cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a "2+1"Sequential Schedule With bOPV in Infants

The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '2+1'sequential schedule with bivalent oral poliovirus vaccine in 2-month-old infants

his study is a randomized, double-blind, active-controlled phrase III clinical trial. The purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by Sinovac Biotech Co., Ltd in a '2+1' sequential schedule with bOPV in 2-month-old infants. 240 infants aged between 60-90 days will be randomly assigned into experimental group or control group in the ratio 1:1. The experimental group received sIPV-sIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group received wIPV-wIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2). The control wIPV was manufactured by SANOFI PASTEUR S.A.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer between 60-90 days old;
* Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
* Proven legal identity;
* Participants or guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
* Complying with the requirement of the study protocol;

Exclusion Criteria:

* Prior vaccination with Poliovirus Vaccine;
* History of allergy to any vaccine, or any ingredient, excipients and Gentamycin Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
* Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
* Autoimmune disease or immunodeficiency/immunosuppressive;
* Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or mental illness;
* Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency, coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation disorders;
* Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) prior to study entry;
* Blood product prior to study entry;
* Any other investigational medicine(s) within 30 days prior to study entry;
* Any live attenuated vaccine within 14 days prior to study entry;
* Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Axillary temperature \> 37.0 °C;
* Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
Medico-economic Interest of Single-use Ancillary Efficiency® in Fitting a GMK® Total Knee Arthroplasty (TKA)

Clinical studies on single-use ancillaries are still few; medico-economic benefits have to be assessed regarding their design and use.

A foreseeable increase in the number of surgeries in the future, tends to change the techniques and consequently to question the medico-economic context. Single-use ancillaries attempt to provide solutions to today's imperatives and could be relevant from a global medico-economic point of view.

For the moment, the conventional ancillaries for TKA are reused after sterilization.

The objective of the study is to improve the fluidity of the intervention process with cost control.

After validation of the inclusion criteria, the surgeon will perform the randomization (1:1): single-use ancillary group or conventional ancillary group. Only the medical team and the block staff will be informed about the ancillary group, not the patient.

The use of the single-use ancillary does not induce any modification of the surgical technique for fitting a TKA. The surgical approach is unchanged and is specific to the surgeon. The appearance and use of the single-use ancillary are similar to the conventional ancillary except for the materials used for their design. Please note that a preliminary training at the beginning of the study will be carried out with the different investigators so that they can handle the different medical devices.

In total, 48 participants will be randomized. The medico-economics assessments will be performed for 20 patients (10 per group) by micro-costing to evaluate the preoperative, intraoperative and post-operative costs : reconditioning time, sterilization and transport time, preparation time and duration of intervention. The qualitative score of subjective assessment of the operator's perception of the ancillary measured during the intervention. The participants will evaluate their QOL by completing a questionnaire 3 month and 12 month postoperative. The safety parameters will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Patient with gonarthrosis or inflammatory arthrosis of the knee leading to surgical indication for total knee arthroplasty
* Informed patient, able to understand the information, not opposing to participate this protocol
* patient affiliate to social security

Exclusion Criteria:

* Extra-joint Deformation needing bone associated gesture
* Preoperative active or suspected infection
* Local evolutive tumoral pathology
* Medical history with bone gesture on concerned knee
* Patient unable or refusing to give his consentement
* Pregnant woman or in age to be pregnant without use any effective contraceptive method
* Patient under maintenance of justice, tutelage or legal guardianship)
* Presence of any family, sociological, political or geographic situation able to interfere with the protocol
Observational Study of Eating Behavior in Patients With Diabetes Mellitus and Obesity Undergoing Liver Transplantation

The study aims to evaluate the presence of eating disorders, which consists of having an altered relationship with food, in patients on the list or already undergoing liver transplantation.

The study involves the enrollment of at least 100 patients, currently followed for the treatment of severe organ failure, on the list or already undergoing liver transplantation and referred for a dietetic visit.

Eligibility Criteria:
Inclusion Criteria:

* signature of written informed consent to participate in the observational study, either by the participant or legal guardian

  * age \> 18 years
  * diagnosis of type 2 diabetes mellitus and/or overweight or obesity, (BMI \> 25)
  * be listed for OLT or have already been submitted to OLT

Exclusion Criteria:

* -previous diagnosis of psychiatric illness;
Consequences in ICU of Vaccination Status of Covid-19 Patients

It is a retrospective cohort study aiming to describe the characteristics, management and prognosis of vaccinated patients hospitalized in the intensive care unit (ICU), in comparison with non-vaccinated patients.

In December 2019 started the first wave of Sars-Cov-2 virus infections in Wuhan, China : the start of a major, deadly global pandemic, which has so far caused more than 6 million deaths worldwide. In response to the scale of this pandemic, a large-scale vaccination campaign was rapidly in place, starting in December 2020. Despite this measure, admission of vaccinated patients to intensive care has been noticed. The aim of this study is to describe the characteristics, management and prognosis of vaccinated patients hospitalized in the intensive care unit (ICU), in comparison with non-vaccinated patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient with Sars-Cov-2 pneumonia confirmed by positive reverse transcription polymerase chain reaction (RT-PCR) assay and hospitalized in the general intensive care unit of the CHR de Metz-Thionville, between 01/03/2020 and 01/06/2022.

Exclusion Criteria:

* missing data for primary or secondary outcomes
COPD AND ASSESSMENT OF RADIOLABELED AEROSOL DURING NONINVASIVE VENTILATION

Background: Beneficial effects from noninvasive ventilation (NIV) in acute COPD are well-established, but couple to nebulization is still challenging. Aim: To compare radioaerosol pulmonary deposition and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) using vibrating mesh nebulizer (VMN) and jet nebulizer (JN) coupled to NIV.Methods: It was a crossover study involving 9 stable moderate to severe COPD randomly allocated for both phases of the study: Phase 1(NIV+MN,n=9) and phase 2(NIV+JN,n=9). Bronchodilators were delivered during NIV using a facemask (pressures of 12 cmH2O and 5 cmH2O - inspiratory and expiratory, respectively). Radioactivity counts were performed using a gamma camera and regions of interest(ROIs) were delimited. We determine aerosol mass balance from the lungs, upper airways, stomach, nebulizer, circuit, inspiratory and expiratory filters, and mask as a percentage.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria were considered as follows: moderate to severe stable COPD (50% ≤ FEV1 \< 80% from predicted values or 30% ≤ FEV1 \< 50% from predicted values)(4); none exacerbation in the last six months; age between 18 - 60 years; both sexes; no smoking history; able to understand verbal commands, and consent to participate in this protocol.

Exclusion Criteria:

Presence of dyspnea; cardiopulmonary diseases (chronic obstructive pulmonary disease, pneumonia, cardiac failure, myocardial infarction, pneumothorax); hyperthermia; hemodynamic instability (heart rate \> 150 bpm and systolic blood pressure \< 90 mmHg); arrhythmia absence; pregnancy; and contraindications for use of NIV (29).
East-West Hepatocellular Carcinoma Study Group

The current treatment guidelines of hepatocellular carcinoma (HCC) of the American and European Associations for the Study of Liver Disease are based on the Barcelona-Clinic-Liver-Cancer classification (BCLC), which does not recommend surgery in patients with large, multinodular and macrovascular invasive disease. The aim of this study was to investigate the role of hepatic resection in a large retrospective multicentric cohort of patients resected for HCC regardless of the BCLC indications.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of hepatocellular carcinoma
* candidate to liver resection as a curative treatment

Exclusion Criteria:

* uncertain diagnosis of hepatocellular carcinoma
* uncertain follow-up data
Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases. A Randomized Trial.

Since the introduction of sentinel node biopsy in breast cancer, it has become clear that its use is reliable and reproducible. Today, it is clinical routine to not remove further lymph nodes from the axilla (arm pit) in case the sentinel node (which is the first lymph node/s reached by lymphatic flow from the breast) is free of tumor deposits. It is also routine to leave remaining lymph nodes behind in case the sentinel node contains a minimal cluster of tumor cells, called isolated tumor cells (formerly submicrometastasis). Even in slightly larger tumor deposits, so called micrometastasis (up to 2 mm in size), it has been shown that a completion axillary clearance (removal of further lymph nodes from the arm pit) does not contribute to a better survival. Data from a randomized study indicate that it seems safe to omit axillary clearance even if the sentinel node biopsy shows up to 2 nodes with tumor deposits over 2 mm in size (macrometastasis). These studies have changed clinical practice in many countries, however, it is still debated whether it is safe to omit axillary clearance in the case of sentinel node macrometastasis due to under-recruitment in the aforementioned study. The rationale for omitting extensive axillary surgery is the avoidance of postoperative morbidity such as arm lymphedema, loss of sensation, pain and swelling.

The hypothesis is that refraining from axillary clearance in breast cancer patients with 1-2 sentinel nodes with macrometastasis will not worsen breast cancer-specific survival by more than a maximum of 2.5% after 5 years.

This study is a prospective international randomized trial including 3500 patients.

Breast cancer patients without signs of axillary nodal involvement will be eligible for sentinel node biopsy. Those who are found to have up to two sentinel node containing macrometastasis will be informed about this trial Those wishing to participate will be randomized to either undergo further axillary surgery (clearance) or not. Outcome measures are breast cancer-specific survival, disease-free survival, axillary recurrence rate and overall survival.

Details can be found on www.senomac.se

Eligibility Criteria:
Inclusion Criteria:

* Patients with invasive breast cancer (T1-T3)
* N0 on palpation
* Preoperative ultrasound performed
* Pathology report shows macrometastasis in 1-2 sentinel lymph nodes
* Patients undergo breast-conserving therapy or mastectomy
* The patient must have provided oral and written consent
* Age ≥ 18 years

Exclusion Criteria:

* Metastases outside of the ipsilateral axilla
* Prior history of invasive breast cancer
* Pregnancy
* Bilateral breast cancer if one side meets exclusion criteria
* Medical contraindication for radiotherapy or systemic treatment
* Inability to absorb or understand the meaning of the study information; for example, through disability, inadequate language skills or dementia.
Rehabilitation With or Without Knee Orthosis Following Meniscal Repair

RCT to determine if a less restrictive postoperative rehabilitation protocol following meniscal repair results in a faster return to normal knee function without compromising rates of healing.

The purpose of the study is to compare rehabilitation after meniscal repair with or without the use of a knee orthosis. There is conflicting evidence regarding optimal postoperative rehabilitation following meniscal repair with ACLR. Many surgeons advocate the use of a knee orthosis which restricts flexion during the first 4-6 weeks following surgery. Some also avoid weight baring and crouching for various periods of time. This is due to the perceived risk that the healing meniscus is exposed to unnecessary strain, potentially compromising healing. There is however evidence that fewer postoperative restriction in the setting of meniscal repair in conjunction with ACLR does not compromise meniscal healing. There is also evidence that accelerated rehabilitation following isolated meniscal repair does not increase the risk of failure.

The study design is a prospective randomized study with equal groups.

A power analysis has been performed indicating that 57 patients in each group are required to detect a significant difference between groups, as such a cohort of 120 patients will be recruited. Randomisation will continue until 60 patients are allocated to both groups.

Randomization process and study design will be done according to the CONSORT guidelines.

Eligibility Criteria:
Inclusion Criteria:

• Meniscal tear in the peripheral zone of the meniscus, repaired using at least two sutures.

Exclusion Criteria:

* Associated injury of the knee requiring surgical or non-surgical intervention that precludes the patient from completing accelerated rehabilitation- fracture, concomitant ligament or cartilage injury.
* Previous meniscal repair in the affected meniscus
* BMI over 30
Effect of Age on the Median Effective Dose(ED50) for Motor Block With Intrathecal Ropivacaine

The primary aim of this study was to determine the median effective dose (ED50) for motor block of intrathecally-administered ropivacaine in adults (20-80 years), and to assess the effect of age on ED50 required for motor block.

This study was performed in adult patients undergoing transurethral, urological or lower limb surgery under combined spinal and epidural anesthesia. Patients were stratified according to age: 20-30, 31-40, 41-50, 51-60, 61-70, and 71-80 years. The spinal component of the anesthetic was established by bolus administration of various up-and-down doses of 0.75% ropivacaine, determined by Dixon's method, with the first patient receiving 15 mg, and with testing intervals of 1.5 mg according to failure or success of the preceding patient's motor block. The degree of motor block after intrathecal administration of each dose was evaluated by the modified Bromage and Hip motor function score. The primary outcome was obtained by administration of the mean dosage that was determined from the midpoints of all independent pairs of patients involving a crossover from failure to success during 5 minutes after the spinal injection. The ED50 were estimated from the up-and-down sequences using the method of Dixon and Massey and logistic regression. Other endpoints were included on the basis of sensory block level, duration of motor blockade, hypotension, and vasopressor requirements.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who were undergoing transurethral, urological or lower limb surgery, primarily under the spinal anesthesia

Exclusion Criteria:

* Patients with diabetes, obesity, neuromuscular diseases, bleeding diathesis, hypersensitivity to amide local anesthetics, lumbar vertebrae abnormality, chronic back pain, or who were pregnant
Product Surveillance Registry; Ear, Nose and Throat - EXTEND Cohort

The purpose of this study is to confirm long-term clinical safety and performance, acceptability of identified risks, and detect emerging risks based on factual evidence for the PROPEL family of products when used according to labeling in a real-world setting.

Ongoing clinical investigation for the purpose(s) of:

* Providing continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products for their intended use
* Obtaining real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used
* Supporting post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/or regulatory authority requests
* Obtaining clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions
* Providing clinical data to support health economics and clinical outcomes research

Enrollment is estimated to take place at up to 10 sites in Europe over 12 months. A single site may enroll no more than 30 patients. Patients may be enrolled up to 60 days prior to the baseline procedure. Subjects will be followed for a total duration of12 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
* Patient has or is intended to receive or be treated with an eligible Medtronic product
* Patient is consented within the enrollment window of the therapy received, as applicable

Exclusion Criteria:

* Patient who is, or is expected to be, inaccessible for follow-up
* Participation is excluded by local law
* Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results
The Ghana Primary Tube Versus Trabeculectomy Study

Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of medications, disease severity and poor compliance. Surgical treatment is likely to be a more practical solution.

The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 85 years, inclusive
* Open angle glaucoma. Including primary open angle glaucoma, pseudoexfoliative and pigmentary glaucoma
* Intraocular pressure 18 - 40 mmHg on maximal tolerated or maximal affordable medical therapy
* Informed consent given and consent form signed.

Exclusion Criteria:

* Unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits
* Pregnant or nursing women
* No light perception vision
* Previous incisional intraocular surgery, other than uncomplicated clear corneal cataract surgery
* Previous ocular laser in study eye
* Iris neovascularisation or proliferative retinopathy
* Primary angle closure or primary angle closure glaucoma
* Iridocorneal endothelial syndrome or anterior segment dysgenesis
* Epithelial or fibrous downgrowth
* Aphakia
* Chronic or recurrent uveitis
* Steroid-induced glaucoma
* Severe posterior blepharitis
* Unwilling to discontinue contact lens use after surgery
* Previous cyclodestructive procedure
* Glaucoma secondary to penetrating keratoplasty, trauma, retinal disease/surgery or neovascular disease
* Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy
* Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery
The Role of ImmuKnow® in the Management of Immunosuppressants in the Renal Transplant Patient

The purpose of this study is to demonstrate whether there are any outcome benefits of a serial ImmuKnow assays in the management of de novo renal transplant recipients.

Background: The management of renal transplant recipients is challenging in keeping a delicate balance of immunosuppression to avoid either infection (overimmunosuppression), or rejection (under-immunosuppression). Conventional clinical parameters are not adequate enough. ImmuKnow (Cylex Inc, Columbia, MD) is an FDA-cleared assay for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant. There have been limited retrospective studies discussing the effectiveness of the ImmuKnow assay. There is no prospective head-to-head trial showing the benefits of periodic ImmuKnow testing.

Objective: To demonstrate whether there are any outcome benefits of a serial ImmuKnow assays in de novo renal transplant recipients Patients and Methods: A prospective, randomized, pilot, controlled 12-month study to compare the outcomes of 2 cohorts of de novo renal transplant patients will be conducted. The outcomes that will be investigated include a combined infection rate (primary end-point), separate infection rates and episodes, acute rejection rate and episodes, quality of life, graft and patient survivals (all secondary end-points). Biopsy of the transplanted kidney is used to confirm rejection whenever possible. Among the study cohort, the patients' immunosuppressants will be adjusted according to the results of a serial ImmuKnow assay besides using conventional clinical parameters; whereas among the control cohort the patients' immunosuppressants will be adjusted according to conventional clinical parameters.

Expected Results: At the end of this study we will be able to learn whether the study cohort patients have less infection, less acute rejection, better allograft function, better quality of life, and better graft or patient survivals.

Eligibility Criteria:
Inclusion Criteria:

1. De novo kidney transplant patients who are eligible for kidney transplant according to UNOS criteria and agree to participate in the study.
2. Patients of both sex aged between 18 to 80 years.

Exclusion Criteria:

* Any patient with a known immunocompromised disease (e.g. patients with AIDS) or leukocytosis(\>15,000u/L)