cyrilzakka/clinical-trials huggingface dataset:
To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe

To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe


Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥40 years old.
2. Subject has radiographic evidence of mild-to-moderate OA (Kellgren Lawrence Scale grade II III) in one or both knees. Radiographs to be taken within 12 months prior to the Screening visit.
3. Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.

Exclusion Criteria:

1. Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.
2. Subject has a documented history of hypersensitivity to HA.
3. Subject has a documented infection or severe inflammation of the target knee joint.
4. Subject has a skin disease in the area of the injection site.
5. Subject has a clinically apparently tense effusion of the target knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
6. Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.
Network Analysis of Adult MDD and ADHD

The study is an investigation to determine co-morbid symptoms between adult major depressive disorder (MDD) and adult attention-deficit hyperactivity disorder (ADHD) using a novel statistical technique called network analysis.


Eligibility Criteria:
Inclusion Criteria:

* participants have a diagnosis of MDD or ADHD or both
* participants are competent to consent to the study
68Ga-NOTA-NFB: Radiation Dosimetry in Healthy Volunteers and Applications in Glioma Patients or Breast Cancer Patients

The purpose of this study is to assess the safety, biodistribution, dosimetric properties of the positron emission tomography (PET) radiopharmaceutical agent 68Ga-NOTA-NFB. To preliminarily evaluate its application in glioma diagnosis.

To assess the application of 68Ga-NOTA-NFB PET/CT in the evaluation of the neoadjuvant chemotherapy in patients with breast cancer before and after the therapy.

6 healthy volunteers with whole-body PET/CT scans 0, 0.5, 1.0, 2.0, and 3.0 hours after tracer injection (mean dose, 4.93 ± 0.10 mCi) will be performed. During the imaging period, 1 mL blood samples will be obtained specifically at 1, 3, 5, 10, 30,60, 90, 120, 150, and 180 minutes after the injection, for time-activity curve calculations. The estimated radiation doses will be calculated by using OLINDA/EXM software.

8-10 patients with glioma will be enrolled for the clinical study of diagnosing glioma, they will be performed with both 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before surgery. The preoperative images are compared and correlated with the pathologically report. Next, the expression of CXCR4 will be determined by immunohistochemical staining of the resected brain tumor tissues.

30 patients with breast cancer will be underwent 68Ga-NOTA-NFB PET/CT and18F-FDG PET/CT scans before and after the neoadjuvant chemotherapy. SUV of lesions before and after therapy will be contrasted.

Eligibility Criteria:
Inclusion Criteria:

* volunteers : healthy patients with glioma: diagnosed by MR and ready for surgery patients with breast: cancer appropritate of neoadjuvant chemotherapy.

Exclusion Criteria:

* patients with glioma: refuse or cannot endure surgery. patients with breast: refuse neoadjuvant chemotherapy.
Immediate Post-Operative Anesthesia With Either Lidocaine or Bupivacaine

Immediate post-suturing administration of either one of two dental anesthetic solutions or a placebo prior to dismissal.

This study seeks to evaluate the pain response following the administration of two anesthetic solutions just prior to patient dismissal from a surgical procedure: 2% Xylocaine with 1:100,000 epi and 0.5% Bupivicaine with 1:200,000 epi in comparison with 0.9% Normal Saline as a placebo. the study team will monitor pain response following these interventions at 4, 8, 12, 24, and 48 hours.

Eligibility Criteria:
Inclusion Criteria:

-Patients who have undergone a comprehensive periodontal evaluation and treatment plan not related to participation in this study and...

1. require flap surgery of 2 to 5 teeth in a continuous site (including flap debridement, flap osseous, extractions, and Guided Tissue Regeneration (GTR) procedures), and...
2. require IV sedation and local anesthesia or local anesthesia only...
3. in either the maxillary or mandibular arch.

Exclusion Criteria:

1. Pregnancy, or those planning to become pregnant
2. allergy or any medical issue using Lidocaine or Bupivacaine
3. inability to take non-steroidal anti-inflammatory drugs (NSAIDS) or acetaminophen
4. non-English speaking
5. not possessing an I-phone or Android device
6. patients requiring narcotic for IV sedation
7. patients requiring either IV or oral steroids during the perioperative period
Safety of the Herpes Zoster Subunit Vaccine in Lupus

This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. In addition, the investigators hypothesize that immunogenicity of the vaccine in SLE patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials.


Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female or male ≥18 years of age at the time of signing the informed consent
3. Meet the 2019 EULAR/ACR Classification Criteria for SLE
4. Female subjects must use 1 effective method of avoiding pregnancy, from the time they sign consent until end of the study period unless the subject is surgically sterile (e.g., bilateral oophorectomy or complete hysterectomy), has a sterile male partner, is at least 1 year postmenopausal, or practices sustained abstinence consistent with the subject's customary lifestyle. Postmenopausal is defined as at least 1 year since last menses and the subject has an elevated follicle-stimulating hormone (FSH) level greater than the threshold laboratory value of post-menopausal women at screening.

Exclusion Criteria:

1. Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or the Varicella-Zoster virus vaccine live (Zostavax)
2. Clinical HZ infection within 12 months prior to screening or during screening
3. Hybrid SLEDAI \>12 at screening visit
4. Presence of a mild, moderate, or severe flare per the rSFI at time of screenin
5. Increase in clinical SLEDAI parameters at time of enrollment relative to screening visit
6. Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within six weeks enrollment
7. Receipt of rituximab or cyclophosphamide within nine months of enrollment
8. Participation in an interventional clinical trial of SLE or other therapeutics within six months of enrollment
9. Moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of enrollment
10. Are pregnant, nursing, or planning a pregnancy while enrolled in the study
11. Known primary or secondary immunodeficiency (malignancy, HIV, common variable immune deficiency) or medications used during cancer chemotherapy
Prospective RCT on Post Prostatectomy Urine Leak

Objectives:

Primary: Comparison of proportion of patient achieving continence between the four arms at 6 months.

Secondary:

* Comparison of time to achieve continence between the four arms.
* Comparison of urinary symptoms and quality of life improvement between the four arms.
* Assessment of adverse events in Duloxetine arms.

Primary outcome/ time frame: Proportion of patient achieving continence at 6 months. Continence is defined as "using no pad"or "only security pad".

Secondary outcome:

* time to achieve continence
* Quality of life tested in relation to incontinence according to Visual Analog Scale (VAS) and King's Health Questionnaire (KQH).
* Urinary symptoms measured with International Prostate Symptom Score (IPSS).

No. of subjects entered: 300 patients informed and included, 240 patients will be randomized.

Statistical methods

* Proportion of patients who achieve continence and time to achieve continence will be compared between the four arms.
* Comparison of quality of life outcomes between the four arms
* Comparison of clinical variables that can affect the primary/secondary outcome - univariate and multivariate analysis (ITT).


Eligibility Criteria:
Inclusion Criteria:

1. All consecutive patients undergoing Robotic Assisted Radical Prostatectomy for clinically organ confined prostate cancer

Exclusion Criteria:

1. Prior urethral, bladder or prostate surgery
2. Pelvic radiotherapy.
3. Overactive bladder
4. Known neurological disease associated to LUTS
5. Hepatic impairment with hepatic insufficiency.
6. Severe renal impairment (creatinine clearance \< 30ml/min)
7. Hypersensitivity to duloxetine
8. Uncontrolled hypertension
9. Narrow angle glaucoma

   Post-operative criteria:
10. Post-void residual urine volume \> 100ml measured 15 days after the RARP
Quality of Life and Economic Repercussions of Combining Proactive Medication Assessment and Electronic Monitoring of Toxicities in Subjects Undergoing Oral Cancer Therapy

Therapies used to treat cancer are administered orally (OT) in 75% of cases, lending themselves to outpatient care. This care pathway raises new issues: specific toxicities, drug interactions, and the relationship between the community (physicians and pharmacists) and the hospital.

Drug interactions can increase toxicities or decrease the effectiveness of treatment and impact overall survival. Detection of drug interactions before treatment initiation is not always performed in routine practice. However, these oral treatments have a low therapeutic index and are associated with side effects that can alter quality of life (QoL). They are classically documented by the physician at the time of the consultation using the Common Terminology Criteria for Adverse Events (CTCAE), which makes it possible to adapt management. Nevertheless, numerous studies have shown a discrepancy between side effects reported by the patient versus those recorded by the physician, who tends to underestimate the intensity of the effects experienced by the patient.

Studies have shown an improvement in the overall survival and QoL of patients followed by electronic patient reported outcomes (ePRO) compared to patients followed conventionally.

Therefore, for this study, the study investigators aim to measure the impact of a care pathway associating a scheduled consultation with the hospital clinical pharmacist integrating a proactive medication assessment and the search for drug interactions and a follow-up of toxicities by ePROs on the QoL of patients treated with oral therapies in oncology and to estimate the economic impact.


Eligibility Criteria:
Inclusion Criteria:

* Patient starting oral therapy treatment in oncology for metastatic or locally advanced cancer
* Patient able to use a connected electronic object
* Patient with a smartphone/tablet or computer with internet access and an email address.
* Patient with WHO status ≤2
* Patients receiving other cancer therapy concurrently with oral therapy may be included
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Patient pregnant, parturient or breast feeding
* Illiterate patient
* Patients with poor prognosis due to a serious uncontrolled medical condition, mild systemic disease, uncontrolled infection (cardiac, pulmonary, renal, etc.)
* Patient receiving hormone therapy alone for breast or prostate cancer
Reconstruction of Ankle and Foot Defects

Reconstruction of soft tissue defects around the foot and ankle region is a challenging problem for reconstructive surgeons due to the lack of locally available tissues for transposition, the relatively poor skin circulation, and the special structural characteristics of this area, bones and tendons can easily become exposed due to trauma. so foot injuries are often associated with a loss of soft tissues and exposed bones . The plantar skin is thick, with solid anchorage to the deep structures. Therefore, the reconstructive aim is to restore the stability of the foot skin to adapt to weightbearing and to resist shearing forces. In addition, good sensibility should be considered in the reconstruction. Additional considerations the ankle region has great tension during movement, and good stability is required for shoes wearing. The medial plantar flap has been effectively used in the reconstruction of soft tissue defects localized to the plantar foot, forefoot, posterior heel, and ankle in small to medium sized defects . This flap can be transferred to the defect as a proximally or distally pedicled island flap . The distally based sural artery flap frequently used for reconstruction of soft tissue defects of the lower leg, foot and ankle in medium and large sized defects .Fascio-cutaneous flaps are highly effective and easy to perform.

This study is a comparative study designed for assessment of the clinical applications of distally based sural flap versus medial plantar artery flap regarding the size of the defect , operative technique and their outcomes (success and complications) as a reconstructive option for foot and ankle defects.


Eligibility Criteria:
Inclusion Criteria:

Patients aging 5 to 70 years. Defect at the foot and ankle. Defect size (5- 15) cm2.

Exclusion Criteria:

Severe infection. Unhealthy skin of posterior or lateral aspect of leg . Defect more than 15 cm . Injury to vascular pedicle of the aimed flap .
Does Glidescope Video Laryngoscope is Related to Less Hemodynamic Response?

Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or reduction of this increment is important for hemodynamic control. In this randomized single blind study, the aim of this study is to compare the hemodynamic responses of two different laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass surgery patients.

Laryngoscopy and endotracheal intubation causes significant hemodynamic response and thus presents an increased risk for patients undergoing cardiac bypass surgery. Prevention or reduction of this increment is important for hemodynamic control. In this randomized single blind study, the aim of this study is to compare the hemodynamic responses of two different laryngoscopy techniques with Glidescope and Macintosh laryngoscope in coronary cardiac bypass surgery patients. After induction with our institutional protocol for cardiac bypass surgery, hemodynamic data including heart rate, systolic and diastolic arterial pressure data will be recorded. Time for intubation, age, sex, ASA status data will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical Status 2-3
* Patients undergoing elective cardiac bypass surgery

Exclusion Criteria:

* Difficult intubation history
* Need for Rapid sequence intubation or alternative intubation method
* Emergency procedures
* Patients that have predictive factors for difficult intubation
* Patients with permanent pacemaker
Phase II Study of Calcitonin for Tumoral Calcinosis

OBJECTIVES: I. Determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis.

II. Determine whether calcitonin reduces or prevents tumor recurrence. III. Determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus.

IV. Determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.

PROTOCOL OUTLINE: Patients are treated with subcutaneous injections of salmon calcitonin every 3 weeks. Ondansetron premedication and intravenous hydration are also administered.

Patients are followed for disease progression and tumor recurrence.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically confirmed tumoral calcinosis --Prior/Concurrent Therapy-- Prior surgical resection of calcinotic lesion required
Natural Evolution of AV Conduction Disorders in Patients Implanted With Cardiac Pacemakers

Observational study to assess AV block incidence and their evolution according to paroxysmal atrial arrhythmia.


Eligibility Criteria:
Inclusion Criteria:

* Sinus Node Disease
* Brady-Tachy Syndrome
* Suspected or documented paroxysmal AVB

Exclusion Criteria:

* Permanent high degree AVB
* Contra indication to the SafeR pacing mode
* PR higher than 350 ms
Reinterpretation of CNV With Unknown Significance: a 5-year Retrospective Analysis

We aim to assess the usefulness of systematic reinterpretation of CNV of unknown significance. To investigate this question we will study all CNV of unknown significance detected between 2010 and 2017.

Array-CGH is a front-line technique in many genetic indications in both prenatal and postnatal settings. It allows the detection of chromosomal rearrangements (duplication or deletion for example) in routine. The interpretation and classification of these copy number variations or CNVs is essential but complex. It requires a systematic and methodical analysis of the variation in the context of the scientific literature. When these revisions do not meet either pathogenicity or benignity criteria, they are referred to as variation of unknown significance (or VUS). They account for a significant proportion of the revisions up to 75% (Palmer et al., 2013).

The detection of VUS does not, in most cases, allow for a diagnosis and often requires the use of other, costly techniques. The human impact may also be significant in the absence of possible genetic counselling (e.g. in the context of a future pregnancy). Reanalysis of an VUS is of major interest for at least two reasons : (1) the first, if it is classified as benign, makes it possible to close the investigation of the variant, to consider other leads without ulterior motives, and to reassure the patient about the absence of pathogenicity of the variant. (2) if the VUS is ultimately pathogenic, this makes it possible to name the disease for the patient, to specify genetic counselling, to avoid further long and costly investigation and possibly to propose treatment.

Currently, VUS can be reanalysed by the laboratory at the request of the prescribing physician or possibly another physician. However, no systematic reanalysis procedure is currently in place.

Although these variations of unknown meanings are frequent and represent an important issue, to our knowledge, no systematic database study has been carried out. Some similar work has nevertheless been carried out over a shorter period or on an ad hoc basis, showing an interest in this type of approach (Palmer et al., 2014).

Indeed, it seems essential to determine the interest of reanalysing such variations in several modes: diagnostic, economic and human.

Eligibility Criteria:
Inclusion Criteria:

* Signed consent for array-CGH (authorization for the conservation of a biological sample and its subsequent use to continue investigations);
* array-CGHcarried out at the genetics laboratory in Nancy between 1st January 2010 and 31th December 2017 (considering the date of validation of the report);
* Identification of variations of unknown clinical significance.

Exclusion Criteria:

* none
A Pilot Study to Explore the Role of Gut Flora in Psoriasis

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Psoriasis.

The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Psoriasis

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by patient
2. Male or female patients age 18 and older.
3. Diagnosis of Psoriasis based on PSAI of greater than or equal to 12 at screening

Exclusion Criteria:

1. Refusal by patient to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.

This study will test long acting mesalamine in the management of PI-IBS. It has the potential to improve QOL and perhaps gastrointestinal symptoms, in patients with PI-IBS. The results of this study, if positive, will provide preliminary data for a large scale clinical trial.

This study will also provide information about plasma cytokines in patients with PI-IBS and whether improvement in symptoms correlates with improvement in plasma cytokines.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria

1. Men and women age 18-75 years
2. Rome III criteria for IBS
3. Symptom onset after apparent acute gastroenteritis
4. Symptoms of 6 months or greater duration
5. Normal gross appearance of the colonic mucosa other than erythema
6. Negative markers for celiac disease and inflammatory bowel disease
7. Normal thyroid function and serum calcium
8. Stable medication regimens for other medical conditions.

Exclusion Criteria:

1. Age \<18 or \>75 years
2. Previous diagnosis of or history compatible with IBS
3. Constipation-predominant IBS.
4. Clinically significant chronic cardiac, pulmonary, hepatic, renal dysfunction or HIV
5. History of/or presence of malignancy
6. Current evidence of any gastrointestinal disorder such as celiac disease, inflammatory bowel disease, chronic pancreatitis, scleroderma, HIV, small bowel or colonic resection, paraplegia or quadriplegia. .
7. Current evidence of drug or alcohol abuse as judged by the investigator
8. Allergy to mesalamine or aspirin
9. Investigator perception of patient's inability to comply with the study protocol
10. Unstable psychiatric disease
11. Recent change in gastrointestinal medications