cyrilzakka/clinical-trials huggingface dataset:
Anaesthesia for Mechanical Thrombectomy

Title: Conduct of anaesthesia during acute ischaemic stroke: a retrospective case series of patients undergoing mechanical thrombectomy.

Design: This study will be a retrospective consecutive observational case series

The Aim of this study is to describe the baseline characteristics, procedural and post-operative clinical characteristics of anaesthetic care delivered to consecutive adult patients who underwent mechanical thrombectomy as part of their routine clinical care between 01/01/2016 and 01/10/2020 at Nottingham University Hospitals NHS Trust (sample size approximately 250).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Undergone mechanical thrombectomy for the management of acute ischaemia stroke between 01/01/2016-01/10/2020 at Nottingham University Hospitals NHS Trust.

Exclusion Criteria:

* No pre-specified exclusion criteria.
Efficacy and Safety Study of QVA149 in COPD Patients

The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged ≥40 yrs
* Smoking history of at least 10 pack years
* Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)
* Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)\< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) \<70%
* Modified Medical Research Council questionnaire grade of 2 or higher

Exclusion Criteria:

* Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Any patient with lung cancer or a history of lung cancer
* Patients with a history of certain cardiovascular co-morbid conditions
* Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
* Patients in the active phase of a supervised pulmonary rehabilitation program
* Patients contraindicated for inhaled anticholinergic agents and β2 agonists
* Other protocol-defined inclusion/exclusion criteria may apply
Non-blinded Data Collection Study of Concussion Using the BrainPulse(TM)

The multi-center study evaluates BrainPulse recordings from subjects with a suspected or confirmed concussion to improve a concussion detection algorithm. Subjects may also consent for a 5 additional follow-ups over a 21-day period to compare the progression of change in their BrainPulse recordings.

The primary objective of this study is to collect un-blinded BrainPulse recordings from youth and adults that have a confirmed diagnosis of concussion per protocol guidelines in order to improve a concussion detection algorithm previously developed by Jan Medical, Inc. In order to gather sufficient variability, subjects with both confirmed concussion and suspected concussion will be included in the study as long as they meet eligibility criteria. BrainPulse recordings from subjects with suspected concussion will be compared to the recordings of subjects diagnosed with concussion. Subjects will be followed for 21 days after the initial injury with BrainPulse recordings to study the subject's recovery process. The symptomatic evaluation, physical examination, and BrainPulse recordings will be entered in a database to assess clinical outcome and device utilization.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 5 years old
2. Suspected or confirmed concussion by medical professional
3. Not more than 3 days since injury/trauma event
4. Willing and able to participate in all required study evaluations and allow access to medical testing and records
5. Signed informed consent/assent, and/or have a legally authorized representative willing to provide informed consent on behalf of the subject
6. Demonstrates a minimum of 3 of the following symptoms:

   * Headache
   * Pressure in head
   * Dizziness
   * Neck pain
   * Fatigue/ low energy
   * Nausea or vomiting
   * Irritability
   * Difficulty in concentrating/performing tasks
   * Memory impairment
   * Insomnia
   * Reduced tolerance to stress
   * Sensitivity to light
   * Difficulty balancing
   * Blurred vision
   * Confusion
   * More emotional than usual
   * Sadness
   * Nervous/Anxious
   * Vacant stare
   * Delayed verbal/motor response
   * 'Feeling like in a fog'
   * 'Don't feel right'

Exclusion Criteria:

1. Wound or open laceration on the head in the area of one of the BrainPulse sensors that would impede use of the BrainPulse device
2. Any serious medical condition that in the opinion of the medical professional would impair ability to provide informed consent/assent or otherwise disqualify a patient from participation
3. Currently participating in or planning to participate in another clinical study during the course of the current clinical study
4. Implantation of any medical device in head (e.g. ventriculoperitoneal shunt)
Clinical Evaluation of Cardiac Output Estimation Based on Pulse Wave Transit Time

The specific aim of this study is to assess whether a device approved by the FDA to measure pulse oximetry can accurately estimate cardiac output.

We will compare three methods for measuring cardiac output: esCCO, PAC, and ECOM. Cardiac output is an important physiological parameter that must be monitored closely during surgery and during an Intensive Care Unit (ICU) stay. The use of a pulmonary artery catheter (PAC) has been the gold standard for accurate cardiac output (CO) measurement. This method requires a catheter to be inserted into the pulmonary artery and cardiac output is indicated by the speed that a temperature gradient dissipates. While the use of the pulmonary artery catheter is widespread, inserting the pulmonary artery catheter is risky, time consuming and requires a high level of skill. For these reasons, new devices have been developed to measure cardiac output.

A second method typically used is called ECOM (Endotracheal Cardiac Output Monitor). A device is inserted into the patient's throat that calculates cardiac output by measuring how electricity moves through the patient's chest.

The third method, estimated Continuous Cardiac Output (esCCO), uses sensors placed on the patient's finger, arm and chest to calculate Pulse Wave Transit Time (PWTT); the time it takes for the heart beat pulse to travel through the patient's body. The esCCO system is FDA approved for safety and efficacy to measure noninvasive blood pressure and pulse oximetry. The purpose of this study is to assess whether the PSTT calculation provides a cardiac output measure that is comparable to the other methods.

This study is sponsored by Nihon Kohden Corporation who owns and manufactures the esCCO system.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgery where cardiac output will be measured with PAC and ECOM.

Exclusion Criteria:

* Failure to obtain consent.
A 3-year Study Following up Patients With Moderate to Severe Rheumatoid Arthritis Treated With Humira in Greece

The objectives of the study are to observe and assess the long-term use, safety and efficacy of Humira (adalimumab), as prescribed by the rheumatologist in a normal clinical setting and in accordance with the terms of the European marketing authorization and to observe compliance of patients with the prescribed treatment.

This is a multi-center, uncontrolled observational study of patients who at the time of entry had moderate to severe rheumatoid arthritis (RΑ) and who were subsequently prescribed Humira (adalimumab) following normal clinical practice, with or without other anti-rheumatic treatments, prior to enrollment in this study.

Once the physician has determined that the patient meets the inclusion criteria, and the patient has agreed to be included in the observational study by signing the informed consent, the patient's Day 1 demographic data, and disease status will be reported in the Day 1 Data Report Forms. The physician will then follow-up with the patient via regular office visits at intervals as determined by routine clinical practice. Patient's safety and efficacy data, if they are part of clinical routine, will be recorded in the Data Report Forms at Day 1, and regular visits which are closest to Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate or severe active rheumatoid arthritis, who have been prescribed and are receiving Humira (adalimumab) under normal clinical practice for at least one month prior to inclusion and according to the approved Summary of Product Characteristics (SPC) in the European Union.
* Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Exclusion Criteria:

* Contraindications according to the SPC.
* Patients should not participate in another observational Abbott study.
Efficiency of Using Copper-Nickel-Titanium Versus Nickel-Titanium Arch Wires on Anterior Segment Crowding Alleviation in Group of Adults With Moderate Crowding

Evaluate the efficiency of using copper nickel titanium (CuNiTi) arch wire on the initial stage of leveling and alignment regarding their rate of alignment in comparison to Conventional Nickel Titanium arch wire (NiTi) by Measuring the amount and rate of alignment achieved every 2 weeks for a period of 2 months.

.

Leveling and alignment is the first stage in fixed orthodontic treatment, performed for every patient. Copper nickel titanium (CuNiTi) was modified from conventional nickel titanium (NiTi) to stabilize the super elasticity properties of the initial nickel titanium (NiTi) arch wire against cyclic deformation. The addition of copper to traditional nickel titanium enhances thermal reactive properties and consistency of forces.so the aim of the study is to Evaluate the efficiency of using copper nickel titanium (CuNiTi) arch wire on the initial stage of leveling and alignment regarding their rate of alignment.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged (18\~33).
2. Moderate crowding (4-8)10.
3. No extractions required.

Exclusion Criteria:

1. Previous orthodontic treatment.
2. Missing teeth other than the wisdoms.
3. Patient with dental anomalies.
4. Patient having a deep bite, open bite or cross bite.
Positive Psychological Intervention for Parkinson's Disease Patients

This study aims to evaluate the impact of positive psychological intervention based on the PERMA model on Parkinson's disease patients by assessing their depression, quality of life, and related psychological indicators before and after intervention.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet the clinical diagnostic criteria for primary Parkinson's disease
* Subjects must not have a history of depression or other significant illnesses (e.g., stroke, coronary heart and tumor disease)
* Subjects should have clear consciousness, effective communication capabilities, and basic comprehension and reading skills to complete routine assessments
* The diagnosis of depression adhered to the ' Chinese Classification and Diagnostic Criteria for Mental Disorders ' (Revised Third Edition)
* Subjectsshould not have schizophrenia
* Subjects should not have substance abuse (alcohol, tobacco or other psychoactive substances)

Exclusion Criteria:

* Subjects with significant mental or cognitive impairment that communication or completion of scale assessments
* Subjects exhibiting severe self-harm or suicidal tendencies
* Subjects with severe dysfunction of the heart, liver, kidney or other critical organs
* Subjects with contraindications for transcranial magnetic stimulation (such as cochlear implant, pacemaker, built-in pump, artificial metal heart valve, suspected metal in the eye or elevated intracranial pressure)
* Subjects with a history of epilepsy that is poorly controlled
* Subjects with Parkinson's disease who have undergone surgical treatment
Process-oriented and Outcome-oriented Visual Assessments

This study aimed to compare the effectiveness of outcome-oriented visual assessment and process-oriented visual assessment using ATP bioluminescence test as a comparator in order to find out which method can be used to assess hospital cleanliness.

This study was conducted in a 17-bed adult medical intensive care unit at a medical center during December 2019 to December 2020. First of all, high-touch room surfaces were selected in patient rooms, including bed rails / controls, light switch, IV pump control, feeding pump control, monitor control, bedside table handle, call button, IV pole (grab area) and suction machine control. Then, Areas to be sampled on those high-touch room surfaces were identified. Whenever the housekeepers started to do terminal cleaning after patients were transferred or discharged, the researcher also started to observe directly the practices of cleaning at the same time and recorded "cleaned" if surfaces were cleaned and disinfected properly. Then, the researcher inspected surfaces and recorded "clean" if surfaces were free of dust, debris, and stains immediately after terminal cleaning.Ten minutes after terminal cleaning, Hygiena Ultrasnap Surface ATP test was performed to swab a standard area of 10 square centimeters on specific surfaces. After completing sampling, swabs were replace back in swab tube and all liquid in bulbs was expelled to activate the reaction. Once activated, samples were read right after shaking swab tube for 5-10 seconds.

Eligibility Criteria:
Inclusion Criteria:

* the environmental surfaces immediately after patients are discharged

Exclusion Criteria:

* no
Testing of DNA Extracted From Tumor Tissue Biopsy Samples Using Therascreen KRAS RGQ PCR Kit

A Non-interventional Biomarker Study for the testing of DNA extracted from tumour tissue biopsy samples, using the therascreen® KRAS RGQ PCR Kit, from patients with Non-Small Cell Lung Cancer, screened in Clinical Study (Protocol No. 20190294).

This is a non-interventional, biomarker screening clinical performance study protocol, for the testing of DNA extracted from tumour tissue biopsy samples (resected and core needle biopsy \[CNB\]/fine needle aspiration \[FNA\] tumour tissue) obtained from patients with Non-Small Cell Lung Cancer (NSCLC), using the KRAS Kit. A formal hypothesis will not be tested in this study.

Up to 7000 patient tissue samples (from approximately 5000 patients at 500 clinical trial sites), obtained in the Clinical Study (Protocol No. 20190294), will be tested using the KRAS kit. The testing will be performed at the investigational device clinical testing sites, Q2 Solutions Laboratories in the four geographical locations: USA, Singapore, UK and China

Eligibility Criteria:
Inclusion Criteria:

* All patients who provided consent (by signing and dating the ICF for Protocol No.

20190294), may be included in the Clinical Performance Study.

Exclusion Criteria:

* Patients whose tumour tissue biopsy samples that are not Clinical Study Assay evaluable
* Patients with samples identified for the study which have insufficient testing material
* Specimens which have undergone decalcification.
Trial of Post-Dated Delayed Antibiotic Prescriptions

Delayed prescriptions have been shown to lower antibiotic use for upper respiratory tract infections (which are mostly viral).

This trial will test the hypothesis that if the clinician post-dates the delayed prescription by 2 days, rather than dating it on the day the patient is seen, there will be a further drop in the rate of antibiotic use.

6 family doctors and 2 nurse practitioners in a small rural town will issue delayed antibiotic prescriptions to adult patients with new acute respiratory tract infections. The delayed prescriptions will be randomly dated for either the day of the office visit, or 2 days later. The 2 local pharmacies will note whether the prescription is cashed, and when.

It is hypothesised that post-dating the prescription will result in a reduced cashing rate.

Each arm of the study (Usual v Post-Dated) will contain 75 subjects. This sample will have the power to detect a 25% change in prescription use.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older
* Adults with an untreated upper respiratory tract infection
* Adults presenting for the first time to a family physician or a nurse practitioner

Exclusion Criteria:

* Less that 18 years
* Having a clear indication for antibiotic therapy
Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain

The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed mild to moderate knee osteoarthritis (KL Grade 2-3) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months
* Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
* 35-80 years of age
* Report a frequent pain score between 4-7 (NRS range: 0-10) during the week preceding enrollment
* Report that knee pain negatively affects quality of life
* Willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study
* Deemed appropriate by their physician or by the study site physician to participate
* Willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device
* Not initiate use of opioid and/or non-opioid analgesic medications
* Willing to discontinue any other interventional treatment modalities on the knee during the study period

Exclusion Criteria:

* Cannot successfully demonstrate the ability to put on and take off the device
* Display any condition which, in the judgment of the investigator, would make participation in the study unacceptable, including, but not limited to, the subject's ability to understand and follow instructions
* Have severe OA or have little to no cartilage in the knee
* Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months
* Is non-ambulatory (unable to walk)
* Is pregnant
* Is a prisoner
* Has a pacemaker
* Has a malignancy in the treatment area
* Has an active infection, open sores, or wounds in the treatment area
* Has impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia
* Has known neuropathy
* Has a hereditary disposition (tendency) for excessive bleeding (hemorrhage)
* Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening
* Modify their medications during the course of the study (medications and doses must remain constant throughout the study)
* Currently taking steroids
* Have contraindication to radiograph
* Have a secondary cause of arthritis (metabolic or inflammatory)
Adherence to Antidepressant Treatment in Subjects With Depression

This study aims to determine whether a combination a first-line antidepressant plus "RT2CK17" in a capsule relative to a first-line antidepressant plus placebo in a capsule results in higher rates of medication adherence in individuals with moderate to severe depression. In this double-blind randomized placebo controlled trial, 100 individuals with a Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR) scale score ≥ 14 will be enrolled to participate in an 8 week treatment study. Participants will be randomized with a 1-1 ratio to receive 5 milligrams (mg) "RT2CK17" + 10 mg escitalopram or placebo + 10 mg escitalopram to be taken orally once per day. Participants will undergo a 3 hour baseline evaluation visit at week 0, two 30-minute office visits (week 2 and 4), one 60-minute office visit (week 8) and three 5-minute phone calls (weeks 1, 3, and 6) during which clinical assessments and measures will be obtained. The trial is designed with two stages: 20 participants in Stage 1 will be used to estimate the adherence effect size; Stage 2 is designed with an interim analysis to test our hypotheses.


Eligibility Criteria:
Inclusion Criteria:

* Baseline QIDS-SR ≥ 14 (moderate depression)
* Age 18 - 65
* Written Informed Consent
* Major Depressive Disorder, single-episode/recurrent, not in remission

Exclusion Criteria:

* RT2CK17-related exclusions
* Uncontrolled hyperthyroidism
* Glaucoma
* Motor tics
* Monoamine oxidase inhibitor treatment
* Serious coronary artery disease, cardiomyopathy, serious cardiac arrhythmias
* Uncontrolled hypertension
* Peripheral vasculopathy
* Pregnancy
* Bipolar Disorder
* Psychotic Disorder
* History of intolerability of study medications
* Currently taking psychiatric medications
* Current Substance Use Disorder (other than nicotine)
* Current Alcohol Use Disorder
Utility of the Audible Alert in Current Generation Medtronic Implantable Cardioverter-defibrillators

The purpose of this study is to determine whether the alert tones emitted by the latest generation of Medtronic implantable cardioverter-defibrillators (ICDs) are audible to patients.

ICD patients can have difficulties hearing the beeps, which are designed to notify patients of possible lead or generator malfunction. In fact, the only published study of this issue, conducted at Englewood Hospital and Medical Center, revealed that only 50% of patients with older Medtronic devices were able to hear alerts. Since then, modifications to the alert have been made by Medtronic. This study will establish the "real-world" value of these changes and also provide useful in vivo information regarding the validity of the in vitro techniques which have been used thus far to design the Patient Alert feature.

There will be a single study visit. In a quiet examination room, the Patient Alert tones will be demonstrated to the subjects. Subsequently, this will be repeated with a wall air conditioner turned on. The subjects will then be asked to complete a three-part questionnaire regarding their perceptions of the Patient Alert tones.

Data analysis will include overall ability to hear tones, as well as subgroup analysis according to gender, age, and BMI.

Simultaneously, in order to calculate the loudness of the alert tones, digital recordings will be obtained using two microphones located near the subject. These digital recordings will be analyzed, and a loudness value will be calculated. The loudness value is a calculated index, devised by Medtronic, which incorporates frequency and intensity. Data analysis will include a correlation between loudness value and patient characteristics, and between loudness value and ability of subjects to perceive the tones.

Eligibility Criteria:
Inclusion Criteria:

* Previous insertion of a Medtronic Generation 2 ICD (Consulta, Secura, Concerto II, Virtuoso II, Maximo II devices) not fewer than 7 days prior to study entry
* Able to provide informed consent

Exclusion Criteria:

* Known deafness
* Recent (fewer than 6 weeks) ICD pocket surgery
* Non-Generation 2 Medtronic ICD
* Pocket hematoma
* Pocket infection