cyrilzakka/clinical-trials huggingface dataset:
Cough Monitoring Study

The aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes.

Cough is an important defense mechanism of the respiratory tract. The presence of chronic cough may indicate the presence of underlying diseases, including reflux. Despite the increased number of patients suffering from cough in the ENT and GI practice, to date, there has been no method/device to objectively assess the frequency of cough episodes in a given patient.

PULMOTRACK-CC, manufactured by KarmelSonix (Haifa, Israel), has recently introduced an innovative device that is able to record cough episodes and then automatically detect and count them with the help of a specific software program. This study will assess the accuracy of this novel cough monitoring and counting technology and validate potential clinical use in patients with chronic cough.


Eligibility Criteria:
Inclusion Criteria:

Arm 1: healthy volunteers:

1. Male and female volunteers 18 years of age and older
2. No history of chronic or acute cough and throat clearing
3. Ability to read a 5th grade script written in English for approximately 20 minutes

Arm 2: patients:

1. Male and female volunteers 18 years of age and older
2. Cough as chief complaint
3. Referred to the GI clinic to evaluate if reflux is the cause of their chief complaint
4. pH testing for standard of care purposes

Exclusion Criteria:

* Subjects who are not able to give informed consent
Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention

To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prevention in patients in the Neuroscience Intensive Care Unit will result in fewer side effects compared to the current standard of care anticonvulsant and will be at least as effective as the current standard of care in preventing clinical and sub-clinical seizure activity.

To show that the use of intravenous levetiracetam(LEV;Keppra)for seizure prophylaxis in the Neuroscience Intensive Care Unit will result in fewer adverse effects compared to the current standard of care anticonvulsant(phenytoin) and will be at least as effective as phenytoin in preventing clinical and sub-clinical seizure activity.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with traumatic brain injury
* Glasgow Coma Score (GCS) score 3-8(inclusive),or GCS motor score of 5 or less and abnormal admission CT scan showing intracranial pathology
* Hemodynamically stable with a systolic BP \>90 mm Hg
* At least one reactive pupil
* A negative pregnancy test in females
* Age at least 18 years
* Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for research form OR
* Subjects with subarachnoid hemorrhage (SAH)
* SAH documented by CT scan
* Hunt-Hess grade 3-5, inclusive
* Hemodynamically stable with a systolic BP\> 90 mm Hg
* At least one reactive pupil
* A negative pregnancy test in females
* Age of at least 18 years
* Signed informed consent and HIPAA authorization for research form

Exclusion Criteria for enrollment

* No venous access
* Spinal cord injury
* History of or CT confirmation of previous brain injury such as brain tumor, cerebral infarct, or spontaneous intracerebral hemorrhage
* Hemodynamically unstable
* Suspected anoxic events
* Other peripheral trauma likely to result in liver failure
* Positive pregnancy test in females
* Age less than 18 years of age
* Known hypersensitivity to any anticonvulsant
* An injury that, in the opinion of the principal investigator, has a high likelihood of death within the first 72 hours.
* Any treatment, condition, or injury that contraindicates treatment with LEV (levetiracetam) or phenytoin (PHT).
* Inability to obtain signed informed consent or HIPAA authorization for research.
Assessing Optimal XR-Buprenorphine Initiation Points in Jail

The goal of this study is to compare two approaches for commencing pharmacotherapy with injectable buprenorphine for opioid use disorder (OUD) among jail inmates: (1) at the time of admission or (2) shortly before release. A sample of eligible inmates with sentences of less than 180 days will be randomly assigned to (1) initiating extended-release buprenorphine (XR-B) treatment at the time of admission (n=80), or (2) initiating XR-B treatment within 30 prior to their scheduled release date (n=80). The groups will be compared with regard to (1) how likely they were to participate in treatment, (2) levels of in-jail opioid use (via post-release interviews), (3) continuation of pharmacotherapy and other OUD treatment in the community, and (4) levels of opioid use 4 and 12 weeks following discharge (self-report and incentivized voluntary urine tests).


Eligibility Criteria:
Inclusion Criteria:

1. Incarcerated adults able to provide written informed consent in English.
2. Currently sentenced with pending release date between 3-7 months.
3. Current moderate-to-severe opioid use disorder (DSM-5)
4. Reasonable likelihood of completing 3-months or longer of community treatment (i.e., no plans to be transferred out of state or to another correctional facility)
5. Willing to accept being randomized to initiating XR-B treatment at the time of jail admission or near the time of release.

Exclusion Criteria:

1. Severe medical or psychiatric disability making participation unsafe or regular follow-up unlikely, including patients with pre-existing moderate to severe hepatic impairment are not eligible to participate
2. Pregnancy, planning conception, or breast-feeding
3. Allergy, hypersensitivity or medical contraindication to either medication
4. Chronic pain requiring opioid pain management
5. On methadone or buprenorphine (SL-B) maintenance prior to incarceration AND intending to remain on methadone or buprenorphine maintenance upon return to the community.
Plaque Registration and Event Detection In Computed Tomography

Disruption of an atherosclerotic plaque is responsible for at least two-thirds of acute coronary syndrome. Thus, identification of plaques vulnerable to rupture has become important. The natural history of individual plaques is unknown and needs to be established. Multidetector computed tomography (MDCT) angiography is a useful noninvasive imaging modality for assessing coronary plaque characteristics. Using MDCT, the researchers prospectively investigate the relationship between the characterization of coronary plaques and cardiovascular events in a large multicenter study.


Eligibility Criteria:
Inclusion Criteria:

* patients with known or suspected coronary artery disease.

Exclusion Criteria:

* irregular heart beat,
* known allergy towards the contrast agent,
* renal dysfunction,
* uncontrolled heart failure,
* previous coronary bypass surgery, or pacemaker or ICD implantation, ST elevation MI or unstable hemodynamic condition,
* impossible breath-hold, OR
* end-stage cancer.
A Study to Evaluate the Effects of Itraconazole on MK-1708 in Healthy Participants (MK-1708-003)

The goal of the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18.5 and ≤32 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer
OCT Evaluation 3 Months After Sirolimus Eluting Stent Implantation

Prospective, single center, randomized and non-inferiority study, to include up to 60 patients with de novo coronary artery disease. Patients will be followed at 30 days, 3, 6 and 12 months. At 3 months all patients will be submitted to angiographic and OCT evaluation.


Eligibility Criteria:
Inclusion Criteria:

* one or two de novo lesions (\> 50% visual estimation)
* lesion diameter between 2.5 and 3.5 mm
* lesion length up to 33 mm.

Exclusion Criteria:

* MI within the last 72 hours
* restenotic lesion.
Arterial Line in Trauma Resuscitation

Accident-related deaths is the 7th leading cause of death in Taiwan, and most of them is due to trauma from falls and traffic accident. Among trauma patients, the common cause of death is from hemorrhagic shock. Thus, real-time and accurate blood pressure monitoring is important for trauma patients. Incorrect blood pressure monitoring can lead to adverse events like traumatic cardiac arrest and shock and can also delay the time for intervention (fluid resuscitation, blood transfusion and operation). The current practice of blood pressure monitoring in trauma patient is by non-invasive blood pressure monitoring, which may be incorrect and not timely. Patient's body type and peripheral perfusion can both influence the result of non-invasive blood pressure monitoring.

With continuous and correct blood pressure monitoring, the resuscitation team can give adequate and timely treatment. In some trauma centers, arterial line insertion in trauma patients is a daily practice, while the evidence is inadequate and the potential benefit in unknown.

The main purpose of this study is to investigate the application of arterial line insertion in trauma patients. The study design is a prospective before-after study to exam whether arterial line insertion in trauma patients can reduce adverse event rate like hypovolemic shock and improve patient's outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma Scale (GCS) 13 or less
* SBP \< 90 mmHg
* Respiratory rate \< 10 or \> 29 breaths/min
* Fall from height \> 6 meters
* High-Risk Auto Crash: Partial or complete ejection, intrusion \> 30 cm any site, Need for extrication for entrapped patient, Death in passenger compartment
* Rider separated from transport vehicle with significant impact
* Penetrating injuries to head, neck, torso, and proximal extremities
* Skull deformity, suspected skull fracture
* Chest wall instability, deformity, or suspected flail chest
* Suspected pelvic fracture
* Suspected fracture of two or more proximal long bones
* Amputation proximal to wrist or ankle
* Active bleeding requiring a tourniquet or wound packing with continuous pressure
* Burns in conjunction with trauma

Exclusion Criteria:

* Pregnancy
* Patient or family who are unable to obtain informed consent
* Known coagulopathy that is inappropriate for arterial line insertion
* Known peripheral arterial occlusion disease that is inappropriate for arterial line insertion
* traumatic cardiac arrest
Absorb BVS vs. Drug Coated Balloon for Treatment Of ISR

AbsorbISR is a randomized, controlled trial, single center, prospective, not blinded to evaluate two strategies of in stent restenosis treatment: Implantation of drug eluting bioresorbable stent scaffold Absorb® vs. balloon angioplasty with drug eluting balloon Sequent Please®.

This is randomized-controlled trial of Absorb® Bioresorbable Vascular Scaffold (BVS) vs. Sequent Please® drug coated balloon in an all-comers population with in-stent-restenosis (ISR). The patients will be randomized in a 1:1 fashion and the investigators intend to include 150 patients.

All patients presenting with ISR and requiring percutaneous coronary intervention will be eligible to be included in this study. This will include patients with stable angina and those presenting with acute coronary syndrome (ACS).

The primary objective of this study is to demonstrate superiority of the Absorb® bioresorbable scaffold compared to the Sequent Please® Drug Coated Balloon when treating patients with In-Stent-Restenosis regards to primary endpoint - angiographic late lumen loss at 9 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Diagnosed with ISR requiring percutaneous coronary intervention: visual diameter stenosis \> 70 % and/or Fractional Flow Reserve \< 0.81 and/or non-invasive testing demonstrating ischemia. This real-life population with in-stent restenosis beside typical stable patients with ISR includes ACS patients with thrombus containing lesions, patients with multivessel disease, patients with ISR in non-infarct related artery, with ISR in bare metal stent (BMS), drug eluting stent (DES) or bioresorbable vascular scaffold (BVS), ISR in lesion previously treated by plain old balloon angioplasty (POBA), drug eluting balloon (DEB) or additional stent implantation.
* Double anti-platelet therapy for the duration of at least 12 months is considered possible at the time of intervention

Exclusion Criteria:

* The participant may not enter the study if the interventionist has doubts that he is not able to deliver and implant the Absorb scaffold (e.g. highly calcified lesions).
* Patients who have any contraindications for using DEB (SeQent Please) or BVS (Absorb) specified in instructions for use are not able to participate in this study.
* Women with childbearing potential must have a negative result of pregnancy test and they must use an effective contraception method for at least 12 months after study procedure.
Potential Impact of Polycystic Ovarian Syndrome on Protein Modifications and Accumulation

A goal of this study is to use a novel methodology to determine whether insulin resistance in women with polycystic ovary syndrome (PCOS) is related to the accumulation of proteins with modifications. This could lead to future research to determine if these modifications interfere with their proper function. Additionally, the investigators will determine how protein quality is affected by exercise training. Aerobic exercise enhances the endogenous oxidant buffering systems which may minimize oxidative damage to proteins. The investigators propose that aerobic exercise minimizes the accrual of modified proteins by increasing the synthesis of new proteins, but also by increasing the degradation and removal of old and damaged proteins. Based on our previous studies the investigators observed that insulin affects plasma protein synthesis and aerobic exercise improves insulin sensitivity not only in muscle but also in liver. The investigators therefore propose that aerobic exercise and related increase in insulin sensitivity (and decline in insulin levels) will reduce accumulation of old and modified skeletal muscle and plasma proteins leading to improved function.


Eligibility Criteria:
Inclusion Criteria:

1. BMI between 25 kg/m2 and 40 kg/m2
2. Fasting blood glucose \< 126 mg/dL
3. Diagnosed with PCOS as outlined by the Rotterdam criteria
4. Insulin resistant as determined by a 3 hour oral glucose tolerance test

Exclusion Criteria:

1. Serum creatinine ≥1.5 mg/ dL.
2. Serum transaminase elevation ≥ 3 times the upper limit of normal range
3. Use of systemic glucocorticoids
4. Use of oral anticoagulation
5. Pregnancy
Echocardiography Predictive of the Inefficacy and/or of the Unsafeness of Recruitment Maneuvers in Patients With Acute Respiratory Distress Syndrome.

The purpose of the study RVSTAR is to evaluate whether echocardiographic criteria exploring the right ventricle can predict the inefficacy and/or the unsafeness of recruitment maneuvers in patients suffering from acute respiratory distress syndrome


Eligibility Criteria:
Inclusion Criteria:

* Endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for one week or less
* A ratio of the partial pressure of arterial oxygen (PaO2 measured in millimeters of mercury) to the fraction of inspired oxygen (FiO2 which is unitless) of 300 mmHg or less and inspired fraction of oxygen FiO2 of more than 50 %
* A positive end-expiratory pressure of 5 cm of water or higher
* A tidal volume of 6 to 8 ml per kilogram of predicted body weight
* Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules
* Respiratory failure not fully explained by cardiac failure or ﬂuid overload
* Written and informed consent
* Adult patients at least 18 years of age
* Ventilatory criteria (PaO2/FiO2 of 300 mmHg or less and Positive End Expiratory Pressure of 5 cm of water or higher) and radiologic criteria (Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules) lasting more than 24 hours

Exclusion Criteria:

* Endotracheal mechanical ventilation for acute hypoxemic respiratory failure lasting for more than one week
* Age younger than 18 years old
* No written and informed consent
* Known pregnancy and/or breastfeeding
* Increased intracranial pressure
* A ratio of the partial pressure of arterial oxygen (PaO2 measured in millimeters of mercury) to the fraction of inspired oxygen (FiO2 which is unitless) higher than 300 mmHg
* Positive end expiratory pressure of less than 5 mmHg
* Ventilatory criteria (PaO2/FiO2 of 300 mmHg or less and Positive End Expiratory Pressure of 5 cm of water or higher) and radiologic criteria (Bilateral opacities on chest radiography not fully explained by effusions, lobar/lung collapse, or nodules) lasting less than 24 hours
* Severe chronic respiratory disease requiring long-term oxygen therapy or mechanical ventilation at home
* Severe chronic liver disease
* Barotrauma such as pneumothorax
* Hemodynamic failure needing more than 3 milligrams per hour of noradrenalin and/or more than 2 milligrams per hour of adrenalin and or rising doses of vasopressors and/or vascular filling exceeding 500 milliliters in the preceding hour
* Arrhythmias such as : ventricular tachycardia, ventricular fibrillation, third degree atrioventricular block
* Atrial fibrillation
A Simple Clinical Tool to Help Assess Patient Volume (Fluid) Status

Patients may have actual or relative intravascular volume depletion in a number of different disease states, particularly with sepsis syndrome. However, it is clinically difficult to determine volume status without invasive monitoring, which may cause unintended complications. Our hypothesis is that we can accurately estimate central venous pressure, which is a surrogate marker of volume status, with a noninvasive portable ultrasound device.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older.
* Healthy, euvolemic volunteers and critically ill patients who are already in an intensive care unit and who will have a central venous catheter placed as part of their planned medical treatment.

Exclusion Criteria:

* Inability to use ultrasound to measure jugular vein (neck brace or bandage), "code" situation.
Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy

Hypothesis: Is the combination of oral L-ornithine-L-aspartate and lactulose more efficacious than oral lactulose alone in treatment of hepatic encephalopathy? Study design; Randomized, double-blinded, placebo controlled trial

Data collection

1. Baseline characteristics

   * demographic data; age, gender, BW, height
   * cirrhosis; cause, duration, Child-Pugh score,complications of cirrhosis such as EV, ascites, hepatic encephalopathy, SBP etc.
   * comorbidity such as DM, CVA
2. After randomization

   * assessment of mental status (West-Haven criteria), Portal-systemic encephalopathy index (PSEI), number connection test, serum ammonia, asterixis at Day 1,3,7 and EEG at day 1,7
   * blood chemistry such as CBC, BUN, Creatinine, electrolyte, LFT, coagulogram, BS at Day 1,3,7
   * record adverse effect of drug such as nausea, vomiting, bloating.
   * record diet, frequency of bowel movement and stool pH
   * compliance

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis
* Age 18-80
* Hepatic encephalopathy grade II-III
* Serum ammonia \> 60 mcg/mL
* Informed consent

Exclusion Criteria:

* Recent GI hemorrhage
* Severe sepsis
* Degenerative CNS disease or major psychiatric illness
* Serum creatinine \> 1.5 mg/dl
* Pregnancy or lactation
* Poorly controlled DM
* Insertion of TIPS
* Received CNS depressants or hypnotics
* Treatment with metronidazole, kanamycin or branched-chain amino acid
* Hypersensitivity to L-ornithine-L-aspartate
Digital Secondary Prevention in Cardiovascular Disease

Although advances in knowledge of the prevention, diagnosis and treatment of atherothrombosis are encouraging, cardiovascular diseases (CVD), with acute and chronic ischemic heart disease in particular, remain a major cause of disability and premature death throughout the world.

Cardiac rehabilitation (CR) and secondary prevention are coordinated multidimensional evidence-based strategies that aim to assist patients with acute and chronic ischemic heart disease return to an active and satisfying life and to prevent the recurrence of further cardiac events. Since CR is time limited after an acute event, secondary prevention proposes a continuum where care is provided for the rest of a person's life according to the existence of cardiovascular risk factors. Secondary prophylaxis is fundamental for the recovery of the patient, but in most cases, it is only insufficiently implemented.

To ensure adequate resources for the delivery of health care and to further improve the level of care, care-delivery models need to be changed in a way that patients themselves become more involved in their own care. Mobile health (mHealth) is a rapidly growing health delivery methodology with the potential to impact on health care research, health care delivery and health outcomes.

Therefore, the aim of the study is to determine the impact of plaque visualization using a digital intervention on treatment adherence to improve the cardiovascular risk profile. Participants will be randomized into two groups: intervention group and control group. Participants of the control group receive the best medical care according to current guideline recommendations without access to the app. Participants of the intervention group receive the best medical care according to current guideline recommendations with full access to the Smartphone application at time of study begin until the completion of the follow-up period of 12 months. The access to the app includes access to relevant findings including ultrasound images of the carotid artery, lipid profile, blood pressure values, and weight.


Eligibility Criteria:
Inclusion Criteria:

* Ultrasound evidence of atherosclerotic plaque in one or both carotid arteries
* Own a smartphone and know how to use apps
* presumed life expectancy of more than one year
* willing to comply with the protocol and provide written informed consent

Exclusion Criteria:

* congestive heart failure with NYHA (New York Heart Association classification) III-IV symptoms
* severe valve disease
* no german knowledge
* unwillingness to user the app and/or undergo diagnostic procedures