cyrilzakka/clinical-trials huggingface dataset:
PRV-based Detection of CAD in Comparison to Standard Methods

This is a validation study comparing a pulse wave based algorithm for the detection of coronary artery disease with parameters from coronary angiography, echocardiography and cardiogoniometry.

The study will validate a pulse wave based algorithm for the detection of coronary artery disease (CAD) with parameters from standard methods. Subjects will be patients admitted to coronary angiography due to suspected CAD. Pulse wave signals will be analyzed according to novelly established algorithm regarding the presence of CAD and/or myocardial ischemia. These results be compared to the diagnoses made by coronary angiography (primary endpoint): presence of minimum one coronary artery stenose \>=50%. For secondary analyses, results will be compared to parameters form echocardiography and cardiogoniometry.

Eligibility Criteria:
Inclusion Criteria:

* Coronary angiography indication present
* informed written consent

Exclusion Criteria:

* Previous coronary angiography
* Known CAD (history of coronary angioplasty, stent implantation and/or bypass surgery)
* atrial fibrillation (at time of measurement)
* severe ventricular extrasystole (e.g. \>=10% ventricular extrasystoles, bigemina)
* pregnancy, lactation
Efficacy of the Nurtured Heart Approach to Reduce ADHD Behaviors in Children

This study evaluates the efficacy of the Nurtured Heart Approach (NHA) to reduce inattention and hyperactivity and impulsivity in children ages 6 - 8 years. Participants are parents or guardians of children diagnosed with, or suspected of, attention deficit hyperactivity disorder (ADHD). Participants are randomized into the immediate (NHA) or delayed (Control) group.

The American Academy of Pediatrics recommends evidence-based parent and/or teacher behavioral therapy and/or medication to treat ADHD. A systematic review by Coates and colleagues found behavioral interventions decreased ADHD behaviors in children. The NHA is an intervention designed to teach parents a set of skills and attitudes to decrease ADHD in children. It has been applied in a number of settings from homes, schools, and foster care agencies both in several states in the U.S. and in over 16 countries. While widely accepted, the Approach has not been evaluated using scientifically rigorous methods.

Eligibility Criteria:
Inclusion Criteria:

* Parent or guardian of a child diagnosed with ADHD or suspected of ADHD
* Child must be 6 - 8 years of age
* Access to a computer with Internet

Exclusion Criteria:

* Child with ADHD, or suspected of ADHD, cannot have a diagnosis of autism
Music for Surgical Intensive Care (MUSIC)

Intensive care units (ICUs) are environments specialized in the care of critically ill patients. Despite significant advances, ICUs are often seen as a dehumanized environment. Among the various stressors in ICUs, anxiety, pain, psychomotor agitation and mental confusion, need for mechanical restraint, lack of privacy, noise, restricted visiting time with family members and excessive lighting stand out. The tripod composed of pain, anxiety and delirium (often associated with the presence of psychomotor agitation, mental confusion and altered level of consciousness) has a high incidence and morbidity. A set of prevention, intensity reduction and treatment measures has been proposed for these conditions, with a growing number of scientific evidence supporting their routine use.

Elderly patients tend to be particularly susceptible to the stressors described above. This aspect represents an additional source of concern for ICUs, since the elderly today represent the majority of patients admitted to ICUs. Hospitalization in ICUs after surgical procedures is often an unknown moment for the individual and, consequently, associated with the development of numerous unpleasant sensations, directly interfering with the patient's recovery.

Music as a therapy tool in medical practice has been used since 1890. After a little more than two decades, in 1914 it was applied in a surgical procedure by physician Evan Kane as a way of "calming patients and diverting attention from fear". associated with combined therapy with local anesthesia. In this context, being a low-cost tool, with minimal adverse effects and high acceptability, the use of music has proven to be a great ally in the arsenal of non-pharmacological therapies for the prevention of delirium, anxiety and pain.

We intend, through a randomized multicenter clinical trial, to investigate whether the use of music as therapy is capable of reducing the incidence of anxiety, pain and delirium in elderly patients undergoing surgical procedures and hospitalized during the postoperative period in intensive care units.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery admitted to the ICU in the immediate period after the surgical procedure; · Age equal to or greater than 65 years

Exclusion Criteria:

* · Moderate to severe dementia, defined by 2 to 3 points in the clinical dementia rating (CDR)66;

  * Impossibility of verbal communication (eg: aphasia);
  * Lack of understanding of the Portuguese language;
  * Inability to listen to music due to hearing impairment or intolerance to the use of headphones;
  * Mechanical ventilation for more than 12 hours;
  * Richmond Agitation Sedation Scale (RASS) less than or equal to 324;
  * Neurosurgical and craniofacial procedures;
  * Refusal or failure to sign the free and informed consent form (TCLE).
Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).

The goal of this open-label study is to study molgramostim as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP) in pediatric patients between age 6 and 18. The main questions it aims to answer are:

The effect of molgramostim on breathing tests and activity in pediatric patients with aPAP and the safety of molgramostim in pediatric patients with aPAP.

This is an open-label study: all participants will receive treatment with molgramostim.

Patients will:

* Take molgramostim once daily via nebulizer every day for 12 months.
* Visit the clinic approximately every 12 weeks for checkups and tests.
* Keep a diary of any oxygen use.

This is an interventional open-label, single arm, multi-center study in pediatric subjects, age 6 through 18 years, who are diagnosed with autoimmune pulmonary alveolar proteinosis (aPAP).

The diagnosis of aPAP should be confirmed by an anti-GM-CSF antibody test and a history compatible with PAP based on patient symptoms, high resolution computed tomography of the lung, lung biopsy or bronchoalveolar lavage cytology.

The study consists of a 4-week screening period followed by a 48-week open-label treatment period. After completing the 48-week treatment or early withdrawal, subjects will enter a 4-week safety follow up period. The maximum treatment duration is 48-weeks, and the maximum study period will be 56 weeks. During the trial, lung lavage will be allowed as a rescue treatment in case of worsening of aPAP.

Eligibility Criteria:
Inclusion Criteria:

* Be ≥6 and \<18 years of age, at the time of signing the informed consent and informed assent (if applicable).
* Have a history of pulmonary alveolar proteinosis, based on examination of a lung biopsy, bronchoalveolar lavage cytology, or a high-resolution computed tomogram of the chest.
* Have a positive serum anti-GM-CSF autoantibody test result confirming aPAP.
* Have a hemoglobin (Hb)-adjusted diffusing capacity of the lung for carbon monoxide (DLCO) ≤70% predicted at Screening.

Exclusion Criteria:

* Have a diagnosis of hereditary (congenital) or secondary PAP, or a metabolic disorder of surfactant production.
* Have undergone treatment with Lung Lavage (WLL) within 1 month of Baseline
An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care

Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial.

Through this study, the investigators will use patient and provider feedback to adapt the ASTHMAXcel mobile intervention, and will conduct a randomized controlled trial to test the intervention's impact on clinical and process outcomes.

Eligibility Criteria:
Inclusion Criteria:

English-speaking individuals \>18 years with:

1. persistent asthma(diagnosis made by a healthcare provider) on a daily controller medication
2. able to give informed consent
3. Smartphone (iOS or Android) access

Exclusion Criteria:

1. use of oral corticosteroids in the 2 weeks prior to the baseline visit
2. pregnancy
3. severe psychiatric or cognitive problems that would prohibit an individual from completing the protocol
4. patients that previously received ASTHMAXcel
Comparison of Barbed and Conventional Sutures in Adhesion Formation Following Cesarean Section

The aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with more postoperative adhesions compared with conventional sutures or not.

The aim of this randomized controlled trial is to determine whether the use of barbed sutures to close uterine incision at cesarean section is associated with an increase in the rate of postoperative adhesions compared with conventional sutures or not. Primigravida patients undergoing transverse lower segment cesarean section will be included in the study.Cesarean section incision will be closed with double layers of continuous barbed or conventional sutures.Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.

Eligibility Criteria:
Inclusion Criteria:

* Primigravida patients undergoing transverse lower segment cesarean section

Exclusion Criteria:

* Previous laparotomies
* Postoperative fever
* Patients with preterm pregnancies or in labor
Plasma Concentrations of Bupivacaine After Peri-articular Injection in Total Knee Arthroplasty

Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot femoral nerve block and periarticular block, so we would like to know the plasma concentration of bupivacaine in these patients.


Eligibility Criteria:
Inclusion Criteria:

* age of 30-70 yr
* ASA I-II
* patient undergo total knee arthroplasty under spinal block and single shot femoral nerve block and periarticular block

Exclusion Criteria:

* patient's refusal
* allergic to bupivacaine
* body weight less than 50 kg
* liver disease
* heart disease
* coagulopathy
* Hct\<35%
* infection at both groin
Involvement of Reticulum Endoplasmic Stress in the Physiopathology of Polycystic Ovary Syndrome

The main objective of the present project is to evaluate the relevance of reticulum stress in the pathogenesis of polycystic ovary syndrome (PCOS), focusing particularly on the underlying mechanisms of insulin resistance, which is the origin of metabolic comorbidities. Furthermore, the investigators will assess the potential of insulin sensitizers as a treatment to control endoplasmic reticulum stress markers in PCOS patients.

To do this, the investigators will evaluate anthropometric, biochemical and hormone parameters, lipid profile and cardiovascular risk markers (using enzymatic and biochemical techniques, nephelometry, enzyme-linked immunosorbent assay, radioimmunoassay), and markers of endoplasmic reticulum stress and the insulin pathway and inflammatory and apoptotic parameters (by means of Western blot, Real Time- Polymerase Chain Reaction (RT-PCR), Luminex® xMAP® Technology ) in patients with and without PCOS. The investigators' second objective is to evaluate (using the abovementioned methodology) the efficacy of different insulin sensitizers (myoinositol and metformin) administered to PCOS patients during a 3-month period after which the investigators will analyze different parameters of oxidative stress and mitochondrial function (using Clark electrode and fluorometric techniques).

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with PCOS using the Rotterdam criteria
* Women of reproductive age

Exclusion Criteria:

* Organic, malignant, haematological, infectious or inflammatory disease
* History of ischaemic heart disease (stroke or thromboembolism)
* Diabetes mellitus,
* Secondary causes of obesity (hypothyroidism, Cushing's syndrome)
* Severe hypertension.
* Smoking or alcohol habit
Incidence OIRD Medical and Trauma Patients

The primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (PCA) or nurse administered intravenous opioids for acute pain. Nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. The secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.


Eligibility Criteria:
Inclusion Criteria:

1. Spontaneously breathing adults 18 to 89 years of age
2. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
3. Admitted to the general care floor from the emergency department
4. Able to provide written informed consent

Exclusion Criteria:

1. Age is less than 18 years or greater than 89 years
2. Transfer to the general care floor from the ICU
3. Provider order for respiratory monitoring using continuous capnography
4. Receiving intrathecal or epidural opioids
5. Trauma patient with a nerve block
6. Inability or unwillingness to wear the EtCO2 sampling line nasal cannula or pulse oximetry sensor
7. History or diagnosis of a sleep disordered breathing syndrome
8. Use of CPAP or BIPAP non-invasive ventilation as home regime
9. Pre-existing co-morbidity that impacts respiration or ventilation (e.g. COPD or pulmonary fibrosis) (for the purpose of this study a trauma patient with rib fractures is not considered having a pre-existing condition)
10. Receiving non-invasive ventilation
11. Unable or unwilling to participate
12. Member of a vulnerable population such as pregnant women or prisoners
Validation of an Assay to Measure Cyclooxygenase-1 Activity

The purpose of this study is to obtain a reference range for a newly developed assay of ex vivo platelet COX-1 activity in normal volunteers taking a routine clinical dose of aspirin.

Aspirin has been shown to reduce cardiovascular events in at-risk individuals, but some aspirin-treated patients fail to exhibit expected changes in bleeding time and platelet aggregation. Recent evidence has correlated aspirin "non-response" to poor cardiovascular outcomes.

In order to study the mechanisms of aspirin resistance, an assay is needed to measure the catalytic activity of platelet cyclooxygenase (which should be inhibited by aspirin). A common assay in general use is the measurement of thromboxane B2 production in clotting whole blood. This measure, however, is influenced by genetic and environmental variations in the glass-activated coagulation pathway, albumin binding capacity, platelet activation pathways, arachidonic acid pools, and phospholipase activity.

Our laboratory has developed a direct assay of platelet cyclooxygenase (COX-1) activity that is not influenced by these variations. This study will generate a reference range in normal volunteers taking a routine clinical dose of aspirin (81mg daily) for this assay.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker
* No chronic medical illness
* No chronic medications

Exclusion Criteria:

* Aspirin/NSAID use in preceding 14 days
* History of chronic NSAID use
* Currently taking NSAIDs, opioid analgesics, corticosteroids, or anticoagulants
* History of coronary artery disease, myocardial infarction, coronary artery bypass grafting, percutaneous angioplasty, diabetes mellitus, or stroke.
* History of hypertension
* Body mass index \> 35
* History of gastric, duodenal, or esophageal ulcers or serious gastrointestinal bleed
* History of frequent headaches, pain syndrome, or other condition requiring frequent use of analgesics
* History of adverse reactions to aspirin
* Screening platelet count \< 100,000/ul or \> 500,000/ul
* Screening hematocrit \< 35% or \> 50%
* Weight less than 110 pounds
* Pregnant females
Raynaud's Treatment Study (RTS)

To determine the relative efficacy of usual medical care and a course of treatment by thermal biofeedback in reducing vasospastic attacks characteristic of Raynaud's syndrome. Also, to confirm the frequency and severity of attacks, examine the role of psychophysiological factors in precipitating attacks, and assess the influence of treatment on health quality of life.

BACKGROUND:

Primary Raynaud's phenomenon is a peripheral vascular disorder resulting in vasospastic attacks provoked by cold and/or emotional stress. Attacks most often occur in the fingers, but may occur in other extremities as well.

DESIGN NARRATIVE:

Randomized. Patients were assigned to one of four treatment groups: slow release Nifedipine, a calcium channel blocker; pill placebo; temperature biofeedback; or electromyograph biofeedback from the frontalis muscle. The primary endpoint was reduction in number of vasospastic attacks. Other endpoints included: other measures of Raynaud's attacks including frequency, severity, duration, response to laboratory-based cold challenge, and quality of life.

Eligibility Criteria:
Men and women with documented primary or secondary Raynaud's syndrome.
Endoscopic Treatment of Intestinal Fistulas and Perforations

Gastrointestinal leaks or perforations are currently treated through either open or laparoscopic surgical procedures. The purpose of this research is to determine whether new endoscopic tools are safe and effective in the treatment of such conditions and can overcome the need of invasive surgical procedures.

Novel endoscopic devices have the potential to overcome the need for invasive surgery for the treatment of gastrointestinal fistulas or perforations.

Instead of a large abdominal incision or multiple incisions with the related postoperative morbidity endoscopic techniques will be used used which require no postoperative limitation of activities. Using novel tissue closure devices, such as a Tissue Apposition System or an endoscopic suturing system, we will evaluate the potential benefit, risks and impact on the patient's quality of life of this modified surgical technique in patients having either chronic gastrointestinal fistulas or acute perforations.

Eligibility Criteria:
Inclusion Criteria:

* Gastrointestinal fistula and perforation
* Ability to undergo general anesthesia
* Ability to give informed consent

Exclusion Criteria:

* Contraindicated for esophagogastroduodenoscopy (EGD)
* Contraindicated for colonoscopy
* BMI ≥ 40
* Presence of esophageal stricture
* Altered gastric anatomy
* Intraabdominal abscess or severe inflammation
Acupuncture for Vasectomy Pre-procedural Anxiety and Pain Control in the Primary Care Setting

This study compares auricular (ear) acupuncture and body acupuncture (Koffman protocol) versus clinic standardized pre-vasectomy medications to determine which has better outcomes at improving pre-procedural anxiety and procedural pain relief and medication usage in adult male patients following vasectomy.

The investigators will compare auricular (ear) and body acupuncture (Koffman protocol) versus clinic standardized pre-vasectomy medications to determine which has better outcomes at improving pre-procedural anxiety and procedural pain relief and medication usage in adult male patients following vasectomy. In this efficacy trial, the investigators hypothesize that acupuncture will provide therapeutic anxiety and pain relief during and after vasectomy. The investigators will measure anxiety immediately before and prior to the procedure and before and after the intervention via a standardized anxiety scale (comparative). The investigators will also measure pain control immediately after the procedure using Defense and Veterans Pain Rating Scale (DVPRS). At the post op check (2-4 days after procedure) subjects will fill out a patient satisfaction survey. During the recovery period over 2 weeks, a medication usage diary will be kept by the subject including the time when the patient returns to full duties.

Eligibility Criteria:
\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Male active duty members and DoD beneficiaries aged 25 years or older
* Scheduled for a vasectomy

Exclusion Criteria:

* Repeat vasectomy
* Chronic pain medication/benzodiazepine use
* Current pain contract/pain management
* Current anxiolytic medication
* History of needle shock
* Diagnosis of anxiety
* Needle phobia
* Blood/injury phobia
* History of vasovagal reflex response
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure

The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.

Patients with hypertrophic cardiomyopathy and symptoms without severe outflow obstruction will be eligible to participate. Enrollment will be limited to subjects who are unable to attain 75% of their maximum predicted MVO2 at cardiopulmonary exercise testing. Subjects with genetic evidence of CYP2D6 poor metabolizer status will be excluded.

Subjects will undergo functional testing at baseline with CPEX testing and 6 minute walk distance testing. They will begin perhexiline orally, and the dose will be adjusted according to plasma level testing. For the first 8 week period, the target therapeutic range will be 100-300 ng/mL, and for the second 8 week period, the range will be 300-500 ng/mL. Functional testing will be repeated at the end of both periods.

Eligibility Criteria:
Key Inclusion Criteria:

* Hypertrophic cardiomyopathy with symptoms of moderate-to-severe heart failure
* Left ventricular hypertrophy with maximum LV wall thickness ≥ 15 mm
* Left ventricular ejection fraction ≥ 50%
* Able to perform exercise testing but unable to exceed 75% of the predicted age-adjusted maximum level

Key Exclusion Criteria:

* CYP2D6 Poor Metabolizer (PM) status
* History of a known chronic liver disease
* ALT, AST, alkaline phosphatase, or LDH \> 1.5 x upper limit of normal
* Total Bilirubin \> 2.0 x upper limit of normal
* Severe LV outflow obstruction
* Asymptomatic patients or cardiomyopathy-related criteria as per protocol
* QT interval related criteria as per protocol