cyrilzakka/clinical-trials huggingface dataset:
Colorectal Anastomosis Outcomes Using the Novel Powered Circular Stapler Compared With Manual Circular Staplers.

Patients whom meet all eligibility criteria will be assigned random 1:1 to one of the following arms:

* ECPS group: Echelon Circular™ Powered Stapler (n=270)
* MCS Group: manual circular staplers (n=270) Patients will be followed during 30 days in order to evaluate the primary endpoint.

Anastomotic Leakage (AL) is the complication that most concerns colorectal surgeons. It leads to prolonged postoperative stay, increased costs, risk of reoperations and a permanent colostomy, together with an increase in morbidity and mortality.

The novel Echelon Circular™ Powered Stapler (ECPS) (Ethicon, Somerville, NJ, USA), introduces design changes that could decrease the rate of technical errors and improve clinical outcomes. The powered stapler decreases the force needed on firing the device, improving stability at the anastomotic site. Atraumatic Gripping Surface Technology reduces the compressive forces on tissues, and along with 3D Stapling Technology allows a better compression distribution throughout the anastomosis and a better hemostasis.

This is a multicenter, randomized, open-label, controlled with parallel groups clinical trial, with 8 participant sites in total (4 sites in Spain and 4 sites in France), to include an approximate sample size (n) of 570 patients who will undergo a colorectal anastomosis after Hartmann reversal, left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology.

540 patients assigned randomly 1:1 to assess whether technical improvements of Echelon Circular™ Powered Stapler (ECPS) have an impact on left-sided colorectal Anastomotic Leakage (AL) rate compared to current manual circular staplers (MCS).

Anastomosis could be performed open, laparoscopically or with robotic assistance.

After surgery, patients will be followed during 30 days in order to evaluate the primary endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Patient or its legal representative informed consent.
* Age ≥ 18 years.
* Patients who will undergo a colorectal anastomosis after left colectomy, sigmoidectomy or anterior rectal resection, for benign or malignant pathology (NOTE: Hartmann reversal cases also included).

Exclusion Criteria:

* Diverting stoma.
* Emergency surgery.
* American Society of Anaesthesiologists (ASA) score ≥ IV.
* Transanal total mesorectal excision approach.
Endoscopic Ultrasound-guided Drainage of Pancreatic Pseudocysts

The purpose of this study is to compare the effect of lumen-apposing metal stent (LAMS) and traditional plastic stent on the drainage of pancreatic pseudocyst, mainly to observe the cyst recurrence rate of 12 months after treatment.

Inclusion criteria

1. Subject with ages from 18-80 years old
2. Subject with pancreatic pseudocysts confirmed by CT
3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
5. Subject has the symptoms related with the pseudocyst
6. The consent form has been signed

Exclusion criteria

1. Subject is younger than 18 years or older than 80 years
2. Pancreatic pseudocyst communicate with the main pancreatic duct
3. Subject can't accept the endoscopic procedure
4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
5. The distance between gastric and the wall of the pseudocyst is more than 1 cm
6. Subject with 2 or more than 2 cysts
7. Subject has blood coagulation dysfunction
8. Pregnant or subject has mental disorders

Eligibility Criteria:
Inclusion Criteria:

1. Subject with ages from 18-80 years old
2. Subject with pancreatic pseudocysts confirmed by CT
3. Subject with a history of MSAP or SAP, the pseudocysts were formed more than 3 months
4. The size of pseudocyst is more than 6 cm, and the cyst adjacent to the gastric wall
5. Subject has the symptoms related with the pseudocyst
6. The consent form has been signed

Exclusion Criteria:

1. Subject is younger than 18 years or older than 80 years
2. Pancreatic pseudocyst communicate with the main pancreatic duct
3. Subject can't accept the endoscopic procedure
4. Pancreatic pseudocyst with infection or subject diagnosed with pancreatic abscess
5. The distance between gastric and the wall of the pseudocyst is more than 1 cm
6. Subject with 2 or more than 2 cysts
7. Subject has blood coagulation dysfunction
8. Pregnant or subject has mental disorders
Prospective Measurement of Normal Venous Sinus Pressures

The purpose of this research is to document normal intracranial venous sinus pressures. Participants who need to have a cerebral angiogram to evaluate a medical problem not related to Idiopathic Intracranial Hypertension (IIH) will be invited to participate. Participation in this research will not require any extra visits. The intervention will take place in the interventional radiology suite when the subject has an angiogram. IIH is a condition that causes increased pressure in the brain in the absence of a tumor or other diseases that may be causing symptoms. Symptoms include headaches and visual disturbances not explained by other things. In IIH there is a narrowing in the sinuses of the brain that causes the increased pressure.

Patients will be prospectively enrolled into the study. All adult patients, aged of 18-60, determined to be candidates for elective cerebral arteriography will be screened for inclusion in this study. Patients consenting to participate and enrolled in the study will first undergo their standard cerebral angiogram procedure, as clinically indicated. Once the procedure is completed, enrolled subjects will then undergo the study intervention.

1. Insertion of an additional catheter in the femoral vein.
2. Navigation of the catheter into the internal jugular bulb and then catheter navigation into the superior sagittal sinus will result in additional fluoroscopic time (requires \~60 seconds of additional fluoroscopy time; carries a minimum risk of vessel perforation or other untoward event \[incidence of complication associated with this procedure in the PI patient series is 0%\]). There is additionally some ear pain that can happen with this Venogram.
3. 5-10 minutes of additional procedure time. Much of this time period is merely a waiting period while the pressures stabilize and are recorded.
4. An additional venogram injection through the catheter which exposes subjects to an additional 1-2 ml of contrast dye and 3-4 seconds of additional fluoroscopy time and its associated radiation dose.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for elective cerebral arteriography

Exclusion Criteria:

* All patients with active, or a history of, intracranial venous pathology (arteriovenous malformation, arteriovenous fistulae, idiopathic intracranial hypertension, venous sinus thrombosis).
* Patients with severe daily headaches or symptoms of idiopathic intracranial hypertension will also be excluded.
* Body mass index \> 35.
* Known diagnosis of heart failure or pulmonary hypertension.
* Pregnant women will be excluded due to the radiation risk associated with Angiogram and Venogram.
Effects of Taping & Exercise Therapy on Lower Back Musculoskeletal Conditions in Pakistani Patients

Lower back pain has been one of the most frequently occurring musculoskeletal disorder among the females. This act as a global burden and is highly prevalent in our society. This pain can result in life long disability, loss of function and mobility among individuals. The female of the society suffers from lower back pain the most because of the under lying causes, prolong standing and stooping as well as because of hormonal changes in their bodies

After studying the prevalence of the lower back pain among the females of Pakistan, the investogator find the need to assess the type of their pain and find out the best way to ease their pains. The motive was to develop a treatment protocol whose effects last longer and is inexpensive for the management of lower back pain.

Moreover, the investigator decided to study that which treatment protocol is better when compared to another and what is the role of sham treatment when given to the patients.

Eligibility Criteria:
Inclusion Criteria:

* Females who were willing to participate.
* Participants with nonspecific lower back pain will only be included and screened through the screening questionnaire.

Exclusion Criteria:

* Post-menopausal women
* Females with any diagnosed co-morbidity.
* Back pain progressive to any neurological deficit
* Sustained or increased back pain with loss of appetite and unexplained weight loss accompanied with fever, nausea and chills
* With any known spinal or lower back pathology
* Tumor of the spine
* Any underlying diseases of spinal cord (i.e, ankylosing spondylosis, spondolisthesis)
* With any steroid therapy for lower back pain in the past three months
* Any inflammatory rheumatic disease
* Sensitive skin or any skin allergy or dermatological condition
* Any rehabilitative services taken for the lower back pain in the past two months
* Rejection to manual conatct
New Methods to Diagnose Constrictive Pericarditis

Until now, diagnosis of constriction was based on pressure changes of ventricle by conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This study will provide answers to persisting questions about volume changes during respiration in patients with constrictive pericarditis by directly measuring both right and left ventricular volume.


Eligibility Criteria:
Subjects referred for right and left heart catheterization will be eligible.
First-line Nurse Manager Authentic Leadership Training Program

Authentic leadership behavior is considered a mandatory strategy for enhancing the nurse manager capabilities and practice as well as achieving positive nurses' attitudes.

Authentic leadership behavior is considered a mandatory strategy for enhancing the nurse manager's capabilities and practice as well as achieving positive nurses' attitudes. This study aimed to investigate the effectiveness of authentic leadership programs for first-line nurse managers on nurses' attitudes, including nursing care self-efficacy and trust.

Eligibility Criteria:
Inclusion Criteria:

First-line nurse managers

* willing to participate in the study
* work in medical and surgical wards
* Sign a consent

Exclusion Criteria:

* First-line nurse managers

  * work in outpatient units and other wards
  * Did not sign a consent
  * Absent from training
Cutaneous Sensory Block Area of the Subcostal Ultrasound-Guided Transversus Abdominis Plane Block

Patients planned for elective laparoscopic cholecystectomy received a peroperative ultrasound-guided subcostal transversus abdominis plane block (USTAP) at the beginning of the procedure. At T90 minutes after the end of anaesthesia the cutaneous sensory block area (CSBA) was measured using cold sensation and mapped with a sterile marker. The CSBA was photodocumented and the area calculated.


Eligibility Criteria:
Inclusion Criteria:

* Planned for elective laparoscopic cholecystectomy, age 18 or older, written and verbal consent

Exclusion Criteria:

* Non-compliant due to language or psychiatric disease, previous surgery to the upper abdomen, incisional hernia, pregnancy, sensory deficit of the abdomen or thorax.
Ectopic Pregnancy Biomarkers

In an attempt to simplify the diagnosis of ectopic pregnancy, the researchers will investigate the presence of specific molecular markers of ectopic pregnancy. The quantification of these (and other proteins) will be performed using the Ciphergen Protein Chip system where serum is sampled with a high-throughput system. The patterns of these peaks will be compared for those with a diagnosis of ectopic pregnancy and normal pregnancy. Later goals of the research will be to identify the actual proteins that correspond to the peaks which discriminate between the two clinical entitles. The goal is to identify a unique protein pattern or protein peak to distinguish a normal intrauterine pregnancy from that of an ectopic implanted gestation.


Eligibility Criteria:
Inclusion Criteria:

* Reproductive-aged women
* Currently pregnant based on serum human chorionic gonadotropin level
* Present for care for pregnancy due to vaginal bleeding and/or pelvic cramping
* Final diagnosis of one of the following:

  1. Live intrauterine pregnancy through 14 weeks, diagnosed by ultrasound demonstrating fetal heart motion
  2. Diagnosed ectopic pregnancy
  3. Ultrasound confirmation of a nonviable gestation (less 14 weeks) such as an anembryonic gestation or a fetal demise

Exclusion Criteria:

* None
Intravenous Thrombolysis in Acute Ischemic Stroke with Active Cancer

The primary hypothesis being tested in this trial is that ischemic stroke patients with active cancer will have improved clinical outcomes when given intravenous thrombolysis compared to standard care.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinical signs of acute ischemic stroke within 24 hours of onset or awakening with stroke (if within 24 hours from the midpoint of sleep). Patients with AIS within 4.5-24 hours of onset must meet the IVT inclusion criteria specified in the guideline
2. Patients with active cancer (Active cancer was defined as cancer diagnosed within the previous 6 months; recurrent, regionally advanced or metastatic cancer, or cancer for which treatment had been administered within 6 months, or haematological cancer without complete remission.)
3. Patients ≥ 18 years old
4. Informed consent has been obtained depending on local ethics requirements.

Exclusion Criteria:

(1) Intended to proceed to endovascular treatment; (2) Pre-stroke mRS score \> 2 (3) Contraindications for IVT：

1. Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.)
2. Previous history of intracranial hemorrhage
3. Severe head trauma or stroke history within the last 3 months
4. Intracranial tumors, giant intracranial aneurysms
5. Intracranial or spinal surgery within the recent 3 months
6. Major surgical procedures within the last 2 weeks
7. Gastrointestinal or urinary tract bleeding within the last 3 weeks
8. Active visceral bleeding
9. Aortic arch dissection
10. Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding
11. Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg
12. Acute bleeding tendency, including platelet count \< 100 × 10⁹/L or other conditions
13. Received low-molecular-weight heparin treatment within 24 hours
14. Oral anticoagulants (warfarin) with INR \> 1.7 or PT \> 15 s; Receiving heparin treatment with aPTT above the upper limit of the normal range within the last 24 hours of onset, Receiving thrombin inhibitors and factor Xa inhibitors within the last 48 hours of onset.
15. Blood sugar \< 2.8 or \> 22.22 mmol/L
16. Head CT or MRI indicates large-area infarction (infarction area ≥ 1/3 of the middle cerebral artery supply area) (4) The judgment is left to the discretion of the investigator
A Efficacy Study of PRX-00023 in Patients With Major Depressive Disorder

The purpose of this randomized, double-blind, placebo-controlled study is to assess the safety and efficacy of PRX-00023 in patients with major depressive disorder.

Patients with major depressive disorder who meet all of the eligibility criteria will be randomly assigned to receive twice daily doses of either placebo or PRX-00023. Study drug will be taken for up to approximately 9 weeks. Patients will have periodic office visits for the purpose of monitoring safety and tolerability, as well as efficacy assessments.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of major depressive disorder

Key Exclusion Criteria:

* Females who are pregnant or nursing
* Electroconvulsive therapy within previous year
* Type 1 diabetes or uncontrolled type 2 diabetes
* HIV, Hepatitis B or Hepatitis C
* Use of illegal drugs, history of drug abuse, and/or alcohol dependence
* Clinically significant abnormal lab results

Other protocol-defined eligibility criteria may apply.
Berlin PRehospital Or Usual Delivery of Acute Stroke Care

Prehospital stroke care in specialized ambulances increases thrombolysis rates, reduces alarm-to-treatment times, and improves prehospital triage. Preliminary analyses suggest cost-effectiveness. However, scientific proof of improved functional outcome compared to usual care is still lacking. The objective of this trial is to show improved functional outcomes after deployment of the Stroke Emergency Mobile (STEMO) compared to regular care.

This is a pragmatic, prospective, multi-center trial with blinded outcome assessment of treatment candidates three months after stroke. Treatment candidates will be defined as patients with final discharge diagnosis of cerebral ischemia, and onset-to-alarm time ≤4 hours, symptoms not resolved at time of ambulance arrival, and able to walk without assistance prior to emergency. These patients will be included if their emergency call from a predefined catchment area in Berlin, Germany, caused a stroke alarm at the dispatch center during STEMO hours (7am-11pm, Monday-Sunday). About 45% of STEMO dispatches will be handled by regular ambulances since STEMO will be already in operation creating the quasi-randomized control group.

B_PROUD uses data from the B-SPATIAL registry. The B-SPATIAL registry has started recruitment in January 2016. However, B_PROUD recruits patients with symptom onset October 1st, 2016 or later (because data access at the dispatch center had to be established first).

Eligibility Criteria:
Inclusion criteria:

1. Suspected acute stroke according to the dispatcher stroke identification algorithm during STEMO hours (7am-11pm, Monday-Sunday) and within the STEMO catchment area

   Inclusion criteria for primary study population:
2. Final diagnosis of ischemic stroke (ICD 10: I63) or TIA (ICD 10: G45 except G45.4)
3. Confirmed onset-to-alarm time ≤ 4 hours at dispatch
4. Pre-stroke modified Rankin scale ≤ 3 (being able to ambulate, in routine clinical care, patients with mRS up to 3 are usually deemed suitable for tissue plasminogen activator treatment)

Exclusion criteria:

1. Symptom remission until arrival of emergency medical service
2. Malignant or other severe primary disease with life expectancy \< 1 year

   Exclusion criteria for primary study population:
3. Major surgery within 4 weeks before study inclusion
4. Confirmed stroke within 3 months before study inclusion
5. Absolute contraindications for thrombolysis AND thrombectomy
Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF)

The goal of this interventional study is to is to compare the effect of a tap block versus a placebo in patients undergoing anterior lumbar spine surgery.

The main question it aims to answer :

• whether tap block can reduce the need for postoperative pain medication Participants will be randomized into two groups and all postoperative pain medication will be recorded over 3 days.

Researchers will compare tap block vs placebo to see if it reduces postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

Patient affiliated or entitled to a social security plan.

* Patient who has been informed about the study and has co-signed a consent form with the investigator. consent to participate in the study.
* Patients over 18 years of age scheduled for abdominal disc surgery on one or two levels.
* Patient with ASA criteria 1, 2 and 3.

Exclusion Criteria:

* Patients with intolerance or contraindication to paracetamol, anti-inflammatory or morphine.
* Patients allergic to local anesthetics.
* Pregnant or breast-feeding patient.
* patient undergoing cancer or trauma surgery trauma.
* Patient participating in another interventional study.
* Patient with a history of lumbar arthrodesis.
* Patient refusing to sign consent form.
* Patient unable to give informed consent.
* Patient under court protection, guardianship or trusteeship.
* Patient not available for study follow-up.
Cost Analysis of Vascular Surgical Techniques

Whilst mortality rates and surgical limitations are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention if available.

Surgical interventions for patients with CLTI include endovascular revascularisation, by-pass revascularisation and amputation.

Clinical outcomes vary greatly for each intervention. The 5-year mortality rate for major amputations i.e., below knee (BKA) and above knee (AKA), is reported to range from 30% to 70%, with AKA having the higher rate of mortality. Concomitant Type II diabetes increases these rates of mortality for both AKA and BKA.

Whilst mortality rates are widely known and understood for each intervention performed, the cost implications, in UHL, are not known. Therefore, it is deemed a matter of interest to understand these costs and weigh them against the mortality rates for each intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Cases where CLTI was treated surgically by a Vascular Consultant at UHL will be included in this analysis. That being individuals who underwent revascularisation procedures and/or lower limb amputation.
2. This analysis will look at cases from a set time frame, that being 1st March 2022 to 1st March 2023.

Exclusion Criteria:

1. Cases where CLTI was treated conservatively/without surgical intervention will not be included.
2. Surgical intervention outside of UHL.
3. Cases that occurred outside of the set timeframe.
Pericapsular Nerve Group (PENG) Block Combined With Periarticular Multimodal Drug Injection (PMDI) Versus Isolated PMDI for Pain Management After Total Hip Arthroplasty: a Randomized Controlled Trial

Adequate pain control after total hip arthroplasty is crucial for early ambulation and patient satisfaction. However, there is no consensus about optimal pain control after post operation. In general, the periarticular multimodal durg injection block has been done for pain control in primary total hip arthroplasty. The pericapsular nerve group (PENG) block has been recently introduced a new technique for blockade of the articular branches of the femoral, obturator and accessory obturator nerves. PENG block is possible to provide sufficient analgesia and preserve lower limb muscle strength. The investigators will compare PENG and PMDI block with isolated PMDI block in patients undergoing total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective unilateral total hip arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study
2. Hepatic or renal insufficiency
3. Opioid dependency
4. Coagulopathy
5. Pre-existing neurologic or anatomic deficits in the lower extremities
6. Severe psychiatric illness