cyrilzakka/clinical-trials huggingface dataset:
BIO|CONCEPT.Amvia Study

The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.


Eligibility Criteria:
Inclusion Criteria:

* Standard indication for pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation, including de novo, upgrade or replacement implantations
* Ability to understand the nature of the study
* Willingness to provide written informed consent
* Ability and willingness to perform all follow-up visits at the study site
* Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring concept

Exclusion Criteria:

* Planned for conduction system pacing
* Planned for activation of atrial anti-tachycardia pacing (aATP) without known history of atrial arrhythmia, or with permanent atrial fibrillation (AF)
* Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
* Pregnant or breast feeding
* Age less than 18 years
* Participation in another interventional clinical investigation according to the definition given in the study protocol
* Life-expectancy less than 12 months
A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease

This study is designed to evaluate the efficacy and the safety of YH14642 in Korea patients with chronic periodontitis, in order to investigate the recommended therapeutic dose.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 20 years of age or older
* Have at least 18 natural teeth
* Four or more clinical attachment level(CAL) ≥ 3mm
* Four or more periodontal pockets with a probing depth (PD) ≥ 4mm
* Have Bleeding on probing
* Provide informed consent and willingness to cooperate with the study protocol

Exclusion Criteria:

* Forbidden History of Panax Notoginseng and Rehmanniae Radix Preparata
* Hypersensitivity of Doxycycline
* Hypersensitivity of Zea mays L. extract
* Critical diseases such as HIV previous three years
* Patients with mental retardation and dementia
* Systemic diseases such as diabetes and hypertension
* Patients who take Anticoagulants or Antiplatelet Agents
* Patients who have malignant tumor
* Smoker
* Continually use for 2weeks of phenytoin, calcium channel blocker, cyclosporin, coumarin, nonsteroidal anti-inflammatory drugs and aspirin use in the previous one month
* Patients who need malignant tumor
* Patients who received periodontal treatment within the last 6 months
* Pregnant or lactating females
Effect of Intravenous Metoprolol Combining RIC on Myocardial Protection in STEMI Patients

The main purpose of this study is to compare the myocardial protection effect of intravenous metoprolol combined with remote ischemic conditioning (RIC) and single treatment before reperfusion in Chinese patients with anterior STEMI. This study sought to find possible strategies to further improve myocardial protection in Chinese patients with anterior STEMI.

This study is a prospective, multi-center, randomized controlled study. It is planned to enroll 1200 patients with anterior STEMI. Immediately after the first medical contact, the patients who were determined by the investigator to meet the inclusion/exclusion criteria were randomized through the interactive web response system (IWRS) and received different pre-reperfusion treatments. The four groups were placebo group, metoprolol group, remote ischemic conditioning (RIC) group and metoprolol \& RIC group. Subsequently, the investigator conduct diagnosis and treatment according to the patient's specific conditions and check the serum level of myocardial damage markers (i.e. CK and CK-MB) at the time of admission, 12, 24, 36, 48, 60 hours, respectively. If the patient undergoes PCI treatment, additional detection of myocardial damage markers immediately after PCI is also required. All patients were followed for 1 year with an office visit or a telephone call at 1, 3, 6, 9 and 12 months to evaluate the health status and adverse clinical events of patients.

Eligibility Criteria:
Inclusion Criteria:

1. ages 18 to 80 years;
2. presenting within 12 h of symptoms onset, with anterior STEMI and planned for pPCI; anterior STEMI was defined as the occurrence of \>20 min of chest pain and ST-segment elevation (\>2 mm) in at least 2 contiguous precordial leads;
3. sign informed consent;

Exclusion Criteria:

1. systolic blood pressure \< 110mmHg;
2. cardiogenic shock or with heart failure symptoms, Killip III\~IV;
3. allergic history of metoprolol;
4. history of asthma or the need for bronchodilators;
5. PR interval \> 240ms, II\~III atrioventricular block；
6. heart rate \< 60 beats/min;
7. unable to consent;
8. pregnancy and lactation women;
9. life expectancy for diseases (i.e. cancer) \< 1 year.
Pediatric Videolaryngoscopic Intubation and Difficult Airway Classification

The study's primary aim is to develop and validate a multivariable diagnostic model for the prediction of difficult videolaryngoscopy (the 'PeDiAC classification') in children undergoing general anesthesia with tracheal intubation. The secondary aim is to compare the diagnostic performance of the PeDiAC-classification with the Cormack-Lehane classification.

Difficult tracheal intubation is one of the major reasons for anesthesia-related adverse events. Videolaryngoscopy has become an important part of the anesthesiology standard of care for difficult airway management in the past decades. This is especially relevant in children, as their airway anatomy differs greatly from adults because they are likely incapable of tolerating brief apneic episodes. Still, medical preconditions and procedural and technical factors related to difficult videolaryngoscopy have not been broadly investigated and not fully been understood.

The primary aim of the PeDiAC study is to develop and validate a multivariable diagnostic model for the classification of difficult videolaryngoscopy (the 'PeDiAC classification') in children undergoing general anesthesia with tracheal intubation. Study planning and conduction are in accordance with the TRIPOD 'Transparent reporting of a multivariable prediction model for individual prognosis or diagnosis' statement. The secondary aim is to compare the diagnostic performance of the PeDiAC-classification with the Cormack-Lehane classification, which is the current clinical standard for assessing intubation via direct laryngoscopy. We conduct a prospective observational study that will include approximately 800 pediatric patients within one year scheduling for tracheal intubation. Patients with age below 18 years will be considered to be eligible for inclusion. Procedural and surgical data, as well as medical preconditions, will be assessed systematically. After tracheal intubation, performed by the responsible anesthetist, the intubation process will be rated by the responsible anesthetist and an additional independent observer, and detailed information regarding procedural and technical factors related to videolaryngoscopy will be documented. All sampled independent variables will be considered to be potential candidate predictors for the multivariable regression model.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients undergoing general anesthesia with tracheal intubation in the study center.
* Informed consent obtained
* Age \< 18 years

Exclusion Criteria:

* Anesthetist prefers conventional laryngoscopy
* Indication for intubation via a bronchoscope or awake intubation
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS

The links between obstructive sleep apnea syndrome (OSAS) and type 1 diabetes (T1D) are poorly studied. This study proposes to evaluate the severity of cardiovascular autonomic neuropathy (CAN) related to T1D in case of associated OSAS. This issue has significant diagnostic and therapeutic implications because of the increased cardiovascular risk in case of confirmed CAN in T1D patients.

Cardiovascular autonomic neuropathy (CAN) is a common complication of type 1 diabetes (T1D) and is associated with increased cardiovascular risk. Otherwise, some studies have found a high frequence of obstructive sleep apnea syndrome (OSAs) in T1D. Cardiac autonomic modulations are deeply altered in OSAS. The combination of T1D and OSAS could therefore increase the severity of CAN and worsen the cardiovascular prognosis.

The most common method used to explore CAN is the study of heart rate variability (HRV). HRV is a practical, non-invasive and reproducible measure of autonomic nervous system function. HRV abnormalities are a predictor of hypertension and increased mortality in T1D.

Th investigators therefore propose to explore the severity of NAC in case of OSAS associated with T1D, and the hypothesis is that cardiovascular damage is increased in the presence of these two pathologies.

The patients included in this study will be patients with type 1 diabetes diagnosed for more than 5 years.

After overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of HRV, cardiovascular autonomic reflex test (Ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using Sudoscan.

The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) ≥15 / hour) compared to T1D patients with IAH \<15 / hour.

Furthermore, glycemic holter will describe the links between glycemic variability, sleep architecture and CAN. Biological oxidative stress assays will improve physiopathological knowledge between T1D, OSAS and CAN. Finally, a 24-hour monitoring of blood pressure will be performed.

An ancillary study is planned to evaluate the evolution of markers of the autonomic nervous system after three months of treatment with CPAP in 15 patients with severe OSAS (AHI ≥30 / hour) having previously participated in the main study. Fifteen patients with IAH \<30 / hour will also be reassessed at three months to assess the intra-individual variability of the HRV.

Eligibility Criteria:
Inclusion criteria:

* Type 1 diabetes patients with a diabetes duration of at least 5 years
* Age between 18 and 60 years old.

Exclusion criteria:

* OSAS treated with CPAP
* Chronic alcoholism
* Neuromuscular disease
* Drugs interfering with sinus variability (betablockers, antiarrhythmics, ivabradine), presence of pacemaker
* Pregant woman
Speeded Anomia Treatment in Chronic Post-stroke Aphasia

The main aim of the study is to investigate the effect of a novel, speeded anomia therapy (Conroy et al., 2018) in a large population of patients with chronic post-stroke aphasia. The treatment will be delivered via a web application (QuickWord).

The main aim is to test the clinical efficacy of a novel, web based, rehabilitation approach to aphasic word-finding difficulties (QuickWord). In an initial development and case-series evaluation, Conroy et al (2018, Brain) found that training for both speed as well as accuracy of naming generated much better outcomes to picture naming accuracy and also augmented the carry-over to connected speech production.

This is a randomised, crossover, clinical trial of QuickWord in a group of aphasic patients in the chronic post-stroke period. The comparison will be standard care. The main outcome measures are clinically relevant improvement in naming to confrontation, and spontaneous use of the target vocabulary in a connected speech sample (detailed picture description). Secondary outcome includes measured use of the vocabulary in a story-telling, connected speech assessment (retelling of the Cinderella story).

Eligibility Criteria:
Inclusion Criteria:

* Native English speakers
* Age 18 years or above
* Stroke (any type) greater than 12 months post onset
* No history of neurological disorders / psychiatric disorders
* Normal or corrected-to-normal hearing \& vision
* Able to give informed consent
* Currently not receiving Speech \& Language therapy
* Minimal repetition skills (\>40% on an immediate word repetition test)
* Evidence of naming difficulties (\<90% in Boston Naming Test - Goodglass et al., 1983)

Exclusion Criteria:

* Non-native English speakers
* Less than 18 years old
* Stroke less than 12 months post onset
* History of neurological disorders / psychiatric disorders
* Uncorrected hearing \& vision
* Unable to give informed consent
* Currently receiving Speech \& Language therapy
* Insufficient repetition skills (\<40% on an immediate word repetition test)
* Good naming performance (\>90% in Boston Naming Test - Goodglass et al., 1983)
Prediction of the Risk of Biochemical Relapse After Radical Prostatectomy for Prostate Cancer Using Radomics on Pre-therapeutic MRI

With 50% of post-operative biochemical failure, efficient predictive models are needed to guide post-operative management.

Radiomic features are quantitative features extracted from medical imaging, supposed to be correlated with tumor heterogeneity.

We aim to build and test three predictive models (clinical, radiomic and combined models).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18yo
* Patients underwent radical prostatectomy
* High-risk prostate cancers: at least 1 criteria (pt3a/pT3b/pT4, R1, Gleason score \> 7)

Exclusion Criteria:

* No available pre-operative MRI
* No analyzable pre-operative MRI
* proof of lymph-node involvement (cN1/2 or pN1/2)
* post-operative PSA \> 0.04ng/mL
BioCurrent Electrical Stimulation for the Treatment of Dry ARMD

This study evaluates the treatment of Dry Macular Degeneration and the resulting change in vision with a very, very low current that is similar to what occurs in the body naturally. In Phase 1, 16 participants will be treated, with half receiving treatment and half a sham (no treatment). After the treatment period of one week, those not treated will be treated. In Phase 2, all participants will be treated.

The study will assess the effectiveness of transpalpebral micro-current electrical stimulation on improving the visual acuity in subjects with vision loss from Dry Macular Degeneration. The BioCurrent electrical stimulation will be applied by a device with the intended use of treating Dry Macular Degeneration. The device delivers a micro-current, an electrical current in the one millionth of an ampere range, to the retina in frequencies changing in a pre-defined pattern from 5Hz to 80Hz during each spot (40 sec). The device also incorporates a voltage limiter (a maximum of 245 micro A is possible) and a current level indicator. 200 micro A will be used. Very low electrical micro-current is delivered to the subject through the goggle probe.

Eligibility Criteria:
Inclusion Criteria:

* Best-corrected visual acuity can be no better than 20/40 and no worse than 20/200 for each enrolled eye
* Confirmed diagnosis of Dry MD
* Vision loss attributable to Dry MD
* Subjects must be highly motivated, alert, oriented, mentally competent and able to understand and comply with the requirements of the study, abide by the restrictions, return for all required visits, and provide voluntary informed consent

Exclusion Criteria:

* Any retinal pathology other than Dry MD
* Evidence or history of wet MD
* Previous intravitreal injection
* Seizure disorders
* Dense cataract
* Eyelid pathology at the treatment sites
* Any prior electrical micro-stimulation treatment to the eyes
* Poor general health
* Active cancer
* Life expectancy less than 12 months
* Non-ambulatory
* Not considered suitable for participation for any other reason
An Online 5-week Professional Identity Group Psychotherapy

This is an online 5-week group psychological intervention for the nursing students during clinical rotation practice. It aims at promoting the professional identity and career sefl-efficacy for them.

Those 110 participants come from two classes in the same grade. One will be randomly allocated as the intervention group, the other will be control group. The intervention will be delivered via an online meeting software, like Zoom. The control group will received five messages fo self care messages forward by the researcher.

Eligibility Criteria:
Inclusion Criteria:

* Full time nursing student
* During clinical rotation practice
* Able to comprehend the intervention

Exclusion Criteria:

* Visual impairment
* Absent more than twice of the intervention
Effects of Lysozyme on Acute Exacerbation of Chronic Obstructive Pulmonary Disease : A Randomised Placebo-Controlled Study

The aim of this study is to assess the effectiveness in preventing exacerbation of 52 weeks lysozyme administration in patients with COPD.


Eligibility Criteria:
Inclusion criteria;

* Patients were eligible for inclusion in the study if they were over 20 years of age and below 85 years of age, and had a smoking history, a diagnosis of COPD, a ratio of FEV1 to forced vital capacity(FVC) of less than 70%, and a documented history of at least one exacerbation leading to any treatment within the previous year.

Exclusion criteria;

* Patients with egg allergy
* Patients with domiciliary oxygen therapy
* Patients with pneumonia or pulmonary tuberculosis
* Patients with severe cardiovascular disorder,severe kidney disorder, severe hepatic disorder, severe hematological disorder.
* Patients with cancer.
A Study to Determine if Carbon Dioxide Lavage During Total Knee Surgery Reduces Intraoperative Embolic Events

The purpose of this study is to determine if the use of a carbon dioxide lavage device (CarboJet) to clean bone surfaces during total knee surgery decreases intraoperative embolic events when compared with standard orthopedic techniques.

Elderly patients undergoing major, orthopedic surgery are at risk of developing postoperative cognitive dysfunction (POCD) or memory impairment following surgery. Transcranial doppler (TCD) monitoring of blood flow to the brain has detected cerebral emboli in 60% of patients following release of the thigh tourniquet during total knee replacement or arthroplasty (TKA). These cerebral embolic events may represent one of the mechanisms responsible for postoperative cognitive problems.

The standard surgical technique for TKA involves cleaning the bone surfaces with pulsed saline lavage prior to cementation and prosthesis insertion. The CarboJet Assisted technique utilizes carbon dioxide lavage to clean and dry the femur canal and bone surfaces prior to cementation and implantation. Because it removes fat globules and marrow particulates from the bone surfaces, it is hypothesized that the use of a carbon dioxide lavage technique in TKA will result in fewer thromboembolic events and increased cement penetration compared with the standard technique using pulsed saline lavage. Cement penetration affects the strength of the bone-cement interface and, therefore, contributes to implant longevity.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 50 years or older who are scheduled for elective TKA with a cemented Smith and Nephew Prosthesis design

Exclusion Criteria:

* Dementia or severe cognitive impairment
* Severe visual or hearing impairments
* Inability to follow directions or comprehend the English language
* Females who are pregnant
* Abnormal distal femur geometry
* Pre-existing hardware or abnormal bony architecture in the proximal tibia
Figure of 8 Walk Test in Multiple Sclerosis

Balance disorder is common in people with MS. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. Given the prevalence and clinical significance of balance dysfunction in individuals with MS, the assessment of balance has become an important focus in MS clinical practice and research. The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking performance required in daily life. Beyond walking straight, turning ability is required in many situations in daily life such as walking around a table, avoiding obstacles and navigating the street. The gait characteristics of walking on a straight and curved road are different. During curved walking, the center of mass of the body shifts to the inner leg as the stance time of the inner leg increases, as opposed to walking on a straight track. Compared to other standardized tests, scoring is not dependent on the subjectivity of the examiner, can be administered by a person with minimal training, and requires minimal time, space, and equipment. The test assesses the ability to quickly change direction of movement and is a timed test involving the use of assistive devices.

Multiple sclerosis (MS) is a progressive disease of the central nervous system characterized by demyelination and destruction of motor and sensory axons. As the disease worsens, it is associated with impaired balance, difficulty walking, decreased mobility, and an increased risk of falling. The prevalence of balance dysfunction in individuals with MS and Given its clinical relevance, the assessment of balance has become an important focus in MS clinical practice and research. The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking performance required in daily life.In the figure of 8 walk test, two cones are placed 1.5 meters apart. The individual stands in the middle of this distance. At the start of the test, he goes around the first cone as fast as he can walk around the first cone, then when he comes to the other starting point, this time around the other cone. The elapsed time is recorded.

The aim of the study is to examine the validity and reliability of the 8-shape walking test in MS patients.

Eligibility Criteria:
Inclusion Criteria:

* Having an EDSS score of 4 and below,
* Being between the ages of 18-65
* Willingness to participate in the study

Exclusion Criteria:

* Being pregnant or within the first 3 months after giving birth,
* Receiving corticosteroid therapy in the last 1 month,
* Using drugs that will affect walking in the last 1 month