cyrilzakka/clinical-trials huggingface dataset:
Ultrasound-guided Pudendal Nerve Block for Pain After Hemorrhoidectomy

The goal of this clinical trial is to investigate the effects of ultrasound-guided pudendal nerve block on postoperative pain, opioid consumption, and quality of recovery in patients receiving Ferguson hemorrhoidectomy.

Patients who have symptomatic hemorrhoids undergoing Ferguson hemorrhoidectomy under spinal anesthesia will be randomized to receive bilateral ultrasound-guided pudendal nerve block with 0.5% ropivacaine or normal saline immediately after surgery. In addition, intravenous patient controlled analgesia, NSAIDs, and acetaminophen will be used in all participants for postoperative pain control. Postoperative pain on numerical rating scale (NRS), opioid consumption, quality of recovery (QOR-15), patient's satisfaction, and complications will be recorded at 6, 12, 24, 48 hours and 7 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic hemorrhoids (grade III and grade IV internal hemorrhoids, mixed hemorrhoids, and external hemorrhoids)
* Age 20 to 65 years old
* American Society of Anesthesiologists (ASA) classification I\~III
* Receiving Ferguson hemorrhoidectomy under spinal anesthesia

Exclusion Criteria:

* Allergy to local anesthetics or analgesics used in this study
* Drug abuse
* Coagulopathy
* An active infection at the injection site
* Patient refusal
* BMI ≥ 30
* Pregnancy
Bivalirudin in Acute Myocardial Infarction

The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days.

This is a prospective, randomized, single-blind, active drug controlled multicenter clinical research and the study would enrolled a total of 380 AMI patients undergoing percutaneous coronary intervention (PCI) to one of two antithrombotic regimens: bivalirudin alone, or unfractionated heparin alone. All enrolled patients would be followed-up to 30 days. The purpose of the study is to evaluate the efficacy and safety of bivalirudin in AMI patients with DES.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 80 years old
2. Planned emergency PCI for acute myocardial infarction (STEMI) Symptom onset within 12h for STEMI (or within 12-24 hrs for patients have unrelieved chest pain, continuous ST elevation or new developed LBBB)
3. Provide written informed consent.

Exclusion Criteria:

1. Age \<18 or \>80 years.
2. Any anticoagulant drugs were regularly used within 3 months.
3. Any anticoagulant agents were used 48 h before randomization.
4. Active bleeding or bleeding constitution, bleeding tendency, including the recent retina or vitreous hemorrhage (1 months), GI or urinary tract hemorrhage (3 months), cerebral hemorrhage (6 months) or cerebral infarction history (3 months), etc.
5. Hemoglobin \< 90 g/L or platelet count \< 100 \* 109 / L.
6. Untreated or uncontrolled hypertension \> 180/110 mmHg.
7. Elevated ALT level higher than three times of the normal upper limit;severe renal insufficiency (eGFR \< 30 mL/min / 1.73 m2).
8. Heparin induced thrombocytopenia.
9. Suspicious aortic dissection, pericarditis and subacute bacterial endocarditis.
10. Known allergy to the study drugs and instruments (UFH, bivalirudin, aspirin and clopidogrel, stainless steel, contrast agents, etc.), or those allergic constitution.
11. Pregnancy , lactation or plan to be pregnant.
12. Known serious progressive diseases such as malignant tumor or prognosis of the patients with severe failure;the survival time \< 6 months.
13. Unsuitable for PCI.
14. Attended any clinical trial 1 month before randomised.
The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy

The aim of this study is to assess the effect of ultrasound guided erector spinae block in control of the postoperative pain and the respiratory functions after laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

• American Society of Anesthesiology (ASA) physical status I-II patients who were scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria:

* Patients refusal
* Contraindications for regional anesthesia
* Alcohol or drug abuse
* Chronic opioid intake
* Patient with psychiatric disorders
* Use of pain killers within the 24 h before the operation
* Respiratory tract infection within the last 2 weeks
* Smoker or history of smoking
* Allergy to local anesthetics
* Respiratory and allergic diseases
* Cardiac disease associated with dyspnea
Camera Qualification Study

A multi-center study to evaluate the performance of an automated device for the detection of diabetic retinopathy with the use of an additional fundus camera with IDx-DR.

A multi-center Study to demonstrate non-inferiority of the automated device detecting diabetic retinopathy using a handheld fundus camera with IDx-DR.

Eligibility Criteria:
Inclusion Criteria:

1. 22 years of age or older
2. Documented diagnosis of diabetes mellitus, as per any of the following:

   1. Having met the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
   2. Hemoglobin A1c (HbA1c) ≥ 6.5%
   3. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)
   4. Oral Glucose Tolerance Test (OGTT) with two-hour plasma glucose (2-hr PG) ≥ 200 mg/dL (11.1 mmol/L), using the equivalent of an oral 75 g anhydrous glucose dose dissolved in water
   5. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)
3. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. Currently participating in an interventional eye study
2. Has a known allergy to or contraindication for the use of Tropicamide 1% or other mydriatic eye drops
3. Has a condition that, in the opinion of a licensed clinical team member or investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation)
4. Pregnancy
5. Self-report of visual symptoms including vision loss or blurred vision that cannot be corrected (e.g., with eyeglasses) or floaters
6. History of laser treatment of the retina, injections into either eye, or any history of retinal surgery
7. Previous confirmed diagnosis of a retinal disease (e.g., macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion)
8. Any condition that is contraindicated for the use of the study camera
9. Contraindication for imaging by devices used in the study due to any of the following:

   1. Subject is hypersensitive to light
   2. Subject recently underwent photodynamic therapy (PDT)
   3. Subject is taking medication that causes photosensitivity
Neo-Sequence 2：NCT Plus Anti-angiogenesis Therapy and Immunotherapy for LADGC

The regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles for locally advanced diffuse gastric cancer.

The biweekly regimen of Albumin paclitaxel+SOX+BEV neoadjuvant therapy lasted for 6 cycles, during which PD-1 monoclonal antibody therapy was interspersed for 4 cycles. Review CT and gastroscopy every 3 cycles to evaluate the therapeutic effect. Patients who have been evaluated as effective after 6 cycles of treatment may consider surgery; Or continue the dual cycle regimen ofAlbumin paclitaxel+Bevacizumab for 3 cycles, while PD-1 monoclonal antibody for 2 cycles. Afterwards, the therapeutic effect will be evaluated, and surgery, radiotherapy, or maintenance medication treatment will be determined based on the therapeutic effect. Surgical patients begin adjuvant treatment 1-2 months after surgery based on the curative and pathological results of the surgery. Those who fail to evaluate during neoadjuvant therapy will undergo surgery or radiation therapy, or switch to a second-line systemic treatment plan.

Eligibility Criteria:
Inclusion Criteria:

1. Local advanced diffuse or mixed type gastric cancer detected by pathology and endoscopy;
2. Chest, abdomen, and pelvis enhanced CT, neck and supraclavicular ultrasound, gastroscopy, and endoscopic ultrasound were used to diagnose T3-4NanyM0 gastric cancer or gastroesophageal junction cancer (refer to AJCC staging, 8th edition);
3. Has not received any anti-tumor treatment for gastric cancer yet;
4. Age range from 18 to 75 years old;
5. ECOG score 0-1 points;
6. Liver and kidney function and blood routine meet the following conditions:

   Neutrophils\>1.5G/L, Hb\>90g/L, PLT\>100G/L; ALT and AST\<2.5ULN; TBIL\<1.5 ULN; Cr\<1.0ULN;
7. Left ventricular ejection fraction\>60%;
8. Good compliance and ability to accept long-term follow-up;
9. Sign informed consent.

Exclusion Criteria:

1. Gastrointestinal obstruction or recurrent bleeding cannot be controlled;
2. Those who cannot swallow pills;
3. Diagnose immunodeficiency or active autoimmune diseases, have received or are currently receiving immunomodulators, systemic steroid therapy, or immunosuppressive drugs within the past two years;
4. Interstitial pneumonia;
5. Moderate to severe cirrhosis caused by any reason;
6. Uncontrollable hypertension, severe kidney disease, and significant cardiovascular and cerebrovascular diseases;
7. Active infections that require systemic treatment;
8. Previously suffered from other tumors, excluding cured skin cancer and cervical cancer in situ;
9. Internal medicine diseases that do not meet the chemotherapy criteria at the same time;
10. Pregnant and lactating patients;
11. Individuals with a history of mental illness and poor compliance.
A Study on the Effects of Dextrose Solutions on the Course of Labor

The purpose is to determine in term nulliparas with singletons that present in active labor (3-5 cm) or with ruptured membranes whether the administration of dextrose solutions to normal saline improves or expedites the course of labor. The researchers' hypothesis is that the addition of a carbohydrate substrate will shorten the length of labor and facilitate a vaginal delivery.

Factors that affect the course of labor have been studied extensively. Surprisingly, there is little data on the effect that different types and rates of intravenous (IV) fluids have during labor. Exercise physiologists have shown that increased fluid intake and carbohydrate replacement improve skeletal muscle performance in prolonged exercise. In a 1992 randomized, controlled study comparing IV fluid rates, Garite et al. showed a lower frequency of prolonged labor, and possibly a decreased need for oxytocin, with higher IV fluid rates in labor. Inadequate hydration may contribute to dysfunctional labor and possibly an increased rate of cesarean section.

We propose that inadequate carbohydrate replacement in labor may also contribute to prolongation of labor and increased need for operative delivery. Glucose is the main energy supply for the pregnant uterus. Physiological requirements for glucose during labor are approximately 10 grams per hour. Adequate supplies of glucose are needed to maintain exercise tolerance and muscle efficiency, which are important factors in the progress of labor. Dysfunctional labor or dystocia, which is the leading indication for primary cesarean delivery, is caused by uterine forces insufficiently strong or inappropriately coordinated to efface and dilate the cervix. Dystocia can also be a result of inadequate voluntary muscle effort in the second stage of labor. It contributes to increased risk for chorioamnionitis, which is a leading cause of maternal and fetal morbidity and mortality. Supplying carbohydrate fuel for working uterine and skeletal muscle may improve progress in labor and, therefore, diminish risk for chorioamnionitis and need for cesarean delivery.

Eligibility Criteria:
* Primiparous
* Singleton gestation
* Vertex presentation
* Spontaneous active labor with or without pitocin augmentation
* Gestational age \> 36 weeks
* Cervical dilation 3 to 5 cm with or without ruptured membranes

Exclusion Criteria:

* Multiparous
* Pregestational or gestational diabetes mellitus
* Preeclampsia at admission
* Previous cesarean section
* Non-vertex presentation
* Multiple gestation
* Chorioamnionitis at admission
* Intrauterine growth restriction (\< 10th percentile)
* Patients admitted for induction
Platelet Reactivity After TAVI: A Multicenter Pilot Study

A high platelet reactivity in patients with severe symptomatic Aortic Stenosis (AS) selected for TAVI (Transcatheter aortic valve implantation) procedure has been demonstrated previously, and the use of double antiaggregation therapy (DAPT) with Clopidogrel and Acetylsalicylic acid (ASA) do not achieve consistent and adequate suppression of platelet reactivity. The purpose of this study is evaluate the efficacy of ticagrelor alone versus DAPT with clopidogrel and aspirin for the suppression of high platelet reactivity following TAVI.


Eligibility Criteria:
Inclusion Criteria:

For inclusion in the study subjects should fulfill the following criteria:

1. Provision of informed consent prior to any study specific procedures.
2. Adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial.
3. Patients with degenerative symptomatic severe AS accepted for TAVI after evaluation of the Heart Team of each center.
4. Patients who are not participating in any other clinical trial or research study (registries allowed).

Exclusion Criteria:

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

1. Recent stroke \<14 days prior to TAVI, non-revascularized severe coronary or carotid artery disease (\>70% stenosis) or life expectancy \< 12 months
2. Patients under chronic oral anticoagulation
3. Patients with proven allergy to aspirin, clopidogrel or ticagrelor
4. Patients that after TAVI cannot undergo a regimen of single or dual antiplatelet therapy for 3 months due to a new post-TAVI medical indication
5. Known pregnancy or breast-feeding
6. Concomitant oral or intravenous therapy with potent inhibitors of cytochrome P450 3A (CYP3A) that cannot be suspended during the course of the study. Medications considered as potent inhibitors are: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (or erythromycin but not astromicin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and more than a daily liter of grapefruit juice.
7. Thrombocytopenia (\<50,000 platelets U/L) well documented and clinically relevant.
8. Patients with documented moderate or severe hepatic insufficiency
9. Any condition that may put the patient at risk or influence the outcome of the trial
10. Patients previously randomized in this trial or in another clinical trial with an investigational product or device over the past 30 days.
11. Patients who cannot attend follow up visits scheduled in the study
Tissue Analysis of Liver Grafts as a Predictor of Transplant Outcome.

Despite the good clinical results in terms of outcome with the application of HOPE prior to liver transplantation, very little is still known about the phenotypic and molecular changes that occur during perfusion/preservation during HOPE, particularly with regard to endothelial trophism and activation. Delving into these aspects would be very useful to allow personalised perfusion treatments in the future, thus improving the outcome of transplantation.

The primary aim of the study is the identification of specific 'endothelial signatures' (markers on tissue with immunohistochemistry and gene expression with RT-PCR) in liver grafts after HOPE treatment, predictive of transplant outcome. Interventional study without drug, including two cohorts of patients: (1) liver donors, on whom an allocation biopsy for organ quality will be performed (as standard of care); (2) liver recipients (from donors in cohort 1) on whom a study-specific biopsy will be performed as soon as the transplant has taken place (after vascular anastomoses with organ revascularisation). The study-specific biopsy constitutes the intervention of the study; patients will be treated according to the judgement of the physician and the information reported in the Technical Data Sheet of each product of any concomitant therapies administered according to clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* For Donors:

Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.

* HOPE performed on the liver graft prior to transplantation.
* For Recipients:
* Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.
* Age greater than/equal to 18 years.

Exclusion Criteria:

* None
Heart Rate Variability (HRV) Biofeedback to Treat Ulcerative Colitis

This is a prospective interventional study exploring the modifiability of physiological metrics, namely Heart Rate Variability (HRV), using a 5-week standardized HRV biofeedback intervention in subjects with symptomatic ulcerative colitis. Participants will be followed for 17 weeks. The goal is the understand if modifying these markers can impact ulcerative colitis related symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18-65 years old)
* Ulcerative colitis with a symptomatic flare (SCCAI ≥3) and without inflammation (FC\<250µg/ml)

Exclusion Criteria:

* Individuals who take medications known to alter heart rate variability
* Individuals with pacemakers or other implantable devices
Aerosolized Colistin to Mechanical Ventilated Patients With Pneumonia

The purpose of this study was to determine the effect of aerosolized colistin on to ventilated patients with carbapenem-resistant gram negative bacteria pneumonia. We hypothesize that adjunct aerosolized colistin, which achieve high drug concentrations in the airway, would more effectively treat the penumbra.

To treat respiratory infection of patients with mechanical ventilation, greater systemic antibiotic dose is required through the patient's venous injection. In this trial, patients with arbapenem-resistant gram negative bacteria pneumonia (CRGNB)were assigned to adjunct aerosolized colistin delivered by a jet nebulizer or a vibrating mesh nebulizer comparing to or standard intravenous injection by a randomizing protocol.

Need for a systemic antibiotic was determined by the clinical physician. Comparisons were made between standard care and study drug for their effects on bacteria eradiation, incidence of nephrotoxicity, and oxygenation.

Eligibility Criteria:
Inclusion Criteria:

* Patients received invasive mechanical ventilation \>48 hours
* Diagnosed with pneumonia caused by carbapenem resistance gram negative bacteria

Exclusion Criteria:

* pregnant or lactating women
* receiving colistin \> 3 days
* recurrent pneumonia caused by carbapenem resistance gram negative bacteria
* allergy to colistin or polymyxin B drugs
* immunocompromised, defined as neutropenia ANC\<500 cells/ul
* HIV positive
* received chemotherapy with 3 months
* renal function deficiency (creatinine clearance \< 30 ml/min)
Utility of the Superior Vena Cava Collapsibility Index (SVC-CI) to Predict Fluid Responsiveness in Patients With Coronary Artery Disease Undergoing Surgical Revascularization

To investigate the superior vena cava collapsibility index (SVC-CI), measured via transesophageal echocardiography (TEE), as a marker of fluid responsiveness. Two groups will be compared in this study. Groups will be identified by obtaining cardiac output (CO) by standard means using the TEE or pulmonary arterial catheter (PAC). Both of these monitors are considered standard for patient's undergoing coronary artery bypass grafting surgery (CABG) and recording initial CO readings. Based on CO, the patient's will be placed in study groups one or two. Participants with normal and mildly reduced left ventricular ejection fraction (LVEF \&gt;40%) for group one and those with moderately to severely reduced LVEF (\&lt;40%) in the second group.

Following group separation, we will measure the SVC-CI and CO metric in both groups. The intervention will be an operating room table tilt test (head up and then head down) to artificially simulate giving the patient additional fluid. Before and after table tilt, the SVC-CI and CO will be obtained and measured. The SVC-CI is a mathematical equation determined by distance measurements taken via TEE to identify how much the superior vena cava has collapsed following table tilt. Participants will be considered responders if the CO increases by 12% following intervention. Non responders less than 12% change in CO following intervention. Our hypothesis is that the SVC-CI can differentiate responders vs non-responders with regards to fluid responsiveness with adequate sensitivity and specificity in participants with CAD undergoing isolated CABG. The SVC-CI numerical values for the two groups, responders and non-responders, will calculate a threshold of sensitivity and specificity percentages for future patients undergoing CABG.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18
2. Participants with CAD undergoing CABG utilizing cardiopulmonary bypass
3. Participants who are able to consent for themselves
4. Primary language is English

Exclusion Criteria:

1. Age less than 18 years of age
2. Participants with CAD undergoing off-pump coronary artery bypass (OP-CAB)
3. Severe cardiac valvular pathologies or active congestive heart failure
4. Participants in active arrhythmia such as atrial fibrillation and atrial flutter at the time of data collection.
5. Participants who are unable to consent for themselves
6. Primary language is something other than English
Vestibular Nerve Stimulation to Improve Sleep

A randomized, double blind sham controlled clinical trial to evaluate the efficacy of vestibular nerve stimulation (VeNS) compared to a sham control a as a means of improving sleep as measured by ISI scores and EEG recordings

The purpose of this investigation device study is to collect data that will be used to design appropriate pivotal studies that can be used for regulatory submissions, primarily in the United States of America (USA), but it may also be used to support submissions in other regions, including the European Union (EU).


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Both genders
* Ages 18-24 years inclusive
* Score above 14 in the insomnia severity index questionnaire
* Willingness to participate in the study.

Exclusion Criteria:

* Use sleep medication
* Ear problems
* Under any kind of treatment
* Practicing sleep improving techniques
* Any other significant health-related problems.