cyrilzakka/clinical-trials huggingface dataset:
Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis

Early phases of systemic sclerosis is characterized by inflammatory and microvasculature alterations. Sildenafil citrate has been shown to have vasodilatory effects and to enhance vasculogenesis. The purpose of this study is to evaluate the effect of sildenafil citrate on hand blood flow of patients with systemic sclerosis, using Laser Doppler Imaging.

Progressive microangiopathy and endothelial dysfunction are identified in early phases of systemic sclerosis. These alterations may result in progressive reduction of vessel lumen, decreased blood flow, and a state of chronic hypoxia resulting in digital ulcers, digital pitting, and, in more severe cases, gangrene and amputation of the extremities. Few studies aimed to evaluate the effects of Sildenafil on the microcirculatory blood flow in patients with Raynaud's phenomenon secondary to systemic sclerosis (SS). Moreover, no study has evaluated the effect of this drug on the number and function of endothelial progenitor cells in SS patients. The relatively new technique of laser Doppler imaging (LDI) allows an objective measurement of superficial cutaneous microvascular blood flow and constitutes a promising approach in the assessment of the digital microvascular vasoreactivity in response to cold stimulus or in response to treatment in SSc patients.

Eligibility Criteria:
Inclusion Criteria:

* Systemic sclerosis according to the classification criteria of the American College of Rheumatology (1980) with no more than 4 years since diagnosis
* Early systemic sclerosis as defined by LeRoy and Medsger (2001)
* 6 or more Raynaud's crisis per week
* Written informed consent provided by the subjects prior to initiating study procedures

Exclusion Criteria:

* Smoking
* Peripheral or central vasculopathy other than Systemic sclerosis
* Uncontrolled Diabetes
* Liver disease
* Pregnant or lactating woman
* Current use of cyclosporin, prostanoids, bosentan or any PDE-5 inhibitors (including current Sildenafil use during randomization)
* History of stroke, myocardial infarction or life threatening cardiac condition within the last 6 months
* History of surgical sympathectomy
* Systolic blood pressure \< 85mm Hg
* History of scleroderma renal crisis
* Known hypersensitivity to Sildenafil or any of the excipients
* History of Retinitis Pigmentosa
* Current use of Nitrates
Nonpharmacologic Analgesia for Invasive Procedures

Analgesics and sedatives administered to control distress from minimally invasive surgical procedures have limited effectiveness and serious side effects. Unabated distress not only interferes with smooth progression of the ongoing procedure, but can elicit adverse responses when patients need additional intervention. The long-term objective of this research is to provide a safe and practical behavioral method for reducing cognitive and physiologic distress associated with invasive procedures. Currently, this method should benefit at least 8 million patients annually in the US. Extrapolating the risk of intravenous conscious sedation to the number of invasive procedures performed annually, we predict that 47,000 patients will suffer serious cardiorespiratory complications and 2,600 will die. These numbers do not include effects of the psychological damage inflicted by poorly managed procedure-related stress on patients' subsequent health behavior. This application sets out to pursue three aims: 1) Prospectively determine the impact of self-hypnotic relaxation on cognitive and physiologic distress during tumor embolizations; 2) Prospectively determine the impact of self-hypnotic relaxation on distress in the postoperative period; 3) Determine the impact of intraprocedural self-hypnotic relaxation on distress during subsequent tumor embolization. We hypothesize that: 1) Self-hypnotic relaxation decreases cognitive and physiologic distress during tumor embolizations. 2) Self-hypnotic relaxation decreases cognitive and physiologic distress after tumor embolization when post-embolization ischemia is expected to induce painful stimuli and systemic distress. 3) The beneficial effect of self-hypnotic coping skills acquired during an invasive procedure carries over to the next invasive procedure. Upon completion, the efficacy and durability of procedural administration of nonpharmacologic analgesia will be known by a rigorous and practical assessment. The relative performance of self-hypnotic relaxation will be quantified compared to standard care and empathic controls in a well-characterized population of patients within the controlled and monitored environment of a busy interventional radiology practice. Results from this competing renewal will provide the next level of data needed for future study design to determine broad clinical utility in a multicenter randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for transcatheter embolization for benign uterine fibroid tumors or malignant hepatic tumors.
* Patients referred for radiofrequency ablation of malignant hepatic or renal tumors

Exclusion Criteria:

* Unable to give informed consent
* Impaired mental function, psychosis, severe chronic obstructive pulmonary disease, intolerance towards midazolam or fentanyl
* Weigh \< 55 kg
* Pregnant
* Unable to hear or understand English
Therapeutic Benefit of Preoperative Supplemental Vitamin D in Patients Undergoing Brain Tumor Surgery

Vitamin D supplementation not only has beneficial effects on morbidity and mortality in critically ill patients but it may also lead to alleviate of seizure, brain edema, infection, pain and some other perioperative complications, possibly in part through an attenuation of the immune response.In this trial patients with brain tumor under craniotomy will receive a single high dose vitamin D compared to control group.

A randomized, double blind, controlled trial will be conducted in neurosurgery ward, operating room (OR) and intensive care unit (ICU) in Tehran, Iran. After a full review of the inclusion and exclusion criteria and explanation of the risks and benefits of the study, written consent form will be completed. The participants are 60 eligible hospitalized patients that diagnosed with brain tumor and need to craniotomy, aged ≥ 18 years. Intervention patients will be received an intramuscular (IM) single dose of vitamin D (300000 IU). Patients will be evaluated for occurrence of perioperative complications and clinical outcomes immediately after surgery until 1 month later and 1 and 6 months mortality.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of patient or legal representative
* 25(OH)D level below 20ng/dL

Exclusion Criteria:

* Other trial participation, including previous participation in the pilot trial
* Pregnant or lactating women
* Hypercalcemia
* Hyperphosphatemia
* Tuberculosis
* Sarcoidosis
* History of nephrolithiasis
* History of hyperparathyroidis
* Medications that interfere with vitamin D metabolism
* Renal Insufficiency
A Study to Test if TEV-50717 is Safe and Effective in Relieving Abnormal Involuntary Movements in Cerebral Palsy

Study TV50717-CNS-30081 is a 55-week study in which participants who have successfully completed the parent study (Study TV50717-CNS-30080) may be eligible to enroll in this study.

The primary objective of this study is to evaluate the safety and tolerability of long-term therapy with TEV-50717 in children and adolescents with DCP.

The secondary objective of this study is to evaluate the efficacy of long-term therapy with TEV-50717 in reducing the severity of DCP.


Eligibility Criteria:
Inclusion Criteria:

* Participant has completed parent Study TV50717-CNS-30080.
* Participant weighs at least 12 kg (26 lb) on day 1 of this study.
* Participant is able to swallow TEV-50717 whole. NOTE- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Participant has clinically significant depression at screening or day 1 of this study. Note: Participants receiving antidepressant therapy may be enrolled if on a stable dose for at least 6 weeks before screening or day 1 (whichever comes first) and anticipated to remain stable (dose and frequency) within the study duration.
* Participant has a history of suicidal intent or related behaviors based on medical or psychiatric history or the C-SSRS at screening visit, if performed, or at the day 1 visit, as applicable according to the participant's age:

  * intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence, at the time of suicidal thought
  * suicidal preparatory acts or behavior.
* Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
* Participant has a first-degree relative who has completed suicide.
* Participant has received any of the following concomitant Participant has received any of the following concomitant medications within the specified exclusionary windows from screening or day 1 (whichever comes first) of this study:

  * within 30 days: tetrabenazine or valbenazine
  * within 21 days: reserpine
  * within 14 days: levodopa, dopamine agonists, and monoamine oxidase inhibitors
* Participant has received treatment with stem cells, deep brain stimulation, transmagnetic stimulation, or transcranial direct current stimulation for treatment of abnormal movements or CP since the week 15 visit of Study TV50717-CNS-30080, or the participant is not in a stable clinical condition.
* Participants with a history of torsade de pointes, congenital long QT syndrome, bradyarrhythmias, other cardiac arrhythmias, or uncompensated heart failure.
* Participant has a known allergy to any of the components of TEV-50717.
* Participant has participated in an investigational drug or device study other than Study TV50717-CNS-30080 and received IMP/intervention within 30 days or 5 drug half-lives of day 1 of this study, whichever is longer.
* Participant is pregnant or breastfeeding. NOTE- Additional criteria apply, please contact the investigator for more information
Early Intervention With a Low-intensity Leg Cycling Exercise Program for Individuals After Stroke

This is a two-stage study. In the first stage, 30 subjects with stroke (onset \> 2 weeks) are recruited, and they are assessed and recorded with clinical characteristics, sympathetic nerve testing, and twice symptom-limit exercise capacity tests. The second stage would recruited 90 subjects with stroke (onset\>2 weeks), and they are randomized to one of three groups (control, low-intensity, high-intensity). They are evaluated before and after the four-week interval with clinical characteristics and twice symptom-limit exercise capacity tests (baseline and after four-week training) .

This is a two-stage study. In the first stage, 30 subjects with stroke (onset \> 2 weeks) are recruited, and they are assessed and recorded with sympathetic nerve testing, anthropometry, and twice symptom-limit exercise capacity tests.The second stage would recruited 90 subjects with stroke (onset\>2 weeks), and they are randomized to one of three groups. The control group undergoes traditional rehabilitation only, The low-intensity exercise group receives a low-intensity four-week cycle ergometry and traditional rehabilitation. The The high-intensity exercise group gets a high-intensity four-week cycle ergometry and traditional rehabilitation. They are evaluated by sympathetic tests, anthropometry, functional scales and activity questionnaires, and symptom-limit exercise capacity tests before and after the four-week training.

Eligibility Criteria:
Inclusion Criteria:

* stroke onset longer than two weeks,
* eligible for exercise testing by Doctor

Exclusion Criteria:

* aphasia,
* apraxia
A Research Study of How Oral Semaglutide Tablets Work in Healthy People Who Are Chinese

This study looks at the way a new medicine tablet called semaglutide moves in and throughout the body over time. It will also look at if the medicine is safe and the body can accept it. The new medicine is planned to treat diabetes. The aim of the study is to see how semaglutide tablets work in healthy people who are Chinese. Participants will either get oral semaglutide tablets or placebo (dummy) tablets - which treatment is decided by chance. The tablet form of semaglutide is a new medicine that cannot be prescribed. Doctors can prescribe semaglutide as an injection only. It is for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 12 weeks (84 days). Participants will get 1 tablet a day to take with up to half a glass of water (maximum 120 mL). Participants must take the tablet first thing in the morning on an empty stomach (water is allowed until 2 hours before taking the tablet). After taking the tablet, participants must not eat or drink anything for at least 30 minutes. After 30 minutes, they can have their first meal of the day and take any other medicines they may need, such as birth control tablets, routine vitamins and use of paracetamol at times.


Eligibility Criteria:
Inclusion Criteria:

* Chinese male or female, aged 18-55 years (both inclusive) at the time of signing informed consent.
* Body weight equal to or above 54.0 kg
* Body mass index (BMI) between 20.0 and 24.9 kg/m\^2 (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods
* History of pancreatitis (acute or chronic) as declared by the subject.
* Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or medullary thyroid carcinoma (MTC) as declared by the subject.
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) as declared by the subject.
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) as declared by the subject.
* Smoker (defined as a subject who is smoking equal to or more than 1 cigarette or the equivalent per day).
* Unable or unwilling to refrain from smoking and use of nicotine substitute products during the inpatient periods, as judged by the investigator.
* Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening.
A Trial of Centanafadine Efficacy and Safety in Children With Attention-deficit/ Hyperactivity Disorder (ADHD)

This trial will be conducted to evaluate the efficacy of centanafadine QD XR versus placebo in the treatment of child subjects (4 to 12 years, inclusive) with ADHD. The trial will consist of a screening period, a double-blind treatment period, and follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 4 to 12 years (inclusive) at the time of informed consent/assent.
* A primary diagnosis of ADHD based on DSM-5 diagnosis criteria as confirmed with the MINI-KID.
* A minimum symptoms total raw score of ≥ 28 on the ADHD-RS-5 at baseline for all subjects.
* A score of 4 or higher on the CGI-S-ADHD at baseline.
* Subjects aged 4 or 5 years only: has failed adequate psychotherapy or in the investigator's opinion, is severe enough to require pharmacotherapy in the absence of prior psychotherapy.

Exclusion Criteria:

* Comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder that is severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Oppositional Defiant Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder that is severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or MDD with current major depressive episode.
* A significant risk of committing suicide based on history and the investigator's clinical judgment, or routine psychiatric status examination, Current suicidal behavior, Imminent risk of injury to self, Active suicidal ideation. A history of suicidal behavior (over the last 6 months).
* BMI ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on US CDC criteria.
* Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or is anticipated to start new treatment during the trial.
MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals

This study collects information to implement MammoScreen for Breast Cancer Screening and Referrals. MammoScreen is a risk assessment questionnaire that identifies individuals at average and increased risk for breast cancer and guides their screening decisions.

PRIMARY OBJECTIVES:

I. Uptake of MammoScreen (the proportion of women who enroll and use MammoScreen, also referred to as Reach.

II. Identification of women with above-average risk for breast cancer by MammoScreen integrated with the electronic health record (EHR).

SECONDARY OUTCOMES:

I. Rates of mammography screening referral. II. Screening completed and mammography results stratified by risk category. III. Among those who meet criteria, genetic counseling referral, visit completed and genetic test done.

OUTLINE:

CLINICAL STAFF: During development some clinical team members will participate in usability testing (up to 30 minutes) of the electronic health record interface with MammoScreen. Some participants will undergo training sessions of about 20 minutes, then participate in interviews lasting up to 30 minutes at baseline prior to MammoScreen launch. Clinical staff also participate in interviews up to 30 minutes after MammoScreen launch during years 2-4. Participants complete surveys during the maintenance phase about six months after the last reminders are sent.

PATIENTS: Patients (enrolled from OHSU IMC) participate in interviews lasting up to 1 hour. Patients medical records are reviewed. Patients will be invited via MyChart to use the MammoScreen. Reminders will be sent via MyChart to non-respondents at 2 and 4 weeks. Patients will use MammoScreen one time right after enrollment. Some patients may also participate in interviews up to 1 hour each during years 3-5.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 40 and 74
* Enrolled in MyChart
* Able to read English

Exclusion Criteria:

* Personal history of breast or ovarian cancer
* Currently Pregnant
* Currently in Hospice
Sepsis Post Market Observational Study and Potential Reduction of Time to Antibiotics - Baylor S&W

The purpose of this study is to demonstrate that addition of the Monocyte Width Distribution (MDW) parameter to current standard of care improves a clinician's ability to recognize sepsis in the Emergency Department, resulting in earlier decision to administer antibiotics from time of ED presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

The objective of this study is to develop a method for identifying sepsis patients from electronic health records (EHR) based on Sepsis-2 criteria. Sepsis patients will be identified using a Sepsis Definition which includes meeting SIRS score of ≥2 within 12 hours of ED presentation and any microbial testing ordered within 24 hours of ED presentation. The patient will be enrolled if it meets the Sepsis Definition and additional EMR data elements will be extracted to complete case report form. Furthermore, objectives include to confirm the clinical validity and performance of MDW in a control population of sepsis patients where MDW is measured but not reported to physicians. This study is an observational study which will simulate the decision impact of MDW on sepsis identification and patient management.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 to 89 years)
* All race and ethnicities
* Presenting to the emergency department with suspicion of infection
* Whose assessment includes a CBC with differential
* Meets EMR Sepsis Definition

Exclusion Criteria:

* Pregnancy
* Prisoners
* Transfers from other ED
* Previously enrolled
A Retrospective Swedish Cohort Study on Health Outcomes, Life Expectancy, Resource Use and Costs in Patients With a History of Myocardial Infarction and Additional Risk Factors for Atherothrombosis

To characterize and estimate the size of different populations with a history of acute coronary syndrome in Sweden. To assess the burden of illness (co-morbidities, mortality rates healthcare resource utilization and atherothrombotic events) among patients with a history of myocardial infarction (MI) 1-3 years ago and additional risk factors for atherothrombosis.


Eligibility Criteria:
Inclusion Criteria:

- Patients hospitalised for ACS between 01.07.2006 and 31.06.2011.

Exclusion Criteria:

- Not applicable
The Unintrusive Detection of EaRly-stage Cancers

According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA methylation-based model for early cancer detection. Blood RNA markers will also be evaluated. The study will enroll approximately 2508 participants, including participants with malignancies and healthy participants.


Eligibility Criteria:
Inclusion Criteria for All the Participants:

* Ability to provide a written informed consent
* 40-75 years old
* Ability to comply with study procedures

Exclusion Criteria for All the Participants:

* Pregnancy or lactating women
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to study blood draw
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer

Inclusion Criteria for Cancer Arm Participants:

* Confirmed diagnosis or suspicious cases of cancer within 42 days prior to study blood draw.
* No prior anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

* Known prior or current diagnosis of other types of malignancies or multiple primary tumors
* Diagnosis of benign diseases by histopathological assessments
* No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign
* Non-small-cell lung cancer patients with ground-class nodularity by radiological examination
* Diagnosis of precancerous lesions

Inclusion Criteria for Healthy Arm Participants:

* No cancer-related symptoms or discomfort within 30 days prior to study blood draw
* No clinically significant finding by physical examinations, hematological assessment, urinalysis, LDCT or ultrasound
* No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants
* No active hepatitis B or hepatitis C infection

Exclusion Criteria for Healthy Arm Participants:

* Prior or ongoing treatment of cancer within 3 years prior to study blood draw
* Clinically significant or uncontrolled comorbidities