cyrilzakka/clinical-trials huggingface dataset:
HsTnT in Stable Coronary Artery Disease

Coronary artery disease (CAD) is one of the leading causes of morbidity and mortality worldwide. Life threatening manifestations such as acute myocardial infarction (AMI) and sudden cardiac death are the most important causes of death in many countries. Cardiac troponin is a biomarker with a high specificity for cardiac necrosis and is recommended for diagnosis of acute myocardial infarction by the Universal definition of myocardial infarction. Since a new generation of high-sensitivity cardiac troponin assays has become commercially available a few years ago, myocardial infarction can be detected earlier and even small AMIs, that were classified as unstable angina pectoris (UAP) with the less sensitive assays, are detectable now. On the other side, more patients with acute or chronic myocardial damage not due to AMI are identified now. Thereby, the reason for elevated troponin levels should be sought actively, because high troponin levels were associated with adverse outcome - independent of the underlying pathomechanism. The reasons for troponin elevations in patients with stable CAD are not clear yet. Associations with extensive atherosclerosis, carotid lesions and complex coronary plaques in coronary CT scans were reported. Therefore, patients with elevated troponin levels represent a risk population and might profit from intensified secondary prevention. In this context, ticagrelor might be part of a prevention strategy as currently tested in the PEGASUS trial.

We plan to conduct a single-centre pilot study in a cohort with clinically stable patients of our outpatient clinic, because data regarding prevalence, causes and prognosis of elevated troponin values in unselected cohorts is sparse. Therefore, all patients (n=910) that presented to our outpatient clinic 12 months after introduction of the high-sensitivity troponin T assay (june 2009) and were free of complaints or presented with UAP are being enrolled. All patients are characterized by demographic, laboratory and clinical characteristics (including medication) and all available imaging data (exercise-ecg, echocardiography, stress-echocardiography, computed tomography, cardiac MRI and coronary angiography) in order to compare baseline characteristics of troponin positive and troponin negative patients. In addition, the Framingham- and PROCAM-Score representing established calculators of long-term risk prediction are calculated.

Prognostic endpoints are defined as severe cardiovascular events and progress of the initially diagnosed disease. Those endpoints are associated with the initial hs-cTnT value and serial changes.


Eligibility Criteria:
Inclusion Criteria:

* Patients of outpatient clinic presenting 12 months after introduction of the hs-TnT test in june 2009

Exclusion Criteria:

* none
Case Series for Traumatized Refugees With Khat Dependence

The research project will offer psychotherapeutic treatment to Somali refugees with PTSD and comorbid khat dependence. In this case series, evidence-based techniques will be applied and adapted to the cultural background of Somali refugees in Kenya.

More than 500.000 Somali refugees live in Kenya. This group is especially burdened by high rates of exposure to traumatic events, high prevalence of PTSD and a high comorbidity with substance use disorders, mainly related to khat (catha edulis). There's a shortage of literature on psychotherapeutic methods that are applicable in this group. The aim of this case series is to develop modifications of standard therapeutic techniques to the Somali culture and to the needs of this group. Twenty successive cases will be recruited from a community clinic where refugees often seek for treatment because of psychiatric problems. Senior level psychotherapists will apply and adapt techniques and approaches like Community Reinforcement Approach (CRA), Relapse Prevention (RP), and Narrative Exposure Therapy (NET); all sessions will be video recorded. Regular supervision with external experts and group discussions will be held to evaluate and adapt the single procedures and techniques. The aim of this study is the development of a standardized approach that can be used in a Randomized Controlled Trial which will be conduced in the future.

Eligibility Criteria:
Inclusion Criteria:

PTSD (DSM-IV) Khat Dependence (DSM-IV)

Exclusion Criteria:

Severe Psychotic Disorder Suicidality Mental Disability
Urine Gene Analysis for Pathogen Detection

The objective of this study is the detection, quantification, and resistance gene identification of pathogens by using the urine of patients with urinary tract infection (UTI) symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women 60 years and older who have urinary tract infection
* Can participate in the informed consent process
* Presenting to the clinic with symptoms of UTI or cystitis with no recent history of UTI within the past 21 days
* Able to provide sufficient urine sample volume via clean catch or catheterization for urinalysis, conventional urine culture, and PCR
* Understand and are willing to comply with the study requirements.
* Sample collection able to be sent out the same day via courier

Exclusion Criteria:

* Individuals under 60 years of age
* Unable to provide informed consent
* Urinary diversion of any type
* Chronic indwelling urinary catheter
* No recent history of UTI within the past 21 days
* No antibiotic therapy within the past 21 days
* No recent therapy with Phenazopyridine
Could a Simple Information Booklet Modify Low Back Pain Patients Beliefs After Lumbar Discectomy?

The purpose of this study is to translate and assess an evidence based educational booklet on low back pain patients beliefs after lumbar discectomy.

A translation / back-translation of the Your back operation was performed and a before / after prospective study was realized. Main outcome assessment was the Quebec Questionnaire. Demographic data, personal medical sciatica pain history, graduation of the whole subject were recorded. Acceptability of the booklet was also measured.

Eligibility Criteria:
Inclusion Criteria:

* A common monoradicular sciatica on a slipped disc with a clinical radio agreement requiring a surgical treatment, after failure of an good ambulatory treatment carried out, one duration of evolution higher than four weeks at naive subjects of any rachidian intervention

Exclusion Criteria:

* People presenting a cruralgia, a secondary sciatica (epiduritis, osseous metastasis...) or without relationship with a slipped disc (spinal stenosis), an lesion biradicular, an horse tail syndrome, an important motor deficit (muscular testing \< 3)
* Cognitive, auditive, major visual disorders or any subject which does not have a good comprehension of spoken French and/or writing, or having recourse to a third for reading and supplementing a document
* Subjects presenting a peripheral neuropathy, a severe and evolved diabetes, a cardiac insufficiency, dialysed subject
* People observing a treatment which included psychotropics for more than three months (other that light hypnotic) because of the disturbances of vigilance and memory
Y Transconjunctival Approach in Open Reduction of Zygomatic Maxillary Complex Fracture

this study was made on fifteen patients who will undergo fracture repair of the zygomaticomaxillary complex.

Postoperative patient evaluation performed with specific attention paid towards, accessibility the exposure duration(time from incision till exposure of the field), esthetic appearance, post-operative pain, post-operative edema, orbital movement, wound healing, scarring infection, and the post-operative ocular complications such as ectropion, entropion, enophthalmos, scleral show and corneal abrasion.

Postoperative clinical examinations along with radiographic examination was done to evaluate the position of zygoma and determine the adequacy of fracture reduction.


Eligibility Criteria:
Inclusion criteria

* Patients with ZMC fractures that requires open reduction with internal fixation.
* Adult patient between 20 and 50 years with no gender predilections.

Exclusion criteria

* Existing lacerations in the inferior and lateral periorbital regions.
* Comminuted fracture with bone loss.
* Existence of infection at the fracture line.
* Presence of Acute and chronic conjunctival diseases.
Vaginal Mesh Procedures for Female Cystocele

This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

Pelvic organ prolapsed (POP) is an important health issue for women all over the world, with cystocele being the commonest type of POP. The side effects related to cystocele include voiding dysfunction, urinary retention, urinary tract infection, hydroureter, or hydronephrosis. The management for cystocele can be classified as non-surgical and surgical methods. Non-surgical methods comprise pelvic floor muscle exercise and vaginal pessaries, while surgical methods can be divided as conventional operations and operations applying mesh augmentation. Conventional surgeries for cystocele such as anterior colporrhapy have high surgical failure rates and complications including vaginal shortening or vaginal stenosis. Operations applying mesh augmentation are becoming the mainstream in the surgeries for cystocle. The Perigee System (American Medical Systems, Minnetonka, MN, USA), which has been approved by American FDA and Taiwan DOH in treating female cystocele, have promising short-term surgical outcomes. However, long-term reports incorporating both functional and morphological outcomes are lacking in the literatures. This study aimed to evaluate primarily the functional outcomes and secondly the morphological outcomes for women who had received standard managements for cystocele at mediate-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of cystocele

Exclusion Criteria:

* Pregnancy or possibility of future pregnancy
* Urinary tract infection
* Diabetes
* Neurological diseases
* Cardiovascular diseases
Ventriculostomies in SAH: ICP Open or Not?

The purpose of this study is explore how cerebrospinal fluid (CSF) drainage impacts outcomes for patients diagnosed with subarachnoid hemorrhage (SAH). This is a non-randomized observational study of two physician-prescribed approaches to managing intracranial pressure monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have intracranial pressure (ICP) monitoring in situ. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.

There are no interventions specific to this observational study. The nurses and physicians who care for subjects in the study are already competent in the care and management of patients with subarachnoid hemorrhage (SAH) and intracranial pressure (ICP) monitoring as a requirement of their current employment at Duke University. Patients with confirmed diagnosis of subarachnoid hemorrhage requiring ICP and CSF management will be admitted to the 16 bed Neurocritical Care Unit (NCCU) at Duke Hospital. After admission procedures and a baseline neurologic assessment are complete, the charge nurse or NCCU fellow will notify an investigator of subjects meeting inclusion criteria. The investigator or research coordinator for this project will complete a review preparatory to research (RPR) to ensure no exclusion criteria are present and once subject appropriateness has been confirmed patients and their families will be introduced to the investigator for the purpose of obtaining informed consent. The subject's legally authorized representative (LAR) will be informed of the study's purpose, risks and benefits, and the rights of research subjects.

Data will be collected that reflects the duration of the patient's hospitalization at Duke University through chart abstraction. The study period will be defined as admission to discharge. The attending physician has, and will continue to, determine the appropriateness of the duration of ICP monitoring, NCCU discharge criteria and hospital discharge criteria. Chart abstraction will be completed daily to obtain the ICP values and CSF volumes during that period of time for which the patient has a ventriculostomy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of subarachnoid hemorrhage
* Age 18 years or older
* Ventriculostomy in situ

Exclusion Criteria:

* Prisoners
* Glasgow coma score = 3
Pediatric Apple Watch Study

Specific Aim #1 - To determine the accuracy of Apple Watch ECG tracings heart rate in children.

Specific Aim #2 - To determine if extended monitoring with the Apple Watch can identify arrhythmia events that were not detected by short term clinical monitoring.


Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients age 6 - 21 years undergoing clinically indicated arrhythmia monitoring
* Patients with developmental ability (as determined by patient and parents) to safely wear the Apple Watch and utilize the patient activated trigger buttons on both the clinical monitor and the Apple Watch.

Exclusion Criteria:

* Age \< 6 years. Those under 6 many not be able to safely use the watch and have the developmental ability (as gauged by clinician and parents) to utilize the trigger features on the watch and cardiac rhythm monitor.
* Inability to effectively utilize the triggered features of the monitor or watch
* Patients unable to utilize the Apple Watch.
Enforced Reduction in Physical Activity and Recovery in Older Adults

Apparently healthy and well-functioning community dwelling 70-80 year-olds will be recruited to the study. All subjects undergo pre-screening for suitability and a physicians examination, as well as 7-day habitual daily steps are measured to ascertain baseline physical activity. Half of the recruited subjects (n=40) will be randomized into the intervention group and half (n=40) randomized into the control group. The intervention group is then required to reduce their daily steps to \<2000 for a 2-week period. Thereafter, the intervention group participates to a 4-week strength+endurance training rehabilitation program and no longer has restricted daily step count. The control group continues their normal habitual physical activity level throughout the 6-week study period.


Eligibility Criteria:
Inclusion Criteria:

1. aged 70-80 years,
2. community-dwelling,
3. able to walk 500 m without assistance or use of walking aid and regularly walking \>5000 steps per day,
4. MMSE \>24,
5. BMI 20-35 kg·m2 (i.e. not underweight or severely obese),
6. no serious cardiovascular or musculoskeletal disease,
7. no risk factors for deep-vein thrombosis (e.g. blood clotting disorder, obesity, bowel diseases, personal or family history of DVT etc.),
8. non-smoker,
9. provision of informed consent.

Exclusion Criteria:

1. Underlying diseases likely to limit lifespan and/or intervention safety. Contraindication for physical exercise or physical tests identified during physician's examination,
2. unwilling/unable to track daily step counts using accelerometer,
3. excessive and regular use of alcohol (more than 7 units per week for women and 14 for men)
4. difficulty in communication due to severe vision or hearing problems
5. unwilling to provide consent or accept randomization into either study group
Near-infrared Imaging With Indocyanine Green for Detection of Peritoneal Metastases for Gastric Adenocarcinoma.

Peritoneal disease at initial presentation for patients with gastric adenocarcinoma (GA) is frequent, with 15-31% of patients presenting with peritoneal metastases (PM) at surgical exploration. The prognosis of patients with PM is poor, overall survival (OS) ranging from 8 to 13 months, reinforcing the importance of optimal patient selection before surgical management of GA.

Indocyanine Green (ICG) fluorescence imaging for intraoperative detection of PM has been described in recent literature as a useful tool in patients undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal malignancies to increase the detection of PM during surgery. However, the role of ICG for patients with GA, and its role during diagnosic laparoscopy (DL), remain unknown.

This is a multicentric, prospective study . Patients will be referred to one of seven surgeons specialized in the surgical management of gastric cancer. Patients will undergo DL, with intravenous (IV) injection of 0.25 mg/kg of free ICG at the start of the surgery. DL will be first performed without fluorescence imaging in the standard fashion, with identification of potential PM. A first peritoneal cancer index (PCI) score will be calculated. Fluorescence imaging will then be performed, and correlation with previously identified lesions will be assessed and a second PCI score (with ICG) will be calculated. Biopsies will be performed to confirm the metastatic status of the lesions. Any suspicion for additional lesions visualized only under fluorescence imaging will be biopsied as well. Peritoneal fluid cytology will be performed at the beginning of the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of gastric adenocarcinoma.
* Clinical stage cT2 or higher.
* No evidence of metastatic disease on preoperative imaging.
* Patient fit for surgery (ECOG 0 or 1).

Exclusion Criteria:

* Indocyanine allergy.
* Gastric cancer subtype other than gastric adenocarcinoma.
* Unconfirmed diagnosis of gastric adenocarcinoma (unable to confirm diagnosis).
* Clinical stage cT1b or lower.
* Evidence of metastatic disease on preoperative imaging.
* Patient unfit for surgery (ECOG 2 or more).
Comparison of Analgesic Requirements in Patients Receiving Nuss Operation Using 2 Different Anesthetic Adjuvants

Nowadays, general anaesthesia is carried under "balanced anesthesia technique" in which many anesthetic adjuvants are used simultaneously, including opioid analgesics in order to reduce the amount of inhalation agents. The most popular adjuvants used are remifentanil, which is an opioid analgesic, and dexmedetomidine. Both of these agents are short acting, can be infused with targeted concentrations, excreted shortly from the body with stable hemodynamics.

Remifentanil, when infused for more than 2 hours, causes hyperalgesia to increase the amount of pain postoperatively as well as the amount of opioid analgesics. However, dexmedetomidine does not cause hyperalgesia and is known to have an opioid -sparing effect. In our center.

In this study, we aim to compare the effects of remifentanil and dexmedetomidine on postoperative pain in patients undergoing Nuss procedure, which is a very painful operation on the chest wall.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged \>20
2. Patients undergoing Nuss bar operation (pectus excavatum repair surgery)
3. American Society of Anesthesiologists classification I \~ III

Exclusion Criteria:

1. Drug abuse history
2. Chronic pain in need of continuous opioid analgesics administration
3. History of psychiatric diseases
4. Preoperative bradycardia (heart rate \< 50/min) or arrythmia
5. Cardiac diseases other than diabetes or hypertension - coronary artery disease, ischemic heart disease
6. Moderate liver or kidney dysfunction
7. Pregnant or breast feeding women
8. Hypersensitivity to the study drugs
9. Patients who do not agree to participate
SOSteniamoci: Stakeholders' Survey

Informal care is defined as the unpaid care provided to an older, frail, or ill person, by a person such as a spouse, a parent, a child, another relative, a neighbor, or a friend. This phenomenon may lead to stress, burden, and decreased informal caregivers' quality of life. Since lack of time, distance from services, and financial strains make the provision of psychological interventions to informal caregivers often challenging, Internet-based (self-help) programs might represent a viable solution to promote their emotional well-being. Still, despite the proven benefits of internet-based intervention, no available programs for informal caregivers are available for the Italian population. Nevertheless, planning and developing an online intervention, involving possible stakeholders (caregivers), might facilitate the understanding and dissemination of, willingness to use, and success of the future intervention. Thus, the goal of the current study is to assess Italian stakeholders' knowledge about, awareness of, attitudes towards, willingness to participate and use, and expected barriers to internet-based interventions.

The present study assessed the knowledge and awareness, attitudes, willingness to participate in, and expected barriers towards using Internet-based interventions to alleviate caregivers' burden in a sample of Italian caregivers and clinicians. To this aim, an online stakeholders' survey was conducted in Italy among clinicians and informal caregivers, using a snowballing sampling technique. Participants were asked to fill in the informed consent and complete the online survey as a clinician, a caregiver, or both. Data were monitored daily. Descriptive statistics and Pearson correlation analysis were used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* clinicians and informal caregivers
* aged 18 years or older
* internet access
* basic computer literacy
Understanding Poor Vaccine Responses to Hepatitis B Vaccination

Vaccines have prevented countless infections but poor vaccine responses remain a major challenge in many scenarios. Hepatitis B vaccine nonresponses are common but immunologically not well-understood.

This study aims to study the immunology of hepatitis B vaccine responses by comparing traditional HBV vaccine, which is associated with nonresponses in some patients, to CpG-adjuvanted HBV vaccine, which is associated with far fewer rates of nonresponses. This research will build upon prior studies of the human immune response to infection to gain a deeper understanding of the complexity of these responses. This information will be broadly useful as many vaccine candidates fail due to lack of immunogenicity, potentially enabling improved vaccine design and better protection.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age
2. Must be able to understand and sign the Informed Consent Form (ICF)

Exclusion Criteria:

1. Known chronic HBV infection
2. Pregnancy
3. Known clinically significant anemia or contraindication to phlebotomy; i.e., anti-coagulation therapy or clinically significant thrombocytopenia
4. Any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study
5. Use of immune-suppressing medications in the 30 days prior to enrollment HIV/AIDS patients will be included in the study as these patients often have poor responses to HBV vaccine.
RecoverLINK Technology Pilot for HF Patients

The primary objective is to examine feasibility of incorporating RecoverLINK into the standard of care as a function of (i) user engagement, (ii) user satisfaction, and (iii) workflow efficiency. As secondary objectives, the investigators will collect preliminary data to examine the association between patient engagement with the RecoverLINK app and (i) changes in patient knowledge and behavior, and (ii) hospital readmission(s) at 30, 60, and 90-day time periods post-enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure (HF) patients with a rapid follow up appointment scheduled at the Mount Sinai HF clinic
* English-speaking
* With either access to (i) an iOS smart device or (ii) wifi at-home

Exclusion Criteria:

Patients meeting any of the following criteria:

* A heart transplant
* A mechanical circulatory support (MCS) device
* An altered mental status
* Serious co-morbidities (as identified by Mount Sinai team)
* Cognitive impairments (as identified by Mount Sinai team)
* Inability to use technology (as identified by Mount Sinai team)