cyrilzakka/clinical-trials huggingface dataset:
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System

The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.

This is an international, multicenter, single arm, prospective, Early Feasibility Clinical Study to evaluate the safety and performance of the Neovasc Tiara Mitral Valve System in subjects with symptomatic severe mitral regurgitation requiring mitral valve replacement who are at high risk for open chest surgery.

A maximum of 30 subjects will be implanted in this study at a maximum of 10 sites. A maximum of 15 subjects will be implanted in the United States.

Subjects satisfying the inclusion criteria and exclusion criteria will be enrolled to receive the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Delivery System via a transcatheter mitral valve replacement (TMVR) procedure.

Eligibility Criteria:
Inclusion Criteria:

* Severe symptomatic mitral regurgitation (Stage D)
* High surgical risk for open mitral valve surgery
* Subject meets the anatomical eligibility criteria for available size(s)
* NYHA Class III or IV heart failure

Exclusion Criteria:

* DMR deemed by the heart team to be operable.
* Prohibitive risk, deemed too frail or listed for cardiac transplant.
* Unsuitable cardiac structure
Effect of Intermittent Oro-esophageal Tube Feeding on Dysphagic Patients With Parkinson Disease

The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.

Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Nasogastric tube feeding has been widely used in patients with Parkinson's disease but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy.

The goal of this or clinical trial is to explore Intermittent Oro-esophageal Tube Feeding vs. Nasogastric Tube Feeding on nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease. The main question it aims to answer are:

• Can stellate ganglion block improve the nutritional status, dysphagia, and activities of daily living in patients with Parkinson's disease, better than Nasogastric Tube Feeding.

Participants will be divided into the control group and observation group evenly. All the patients were provided with routine therapy and given nutritional support by Intermittent Oro-esophageal Tube Feeding and Nasogastric Tube Feeding respectively. The nutritional status, swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.
* Diagnosed with dysphagia confirmed by the video fluoroscopic swallowing study.
* Water swallow test\> Level 3.
* Stable vital signs, conscious, able to cooperate with assessment and treatment.

Exclusion Criteria:

* Dysphagia possibly caused by other reasons, such as cerebrovascular disease, trauma, neuromuscular diseases, malignant diseases of the pharynx and larynx, and digestive tract diseases.
* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
Atrial Fibrillation Ablation on Gastric Motility "The AF Gut Study"

You are being scheduled to undergo an ablation procedure to treat your atrial fibrillation. Complications of ablation procedures include damage to structures near the heart from the heat energy used during the ablation procedure. These complications include damage to the esophagus (the tube through which food passes when you swallow) and stomach. A rare but often fatal complication resulting from severe heat damage is called an atrio-esophageal fistula (an abnormal connection between the heart and esophagus). However, the frequency of minimal damage to the esophagus or nerves of the gut that may go unnoticed are not known.

This study is designed to determine how often atrial fibrillation ablation causes problems with the stomach and esophagus.


Eligibility Criteria:
Inclusion criteria:

* All patients aged 18 years or more who undergo pulmonary vein isolation with radiofrequency ablation for clinically indicated atrial fibrillation.

Exclusion criteria:

1. Patients with established diagnosis of esophageal or gastric function abnormalities.
2. Patients who are unable to give consent or major psychiatric condition not under control.
3. Patients who had abdominal surgical procedures on stomach, esophagus or pancreas (Esophagectomy, Gastrostomy, Gastrectomy (Billroth I, Billroth II, Roux-en-Y), Bariatric surgery \[Gastric bypass surgery, Adjustable gastric band, Sleeve gastrectomy, Vertical banded gastroplasty surgery\], Gastroenterostomy, Hill repair, Nissen fundoplication, Gastropexy, Pancreatectomy, Pancreaticoduodenectomy, Pancreas transplantation, vagotomy).
4. Patients who unable to undergo any of the above mentioned procedures namely, esophageal manometry or sham feeding test or scientigraphy gastric emptying scan.
5. Patients with chronic pancreatitis.
6. Patients with either acute or chronic neuropathies such as diabetic, inflammatory, autoimmune and cranial neuropathies effecting vagal nerve or gastroparesis or achalasia. Limited peripheral neuropathies such as carpal tunnel syndrome or isolated Bell's palsy can be included.
7. Patients who have undergone previous radiofrequency ablation for atrial fibrillation or patients who had history of either minimally invasive or invasive or maze or modified maze procedures for atrial fibrillation.
Fetal Evaluation at Term Using Statistical ECG Signal Processing (FETUSES)

Background

The fetal heart rate (FHR) is commonly monitored during labor to detect early fetal acidosis. FHR variability is traditionally investigated using Fourier transform, however, fetal conditions differ from adults (higher frequency, widely instable signal) modifying spectrum repartition along frequencies, making this approach inappropriate. New mathematic approach, including Multifractal analysis, adaptative multiscale complexity analysis, nearest-neighbor based wavelet entropy rate measures, scattering transform, may identify parameters associated with fetal acidosis. Modern classification system, driven by the data, based on these relevant parameters should help to dsiccriminate the fetus at risk for acidosis and help the clinician in decision making for the management and termination of labor. Analysing 20 to 30 minutes sliding windows with these different methods in a limited number of cases (foetus born with acidosis) and controls (foetus without acidosis) should lead to identify relevant parameters, which will be submitted to these classification tools. For external validation, a large database, including more than 4500 FHR recording documented with foetal outcomes, will be used to evaluate the performance of the combination of parameters identify and classification system used to discriminate foetuses at risk for short term acidosis or not, in order to give a relevant information to the clinician before acidosis occurs, to make the appropriate decision.


Eligibility Criteria:
--- Inclusion Criteria:

* women with singleton pregnancy and fetal ECG recording using a scalp electrode, with recording lasting more than 60 minutes, with less than 20 % of missing data and less than 20 minutes between the end of recording and birth.

  * Exclusion Criteria:
* Women with recirdin lasting less than 60 minutes, with more than 20 % of missing data, or more than 20 minutes between the end of recording and birth.
Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression

The primary objective of the proposed research is to determine whether prenatal insomnia and ruminative thinking predict severity of postpartum depression (PPD) symptoms. Additionally, the investigators will also determine the effectiveness of digital/internet-based Cognitive Behavioral Therapy for Insomnia (dCBTI) in reducing the risk for PPD.

The purpose of this study is to 1) explore the relationship between prenatal insomnia, ruminative thinking and the severity of PPD symptoms. and 2) determine the effectiveness of Digital Cognitive Behavioral Therapy (dCBTI) in reducing the risk for postpartum depression in pregnant mothers entering into their third trimester. dCBTI is an online form of Cognitive Behavioral Therapy (CBT) that is used with people who experience trouble sleeping at night (insomniacs). As pregnant women are especially vulnerable to sleep problems during this period, this study will help us determine whether dCBTI is helpful in improving sleep and reducing the risk for PPD in this population.

Pregnant women entering their third trimester will be recruited from the Henry Ford Health System through the HFHS Electronic Medical Record (EPIC). They will receive an email from study personnel describing the study, and encouraged to schedule a phone call to discuss study details. Participants will then complete a consent and an online screening survey. Upon meeting inclusion criteria, participants will complete weekly surveys and randomized into one of 2 active online insomnia treatment conditions. Each treatment involves 6 weekly "sessions" which each take up to 20 minutes to complete.

Subjects will complete weekly online surveys beginning at week 30 of pregnancy, and continuing through 6 weeks after giving birth.

Eligibility Criteria:
Inclusion Criteria:

* Must be entering their 3rd trimester of pregnancy
* Must deny any concerns or indications of a high risk pregnancy associated with increased risk for the mother or fetus for negative health outcomes

Exclusion Criteria:

* Age \< 18 years old
* Bipolar or seizure disorders (due to risk in CBTI)
* Known sleep disorders other than insomnia (eg narcolepsy, restless legs syndrome, obstructive sleep apnea)
* Women already in their 3rd trimester
* Women who are not pregnant
* Women with high risk pregnancy
Evaluation of Risk Factors Regarding Extubation Failure in Severe Brain Injured Patients.

Severe brain-injured patients require prolonged mechanical ventilation. Weaning these patients from mechanical ventilation is challenging. During neurologic recovery, brain injured patients usually present satisfactory respiratory autonomy. However, the exact timing of extubation is unknown and is frequently delayed because of potential inhalation.

To date, there are no clinical signs available in the current literature that can help the attending physician in the decision-making process of extubation in brain-injured-patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with brain-injury (traumatic brain injury, subarachnoid haemorrhage, stroke, intracerebral hemorrhage, brain tumour) requiring ≥ 48 hours of mechanical ventilation after admission

Exclusion Criteria:

* Pregnant women
* Patient consent withdrawal
Prevention of Postoperative Acute Kidney Injury

Postoperative acute kidney injury (AKI) refers to increased mortality and morbidity in patients after non-cardiac surgery. The Kidney Disease Improving Global Outcomes (KDIGO)-guidelines recommend a bundle of procedures to prevent the occurrence of AKI: A protocol for the improvement of the hemodynamic situation and a standardized proceeding in hemodynamic monitoring, consequent avoidance of nephrotoxic substances, regular measurement of creatinine and urine output, as well as normoglycemia. The primary goal is to determine if the consequent application of the KDIGO-bundle leads to a prevention of the occurrence of AKI in patients at risk after non-cardiac surgery.

All patients included in the study will be treated with the KDIGO-bundle (hemodynamic stabilization, avoidance of nephrotoxic substances, normoglycemia and measurement of creatinine in serum and urine output). 12 h, 24h as well as on day 2, 3, 5 and 10 after admission on ICU the occurence of AKI (according to KDIGO) will be assessed.

Eligibility Criteria:
Inclusion criteria:

* Age \> 65 years
* chronic kidney disease
* diabetes mellitus, chronic heart, lung or liver disease
* hemodynamic instability (intra and/or post-operative)
* trauma, burn injury, major surgery, usage of x-ray contrast and sepsis.

Exclusion criteria:

* Age \< 18 years
* pregnancy
* kidney graft recipient
* chronic renal disease with or without renal replacement therapy and cardiac surgery.
Effect of Paroxetine on COAT-Platelet Production in Normal Volunteers and Patients With Cardiovascular Disease

COAT-platelets stands for collagen and thrombin stimulated platelets, which are two things in the body that make platelets stick together. These platelets may be important in the initiation of a heart attack (myocardial infarction). A chemical in the body called serotonin maybe responsible for COAT-platelet production. Paroxetine causes a significant reduction in platelet serotonin and therefore may have value in preventing heart attacks. Therefore, the current study is designed to determine whether paroxetine will decrease COAT-platelet production in normal volunteers and patients with cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* normal volunteers (without heart disease)
* patients with heart disease
* between ages 18 \& 65

Exclusion Criteria:

* children less than 18 years
* adults greater than 65 years
* those who can not keep appointments
* patients within 2 weeks of a coronary catheterization
* patients within 6 months of unstable angina or myocardial infarction
* individuals with allergies to paroxetine or similar medications
* individuals having adverse events to paroxetine or similar medications
* individuals with diagnosis of mania
* individuals with a diagnosis of hypomania
* individuals with a diagnosis of bipolar disorders
* individuals with a diagnosis of depression
* individuals with a diagnosis of panic disorders
* individuals with a diagnosis of seizure disorders
* individuals with a history of suicide attempts
* individuals with a diagnosis of hyponatremia
* individuals with active bleeding disorders
* individuals with a diagnosis of narrow angle glaucoma
* individuals with an estimated creatinine clearance of less that 30 ml/min
* individuals taking potentially interacting medications
Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- Compatibility

The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINBACK Tangerine Mix (Lactic Acid).


Eligibility Criteria:
Inclusion criteria:

* Age between 18 and 60 years old;
* Phototype Skin I,II, III e IV;
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation;
* Personnel history of atopy;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study;
Evaluation of the Ambu ® aScope® for Tracheal Intubation in Difficult Airways

The purpose of this study is to evaluate a disposable fiberscope (Ambu ® aScope®) for tracheal intubation in difficult airways due to cervical immobilization by a cervical collar, and compare it to a conventional reusable fiberscope.

Any general anesthesia requiring tracheal intubation for controlled ventilation includes the likelihood of intubation failure and, in case of difficult or impossible mask ventilation, can be life-threatening. In patients with diagnosed or suspected disease of the cervical spine, airway control can be tricky. Indeed, the cervical collar used to secure the cervical spine makes direct laryngoscopy impossible. In elective surgery, the most commonly used technique is fiberoptic intubation, achievable without removing of the cervical collar.

A new disposable fiberscope was recently developed by Ambu ®: the aScope®. It consists of a disposable flexible fiberscopic device, whose distal end is fitted with a camera that can be directed. This device is connected to a separate reusable LCD display. The aScope® is used as a conventional flexible fiberscope to guide the instrumentation of the airway.

With the exception of case reports, all studies of this device in difficult conditions were performed on mannequins.

The investigators propose to assess and validate this device on real patients with difficult airways caused by a rigid cervical collar and compare intubation conditions and time to the gold standard technique, the classical reusable fiberscope.

Induction of general anesthesia is performed by the anesthesiologist responsible for the patient, according to the standards in the anesthesiology department.

The cervical collar is fitted and positioned once the patient is asleep in addition to a dedicated oropharyngeal cannula (Ovassapian fiberoptic intubating airway cannula) in order to guide the aScope® or fiberscope in the oropharynx. The timer is activated once the investigating physician takes the aScope® or fiberscope in his hands. The device is advanced into the airway with visual control on the LCD screen for the aScope® or on an external dedicated screen for the fiberscope. Once in the trachea, the device will serve as a guide for introduction of the orotracheal tube, according to standard fiberscopic intubation technique. Tracheal intubation is confirmed through visualization of the distal end of the tube into the trachea, the onset of an end tidal CO2 curve and auscultation. The timer will be stopped at the onset of the end tidal CO2 curve.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 16 years
* ASA 1-2
* BMI \< 35 kg/m2
* Surgery requiring general anesthesia with intubation of the trachea

Exclusion Criteria:

* Emergency operation
* Patient ASA 3 or more
* BMI above 35 kg/m2
* History of difficult airways
* History of surgery or radiotherapy in head and neck
* Presence of gastro esophageal reflux
Robotic Assisted Major Lung Resection in Elderly Patients

The study is a retrospective observational study. The study is designed to be multicentric and it will analyze medical records from selected patients that underwent major lung resection using DaVinci surgical platform performed in the participating centers.

There are no risks for the patients, as this is a retrospective data collection.

The investigators will recruit all patients who underwent major lung resection (segmentectomy, lobectomy, bilobectomy, or pneumonectomy using a robotic system) from May 2015 to December 2022.

Patients are divided into two groups: older than 80 years (case- very elderly patients) and younger than 80 years (control- elderly).

the aim: Minimally invasive techniques such as robot-assisted thoracoscopic surgery (RATS) can potentially reduce surgical trauma and therefore prove particularly beneficial for elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years at the moment of surgery
* Suspected or confirmed diagnosis of lung cancer
* The patient can be candidate in terms of cardiac, kidney, liver and respiratory function the primary pathology is under control or controllable
* Absence of extrapulmonary metastases that are not controlled or controllable
* All procedures included use of DaVinci robot system

Exclusion Criteria:

* Age \< 18 years at the moment of surgery
* Patients who cannot undergo surgery, as they do not meet the conditions outlined above
Disease Containment Measures Among Older Adults During the Covid-19 Pandemia

This study will examine which impact lockdown strategies intending to prevent the spread of COVID-19 had on people with cognitive impairment and dementia.

Comprehensive data from two large health studies in Norway, conducted before and after the COVID-19 outbreak, will be linked with health register data on the use of health care services and medication. Further, it will be conducted a survey addressing questions on social isolation and use of communicative technology, from March 2020 to January 2021. The knowledge gained from this study can improve the health care system's ability to respond more adequately to pandemics and other unforeseen events, so that the negative consequences for older adults with dementia and cognitive impairment can be reduced.

Introduction: To prevent the spread of COVID-19 societies around the world have implemented various levels of lockdown strategies. Norway locked down major parts of the society from March 2020. Specifically, this meant that public services were closed (e.g. most in-home healthcare services, day care centres, group exercise/gyms and services that offer physiotherapy, medical and psychological consultation). For people with cognitive impairment and dementia, social distancing and self-isolation may have limited the use of normal strategies (e.g., distraction, stimulation, and social interaction) that are routinely adopted to manage some of the dementia symptoms, such as neuropsychiatric symptoms. A lack of daily routines may change the clinical conditions of patients with dementia. Worsening of preexisting and/or the onset of new neuropsychiatric symptoms may occur, in addition to a possible decline of cognitive and functional capacities

Aim: The overarching aim of this project is to provide decision makers with vital information to improve the healthcare of people with dementia and cognitive impairment in the context of an epidemic.

Method: We will use four data sources:1) The fourth wave of the Trøndelag Health study (HUNT, HUNT4 70+), 2) Three national health registries (The Norwegian Patient Registry (NPR), the Norwegian Registry for Primary Health Care (NRPHC) and the Norwegian Prescription Database (NorPD)), 3) A postal questionnaire concerning social isolation during the COVID-19 epidemic, and 4) The Ageing in Trøndelag study (AiT), which is a follow-up of the HUNT4 70+ study.

With this linkage of cohort data and national health registry data, we can identify factors that may make people with cognitive impairment and dementia vulnerable to loss of healthcare services because of COVID-19 and subsequently to negative health consequences.

Eligibility Criteria:
Inclusion Criteria:

* Inhabitants living in the designated areas

Exclusion Criteria:

* None