cyrilzakka/clinical-trials huggingface dataset:
TRANscatheter or SurgIcal Aortic Valve ReplacemenT in All-Comers With Severe Aortic Valve Stenosis

The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR) with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Age must be at least 19 and less than 75 years old
* Severe aortic valve stenosis with echocardiographically derived criteria: mean gradient \> 40mmHg or jet velocity greater than 4.0 m/s AND an initial aortic valve area (AVA) of ≤ 0.8 cm2. Echocardiogram must be within 3 months of the date of the procedure
* Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA class II or greater.
* The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

* Life expectancy \<1 year due to medical illness
* Suspected Malignancy
* Inoperability evaluated by surgeon
* Concomitant severe coronary artery disease not amenable for percutaneous coronary intervention
* Concomitant severe mitral valve or significant aorta disease requiring surgery
* Active bacterial endocarditis within 6 months of procedure
* Leukopenia (WBC\<3000 cell/mL), acute anemia (Hgb\<8g/dL), thrombocytopenia (platelet \< 50000 cell/mL)
* Intracardiac thrombus
* A known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure.
* Native aortic annulus size \< 18 mm or \> 25 mm as measured by echocardiogram.
* Expectation that patient will not improve despite treatment of aortic stenosis
* Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients

The investigators hypothesize that macrophages play a crucial role in the pathogenesis of atherosclerosis in patients with type 2 diabetes mellitus (T2DM).

Cardiovascular events are the leading cause of death in developed countries worldwide, including Taiwan. Type 2 diabetes mellitus (T2DM), previously considered merely as one of the risk factors, has been recently unanimously accepted to be coronary artery disease-equivalent. How T2DM may lead to accelerated atherosclerosis remains obscure.

Hyperglycemia with or without hyperinsulinemia may lead to higher oxidative stress and generalized inflammation. The oxidative stress and inflammation may play a significant role in the pathogenesis in diabetic complications, including micro- and macro-vascular complications. Macrophages together with T-lymphocytes are the earliest cell-types found in fatty-streaks, the earliest atherosclerotic lesions. Macrophages are also well known cellular mediators of oxidative stress and inflammation. Therefore, it is plausible to hypothesize that macrophages play a crucial role in the pathogenesis of atherosclerosis in patients with T2DM. In addition, the other cell types of the peripheral white blood cells (WBC), such as neutrophils, have been shown to be intimately related to acute coronary syndrome. Therefore, the study on the biology of peripheral WBCs may tell us something about the pathophysiology of diabetic macro-vascular complications.

Methods:

1. Normal control: fasting plasma glucose (FPG) less than 126 mg/dl.
2. T2DM: FPG \>＝126 mg/dl.

   * Group 1 (good glycemic control): hemoglobin A1c (HbA1c) \<＝ 7% in the past 6 months
   * Group 2 (poor glycemic control): HbA1c \>＝ 8% in the past 6 months
3. Blood sample will be collected at baseline and after aggressive control.

Eligibility Criteria:
Inclusion Criteria:

* Normal control: fasting plasma glucose (FPG) less than 126 mg/dl.
* T2DM: FPG \>＝126 mg/dl.

  * Group 1 (good glycemic control): HbA1c\<＝7% in the past 6 months
  * Group 2 (poor glycemic control): HbA1c\>＝8% in the past 6 months

Exclusion Criteria:

* Acute systemic diseases
Efficacy of Exercise Videogames for Physical Activity Adoption and Maintenance

This is a 3-arm trial to compare exercise videogames versus traditional standard exercise using stationary bikes and treadmills versus a control condition. Results will examine minutes of physical activity at 12 weeks and 6 month follow up between conditions. We will also examine changes in indicators of cardiovascular health (e.g., body mass index, lipids) and changes in psychological factors that may be predictive of continued exercise engagement.

To test the efficacy of a 12-week supervised, laboratory based program of an exercise videogame (EVG) program to increase time spent in moderate-to-vigorous physical activity (MVPA) and improve cardiovascular health and fitness indices compared to Standard and Control programs. Participants will be randomly assigned to (1) a supervised program of Exercise Videogames (EVG); (2) a supervised standard exercise program (Standard), using aerobic exercise equipment (e.g., treadmill, stationary bike); or (3) a Control condition. We will also examine the effect of home-based exercise videogames compared to a home-based standard PA program on MVPA maintenance during the 6-month follow up period. We will examine changes in cardiorespiratory fitness (i.e., estimated VO2max), blood pressure, resting heart rate, body composition and blood lipids at baseline, week 12 and at 6-months follow up. We will also examine changes in theoretically-based cognitive and affective constructs associated with physical activity including: enjoyment, outcome expectations, self-efficacy, motivation, and goal-orientation.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18,
* In generally good health
* No medical conditions that would interfere with exercise
* Currently engaging in less than 60 minutes of physical activity per week

Exclusion Criteria:

* body mass index over 40
* current or planned pregnancy
* hospitalization from a physical or mental disorder in the past 6 months
* hypertension (defined as: blood pressure ≥ 140/90)
* anti-hypertensive medication
* medications that may impair physical activity tolerance (e.g., beta blockers)
* current cardiovascular disease
* current pulmonary disease
* diabetes
* thyroid disorders
* renal or liver disease
* orthopedic conditions that would prevent or limit exercise
Treating Primary Progressive Aphasia and Apraxia of Speech Using Non-invasive Brain Stimulation

The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., pre-supplementary motor area and left inferior frontal gyrus) thought to aid in memory will improve speech and language difficulties in patients with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS). The primary outcome measures are neuropsychological assessments of speech and language functions, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.

This pilot study has one treatment arm with open-label treatment and will examine improvement of speech output, verbal fluency, and other cognitive deficits associated with primary progressive aphasia (PPA) and progressive apraxia of speech (PAOS), by utilizing 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to pre-supplementary motor area or left inferior frontal gyrus for 20 minutes over 10 sessions. There will be baseline testing, and follow up testing immediately after and 8 weeks after completion of treatment.

All patients with a clinical diagnosis of PPA or PAOS will be assigned to either one of the two open-label arms to receive active tDCS. Primary outcome speech and language measures, secondary neuropsychological and electroencephalography (EEG) measures, and pre-screening assessments for study medical history and contraindications for treatment will be collected prior to the treatment (i.e., baseline).

Primary outcome speech and language functions measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected after treatment session 10 and following treatment competition (i.e., 8-week).

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 years of age
* A formal diagnosis of primary progressive aphasia (nonfluent/agrammatic, semantic, logopenic variants or mixed) and/or progressive apraxia of speech
* Capable of understanding and signing an informed consent. Medical information/history, as well as mental status exam and diagnosis provided by referring physician will determine whether or not a caregiver is required to be involved during this process.

Exclusion Criteria:

* Has an implanted device, such as a pacemaker, metallic cranial implant, or a neurostimulator
* Skull defects
* Pregnant
* A significant history of arrhythmia or epileptic seizures.
* Not a native English speaker
* Currently receiving speech-language intervention
* Unable to communicated verbally
European Registry of Type A Aortic Dissection

Acute Stanford type A aortic dissection (TAAD) is a life-threatening condition. Surgery is usually performed as a salvage procedure and is associated with significant postoperative early mortality and morbidity. Understanding the patient's conditions and treatment strategies which are associated with these adverse events is essential for an appropriate management of acute TAAD.

Twenty centers from eight European centers of cardiac surgery have collaborated to create a multicentre observational registry (ERTAAD), which will enroll consecutive patients who underwent surgery for acute TAAD from January 2005 to March 2021. The investigators will compare patient's comorbidities, condition at referral, surgical strategies and perioperative treatments in patients with and without early and late adverse events. The primary clinical outcome will be in-hospital mortality, late mortality and reoperations on the aorta. Secondary outcomes will be stroke, acute kidney injury, surgical site infection, reoperation for bleeding, transfusion of blood products and length of stay in the intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* Type A aortic dissection or intramural hematoma involving the aortic root/ascending aorta;
* Patients aged \> 18 years:
* Symptoms started within 7 days from surgery;
* Primary surgical repair of acute type A aortic dissection;
* Any other major cardiac surgical procedure concomitant with surgery for type A aortic dissection.

Exclusion Criteria:

* Patients aged \< 18 years;
* Onset of symptoms \> 7 days from surgery;
* Prior procedure for type A aortic dissection;
* Retrograde type A aortic dissection (with primary tear located in the descending aorta);
* Concomitant endocarditis;
* Type A aortic dissection secondary to blunt or penetrating chest trauma.
Effects of Colesevelam on How the Body Responds to Insulin in Patients With Type 2 Diabetes

This study is designed to assess the potential mechanism of action by which WelChol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 18 - 75, inclusive
* Diagnosed with type 2 diabetes
* Hemoglobin A1c value greater than or equal to 8.0%
* Antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn)
* Overweight, obese (body mass index 25-45 kg/m2)

Exclusion Criteria:

* Change of dose of lipid or blood pressure lowering therapy within past three months
* Previous treatment with colesevelam for hyperlipidemia
* Serum triglyceride greater than 500 mg/dL
* Serum low density lipoprotein-cholesterol less than 60 mg/dL
Kentucky LEADS Collaborative: Lung Cancer Survivorship Care Program

The objective of the Kentucky LEADS Lung Cancer Survivorship Care Program is to develop, administer and evaluate the impact of a comprehensive psychosocial survivorship care program for individuals diagnosed with lung cancer and their caregivers to improve lung cancer survivorship and delivery of high-quality lung cancer care. The investigators hypothesize that the Kentucky LEADS Lung Cancer Survivorship Care Program will demonstrate improved quality of life, better symptom control, increased tobacco treatment, and reduced distress among lung cancer survivors and their caregivers.

The study design is a single-arm clinical trial, or a prospective cohort design, where a longitudinal series of data will be collected from participants. Participants will be consented and asked to complete a baseline questionnaire (PRE) which includes topics measuring quality of life, distress, symptom management, social support, healthy behaviors, demographics and health history. Two similar questionnaires will be administered after exposure to the Survivorship Care Program (POST and FOL). In addition, the consent form requests permission from survivors to collect clinical data from medical records and the Kentucky Cancer Registry regarding diagnosis and treatment for lung cancer. The study will enroll 300 participants, with an estimate of approximately 30 participants enrolled at each site. However, if a participating site enrolls 30 participants and the overall study accrual has not yet been met, the study PI may allow that respective participating site to continue to enroll participants. Study accrual is competitive across participating sites until the overall study accrual has been met.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have been diagnosed with lung cancer (survivor) or
* Caregiver of a participating lung cancer survivor
* Ability to read and write in English

Exclusion Criteria:

* Individuals with significant psychiatric disturbance that requires a higher level of care
* Individuals with substance abuse/dependence problem that require a higher level of care
* Incarcerate individuals or individuals detained within the legal system
Evaluation of a Non-invasive Sensory Feedback System in Hand Prostheses

Implication and evaluation of a non-invasive sensory feedback system in hand prostheses in everyday life.

A non invasive sensory feedback system in embedded in the prosthetic socket will be tested on forearm amputees in their everday life. Pretests and follow up will contain objective outcome assessments and semi-structured interviews.

Eligibility Criteria:
Inclusion Criteria:

* acquired forearm amputation

Exclusion Criteria:

* psychiatric disorders
Pharmacodynamics of NPC-01/IKH-01; Effect of NPC-01/IKH-01 on Sexual Hormone Concentrations in Healthy Female Volunteers

The purpose of this study is to compare the serum levels of estradiol, progesterone, FSH and LH in NPC-01 or IKH-01 one treatment cycle with those in before and after administration cycle.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female aged between 20 to 35 years
* BMI:18.0-26.0

Exclusion Criteria:

* Females who are pregnant
* Drug use affecting sex hormone secretion
Open-label Trial in Parkinson's Disease (PD)

The purpose of this study is to evaluate the safety and efficacy of long-term administration of flexible doses of tavapadon in participants with Parkinson's Disease.


Eligibility Criteria:
Key Inclusion Criteria:

Rollover participants are eligible for the study if they met the following inclusion criteria:

* Participants who complete the 27-week double-blind Treatment Period of Trial CVL-751-PD-001 (NCT04201093) or Trial CVL-751 PD-003 (NCT04542499) or the 27-week double-blind Treatment Period and 10-day Safety/Withdrawal Assessment Period of Trial CVL-751-PD-002 (NCT04223193) and enter this trial within 72 hours after completing the last trial visit in the double-blind trial. Rollover participants from Trial CVL-751-PD-003 must continue to use levodopa/carbidopa (or levodopa/benserazide) for the duration of the trial.
* Sexually active men or women of childbearing potential must agree to use acceptable (at minimum) or highly effective birth control, or remain abstinent during the trial and for 4 weeks after the last dose of trial treatment.
* Participants who are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
* Participants who are willing and able to refrain from any PD medications that are not permitted by the protocol (including dopaminergic agents) throughout participation in the trial.
* Participant who, in the judgement of the investigator, demonstrated adequate compliance with the IMP and protocol requirements in the double-blind trial.

Key Exclusion criteria:

Rollover participants are excluded from the trial if any of the following met:

* Participants who do not enroll in this open-label trial within 72 hours after completing the last trial visit in the double-blind trial
* Participants who answer "yes" on the C-SSRS Suicidal Ideation Item 4 or Item 5 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan, or Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting the criteria for C-SSRS Item 4 or Item 5 occurred within the last 6 months, OR Participants who answer "yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting the criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 2 years, OR Participants who, in the opinion of the investigator, present a serious risk of suicide.
* Participants who had previously been enrolled in this open-label trial and had subsequently withdrawn.
Preoperative Assessment of Colon Tumor

The purpose of this study is to determine whether a colonic tumor can be classified as malignant or benign with magnetic resonance (MR) colonography. Patients with a verified colon carcinoma or benign tumor based on diverticulitis are offered a MR colonography with intravenous (I.V.) contrast. The tumor is classified as malignant or benign by assessing the dynamic contrast uptake and morphology. The Investigator is blinded from the verified diagnosis and the MR classification is compared to the histological diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer
* Colorectal tumor

Exclusion Criteria:

* Active diverticulitis
* Pacemaker
* Metal in the body
* Claustrophobia
The Difference Between Acupuncture and Far-infrared Ray Illumination at CV12 Acupoint

The purpose of the study was to investigate the changes of Ryodoraku value at 12 source acupoints, and heart rate viability (HRV) when acupuncture or far-infrared ray illumination applied to CV12 acupoint.

Acupuncture and far-infrared ray illumination at CV12 acupoint have been widely used to treat many diseases in clinic. To our knowledge, the report is about the different reaction on autonomic nervous system between acupuncture and far-infrared illumination is very rare until now.Therefore,the study was to investigate the different changes on autonomic nervous system from Ryodoraku value at 12 source acupoints and heart rate viability (HRV) when acupuncture or far-infrared ray illumination applied to CV12 acupoint.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers, male or female, ages between 20 and 40
* Neurological and physical examination without abnormal functions
* Far-infrared ray illumination without allergic reaction and contra- indication
* The participants were explained the objective of the study, agreed to accept the test and signed a letter of consent

Exclusion Criteria:

* People less than 20 years of age or more than 40 years
* Women in pregnant or lactating
* People with mental or behavioral anomalies could not follow the researchers
* People with pacemakers
* People suffered from serious diseases such as myocardial infarction , heart failure, serious arrhythmia, hypertension, diabetes, autoimmune disease, chronic obstructive pulmonary diseases, and kidney failure, liver cirrhosis and cancer
* People accepted acupuncture and moxibustion in a week, or were taking any drugs for treatment
* People suffered from limb edema and serious skin diseases
* People with excessive obesity (body mass index, BMI\>30)
* People did not sign a letter of consent
Fetal Kidney in Estimation of GA in Pregnancy

A true estimation of gestational age (GA) plays animportant role in quality of maternity care such asassessment of fetal growth and to schedule the labordate. Any inaccurate estimation may lead to peri-natalmorbidity and mortality due to iatrogenic pre- or post-maturity .

Several longitudinal studies have been performed in the western countries concerning sonographic measurement of fetal kidney length. Initially these were done for diagnosis of renal malformation in utero \& later on they were to find out the correlation between the fetal kidney length and the gestational age

Eligibility Criteria:
Inclusion Criteria:

1. Single fetus.
2. pregnant ladies. with no medical disorders
3. Fetal kidneys are normally seen

Exclusion Criteria:

* Medical disorders with pregnancy
* Renal anomalies
* Renal agesnesis
Front-of-package Marketing on Fruit Drinks: Online RCT

This study will test the independent and combined effects of front-of-package claims, imagery, nutrition disclosures, and added sugar warning labels on parents' purchases and perceptions of beverages for their children.

Fruit drinks are widely consumed by 0-5-year-olds. Parents purchase these drinks for their children in part due to misperceptions that they are healthful, which may be driven by front-of-package (FOP) marketing. The FDA is considering changes to FOP marketing regulations but lacks data on how label elements influence consumer behavior. Our study will test the independent and combined effects of FOP claims, imagery, nutrition disclosures, and added sugar warning labels on parents' purchases and perceptions of beverages for their children.

We will conduct an online randomized controlled trial with 5,000 racially/ethnically diverse primary caregivers of children aged 0-5 years. Participants will choose a beverage for their child in an online store and rate health perceptions of different fruit drinks. Participants will be randomized to see high-added-sugar beverages (\>20% DV added sugar/serving) with 1 of 7 FOP label conditions: 1) vitamin C claim and fruit imagery (control); 2) imagery only; 3) claim only; 4) no claim or imagery; 5) claim, imagery, and % juice disclosure; 6) claim, imagery, and added sugar warning; or 7) claim, imagery, and added sugar warning w/teaspoons of added sugar.

Primary outcomes will include total calories and added sugar (grams) from chosen online store beverages. Secondary outcomes will include health perceptions and knowledge of added sugar and % juice content in low- and high-added-sugar fruit drinks.

This research will inform federal regulation to correct health misperceptions of sugary drinks.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of a child 0-5 years old
* \>= 18 years old
* U.S. citizen

Exclusion Criteria:

* Participants who complete the survey in less than 1/3 of the median completion time
* Observations from duplicate IP addresses (keep first observation that is unique)
* Participants who answer data integrity check incorrectly