cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 Given as 1 or 2 Doses to Healthy 9-12 Months Old Toddlers.

The purpose of the study is to characterize the safety and immunogenicity of 1 dose of GSK134612 vaccine at 12 months of age and of GSK134612 vaccine administered as 2 doses at 9 and 12 months of age.

The protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the FDA amendment Act, Sep 2007. Sections impacted are Brief Title, Official Title of the study, Brief Summary, Key Inclusion \& Exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
* A male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment.
* Up to date on vaccinations based on ACIP recommendations and the standard practice at the investigational site.
* Written informed consent obtained from parents/guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, or planned use during the study period.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
* Planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine.
* Planned administration of a tetanus toxoid (TT) containing vaccine throughout the active phase of the study (through one month after the last vaccination).
* Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C W and/or Y.
* History of meningococcal diseases.
* Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing is required).
* A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
* History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
* Major congenital defects or serious chronic illness.
* History of any neurologic disorders or seizures.
* Acute disease at the time of enrollment.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).
Gene Signatures Searching of Sensitivity/Resistance to Neoadjuvant Radiotherapy in Patients With Resectable STS

To date, the radiation oncologist are missing biomarkers predictive of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Our proposal is to conduct a cohort study aiming at identifying transcriptomic biomarkers predictive of sensitivity and/or resistance to RT in limbs STS patients

Whether RT should be performed pre or post-operatively is still a debated question. To date, the radiation oncologist are missing signature of response/resistance to RT in order to identify patients who may benefit from RT and personalize the RT schedule. Therefore, predicting the likelihood of response/resistance to RT is essential. The individual exploration with high-throughput approaches will participate in describing biological mechanisms involved in STS tumor cell pan-resistance, thus identifying potential molecular targets that could be inhibited to reverse intrinsic radioresistance. In this context, our proposal is to conduct a cohort study aiming at identifying transcriptomic signature predictive of sensitivity and/or resistance to RT in limbs STS patients.

Eligibility Criteria:
Inclusion Criteria:

* Male and female ≥ 18 years at time of non-opposition to participate to the study
* Patient with documented non-opposition to participate to the study.
* Patient with histologically and cytologically confirmed diagnosis with STS (..)
* Patient with availability of FFPE tumor block from initial diagnosis biopsy (mandatory) and surgery specimen (optional).
* Patients with tumor FFPE samples prepared with the last 4 years
* Patient with evaluable tumor sample meeting the following quality/quantity control criteria (..)

Exclusion Criteria:

* Patients with metastatic soft tissue sarcoma at diagnosis
* Patients with exclusive radiotherapy without surgical resection
* Patients receiving neo adjuvant systemic treatment (chemotherapy, immunotherapy, targeted therapy)
Assesment of the Immune Response to RSV Vaccine in Patients With Myeloma, Lymphoma and Hematological Leukemia

A prospective study in which hematological oncology patients who were vaccinated against RSV will undergo a blood test to assess their immune response to the vaccine. As part of the study, hematological oncology patients with CLL, lymphoma, acute leukemia, myelodysplastic syndrome, and multiple myeloma, who are being monitored at the Hematology Institute at Ichilov, will be offered a blood test to evaluate their immune response to the RSV vaccine (serology, neutralizing antibodies, and cellular response). In the study, a blood sample of up to 10 ml will be taken in a chemistry tube and blood bank on the day of vaccination and about one month after that. The serological test will be conducted in the hospital's virology laboratory. The test result and its significance will be communicated to the patient by the treating hematologist in our clinic. In this group of patients, a follow-up will be conducted over a 12-month period (during routine clinic visits) to document the incidence of RSV infection and complications related to the vaccine.

participants 250 Single-center Research hypothesis approximately 60%-70% of the 250 hematological oncology patients who will participate in the study will achieve a positive serological response. This estimate is based on a study published in the NEJM which included participants aged 60 and above, without hematological oncological diseases or other conditions causing immunosuppression, where a response was observed in 83.7% of participants. We estimate that the response rate in hematological oncology patients will be lower, ranging from 60-70%, reflecting the degree of immune suppression associated with their disease and the treatment they received.

The study will include patients with chronic lymphocytic leukemia (CLL), lymphoma, myelodysplastic syndrome, leukemia, and myeloma. We expect that approximately 60 patients will belong to each of these subgroups, so the sample size will allow an assessment of the immune response within these subpopulations.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 years and older
* Patients diagnosed with multiple myeloma(MM) or lymphoma or CLL or myelodysplastic syndrome (MDS) or acute leukemia

Exclusion Criteria:

* Patients who have been previously vaccinated against RSV
* Patients who have experienced a severe reaction to any vaccine in the past
Enhancing Digitally Delivered Diabetes Education With Real-Time CGM

The current research study will add continuous glucose monitoring devices to the evidence-based text messaging diabetes education program for patients with type 2 diabetes for 6 months. Results on the effectiveness of this intervention will be compared for non-insulin using patients.

The current research study seeks to investigate the impact of incorporating Continuous Glucose Monitoring (CGM) into the evidence-based text messaging diabetes education program, Dulce Digital, focusing on individuals with Type 2 Diabetes (T2D) who are not on insulin therapy. This innovative approach stems from the rationale that real-time continuous glucose monitoring (CGM) can offer valuable insights into glycemic control, thereby enhancing diabetes self-management. In standard care, individuals with T2D, particularly those not on insulin, may not routinely have access to CGM devices. The CGM device, an integral part of recommended diabetes therapy, is FDA approved for use in all people with diabetes. However, reimbursement for CGM devices varies by health plans, and currently, Centers for Medicare \& Medicaid Services (CMS) does not reimburse for their use in non-insulin-using diabetes, except in cases of repeated severe hypoglycemia. Despite this, the investigators hypothesize that there are both clinical and financial benefits to providing a CGM device during diabetes self-management education for individuals with non-insulin-using T2D. This study aims to determine if adding a CGM device for this patient category yields significant benefits, contributing to the understanding of the potential advantages and informing future diabetes care practices.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes
* Are not currently using a CGM
* Are not using insulin therapies
* Speak English, Spanish or Arabic
* Have A1c between 7.5% and 12.0% in last 90 days
* Have a cellphone that can receive/send text messages and counts steps

Exclusion Criteria:

* Are using insulin therapies
* Are pregnant
* Are currently using a CGM
* Are currently participating in another diabetes-related study
A Pilot Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions

The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years old.
2. Subject has a symptomatic malignant pleural effusion requiring intervention. For an effusion to be defined as malignant, at least one of the following must be true:

   * There is histocytological confirmation of pleural malignancy
   * The effusion is an exudate (as per Light's criteria) in the context of histocytologically proven malignancy elsewhere, with no other clear cause for fluid identified
3. Subject has a history of at least one ipsilateral pleural effusion causing dyspnoea that responded to thoracentesis where the lung expanded and the dyspnoea was relieved.
4. Subject is willing and able to provide written informed consent.
5. Subject is willing and able to meet all study requirements, including attending follow-up visits or receiving trial-related telephone calls.
6. There is sufficient fluid on thoracic ultrasound to allow safe insertion of an indwelling pleural catheter
7. Negative pregnancy test if appropriate

Exclusion Criteria:

1. Subject has significant trapped lung (\>20%), or a proximal bronchial obstruction which is likely to lead to trapped lung.
2. Subject has a Karnofsky score of less than 50, or a WHO/ECOG performance status of 3\* or more.
3. Subject is pregnant, planning to become pregnant, or is lactating.
4. Subject has a history of empyema.
5. Subject has a history of chylothorax.
6. Subject has an uncorrected coagulopathy.
7. Subject is allergic to device materials.
8. Subject has evidence, in the opinion of the Chief Investigator, of either on-going systemic or pleural infection.
9. Subject has had a lobectomy or pneumonectomy on the side of the effusion.
10. Subject has undergone a previous attempt at pleurodesis which has failed.
11. Subject has previously been diagnosed with a serious immunodeficiency disorder.
12. Subject has bilateral pleural effusions, with both being at least moderate in size (greater than 1/3 of the hemithorax on chest x-ray).
13. Subject has evidence of fluid loculation such that attempts at pleurodesis are likely to be futile.
14. Subject has a mediastinal shift of ≥2cm toward the side of the effusion.
15. Subject is receiving concurrent intrapleural chemotherapy or radiation therapy to the ipsilateral chest.
16. Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the Chief Investigator, would mean participation in the study would be contraindicated.
17. Subject has no access to a telephone
18. No details of blood values (full blood count, clotting screen, urea and electrolytes, liver function) from within the last 10 days \* Patients who have a performance status of 3 may be considered for the trial if the removal of their fluid would likely improve their performance score by 1 or more.
Safety Assessment of One-hour Infusions of SNS-032 for the Treatment of Select Advanced Solid Tumors

The purpose of this study is to assess the safety and tolerability of one-hour infusions given once daily for 5 consecutive days in a 21-day treatment cycle; to define a recommended phase 2 dose; and to learn more about the clinical activity of SNS-032.

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the body), preliminary evaluation of biomarkers to see how the levels of certain proteins change after administration of SNS-032; assessment of the effects of SNS-032 on QT interval.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide written informed consent
* Advanced, progressing solid tumor that has no cure

  * In Stage 1, any advanced solid malignancy
  * In Stage 2, advanced breast cancer, melanoma, or non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
* Recovered from radiation therapy that may have been given in the last 21 days
* Recovered from surgery

Exclusion Criteria:

* Prior exposure to SNS-032 (previously known as BMS-387032)
* Pregnant or breastfeeding
* Women or male partners of women who are able to have children but are unwilling to use an approved, effective means of birth control
* Took part in another clinical trial during the last 21 days
* Abnormal lab values for serum potassium, hemoglobin, neutrophils, platelets, creatinine, AST, ALT, or total bilirubin
* Brain metastases, if patient is not neurologically stable or has needed corticosteroids or anticonvulsants at anytime within the 28 day period before enrollment.
* Other active malignancies
* Prior pelvic radiation therapy to ≥ 25% of bone marrow reserve
* Any other condition that would keep the patient from safely taking part in the clinical trial

Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application

One in ten births will occur prior to 37 weeks of gestation leading to serious complications such as problems with lung, heart and brain function and an increased risk of infant mortality. Solutions exist to treat risk factors related to preterm birth but these solutions require timely identification of the risks which is often not possible within regular prenatal care. This study will evaluate MyHealthyPregnancy, an application that monitors for common risks associated with preterm birth and recommends solutions to the expectant mother and care team.

MyHealthyPregnancy (MHP) is an application that was developed using behavioral decision science principles. This study seeks to evaluate the effectiveness and efficacy of the application. MyHealthyPregnancy was offered to expectant mothers at the University of Pittsburgh Medical Center in conjunction with usual prenatal care. The primary objective is to compare the reduction in gestational age at birth between MHP and usual care cohorts. Secondary objectives include comparing births occurring prior to 37 weeks of gestation, depression rates, anxiety rates, referrals to behavioral health, referrals to social workers, preeclampsia rates, gestational weight gain, number of prenatal appointments attended, and percent of required prenatal appointments attended between the MHP and usual care cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Offered a prescription for MyHealthyPregnancy
* 18+ years of age
* Pregnant
* Seeking care at a UPMC hospital
* Delivered at a UPMC hospital
Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery

The purpose of the study is to evaluate the surgical outcomes of injecting platelet-rich plasma (PRP) into the vaginal tissue as an adjunct therapy at the time of prolapse surgery

Platelet rich plasma (PRP) is an autologous product with high levels of platelets which are concentrated with bioactive growth factors responsible for accelerating tissue healing by stimulating the number of reparative cells to create collagen production, angiogenesis and neurogenesis. The overarching goal is to evaluate the effectiveness and safety of the adjunct application of PRP in the fibromuscular connective tissue (the site of anterior tissue plication) at the time of anterior colporrhaphy (the site of highest recurrence risk) in women undergoing native tissue vaginal prolapse repair, to promote tissue healing and regeneration, thus to improve surgical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Desire surgical treatment via a transvaginal native tissue approach.
* Completed child-bearing

Exclusion Criteria:

* Unable to follow-up, not willing to, or unable to participate in the proposed study
* Prior pelvic surgery within the past 12 months
* Prior anterior/apical suspension procedures
* Prior graft augmented prolapse surgery
* Pelvic/abdominal radiation
* Pelvic mass
* History of solid organ malignancy
Clinical Investigation of ENO/TEO/OTO Pacing System Under MRI Environment

The interest of the CAPRI study is to confirm the safety and the efficacy of the ENO/TEO/OTO pacing system when used under 1.5 or 3 Tesla MRI environment and in accordance with the MRI solutions guideline.

The purpose of CAPRI study is to confirm the safety and the efficacy of the CE marked MR conditional pacing system composed of the ENO, TEO or OTO pacemaker with VEGA pacing lead(s). Conditions to undergo an MRI scan are provided in the MRI solutions guideline.

The primary objective is to confirm the clinical safety of the ENO/TEO/OTO pacing system when used under 1.5 and 3 Tesla specific MRI conditions without scan exclusion zone.

The study secondary main objectives are aiming to assess the performance of the MR conditional pacing system in the right atrium and ventricle at 1 month following the MRI scan:

* Stability of the Pacing Capture Threshold
* Stability of the lead sensed amplitude

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all the following criteria at the time of inclusion visit may be included:

* Already implanted in the left or right pectoral region for at least 6 weeks with:

  * ENO, TEO or OTO single chamber rate response (SR) pacemaker with a VEGA pacing lead, or
  * ENO, TEO or OTO dual chamber rate response (DR) pacemaker with two VEGA pacing leads.
* Implanted pacing system must fulfill the following parameters:

  * Battery impedance is \< 5 Kilo Ohm (kΩ)
  * Pacing capture threshold value is ≤ 2 Volts (V) at 0.35 millisecond (ms)
  * Lead impedance value between 200Ω and 3000Ω
  * No diaphragmatic or pectoral stimulation at 5V/1ms
  * P-wave minimum sensed amplitude ≥ 1mV for patients with sinus rhythm
  * R-wave minimum sensed amplitude ≥ 4mV for patients with spontaneous conduction rhythm
* Must agree to undergo a non clinically-indicated MRI scan without intravenous injection and without sedation;
* Have reviewed, signed and dated informed consent.

Subjects who meet any of the following criteria are not eligible to be included in the study:

* Included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device;
* Have other active or abandoned cardiac implants already implanted;
* Have other active or passive non MR conditional devices implanted such as metallic foreign body;
* Have a history of brain aneurysm with ferromagnetic clipping;
* Have a planned cardiac surgery within the 3 months of inclusion;
* Have a medical MRI examination prescription planned within the 3 months of inclusion;
* Age less than 18 years old or under guardianship or kept in detention;
* Known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method ;
* Be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate.
Caffeic Acid Tablets as a Second-line Therapy for ITP

The investigators are undertaking a multicentre, randomised controlled trial of 120 adults with newly diagnosed ITP from 5 medical centers in China. Part of the participants are randomly selected to receive caffeic acid tablets combining dexamethasone and the other part are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

All participants' platelet count will be monitored weekly. Response will be evaluated after 3, 6 and 12 months after treatment. If the participant did not get complete response or response after 3 months, he would quit the trail.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia
2. Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years
3. To show a platelet count \<30 \* 10\^9/L, and with bleeding manifestations
4. Willing and able to sign written informed consent

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit
3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study
4. Current HIV infection or hepatitis B virus or hepatitis C virus infections
5. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period
7. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test
8. Patients who are deemed unsuitable for the study by the investigator