC has not yet been explored. In the long term, we envision using \[68Ga\]DOTATATE-PET to identify HCC patients with adequate SSTR expression for TRT using \[177Lu\]DOTATATE.

Liver transplantation is the only curative therapy for HCC and is an option for a selected subset of HCC patients. For those who are not candidates for transplantation, locoregional therapies with limited efficacy are available such as percutaneous ablation, arterial chemoembolization, and Y-90 microsphere radionuclide therapies. There are few options for patients who progress or are not candidates for these therapies. The first line systemic therapy is sorafenib, a tyrosine kinase inhibitor. Sorafenib is often not well tolerated due to its side effects and there is need for additional systemic treatments. Multiple tissue-based studies demonstrate SSTR positivity in 20-50% of HCCs.\[1-3\] However, the fraction of HCCs have high enough levels of SSTR for \[177Lu\]DOTATATE therapy has not yet been assessed. This research plan is a critical prerequisite for determining the feasibility of this theranostic approach to treating HCC. If we obtain positive results, these data will be critical for designing a combined imaging and therapeutic study in HCC using DOTATATE.


Eligibility Criteria:
Inclusion Criteria:

* Known diagnosis of hepatocellular carcinoma, either by imaging criteria or pathology on biopsy
* Standard of care liver MRI or CT demonstrating viable HCC based on arterial contrast enhancement measuring at least 1.5 cm in largest axial dimension

Exclusion Criteria:

* History of neuroendocrine tumor or other SSTR-positive tumor
* Interval locoregional therapy or new systemic therapy between standard of care liver MRI or CT study showing viable HCC and \[68Ga\]DOTATATE-PET/MRI
EDWARDS INTUITY Valve System CADENCE Study

The study purpose is to compare the EDWARDS INTUITY valve system with commercially available stented aortic bioprostheses, in patients requiring aortic valve replacement surgery with coronary artery bypass.

This is a randomized study comparing the cross-clamp time (XCT) and cardiopulmonary bypass time (CPBT) of the EDWARDS INTUITY valve system with any commercially available stented aortic bioprosthesis, in patients with logistic EuroSCORE 1 ≥ 6 undergoing elective surgical aortic valve replacement surgery with concomitant coronary bypass grafts.

Additionally, the aim is to gather sufficient data to quantify the effect size of short term patient benefit outcomes previously identified from literature and finally to explore additional healthcare resource utilization or health economic endpoints.

Eligibility Criteria:
Inclusion:

* ≥18 years of age
* aortic stenosis / mixed aortic stenosis and aortic insufficiency
* SAVR+CABG (1-4 distal anastomoses)
* Log. EuroSCORE ≥6
* NYHA Class ≥II

Exclusion (i.a.):

* pure aortic insufficiency
* pre-existing prosthetic heart valve or ring
* congenital true bicuspid / unicuspid aortic valve
* LVEF \<20%
A Phase I Study of OCV-501 in Acute Myeloid Leukemia Patients

The purpose of this study is to assess the safety, tolerability of OCV-501 in patients with acute myeloid leukemia (AML) who achieved complete remission after induction regimen and who completed a standard consolidation therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Patients with acute myeloid leukemia including patients with secondary leukemia. However, the patients with MDS apparently evolved itno AML and patients with AML accompanied by t(15;17)(q22;q12),(PML/RARalpha) , should be excluded.
* Patients who achieved the first complete remission after the induction regimen and finished a standard consolidation therapy.
* Age: ≥ 60years of age(at the time of signature of the informed consent form)
* Sex: Male and Female
* Patients who are capable of giving informed consent
* Patient's blasts cells show expression of WT1mRNA, detected by quantitative RT-PCR.
* Patients must be one of the following HLA DRB1 types: HLA-DRB1\*01:01, \*04:05, \*15:01, \*15:02, \*08:03 and \*09:01.

Key Exclusion Criteria:

* Patients who are scheduled for a bone marrow transplantation
* Patients who were administered exceeded acceptable therapeutic dose of immunosuppressants and adrenal cortical steroids.
* Patients with uncontrollable active infectious diseases
* Patients with autoimmune diseases (including Hashimoto's disease, idiopathic thrombocytopenic purpura, and autoimmune hepatitis) or with a medical history of active autoimmune diseases
* Immunocompetent patients
* Patients with a complication of interstitial pneumonia or with a medical history of interstitial pneumonia