cyrilzakka/clinical-trials huggingface dataset:
Racz Catheter Technique Versus Conventional Technique in Lumbar Epidural Steroid Injection for Management of Low Back Pain

The aim of this study is to compare Racz catheter technique and conventional technique in lumbar epidural steroid injection for the management of low back pain.

Low back pain (LBP) is defined as a localized discomfort sensation below the costal margin and above the inferior gluteal folds, with or without leg pain. Conservative treatment for LBP is focused on delaying or preventing the need for surgery. Indeed, LBP can improve spontaneously or with non-surgical treatment. However, cases that fail to improve with conservative management may need to be considered for a surgical approach.

The epidural injection is a well-founded anesthetic and analgesic technique; moreover, nowadays, new technological devices can help anesthesiologists to learn and to administer it. One of these devices is Racz catheter epidural adhesiolysis. Racz catheter epidural adhesiolysis treatment addresses two issues, the injectate always reaches the area being targeted also the injections are likely to loosen fibrotic adhesions which may be the main cause of the pain in some cases.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* Patients suffering from persistent lumbar pain, grade 1 spondylolisthesis, facet osteoarthropathy, and small disc on radiological findings.

Exclusion Criteria:

* Uncooperative patients.
* Contraindications to perform the proper technique e.g., coagulopathy and skin infection.
* History of allergy to contrast medium.
* Rupture disc.
* Lumbar canal stenosis.
* Previously operated traditional spine surgeries.
Continuous Finger-cuff Arterial Pressure Monitoring and Intraoperative Hypotension During Non-cardiac Surgery: the Randomized DETECT II Trial

This is a randomized trial (1) investigating whether continuous finger-cuff - compared to intermittent oscillometric - arterial pressure monitoring reduces the amount of intraoperative hypotension (specifically, from the start of induction of general anesthesia until the end of surgery) in low-to-moderate risk patients having elective non-cardiac surgery.

not provided

Eligibility Criteria:
We will include three types of patients:

1. Patients scheduled for ambulatory (outpatient) elective non-cardiac surgery expected to last ≥30 minutes
2. Low-risk patients (ASA I+II) having inpatient elective non-cardiac surgery expected to last ≥60 minutes
3. Moderate-risk patients (ASA III) having inpatient elective non-cardiac surgery expected to last ≥60 minutes

We will only include patients who are 18 years or older; who will have general anesthesia; and in whom intermittent arterial pressure monitoring with upper-arm cuff oscillometry is planned.

Patients that meet one or more of the following exclusion criteria cannot participate in the trial:

* Emergency surgery
* Patients on renal replacement therapy
* Contraindications for finger-cuff monitoring (e.g., Raynaud disease)
Use of Hextend in Trauma

This is a chart review of all trauma patients during the specified time period. The purpose of this study is to examine the effects of resuscitation with hextend after trauma, in the adult population. The authors hypothesize that when compared to patients resuscitated with standard of care, resuscitation with Hextend will result in a mortality difference.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the trauma center

Exclusion Criteria:

* Pregnant women, children, psychiatric patients and prisoners.
Surgical Versus Nonsurgical Treatment of Fibular Fractures: A Prospective Randomized Study

Isolated surgical repair of the inside portion of the tibia may be enough to stabilize an ankle fracture in which both the tibia and the fibula are broken. This would alleviate the need for another incision, plate, and screws to repair the fibula. The purpose of this study is to help determine if surgically repairing only the tibia fracture will lead to equivalent clinical outcomes when compared with surgical repair of both bones.

The hypothesis of this study is that operative stabilization of the medial malleolus fracture only, in otherwise ligamentously stable bimalleolar and/or trimalleolar fractures of the ankle, will lead to equivalent clinical outcomes and functional scores as those treated with operative stabilization of both malleoli and/or all malleoli.


Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patients ≥ 18 years of age with acute, closed bimalleolar and/or trimalleolar ankle fractures
* Operative fixation of the ankle fracture is within 3 weeks from date of injury
* Bimalleolar and/or trimalleolar ankle fractures in which the medial malleolus fragment is greater than 1.7cm wide on lateral x-ray imaging
* Bimalleolar and/or trimalleolar ankle fractures in which the posterior malleolus fragment is less than 20% of the depth of the tibial articular surface

Exclusion Criteria:

* Skeletally immature patients \< 18 years of age
* Single malleolar ankle fractures
* Open fractures
* Operative fixation of the ankle fracture is more than 3 weeks from date of injury
* Bimalleolar and/or trimalleolar fractures in which the medial malleolar fragment is less than or equal to 1.7cm wide on lateral x-ray imaging
* Bimalleolar and/or trimalleolar ankle fractures in which the posterior malleolus fragment is greater than or equal to 20% of the depth of the tibial articular surface
* Ankles with previous fractures of the medial and/or lateral malleolus requiring operative intervention
Study to Assess the Performance of MagnEtOs Flex Matrix Compared to Cellular Allograft

The purpose of this study is to demonstrate the performance of MagnetOs Flex Matrix in patients with leg pain and/or back pain.

This is a prospective, randomized, multi-center study that intends to demonstrate the performance of MagnetOs Flex Matrix compared to Cellular Allograft in patients with leg pain and/or back pain requiring up to four-level instrumented PLF surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is able to read/be read, understand, and provide written informed consent and has signed the IRB approved informed consent.
2. Male or female patient ≥ 18 years old.
3. Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1).
4. Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.

Exclusion Criteria:

1. Requires greater than four-level fusion or expected to need secondary intervention within one year following surgery.
2. Had prior PLF fusion or attempted PLF fusion at the involved levels.
3. Had previous decompression at the involved levels.
4. Women who are or intend to become pregnant within the next 12 months.
5. To treat conditions in which general bone grafting is not advisable.
6. In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible).
7. In case of significant vascular impairment proximal to the graft site.
8. In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
9. In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
10. When intraoperative soft tissue coverage is not planned or possible.
11. Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
12. Receiving treatment with medication interfering with calcium metabolism.
13. Has leg pain, and/or back pain related to benign or malignant tumor.
14. Has history or presence of active malignancy.
15. Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
16. Is involved in active litigation relating to his/her spinal condition.
17. Has participated in an investigational study within 30 days prior to surgery for study devices
A Phase I, Multicenter Dose Escalation Study in Patients With Hairy Cell Leukemia

A dose-escalation study to identify the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), defined as the highest dose that can safely be given to a participant and establish the safest dose based on the highest tolerated dose for clinical testing.

A Phase 1, multicenter, dose escalation study of moxetumomab pasudotox (CAT-8015) in participants with relapsed or refractory hairy cell leukemia (HCL) to estimate the MTD, defined as the highest dose that can be safely administered to a patient, and to establish a safe dose, based on the MTD, for subsequent clinical testing (Phase 2 recommended dose).

Eligibility Criteria:
Inclusion Criteria: Confirmed diagnosis of HCL, Measurable disease, Participant's must have had at least 2 prior systemic therapies. There must have been at least 2 prior courses of purine analog, or 1 if the response to this course lasted less than (\<) 2 years, or if the participant had unacceptable toxicity to purine analog, Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, Participant's with other cancers who meet eligibility criteria and have less than 5 years of disease free survival will be considered on a case-by-case basis, Life expectancy of greater than 6 months, as assessed by principal investigator, Must be able to understand and sign informed consent, Must be at least 18 years old, Female and male participants must agree to use an approved method of contraception during the study.

Exclusion Criteria: - History of allogeneic bone marrow transplant, Documented and ongoing central nervous system involvement with their malignant disease (history of central nervous system (CNS) involvement is not an exclusion criteria), Pregnant or breast-feeding females, HIV positive serology (due to increased risk of severe infection and unknown interaction of CAT-8015 with antiretroviral drugs, Hepatitis B surface antigen positive. - Hepatic function: Serum transaminases (either alanine transaminase (ALT) or aspartate transaminase (AST)) or bilirubin: greater than or equal to (\>=) Grade 2, unless bilirubin is due to Gilbert's disease. -Renal function: Serum creatinine clearance less than or equal to (\<=) 60 millilitre per minute (mL/min) as estimated by Cockroft-Gault formula. -Hematologic function: The absolute neutrophil count (ANC) \< 1000/ cubic millimetres (cmm), or platelet count \<50,000/cmm, if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy). -Pulmonary function: Participant's with \< 50% of predicted forced expiratory volume (FEV1) or \<50% of predicted diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin concentration and alveolar volume. Uncontrolled pulmonary infection, presence of pulmonary edema, Oxygen saturation at rest \< 88% measured by pulse oximetry or partial pressure of oxygen (PaO2) \< 55 millimetre(s) of mercury (mm Hg), Serum albumin \< 2 g/dL, Radioimmunotherapy within 2 years prior to enrollment in study.
Breath Analysis in Children by New Point-of-care Instruments

In this study new hand-held devices for measuring exhaled breath will be tested in children with asthma, CF, and healthy controls. Main objectives will be feasibility and discriminative value of these techniques.

Rationale: Assessment of volatile organic compounds (VOCs) is a new recently developed non-invasive technique to assess airway inflammation. The non-invasive character makes it highly suitable for use in (preschool) children. However, the analysis of VOCs by gas chromatography mass spectrometry technique (GC-MS), the gold standard, is expensive and time consuming. Therefore, new hand-held devices (such as electronic Noses (eNoses) and Ion Mobility Spectrometer techniques) have been developed. However, these new point-of-care instruments have not been studied in children.

Objectives: 1) To test whether new point-of-care instruments for the measurement of VOCs in exhaled breath are feasible for use in children aged 6 to 16 years; 2) To explore whether these techniques can differentiate between healthy children, asthmatic children and children with Cystic Fibrosis (CF).

Study design: Cross-sectional study design. Several VOCs tests will be performed in all participants.Besides, fraction of exhaled nitric oxide (FeNO) and inflammatory markers in exhaled breath condensate (EBC) will be measured.

Study population: Three groups of children aged 6 to 16 years: 20 healthy children, 20 children with doctor's diagnosed asthma, 20 children with CF.

Main study parameters/endpoints: Each technique will be evaluated for its use and feasibility in children. For each technique, VOC profiles between study groups will be evaluated for its discriminative power.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 to 16 years
* Healthy group: See exclusion criteria
* Asthma group: Doctor's diagnosed asthma
* Cystic Fibrosis group: A diagnosis of cystic fibrosis, confirmed by a sweat test or genetic analysis

Exclusion criteria

* Recent course of prednisone or antibiotics (\< 1 month before test)
* Passive smoking
* Other chronic inflammatory disease (e.g. inflammatory bowel disease, rheumatic disease, auto-immune disease)
* Healthy children:

  * No current or history of respiratory symptoms
  * No current or history of allergic rhinitis
Grazoprevir and Elbasvir Without Ribavirin for 12 Weeks in Patients With HCV-related Cryoglobulinemic Nephropathy

CryoKid is a no-profit, multi-center, single-arm, open-label, pilot study. The study aims to evaluate the tolerability of MK-8742 (Elbasvir) / MK-5172 (Grazoprevir) administrated for 12 weeks without Ribavirin in patients with HCV chronic hepatitis (G1b and G4) and cryoglobulinemic nephropathy.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent form signed,
2. Male or female at least 18 years of age at time of Screening.
3. Chronic infection with Hepatitis C virus G1b
4. Chronic infection with Hepatitis C virus G4 naïve, and experienced with baseline HCV RNA level \<800,000 IU/ml
5. Metavir score ranging between F0-F4 (with Child-Pugh score ranging from A5 to A6)
6. Diagnosis of mixed cryoglobulinemia MC (type III or II) according to standard criteria
7. Chronic renal impairment due to cryoglobulinemic nephropathy. Subjects with renal impairment will include CKD Stage 5 (eGFR \< 15mL/min or dialysis dependent), CKD Stage 4 (eGFR 15-29 mL/min), CKD Stage 3 eGFR (30-59 mL/min) and CKD Stage 2 (60-89 mL/min) HCV patients.
8. Albumin level ≥ 3.0 g/dl,
9. Platelet count ≥ 75 x 103/μL.

Exclusion Criteria:

1. Age \<18 years
2. Chronic infection with Hepatitis C virus G4 experienced with baseline HCV RNA level \>800,000 IU/ml
3. Patients with HCV genotype 1a, 2, 3, 5, 6,
4. Coexistence of life-threatening condition(s) unrelated to MC
5. Diagnosis of malignancy
6. Pregnancy or breast feeding.
7. Child-Pugh score \> A6
8. Decompensated cirrhosis or previous decompensation
9. Platelet count \< 75 x 103/μL
10. Albumin level \< 3 g/l
11. Co-infection with more than one HCV genotype.
12. Any serious or active medical illness which, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance
13. HIV or chronic hepatitis B virus (HBV) infection (HBsAg positive)
14. Known hypersensitivity to Grazoprevir, Elbasvir or any of its components
Safety and Efficacy of OCL 503 in Prostate Artery Embolization

This is a prospective, pilot, open-label, uncontrolled, non-randomized safety and effectiveness study of OCL 503 in men with BPH.

Prior to entering the study, all patients will undergo pre-study assessments including compliance with inclusion and exclusion criteria, laboratory assessments, IPSS, uroflowmetry, IIEF, and MRI pelvic imaging. Following conventional catheter angiography with cone-beam CT to confirm catheter placement and prostatic vasculature, each patient will undergo transarterial embolization with OCL 503. OCL 503 will be administered intra-arterially via microcatheter until there is stasis of blood flow.

Patient assessments include blood work, IPSS, uroflowmetry, IIEF, MRI and patient interviews conducted at 3 months, 6 months, and 12 months post embolization.

Eligibility Criteria:
Inclusion Criteria:

* Patient has received a diagnosis of BPH with moderate to severe LUTS, as determined by IPSS
* Patient is greater than 50 years of age
* Patient has had a pelvic examination within the past 6 months
* Patient has been refractory to medical therapy for the last 6 months, or has refused medical therapy
* Patient has a Qmax below 15 mL/s or acute urinary retention
* Prostate is larger than 40 cubic centimetres
* Patient is willing and able to provide written, informed consent

Exclusion Criteria:

* Known malignancy
* Serum PSA \> 10 ng/mL at screening
* Advanced atherosclerosis and tortuosity of the iliac arteries
* Prior transurethral resection of the prostate (TURP)
* Post void retention (PVR) \> 250 mL
* Chronic use of metronidizole
* Phytotherapy for BPH within last two weeks of screening visit
* Secondary renal insufficiency due to prostatic obstruction
* Chronic renal failure (GSR \< 60)
* Large bladder diverticula or bladder stones
* Claustrophobia or other contraindications related to performing MRI
* Compromised hematopoietic function
* Anaphylactic reaction to drug or anesthetic, allergic reaction to iodine or contrast media
* Investigational drug or experimental therapy in the past 4 weeks
* Abnormal coagulation profile
* Allergy to bovine collagen
The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients

The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1 and ICAM-1 in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and hsCRP of migraine patients.

The aim of this study is to determine the effects of omega 3 fatty acid, curcumin and their combination or placebo for 2 months on the gene expression of cyclooxygenase-2 (COX-2), inducible nitric oxide synthase (iNOS), Tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), interleukin-6 (IL-6), vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1) in the peripheral blood mononuclear cell (PBMC) and serum levels of COX-2, iNOS, TNF-α, IL-1β, IL-6, VCAM-1, ICAM-1 and high-sensitivity C-reactive protein (hsCRP) of migraine patients.

In this randomized, double-blind clinical trial, placebo-controlled study, 80 women and men with migraine are enrolled from the Iranian Center of Neurological Research. At the start of study, all participants will sign informed consent and complete a general information form. 24-hour food recall for 3 days will be taken from the patients at the beginning and the end of the study. Selected samples by using stratified randomization method based on sex, gender and body mass index (BMI) are classified into 4 groups: 1) receiving omega 3 fatty acid supplement and curcumin supplement 2) receiving omega 3 fatty acid supplement and curcumin placebo 3) receiving curcumin supplement and omega 3 fatty acid placebo 4) receiving omega 3 fatty acid placebo and curcumin placebo.

The omega 3 fatty acid supplement group will receive 1200 mg Eicosapentaenoic acid (EPA) and 600 mg Docosahexaenoic acid (DHA) totally 1800 mg daily for 2 months. The curcumin supplement group will receive 1000 mg curcumin daily for 2 months. The omega 3 fatty acid placebo group will also receive placebo containing 1800 mg edible paraffin oil and curcumin placebo group will receive 1000 mg starch powder both similar in terms of color, shape and size. participants are advised to maintain their diet, level of physical activity and medication dose during the study. Blood samples will be collected after anthropometric parameter measuring then target biochemical parameters, gene expression and serum levels and physical activity will be measured before and after the trial.

Eligibility Criteria:
Inclusion Criteria:

* migraine patients 20- 50 years old
* body mass index more than 18.5
* avoidance of dietary supplements, vitamins and herbal products at least 4-6 weeks before and throughout the intervention
* willingness to participation

Exclusion Criteria:

* sensitivity to omega 3 fatty acid and curcumin
* pregnancy and lactation
* sever change in regular diet and life style
* change in type and dosage of regular medication (s)
* inflammatory disease which need take anti inflammatory drugs over than 2 weeks
Does Respiratory Physiotherapy Allow for Earlier Withdrawal of Mechanical Ventilation in Respiratory Resuscitation Service?

Respiratory physiotherapy is not routinely prescribed in the resuscitation department and few studies deal with this subject, especially in respiratory resuscitation


Eligibility Criteria:
Inclusion Criteria:

* Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult
* Major Patient over 18 years of age
* Patient affiliated to social security

Exclusion Criteria:

* Sedate
* With restrictive or tracheotomized syndrome
* With rib fractures
* Not able to benefit from physiotherapy within 3 hours after the start of the weaning protocol
* Refusal of patient or family
* Physiotherapy contraindications
* Patient under tutorship or curatorship
* Pregnant women
Validation of a Computerized Triage Algorithm for Ophthalmic Emergencies

The investigators conceived a computerized interactive tool for Emergency Triage, based on a patient's symptoms, medical history and background. Using this tool, the patient (alone or helped by a nurse / supporting person) presenting to an ophthalmologic ER, should be able to detect and prioritize his most urgent symptoms (A,B), in opposition to less urgent (C) or non urgent symptoms (D). To test the validity of this tool, each patient presenting at the Rothschild Foundation ER (Paris, France) with an ophthalmological problem should be included and sorted by the algorithm before the medical consultation. Neither the patient nor the practitioner are aware of the scoring (A,B,C,D) defined by the algorithm. The practitioner should then give his own emergency scoring (A,B,C,D) after patient examination. A total of 1000 patients is expected.


Eligibility Criteria:
Inclusion Criteria:

* Patients attending the Emergency Room for Ophthalmologic concerns

Exclusion Criteria:

-