cyrilzakka/clinical-trials huggingface dataset:
Arthroscopic Diagnosis and Treatment of Dorsal Wrist Syndrome in Patients With Synovial Hypertrophy

The objective of the study is to evaluate de results of the arthroscopic diagnose and arthroscopic treatment of the dorsal wrist pain syndrome associated with dorsal synovial hypertrophy.

It is a prospective study of 25 consecutive patients with the diagnosis of dorsal wrist radiographies and MRI) have discarded other concomitant pathologies. After being refractory to the conservative measures consisting in physiotherapy for at least 3 months, a wrist arthroscopy will be performed with diagnostic and treatment objectives. All these procedures will be performed by the same surgical team. Only will be included those patients whose diagnostic arthroscopy show absence of other concomitant lesions as scapho-lunate or luno-triquetral tears, triangular fibrocartilage injuries, chondral injuries, fractures, arthritis or other injuries that will be considered as exclusion criteria. In those cases where a hypertrophy of the dorsal synovial is confirmed, an arthroscopic synovectomy and radiofrequency thermocoagulation of the hypertrophic synovial will be performed. The standard radiocarpal portals for wrist arthroscopy will be performed: 3-4 portal and 6-R portal.

The pain syndrome described as dorsal localized wrist pain, especially reproductible in hyperextension and axial load of the wrist and in whom the complementary tests (plain The following data will be reviewed and analyzed: age, sex, right/left wrist, right/left-handed, anamnesis, physical exam, MRI findings, arthroscopic diagnosis and functional outcome through Mayo score as a main viable and also, VAS(visual analogue scale for pain), DASH score, grip strength measured with jamar dynamometer and articular balance. All these parameters will be registered pre-surgery and post-surgery at 6 weeks, 3 months and 12 months of the follow-up and at the end of follow-up. The minimum follow-up will be at least of 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women
2. Age 18-65 years old, both included
3. Diagnose of primary dorsal wrist syndrome, defined as:

   3.1 Radiocarpal dorsal focal pain 3.2 Pain increases in hyperextension of the wrist and in axial load 3.3 X-rays and MRI without significant findings 3.4 Watson test, extension finger test, Kleinman shuck test, distal radio-ulnar ballottement test, fovea sign all of them negatives and absence of tenosynovitis of the extensor tendons.
4. Refractory to conservative treatment consisting in at least 3 months of physical therapy.
5. Presence of a hypertrophy of the dorsal synovial of the wrist diagnosed through direct visualization in wrist arthroscopy.
6. Other diagnoses excluded through wrist arthroscopy

Exclusion Criteria:

1. Hand or wrist fractures
2. Arthritis
3. Carpal boss
4. Scapho-lunate ligament tears
5. Luno-triquetral ligament tears
6. Triangular fibrocartilage tears
7. Bone necrosis
8. Systemic arthritis as rheumatoid arthritis, psoriasic arthritis, gouty arthritis, etc.)
9. Dorsal or volar ganglions
10. Distal radio-ulnar joint injury or instability
11. Hand or wrist infections or tumors
DCB Compared Stenting in Popliteal Lesions

This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Symptomatic peripheral artery disease:
* Moderate or severe claudication (Rutherford category 2 or 3)
* Critical limb ischemia (Rutherford category 4 or 5)
* Atherosclerotic popliteal artery disease (stenosis \> 50%)
* Patients with signed informed consent

Exclusion Criteria:

* Acute critical limb ischemia
* Severe critical limb ischemia (Rutherford category 6)
* Involvement of SFA disease with stenosis
* Continous total occlusion of all proximal infrapopliteal arteries (origin of the anterior tibial artery or tibioperoneal trunk).
* Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agent
* Age \> 80 years
* Severe hepatic dysfunction (\> 3 times normal reference values)
* Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
* LVEF \< 40% or clinically overt congestive heart failure
* Pregnant women or women with potential childbearing
* Life expectancy \<1 year due to comorbidity
* Previous bypass surgery or stenting for the target popliteal artery
* Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)
PBP vs Traditional Training: the T-REC Trial

This randomized controlled trial aims to compare the effectiveness of traditional training approach to training with the proficiency-based progression (PBP) approach for teaching the technical skills (TS) and non-technical skills (NTS) for surgeons in the context of an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery.

In a prospective, randomized and blinded study surgical residents (n = 48) from Belgium university (i.e. the Katholieke Universiteit \[KU\] Leuven and University of Gent residency training programs) will be enrolled and randomized to Traditional type training proficiency-based progression (PBP) training to learn how to perform an emergency scenario where open conversion is necessary due to vessel injury during robotic surgery on a dry lab model. Specifically, this study will include four independent arms, each employing different training methodologies for technical skills (TS) and non-technical skills (NTS).

Group 1 will receive standard training for both TS and NTS. Group 2 will receive PBP training for TS and standard training for NTS. Group 3 will receive standard training for TS and PBP training for NTS. Group 4 will receive PBP training for both TS and NTS.

All four group will receive the same e-learning on TS and NTS (on an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery on a dry lab model). The PBP trained group will however be required to demonstrate quantitively defined proficiency benchmarks for training progression (i.e., for the e-learning, TS and NTS). The Traditional trained group will train in the same laboratory for a case-matched period of time as the PBP group, with the same level of supervising faculty proctors and using the same training resources but with no proficiency benchmarks.

Investigators will be trained in pairs to assess performance from a pre-defined set of explicitly defined binary metric events reliably (inter-rater reliability \> 0.8). They will also be blinded as to the identity of the trainee performing the procedure, how they were trained (i.e., group) and procedure order.

H1 It is hypothesized that implementation of PBP training in teaching TS and NTS for surgeons in the context of an emergency scenario where (simulated) open conversion is necessary due to vessel injury during robotic surgery, leads to better surgical training outcomes (i.e., lower number of performance errors) when compared to traditional training.

Eligibility Criteria:
Inclusion Criteria:

* recently accepted, form first to last year residents' gynecology and obstetrics, urology and general surgery.
* Ability to perform a laparotomy

Exclusion Criteria:

* Any robotic experience with emergency undocking.
REKinDLE: Registry With Enbrel® or Kineret® in a Database Using Longitudinal Evaluations

The purpose of this study is to determine if Enbrel® or Kineret® will have a positive effect on subject functionality as measured by the Health Assessment Questionnaire Disability Index (HAQDI).


Eligibility Criteria:
Inclusion Criteria: - Subjects with active rheumatoid arthritis as defined by ACR criteria - Able to start Enbrel® or Kineret® therapy (per the approved product monographs) within approximately 30 days of confirmed enrolment Exclusion Criteria: - Active infections at the time of initiating Enbrel® or Kineret® therapy - Malignancy other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years - Known hypersensitivity to E. coli derived products - Known hypersensitivity to Enbrel® or any of its components - Subjects receiving, or who received:\* Enbrel® in the previous 30 days; \* Remicade® in the previous 3 months; \* Humira® in the previous 3 months; \* Kineret® in the previous 15 days. - Subjects beginning Enbrel® therapy, or treated with prior or current treatment using Enbrel® - Subjects beginning Kineret® therapy, or treated with prior or current treatment using Kineret® - Treatment with any investigational therapy in the 30 days prior to enrolment confirmation - Presence of any significant and uncontrolled medical condition which, in the investigator's opinion, precludes the use of Enbrel® - Sepsis or at risk of septic syndrome
30-Day MoonBrew Sleep & Stress Study

This study aims to assess how consuming MoonBrew each evening for 30 days impacts sleep quality and stress levels. Poor sleep and high stress often go hand-in-hand, worsening overall health. By using validated self-reported outcome measures, this study bridges the gap between anecdotal evidence and scientific proof (without requiring a connected health device), contributing valuable insights into natural solutions for better sleep.

Poor sleep and high stress levels are pervasive issues affecting millions globally, leading to significant health problems. Research has consistently shown that poor sleep quality can exacerbate stress, while high stress levels can further disrupt sleep patterns. We have some great anecdotal evidence that suggests Moonbrew really works. This study aims to bridge the gap between anecdotal evidence and scientific evidence.

The aim of this study is to scientifically assess the impact of MoonBrew on sleep quality and stress levels using the PROMIS Sleep Disturbance Scale and NIH Toolbox® Item Bank v3.0 - Perceived Stress survey. Our objective is to determine whether regular consumption of MoonBrew can significantly improve sleep patterns and reduce stress over a 30-day period.

This study is significant as it seeks to provide scientific evidence on the efficacy of MoonBrew, a popular natural remedy, in enhancing sleep quality and reducing stress. Expected outcomes include improved sleep patterns and lower stress levels among participants. However, limitations include self-reported data and individual variations in response to MoonBrew. Nonetheless, the findings could pave the way for evidence-based recommendations and broader acceptance of natural sleep aids.

Eligibility Criteria:
Inclusion Criteria:

* US-based participants

Exclusion Criteria:

* allergies to mushrooms or adaptogens
Efficacy of Flomax to Improve Stone Passage Following Shock Wave Lithotripsy

The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.

Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old and above with urolithiasis scheduled for shock wave lithotripsy.

Exclusion Criteria:

* Contraindications to Flomax
* Patients with renal impairment (serum creatinine above 2.0)
* Patients with hepatic impairment (liver enzymes 2.5 times the upper limit of normal)
* Use of other oral alpha blockers
Impact of Early Enteral vs. Parenteral Nutrition on Preservation of Gut Mucosa Integrity in Patients Requiring Mechanical Ventilation and Catecholamine

To demonstrate that a strategy involving early first-line enteral nutrition is associated with improved preservation of gut mucosa integrity, as assessed based on the plasma citrulline level at H72, compared to a strategy involving early first-line parenteral nutrition

Published data suggest that enteral nutrition may be associated with improved preservation of the gut lymphoid tissues and gut immune function, as well as with decreased gut mucosa permeability, thereby diminishing the risk of organ failure. Citrulline is an amino acid produced from glutamine by small-bowel enterocytes. Plasma citrulline levels reflect functional enterocyte mass. Intestinal fatty acid-binding protein (I-FABP, also known as FABP2) is a small protein found in the cytosol of small-bowel enterocytes. Plasma I-FABP is normally undetectable and, when elevated, constitutes a reliable marker for enterocyte damage. The hypothesis underlying this ancillary study is that first-line enteral nutrition is associated with improved gut mucosa integrity and function compared to parenteral nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation expected to be required more than 48 hours
* Nutrition started within 24 hours after initiation of endotracheal mechanical ventilation
* Treatment with vasoactive drug administered via a central venous catheter
* Age over 18 years
* Signed information

Exclusion Criteria:

* Abdominal surgery within 1 month before inclusion
* History of esophageal, gastric, duodenal or pancreatic surgery
* Bleeding from the esophagus, stomach or bowel
* enteral nutrition via gastrostomy or jejunostomy
* pregnancy
* Treatment-limitation decisions
* Current inclusion in a trial on comparison between enteral and parenteral nutrition
Effect of Parenteral Iron Therapy on Inflammatory Response and Oxidative Stress Chronic Hemodialysis

Parenteral iron therapy is now commonly administered to dialysis patients with the majority of patients receiving this therapy as part of the treatment for their anemia. Although intravenous iron has improved clinical response to recombinant erythropoietin, there is a concern that iron therapy may have deleterious effects in Chronic Kidney Disease (CKD) patients. Iron can damage tissues by catalyzing the conversion of hydrogen peroxide to free-radical ions that attack cellular proteins, DNA and membranes as part of oxidative stress. Numerous in vitro studies have shown tissue toxicity from iron and increased infectious potential. Oxidative stress can also lead to activation of the systemic inflammatory response with the release of a number of key cytokines and growth factors. There is now a link between inflammation, oxidative stress and acceleration of vascular disease in both patients with normal as well as reduced renal function. In a study comparing normal versus low hematocrit levels in hemodialysis patients, mortality was higher in the normal hematocrit group. The major difference between the two groups has been attributed to the fact that patients in the normal hematocrit group received significantly more iron than the patients with low hematocrit. There was a 2.4 fold greater mortality rate in patients receiving parenteral iron.

The effect of parenteral iron administration on activation of the systemic inflammatory response in hemodialysis patients has not been evaluated. The purpose of this study is to measure a number of key cytokines, inflammatory and oxidative stress markers in hemodialysis patients receiving iron repletion therapy as part of their standard care.

Study Design

Patients who have been prescribed iron repletion therapy (100 mg IV every dialysis treatment for ten treatments) by their primary nephrologist will be recruited for the study. Baseline blood samples will be obtained before and after each dialysis treatment for two dialysis treatments prior to the administration of iron. On the day of dialysis that iron therapy is started, blood samples will be obtained before and after the dialysis treatment via the patient's vascular access. This procedure will be repeated each dialysis treatment for the ten sessions during which the patient is receiving intravenous iron. Subsequently, pre-dialysis blood samples will be obtained every week for four weeks after the administration of intravenous iron has been completed

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients age 18 or greater who are prescribed parenteral iron by their primary nephrologist
Organ Dysfunction Change in Acute Necrotizing Pancreatitis Patients With Sepsis After Open Necrosectomy

The purpose of this study is to characterize organ dysfunction change in acute necrotizing pancreatitis patients with sepsis after open necrosectomy.

Before surgery, study participants will be asked questions about age, gender, education level, etc. Study participants will also be questioned regarding pancreatic symptoms, as measured on the patient-Reported Outcome Scale in Acute Pancreatitis (including, pain, abdominal distention, eating, bowel movements, nausea and vomiting, thirst, and weakness). Organ dysfunction was defined according to the sequential organ failure assessment (SOFA) score. The SOFA score will be measured at preoperative (T1), postoperative day 1 (T2), postoperative day 3 (T3), postoperative day 7, or at hospital discharge, whichever comes first (T4). Following discharge from the hospital, study participants will be contacted at 1 month, 3 months, 6 months, and 1 year after surgery, and asked to complete a survey about their pancreatic symptoms and survival status after surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years or older
2. Diagnosis of Acute pancreatitis according to the revised Atlanta classification, requires two of the following three criteria: (A) typical abdominal pain, (B) an increase in serum amylase or lipase levels higher than three times the upper limit of normality, and (C) signs of AP in imaging
3. Patients with confirmed or suspected infected pancreatic or peripancreatic necrosis were scheduled for open necrosectomy
4. Meet Sepsis-3 criteria

Exclusion Criteria:

1. Patients refuse to participate
2. Patients undergo repeat surgery on the same site
Neuromuscular Block and Anesthetic Depth Monitoring

The purpose of this study is to evaluated whether the depth of neuromuscular block may affect the unicon value of anesthetic depth monitoring system (ADMS).


Eligibility Criteria:
Inclusion Criteria:

* Gall bladder disease
* American Society of Anesthesiologist physical status 1 or 2

Exclusion Criteria:

* Pregnancy
* Body mass index \< 16
* Body mass index \>30
* Neuromuscular disease
* Previous intraabdominal surgery
Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST

The goal of this Mesylate apatinib versus standard second-line TKI in the treatment of advanced gastrointestinal stromal tumors: a randomized, open, controlled, single-center clinical study is to explore the efficacy and safety of Apatinib compared with second-line treatment in advanced GIST patients with first-line TKI failure. The main questions it aims to answer are:

* To explore the efficacy and safety of Apatinib compared with standard second-line treatment for GIST with advanced first-line TKI failure.
* To explore the expression level and MVD value of VEGFR2 in GIST, and to explore the relationship between the expression level and the location, size, mitotic image and recurrence risk grading of GIST.

Patients with advanced GIST were randomly included in the trial group and the control group at a ratio of 1:1.

The objectives of this study were as follows:

1. To explore the efficacy and safety of Apatinib compared with standard second-line treatment of advanced GIST with first-line TKI failure, and to provide high-level clinical evidence for the treatment of late-stage plasmatoma;
2. Explore the expression level and MVD value of VEGFR2 in GIST, and explore the relationship between the expression level and the location, size, mitotic image and recurrence risk grading of GIST.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were enrolled voluntarily and signed a written informed consent with good compliance and follow-up;
2. Age ≥18 years (calculated on the date of signing the informed consent) for both men and women;
3. Previous first-line TKI (Imatinib/Avatinib) therapy and eventual treatment failure (disease progression or toxicity intolerance during treatment);
4. Subjects who provide pre-C-Kit /PDGFRA test reporting can provide 10ml blood sample and fresh or archived tumor tissue for genetic testing.
5. ECOG score: 0 \~ 1;
6. Predicted survival ≥12 weeks.

Exclusion Criteria:

1. Previous molecular targeted therapy other than imatinib/Avatinib for the treatment of gastrointestinal stromal tumor;
2. Toxicity of previous imatinib/Avatinib treatment or other treatments has not recovered or reached NCICTCAE5.0≤ level 1;
3. Patients with clinical symptoms of ascites or pleural effusion who need puncture drainage or who have received thoracic and ascites drainage within 1 month before signing informed consent, except those who only show a small amount of ascites or pleural effusion without clinical symptoms;
4. A second primary malignancy within the last 5 years, except for basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been adequately treated;
5. Gastrointestinal stromal tumor with central nervous system metastasis;
6. Inability to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting drug administration and absorption.
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04629991 in Healthy Volunteers

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.


Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking men and women
* body mass index 18-30 kg/m2

Exclusion Criteria:

* Women must not be able to have children
* no current infections
Role of Bone in Knee Osteoarthritis (OA)

The purpose of the study is to investigate protein and gene expression among damaged knee tissues. We will perform MRI's on subjects prior to total knee replacement to identify the location of bone marrow lesions. Connective tissues including tendon, ligament, and meniscus specimens normally discarded from total joint replacements will be used for live cell harvest, and protein and gene expression analyses of tissue or cultured cells.

BACKGROUND AND SIGNIFICANCE:

Although the presence of bone marrow lesions (BML) on MRI is strongly associated with osteoarthritis (OA) progression and pain in some studies, the mechanism for this relation and the underlying pathology is not well established. The lack of knowledge on what these lesions constitute hampers their clinical utility both with regards to measurement and targeting for therapeutic intervention.

Our preliminary data has localized specific changes in bone mineralization, remodeling and defects within BML features that are adjacent to the subchondral plate. BMLs appear to be sclerotic compared to unaffected regions; however, the mineral density in these lesions is reduced and may render this area to be mechanically compromised, and thus susceptible to attrition. Limited histological analysis of BMLs reveal thrombi, diffuse fibrinoid necrosis and hyperplasia of blood vessel walls - all indicative of infarction-like pathology.

The aim of this research proposal is to create more specific targets and improve our understanding of the pathology in BMLs.

Specific Aim 1:

- To collect tissue to evaluate protein and gene expression of these tissues and cultured cells.

Eligibility Criteria:
Inclusion Criteria:

* subjects having primary knee replacement surgery with 1 participating surgeon at NEBH (principal investigator)

Exclusion Criteria:

* subjects having a revision knee replacement instead of a primary knee replacement
* contraindications for MRI
* pregnancy