cyrilzakka/clinical-trials huggingface dataset:
The LEADLESS II IDE Study for the Nanostim Leadless Pacemaker

Prospective, non-randomized, single-arm, international multicenter, clinical safety and effectiveness of a leadless pacemaker system in patients who are indicated for a VVIR pacemaker.

Following completion of enrollments in the IDE, patients will continue to be enrolled in the continued access phase of the study under the same protocol.

The purpose of this study is to evaluate the safety and effectiveness of the leadless pacemaker system in treating patients with a slow heart rate or irregular heartbeats. The Nanostim leadless pacemaker provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for permanent implantation in the right ventricle. As a leadless pacemaker, it does not need a connector, pacing lead, or pulse generator pocket, but it has the same operating principles as a conventional pacemaker.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must have one of the clinical indications before device implant in adherence with Medicare, ACC/AHA/HRS/ESC single chamber pacing guidelines including:

   * Chronic and/or permanent atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block), including slow ventricular rates (with or without medication) associated with atrial fibrillation; or
   * Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or
   * Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and
2. Subject ≥18 years of age; and
3. Subject has life expectancy of at least one year; and
4. Subject is not enrolled in another clinical investigation; and
5. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
6. Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the IRB; and
7. Subject is not pregnant and does not plan to get pregnant during the course of the study.

Exclusion Criteria:

1. Subject has pacemaker syndrome, has retrograde VA conduction or suffers a drop in arterial blood pressure with the onset of ventricular pacing; or
2. Subject is allergic or hypersensitive to \<1 mg of dexamethasone sodium phosphate; or
3. Subject has a mechanical tricuspid valve prosthesis; or
4. Subject has a pre-existing endocardial pacing or defibrillation leads; or
5. Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); or
6. Subject has an implanted vena cava filter; or
7. Subject has evidence of thrombosis in one of the veins used for access during the procedure; or
8. Subject has an implanted leadless cardiac pacemaker; or
9. Subject had recent cardiovascular or peripheral vascular surgery within 30 days of enrollment
Mediterranean Diet and Nutritional Support in Heart Failure Sarcopenia

Heart failure (HF) is a chronic disease with an increasing incidence; it represents the final stage of multiple cardiac diseases and significantly affects the QoL of the patients. Its prevalence is about 26 million people in the world, especially in elderly. Sarcopenia has been directly associated with the presence of increased comorbidity in patients with HF. In this study the investigators aim to compare the clinical evolution of patients with HF after receiving nutritional support with Mediterranean diet alone or in combination with a hypercaloric, hyperproteic oral nutritional Supplement

All participants will receive general counseling, education about MedDiet and vitamin D supplementation in order to reach levels of sufficiency (25OH vitamin D\>30 ng/dL) for avoiding confounding results. Participants (n=50) will be randomly allocated to MedDiet or MedDiet plus hypercaloric, hyperproteic standard oral nutritional supplement (ONS), 2 ONS per da). Participants will be evaluated at baseline, 12 and 24 weeks after nutritional support

Eligibility Criteria:
Inclusion Criteria:

* - Patients with a previous admission due to HF in the previous 12 months
* Moderate or severe LVEF
* Both sexs
* Age \>18 years old.

Exclusion Criteria:

* MDRD \<15 ml/min
* End-stage liver disease.
The Use of Computer-Assisted Learning Pediatrics Program (CLIPP) in the Pediatric Clerkship

The purpose of this study is to determine if utilizing CLIPP (Computer-Assisted Learning Pediatrics Program) cases in the pediatric clerkship will standardize students' exposure to essential pediatric conditions and enhance their learning experience.

The Computer-Assisted Learning Pediatrics Program was developed by members of the Council on Medical Student Medical Education (COMSEP) and has been very well received by both medical students and faculty. The program is a comprehensive Internet-based learning method designed for use by third year medical students during their pediatric rotation. More than 80 medical schools in the US and Canada have been successfully using the CLIPP cases with an estimated 3000 to 4000 cases being reviewed by students weekly. All third year medical students will be required to complete specific cases, based on gaps identified through review of prior student contact logs. Using the students' own patient contact logs, they will also be strongly encouraged to complete any cases for which they have not met the clerkship requirement. Students will be allowed to complete any other cases they choose. The study proposes that by utilizing CLIPP cases in the pediatric rotation, student exposure to essential pediatric conditions will increase, thereby increasing retention of knowledge and increasing their performance on end of clerkship OSCEs (Observed Structured Clinical Exam) and on NBME Pediatric Subject Exam (shelf exam).

Eligibility Criteria:
Inclusion Criteria:

* all third year medical students will be required to complete a specific number of CLIPP cases as part of their pediatric rotation.

Exclusion Criteria:

* none
JAK Inhibition in Ulcerative Colitis

The treatment for Ulcerative Colitis (UC) aims to achieve and maintain remission and is usually lifelong and expensive. Current available medications are unable to break the cycle of chronic inflammation, and still a significant proportion of patients will fail to respond (primary non-response) or lose response over time (secondary non-response). There is now growing evidence that there is substantial interpatient variation in the composition of the inflammation associated network of immune cells. A deeper knowledge of the patient's alterations in the mucosal immune response would help identify key drivers of inflammation and select the appropriate therapy. By analyzing the changes in the composition of immune cells induced by Janus Kinase (JAK) inhibition, we aim to obtain a better insight into the mechanistic effects of JAK inhibition and the downstream effects. These mechanistic insights are needed to identifying potential responders and non-responders in the future.


Eligibility Criteria:
Age Ulcerative colitis active disease
A Dialectical Behavioral Therapy Digital Health Solution for Outpatients Seeking Support for Substance Use

The purpose of this study is to compare the feasibility, acceptability, and efficacy of a dialectical behavior therapy skills training webapp known as "Pocket Skills" in outpatients and community members seeking treatment for substance use, across those who receive immediate versus delayed access to the intervention (e.g., a waitlist control condition).

Seventy adult outpatients and community members seeking treatment for substance use from the Centre for Addiction and Mental Health Addictions Program will be randomized to receive immediate or delayed (1 month) access to a web-based DBT skills training intervention called Pocket Skills in addition to standard care. Participants will complete interviews and questionnaires at baseline. Following baseline, participants complete questionnaires at months 1, 2, and 3 months. Measures will assess alcohol and drug consumption, substance use disorder symptoms, and other clinical features.

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years of age
2. Fluency in English
3. Understanding and willingness to comply with study requirements
4. Referred to Addictions Program at CAMH or seeking treatment from the community and currently waiting for psychosocial services
5. Smartphone, tablet, or computer with access to the Internet
6. Reports at least "contemplation" levels of wanting to reduce substance use
7. Use of target substance in past month
8. Alcohol or substance use disorder in the past year

Exclusion Criteria:

1. Any known practical factor that would preclude participation (e.g., extended absences)
2. Untreated or unstable severe psychiatric or medical disorder that precludes participation in the study (e.g., acute suicidality, untreated psychosis)
3. Participation in another treatment/intervention study
EU Safety and Efficacy Study Regarding the R3 Acetabular Hip System

The objective of this study is to determine the long-term safety and effectiveness from the R3 Acetabular Hip System. The study hypothesis is that implant survivorship of the R3 cup is at least 97% at 3 years, 95% at 5 years, 93% at 7 years, and 90% at 10 years follow-up.

This is a multicenter prospective observational post-market clinical follow-up study that will include 500 patients who will have total hip replacement with the R3 Acetabular System and either cemented or cementless hip stem.

Effectiveness will be assessed by comparison of changes in parameters contained in the HOOS questionnaire and based upon incidence of revision and change in Harris Hip Score and UCLA Rating. Safety will be measured by assessing all adverse events experienced by patients from study enrolment through to study completion.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following characteristics for inclusion in the study.

* Patient is 18-75 years old and he/she is skeletally mature
* Patient requires primary total hip arthroplasty due to non-inflammatory degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/DDH or inflammatory joint disease (e.g., rheumatoid arthritis)
* Patient has met an acceptable preoperative medical clearance and is free from or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
* The patient is willing to comply the follow-up schedule

Exclusion Criteria:

Subjects with any of the following characteristics must be excluded from the participation in the study.

* Patient has active infection or sepsis (treated or untreated)
* Patient is a prisoner or has an emotional or neurological condition that would pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse.
* Patients with acute hip trauma (femoral neck fracture)
Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea

Irinotecan (7-ethyl-10- {4(-1-piperidino)-1-piperidino} carbonyloxy camptothecin) is a semisynthetic camptothecin derivative introduced in the 1980's. Irinotecan is a prodrug metabolized by carboxylesterases to an active metabolite 7-ethyl-10-hydroxy-camptothecin (SN38). SN38 exerts its cytotoxic effect by forming stable complexes with topoisomerase I and DNA. These complexes collide with replication forks and cause breaks in DNA. Studies substantiated irinotecan's activity in 5FU resistant colorectal cancer and led to its approval for treatment of 5FU resistant colorectal cancer in the United States, Canada and Europe.Colorectal cancer studies demonstrated that single agent irinotecan's dose limiting toxicity was diarrhea occurring 5 to 6 days after its administration. High dose loperamide at first occurrence of diarrhea has decreased the incidence of diarrhea but the incidence of grade 3/4 diarrhea remains high at 28 to 40%.


Eligibility Criteria:
Inclusion Criteria:

* metastatic colorectal cancer to be treated with FOLFIAT chemo

Exclusion Criteria:

* severely abnormal liver and kidney function
Clinical Outcome After Lumbar Fusion

The main objective of this prospective study is to compare the clinical outcomes after lumbar fusion for chronic low back pain using the four techniques commonly employed in our surgical practice. Lumbar fusion stops motion at a painful vertebral segment, which can decrease back pain. The four techniques are standard transforaminal lumbar interbody fusion (S TLIF), minimally invasive transforaminal lumbar interbody fusion (MI TLIF), extreme lateral interbody fusion (XLIF), and axial lumbar interbody fusion (AxiaLIF). Each differ in where incisions are made and level of invasiveness; not all may be implemented in each surgical case. The four different techniques are all standard approaches with different advantages and have yet to be compared in efficacy for relieving chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Severe chronic low back pain (at least 7 out of 10 on the VAS scale).

  * Age: 25-65 years.
  * Pain duration at least 2 years.
  * The treating surgeon should interpret the pain as emanating from L4-S1.
  * The patient must have had unsuccessful maximal possible conservative (non surgical) treatment for at least one year.
  * Radiographic evidence (MRI, CT, CT-SPECT, and/or plain films) of degenerative changes ("spondylosis")

Exclusion Criteria:

* Psychiatric illness or evidence of emotional instability.

  * Previous spine surgery except for successful removal of a herniated disc more than 2 years before entering the study and with no persistent nerve root symptoms.
  * Specific radiologic findings, such as fractures, infection, inflammatory process, or neoplasm.
  * Obvious painful and disabling arthritic hip joints and anamnestic and radiologic signs of spinal stenosis.
  * Involvement in Workman's Comp or litigation.
Intermittent Suction Technique in the Diagnosis of Pancreatic Solid Lesions

The aim of this study is to compare the diagnostic yield of intermittent versus continuous suction in the diagnosis of pancreatic solid lesions.

Solid lesions of the pancreas can be neoplastic or non neoplastic and it is important to accurately differentiate between them because of the poor prognosis related to pancreatic neoplasm. There are many types of solid pancreatic lesions: pancreatic adenocarcinoma, neuroendocrine tumor, lymphoma, solid pseudopapillary neoplasm and pancreatic metastasis.

There are several diagnostic methods for the study of pancreatic solid lesions. The different imaging test allow detection and characterization of those lesions, but most times an anatomopathological diagnosis is needed before stablishing the most appropriate treatment.

Endoscopic Ultrasound guided fine needle aspiration (EUS-FNA) is the diagnostic method of choice for the diagnosis of these lesions as it detects small lesions that sometimes cannot be found in radiological imaging test, evaluates vascular invasion and the presence of liver metastasis, and allows pancreatic puncture for a cytological diagnosis. EUS-FNA is the safest technique for pancreatic puncture and the least related to needle track seeding.

In order to gather as much material as possible different techniques have been proposed:

* Fanning technique and multiple pass technique: to guide the needle into different regions of the target lesions with or without removing the needle out of the lesion depending on wether the lesion is hard or soft.
* Use of stylet: there are no data clearly demonstrating that the use of suction increases the yield of EUS-FNA. Some authors do slow withdrawal of the stylet.
* Size of the needle: 19 gauge, 22 gauge, 25 gauge, depending on the localization, size and vascularization. There is increasing evidence that smaller needles offer at least similar results in diagnostic yield compared to larger needles and are also easier to manipulate.
* Use of suction: there is conflicting evidence in this point. Several studies have evaluated the use of high volume aspiration vs low volume aspiration, continous aspiration vs no aspiration and suction with empty syringe vs water-filled syringe but none is clearly better than other.

The investigators aim is to evaluate if the use of intermittent suction improves the diagnostic yield of pancreatic lesions compared to standard (continuous) suction. Up to our knowledge this method has not been yet evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic solid lesion
* Patients over 18 years old
* Suitable for endoscopy

Exclusion Criteria:

* Contraindication for endoscopy
* Active anticoagulant therapy
* Thrombocytopenia or coagulopathy in the absence of its correction prior to the procedure
* Absence of informed consent
* Pregnancy
* Not accessible lesion for endoscopic ultrasound puncture
Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia

The prevalence of cervical neoplasia in Cambodia is not known. There are no screening programs in place. The investigators plan on introducing a screening program based on WHO criteria and utilizing visualization with acetic acid. Patients who are positive will be offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).


Eligibility Criteria:
Inclusion Criteria:

* female, age 30-49, able to give informed consent

Exclusion Criteria:

* pregnancy, gross cervical mass, prior cervical cancer, unable to give informed consent, prior complete hysterectomy, allergic to acetic acid
Is Thymus Size of Infants Who Born to COVID-19 Positive Mothers Associated With Neonatal Morbidities?

COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.

COVID-19 infected pregnant women is thought to have variable degrees of inflammatory response against the disease. Fetus is known to be influenced by maternal systemic infections. Thymus size of fetus and the neonate, is proven to be changed by primarily inflammatory/infectious diseases. Investigators of present study, suggested that fetuses are affected from the possible fetal inflammatory syndrome in case of maternal COVID-19. Therefore the aim of his study is to evaluate that if the cardiothymic index is affected by the maternal COVID-19 and to demonstrate any possible association of this measurement with neonatal morbidities.

Eligibility Criteria:
Inclusion Criteria:

* Infants born to COVID-19 positive or negative mothers
* Accepted to participate with an informed consent
* Infants who required to get chest X-ray within the first 6 hours

Exclusion Criteria:

* Infants whose mothers' have any kind of acute or chronic systemic disease or inflammation/infection
* Lack of an informed consent
* Infants who did not require to get chest X-ray within the first 6 hours
Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

The goal of this clinical trial is to learn about the effect of intraoperative esketamine infusion on postoperative sleep disturbance(PSD) of patients undergoing spinal surgery. The main aims to answer are:

* To explore the effect of intraoperative infusion of esketamine on the incidence of postoperative sleep disturbance and sleep quality in patients undergoing spinal surgery.
* To explore the effect of intraoperative infusion of esketamine on postoperative pain, anxiety and depression ; Participants will be patients undergoing spinal surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg/h esketamine or saline will be infused during surgery . The incidence of sleep disturbance , sleep quality, pain scores, hospital anxiety and depression scores and perioperative adverse events after surgery will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old,
* American Society of Anesthesiologist (ASA) Physical Status classification I to III ;
* Patients scheduled to undergo elective spinal surgery under general anesthesia;
* Signed informed consent ;

Exclusion Criteria:

* BMI \> 35kg / m2 ;
* Severe lesions of important organs and systems ;
* The estimated duration of surgery is more than 4 hours
* Patients who were retained tracheal intubation or admitted to intensive care unit (ICU) postoperatively.
* History of adverse reactions or contraindications to ketamine and esketamine ;
* Cognitive dysfunction, communication disorders ;
* Refused to participate in this study.
Sexual Dysfunction Among Inflammatory Bowel Disease Adults-Clinical Trial

Patients with Inflammatory Bowel Disease (IBD) have higher rates of sexual dysfunction than the general population. We offer an educational program on IBD including a specific discussion on intimacy and sexuality for IBD patients. Our objective is to investigate the benefit of this intervention on sexual function in patients with IBD.

Patients with Inflammatory Bowel Disease (IBD) have higher rates of sexual dysfunction than healthy controls. No interventional study has addressed this matter so far. The aim of our study is to investigative the benefit of a psycho-educational intervention on sexual function in patients with IBD, by comparing patients participating to an educational program including a specific discussion on intimacy and sexuality to patients followed in usual care.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Crohn's disease or Ulcerative Colitis diagnosed according to usual criteria
* Participation to IBD educational program

Exclusion Criteria:

* Unability to read or write French
* Patients without sexual activity for religious reasons