cyrilzakka/clinical-trials huggingface dataset:
Utilizing Carbon Dioxide for Assessing Coronary Blood Flow in Subjects With Coronary Artery Disease

This is a prospective pilot study to evaluate the safety, tolerability and technical feasibility of utilizing carbon dioxide for assessing coronary blood flow in subjects with coronary artery disease.

The purpose of this study is to noninvasively assess changes in the heart's blood flow through inducing changes in the amount of carbon dioxide in the participant's blood and having them breathe various combinations of carbon dioxide and oxygen.

Eligibility Criteria:
Inclusion Criteria:

1. Adults \> 18 years of age
2. Clinically stable individuals with suspected or known coronary artery disease (CAD)
3. The SPECT/PET study indicates at least a mild to moderate myocardial ischemia (\>5-9%) or fractional-flow-reserve (FFR) of \<0.75.

Exclusion Criteria:

1. Prior myocardial infarction by clinical history (subjects with prior coronary revascularization without myocardial infarction will not be excluded)
2. Hypotension (systolic blood pressure \< 100 mmHg)
3. Significant non-coronary cardiac disease (e.g., valvular abnormality, or cardiomyopathy, etc.)
4. Inability to schedule the research study within 30 days of the SPECT/PET study and prior to any coronary revascularization procedure
5. Inability to voluntarily increase their breathing rate if prompted to do so
6. Persons with mechanically, magnetically, or electrically activated implants (such as cardiac pacemakers, neurostimulators, and infusion pumps), with ferromagnetic implants or foreign bodies (such as intracranial, aneurysm clips, shrapnel, and intraocular metal chips)
7. Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)
8. Persons with a history of significant heart, lung, kidney, or liver disease
9. Persons with asthma
10. Persons who have abnormal cardiac rhythm and rate
11. Persons unable to tolerate MRI secondary to an inability to lie supine for 60-90 minutes or severe claustrophobia
12. Persons whose renal function test does not meet MRI contrast protocol requirements \[estimated Glomerular filtration rate (eGFR) \< 40 mL/min/1.73m2\]
13. Persons with a known history of allergy to gadolinium-based contrast
14. Enrollment in another research study.
15. Inability or unwillingness to provide informed consent
Self Focus in Bipolar Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study

The investigators propose to examine both resting state activity and functional activity during rumination and during self-processing to study the relationship between neural correlates of rumination/self-focus and self-processing in major depression and bipolar disorder.

Negative rumination, a specific form of self-focus, characterized by repetitively focusing on one's symptoms of distress, and the possible causes and consequences of these symptoms, is a hallmark of depression. Nearly a decade of research has culminated in evidence that the tendency to engage in negative rumination is highly correlated with depressive symptoms. Rumination also plays a critical role in the etiology and maintenance of depressed states and predicts risk for mania in bipolar disorder. Despite the central role of rumination in major depression and bipolar disorder, there have been few studies to date investigating the functional neuroanatomy of negative rumination, and no studies of positive rumination. The few neuroimaging studies that have utilized measures of the tendency to engage in negative rumination have focused on brain functioning when performing tasks that involve processing emotional or self-referential stimuli, but they have not studied resting state activity or functional activity during negative and positive rumination. We are examining both resting state activity and functional activity during negative and positive rumination and during self-processing to study the relationship between the neural correlates of rumination/self-focus and self-processing in major depression and bipolar disorder.

Eligibility Criteria:
Inclusion Criteria Healthy Controls:

* Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
* Normal or corrected-to normal vision and hearing

Exclusion Criteria for Healthy Controls:

* Any current or past psychiatric history
* Significant medical, psychiatric or neurological illness
* Currently taking antidepressants, mood stabilizers, or benzodiazepines
* Positive MR screen (e.g., metal implant, claustrophobia, etc)

Inclusion Criteria for Patients with Major Depression:

* Current diagnosis of MDD
* Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
* Normal or corrected-to normal vision and hearing

Exclusion Criteria for MDD Patients:

* If a history of substance abuse, at least 6 months in remission
* Current suicidal ideation or history of suicide attempts
* Positive MR screen (e.g., metal implant, claustrophobia, etc)

Inclusion Criteria for patients with BPAD:

* Current diagnosis of BPAD
* Right-handed (as determined by the Handedness Inventory; Oldfield, 1971)
* Normal or corrected-to normal vision and hearing

Exclusion Criteria for BPAD Patients:

* If a history of substance abuse, at least 6 months in remission
* Current suicidal ideation or history of suicide attempts
* Positive MR screen (e.g., metal implant, claustrophobia, etc)
A 6-week Study to Evaluate the Safety and Efficacy of Methylphenidate HCl ERCT in 4-5 Year Old Children With ADHD

This 6-week study is to determine if the study drug, Methylphenidate Hydrochloride (HCl) Extended-Release Chewable Tablets (ERCT), is safe, tolerable and effective when compared to a sugar pill or placebo in children 4 to 5 years of age with ADHD.

Phase 4 Double-blind, Randomized, Parallel Group, Placebo-controlled Study of the Efficacy And Safety of Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablets (ERCT) In 4-5 Year Old Children With Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria:
Inclusion Criteria:

1. Male or female child 4-5 years of age at screening.
2. Signed and dated informed consent provided by the subject's parent/legal and assent of the child (as applicable).
3. Meets DSM-5 criteria for ADHD based on the K-SADS-PL.
4. ADHD RS-IV Preschool-Home Version score at Screening and Baseline \>/= 90th percentile for gender and age in \>/=1 of the following: hyperactive-impulsive subscale, inattentive subscale, or total score.
5. Peabody Picture Vocabulary Test 4 (PPVT-4)Standard Score \>/=70.
6. Child Global Assessment Scale (CGAS) score \</= 55.
7. Participation in a school type program (day care, preschool, kindergarten, transitional kindergarten, or elementary school) for at least \>/=2 half days of the week for at least 3 months and that is anticipated to continue during the study.
8. History of an adequate course of non medication treatment for ADHD based on investigator judgment or, where such treatments are not available, the severity of the subject's ADHD symptoms are such that medication treatment is deemed necessary by the investigator

Exclusion Criteria:

1. Treated with atomoxetine within 30 days prior to the Baseline.
2. Received any investigational products or devices within 30 days prior to the Baseline visit.
3. History of stimulant nonresponse, intolerability or hypersensitivity to any dose of methylphenidate or other stimulant. If a known allergy to D\&C red #30, he/she should not be enrolled in the study.
4. An intelligence quotient (IQ) \<70.
5. History of acute or chronic medical or psychiatric condition or cardiac or laboratory abnormality.
6. Less than 5th percentile for height or weight at Screening.
7. History of recent clinically significant self-harming behaviors.
Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes

In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise versus resistance exercise) without calorie restriction on total and regional adiposity, and risk of type 2 diabetes in overweight children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Healthy overweight (BMI \>-95th) youth between 12 and 18 years of age
* Waist circumference \>-75th percentile
* Sedentary (no structured exercise \>2 times/week for past 6 months)
* Non-smokers, non-diabetic, no medical conditions
* Weight stable for past 3 months

Exclusion Criteria:

* Smokers,
* diabetic,
* psychiatric disorders,
* syndromatic obesity
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy

This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy. Blossom Smart Expander Technology allows for slow and continuous injection of small amounts of saline, from an external pouch and based on precise pressure and volume measurements, into breast expander implants. It may help in achieving the same reconstructive goals as conventional tissue expansion in a shorter period of time and while avoiding frequent injections through the skin, which cause patient discomfort and require many clinic visits.

PRIMARY OBJECTIVES:

I. To assess the clinical effectiveness of the application of Blossom Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction.

SECONDARY OBJECTIVES:

I. Patient satisfaction. II. Patient self-reported pain. III. Incidence of complications.

OUTLINE:

After mastectomy, participants undergo 2-staged implant-based breast reconstruction (IBR) with the Blossom Smart Expander Technology comprising of the Blossom syringe assist device connected to the Mentor SPECTRUM adjustable saline breast implant.

After completion of study treatment, participants are followed up at 1 week and then every week or every month thereafter for up to 12 months

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of breast cancer or reason for prophylactic mastectomy (e.g., BRCA mutation and/or strong family history of breast cancer), both unilateral or bilateral mastectomy
* No prior breast surgery (excluding biopsy and lumpectomy) or breast radiation
* Ability to understand and the willingness to sign a written informed consent document
* No life expectancy restrictions
* Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
* No requirements for organ and marrow function

Exclusion Criteria:

* Recent steroid use
* No major medical comorbidities (defined as American Society of Anesthesiologists \[ASA\] III or greater)
* No connective tissue disorder
* Prior breast surgery, excluding biopsy and lumpectomy
* History of or plan for breast radiation
* Pregnancy and nursing patients will be excluded from the study
* No restrictions regarding use of other investigational agents
* No exclusion criteria related to history of allergic reactions
* No exclusion criteria relating to concomitant medications or substances that have the potential to affect the activity or pharmacokinetics of the study agent
* No other agent-specific exclusion criteria
* No exclusion of cancer survivors or those who are human immunodeficiency virus (HIV)-positive
Can 10 Seconds Inspiratory Hold Open Atelectasis in Mechanically Ventilated Patients?

This study evaluates whether sustaining inspiratory pressure for 10 seconds at a time can open collapsed lung areas in non-dependant regions of the lung in mechanically ventilated patients.

Collapse of lung volume, atelectasis, is a common complication in sedated and mechanically ventilated patients. In adults the atelectasis occur mainly in the dependant areas of the lung. In this study the investigators examine whether these atelectasis can be opened by repeatedly sustaining the inspiratory pressure for 10 seconds when the patient has been positioned so that the atelectasis is located in a non-dependant position. Furthermore, the investigators examine how many times the inspiratory pressure needs to be sustained before the atelectasis is opened and at what pressure.

Eligibility Criteria:
Inclusion Criteria:

* Continuously or intermittently mechanically ventilated with artificial airway (endotracheal tube or tracheostomy tube)
* Pressure controlled or pressure supported ventilator mode
* PEEP ≤ 12 cm H2O, registered peak pressure ≤ 32 cm H2O
* Non-ventilated lung regions according to E.I.T. measurements
* Richmond Agitation Score 0 -(-5)
* Circulatory stable or stabilized

Exclusion Criteria:

* Pregnancy
* BMI \> 50
* Pacemaker or other electrically active implants
* Skin lesions, wounds or bandages on chest area where E.I.T. belt needs to be placed
* Undrained pneumothorax
* Pulsating air-mattress
* Unstable skeletal injury to spinal column
* Recent brain injury or spinal chord injury
* Recent injury to heart, to major blood vessels in chest, to major airways or to the oesophagus.
Differentiation Between Healthy Cerebral Tissue and Tumor Tissue Using a Tissue Sensing Instrument

Differentiation between glioma tumor tissue and normal cerebral tissue using Diffuse Reflectance Spectroscopy (DRS) on surgical tissue samples ex-vivo

Background: Diffuse reflectance spectroscopy is an optically based technique which measures the amount of diffusely reflected light after it has undergone multiple scattering and absorption events within the tissue. Each DRS spectrum therefore has a specific 'optical fingerprint' reflecting the composition and morphology of the tissue within the probing volume. The technology is easily built into very small instruments that can be fused with regularly used surgical equipment. DRS has previously been widely investigated for the purpose of margin assessment in other regions of the body.

Aim \& Hypothesis: The primary goal is to show the feasibility of applying optical tissue sensing using diffuse reflectance spectroscopy (DRS) to differentiate healthy cerebral tissue from tumorous tissue in ex vivo human tissue samples. This will be a basis for further development of surgical equipment able to identify the margin between healthy brain tissue and tumor tissue intraoperatively.

Method: Using DRS we aim to determine spectroscopy thresholds that enables differentiation of cerebral tissue from different forms of tumor tissue. We aim to determine these thresholds by collecting DRS data on ex vivo brain and tumor samples. The tumor samples will be part of the normal extraction of tissue during tumor surgeries and the non tumorous tissue can be extracted in temporal/frontal lobe resections as well as epilepsy surgery, where non tumorous brain tissue is to be removed. The DRS measurements are performed in direct connection to the extraction of tissue during surgery, and the tissue is thereafter sent to the pathologist according to standard clinical procedures. No extra tissue will need to be resected for the purpose of this study. Based on the experiments we will propose a theoretical model for differentiating normal cerebral tissue from tumor tissue in humans for use during surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgical resection of glial tumor or epileptic focus

Exclusion Criteria:

* Unable to give informed consent
Integrated Eye Tracking and Neural Monitoring for Enhanced Assessment of Mild TBI: Primary Study

This study was conducted to develop and validate integrated eye tracking and EEG measures for assessment of mild traumatic brain injury.


Eligibility Criteria:
Inclusion Criteria:

* age 18 -55, ability to use left and right hands and right foot to complete cognitive and motor tasks without adaptive equipment, and fluent in English

Exclusion Criteria:

* history of severe TBI, history of neurological illness unrelated to TBI, vision problems that are uncorrected by contacts or glasses, history of psychotic disorder, or current homicidal or suicidal ideation or intent
Image Guided Targeted Photoablation for the Treatment of Localized Hyperhidrosis

Hyperhidrosis is a condition in which sweating is in excess of that required for normal regulation of body temperature. Commonly affected areas in primary hyperhidrosis include axillae, palms and soles. Secondary hyperhidrosis can affect scalp, face, neck, back, groin and legs. Hyperhidrosis can negatively impact, employment, relationships, or other aspects of quality of life.

The investigators propose to investigate the use of a unique image-guided laser to specifically ablate eccrine sweat glands.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects of ages between 18 and 65 years.
2. Subjects with any Fitzpatrick skin type.
3. Subjects who are proficient in the English language.
4. Willingness to participate in the study.
5. Willingness to undergo experimental procedure.
6. Informed consent agreement signed by the subject.
7. Willingness to follow the follow-up schedule.
8. Willingness not to use any other hyperhidrosis treatment to the tests sites during the study period (i.e. deodorant, at-home iontophoresis, Botox, MiraDry).
9. Patient rates symptoms at level "3" or "4" on the hyperhidrosis disease severity scale (HDSS, see below).
10. Subject in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.
11. No known allergy to iodine or potato starch

Exclusion Criteria:

1. Pregnancy
2. Subjects on systemic treatment for hyperhidrosis, such as anticholinergic drugs (e.g. glycopyrrolate), sedatives or tranquilizers, within the past 8 weeks.
3. Subjects who have undergone surgical excision of sweat glands or sympathectomy for hyperhidrosis.
4. Subjects with an underlying disorder, such as neurologic injury or disease affecting the autonomic system, vascular disorders and metabolic disorders (e.g. hyperthyroidism, diabetes mellitus) that can produce hyperhidrosis
5. Subjects with a history of coronary artery disease.
6. Subjects with a history of poor compliance or psychosis
7. Subjects taking SSRIs, SNRIs, TCAs, or MAOIs
8. Subjects with known hypersensitivity to methylene blue
9. Subjects with cardiac pacemaker or any other electrically powered implantable device.
10. Subjects not proficient in the English language.
11. Subject not in appropriate physical health to ride a stationary bicycle to the point of eliciting sweat.
12. Known allergy to iodine or potato starch.
A Study of Tafetinib in Chinese Patients With Advanced Solid Tumor

Tafetinib is an oral multitargeted tyrosine kinase inhibitor that inhibits Vascular Endothelial Growth Factor Receptor (VEGFR).

This phase I trial was conducted to evaluate the pharmacokinetics (PK), safety, and preliminary efficacy of tafetinib in Chinese patients with advance solid tumor. The study are conducting in Cancer Hospital Chinese Academy of Medical Sciences.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with histologically confirmed advanced solid malignancies.
* ECOG score 0-1.
* 18-65 years old.
* Withdrawal other chemotherapy drugs more than 30 days. No nitrosoureas or mitomycin C within the previous 6 weeks.
* Function of organs must meet the following requirements:
* Neutrophil count ≥1500/ul;
* AST and ALT≤1.5 times the upper limit of normal (ULN);
* Total serum bilirubin≤1.5 times ULN;
* Hemoglobin≥90g/L;
* Platelet≥100000/ul;
* The creatinine in the normal range or creatinine clearance rate ≥60ml/min;
* Left ventricular ejection fraction (LVEF) ≥50%;
* Females of childbearing age are required to be practicing effective contraceptive measures and to have a negative serum or urine pregnancy test before study.
* Written informed consent is obtained.

Exclusion Criteria:

* included a history of or current brain metastases, clinically significant cardiovascular disease or uncontrolled hypertension.
Combination of Orbital Compression Surgery and Strabismus Surgery for Thyroid Associated Ophthalmopathy

The purpose of this study is to determine whether combination of orbital compression surgery with strabismus surgery is better than strabismus surgery after orbital compression surgery in the treatment of moderate-to-severe thyroid associated ophthalmopathy

This study will be a interventional case series. Patients with moderate-to-severe thyroid associated ophthalmopathy will be randomized to receive combination of orbital compression surgery with strabismus surgery or strabismus surgery after orbial compression surgery.Patients will be followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* moderate-to-severe thyroid associate ophthalmopathy
* CAS≤3 score
* monocular strabismus,deviation≥20° or 35▲
* stable thyroid function for at least 6 months, confirmed by an endocrinologist

Exclusion Criteria:

* any previous disease in the study eye.
* any previous systematic disease
Modified Paramedian Versus Conventional Technique in the Residency Training: An Observational Study

Residency training includes positive and negative aspects. Well-trained doctors must be educated, but the process may bring additional risks to patients. Anesthesiologists' performance when conducting neuraxial anesthesia is related to their experience. We hypothesized that a modified neuraxial anesthesia method would improve both residency training and patient safety.

Residency training is performed using trial and error. Several studies have shown that the training process, practice period, and resident's attitude are important factors for determining performance. During the training process, neuraxial anesthesia safety is related to the operator's experience. Ultrasound can improve resident performance; however, using ultrasound technologies in well-established training programs may not be practical for all residencies.

The paramedian approach bypasses most of the bony structures that may impede the advancement of an epidural needle in the midline approach. However, the paramedian approach requires a sharpened three-dimensional insight compared with the midline approach. We hypothesized that the higher the three-dimensional barrier, the higher the complications and number of puncture attempts. A modified paramedian approach may improve residency training and patient safety. The aim of this study was to investigate whether the modified method decreased practice attempts and patient complications.

Eligibility Criteria:
Inclusion Criteria:

* parturients who were elective for cesarean section

Exclusion Criteria:

* history of allergy to the medications used in this study
* chronic or acute headaches
* possible conversion to general anesthesia
* other contraindications to practice (infection, coagulopathy, abnormal spinal anatomy, unstable vital signs, and refusal to participate in the study)
Effect of Heat Stress on Global LV Function in Anesthetized Humans

Recent data suggests that increased temperature improves inotropic function during systole and may improve diastolic function in healthy humans at rest, despite a reduction in left ventricular volume at end diastole. The effect of heat stress has not been reported in patients receiving general anesthesia and the impact of general anesthesia on these findings is not known. Trans-esophageal echocardiography will be used to measure parameters important to both systolic and diastolic function at temperature intervals of 1°C in patients undergoing "Heated Intraoperative Peritoneal Chemotherapy" (HIPEC.) That general anesthesia will not alter the cardiovascular effects of increased temperature that has been reported in healthy, un-anesthetized humans is the hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* any patient presenting for hyperthermic intraperitoneal chemotherapy.

Exclusion Criteria:

* Subjects less than 18 years old.
* pregnant women
* prisoners,
* institutionalized individuals
* Any patient with known contraindication to Transesophageal echocardiography.
* Patients with known cardiac dysfunction prior to screening will be excluded.