cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety Profile of Primary Dose of bOPV Bio Farma Given Simultaneously With Pentabio And IPV

This study is to assess protectivity following four doses of bOPV which given simultaneously with Pentabio® and 1 dose of IPV at the 4th visit

To describe serological response after four doses of bOPV with 1 dose of IPV. To describe the antibody status to polio 60 days after birth dose of bOPV To assess the safety of bOPV which given simultaneously with Pentabio® and 1 dose 1 dosde of IPV at the 4th visit

Eligibility Criteria:
Inclusion Criteria:

* Healthy, full term, newborns infants.
* Newborns residing within a relatively short and easily accessible distance (\<30 km) from the study clinic(s) and not planning to travel away during the entire study period.
* Infant born after 37 weeks of pregnancy
* Infant weighing 2.5 kg or more at birth (Birth weight \> 2.5 kg)
* Healthy newborns, with no history of asphyxia or meconium aspiration.
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
* Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.
* Mother at least elementary school graduate

Exclusion Criteria:

* Child concomitantly enrolled or scheduled to be enrolled in another trial
* Known history of congenital or acquired immunodeficiency (including HIV infection)
* Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C )
* Newborns requiring hospitalization at birth.
* Infant immunized with non-scheduled bOPV or IPV during trial
Using Buccal Pad of Fat Free Tissue Transfer With Immediate Implant Placement

Implants placed immediately after tooth extraction usually present challenges in obtaining soft tissue coverage with high risk of bacterial invasion, wound dehiscence and subsequently adverse effect on the success rate of the implant due to lack of primary soft tissue closure over the implant.

Different surgical methods have been described to achieve primary soft tissue closure in maxillary fresh socket, each having its advantages and disadvantages, based on that, buccal pad of fat can solve this soft tissue coverage problem with minimal complications and high success rate of the placed implants.The objective of this study is to evaluate the use of buccal pad of fat tissue with immediate implant placement in the posterior maxillary area.

Ten patients will be selected randomly from the outpatient clinic, Alexandria University seeking for an immediate implant placement. The sample will be selected to match the inclusion and exclusion criteria. It will be operated upon in the Oral and Maxillofacial Department, Faculty of Dentistry, Alexandria University. One stage surgery will include tooth extraction, placement of an immediate implant, bone grafting material and autologous soft tissue graft from the buccal pad of fat. Patients will be assessed clinically and radiographically to evaluate bone and soft tissue measurements.

Eligibility Criteria:
Inclusion Criteria:

* Patients age between 20-45 years with no gender predilection.
* Patients with non-restorable maxillary posterior tooth which need to be extracted (premolar -molar region).
* Patients with good oral hygiene.
* Bony defects more than 2 mm during implant placement treated by bone substitute.
* Patients fully capable to comply with the study protocol.

Exclusion Criteria:

* Patients with any systemic disease affecting bone quality as uncontrolled diabetes.
* Heavy smokers (more than 20 cigarettes per day).
* Sites with acute oral infection.
* Pregnant and lactating patients.
* Untreated periodontal disease.
* Previous chemotherapy or irradiation of the head and neck.
* Inadequate interocclusal space.
Correlation Between a Novel Subset of Neutrophil and Corneal Neovascularization.

The purpose of this study is to determine whether a novel subset of neutrophils is correlated with corneal neovascularization in the patients suffered from ocular chemical injury.

Cornea is an avascular transparent tissue providing refractive power for suitable optical performance. But under the condition of injury or infection, the stable microenvironment of ocular surface has been destroyed. Vessels sprout from the limbus to form corneal neovascularization, becoming an important pathological feature and leading cause of blindness. However, the underlying mechanism particular the inflammation-mediated mechanism remains unclear.

With the advancement of single-cell RNA sequencing (scRNA-seq), the investigation of immune cell transcriptomes has obtained great process . Using this advanced method, we identified different immune cell types in the ocular surface microenvironment in corneal neovascularization mouse model. Particularly, we found a specific subset of neutrophils played important role during the corneal angiogenesis. Using the loss-of-function and gain-of-function experiment, we clarified that this novel subset of neutrophils is the major factor that promoting corneal angiogenesis in mouse model. To further explore the relationship between this subset of neutrophils and angiogenesis in human, we plan to detect whether the neutrophil subset is increased in the circulation of chemical burned corneal neovascularization patients.

The main purpose of this study is to assess whether the novel subset of neutrophils has correlation with chemical burned corneal neovascularization. Approximately 33 patients and 33 age matched healthy controls will be recruited. The clinical characteristics, 4ml peripheral blood and the images of slit lamp photography will be obtained.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed ocular chemical injury with or without corneal neovascularization.

Exclusion Criteria:

1. Those who are diagnosed ocular diseases except for chemical ocular injury, such as uveitis, retinopathy.
2. Those who are diagnosed allergic disease, autoimmune diseases or hematological diseases, infectious disease, such as eczema, systemic lupus erythematosus (SLE), agranulocytosis and viral hepatitis.
3. Those who took immunosuppressive treatments in the past 3 months.
4. Pregnant or nursing women.
5. Those who have serious heart, lung, liver or kidney diseases.
6. Those who have serious systemic diseases.
7. Those who performed ocular surgery (including cataract surgery) in recent three months.
8. Those who have been enrolled in other interventional clinical studies at the same time.
9. Those who are unable to complete the study according to the investigators' requirements.
The βIG-H3 Protein: a New Marker in PANCreatic Adenocarcinoma (BIGHPANC)

The primary objective of this trial is to evaluate the correlation between the intensity of the protein big-h3 expression at tumoural microenvironment and the TNM/UICC staging (from I to IV) of pancreatic adenocarcinoma lesion.

The pancreatic adenocarcinoma is the most common pancreatic cancer. Currently, it represents the fourth cause of death by cancer in France. The diagnosis is often realized when the disease is at an advanced stage because of its delayed clinical expression. Only 20% of the patients are diagnosed at a stage enabling a tumour resection.

Scientists discovered a protein playing a key role: the βig-h3 protein. In mouse models, this protein is present in several stages of the tumorigenesis. A mutation of the gene Kras leads to the development of PANin (Pancreatic Intraepithelial Neoplasia) type precancerous lesions. The βig-h3 protein is early and highly expressed in the stroma around these lesions and in the pancreatic adenocarcinoma stroma. Moreover, studies showed that protein neutralization leads to a tumour size reduction by increasing the CD8+anti-tumor activity.

This protein is detected in the blood serum of patients suffering from a pancreatic adenocarcinoma. So, this protein which is secreted by the extracellular matrix could be a predictive marker for the pancreatic adenocarcinoma.

In this prospective, multicentric non-interventional study, it is anticipated to recruit 80 patients (20 per TNM/UICC stage).

Included patients will undergo two samples: A blood sample (5 ml) and a tumour sample (surgical exeresis piece or tumour tissue obtained for the initial diagnosis). In case of relapse, new samples will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the day of consenting to the study
* Patient with a potential pancreatic adenocarcinoma whatever the TNM/UICC stage
* Systematic treatment not initiated
* Signed and dated informed consent document.

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Geographical, social or psychiatric reason preventing the patient from completing the study follow-up
Thyroid Function in Critically Ill Patients With Acute Kidney Injury

The objective of this study was to assess the changes in thyroid hormones and its activity during CRRT in patients with Acute Kidney Injury.

After approval from the local Bioethics Committee of the Medical University of Gdańsk in Poland, the study was carried out between February 2019 and February 2020 among 32 patients admitted to ICU. There was no need to obtain written consent from the patients since the study was observational with no therapeutic intervention and decisional incapacity caused either by sedative drugs or severe condition of the patient.

Patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT) were included to this study irrespective of their gender, race and age. Exclusion criteria were patients with previous end-stage chronic kidney disease treated with dialysis.

After decision to implement CRRT the serial blood samples were collected into two red-top tube (no anticoagulant or preservative) before initiation of CRRT and at 1,2,3,6,9,12,15,18-day following. Last samples were collected 3 days after the end of CRRT. Level of TSH, fT3 and fT4 were checked from the first tube after collecting the blood. Second tube was kept frozen until levels of TRH, TT3, TT4, rT3 could be measured. In all the patients high-dose continuous veno-venous hemodiafiltration (CVVHDF) with citrate anticoagulation was performed. Blood flow and dialysis dosage were the same for every patient depending on their weight. The weight was rounded up or down and patients were assigned to the nearest group.

Eligibility Criteria:
Inclusion Criteria:

Patients with acute kidney injury and indications for initiation of continuous renal replacement therapy (CRRT)

Exclusion Criteria:

Exclusion criteria were patients with previous end-stage chronic kidney disease treated with dialysis or with history of hypothyroidism.
Safety and Performance of the SPINEVISION Hexanium ACIF in the Treatment of Cervical Spine Degenerative Disc Disease

The goal of this observational study is to confirm the safety and efficacy of the Hexanium ACIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal disk breaks down) at the cervical spine level (C3-C7).

Part of their standard of care, participants will be questioned on their neck and arm pains, their disability and if they have encountered any adverse effects since the Hexanium ACIF system implant surgery. Those data will be collected up to twenty four (24) months after the Hexanium ACIF system implant surgery.

The Hexanium ACIF study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with the Hexanium ACIF system (retrospective subjects) or subjects planned for treatment with the Hexanium ACIF system (prospective subjects) can be enrolled in hte study.

Standard of care subjects data up to twenty four (24) months post Hexanium ACIF system implant procedure will be collected; key data include neck and arm Visual Analogue Score (VAS), Neck Disability Index (NDI) score, and adverse events.

Data will be collected at Month 2, Month 6, Month 12 and Month 24 post surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient planned for Hexanium ACIF system implant or patient implanted with Hexanium ACIF system (not prior July 2020)
* Patient of 18 years old or more
* Patient has provided signed informed consent, or did not oppose to his/her data collection, per local regulation

Exclusion Criteria: contra-indication

* Infection, local to the operative site
* Signs of local inflammation
* Fever or leukocytosis
* Morbid obesity
* Pregnancy
* Paediatric cases, or patient still having general skeletal growth
* Spondylolisthesis unable to be reduced to Grade I
* Suspected or documented allergy or intolerance to metal
* Any case where the implant components selected for use would be too large or too small to achieve a successful result
* Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality
* Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance
* Prior fusion at the level to be treated
* Any case not needing a bone graft or fusion
* Any abnormality present which affects the normal process of bone remodelling including, but not limited to severe osteoporosis involving spine, bone absorption, osteopenia, primary or metastasis tumours involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis
* Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumours or congenital abnormalities, fracture local to operating site, elevation of segmentation rate unexplained by other diseases, elevation of white blood count (WBC), or marked left shift in the WBC differential count
* Mental illness
* Any patient unwilling to cooperate with postoperative instructions
Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

To observe and to describe the safety during Days 0 to 21 following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged ≥ 60 years.

To measure and to describe the immune response (antibodies to hemagglutinin) 21 days following injection of the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged ≥ 60 years.

The time of onset and duration of local and systemic solicited reactions will be assessed and reported. Unsolicited adverse events (including serious adverse events) will be collected and categorized throughout the study period.

Antibody levels will be evaluated by hemagglutination inhibition (HI) assay from sera obtained pre-vaccination (Day 0) and 21 days post-vaccination, for antigens from the 2004-2005 influenza virus strains: A/New Caledonia/20/99 (H1N1), A/Wyoming/03/2003 (H3N2), and B/Jiangsu/10/2003.

Eligibility Criteria:
Inclusion Criteria :

* Participant aged 18 years or older.
* Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
* Participant is in reasonably good health as assessed by the investigator.
* Participant willing and able to meet protocol requirements.
* Participant willing and able to give informed consent.

Exclusion Criteria :

* Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
* An acute illness with or without fever (temperature \>100.4°F) in the 72 hours preceding enrollment in the trial.
* Clinically significant findings in vital signs (including temperature \>100.4°F) on review of systems.
* Self-reported history of severe adverse event to any influenza vaccine.
* Vaccination against influenza in the 6 months preceding enrollment in the study.
* Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
* Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study.
* Immunogenicity or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 3 months.
* Receipt of blood or blood products within the 3 months preceding enrollment in the study.
* Diabetes mellitus requiring pharmacological control.
* Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled, or could interfere with the evaluation of the vaccine.
* Person deprived of freedom by an administrative or court order (having legal or medical guardian).
* For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
Neuromodulation in Lateral Elbow Pain

Lateral epicondylitis (LE), also known as tennis elbow, refers to a painful condition at or around the lateral epicondyle of the humerus and common extensor tendon (CET) that is aggravated by dorsiflexion and/or supination of the wrist against resistance. Lateral epicondylitis is one of the most common injuries of the elbow, affecting 1-3% of the population.

Therefore, determining an effective intervention that helps manage the condition and lessens the financial burden is important. Passive physical modalities, including electrotherapy and orthotic devices, are common treatments for the management of elbow pain. Passive physical modalities are physical treatments involving a device that does not require active participation by the patient. In a systematic review, 2017, Dion et al examined the effectiveness of passive physical modalities for the treatment of soft tissue injuries of the elbow, but little evidence exists to support or refute their use.

Clinically, an invasive technique has appeared, known as Ultrasound-guided Percutaneous Neuromodulation (PNM). This minimally invasive intervention consists in the applicacion of a percutaneous electrical stimulation (PES) through an acupuncture needle-like electrode that is placed in close proximity to the nerve or motor point of the muscle with ultrasound guidance. At the clinical level, the PES is always used with the therapeutic aim of relieving chronic pain and neuropathic pain. Similarly, in sports, PES is used with the aim of improving muscular activity. Therefore, according to the characteristics and the therapeutic benefits of this technique, further research is needed to discover multiple clinical indications.

The aim of this pilot study was to examine the effects of a percutaneous neuromodulation intervention in patients with unilateral refractory lateral epicondylitis. Findings from this study may provide further evidence for the relevance of neural tissues in determining the elbow pain and may indicate effects of US-guided NMP technique on the rehabilitation and/or prevention of in patients with unilateral refractory LE.


Eligibility Criteria:
Inclusion Criteria:

* Presence of pain in the elbow region at least for three months
* Flares with activity
* Tenderness at or within 2cm of the lateral humeral epicondyle on resisted extension of the wrist and/or the third finger.

Exclusion Criteria:

* Participants who had constant or radicular pain
* Any previous surgery or acute trauma in the upper extremity.
* Elbow deformity
* Bilateral symptoms
* Clinical or electrophysiological findings referable to peripheral nerve (ulnar and median) disease and
An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer

The purpose of this study is to determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of invasive breast cancer.
* Stage IV disease.
* Documented HER2 and hormonal receptor status per protocol, ER/PR+ patients must be refractory to at least one prior hormonal treatment.
* ECOG Performance status 0-1.
* Measurable disease per RECIST (1.1).
* Adequate hematological function per protocol.
* Adequate hepatic function per protocol.
* Adequate renal function per protocol.
* Negative serum pregnancy test at study entry for patients of childbearing potential.
* Ability to understand and sign written consent and to comply with the study protocol.

Exclusion Criteria:

* Presence of active or untreated CNS metastases as determined by MRI/CT scan performed during screening.
* Active malignancies other than MBC within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin.
* Bone as the only site of metastatic disease from breast cancer.
* Prior radiotherapy to the only area of measurable disease. NOTE: Radiotherapy to a limited area other than the sole site of measurable disease is allowed, if received prior to initiation of ganetespib treatment. Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of ganetespib.
* Pregnancy or lactation.
* Known serious cardiac illness.
* Uncontrolled intercurrent illness per protocol.
* Other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study.
Efficacy Study of TKcell in Advanced Gastric Cancer

The purpose of this study is to determine efficacy of NKCell combined FOLFOX-4 chemotherapy in gastric cancer


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Diagnosis of histologically confirmed adenocarcinoma of the gastric
* ECOG performance status of 0 - 2
* At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥2cm in physical examination
* Adequate liver, renal, bone marrow functions as evidence by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 7.5 x 109/L; Bilirubin less than 2 mg/dL ASAT and/or ALAT \< 5 UNL; serum creatinine ≤ 2 ULN
* Minimum life expectancy of 12 weeks
* Effective contraception for both male and female subjects if the risk of conception exists

Exclusion Criteria:

* Brain metastasis and/or leptomeningeal disease (known or suspected)
* Previous chemotherapy for gastric cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment.
* Previous oxaliplatin-based chemotherapy
* Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization and chemotherapy
* HIV antibody (+), Chronic hepatitis
* Uncontrolled infection
* Concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal therapy not indicated in the study protocol except for contraception
* Clinically relevant coronary artery disease, history of myocardial infarction, high risk of uncontrolled arrhythmia
* Known hypersensitivity reaction to any of the components of the treatment.
* Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
* Participation in another clinical study within the 30 days before randomization
* Significant disease which, in the investigator's opinion, would exclude the subject from the study