cyrilzakka/clinical-trials huggingface dataset:
NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.

Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.

There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

NSE-Ancillary Study of HYPERION Trial will determine impact on neurospecific enolase (brain biomarker) of two temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in non-shockable rhythm.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest in nonshockable rhythm and
* Glasgow Coma Scale score ≤8. In patients receiving sedative therapy at ICU admission, the Glasgow Coma Scale score assessed by the emergency physician just before sedative therapy initiation is used.
* Patient must be randomized in a center which participate in the ancillary study.

Exclusion Criteria:

* No-flow time \>10 min (time from collapse to initiation of external cardiac massage);
* Low-flow time \>60 min (time from initiation of external cardiac massage to return of spontaneous circulation).
* Major hemodynamic instability (defined as a continuous epinephrine or norepinephrine infusion at a flow rate \>1 μg/Kg/min)
* Time from cardiac arrest to study inclusion \>300 min
* Moribund patient
* Child C cirrhosis of the liver
* Age \<18 years
* Pregnant or breastfeeding woman
* Correctional facility inmate
* Previous inclusion in another randomized clinical trial on cardiac arrest with day-90 neurological outcome as the primary endpoint
* Patient without health insurance
* Decision by the patient or next of kin to refuse the study
Upper Limb Rehabilitation After Stroke Assisted With a Hybrid Electrical Stimulation (ES)-Robot System

The purpose of this study is to investigate the combined training effectiveness of mechanical robot and neuromuscular electrical stimulation on upper limb rehabilitation after stroke.


Eligibility Criteria:
Inclusion Criteria:

The recruited subjects will

* have unilateral ischemic brain injury or intracerebral hemorrhage at least 6 months after the onset of single stroke
* have moderate level of motor impairment in the affected upper limb, assessed by Fugl-Meyer Assessment (9\<shoulder/elbow\<27; 6\<wrist/hand\<18)
* have enough cognition to be able to follow the training protocol as assessed by Mini-metal State Examination (MMSE\>21)
* have detectable EMG signals (3 times of the standard deviation above the baseline) from the upper limb muscles.
Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy For Locally Advanced Breast Cancer

This study is being done to help the investigators determine how accurate the sentinel lymph node biopsy (SLNB) procedure is in identifying residual cancer cells after neoadjuvant chemotherapy in patients presenting with locally advanced breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female patients over 18 years of age with biopsy-proven breast cancer
* Patients presenting with locally advanced disease in the breast (cT4) and/or in the nodes (cN2/N3) as assessed by clinical exam and imaging
* Patients presenting to surgery clinic after receipt of NAC at outside hospital with documentation of cT4 or cN2/3 disease on initial outside physical exam and imaging studies
* Patients receiving NAC and having a nodal complete clinical response as assessed by physical exam

Exclusion Criteria:

* Patients with a prior history of ipsilateral breast cancer
* Pregnant patients
* Patients with persistent palpable axillary nodes after NAC, as assessed by physical exam
* Patients not consenting to ALND
The Safety and Effectiveness of Steep Pulse Therapy System for the Ablation of Benign Prostatic Hyperplasia

The goal of this clinical trial is to assess the efficacy of steep pulse ablation in treating benign prostatic hyperplasia (BPH) and to evaluate its safety profile in treating BPH. The main questions it aims to answer are:

1. whether steep pulse ablation can effectively manage BPH symptoms and to investigate any potential safety concerns associated with its use in treating BPH.
2. If steep pulse ablation can perform superior effect than Tamsulosin Hydrochloride in treating BPH.

Participants will be asked to do:

1. Participants will be given Tamsulosin Hydrochloride or undergo steep pulse ablation.
2. Participants will be followed up after 1 month and 3 month after taking drug or undergo ablation for test and relative examinations.


Eligibility Criteria:
Inclusion Criteria:

1. patients with BPH diagnosed through digital rectal examination, B-mode ultrasound and urinary flow rate.
2. international prostate symptom score(IPSS)\>=12.
3. Maximum urinary flow rate between \>5ml/s and \<15ml/s with a minimum voided volume ≥ 150ml.
4. Age ≥ 50 years old.
5. Subjects are willing to participate and have signed the informed consent form.

Exclusion Criteria:

1. Patients with acute or severe urinary tract infections.
2. Patients clinically diagnosed with prostate cancer.
3. Patients with neurogenic bladder or bladder dysfunction due to other factors.
4. Patients with urethral stricture.
5. Patients who have undergone previous prostatectomy (TURP), enucleation, or laser surgery.
6. Patients with implanted pacemakers or metal replacements in the pelvis or hip joints.
7. Patients who cannot tolerate general anesthesia or surgery due to severe systemic diseases, heart diseases, pulmonary insufficiency, failure of vital organs, or other reasons.
8. Patients in the trial group who have taken medications that can affect BPH symptoms within 3 months of postoperative follow-up.
9. Patients who have participated in other drug trials or medical device clinical trials within 3 months prior to enrollment.
10. Patients deemed unsuitable for participation in this clinical trial by the investigator.
Ultrasound-Guided Microendoscopic Versus Fluoroscopic-Guided Lumbar Transforaminal Epidural Steroid Injections

The purpose of this study is to compare the Microendoscopic combined with ultrasound technique to the standard routinely used X-ray guided transforaminal steroid injection technique.

After being informed about the study and potential risks, all patients giving written informed consent will undergo screening to determine eligibility. Patients who meet the eligibility criteria will be randomized in a double-blind manner to two groups. Patients assigned to Group A will undergo a fluoroscopy guided procedure while patients in Group B will undergo a microendoscopic combined with ultrasound technique.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 64 years old of either sex
* Disease status of American Society of Anesthesiologists grades I to II
* Patients presenting with single-level disc disease and radiculopathy (L2-L3; L3-L4; L4-L5) for steroid injection
* Confirmation of herniated disk by CT or MRI
* Able to give informed consent

Exclusion Criteria:

* Age under 18 or over 64 years old
* Pregnant women
* Disease status of American Society of Anesthesiologists grades III to IV
* Unable to provide an informed consent
* Radiculopathies at multiple spinal levels
* Non-lumbar herniated discs
* Clinically obvious or known spinal deformity or stenosis
* Previous spine surgery
* Local or systemic infection
* Allergy to steroids, anesthetics, or contrast material
* Uncorrectable coagulopathy and patients on anticoagulation therapy
* Patients who refuse the procedure
* Spine tuberculosis or tumors
* Prior injections within 3 months
Study to Evaluate the QTC Interval in Healthy Volunteers Dosed With Dexpramipexole (QTC = Electrocardiogram (ECG) Interval Measured From the Onset of the QRS Complex to the End of the T Wave Corrected for Heart Rate)

To evaluate whether dexpramipexole prolongs the QTc interval when orally administered to healthy volunteers.

This is a Phase I, single-center, blinded (with respect to dexpramipexole administration), randomized, placebo- and active-controlled, 4-period crossover study in approximately 68 healthy volunteers. This thorough QT/QTc study will be conducted to formally evaluate the effect of dexpramipexole on QT prolongation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 60 years old inclusive on Day 1.
* Subjects who, in the opinion of the Investigator, are healthy as determined by pre study medical history, physical examination, and 12 lead ECG.
* Male subjects and female subjects of childbearing potential must practice effective contraception (per protocol specifications).
* Normal systemic blood pressure defined as a systolic blood pressure of 90 to 140 mmHg and a diastolic blood pressure of 50 to 90 mmHg.

Exclusion Criteria:

* History of cardiovascular disease (e.g., hypertension, arrhythmia, heart failure, Long QT Syndrome, or other conditions/diseases causing prolongation of the QT/QTc interval), in the opinion of the Investigator.
* A prolongation of QT/QTc interval (e.g., repeated demonstration of a QT/QTc interval \>450 ms before study treatment administration.
* Clinically important abnormalities in resting ECG that may interfere with the interpretation of QTc interval changes at screening, check-in, or pre-dose on Day -1 of the first treatment period.
* Other medically significant illness.
* Clinically significant abnormal laboratory values.
* Pregnant women or women breastfeeding.
EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction (AXIOS-CPRE)

The main objective is to compare the EUS-BD with the insertion of a LAMS vs. traditional ERCP to restore biliary patency. Although ERCP has been the primary treatment for many years, it is associated with a significant risk of procedural complications and possible stent blockage. EUS-BD has been shown to be potentially safer and is associated with a lower risk of stent blockage. We seek with our study to determine whether EUS-BD may be the most effective treatment modality.


Eligibility Criteria:
Inclusion Criteria:

* Radiological diagnosis (with or without pathological diagnosis) of a malignant obstruction of the borderline resectable distal bile ducts, locally advanced or unresectable distal to the hilum, at a minimum distance of 2 cm.
* Resectability based on tumor staging after axial imaging and evaluation by a physician (surgeon, oncologist and / or gastroenterologist).
* High results of the liver function test with a serum bilirubin level at least 3 times above the upper limit of normal (18.9 μmol / L)
* Dilated extrahepatic bile duct measuring at least 1.2 cm in axial imaging, ultrasound or endoscopy.
* Karnofsky index\> 30%
* ASA score \<IV
* Patient accepting the constraints of research
* Patient affiliated or beneficiary of a social security scheme
* Patient having signed an informed consent

Exclusion Criteria:

* - Hilar obstruction (biliary obstruction located \<2 cm from the hilum)
* Coagulopathy and / or thrombocytopenia that cannot be corrected
* Age \<18 years old
* Liver metastases involving\> 30% of hepatic volume
* Liver cirrhosis with portal hypertension or ascites
* Biliary sphincterotomy or placement of a stent performed in the past
* Anatomy modified by surgery
* Common bile ducts measuring less than 1.2 cm will be excluded.
* Patient with clinical and radiological signs of stenosis of the gastric outlet
* Patient participating in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Patient hospitalized without consent
Recovery Time and Affecting Factors in Hemodialysis Patients

Patients undergoing hemodialysis (HD) can experience symptoms such as lassitude, pain, muscle cramps, nausea, vomiting, constipation, diarrhea, rash, skin dryness, sleep disorders, and emotional and sexual problems after the treatment. Many chronic HD patients do not feel well after the treatment sessions and need some time to recover. This recovery time is defined as the time required to recover from the feelings of lassitude and fatigue.

The recovery time not only decreases the quality of life but also increases the risk of mortality and morbidity. As a prolonged recovery time affects both the patients and the healthcare professionals and caregivers, there has been increased interest on determining the modifiable treatment-related factors in the international literature. The patients are limited in their daily living activities at home and at work during this period and a significant amount of time is therefore required to go back to normal life.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Being on HD for 4 hours a day on 3 days per week for at least 6 months
* No communication problem
* Volunteering to participate to the study

Exclusion Criteria:

* Younger than 18 years
* Shorter being on HD for 4 hours a day on 3 days per week for at least 6 months
* Have communication problem
* Not volunteering to participate to the study
Clinical Validation of a Urinary Exosome Gene Signature in Men Presenting for Suspicion of Prostate Cancer

Validate a non-DRE exosome gene expression test, with an NPV \>/= 90% certainty, will exclude the presence of high gleason grade/ score (\>/=7) prostate cancer in a prostate needle biopsy.

The purpose of this multi-center clinical study is to determine the association of an Exosome Urine Test score with the presence of high Gleason grade / score (GS\>/=7) prostate cancer on a prostate needle biopsy and validate the assay's performance characteristics in men presenting to their urologist with or without a previous negative biopsy, and recommended for an initial or subsequent biopsy. The results of this study are to support the use of this assay as a laboratory developed test. A secondary objective is to develop an assay that accurately predicts the presence of any Gleason grade prostate cancer in men at risk for prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Male, \>50 years of age with a clinical suspicion for prostate cancer based in part on an elevated PSA (limit range: 2.0 - 20 ng/ mL), and or suspicious DRE, with or without the clinical history of a single prior negative biopsy, and who have been recommended for a repeat and or first time biopsy.
2. The subject must be able to comprehend and sign an approved informed consent form and other applicable study documents.

Exclusion Criteria:

1. Use of medications or hormones that are known to affect serum PSA levels within 3-6 months of study enrollment.
2. Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
3. History of prostate cancer.
4. History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
5. Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion or results of this trial, or constitutes an unacceptable risk to the subject.
6. Participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. Exception: Trials for non-prostate conditions may be acceptable, with approval by the investigator and Sponsor.
7. No known hepatitis (all types) and/or HIV documented in patient's medical record.
8. Patients with history of concurrent renal/bladder tumors within 6 months of study enrollment.
Risk of Developing Antibodies to Heparin-PF4 After Heart Surgery

Heparin is a drug that is widely used to prevent and treat blood clotting. Individuals undergoing cardiopulmonary bypass surgery are administered high doses of heparin, and some of them develop antibodies to the drug. This immune response can lead to the formation of blood clots, setting the stage for a potential heart attack or stroke. The purpose of this study is to evaluate how often an immune response to heparin leads to the formation of blood clots in individuals who have had heart surgery.

Heparin is a drug that is widely used to prevent and treat blood clotting. However, heparin can also cause serious adverse events. Individuals undergoing cardiopulmonary bypass surgery are administered and therefore exposed to high doses of heparin. Studies have shown that up to 61% of cardiac bypass patients develop elevated levels of antibodies to heparin-PF4 after surgery. This immune response may activate blood platelets, possibly resulting in a blood clot. These clots most often develop in the legs and lungs, and may lead to a heart attack or stroke. The frequency of such a reaction has yet to be determined definitively. This study will evaluate the incidence of an immune response to heparin-PF4 that leads to the formation of blood clots in individuals who have had heart surgery.

Participants in this study will be recruited prior to a scheduled cardiac bypass surgery. They will first complete a structured pre-operative interview to collect baseline measures on demographics, comorbidities, history of heparin exposures, and prior thromboembolic events. Immediately prior to surgery, a blood sample will be taken to assess the individual's platelet count and level of antibodies to heparin-PF4. Following the operation, participants will be followed daily to assess heparin exposure, platelet counts, and any blood clotting. Subsequent blood samples will be taken 5 days and 1 month following the surgery to again evaluate the individual's platelet count and level of heparin-PF4 antibodies. Additionally, participants will undergo a structured interview at 1 and 3 months post-surgery to evaluate the incidence of outcomes related to heparin-PF4 antibodies.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for cardiac bypass surgery at Duke University Hospital

Exclusion Criteria:

* Plans to receive warfarin during the post-operative inpatient stay
* Plans to receive a full anticoagulant dose of low-molecular weight heparin during the post-operative inpatient stay
* Plans to receive a full anticoagulant dose of unfractionated heparin during the post-operative inpatient stay
* Use of any drug other than unfractionated heparin for anticoagulation during cardiopulmonary bypass
* Warfarin, heparin, or low-molecular weight heparin administered during a readmission to the hospital for a reason other than one of this study's outcomes does not constitute criteria for exclusion
Effect of Saphenous Nerve and Nerve to Vastus Medialis Block Within Subsartorial Femoral Triangle on Quadriceps Strength

This research objective is to compare quadriceps strength by measuring maximal voluntary isometric contraction (MVIC) and risk of fall before and after subsartorial femoral triangle block (SSFTB)


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are all ASA class I-III, age 18-80 years, and have plan to perform SSFTB at Thammasat University Hospital consecutively

Exclusion Criteria:

* Exclusion criteria are patients who refuse to participate the study, morbid obesity (BMI ≥ 35 kg.m2), lower extremity neurological dysfunction, performing other peripheral nerve blocks, patients who cannot cooperate or measure MVIC, difference of quadriceps strength between two side of knees more than 10 percent, and SSFTB is not finally performed or failed block.
Evaluation of Frequency Lowering Technique

The purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality.

This is a controlled, single blinded and randomised comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test two frequency lowering techniques with an amount of 30 moderate to severe, symmetrically sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during 6 months including seven appointments of 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* female and male adults (\>18 years old)
* mild to severe Hearing Loss
* symmetric Hearing Loss
* german native speakers

Exclusion Criteria:

* persons who are not able to attend multiple appointments
* persons who are not able to handle a hearing aid
* persons with a mental handicap
* persons with limited access to multiple hearing situations
* persons with psychological disease
* no acclimatization to hearing aids
Adductor Canal Block Versus Periarticular Bupivicaine Injection in Total Knee Arthroplasty

The objective of the study is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty. This randomized clinical trial will compare outcomes between adductor canal blocks, periarticular bupivacaine injections, and periarticular liposomal bupivacaine injections. Results from this study will help determine the most appropriate perioperative pain management strategy for patients undergoing a total knee arthroplasty.

Over 600,000 total knee arthroplasties (TKAs) are performed each year in the United States, with expectations for greater than 4 million/year by the year 2030. Since the onset of TKAs in the 1960's, there have been developments that have improved both functionality and patient satisfaction. In the last decade, a focus has been made on multimodal pain management protocols, more rapid functional recovery, reduced length of hospital stay, and minimizing side effects of treatment while maintaining function and durability. The widespread use of regional anesthesia has led to improvements in pain control, more rapid functional recovery, and reduced length of stay. In recent years many surgeons have transitioned from femoral nerve blocks (proximal femoral nerve) to adductor canal blocks (distal femoral nerve) to maintain a sensory block for pain control, while minimizing any motor blockade that is typically seen in proximal femoral nerve blocks, which would hamper rehabilitation, and increase risk of falls. In addition to regional blocks, which are typically performed in the preoperative setting, some surgeons favor an intraoperative periarticular anesthetic injection (PAI), typically with bupivacaine or the long acting form liposomal bupivacaine, either in conjunction with an adductor canal block, or independently. In theory, PAI has the advantage of a comparable sensory nerve block as an adductor canal block, without the disadvantages and risks, which include prolonged quadriceps weakness, fall risk, and neurologic dysfunction.

The purpose of this randomized control trial is to compare the efficacy of adductor canal blocks versus periarticular bupivacaine injections for pain management in total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergoing an unilateral primary total knee arthroplasty under the care of the two senior arthroplasty surgeons.

Exclusion Criteria:

- Allergy to bupivicaine or liposomal bupivicaine.