cyrilzakka/clinical-trials huggingface dataset:
Study of Rubella Immunity. Response to Vaccination of Subjects With Very Low, Equivocal or Undetectable Titers of Rubella Virus Antibodies

The aim of the research is to study humoral and cellular immunity in pregnant women for who the level of rubella virus antibodies is weakly positive, equivocal or negative with the usual laboratory technique.


Eligibility Criteria:
Inclusion Criteria:

* Women over 18
* Rubella serology negative, ambiguous or weakly positive during a first prenatal consultation and for which the second determination of the immunity anti rubella is necessary after 18 weeks of pregnancy
* Accepting the rubella vaccination after the childbirth;
* Accepting a blood test, during a postnatal consultation, 6 in 8 weeks after vaccination, to verify their immunity towards the virus of the rubella.
* Affiliated to a social security scheme
* Having given a written consent

Exclusion Criteria:

* Rubella contracted since the first serology realized during the first prenatal consultation
* Autoimmune pathologies
* Intolerance / allergy known about a previous vaccination whatever it is
* Immunosuppression (HIV, transplants)
* Injection of multivalent immunoglobulins (except anti-D)
Clinical Evaluation of Two Monthly Contact Lenses

The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign an approved informed consent form (ICF);
* Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
* Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
* Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
* Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
* Refractive, ocular, or intraocular surgery, as specified in the protocol;
* Current or history of eye injury or disorders, as specified in the protocol;
* Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
* Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Use of topical ocular medications that would require instillation during contact lens wear;
* Other protocol-specified exclusion criteria may apply.
Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

It's of great importance to effectively induce and maintain disease remission in patients with moderate to severe ulcerative colitis (UC). Vedolizumab (VDZ) is known for its high safety profile and confirmed therapeutic efficacy in UC treatment. However, according to the experience in clinical practice, the effect onset speed of vedolizumab is relatively slow. Upadacitinib (UPA), however, works quickly, which complements the defect of slow onset of VDZ induction. However, the safety of UPA used in situations such as infection and tumors is inferior to that of VDZ, and long-term use requires testing for the risk of adverse events such as deep vein thrombosis. Therefore, if the advantages of long-term maintenance therapy safety of VDZ and rapid induced remission of UPA are fully utilized, the combination of VDZ and UPA induction for 8 weeks, followed by the use of single drug VDZ in maintenance therapy, can maximize the clinical benefits of UC patients. Due to the lack of high-level clinical research data at home and abroad, we plan to conduct a multicenter prospective randomized controlled clinical study to provide the evidence-based basis for the efficacy analysis of the sequential treatment of moderate to severe UC patients with VDZ and UPA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis
* Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2
* Indications for VDZ or UPA application

Exclusion Criteria:

* Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy
* Evidence of toxic megacolon was found during screening
* Previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to UC
* Subjects who require surgery due to UC or plan to undergo elective surgery during the study period
* There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases
* Evidence of active hepatitis B or C infection during screening
LeMaitre® CARDIAL Dialine II Post Market Study

This clinical study will capture clinical data specific to the performance and safety of the LeMaitre® CARDIAL Dialine II. It is a retrospective, monocenter, post-market safety and performance study. Following the new MDR regulation, this study will allow the clinical data of the prosthesis to be completed in order to renew its CE marking.

The LeMaitre Cardial Dialine® II Vascular Prostheses (Dialine II) is a knitted PET (Polyethylene Terephthalate) graft manufactured with multifilament yarns and impregnated with bovine origin collagen to achieve a strong and dilatation resistant graft, which eliminates the preclotting step. The bovine collagen is then gradually resorbed by the patient. The Dialine II comes with black guide lines and crimped construction to facilitate implantation.

Other design features include:

* Thin wall design (0.50+/-0.12mm) with excellent conformability
* Special impregnation process for maximum leakage resistance
* Water permeability \< 10 ml/cm2/min

The Dialine II is indicated for replacement or bypass procedures in aneurysmal and/or occlusive diseases of the abdominal aorta or peripheral arteries. The Dialine II is also indicated for arterial reconstruction in patients requiring systemic heparinization. The unique collagen impregnation results in exceptional resistance to leakage, even under systemic heparinization.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, ≥ 18 years of age
* Subject who has undergone surgical treatment for the replacement or bypass in aneurysmal and/or occlusive diseases and for arterial reconstruction in patients requiring systemic heparinization with LeMaitre Cardial Dialine II (between 01JAN2010 and 31JUL2016).

Exclusion Criteria:

* Co-morbidity that in the discretion of the investigator might confound the results.
* Patient operated on with a Dialine II Vascular prosthesis in conditions where it is connected with another one and that will make impossible to attribute the complication in the case it occurs
* Infection that may affect the safety or the efficacity of the prothesis
The Effect of Exercise on Amateur American Football Players

Football is a team activity that calls for numerous sophisticated talents, including speed, endurance, speed, strength, and quickness. It is getting more and more popular among professional and amateur players, particularly in America.

Current research demonstrates that characteristics of American football players like body composition, sprint performance, metabolism, and strength are influenced by elements like the league played, training history, and position played. The ability to generate power with both the upper and lower bodies, change direction quickly, accelerate quickly in both positive and negative directions, run quickly, engage in high-intensity collisions repeatedly, and maintain muscular strength endurance are all skills that players on the court may need.

Eligibility Criteria:
Inclusion Criteria:

* Male individuals between the ages of 18-25
* Being an American football player
* Regular attendance at training sessions

Exclusion Criteria:

* Known neurological disorder
* Serious orthopedic disorders that will prevent him from exercising
* cognitive impairment
Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma

The primary objective of this study is to assess the safety and tolerability of bendamustine as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma (MM).


Eligibility Criteria:
Inclusion Criteria:

The patient:

* has a diagnosis of multiple myeloma.
* currently has multiple myeloma with measurable disease.
* must have received at least 1 previous treatment regimen and shows signs of progressive disease at the time of study entry.
* if a woman of child bearing potential (not surgically sterile or at least 12 months naturally postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
* if a man, must agree to use an acceptable method of contraception throughout the study and for 90 days after last dose study drug.
* must have an Eastern Cooperative Oncology Group (ECOG) performance status not greater than 2.
* must have a life-expectancy of greater than 3 months.
* must meet specific protocol-related hematological and laboratory criteria within 14 days of enrollment.

Exclusion Criteria:

The patient has:

* had a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
* plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome.
* plasma cell leukemia.
* non-measurable multiple myeloma.
* Common Terminology Criteria for Adverse Events (CTCAE) grade 2 (or greater) peripheral neuropathy within 14 days before enrollment.
* previously participated in a Cephalon-sponsored clinical study with bendamustine.
* impaired cardiac function or clinically significant cardiac diseases.
* undergone major surgery within 4 weeks prior to screening or has not recovered from side effects of such therapy.
* severe hypercalcemia.
* other concurrent severe and/or uncontrolled medical or psychiatric conditions.
* known positivity for human immunodeficiency virus (HIV) or hepatitis B or C.
* a history of allergic reaction attributable to compounds of similar chemical or biological composition to bendamustine, bortezomib, boron, or mannitol.
* received chemotherapy within 3 weeks before enrollment, with the exception of nitrosoureas, which should be discontinued at least 6 weeks before enrollment.
* received corticosteroids (greater than 10 mg/day prednisone or equivalent) within 3 weeks before enrollment.
* received immunotherapy, antibody, or radiation therapy within 4 weeks before enrollment.
* a status as a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study.
* a status as a male whose sexual partner is a woman of childbearing potential not using effective birth control.
* used an investigational drug within 1 month before the screening visit.
Investigating Variation in Hospital Acute Coronary Syndrome Outcomes

To investigate the causes of hospital variation in outcomes from acute coronary syndromes in England and develop recommendations for improving patient care.

Over the last few years the chance of dying from a heart attack in England and Wales has reduced dramatically. Even so, there remain huge differences in mortality between hospitals. For example, up to a third of patients with a heart attack who attend hospitals in England are more likely to die than would be expected. That is, the type of treatment and the risk of death depends upon where a patient lives and which hospital they attend. In part, the variation in death may be due to the services available at the hospital or to factors such as socioeconomic deprivation. It may also relate to other factors such as depression, cardiac rehabilitation and whether patients take their medication after discharge from hospital. Using powerful statistical approaches that include measures of quality of life, we propose to examine data about heart attacks in England and investigate the 'postcode lottery of care'. Our aim, using regional data about heart attacks is to identify and measure the effects of hospital care. This research will identify hospital qualities that promote improved patient care. In doing so, best practice will be highlighted and healthcare policy changed so that all patients will have an equal chance of surviving a heart attack.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Both sexes
* Acute admission to the acute Trust with suspected acute coronary syndrome

Exclusion Criteria:

* Patients at a terminal stage of any illness
* Those in whom follow up would be inappropriate or impractical
Comparison of the TOFScan and the WiTOF During Recovery of Neuromuscular Function

The purpose of this study is to compare two neuromuscular blockade monitors on recovery from an ATRACURIUM intra veinous injection for surgery. The TOFscan, a wired connected monitors and the WiTOF, a wireless connected monitor.

The secondary objective will be to compare the performance of the two monitors on the abductor pollicis muscle with all the curarisation parameters (TOF, PTC, T4/T1R) and to assess interference occuring during the surgery which could limit the usage of a wireless monitor.

Eligibility Criteria:
Inclusion Criteria:

* All programmed surgery with intraveinous injection of ATRACURIUM
* American society of anesthesiology patient score of I, II or III
* Patient being free of tutorship or curatorship
* Acceptance of the patient after clear and loyal information

Exclusion Criteria:

* Surgery without access simultaneously to the two arms
* Emergency surgery
* Rapid sequence induction
* Usage of an other curare than ATRACURIUM
* Contraindication on ATRACURIUM usage
* Patient with pace maker
* Patient with Arné score \> or = to 11
* Patient without social security coverage
* Pregnant of breastfeeding women
* Patient under social protection
Intraoperative Use of the BP Device for Detecting Positive Margins During Lumpectomy Procedure

This protocol was designed for testing the intraoperative use of the Dune device. This multicenter study will take place in Israel at 12 sites.

Use of the device will take place during a partial mastectomy procedure (lumpectomy).The patient will be randomized to enter the device or control arm.

Eligibility Criteria:
Inclusion criteria

1. Women diagnosed with carcinoma of the breast
2. Undergoing lumpectomy (local wide excision) procedure.
3. Over 18 years of age
4. Signed ICF

Exclusion criteria

1. Neoadjuvant systemic therapy
2. Previous radiation in the operated breast
3. Prior surgical procedure in the same quadrant
4. Implants in the operated breast
5. Pregnancy
6. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
COVID-19 Vaccines and the Development of New LUTS

This study was conducted to check whether coronavirus disease 2019 (COVID) vaccines have a relationship with LUTS or not in a healthy and mostly medically free population.


Eligibility Criteria:
Inclusion Criteria:

1. Medical Student
2. Having had a COVID-19 Vaccine

Exclusion Criteria:

None
Efficacy of Rapamycin in the Treatment of Cervico-facial Lymphatic Malformations

To evaluate the efficacy of Rapamycin in extended cervicofacial lymphatic malformations in pediatric patients. Rapamycin is administered oral for a 6 month period.

The success rate is determined by volume reduction superior to 1/5e of the initial volume measured by MRI, impact on QOL and reduction of bleeding in case of mucosal involvement.


Eligibility Criteria:
Inclusion Criteria:

* Patient from 0 to 18 years of age, presenting with poly-cystic suprahyoid or mediastinal lymphatic.
* with chronic pain or functional respiratory or swallowing impairment with a CDS score \< 8
* Curative treatment is not possible or associated with a high risk of morbidity ,mortality and functional and cosmetic impairment
* Karnofsky Score (\> 10 years of age) or Lansky score (≤10 years of age) \> 50%
* Biology

  * Neutrophils count≥1.0 x 109/L
  * Platelets count ≥ 100 x 109/L
  * Hemoglobin ≥ 8 g/dL
  * Bilirubin ≤ 1,5 ULN
  * Transaminases \< 2,5 ULN
  * Serum albumin ≥ 2 g/dL.
  * LDL cholesterol \<160 mg/dL
  * Triglycerides \< 150 mg/dL
* Negative test of pregnancy if relevant
* Social security affiliation
* At least 2 months after a previous procedure on the malformation

Exclusion Criteria:

* Non-respect of inclusion criteria
* Other immunosuppressive therapy or long-term general corticosteroid therapy without a 28-day washout period
* renal failure
* Liver failure
* Digestive disease leading to rapamycin malabsorption
* uncontrolled or severe infectious disease
* Patients requiring treatment interfering with CYP3A4 isoenzyme (rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin) or inhibiting CYP3A4 isoenzyme's activity (ketoconazole, voriconazole, itraconazole, telithromycin, clarithromycin, Diltiazem, Verapamil, nicardipine, clotrimazole, fluconazole , troleandomycin, bromocriptine, cimetidine, danazol, protease inhibitors) -patients requiring treatment by cisapride and metoclopramide
* Concomitant administration of mTOR inhibitor
* Peanuts or soya allergy
* Impossibility to receive informed consent
* Absence of social security affiliation
* refusal to sign consent
* Ongoing pregnancy or breastfeeding
* refusal to participate
Ablation of Oligometastasis Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma

Ablation has been an effective approach for treating intrathoracic metastases. However, for hepatocellular carcinoma with oligometastasis, ablation of metastases remains relatively unexplored.

Systemic therapy is the standard treatment for advanced hepatocellular carcinoma (HCC) with metastasis. However, metastases with limited number (oligometastasis) can represent a subtype and transition point between localized disease and widespread metastases. Thus, eliminating metastases could be advantageous and beneficial to the prognosis if feasible and permitted. Image-guided ablation therapy, such as microwave ablation (MWA), radiofrequency ablation (RFA), and cryoablation, has attracted great interest as a minimally invasive approach against intrathoracic metastases. Recently, ablation has been used on patients with pulmonary metastases from various cancers. This technique yields high proportions of sustained complete responses and is associated with relatively low morbidity. Thus, we conduct this multicenter single arm study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with metastases-directed ablation in advanced HCC. This study focuses on the management of ablation of oligometastasis therapy combined with lenvatinib and PD-1 inhibitor. This study aims to evaluate the survival benefits of ablating oligometastasis for advanced HCC.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases 20;
2. presence of oligometastasis, the metastases found within three month of HCC diagnosis;
3. metastases with limited five sites and no more two organs involved, with a maximum diameter of ≤5cm;
4. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy for a minimum of 3 months before study ablation, with controlled intrahepatic tumors and no progression of metastases. Controlled intrahepatic tumors were defined as those showing a partial or stable response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST);
5. undergone locoregional treatments, including transarterial artery chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC);
6. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
7. no history of other malignancies.
8. life expectancy more than 3 months;
9. agreed to participated in this clinical trial;
10. Hemameba ≥3.0 x109/L, neutrophil ≥1.5x109/L, hemoglobin≥10.0 g/L, platelet≥100x 109/L, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml/min.

Exclusion Criteria:

1. recurrent HCC;
2. advanced HCC Lenvatinib and PD-1 inhibitor treated with as second systemic therapy;
3. age \< 18 years or \> 75 years;
4. advanced HCC with more than five metastases;
5. no response to Lenvatinib;
6. metastases size \> 5 cm;
7. life expectancy less than 3 months.
Maxillary Sinus Floor Elevation Using DENSAH Burs Versus Summers Osteotomes

To investigate the efficacy of osseodensification drills (Densah bure) as a new closed sinus lift tool and to compare the effect of it in bone gaine versus traditional osteotomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤8 mm length implants.
* both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Sinus pathology.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems.
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
MRI Guided Transrectal Prostate Laser Ablation for Benign Prostatic Hypertrophy (BPH)

Over 100,000 BPH procedures are performed annually in the US. The purpose of this study is to evaluate the effectiveness of performing MRI guided transrectal laser ablation using a 980 nm laser (VisualaseTM by Medtronic, Inc., a Minnesota, U.S.A. company) to treat benign prostatic hypertrophy (BPH). The laser system will be used to necrotize urological soft tissue within the prostate under MRI guidance. This will be a single center, single arm prospective trial with an anticipated enrollment of 10 men. Patients who elect this treatment option and choose to be part of the study will be enrolled consecutively.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of lower urinary track symptoms (LUTS).
2. Prostate volume of 40 - 200 cc.
3. Men ≥ 45 years old.
4. IPSS ≥ 15.
5. BPH Impact Index ≥ 5.

Exclusion Criteria:

1. History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, or findings suggestive of likely underlying prostate cancer.
2. Need to catheterize to relieve obstruction.
3. Daily use of incontinence materials/padding.
4. Neurogenic or hypotonic bladder, Parkinson's Disease, or a history of uncontrolled diabetes.
5. Prior interventional or surgical treatment of BPH.
6. Penile prosthesis.
7. Artificial urinary sphincter or collagen bladder injection.
8. Urethral stricture.
9. Bleeding disorder/coagulopathy.
10. Inability to refrain from blood thinners in the peri-procedural period.
11. Inability or chooses not to provide informed consent.
12. Any serious medical condition which would make proceeding to treatment unsafe.
13. Significant contraindication to MRI or gadolinium contrast.
14. Hip replacement.
15. Lack of a rectum.
16. Life expectancy of less than two years.
17. Unable or unwilling to complete all required questionnaires and follow-up assessments.