cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Peripheral, Cobalt-chromium Sirolimus Eluting Stent (PERS) Versus Cobalt-chromium Stent (Neptune C)

The aim of this study is to assess the safety and efficacy of PAD treatment by revascularization with new cobalt-chromium sirolimus stent implantation, which is expandable on balloon PERS (CoCr SES) compared to cobalt-chromium balloon-expandable (Neptun C) stent (CoCr BMS) in patients with symptomatic iliac arteries disease requiring revascularization.


Eligibility Criteria:
Inclusion Criteria:

1. De novo lesion or restenosis without previously implanted stent, in a common or external iliac artery with a reference diameter of 5 to 12 mm, length up to 10 cm and stenosis ≥ 50% and ≤ 99% (in quantitative assessment by peripheral angiography), which may be treated with one stent or total occlusion of vessels up to 50 mm long.
2. Ability to cross the lesion with guidewire (assessed during diagnostic angiography).
3. ABI ankle-brachial index \<0.9.
4. Signs of lower limb ischemia based on the Rutherford scale in the range from 2 to 4.
5. Age ≥ 18 years.
6. Patient signed informed consent form.

Exclusion Criteria:

1. Life expectancy less than two years.
2. Chronic kidney disease in stage III-V.
3. Lesion in the previously implanted by-pass.
4. Target lesion is a chronic total occlusion of significant length, not eligible for percutaneous revascularization.
5. Acute lower limb ischemia.
6. Stenosis (\> 50%) or occlusion proximally to the lesion being treated.
7. Angiographically confirmed thrombus in the lesion to be treated.
8. Treatment requires an atherectomy to deliver stent to treated lesion.
9. Known allergy or hypersensitivity to clopidogrel.
10. Hemorrhagic stroke in the last three months.
11. Contraindications for acetylsalicylic acid (hypersensitivity, hemorrhagic diathesis).
12. Pregnancy or women of childbearing potential not using effective contraception.
13. Active inflammation at the planned access site.
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?

The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication

Exclusion Criteria:

* Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD
* Patients with known and documented allergies to any of the penicillins, cephalosporins, or β-lactamase inhibitors
* Patients who are otherwise ineligible to receive the antibiotics in this study
* Patients highly unlikely to undergo PD according to the surgeon's judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc.
* Patients with long-term glucocorticosteroid use. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
* Patients unable to provide informed consent
* Creatinine clearance (CrCl) \</= 40 mL/min
* Patients receiving hemodialysis or peritoneal dialysis
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
* Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery
Assessment of Intravitreous Injections of Vitrase for Inducing Posterior Vitreous Detachment

The purpose of this study is to assess the efficacy of intravitreous injections of Vitrase to induce posterior vitreous detachment(PVD) in subjects with moderate to severe non-proliferative diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Moderately severe to severe non-proliferative diabetic retinopathy
* Best Corrected Visual Acuity (BCVA) in Early Treatment Diabetic Retinopathy Study (ETDRS) with pinhole of 20/320 or better in study eye \& 20/50 or better in non-study eye.

Exclusion Criteria:

* Contraindications or hypersensitivities to Vitrase or anesthesia
* Any significant illness that could be expected to interfere with trial
* Prior Vitrase therapy
* Either a past diagnosis of clinically significant macular edema (CME) in study eye that required treatment or current CME that may require focal laser treatment within the next 30 days
* For either eye: ongoing ocular infection, inflammation or history of herpetic corneal lesion; an intravitreous injection within 30 days; glaucoma; intraocular pressure (IOP) of less than 5mmHg; retinal detachment or ocular tumors
* For study eye: vascular occlusive disease of fundus; corneal, lenticular or ocular media abnormalities; a significant ocular trauma within 6 months; previous vitrectomy; any prior laser treatment, cryo-retinopexy or any intraocular surgery; either a partial or complete posterior vitreous detachment (PVD); myopia of 6 or more spherical diopters and/or axial length exceeding 26mm; significant retinal pathology
Spinal Cord Stimulator Implant Study

This study is for patients who have been approved by their doctors and insurance companies to receive spinal cord stimulator implants.

The goal of this study is to investigate if pain and disability is improved in patients with an implant in combination with coping skills training. These patients are compared with those with an implant that receive chronic education information and those with an implant that are in the control group and receive no additional training or information.

This study tests the hypotheses that a pain coping skills program in combination with an SCS implant can improve short- and long-term outcomes in self-efficacy for coping with chronic pain, physical disability, psychological distress, and pain intensity.

Participants are patients who have been approved by their doctors and insurance companies to receive the spinal cord stimulator trial. After patients have been approved, they can be enrolled in this study. After completing a baseline evaluation, patients are randomized into (1)six individual pain coping skills training sessions(relaxations techniques, communication skills, goal setting), (2) six individual chronic pain education sessions (discussion approach to etiology and treatment of chronic pain and information on spinal cord stimulator implants, or (3) treatment as usual (no study intervention).

Participants are evaluated prior to or shortly after their surgery, at post treatment, at 6 month follow-up and at 12 month follow-up. All participants continue their routine medical care throughout the study.

Eligibility Criteria:
Inclusion Criteria

* daily back pain for 6 months or more
* approved by physician and psychologist for implant
* ability to read and write English
* at least 18 years old

Exclusion Criteria:

* pending litigation
* not approved for implant
Efficacy of Immunomudulatory Therapy With All-trans Retinoid Acid for Adults With Chronic Immune Thrombocytopenia

The purpose of this study is to determine whether All-trans retinoic acid (ATRA) are effective in the treatment of refractory idiopathic thrombocytopenic purpura (RITP).

Idiopathic thrombocytopenic purpura(ITP), an acquired immune disease is characterized by impaired generation of autoantibody-specific platelet. At least 30% adult patients turn into refractory ITP. The pathogenesis of ITP remains to be elucidated. Now ,CD4+ helper cells have been classified as belong to T-helper 1(TH1), T-helper 2(TH2), T-helper17and Regulory T cell(Tregs). All-trans retinoic acid(ATRA) mainly applied in skin disease and acute promyelocytic leukemia. Recently, ATRA is also a immunomodulator which can induce differentiation, proliferation, apoptosis of cells, and immunomudulatory. In the international, the investigators first treat RITP with ATRA. To investigate the therapeutic effects of ATRA on RITP, and using new index in the cells, cytokines and molecular biology of three in-depth study of its mechanism.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of refratory idiopathic thrombocytopenic purpura
* Hormone and immune suppression, splenectomy is invalid

Exclusion Criteria:

* Other autoimmune diseases
HRCT in Prediction of Tumor Invasion in GGO Lung Adenocarcinoma (ECTOP-1008)

This study is one of Eastern Cooperative Thoracic Oncology Projects (ECTOP-1008). It aims to evaluate the correlation between radiological diagnosis based on HRCT and pathological invasiveness.Investigators observe the radiological features and the correlation with the postoperative pathological findings.

Preoperative evaluation of pathologic tumor invasion of ground glass opacity (GGO) featured lung adenocarcinoma is important for selection of appropriate surgical extent. Whether thoracic high-resolution computed tomography (HRCT) scan could precisely predict pathologic tumor invasion remains unknown. Patients with peripheral GGO nodules (GGNs) would be enrolled, and HRCT with target scan would be performed preoperatively. Pathologic tumor invasion (invasive adenocarcinoma \[IAD\] versus adenocarcinoma in situ \[AIS\]/minimally invasive adenocarcinoma \[MIA\]) would be evaluated according to radiologic parameters of HRCT before surgery. Primary endpoint of this trial is the diagnostic sensitivity of pathologic tumor invasion evaluated by HRCT. Secondary endpoint is the diagnostic value of radiologic parameters of HRCT for pathologic tumor invasion of GGO featured lung adenocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

(1) GGNs on HRCT scan; (2) clinical stage IA; (3) simultaneously no more than three nodules; (5) Age ranging from 15 to 85 years.

Exclusion Criteria:

(1) pathologically confirmed non-adenocarcinoma; (2) patients who did not receive surgery.
Metagenomic Next-Generation Sequencing for Diagnosis of Ascites Infection in End-stage Liver Diseases

Ascites is the most common complication of cirrhosis, and its development is associated with substantially increased mortality. Ascites infection including spontaneous bacterial peritonitis (SBP), bacterascites and fungal infections. SBP is one of the most feared complications of ascites. The EASL guidelines recommend that diagnostic criteria of SBP is defined on the ascitic fluid polymorphonuclear leucocytes (PMN) count ≥250 cell/μl, with or without ascites fluid positive culture. However, in clinical practice. Up to 30% of hospitalized patients are considered as suspicious SBP, and treated as SBP without a laboratory-confirmed cause of infection. and is present in 10-30% of all hospitalized patients with ascites. Besides, fungal infection in ascites was aslo related to high mortality in cirrhosis patients.

Thus, to diagnose ascites infection promptly is the key step to prevent the complication. Since, the sensitivity of bacterial culture is limited even if ascites is directly injected into blood culture bottles at the besides. New method to identified the pathogen is needed.

Here, we aim to use metagenomic next-generation sequencing(mNGS) to provide the first-ever demonstration of precision medicine for the diagnosis of ascites infection in hospitalized patients, with immediate impact on clinical care and patients outcomes. The method of mNGS is undertaken by BGI Genomics Company which is a licensed clinical diagnostic laboratory in China. In this multicenter and prospective clinical study, we are planning to detect ascites sample by mNGS and compare the performance of mNGS and routine microbiological testing. Ultimately, we aim to improve the diagnosis of ascites infection and improve patients' outcomes.

The study is divided into 2 parts:

Firstly, the study will test 3 types of sample by means of mNGS, including ascites fluid, peritoneal dialysis fluid and postoperative drainage fluid and evaluate the sensitivity and specificity of NGS.

Secondly, the clinical validation of mNGS will be performed in multicenters for ascites infection in cirrhosis patients. Furthermore, the study will collect the paired plasma sample for NGS testing at the same time to evaluate the protential sources of microorganisms in ascites.The aim of the study is to observe the performance of mNGS in ascites infection diagosis and the protential clinical effect in cirrhsis patients.

Eligibility Criteria:
Inclusion Criteria:

1. Hospitalization cirrhotic patients;
2. Age \>18 years old;
3. Paitents with ascites at hospital admission.

Exclusion Criteria:

1. Pregnant women;
2. Hepatic tumor or extrahepatic related cancer;
3. Identified secondary peritonitis;
4. Ascites not related to portal hypertension;
5. Not provide written consent.
Vaginal Progesterone to Prevent Preterm Delivery in Women With Preterm Labor

The administration of vaginal progesterone, in addition to standard tocolysis, will decrease the risk of delivering prematurely and of recurrent preterm labor. We also hypothesize that the reduction in preterm delivery will be associated with a decrease in infant mortality and morbidity.

The principal aim is to demonstrate that progesterone reduces preterm birth before 37 weeks of gestation. Secondary aims are to show that progesterone 1) reduces preterm birth before 32 and before 34 weeks of gestation 2) reduces the number and duration of recurring episodes of preterm labor and 3) reduces infant mortality and morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 240/7 et 336/7 weeks of gestation (based on a reliable estimate by ultrasound performed before 22 weeks)
* Singleton pregnancy
* Intact membranes
* Preterm labor defined as:

  * 2 or more regular and painful uterine contractions in 10 minutes plus one or plus of the following criteria:
  * short cervix detected by vaginal ultrasound scanning (cervical length less than 30 mm until 31 weeks and less than 25 mm from 32 weeks)
  * cervical changes detected clinically (cervical length less or equal 10 mm or Bishop score less than 6
  * cervical changes during hospitalization (more or equal 5 mm between two clinical or US exams)
  * positive fetal fibronectin
* Age ≥ 18 years old
* Signed informed consent
* Possible and accepted follow-up

Exclusion Criteria:

* Multiple gestation
* Cervical cerclage
* Hydramnios (AFI \>95th percentile for gestational age or greatest pocket \>8 cm)
* Premature rupture of membranes
* Chorioamnionitis (criteria for clinical diagnosis are: elevated WBC, elevated CRP, maternal tachycardia, fetal tachycardia, uterine tenderness and/or amniotic fluid foul odor)
* Cervical dilatation \> 3 cm
* Placenta praevia or abruptio placentae
* Intra-uterine growth restriction or non-reassuring fetal status
* Pre-eclampsia or severe hypertension
* Any other maternal or fetal pathology which should indicate medically preterm delivery
Quality of Life in Patients Post Radiofrequency Ablation

Radiofrequency ablation is a procedure done in the Catheterization Laboratory to help correct specific problems that cause the heart to beat faster than it should. Quality of life includes the physical as well as the emotional aspects of a patient. Doctors have always tried to take care of a medical problem with minimal physical and emotional risk. It is assumed that once the medical problem is fixed, the patient will have an improved quality of life. To know if this assumption is true, the investigators are asking children scheduled for this procedure, along with their family, to answer questions before the ablation, then answer the same questions 5-6 months after the ablation.

When a patient (age 5-18 years) is scheduled for an ablation at Children's Healthcare of Atlanta, the research coordinator contacts the family prior to the procedure and describes the study to them, details the goals, benefits versus risks, and answers any questions they may have. Written consent is obtained from the parents. Assent is obtained from the child. Both the parent and child are given the age appropriate Peds QL (tm) Pediatric Quality of Life Inventory, version 4.0. The forms are returned to the research coordinator. If the child is ablated, then 5-6 months after the ablation, the same questionnaire is sent to the child and parent. Data are entered into a database.

Eligibility Criteria:
Inclusion Criteria:

* 5-18 years of age
* English is the primary language
* Scheduled for an ablation at Children's Healthcare of Atlanta
* Normally structured heart

Exclusion Criteria:

* Congenital heart defect
* English is not the primary language
* Children with significant neurocognitive deficits as determined by the investigator
Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas

Comparison of methotrexate versus interferon-alfa 2b on efficacy, safety and quality of life in patients with primary cutaneous T-cell lymphomas after failure of topical or phototherapy treatment.

Methotrexate and interferon are widely used drugs in treatment in patients with cutaneous T-cell Lymphomas. Efficacy and safety of both drugs have never been compared directly in one study.

Patients will be randomly assigned to receive Methotrexate or Interferon Alfa 2b. Treatment will continue until disease progression or the development of intolerable toxicities. Study is conducted to analyse and compare efficacy, safety and quality of life provided by Methotrexate or Interferon Alfa 2b.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed primary cutaneous T-cell lymphoma (CTCL)
2. Age ≥ 18 years
3. Performance status WHO\<=2
4. Subject must have adequate bone marrow, renal and hepatic function
5. Topical and phototherapy treatment failure in the past
6. Signed informed consent

Exclusion Criteria:

1. Subject has received prior systemic methotrexate or interferon therapy
2. Unacceptable methotrexate or interferon treatment toxicity in the past
3. Inadequate bone marrow, renal or hepatic function as follows:

   * Bone Marrow: Absolute neutrophil count (ANC) \< 1,500/mm 3 (1.5 × 10 9 /L); Platelets \<100,000/mm 3 (100 × 10 9 /L); Hemoglobin \< 9.0 g/dL (1.4 mmol/L);
   * Renal function: Creatinine \>1.5 x Upper limit of normal (ULN)
   * Hepatic function: Aspartate and Alanine transaminase (AST and ALT) \>3× ULN; bilirubin \> 1.5 × ULN
   * Active hepatitis B or hepatitis C
4. anorexia
5. major depression with suicidal ideation or suicide attempt in the past
6. Symptomatic congestive heart failure
7. Epilepsia or other symptomatic central nervous system dysfunction
8. active skin infection not related to underlying CTCL, active Tuberculosis, HIV infection
9. Subject is pregnant or lactating
10. Psychiatric illness/social situation that would limit compliance with study requirements
The JUMPSTART Program: Encouraging Early Mobilization and Optimizing Recovery of TAVR Patients' Post-hospital Discharge

A virtual, self-directed, and tailored early mobilization program called JUMPSTART, that aims to bridge cardiac rehabilitation intake for post-TAVR patients has been developed at the Hamilton General Hospital. The program includes a series of exercise videos at varying levels of intensity, designed for patients to follow at home, post-discharge. JUMPSTART is currently being offered as part of clinical care. In this new pilot study, the study team plans to develop and test new strategies to optimize recruitment and participation, develop additional JUMPSTART materials and evaluate outcomes through follow-up surveys and registry/administrative data at Hamilton General Hospital.

Post-TAVR patients who have successfully completed a pre-discharge ambulation assessment and are deemed eligible for discharge will be eligible to participate. Potential participants will be introduced to the study in the pre-TAVR clinic by the nurse practitioner or their delegate. Participants who agree to be contacted for research purposes will provide written consent in the pre-TAVR clinic when they meet with the nurse practitioner. Confirmation of eligibility for the research study will be conducted post-TAVR by the nurse practitioner. The JUMPSTART program will be offered to all eligible patients as part of standard clinical care, regardless of their consent to participate in the research study. No data will be collected for the purposes of the research study from patients who do not provide consent. The primary outcomes will be adoption (the number of eligible post-TAVR patients who participate in the JUMPSTART early mobilization program), and a preliminary comparison of quality of life (measured using the Toronto Aortic Stenosis Quality of Life Questionnaire) between people who do and do not participate in the JUMPSTART program.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients who have undergone a TAVR procedure at the Hamilton General Hospital
* Patients who are managed through the overnight-model pathway
* Patients who successfully completed ambulation assessment
* Patients who are deemed eligible for discharge

Exclusion Criteria:

* Patients who are hospitalized after the procedure (inpatients)
* Patients who had an axillary approach for TAVR
* Patients who had a pacemaker temporarily left in at the end of case, and
* Patients who received a permanent pacemaker in the last month
Effect of Core Stabilization Exercises and Neuromuscular Electrical Stimulation in Patients With Idiopathic Pulmonary Fibrosis

Interstitial lung disease (ILD) refers to various diseases that occur idiopathic or secondary to some causes, commonly affecting the lung parenchyma, and present with varying degrees of inflammation and fibrosis. Idiopathic pulmonary fibrosis (IPF) progressing with progressive shortness of breath causes a decrease in exercise capacity and quality of life, restrictive changes in pulmonary function tests and a decrease in diffusion capacity. It has been reported that core stabilization exercises improve respiratory function, respiratory muscle strength and functional capacity in healthy individuals and some disease groups. It has also been reported that neuromuscular electrical stimulation (NMES) applied to lower extremity, upper extremity and back or quadriceps muscles reduces dynamic hyperinflation and dyspnea during exercise and increases exercise capacity in COPD patients.No studies have been performed using core stabilization exercises and NMES in IPF patients. It can be assumed that this therapeutic intervention may also be useful in IPF.

Our study was planned to investigate the efficacy of core stabilization exercises and NMES in patients with IPF.

Stable idiopathic pulmonary fibrosis will be included in the study from the Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital. Patients will be randomized into 2 groups; Neuromuscular Electrical Stimulation (NMES) and Core Stabilization Exercises Training Group (n: 18): 2 days per week for 6 weeks duration. The demographic measurements, respiratory function test, respiratory muscle strength, dyspnea, 6 minutes walking test, quality of life, depression and clinical characteristics and physical fitness of the patients will be recorded. The following parameters will be evaluated before and after the training of the patients in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable
* Having no infection or exacerbation in the last 3 months
* Having no uncontrolled cardiological, psychological problems
* Having no neoplasm, sarcoidosis or collagen vascular diseases
* Having no neurological, inner ear or orthopedic disease
* Patients who volunteered to study

Exclusion Criteria:

* Over 75 years,
* Chronic obstructive pulmonary disease (COPD)
* Acute coronary artery disease,
* Collagen vascular disease,
* Pneumoconiosis,
* Sarcoidosis,
* Cancer
* Non-parenchymal restrictive lung disease and other serious comorbid conditions,
* Oxygen saturation in room air at rest \<80%
* During acute exacerbation,
* Echocardiography RVSP\> 50 mmHg
* Patients taking more than 20mg corticosteroid per day
* Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)