cyrilzakka/clinical-trials huggingface dataset:
Comparison of Time Taken to Diagnose Intraoperative Coagulopathies Using VET and SCL

The present study is a prospective multi-center observational trial comparing the time it takes to diagnose coagulopathies due to intraoperative bleeding using point-of-care (POC) viscoelastic tests or standard central laboratory tests (SCL tests).

The present study is a prospective multi-center observational trial comparing the time for diagnosing coagulopathies due to intraoperative bleeding using POC viscoelastic tests, such as rotational thromboelastometry (ROTEM) and thromboelastography (TEG) and standard central laboratory tests (SCL test, such as PT-INR, aPTT, s-fibrinogen level, platelet count).

The study will be performed during surgeries that are expected to entail a moderate to severe amount of bleeding and warrant the use of either POC viscoelastic tests, SCL tests, or both to determine the possible association of coagulopathy.

The tests will be conducted when an intraoperative condition requires identifying possible associations of coagulopathies during and after surgical bleeding. The test results will prompt appropriate coagulation management.

The primary objective is to compare the diagnosis time for intraoperative coagulopathy upon using the POC viscoelastic test or SCL test. The time will be defined as the time lapsed from obtaining a blood sample for the POC viscoelastic test or SCL test to acknowledging the test results.

Researchers hypothesized that using POC viscoelastic tests would shorten the time for diagnosis compared to SCL tests.

Eligibility Criteria:
Inclusion Criteria:

* patients who will undergo elective surgery with a high risk of moderate to severe amount of intraoperative bleeding or coagulopathy (e.g., cardiac surgery, joint replacement, spine surgery, hepatectomy, radical prostatectomy)
* patients who provide written informed consent
* patients who may warrant the intraoperative use of POC viscoelastic test or SCL test

Exclusion Criteria:

* pregnancy
* withdrawal of consent
* termination of surgery without performing either POC viscoelastic test or SCL tests
* when the study conductor deems it inappropriate to proceed with the protocol with the patient
Efficacy and Safety of Oral Bosentan in Pulmonary Arterial Hypertension Class II

The present trial investigates a possible use of oral bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) Class III and IV, to patients suffering from PAH Class II.


Eligibility Criteria:
Inclusion Criteria:

* PAH NYHA Class II
* Significant elevation of mean pulmonary arterial pressure
* Significant elevation of pulmonary vascular resistance at rest
* Limited 6-minute walk distance

Exclusion Criteria:

* PAH secondary to portal hypertension, complex congenital heart disease or reverse shunt
* Restrictive or obstructive lung disease
* Significant vasoreactivity
* Treatments for PAH (within 4 weeks of randomization)
Comparison Between Atenolol,Propnalol and Ivabradine

The aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.

This study will investigate the effect of atenolol, propranolol, and ivabradine as oral premedication in adult patients undergoing LUMBAR SPINE SURGERY to achieve bloodless field anesthesia.

AIM OF THE WORK

* The primary aim of this work is to compare atenolol, propranolol, and ivabradine as a premedication to achieve bloodless field anesthesia primarily controlling heart rate in lumbar spine surgery.
* The secondary aims are to assess field visibility and measure the amount of blood loss in patients, and surgeon satisfaction and also to asses if there are any associated undesirable side effects of atenolol, propranolol, or Ivabradine will appear.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I and II,

  * aged from 18 to 50 years old
  * scheduled for elective lumber spine surgeries will be included in this study.

Exclusion Criteria:

* Hypertension.
* Hepatic or renal disease.
* Diabetes Mellitus.
* Pregnancy.
* Coagulation disorders.
* Anemia (Hb \< 10 g/dL).
* Ischemic heart disease
* Drug or alcohol abuse.
* Allergy to any of atenolol, propranolol, and ivabradine.
* History of beta-blockers, calcium channel blockers, Tricyclic antidepressants, anticoagulant or clonidine intake.
Impact of Intraoperative Non-invasive Analgesia Monitoring Using Nociception Level Index on Patient Management

This prospective randomised clinical trial aims to assess the impact of intraoperative nociception monitoring using NOL on anesthetic management during major abdominal surgery. Additionally, the study will objectively evaluate using NOL how intravenous lidocaine administration, influences opioid requirements and the effect of this multimodal approach on early postoperative outcomes. The investigators hypothesize that NOL-guided intraoperative opioid administration reduces both intraoperative and postoperative opioid use, positively influencing 24-hour outcomes. Furthermore, the addition of intraoperative lidocaine in NOL-guided analgesia may further decrease opioid consumption.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* ASA score I-III
* surgery for gastric or hepatobiliary or pancreatic neoplasia

Exclusion Criteria:

* pregnancy
* lactation
* neuraxial or regional anesthesia
* chronic treatment with drugs that can influence autonomic nervous system
* diuretics or nitroglycerin administration on the day of surgery
* severe neurological disability
* severe hemodynamic instability
* chronic pain
* chronic opioid treatment
* allergy to any of the study drugs
* severe untreated disease or organ failure
* pacemaker
* emergency surgery
* patient refusal to participate
Risk Factors and Multiomics Study of Chronic Kidney Disease Caused by Metabolic Diseases

With the development of China's economy, people's living standard have improved, and the dietary structure have changed. Metabolic diseases, such as hypertension, diabetes, hyperuricemia and obesity have gradually become an important health burden in China. The pathophysiological mechanism of renal injury caused by metabolic diseases has always been a hotspot of research. Currently, it is believed that various mechanisms including the activation of Renin-Angiotensin-Aldosterone System, vascular endothelial dysfunction, oxidative stress and inflammatory process may be involved. Although there are differences in renal pathological manifestations caused by different metabolic diseases, the kidney will eventually present ischemic changes and fibrosis with the progression of the disease. So there must be some common pathogenesis. This study is designed to build a disease cohort of patients with chronic kidney disease caused by metabolic diseases, to identify risk factors leading to disease progression and to explore biomarkers for early diagnosis and treatment of kidney damage.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of metabolic diseases were confirmed;
* Be able to understand the process of the research;
* Volunteer for participation and be able to sign the informed consent.

Exclusion Criteria:

* Age \<18 yrs or \>80yrs;
* Patients with primary and secondary glomerular diseases
* Patients with other comorbidities that could affect the volume or the components of the kidney, such as renal cysts, polycystic kidney disease, medullary sponge kidney, hydronephrosis, renal artery stenosis, renal vein thrombosis and/or renal tumors;
* Contraindications for MRI examination;
* Pregnant or lactation patients;
* Patients with unstable vital signs, failure of other organs or dysphoria.
Idiotypic Vaccination for Follicular Lymphoma Patients

Poor prognosis follicular lymphoma patients have an estimated median overall survival of 5-6 years. The proposed trial offers life-time idiotypic vaccination to all such patients in first relapse/progression who will achieve second (first, in the case of patients who have never achieved complete response following standard first-line treatment) complete response through autologous stem cell transplant prior to vaccination start. The ultimate goal is a cure, defined as a vaccine-maintained complete response lasting both at least 10 years and at least twice as long as each patient's first complete response.

Idiotypic vaccination has already proved capable (in responding patients) of: biological efficacy, that is the capacity of inducing an idiotype- and tumor-specific immune response (Kwak LW et al. NEJM 1992); clinical efficacy, that is the capacity of inducing specific immune responses able to kill in vivo follicular lymphoma cells that had survived pre-vaccine chemotherapy (Bendandi M et al. Nature Med 1999): clinical benefit, that is the capacity of prolonging survival of responding patients (Inoges et al. JNCI 2006). Now, we want to test whether it is also capable of contributing to the ultimate goal of preventing relapse indefinitely in responding patients.

Eligibility Criteria:
Inclusion Criteria: at least one of the following:

* FLIPI score 3 thru 5 at diagnosis and/or at relapse
* First complete response shorter than 3 years, if no maintenance (Interferon, Rituximab, etc) treatment was administered, or than 5 years if maintenance treatment was administered
* No treatment has been able to induce complete response until autologous stem cell transplant
* Poor-prognosis genomic profiling

Exclusion Criteria: any of the following:

* Unavailability of a harvestable lymph node of at least cm 2x2x2
* Life expectancy \< 1 year
* Abnormal heart or liver or kidney function
* ECOG Performance Status \> 2
* Failure to sign informed consent before enrollment
A Study of Lispro Formulations in Healthy Participants

The purposes of this study are to determine:

* Part A

  * How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation.
  * The safety of insulin lispro in different formulations and any side effects that might be associated with it.
* Part B:

  * How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A).
  * The safety of insulin lispro in different formulations and any side effects that might be associated with it.

Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.


Eligibility Criteria:
Inclusion Criteria:

- Overtly healthy males or females (nonchildbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination

Exclusion Criteria:

- Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening
Hearing Loss, Vestibular Loss and Cognitive Performance

Hearing loss is an established independent risk factor for dementia. Likewise, recent research demonstrated cognitive deficits in subjects with vestibular loss. However, in these studies data have not been adjusted for the hearing status of the enrolled study subjects. As hearing loss prevalence is high in patients with vestibular loss, this could be a major confounder. Therefore, in this study the investigators investigate cognition in patients with bilateral vestibulopathy with and without hearing loss. The investigators adjust data for the hearing status of the patients to explore the link between hearing loss, vestibular loss and cognition.


Eligibility Criteria:
Inclusion criteria for BVP patients were:

1. Bilaterally reduced vestibular function, as defined by the Bárány Criteria for BVP (Michael Strupp 2017):

   * horizontal angular VOR gain \< 0.6 measured by the vHIT, and/or
   * reduced caloric response (sum of bithermal, 30° and 44°, max. peak slow phase velocity (SPV) on each side \< 6°/sec), and/or
   * reduced horizontal angular VOR gain \< 0.1 upon sinusoidal stimulation on a rotatory chair. At our clinic rotatory chair tests are performed using sinusoidal rotation (0.05 Hertz) with a peak velocity of 60°/sec (Van der Stappen A 2000).
2. Disease duration of BVP \> 6 months.

Healthy controls (HC). Only subjects with no history of vertigo, scores \<5 on the Dizziness Handicap Inventory (DHI) and normal hearing thresholds at 0.25 - 8 kHz, based on age and sex (defined by the BS 6951:1988, EN 27029:1991 and ISO 7029-1984 standards), were enrolled in the study.

For both BVP patients and HC the following additional inclusion criteria were applied: 1) Age ≥ 18 years; 2) Fluency in Dutch; 3) No history of neurological diseases (e.g. dementia, Parkinson's disease, cerebrovascular accident, etc.); 4) Absence of clinical signs indicating dementia or mild cognitive impairment.
The Effect of DA9301 on Tablet Computer-Induced Asthenopia

Asthenopia or eye strain describes nonspecific symptoms of an eye when it is tired from intensive work. Vaccinium uliginosum is a flowering plant in the genus Vaccinium. This plant is native to cool temperature regions of the Northern Hemisphere. Considering its antioxidative ingredients, the extract of Vaccinium uliginosum is expected to play a significant role in treating various ocular pathologies. The investigators performed a randomized, case-controlled study in healthy subjects and investigated the protective effect of Vaccinium uliginosum extract (DA-9301) on tablet computer-induced asthenopia.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subject aged 20 to 65 years with more than 2 hours of daily use of a smart phone or computer including a tablet and television

Exclusion Criteria:

1. Ocular disease in either eye

   * Ocular surface disease
   * Best corrected visual acuity \< 20/30
   * Intraocular pressure \> 21 mmHg
   * Optical coherence tomography proven retinal nerve fiber defect
   * Significant cataract (lens opacities classification system III)
   * Significant entropion or ectropion
   * Significant tear drainage problem proved with fluorescein dye dilution test
2. Soft or Hard contact lens use 3 or more days a week
3. History of oral intake of health supplement designed to improve asthenopia within 4 weeks before participating this study
4. Pregnant woman
5. Systemic disease

   * Uncontrolled hypertension (systolic /diastolic blood pressure \> 140/90mmHg)
   * Uncontrolled diabetes mellitus (fasting blood glucose level \> 180mg/dL)
   * Rheumatoid arthritis
   * Malignant disease
   * Active hepatitis (type B and C)
   * Acute or chronic infectious disease
   * Renal disease
PACS System in the Training of Ophthalmologists

The purpose of this study is to evaluate teaching effect of CBL (case based learning) teaching method based on PACS (picture archiving and communication systems).

In this randomized controlled clinical trial, we aim to explore the teaching effect of CBL (case based learning) teaching method based on PACS (picture archiving and communication systems) for doctors to master the specialized knowledge of orbital tumor.

Eligibility Criteria:
Inclusion Criteria:

* Orbital diseases standardized training of doctors
* Willing to receive training

Exclusion Criteria:

* Refuse to attend the assessment
Variable Perception of Cutaneous Stimulation

Perception of cutaneous sensory stimulation shows a large range of variability across multiple populations. Understanding this variability is critical to medical practice as interpretation of discomfort and pain is critical to diagnosis and treatment. Further, procedural medicine involves inflicting pain on patients in the form of injection of local anesthetic. Our protocol aims to determine how patients differentially interpret the non-noxious stimulation of vibration and the differences in perceiving anesthestic injection after the vibratory stimulus. We will explore how this ranges across all patients treated in a dermatological surgery out-patient setting. The goal is to identify which variables, such as age, gender, medical history, influence how sensation is interpreted.


Eligibility Criteria:
Inclusion Criteria:

* All patients

Exclusion Criteria:

* Patients less than 18 years of age
Text Message Vaccine Reminders for Adolescents With Chronic Medical Conditions

There are a growing number of adolescents with chronic medical conditions in the United States. The Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination and annual influenza vaccination of all adolescents. Pneumococcal polysaccharide vaccination is also recommended for certain high-risk patients. Limited studies suggest that vaccination coverage of this population remains sub-optimal. Text message vaccine reminder/recall has been shown to be effective in increasing uptake of select pediatric and adolescents vaccines, but has yet to be examined among patients with chronic medical conditions who may also face unique barriers to vaccination. This intervention aims to implement and evaluate the use of text message vaccine reminders among urban low-income minority adolescents with chronic medical conditions. This investigator-initiated study is supported in part by a grant from the Pfizer Medical Education Group.


Eligibility Criteria:
Inclusion Criteria:

Parent with

1. adolescent aged 11-17 years;
2. adolescent with ≥1 chronic medical condition;
3. adolescent with clinic visit in last 12 months;
4. cell phone number listed in hospital registration system

Exclusion Criteria:

Parent who:

1. does not speak English or Spanish;
2. is unwilling to receive text message vaccine reminders;
3. anticipates moving from area in coming 12 months
Comparison of the Different Exercises on Chronic Neck Pain

Neck pain is a widespread problem in the general population and is second only to low back pain in musculoskeletal issues.

The aim of this study is to compare the conventional therapy, cervical stabilization exercise approach, and core stabilization exercise in addiction to cervical stabilization in patients with chronic neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Chronic neck pain more than 3 months
* Medically stable

Exclusion Criteria:

* Patients with benign or tumors in the cervical region
* Patients with active, localized osseous and discal infection in the spine (spondylodiscitis)
* Patients with history of spinal fractures
* Patients with congenital anomaly
* Patients with neck surgery and spinal instability
Effect of Music Therapy on Anxiety of Caregivers of Alzheimer's Disease Patients

This clinical trial evaluates the impact of music interventions on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day care hospital "Memory and Frailty" (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital.

This clinical trial evaluates the impact of music on caregivers of patients with memory disorders, Alzheimer's disease, dementia and related disorders. This study will follow caregivers of patients within the rehabilitation day hospital "Memory and Frailty " (Hôpital de Jour de Réadaptation Mémoire et Fragilités), Sainte-Marie Paris Hospital.

All participants will benefit from a first session of a relaxation-type musical technique in the Day care Hospital (HDJ), they will then follow the sessions in their own homes. During the first visit, all participants will complete self-assessments, including a questionnaire on musical preferences and a self-assessment anxiety scale.

The expected inclusion period is 30 days. Carers will be equipped with tablets, headphones, eye masks and workbooks/questionnaires to use every day for one month in their homes. A relaxation-type receptive musical technique is used. The standardized 20-minute musical sequence is broken down into several phases that gradually lead the patient to a state of relaxation using the new U technique. The effect works by reducing the musical rhythm, orchestral formation, frequencies and volume (the "U" descending phase). After a maximum relaxation phase (lower part of the "U"), a re-activating phase (ascending branch of the "U") follows. All the musical sequences, built with the U-shape editing method, were specially produced by the music publishing company Music Care©. During the first session in HDJ, the subjects will lie on a relaxation table with a raised headrest (extended or semi-seated listening position) in an enclosed space, calm, secure and comfortable, with minimum lighting, so that the participant feels comfortable. The music will be played on headphones.

The main objective is to reduce anxiety among carers who accompany patients with memory disorders, Alzheimer's disease and related dementia.

Eligibility Criteria:
Inclusion Criteria:

* Anxiety Self-Assessment Score (STAI) greater than 46 at Day 1
* Patient relationship (child, spouse, brother/sister)

Exclusion Criteria:

* Presence of a psychiatric disorder
* Intellectual disability
* Major hearing loss
* Professional musician
Impact of Negative Pressure Wound Therapy on Free Muscle Flaps

Aim of the study is to prove the utility and safety of the negative pressure wound therapy (NPWT) in the postoperative management of free flaps.

The quantitative assessment of the entirety of clinical main relevant parameters like edema formation, microcirculation, macrocirculation and wound healing should create a better and comprehensive understanding of the NPWT effects in this field.

This study evaluates the impact of negative pressure wound therapy on free muscle flaps. Flaps were treated with NPWT or with a conventional dressing (control) for five days following tissue transfer. Edema formation is measured by a 3D scan (Artec SpiderTM) during the operation, five and fourteen days after surgery. The macrocirculation- and microcirculation parameters of the flaps are assessed using an implanted Doppler probe (Cook-Swartz®) as well as combined flowmetry and remission spectroscopy (O2C®). These measurements are conducted daily at the day of the operation as well as the first five days following the operation. Following dressing removal at the fifth postoperative day, skin graft take is assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring free muscle flap reconstruction at the lower extremity covered with a split thickness skin graft
* existing cognitive faculty
* consent

Exclusion Criteria:

* non-compliance
* non-consent
Impact of Unenhanced Computed Tomography (CT) in Elderly Patients Admitted to the Emergency Department With Acute Abdominal Pain

The purpose of this study is to determine whether non-contrast abdominal computed tomography (CT) impacts management (diagnosis, need for surgery and treatment) in elderly patients admitted to the emergency department with abdominal pain.

A systematic unenhanced abdominal CT is performed in elderly patients admitted to the emergency patients with acute abdominal symptoms. Accuracy of unenhanced CT is assessed by comparing diagnosis and therapeutic management recorded before and after unenhanced CT versus gold standard diagnosis and management. Gold standard diagnosis and management are established at 3 month follow up, based on patient's medical records and a systematic telephone interview.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients admitted to the emergency department (aged 75 year old and older)
* acute abdominal pain
* informed consent

Exclusion criteria:

* traumatic pain
* symptom duration of more than a week
* unability for the patient to give informed consent