cyrilzakka/clinical-trials huggingface dataset:
Biomarkers in Patients Undergoing Mechanical Ventilation

To evaluate in a cohort of patients on mechanical ventilation, for non-infectious reasons and for documented sepsis of pulmonary as well as non-pulmonary origin, the bacterial load, procalcitonine (PCT), C-Reactive Protein (CRP), temperature, White cell count (WCC), American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) consensus conference criteria, Sequential Organ Failure Assessment score (SOFA) and simplified Clinical Pulmonary Infection Score (CPIS) through the mechanical ventilation period

The investigators hypotized that:

1. In patients on mechanical ventilation for a non-infectious cause of respiratory failure, the tracheal bacterial load should be absent or below the cut-off values defined for infection, that is to say tracheal colonization.
2. In patients without the diagnosis of Ventilator-Adquired Pneumonia (VAP) and not taking antibiotics till the weaning process, tracheal bacterial load should remain below the predefined cut-off values and the biomarkers (PCT and CRP) should be surrogate markers of this clinical course.
3. In patients developing VAP, an increase in tracheal bacterial load should precede diagnosis with an associated rise in the biomarkers levels (PCT and CRP). Finally, after institution of antibiotic therapy, adequate therapy should be associated with a decrease tracheal bacterial load as well as of the biomarkers (PCT and CRP).
4. In patients admitted with clinical suspicion of pneumonia, either community-acquired (CAP) or hospital-acquired (HAP), with microbiological documentation, after institution of antibiotic therapy, adequate therapy should be associated with a decrease tracheal bacterial load as well as the biomarkers (PCT and CRP).
5. In patients admitted with clinical suspicion of a non-pulmonary infection (e.g. peritonitis and urosepsis) and on mechanical ventilation for an expected length longer than 3 days, either community or hospital-acquired, preferentially with microbiological documentation, after institution of antibiotic therapy, adequate therapy should be associated with a decrease of biomarkers (PCT and CRP).

Eligibility Criteria:
Inclusion criteria:

* Patients admitted in the ICU, with an expected length of mechanical ventilation \> 3 days.
* Not receiving antibiotics for \>24 hrs before ICU admission- An expected length of mechanical ventilation \> 3 days

Exclusion Criteria:

* Patients \<18 yrs old
* Pregnancy and lactation
* Fulminant hepatic failure
* Pancreatitis
* Patients with the diagnosis of disseminated cancer, expected to die or undergo withdrawal of treatment within 72 hours after enrolment.
Wound Vac Bandage Comparison After Spinal Fusion

The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted closure (VAC) therapy in the prevention of infection after posterior spinal fusion for pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.

A prospective randomized controlled study: Patients undergoing posterior spinal fusion will be randomized to a standard postoperative dressing versus an incisional VAC dressing. Both groups will have hematocrit, total lymphocyte count, and albumin checked preoperatively to assess nutritional status, drawn at the same time as standard preoperative labs during history and physical visit. Both groups will undergo standard wound closure and dressing application before breaking the sterile field. The incisional VAC group will undergo placement of an Adaptic dressing over the incision. A standard VAC sponge will be placed and secured with adhesive dressing, and a suction tube will be connected to a VAC machine set to 75 mmHg of continuous suction. The incisional VAC will be left in place for 72 hours postoperatively. Remainder of postoperative care will follow our standard posterior spinal fusion protocol and will be identical in both groups. Patients will be followed for a minimum of 2 years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* any patient 17 years and younger
* neuromuscular scoliosis undergoing posterior spinal fusion

Exclusion Criteria:

* idiopathic and congenital scoliosis
* any type of spine surgery other than posterior spinal fusion (eg. vertical expandable prosthetic titanium rib placement, growing rod placement, anterior spinal fusion)
* intraoperative dural tear
* documented allergy to adhesive dressings
THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.

This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic regurgitation.

Eligibility Criteria:
Inclusion Criteria:

* Patient with severe aortic regurgitation (AR).
* Patient at high risk for open surgical valve replacement
* Patient symptomatic according to NYHA functional class II or higher
* The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.

Exclusion Criteria:

* Congenital uni or bicuspid aortic valve morphology
* Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
* Endocarditis or other active infection
* Need for urgent or emergent TAVR procedure for any reason
* Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
* Severe mitral regurgitation
Comparison of EzVision® Videolaryngoscope and Gum Elastic Bougie-Assisted Machintosh Laryngoscopy

The aim of this study is to compare the EzVision® videoryngoscope with conventional laryngoscopy using a Macintosh blade in patients with suspected difficult intubation. This study primarily aims to test the hypothesis that laryngoscopy image is better with EzVision® videoryngoscopy compared to direct laryngoscopy. The secondary hypothesis is also to test the view that, compared to direct laryngoscopy, EzVision® videolingoscopy will improve intubation success, reduce intubation attempts, shorten intubation time, facilitate intubation, and cause less additional complications such as bleeding or sore throat.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 65 years old;
2. American Association of Anesthesiologists (ASA) physical condition I-II-III;
3. Elective surgery requiring oral endotracheal intubation for general anesthesia;
4. Compliance with one of the difficult intubation estimation criteria (if more than one)
5. Expected extubation in the operating room

Exclusion Criteria:

1. Refusal to participate in research;
2. Age \<18 and \>65
3. ASA IV and above
4. Emergency cases
5. Body Mass Index (BMI) \> 40 kg/m2.
6. Pregnancy
7. Cardiac surgery
8. Unexpectedly difficult intubation
Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions

Objective:

To compare the rate and extent of release of the drug substance from the two tablet formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of at least 7 days.

Study Design:

Randomized, open label, two treatment, two period, two sequence, single dose, crossover study in healthy human adult subjects


Eligibility Criteria:
Inclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:

  * Sex: male.
  * Age: 18 - 45 years. .
  * Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
  * Healthy and willing to participate in the study.
  * Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
  * Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:

  * Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  * Clinically significant abnormal ECG or Chest X-ray.
  * Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  * Pulse rate less than 50/minute or more than 100/minute.
  * Oral temperature less than 95°P or more than 98.6°P.
  * Respiratory rate less than 12/minute or more than 20/minute
  * History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  * History of alcohol or drug abuse
  * Positive breath alcohol test
  * Recent history of kidney or liver dysfunction.
  * History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
  * Volunteers suffering from any chronic illness such as arthritis, asthma etc.
  * History of heart failure.
  * HIV, HCV, HBsAg positive volunteers.
  * Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
  * Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
  * Administration of any study drug in the period 0 to 3 months before entry to the study.
  * History of significant blood loss due to any reason, including blood donation in the past 3 months.
  * History of pre-existing bleeding disorder.
  * Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
  * Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Evaluating Results of Neusidl Corneal Inserter in Descemet's Stripping Automated Endothelial Keratoplasty (DSAEK)

This project compares the Neusidl Corneal Injector (NCI) device developed by Fischer Surgical, Inc. for the delivery of tissue into the eye in DSAEK surgery to the current standard forceps insertion DSAEK technique. The goal of this study is to examine the damage to the corneal endothelium resulting from the use of the NCI device in comparison to the use of our standard surgical DSAEK technique over time.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 and over
* A diagnosis of Fuchs' Corneal Endothelial Dystrophy

Exclusion Criteria:

* Under age 21
* Diagnosis of advanced glaucomatous disease
* Diagnosis of significant retinal disease
* Diagnosis of any other corneal dystrophy
* Previous corneal transplant surgery
* Previous glaucoma surgery
* Previous retinal surgery
* Previous refractive surgery
A Study to Assess the Bioequivalence of a New ULTRACET Extended Release (ER) Tablet With Respect to a Marketed ULTRACET ER Tablet Under Fasted Condition

The purpose of this study is to evaluate the bioequivalence of a newly developed ULTRACET extended-release (ER) tablet of tramadol hydrochloride and acetaminophen, to the current marketed ULTRACET ER tablet, in healthy participants under fasted condition.


Eligibility Criteria:
Inclusion Criteria:

* Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate
* Must agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
* Body mass index (weight \[kg\]/height2 \[m\]2) between 18.5 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
* Blood pressure (after the participant is sitting for 5 minutes) between 90 and 140 mm Hg systolic, inclusive, and no higher than 90 mm Hg diastolic
* A 12-lead electrocardiogram (ECG) consistent with normal cardiac function, including sinus rhythm, pulse rate between 45 and 90 bpm, QTc interval \<= 450 ms, QRS interval of \<110 ms, PR interval \<200 ms, and morphology consistent with healthy cardiac function

Exclusion Criteria:

* History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic (blood) disease, coagulation disorders (including any abnormal bleeding), lipid abnormalities, significant lung disease (including bronchospastic respiratory disease), diabetes mellitus, kidney or liver insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the study center as deemed appropriate by the investigator
* Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening (or at admission to the study center) as deemed appropriate by the investigator
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for oral contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled
* History of, or reason to believe a participant has a history of, drug or alcohol abuse within the past 5 years
Effects of Scapulathoracic Stabilization Exercises Plus Complex Decongestive Therapy in Women With Lymphedema

The aim of the study is to investigate the effects of scapulathoracic stabilization exercises additionally applied to complex decongestive therapy after mastectomy on posture, balance and quality of life.

Lymphedema is a chronic and progressive condition that occurs with the accumulation of protein-rich fluid in interstitial tissue spaces as a result of abnormal development or damage to the lymphatic system. Lymphedema is divided into 2 as primary and secondary. Secondary lymphedema is the most common form seen in upper extremity, usually after breast cancer treatment approaches. In lymphedema, not only upper limb affected, but also posture, balance, shoulder girdle, scapula and quality of life can be adversely affected. Complex decongestive therapy has been accepted as the gold standard treatment in lymphedema to reduce edema, however, there were insufficient studies investigating the effects on the posture and the balance in patients with lymphedema. Scapulatoracic stabilization exercises aim to increase muscle stability ability, kinesthetic awareness, ovarall stability and balance. However, when the literature is reviewed, no study is found investigating the effect of scapulatoracic stabilization exercises in individuals who developed lymphedema after mastectomy.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* Agree to participate in the study,
* Undergoing unilateral mastectomy due to breast cancer treatment and additionally development of limb lymphedema,
* Lymphedema stage 2 and 3,
* Being a woman,
* Having spent at least 6 months after the operation
* With or without radiotherapy and / or chemotherapy.

Exclusion Criteria:

* Irregular participation to the treatment program,
* Severe heart failure and / or rhythm disturbance,
* Uncontrolled hypertension,
* Presence of metastasis,
* Infection in the affected arm,
* Any problems that may affect balance (rheumatological, vestibular, visual, neurological),
* Muscular and skeletal system problems (limb shortness, ankle sprain ...), which may affect the balance and posture negatively.
* Presence of spinal deformity,
* Those who have had spinal surgery in the last 6 months.
Pulmonary Vein (PV) Imaging by Intracardiac Echography (ICE) After Ablation

To test the hypothesis that structural changes documented by ICE after pulmonary vein deconnection by RF can predict AF recurrences

Patient undergoing first RF ablation for sympomatic paroxysmal atrial fibrillation will be enrolled. ICE visualization of PV antra before and after PV deconnection (electrophysiological endpoint). Changes in echogenicity as documented by ICE will be evaluated by a dedicated software and correlated to long term recurrences

Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation ablation candidates

Exclusion Criteria:

* Previous catheter ablation
* Persistent atrial fibrillation
Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants

This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes.

This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure.

It is hypothesized that neonates and infants will have improved respiratory severity score (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased estimated energy expenditure.

This single center, prospective cohort crossover study will involve mechanically ventilated neonates and infants who are determined to be on stable ventilator settings in either the NAVA or SIMV(PC) + PS modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and energy expenditure.

Infants will be screened for stability criteria including: being stable on the ventilator in either SIMV (PC) + PS or NAVA mode, on weaning or unchanged ventilatory support in previous 12 hours, and no need of escalation of ventilatory pressure or rate in prior 12 hours.

After screening criteria is met and consent has been obtained, data will be retrospectively collected for 12 hours prior to randomization. After the subject is randomized, the infant will be stabilized and data will be collected for 12 hours in the randomized mode. Data will then be collected for 12 hours afterwards in the crossover mode. Data will be collected in areas of patient demographics, diagnoses, indications for mechanical ventilation, hemodynamic variables and respiratory parameters. While in each mode, the patient will also have indirect calorimetry obtained to determine estimated energy expenditure of each mode.

Eligibility Criteria:
Inclusion Criteria:

* Neonates and infants, 22 weeks gestation age or older at birth
* Require mechanical ventilation for respiratory support in either SIMV (PC) + PS or NAVA modes
* Stable on the ventilator with a fractional inspired oxygen requirement (FiO2) of 0.60 or less.
* Stable on the ventilator with weaning or unchanged ventilatory support without need of escalation of ventilatory pressure or rate in prior 12 hours.

Exclusion Criteria:

* Major congenital anomalies
* Neurologic compromise of respiratory drive
* Phrenic nerve palsy
* Sedated enough to suppress respiratory drive
* Respiratory support with volume mechanical ventilation
* Respiratory support with high frequency oscillatory ventilation
3D Telemedicine: A Clinician Feedback Study

The use of Telemedicine has increased significantly due to constraints imposed by the Covid pandemic. 3D telemedicine uses multiple cameras in the clinic room which can reconstruct an image in 3 dimensions in real-time, which may be beneficial in more visual focused specialties such as Plastic Surgery. There are no clinical data regarding the use of 3D telemedicine, with previous studies laboratory based without clinicians or patients. This study aims to provide clinician data comparing 3D and 2D Telemedicine, and feedback to allow incremental improvement of the system prior to clinical trials involving patients.

Aims The aim of this study is to assess 3D telemedicine and 2D telemedicine from the clinician's perspective, to optimise the system prior to clinical trials with patients. This will provide baseline validated outcome data on areas such as usability, presence (the realism or immersion of a system), mental effort and task load. "Keep, Lose and Change" prompts will be used to aid improvements in the 3D Telemedicine system prior to clinical trials.

Participants This will be a clinician feedback based study on 2D telemedicine and 3D telemedicine. Clinicians will include nurses, doctors and physiotherapists from Canniesburn Plastic Surgery Unit, Glasgow, UK.

Consent Clinicians will consent in writing to participate

Method Clinicians will use both 3D and 2D Telemedicine systems to examine a member of the research team who will act as a "patient". There will be a single clinician (consultant, nurse specialist or physiotherapist) examining the patient during the clinic.They will use each system for 10 minutes each. No randomisation will take place. This will be followed by a questionnaire which will be filled in once per patient by the clinician in the clinic.

Outcome measures No primary or secondary measures are specified as this is an observational feedback study, not an interventional clinical trial.

Satisfaction - Visual Analogue Scale 0-100 Mental Effort Rating Scale - single instrument Likert scale (Paas 1996) System Usability Scale - 10 item industry standard technology scale Presence Questionnaire - 29 item scale - assessment of presence in the system/virtual environment (PQ, Witmer 2005).

Semi Structured exit interview - will discuss with participant their views on the telemedicine system, using "Keep, Lose and Change" prompts to aid system improvements.

Eligibility Criteria:
Inclusion Criteria:

* clinicians in Canniesburn Plastic Surgery Unit
* doctors
* nurses
* physiotherapists

Exclusion Criteria:

* visual problems whereby participant is legally blind
* cannot consent