cyrilzakka/clinical-trials huggingface dataset:
Dose Escalation Study Assessing the Safety and Immune Response of PPV-06 Vaccine

PPV-06 immunotherapy targets interleukin-6 (IL-6), a key molecule of the immune system whose overproduction is implicated in many inflammatory and autoimmune diseases such as rheumatoid arthritis and osteoarthritis. The benefit of vaccination with PPV-06 is to induce, in response to immunizations, the production of antibodies directed against IL-6. The antibodies produced will neutralize the biological activity of IL-6 involved in the body's inflammatory process.

The primary objective is to evaluate the safety/tolerability of vaccination with PPV-06.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged over 40 years;
2. Diagnosis of primary inflammatory Knee Osteoarthritis (KOA),
3. Body mass index (BMI) of 18-32 kg/m2 at screening;
4. Patients with normal organ function at baseline
5. Contraceptives measures
6. In the investigator's opinion, the patient is capable and willing to comply with the requirements of the study;
7. Willing and able to sign a written informed consent;
8. Affiliated to social security insurance.

Exclusion Criteria:

1. Systemic Autoimmune or immunodeficiency disease;
2. Administration of non-steroidal anti-inflammatory drug (NSAID):
3. Administration of prednisone or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids;
4. Patients treated with biologics such as anti-TNFAlpha, anti-IL-6 and anti-CD-20
5. Participation in another investigational drug or vaccine trial;
6. Knee surgery planned before screening and throughout the study;
7. Knee surgery within the year of baseline;
8. Knee trauma within 2 months of baseline;
9. Chronic hepatitis B and/or C infection. Patients with previous infection, resolved in the past, are eligible;
10. HIV-positivity;
11. History of allergic reaction to any constituents of the study drug;
12. Diagnosis or history of any inflammatory arthritis;
13. Neurologic disorders involving the lower limbs;
14. History of malignancy within the last 5 years;
15. Uncontrolled congestive heart failure or hypertension, unstable heart disease
16. Evidence of any clinically significant abnormality on a chest X-ray which, in the opinion of the investigator, could represent active infection or latent tuberculosis;
17. Moderate or severe acute illness/infection, persistent diarrhea or vomiting on the day of vaccination;
18. Received any licensed, non-live vaccine within the 14 days before receipt of any dose of the study vaccine or is scheduled to receive any licensed, non-live vaccine within 30 days following receipt of any dose of the study vaccine;
19. Receipt of immune globulins, blood or blood-derived products;
20. Pregnant or lactating females;
21. The investigator considers the patient unfit for the study as a result of the medical interview, physical examination, or screening investigations.
Validation of Methods for Evaluating Operation Force, Motion and Visual Perception in Weightlessness

Previous studies have neglected two important aspects for the China National Space Administration. First, while biomechanical models are very sensitive to the characteristics of the subjects, data have been collected on subjects with biomechanical characteristics very different from those of "typical" Chinese astronauts. Second, pure video analysis techniques and kinematic data lack the necessary acceleration information important to understanding the forces exerted during movement and control of human motion. While some studies used force and moment sensors to aid in robot torque control and human joint work estimation, investigators are unaware of any studies performed in a microgravity environment that have combined the kinetic force and moment information with acceleration measurements to enable more reliable motion tracking without the need for acceleration estimation.

This is why MICR0-G sensors and accompanying kinematic video system have been developed in order to provide for detailed analyses of the astronaut movement control strategy (joint forces and torques, kinetic and acceleration measurements). Knowledge of the joint torques permits us to calculate the joint and musculoskeletal dynamics required to execute the microgravity motions, as well to provide insight into the altered movement strategies in reduced gravity as compared to 1-G locomotion.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese volunteers (men or women)
* Living in France and affiliated to a French Social Security system
* Aged from 22 to 45
* Body Mass Index from 19 to 25
* Who accepted to take part in the study
* Who has given their written stated consent
* Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection

Exclusion Criteria:

* Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
* Pregnant women
HAFAI Cohort 5 Year Follow up of Patients With Femoroacetabular Impingement Undergoing Hip Arthroscopy

Patients included in the HAFAI cohort will be invited for 5 year follow up.

Patients with femoroacetabular impingement will be investigated 5 years after surgery. We will used the Copenhagen Hip and Groin Score to evaluate pain, activities of daily living, sport, participation in sport and hip-related quality of life. Furthermore, degree of hip osteoarthritis will be evaluated using standing x-rays. Last, we will investigate number of re-operations and conversions to total hip replacement.

Eligibility Criteria:
Inclusion Criteria:

* Included in the HAFAI cohort

Exclusion Criteria:

* Non
PD-1 Knockout EBV-CTLs for Advanced Stage Epstein-Barr Virus (EBV) Associated Malignancies

This study will evaluate the safety of PD-1 knockout EBV-CTL cells in treating EBV (Epstein-Barr virus) positive advanced stage malignancies. Blood samples will also be collected for research purposes.

This is a study of CRISPR-Cas9 mediated PD-1 knockout-T cells from autologous origin. Patients are assigned to receive 4 circles of cell therapy. The safety and clinical response are evaluated. Biomarkers and immunological markers are also monitored.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically verified stage IV gastric carcinoma, nasopharyngeal carcinoma and lymphoma with measurable lesions (At least one measurable lesion or the immunotherapy)
* Pathologically verified as EBV positive malignancies
* Human leukocyte antigen (HLA) genotypes: HLA-A02, HLA-A24 or HLA-A11 genotypes
* Progressed after standard treatment or the patients refused to accept the standard treatment
* Performance score: 0-1
* Expected life span: \>= 3 months
* Toxicities from prior treatment has resolved. Washout period is 1 months
* Major organs function normally
* Women at pregnant ages should be under contraception
* Willing and able to provide informed consent

Exclusion Criteria:

* Patients with possible drug allergy of immunotherapy
* Patients with active bacterial or fungal infections
* Coagulopathy, or ongoing thrombolytics and/or anticoagulation
* Blood-borne infectious disease, e.g. hepatitis B, hepatitis C and HIV
* History of coronary artery disease, asthma, or vascular disease or other disease inappropriate for treatment deemed by treating physician
* With other tumors except for in situ cervical cancer, treated squamous cell carcinoma and bladder cancer (Ta and TIS) or other malignancies that have been treated with radical therapy (at least for 5 years before the enrollment)
* With other immune diseases, or chronic use of immunosuppressants or steroids
* Pregnant and lactating women
* Compliance cannot be expected
* Other conditions requiring exclusion deemed by physician
Vaginal Uphold Hysteropexy and Laparoscopic Sacral Hysteropexy for the Treatment of Uterovaginal Pelvic Organ Prolapse

The purpose of this study is to evaluate surgical success or failure one year after surgery for pelvic organ prolapse.

This will be a prospective parallel cohort study comparing a laparoscopic sacral hysteropexy (LSHP) to a vaginal Uphold hysteropexy (VUHP). Symptomatic and anatomic improvement of pelvic organ prolapse will be evaluated at 3 months and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Desires surgical treatment for uterovaginal prolapse.
* Symptomatic stage II-IV POP including:
* cystocele (AA or BA \> or = 0) by POP-Q and
* apical descent below the mid-vagina (point C \> -(TVL / 2)) by the POP-Q and
* a positive response to questions 3 of the PFDI 20: Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? (Appendix A)
* Eligible for and undergoing one of the following procedures: laparoscopic sacral hysteropexy (LSHP) or Vaginal Uphold hysteropexy (VUHP)
* Female age 40 to 75.
* Completed childbearing confirmed by subject or practicing reliable form of birth control defined as permanent sterilization, hormonal contraception, abstinence, IUD.
* Normal size uterus (length less than 10 cm) on bimanual exam or ultrasound within the past 6 months.

Exclusion Criteria:

* Prior hysterectomy.
* Patient with synthetic material placed to augment previous pelvic organ prolapse repair. (previous prolapse repair without synthetic mesh is acceptable).
* Current vaginal or pelvic foreign body complications (including but not limited to erosion, fistula, abscess). This includes foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
* Desires hysterectomy at the time of prolapse repair.
* Cervical elongation with anticipated need for cervical shortening at the time of prolapse repair as determined by surgeon.
* History of cervical dysplasia (diagnosed within the past 5 years) or increased risk of cervical dysplasia (HIV, immunocompromise, DES exposure), chronic pelvic pain, uterine abnormalities (symptomatic uterine fibroids, polyps, endometrial hyperplasia, cancer) or any uterine disease that would preclude prolapse repair with uterine preservation in the opinion of the surgeon.
* Any postmenopausal bleeding in the past 12 months (regardless of endometrial biopsy or ultrasound results) or any postmenopausal bleeding more than 12 months prior without adequate evaluation in the opinion of the investigator.
* Premenopausal women with menstrual issues including irregular bleeding, menorrhagia, dysmenorrhea,
* Pregnancy (confirmed before surgery with a pregnancy test).
Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients

In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This study was designed to evaluate short and long term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.


Eligibility Criteria:
Inclusion Criteria:

* Active disease, under octreotide treatment at least 9 months

Exclusion Criteria:

* Cabergoline allergy
A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis, documented by medical history and physical examination, is acute otitis media \<=1 week
* Clinical signs and symptoms include \>=1 of the following: ear pain; ear fullness, decreased hearing, or discharge from the external auditory canal (following acute perforation of the tympanic membrane).
* At least two of the following conditions are present in at least one ear: bulging tympanic membrane, which may have redness; loss of the normal light reflex and tympanic membrane landmarks and abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind it and edema of the tympanic membrane.
* Have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry.
* Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results

Exclusion Criteria:

* Previous enrollment in this study.
* Enrollment in any other investigational study using unapproved products or unapproved doses, including investigational vaccines in the previous four weeks prior to study start.
* Hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, other drugs, and/or sensitivity to multiple allergens.
* Presence of tympanostomy tubes or otitis externa at Evaluation 1.
* Systemic treatment with any anti-infective agent within 7 days (14 days for azithromycin) prior to Evaluation 1 or during the study.
* Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G benzathine) within 4 weeks prior to study drug administration.
* Concomitant infection, that requires additional antimicrobial therapy.
* Evidence of chronic, suppurative otitis media.
* Evidence of a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.
* Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.
* Known, severe renal impairment (i.e., creatinine clearance \< 30 mUmid1.73 m2).
* History of Augmentin-associated cholestatic jaundicehepatic dysfunction.
Impact of Personalized Feedback Alone on Substance Use Behaviors

The investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions for risky substance use behaviors by comparing a brief coach directed intervention to a tailored report only group.

Screening and brief intervention (SBIRT) generally involves universal screening for risky substance use behaviors in medical settings and the immediate provision of a 3-15 minute intervention to those found to be at risk. In this pilot study, the investigators seek to develop a more efficient and effective approach to providing brief behavioral health interventions in the field by comparing a brief coach directed intervention to a tailored report only group. The goal is to create a cost-effective and sustainable system that provides consumers with tailored information that will help them both initiate and sustain the lifestyle changes necessary for improving their overall health.

Hypothesis 1: In a medical setting, personalized feedback alone will be associated with a reduction in risky substance use behaviors.

Hypothesis 2: In a medical setting, personalized feedback alone will have the same impact on behavior as that information plus a brief coach education session on risky substance use behaviors..

Eligibility Criteria:
Inclusion Criteria:

* Low level risky substance use

Exclusion Criteria:

* high substance use risk levels
* potential alcohol or drug addiction or dependence
Ketoconazole Administration: How it is Affected by the Body and Broken Down and How it Acts on the Body When Used With Velcade

The purpose of this study is to investigate how ketoconazole (Nizoral) affects the pharmacokinetics (how the study drug is affected by the body and broken down) and pharmacodynamics (how the study drug acts on the body) of the active ingredient in the study drug Velcade (bortezomib).


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients 18 years of age or older, with a diagnosis of advanced solid tumor for which no curative or other treatment of higher priority is available
* Karnofsky Performance Status (KPS) equal to or greater than 70%
* Normal liver function tests (aspartate transaminase \[AST\] or alanine transaminase \[ALT\] equal to or less than 2 x upper limit of normal \[ULN\])
* Total bilirubin equal to or less than 1.5 x ULN
* Calculated creatinine clearance equal to or greater than 50 mL/min
* Normal serum calcium

Exclusion Criteria:

* Patients with significant cardiac disease
* Equal to or greater than Grade 2 neuropathy
* Active hepatitis
* HIV infection
* Secondary malignancy
* Transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment
* Patients taking concomitant medications having inhibitory or inducing activity for CYP 3A4
Results of the Use of Two Stentrievers Simultaneosly Compared With One as a Primary Treatment in Acute Ischemic Stroke

Several studies have demonstrated that simultaneous treatment with two stentrievers (STs) as rescue treatment is very effective, with high recanalization rates even in this group of patients where other revascularization techniques have failed. There has been no observed increase in hemorrhagic complications. Recently, a prospective study has been published where treatment with two ST has been shown to be effective and safe if used as a first-choice treatment (not as rescue) with a successful recanalization rate (eTICI 2c/3) after the first pass of 69%. These results have been reinforced after the publication of a randomized study that confirms, in vitro, the superiority of using two ST over one.

The use of a double stent retriever has been proposed as a safe and effective technique. The investigators hypothesized that the use of double stentriever primary could lead to higher first pass effect rates and better outcomes compared to single stentriever primary.

Our goal is to develop a research project to provide additional information on the potential benefits of the simultaneous double stent approach primarily in stroke patients receiving endovascular treatment.

A randomized study to compare the efficacy of double primary stentriever versus single primary stentriever.

Eligibility Criteria:
Inclusion Criteria:

* A new disabling focal neurological deficit compatible with acute cerebral ischemia.
* Any age. Informed consent obtained from the patient or representative.
* NIHSS score ≥ 6.
* Pre-existing functional clinical status less than or equal to 2 according to the mRS clinical scale.
* Maximum time of 24 hours from symptom onset to arterial puncture. • TICI 0-1 in the diagnosed TICA (terminal internal carotid artery) , MCA (middle cerebral artery), and BA( basilar artery confirmed by angioCT and angiography).
* ASPECTs score on baseline CT greater than or equal to 6.
* In cases where it is indicated, prior intravenous fibrinolysis will be administered according to the protocols of each center.

Exclusion Criteria:

* Those described in the usual protocols for mechanical thrombectomy of each hospital.
* Pre-existing functional clinical status greater than 2 according to the mRS clinical scale
* Patients with tandem lesions of dissection or arteriosclerotic origin located in the extracranial internal carotid artery.
* Initiation of treatment with a different technique than the one described.
* Inability to use a proximal balloon guide catheter.
* Use of aspiration catheter.
* Intracranial atherosclerotic plaque as the cause of occlusion.
* Advanced or terminal disease with a life expectancy of less than 6 months.
* Patient who is participating in another study that may affect this one.
* ASPECTS score less than or equal to 6 on baseline CT.
* Evidence of significant hemorrhage or mass effect with midline shift on baseline CT.
* Patients with occlusions in multiple vascular territories.
* Evidence of intracranial tumor (except for small meningiomas)
Acute Kidney Injury After Cardiac Surgery

PrimECC is a colloid priming solution for cardiopulmonary bypass/ extracorporeal circulation (ECC) based on Ringers Lactate, supplmeneted with Dextran 40 and Dextran 1. In a previous RCT comparing PrimECC with crystalloid priming fluid, patients in the PrimECC group experienced less hemolysis, less tubular cell injury and beneficial effect on the fluid balance. This study will investigate if, in a population at high risk of acute kidney injury (AKI), priming the ECC circuit with PrimECC instead of crystalloid solution will lead to a reduction of postoperative AKI. The hypothesis is that PrimECC, compared to crystalloid prime, will reduce postoperative AKI.

The study is a Swedish multicenter, double-blinded, randomized, controlled clinical trial. The trial will include 366 patients aged ≥18 years, scheduled for cardiac surgery with cardiopulmonary bypass, with an "Acute kidney injury risk score" ≥30% according to Birnie et al. (2014). The primary outcome of the study is the incidence of postoperative AKI of any stage according to the KDIGO creatinine criteria (serum-creatinine increase ≥ 27 μmol/l within 48 h or ≥ 50 % increase from baseline) within 96 hours after arrival to the ICU. Secondary outcomes are between-group differences in hemolysis, tubular cell injury (NAG-excretion), estimated GFR, and incidence of AKI of different stages according to the KDIGO creatinine criteria. In addition, differences in CNS (Tau, NFL, NSE, and S100B) and cardiac (TNT/TNI) injury markers will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Has signed and dated the EC approved informed consent
* Subject is ≥ 18 years of age
* Requires elective or urgent (non-emergency) cardiac procedure requiring the use of ECC.
* Preoperative "Acute kidney injury risk score" ≥30%, found at http://cardiacsurgeryleicester.com/our-research/acute-kidney-injury-risk-score-calculator/

Exclusion Criteria:

* Unable to give informed consent
* Known bleeding disorder
* Known intolerance or contraindication to dextran
* Acute Surgery (requires emergency cardiac procedure/surgery)
* Currently using an antithrombotic medication which has not been discontinued per institution protocol
* Malignancy; Surgery within 5 years or ongoing antitumoral treatment
* Has ongoing sepsis or endocarditis
* Requires pre-operative dialysis
Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder

This efficacy study compares an adjuvant specific psychotherapy and an active control intervention for Bipolar Disorder under mood stabilizer to prevent relapse an maintain remission. Patients should be in their early (18-30 yr.) phase of illness without having suffered of to many affective episodes (below 6), already. In addition, psychological, social, and neurobiological mediators and moderators well be identified.

There is still a lack of controlled outcome and follow-up studies about the role of adjuvant psychotherapy in Bipolar Disorder. By treating older subjects having suffered of multiple affective episodes, the potential benefit of psychotherapy to prevent relapse and help to adjust to this chronic illness might be underestimated. In addition, the investigators have no knowledge of mechanism (mediators) of positive changes by successful psychotherapy and of subjects with good outcome of adjuvant psychotherapy (moderators, indicators, predictors). Possible mediators and moderators can be sociodemographic, psychological (cognitive, interactional), and/or biological (neuronal, genetic). The planned study will address all three areas of questions. In a multi-center study, 300 younger subjects suffering of a Bipolar Disorder will be included and provide with one of two treatments in addition to stable medication. Moderators and mediators are selected on promising preliminary results and based on a psycho-biological understanding of Bipolar Disorder.

Eligibility Criteria:
Inclusion Criteria:

* Bipolar I and Bipolar II Disorder,
* 18 to 55 years of age,
* giving informed consent to assessment, treatment, and randomization,
* currently remitted (for at least 4 weeks) and taking medication,
* less than 6 previous affective episodes

Exclusion Criteria:

* currently symptomatic (depressed, manic, hypomanic),
* suicidal,
* not taking medication,
* schizo-affective, schizophrenic, borderline personality disorder,
* not giving or withdrawing consent