cyrilzakka/clinical-trials huggingface dataset:
Comparitive Effectiveness of PME Versus Transthoracic Echocardiogram (TTE)

A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to traditional transthoracic echocardiography (TTE).

The investigators are evaluating the effectiveness of this hand-held echo (HHE) device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.

A new hand held pocket echo device (GE Vscan) has now become available to clinicians, with limited data available comparing the effectiveness of this device as a screening tool when compared to TTE.

We are evaluating the effectiveness of this HHE device in detecting cardiac pathology in a both an inpatient and outpatient clinical setting as compared to a comprehensive TTE evaluation.

This study compares the images from the two modalities with regards to multiple parameters typically evaluated by traditional TTE. This would include the following:

1. Ejection fraction: estimates how well the heart is squeezing/functioning.
2. Segmental wall motion abnormalities: if one wall of the heart is not moving well, this suggests that part of the heart is not getting enough blood supply and could represent a blockage in a blood vessel supplying the heart or in other terms a heart attack.
3. Left ventricular end-diastolic dimension: allows us to see if the heart is dilated
4. Inferior vena cava size: the size of this great vein can help estimate if patient has too much fluid in their vascular bed.
5. Aortic valve pathology: whether or not there is thickening of the valve or impairment of it's opening.
6. Mitral valve pathology: whether or not the valve is significantly thickened or with impaired closing and opening.
7. Pericardial effusion: excessive fluid in the sack around the heart.

The images obtained on the HHE will be evaluated by two experienced echocardiographers as well as two cardiology fellows who have obtained training in image acquisition and interpretation. The readers of the HHE images are blinded to the TTE results, and vice versa.

A comparison of these individual parameters on HHE and TTE allows us to validate this new, convenient screening tool in detecting cardiac pathology.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects with an order for a routine transthoracic echocardiogram based on clinical indications.
2. Vscan images will be obtained to evaluate multiple parameters (noted on research summary).
3. Immediately after Vscan imaging, a complete transthoracic echocardiogram will be performed.
4. Images will be compared between the Vscan device and the traditional transthoracic echocardiogram.

Exclusion Criteria:

1. Subjects who had a limited transthoracic echocardiography (i.e limited views)
2. Vscan imaging not attempted for a certain parameter
Ultrasound-guided Thoracic Paravertebral Block Using Ropivacaine With/Without Dexamethasone in Elective Thoracotomy

The procedures of thoracotomy are among the most painful operations. In addition to post-thoracotomy pain, the outcomes of surgery are affected adversely by postoperative discomfort. Therefore, post-thoracotomy pain control can improve the satisfaction of patient and prevent postoperative complications such as pneumonia, atelectasis, or respiratory failure. Thoracic epidural analgesia (TEA) used to be widely considered as a standard technique for providing analgesia after a thoracotomy. However, TEA carries side-effects such as incomplete or failed block, epidural hematoma, abscess, hypotension, respiratory depression, or bradycardia, etc. Recently, thoracic paravertebral block (TPVB) is an alternative technique for TEA that may offer a comparable analgesic effect and a better side -effect profile for post-thoracotomy analgesia. When local anesthetic agents are used as single injection, they can provide analgesia for limited period. Various adjuvants have been tried in the past in order to enhance the duration and quality of postoperative analgesia. Previous studies with perineural dexamethasone demonstrated that it enhanced the duration of local anesthetic block. The mechanism of its action is blocking the nociceptive impulse transmission along the myelinated C fibers. Patient-controlled analgesia (PCA) devices have been shown to provide superior analgesia and greater patient satisfaction compared with intermittent administration. System of wire-less PCA provides remote monitoring, information management and PCA devices with high precision. The purpose of this research is to determine whether dexamethasone might prolong the duration of analgesia and improve the short-time outcomes when administered for TPVB along with local anesthetic agents in elective thoracotomy.


Eligibility Criteria:
Inclusion Criteria:

1. patient American Society of Anesthesiologists（ASA） I\~III undergoing elective thoracotomy
2. written informed consent from the patient or the relatives of the participating patient

Exclusion Criteria:

1. mental illness
2. thoracic paravertebral blocks contraindicated
3. local anesthetic allergy
4. people who have heart disease
5. people who have severe liver or renal disease
6. people who have severe endocrine disease
7. people who can't communicate effectively because of hearing or visual disorders
Effect of Ghrelin on Decision-Making

This study evaluates the effect of the "hunger hormone" ghrelin on human decision-making. Participants will be given an injection of ghrelin or saline on different study days and will then be asked to make a series of computer-based decisions. The investigators hypothesize that ghrelin will increase participant's preference for energy-dense foods and will also increase impulsiveness in decision making.

Ghrelin is a hormone made by the stomach that stimulates hunger and feeding behavior. How ghrelin affects human decision-making is poorly understood. This study will investigate the effect of ghrelin on nutrition-related and time-based decisions in humans. Participants eye movements will be tracked by a computer during the decision-making process.

Eligibility Criteria:
Inclusion Criteria:

* Ability to speak and understand English
* BMI of 18.0 - 24.9 kg/m2 or 30.0 - 50.0 kg/m2

Exclusion Criteria:

* Diagnosis of diabetes mellitus (including gestational diabetes)
* Active infections
* History of malignant or inflammatory conditions, such as rheumatoid arthritis and inflammatory bowel disease
* History of myocardial infarction or congestive heart failure
* Active liver or kidney disease
* Uncontrolled hypertension
* Pituitary or adrenal disorders or neuroendocrine tumors
* History of anorexia nervosa, bulimia, or eating disorders not otherwise specified (NOS); Score of "at risk" on the EAT-26 eating disorder screening tool
* Diagnosis of attention-deficient/hyperactivity disorder (ADHD)
* Malabsorptive gastrointestinal disease, gastroparesis, or history of gastrointestinal surgery
* Pregnancy or lactation
* Requirement of daily medications that alter gastrointestinal function (including, but not limited to, glucocorticoids, psychotropics, narcotics, and metoclopramide).
* Requirement of glasses for impaired vision (including reading glasses). Subjects who wear contact lenses for vision correction will not be excluded.
* Insufficient visual acuity to read and interpret the decision stimuli
* Insufficient motor capabilities to press a button, move the joystick, or move their eyes to indicate a response
A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation

This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants. \>/= 18 years of age
* Histologically confirmed metastatic or unresectable papillary thyroid cancer for which standard curative or palliative measures do not exist or are no longer effective; participants whose tumors exhibit areas of "other histology" may be enrolled, provided the tumor histology remains predominantly papillary
* Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test)
* Radioactive Iodine resistant disease
* Prior therapy excluding (Cohort 1, TKI Naive) or including (Cohort 2, TKI Experienced) TKI
* Clinically relevant disease progression according to RECIST criteria within the prior 14 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate hematological, renal and liver function

Exclusion Criteria:

* Histological diagnosis other than papillary PTC, including squamous cell variants of PTC or PTC with areas of squamous metaplasia
* Active or untreated central nervous system metastases
* History of or known carcinomatous meningitis
* Anticipated or ongoing administration of any anti-cancer therapies other than those administered in the study
* Active squamous cell skin cancer that has not been excised or adequately healed post excision
* Previous treatment with any agent that specifically and selectively targets the MEK or BRAF pathway
* Prior radiotherapy to the only measurable lesion
* Clinically relevant cardio-vascular disease or event within the prior 6 months
To Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices.

After successful screening of patients based on inclusion criteria, we will measure the baseline Hepatic Venous Pressure Gradient. At day 1 patients will undergo complete blood investigation including complete haemogram, kidney function test, liver function test, prothrombin time, AFP (Alfa Feto Protein) level, chest x ray, ultrasonography, fibroscan. Routine complete physical examination will be done.


Eligibility Criteria:
Inclusion Criteria:

1. All patients of chronic liver disease with esophageal varices.
2. Age more than and equal to 18 years.

Exclusion Criteria:

1. Patients of chronic liver disease with history of upper Gastro Intestinal bleed.
2. Patients of acute on chronic liver failure
3. Thrombosis of splenoportal axis
4. Hepatocellular carcinoma
5. Patients who were on primary variceal ligation sessions as prophylaxis
6. Patients who are beta blocker intolerant (Prior h/o hypotension, bradycardia).
7. Patients who are contraindicated for beta blockers {H/O COPD (Coronary Obstructive Pulmonary Disease), heart block, refractory Ascites, SBP(Spontaneous Bacterial Peritonitis) , HRS(Hepato Renal Syndrome)}.
8. Failure to give consent for inclusion in the study
Biofilm Correlation and Validation

This is a prospective, single-blind, controlled trial. There are two arms and 20 patients with acute or chronic wounds with clinical suspicion of biofilm (CSB+/CSB-) are allocated in each arm. The primary objective is to evaluate the diagnostic accuracy of MolecuLight fluorescence in identifying biofilm as validated by gold standard SEM imaging.


Eligibility Criteria:
Inclusion Criteria:

1. Patients presenting with acute or chronic wounds
2. 18 years or older
3. Willing to consent

Exclusion Criteria:

1. Treatment with an investigational drug within 1 month of enrolment
2. Any contra-indication to regular wound care
3. Inability or unwillingness to consent
Prophylactic Cranial Irradiation in Patients With Lung Adenocarcinoma With High Risk of Brain Metastasis

Lung cancer is the first cause of death among cancer patients. Non Small Cell lung cancer (NSCLS) represents about 80-85% of the cases. Of this, about 80% presents with locally advanced or metastatic disease. Important to mention the number of patients that progress or recur in central nervous system (CNS). It has been reported that patients with adenocarcinoma, who are under 60 years and with elevated carcinoembryonic antigen (CEA) are in the highest risk to develop brain metastasis. In small cell lung cancer, treatment with prophylactic cranial irradiation (PCI) is the standard of care in patients without progression after locoregional or systemic treatment because the proven benefit in overall survival (OS) and progression free survival (PFS). However, in NSCLC PCI has not been able to prove any survival benefit, only in CNS PFS, probably because there is no trial, to our knowledge, of PCI in NSCLC that include only the specific group of patients considered in high risk of developing brain metastasis.

Objectives:

1. To obtain a greater PFS and CNS PFS in patients with NSCLC treated with PCI after locoregional or systemic treatment.
2. Evaluate the benefit in OS in the specific group of patients who are at increased risk of developing brain metastasis
3. Evaluate quality of life and mental function before and after treatment with PCI and compare it with patients in the observation group.

Methods: One hundred and twenty eight patients with locally advanced or metastatic (except CNS metastasis) NSCLC will be included and randomized to receive either observation or PCI 25 Gy in 10 fractions Whole Brain Radiotherapy (WBRT) once the initial treatment has been completed and progression of the disease ruled out.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven advanced NSCLC (Stage IIIB or IV) including wild-type, EGFR-mutated or ALK-rearrangements who received treatment and were without progression at the end.
* Above 18 years
* General status with a Karnofsky \>80%
* Eastern Cooperative Group (ECOG) ≤2
* Negative CNS MRI at the beginning of any treatment
* Carcinoembryonic antigen \> 20 pg
* Hepatic and hematic cytology test within normal range
* Adequate renal function
* Those who accepted to participate in the study and who sign the letter of informed consent.

Exclusion Criteria:

* Patients with another type of cancer
* Patients who refuse participate in the protocol
* General status with a Karnofsky \<80%
* Eastern Cooperative Group (ECOG) \>2
* Previous treatment with WBRT
* Previous treatment with chemotherapy
* Disease progression after initial treatment, either chemotherapy or chemoradiotherapy depending the case.
* CNS metastasis at diagnosis
* Abnormal laboratory test that interfere with chemotherapy or TKI administration
Reducing Medical Risks in Individuals With Bipolar Disorder - Full Study

The primary aim of this project is to understand whether it is possible to reduce medical risk factors in adults with bipolar disorder and, in doing so, to improve psychiatric and functional outcomes. We will examine the role of behavioral risk factors and presumed behavioral mediators and moderators of health risk in individuals suffering from bipolar I disorder. The investigators will employ an innovative behavioral intervention with guideline based psychiatric care ( Integrated Risk Reduction Intervention - IRRI) in order to target modifiable medical risk factors.

IRRI is aimed at improving sleep/wake and social rhythm disturbance and achieving modest weight reduction by increasing physical activity and improving nutrition and dietary habits, while at the same time providing optimal psychiatric care and medical monitoring. This will allow us to investigate the role that improvements in sleep/wake and social rhythm regularity, diet, and physical activity have in improving psychiatric and functional outcomes. In order to examine another set or possible pathways (i.e., that it is the amelioration or psychiatric symptoms that leads to the improvements in physical health), we will contrast outcomes of subjects receiving IRRI with those of subjects receiving psychiatric care with medical monitoring (PCMM), which incorporates the same optimal psychiatric care plus monitoring of medical conditions. These aims will be achieved in a 24-month randomized treatment trial of 144 adult subjects with bipolar I disorder.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 55 years
2. Body mass index (BMI) \>25
3. Meets DSM-IV criteria for lifetime bipolar I disorder
4. Is in remission (with possible sub-threshold symptoms), i.e., as a HRDS-25 \< or equal to 10, YMRS \< or equal to 8, and CGI-BP-S \<3 for two weeks
5. Able to give basic informed consent
6. Current diagnosis or past history of anxiety disorder, eating disorder, or other psychiatric comorbidities will not be exclusion criteria for participation, except those listed in the exclusion criteria below

Exclusion Criteria:

1. Ultra-rapid cycling (\>8 episodes per year) bipolar I disorder
2. Presence of pervasive developmental disorder, antisocial personality disorder, current substance dependence or abuse, and organic mental disorder
3. Unstable and severe medical illness that requires immediate and intensive medical attention, for instance, a subject with a terminal illness or a subject with severe and unstabilized coronary artery disease; these subjects will be immediately referred to the most appropriate medical and psychiatric treatment. When appropriate, the subjects can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study
4. Unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations)
5. Not competent to provide informed consent in the opinion of the investigator
6. Women who are planning to become pregnant, currently pregnant, or breast-feeding
Retreatment Study of Galiximab + Rituximab in Follicular Non-Hodgkin's Lymphoma (NHL)

This is a Phase III, multicenter, global, open-label, single-arm, retreatment study of an investigational drug called galiximab in combination with an approved drug called rituximab in subjects with relapsed or refractory, follicular NHL who demonstrated a response on Study 114-NH-301 with a time-to-progression \>=6 months.


Eligibility Criteria:
Key Inclusion Criteria:

* Demonstrated a response (CR, CRu, or PR) on Study 114-NH-301 (Galiximab in combination with Rituximab compared with Rituximab in combination with Placebo) and then relapsed or progressed with a TTP \>=6 months. Relapsed disease is defined as documented disease progression using the International Workshop Response Criteria (IWRC).
* Bidimensionally measurable disease with at least 1 lesion \>=2.0 cm in a single dimension.
* Acceptable hematologic, hepatic, and renal function.

Key Exclusion Criteria:

* Any lymphoma therapy between Final Visit on Study 114-NH-301 and Study Day 1 of this retreatment study.
* Chronic or intermittent corticosteroids for inflammatory or autoimmune disorders within 3 weeks prior to Study Day 1.
* Transfusion-dependent subjects.
* Presence of central nervous system (CNS) lymphoma.
* Histologic transformation.
* Presence of pleural or peritoneal effusion with positive cytology for lymphoma.
* Another primary malignancy requiring active treatment.
* Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions that would compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
* New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to Study Day 1.
Comparison of Conventional GlideScope to Single-Use GlideScope Cobalt for Orotracheal Intubation

Patients presenting for elective surgery requiring orotracheal intubation will be randomized to being intubated with either the conventional (reusable) GlideScope videolaryngoscope or the single-use GlideScope videolaryngoscope. The primary outcome is time to intubation.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who is ≥ 18 yrs. coming for elective surgery.
* Endotracheal tube is indicated for the procedure in the opinion of the attending anesthesiologist.
* Any operator who has performed ≥ 10 GlideScope intubations.

Exclusion Criteria:

* Any patient in whom the use of the GlideScope is contraindicated in the opinion of the attending anesthesiologist.
* Any patient with cervical spine abnormalities.
* Any patients with known or probable difficult airways (this rare occurrence is unlikely to be evenly distributed between the groups and could skew the data).
* Any patient requiring rapid sequence induction.
Improving Medication Adherence in ADHD Adolescents

Investigates whether a family-based intervention for adolescents with Attention Deficit Hyperactivity Disorder (ADHD) will improve adherence to prescribed medication regimen in adolescents with history of medication nonadherence.

We will evaluate a dual component family-based intervention for adolescents with ADHD to improve medication adherence (Supporting Teen Adherence and Responsibility; STAR). STAR pairs Motivational Interviewing with parent-teen behavioral contracting. In the proposed study, adolescents with ADHD and a history of chronic nonadherence to their ADHD medication will be randomly assigned to medication alone (medication as usual: MAU) or MAU+STAR. They will be treated for 6 months with a 12 month maintenance period and 12 month followup. All interventions will occur at the offices of participants primary care physicians.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD; currently prescribed an FDA-approved medication for ADHD, history of medication nonadherence (taking less than 60% of prescribed doses); full scale Intelligence Quotient \>80, no current language delay and/or had no language delays before age 3.

Exclusion Criteria:

* active medical conditions that could be worsened by stimulants (seizures, arrhythmias, hypertension) unless patient has clearance from primary specialist taking care of existing condition, pregnancy, Bipolar Disorder, schizophrenia, and/or other psychotic disorders, and diagnosis of current substance abuse or dependence (except nicotine), current psychotropic medication for conditions other than ADHD.