cyrilzakka/clinical-trials huggingface dataset:
A Study of VERVE-102 in Patients with Familial Hypercholesterolemia or Premature Coronary Artery Disease

VT-10201 is an Open-label, Phase 1b, Single-ascending Dose Study That Will Evaluate the Safety of VERVE-102 Administered to Patients With Heterozygous Familial Hypercholesterolemia (HeFH) or Premature Coronary Artery Disease (CAD) Who Require Additional Lowering of LDL-C. VERVE-102 Uses Base-editing Technology Designed to Disrupt the Expression of the PCSK9 Gene in the Liver and Lower Circulating PCSK9 and LDL-C. This Study is Designed to Determine the Safety and Pharmacodynamic Profile of VERVE-102 in This Patient Population.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HeFH or premature CAD
* Females of non-childbearing potential or males

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Active or history of chronic liver disease
* Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe
* Clinically significant or abnormal laboratory values as defined by the protocol
Pilot Study of Cognitive and Functional Outcomes Following TAVI

Narrowing of the aortic valve in the heart, known as severe aortic stenosis, can impede blood delivery and is associated with poor quality of life and death. In the elderly with considerable medical burden, a relatively new non-invasive valve replacement technique called Transcatheter Aortic Valve Implantation (TAVI) can be used instead of open-heart surgery. However, long term changes in cognition after TAVI remain unclear and previous studies have suggested an increased risk of cognitive decline in patients following the surgical procedure. In this pilot study, the investigators will characterize changes in cognition, physical capacity, overall quality of life and neuropsychiatric symptoms (depression and apathy) over 6 months after TAVI.

Cardiovascular disease including valvular heart disease, contributes to an estimated 36% of all deaths over the age of 70. In particular, severe aortic stenosis is the most common valvular heart disease in the elderly in the Western world and is associated with reduced quality of life and increased mortality. TAVI has been shown to improve survival, with an all-cause mortality at 1 year similar to surgical aortic valve replacement (SAVR) with favourable outcomes long-term including improved functional capacity and quality of life. Recent evidence from randomized controlled trials suggests an increased risk of neurological events (e.g. cognitive decline) up to 1 year after TAVI in comparison to both SAVR and medical treatment. Studies have shown no change in short-term memory, working memory, verbal learning, delayed recognition and verbal fluency 3 months after TAVI. In addition, patients with severe aortic stenosis have an increased risk of mortality and future health complications. This study will be an observational, prospective cohort pilot study to examine changes in cognitive performance and functional outcomes after TAVI. We propose to recruit 34 patients for this study. Cognitive performance will be measured using a standardized cognitive battery prior to TAVI and 6 months post-TAVI. Functional capacity, changes in neuropsychiatric symptoms and quality of life will also be assessed prior to TAVI and 6 months post-TAVI. We hypothesize there will a change in cognitive performance, functional capacity, mood outcomes and quality of life over 6 months after TAVI.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of severe symptomatic aortic stenosis
* undergoing TAVI
* speak and understand English

Exclusion Criteria:

* emergency TAVI
* any medical conditions that will affect their ability to complete the protocol
Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon

Exocrine pancreatic insufficiency (EPI) is a condition that is caused by the inadequate pancreatic enzymes needed for normal digestion and is commonly associated with a wide range of chronic diseases, including cystic fibrosis (CF), chronic pancreatitis (CP), and pancreatic cancer. This study will assess clinical symptoms when participants with CF or CP are treated with Creon with alternate source of active drug.

Creon is an approved drug for the treatment of EPI. This study is subject-blinded which means participants will not know the source of the study drug they are given. Approximately 30 adult participants with CF or CP will be enrolled at approximately 15 sites across the Unites States.

Participants will receive oral capsules of CREON for 113 days and will be followed for 30 days.

Participants will attend regular visits during the study at a hospital or clinic or via telemedicine. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of cystic fibrosis (CF) or chronic pancreatitis (CP).
* Previous diagnosis of exocrine pancreatic insufficiency (EPI) that is currently clinically controlled.
* Total Symptom Score (TSS) \< 1.8 on Pancreatic Exocrine Insufficiency Questionnaire (PEI-Q) at Screening.

Exclusion Criteria:

- Malignancy involving the digestive tract in the last 5 years, or other significant disease or medical condition that may interfere with EPI symptom assessment.
Intravenous Streptokinase in Acute Myocardial Infarction

To determine whether the administration of intravenous streptokinase (SK) early in the course of acute, transmural myocardial infarction would limit myocardial damage.

BACKGROUND:

Determination of the potential value of thrombolytic therapy in patients with acute myocardial infarction was an issue of major importance in 1983. An estimated 1.4 million heart attacks occurred each year, of which over 500,000 were fatal. Reduction of mortality required an effective means to reduce infarct size. Studies indicated that reperfusion represented a potent means of achieving salvage of ischemic myocardium. Pilot clinical studies indicated that reperfusion could be achieved in a substantial percentage of patients by lysis of coronary thrombosis with both intracoronary and intravenous streptokinase administration. Intracoronary thrombolysis was receiving widespread clinical applications but had many limitations. The intracoronary route took 90-120 minutes longer to administer than the intravenous route. Because intracoronary therapy required the availability of a catheterization laboratories and highly skilled invasive cardiologists, this treatment was not available to large numbers of patients who were hospitalized in smaller community hospitals.

DESIGN NARRATIVE:

Randomized design with two groups and fixed sample size. Control patients received routine coronary care. The treatment group received intravenous streptokinase plus conventional care. This was followed with intravenous heparin and warfarin. The primary endpoint was 14 day mortality. Secondary endpoints included angiographic patency of the involved coronary artery at 10 to 14 days, left ventricular function, segmental wall motion analysis, and myocardial infarction size at 30-45 days.

Eligibility Criteria:
Men and women, aged less than 75. Myocardial infarction onset within six hours.
Efficacy and Safety of Ethanol Extracts of Porphyra Tenera(PTE10) on Promotion of Immunity

This study was conducted to investigate the efficacy and safety of ethanol extracts of Porphyra tenera(PTE10) on promotion of immunity

This study was 8 weeks, randomized, double-blind, placebo-controlled human trial. 120 subjects were randomly divided into ethanol extracts of Porphyra tenera(PTE10) group or placebo group. The investigators measure Natural Killer cell activity, Cytokines(IL-2, IL-6, IL-12, IFN-γ, TNF-α), questionnaire scores of upper airway infection.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 50 years over at the screening
* Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions

Exclusion Criteria:

* Patients whose white blood cell(WBC)\<3000/㎕ or \>8000/㎕ in the screening examination
* Patients receiving influenza vaccination within 3 months before the screening examination
* Patients who have a body mass index(BMI)\<18.5 kg / m\^2 or ≥35 kg / m\^2 at the screening examination
* Patients with a clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry, musculoskeletal system, inflammatory and hematologic
* Patients who take a medication or health function food that affects your promotion of immunity within 1 month prior to the screening examination
* Patients receiving antipsychotic medication within 3 months prior to the screening examination
* Patients who alcoholic or drug abuse suspected
* Patients who have participated in other clinical trials within 3 months prior to the screening examination
* Patients who show the following relevant results in a Laboratory test

  * Aspartate Transaminase(AST), Alanine Transaminase(ALT) \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dl
* Patients who are pregnant or breastfeeding
* Patients who may become pregnant and have not used appropriate contraceptives
* Patients who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc
Early Chair Sitting Exercise in Mechanically Ventilated Critically Ill Patients

The occurrence of an acute respiratory failure necessitates mostly admission to ICU and mechanical ventilation (MV). Rapid and safe discontinuation of MV should be the objective for the majority of patients. Many reasons may contribute to weaning, extubation failure and prolongation of MV. Critical illness myopathy, induced by immobilisation and prolonged MV, may represent a main factor and early rehabilitation may reverse these conditions and improve the success of weaning from MV.The objective of this study is to evaluate the effect of an early chair sitting (while the patient is awake but still mechanically ventilated) on weaning from mechanical ventilation and ICU mortality.

Methods: Chronic respiratory failure patients with an acute decompensation and requiring MV for more than 48 hours will be randomized to 2 groups at the initiation of weaning schedule: the studied group (20 patients): chair-sitting group will be transferred from bed to arm chair for at least 1 hour and once a day; the control group will stay in bed until extubation. Ventilator free days, extubation failure, nosocomial infections, ICU mortality, ICU length of stay are assessed and compared between groups. Expected results: Early chair sitting would decrease MV duration, number of extubation failure, nosocomial infections and ICU mortality. Feasibility and safety of this intervention will also be evaluated and also the related work load.


Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory failure
* Requiring mechanical ventilation for more than 48 h
* Informed consent

Exclusion Criteria:

* Body mass index \> 40 kg/m2
* Severe neuropathy
* Hemodynamic instability, acute cor pulmonary embolism, acute myocardial ischemia/necrosis, hypoxemia
* Deep sedation
Three Modalities of Treatment in Operable and Resectable Stage IIIA (T1-3, N2) Non-Small Cell Lung Cancer (NSCLC)

Stage IIIA non-small cell lung cancers comprising a mediastinal ganglionic invasion N2 account for 20 to 30% of the NSCLCs. They are almost always potentially resectable, but the results obtained by surgery alone or surgery followed by chemotherapy (CT) and/or radiotherapy (RT) are insufficient. The neoadjuvant approach was tested, in randomized tests of exclusive CT, or in noncomparative tests of RT-CT.

These results justify the choice of the study design currently suggested, testing the preoperative feasibility

1. chemotherapy: cisplatin-Gemzar (arm A) or
2. chemoradiotherapy: cisplatin-navelbine-radiotherapy (arm B) or Carboplatin-Taxol-radiotherapy (arm C).

The results obtained, in terms of feasibility and toxicity, will make it possible to select the optimal diagrams for a phase III study.

Eligibility Criteria:
Inclusion Criteria:

* Operable and resectable stage IIIA (T1-3, N2) NSCLC
* World Health Organization (WHO) performance status of 1 or less

Exclusion Criteria:

* Severe cardiac, respiratory, renal or hepatic failure
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women

The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, postmenopausal women, aged 40 to less than 65 years
* Intact uterus
* At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels \> 40 mIU/mL.

Exclusion Criteria:

* Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within 8 weeks before screening (12 weeks for the osteoporosis substudy)
* A history or active presence of clinically important medical disease
* Malabsorption disorders
Comparison of RVOT Gradient Under Anaesthesia With Post-operative Gradient in Patients Undergoing TOF Repair

The primary objective of the study will be to compare intraoperative post TOF repair RVOT gradient under two different anaesthetic depths. Secondary objectives will be to follow up change in RVOT gradient till 1 month post-operatively, observe extubation time, inotropes used post-operatively by vasoactive- inotropic score (VIS), RV functions at discharge from ICU and at 1 month follow- up

After completion of the TOF repair and rewarming to normothermia, all the patients will be assessed by TEE for adequacy of repair and separated from the cardiopulmonary bypass using vasopressors and inotropes. The choice of vasoactive and inotropic agents will be as per the requirement to maintain stable hemodynamics of the patients. Post bypass sevoflurane 1% end tidal concentration (0.5 MAC) will be used in all the patients. RV pressure and gradients across RVOT will be measured directly by placing a 23 gauge needle into the RV and pulmonary artery, and also by TEE using Bernoulli's equation by placing continuous Doppler across tricuspid regurgitation jet and RVOT, as is being routinely done for patients undergoing TOF repair. In addition, velocity time integral (VTI) across left ventricular outflow tract (LVOT) will also be recorded along with other hemodynamic parameters such as HR, SBP, DBP, MAP and SpO2. Subsequently, these measurements will be repeated again after increasing the sevoflurane to 2% end tidal concentration (1 MAC) and allowing the patients to stabilise on this new concentration for 5 minutes while maintaining systemic pressure within a range of 5% of the previous value. Normocarbia (EtCO2 30-35 mmHg) will be maintained during these measurements by adequate minute ventilation.

Following the surgery, all the patients will be shifted to cardio-surgical ICU and will be extubated once they meet the extubation criteria. Post-operative RVOT pressure gradient and RV functions will be assessed by trans-thoracic echocardiography at 2 hrs post extubation, at discharge from ICU and after 1 month of surgery on first follow-up. RV functions on echocardiography will be assessed using TAPSE (Tricuspid annular plane systolic excursion) and fractional RV area change during systole. The duration of post-operative mechanical ventilation, vasoactive inotropic score (VIS), PaO2/FiO2 ratio till discharge from ICU and any morbidity or adverse outcome during hospital stay will be noted.

Eligibility Criteria:
Inclusion Criteria:

* All the children between 6 months to 16 years of age undergoing TOF repair will be included in the study.

Exclusion Criteria:

* TOF patients with pulmonary atresia, atrioventricular canal defects and where consent is refused will be excluded from the study.
Testing the Effects of Singapore's Front-of-Pack Healthier Choice Symbol Label With or Without a Physical Activity Equivalent Label

Poor diets are known risk factors for chronic diseases, and in recent years, food labelling has been increasingly sought-after as a cost-effective intervention to help stem the rising trend in chronic diseases.

In efforts to promote a healthy diet, the Singapore Health Promotion Board (HPB) supplements traditional nutrition labelling with the Healthier Choice Symbol (HCS), which identifies food items within a specific category of foods as healthier choices. The original logos were enhanced to include additional information focusing on particular macronutrients, taking one of two themes; it either indicates that a product contains more of a healthier ingredient, or less of a less healthy ingredient.

However, to date, no published studies have assessed the role of the original and enhanced HCS logos in influencing food choices. There is a lack of scientific evidence on the role of the existing symbols in assisting consumers make healthier food purchasing decisions. There are also concerns over the unintended consequences of health claims made based on a single aspect of nutrient content, without considering other aspects. That is the goal of this effort. Specifically, the investigators

propose to conduct the following:

Use a three arm randomized controlled trial (RCT) and an experimental fully functional web-based grocery store to assess the causal effect of the new HCS logos on measures of diet quality either alone, or in combination with a complementary front-of-package (FOP) label: Physical Activity Equivalents (PAEs), which provides information on how long one would need to engage in a certain activity (e.g., jogging) to burn off one serving of the product.

The investigators hypothesize that the greatest reduction in calories per serving (primary outcome) will occur in the HCS plus PAEs arm, followed by HCS only, and no logo control arm.


Eligibility Criteria:
Inclusion Criteria:

* Singapore residents
* 21 years of age and above
* Primary grocery shopper for the household

Exclusion Criteria:

* Not residing in Singapore
* Under 21 years of age
* Not the primary grocery shopper for the household
Robot-Assisted Neurovascular Intervention

Patients scheduled for neurovascular interventions may be eligible to have their procedure done robotically.

Patients scheduled for manual neurovascular interventions, such as diagnostic cerebral angiography for cerebrovascular diseases, arterial embolization for meningioma treatment, and thrombectomy for thrombotic arterial occlusion-induced cerebral ischemia, may be considered to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for neurovascular interventions, such as diagnostic cerebral angiography for cerebrovascular diseases, arterial embolization for meningioma treatment, and thrombectomy for thrombotic arterial occlusion-induced cerebral ischemia, are selected according to the same criteria as standard cerebral angiography and interventional procedures.

Exclusion Criteria:

Exclusion Criteria 1 (General):

1. Patients who have undergone surgery within 4 weeks prior to study participation or have not fully recovered from surgery.
2. Patients who are pregnant or breastfeeding.
3. Patients with existing or anticipated vasospasm, bleeding, or severe atheromatous disease.
4. Patients allergic to contrast agents used in angiography.
5. Patients with renal failure.
6. Patients with a history of cardiac events, such as myocardial infarction or superior vena cava (SVC) syndrome, within 3 months prior to study participation, or with existing heart disease.
7. Patients unable to cooperate due to difficulty in expressing intent to the extent that the procedure cannot proceed.
8. Patients with severe or life-threatening comorbidities that could significantly affect symptom improvement or render the procedure unbeneficial.
9. Patients with non-life-threatening comorbidities that prevent proper follow-up for treatment.

Exclusion Criteria 2 (Cerebral Ischemic Stroke Patient):

1. Patients with an ASPECTS score of 0-2 on a pre-treatment non-contrast CT.
2. Inability to perform femoral puncture within 60 minutes of completing CT angiography (if CT perfusion is performed, it must be done after CT angiography).
3. Absence of a femoral pulse.
4. Cases where vascular access is highly challenging, with an anticipated time exceeding 90 minutes from CT angiography to reperfusion.
5. Patients suspected to have cerebral artery dissection or atherosclerosis as the cause of stroke.
6. Patients where the intracranial occlusion is determined to be chronic based on clinical history, prior imaging, or clinical judgment.
An Extension Study of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps

The overall purpose of this study is to evaluate the safety, efficacy, and durability of response of omalizumab in an open-label setting in adult participants with chronic rhinosinusitis with nasal polyps who completed the double-blind, placebo-controlled, Phase III studies GA39688 (NCT03280550) or GA39855 (NCT03280537). Participants will be eligible for enrollment in the study at, or within 28 days after, the Week 24 visit of Studies GA39688/GA39855. After enrollment into this open-label extension (OLE) study, participants will receive 28 weeks of dosing of omalizumab before entering a 24-week off-treatment observation phase of the study. Baseline in this OLE study is defined as the last pre-treatment measurement prior to randomization in Studies GA39688/GA39855 (i.e., baseline of Studies GA39688/GA39855). The data that will be reported from baseline to Week 24 inclusive will come from Studies GA39688/GA39855.


Eligibility Criteria:
Inclusion Criteria:

* Ability to comply with the study protocol, in the investigator's judgment
* Participation in Study GA39688 or GA39855, including completion of endoscopy and other assessments at Week 24, without discontinuation of study drug
* Completion of eDiary daily assessments for at least 4 out of 7 days in the week prior to the Week 24 visit of Study GA39688 or GA39855
* For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 60 days after the last dose of study drug

Exclusion Criteria:

* Anaphylaxis/hypersensitivity related to study drug in Study GA39688 or GA39855
* Serious adverse events related to study drug in Study GA39688 or GA39855 that the investigator or Sponsor determines may jeopardize the patient's safety if he or she continues in the study
* Uncontrolled epistaxis within Study GA39688 or GA39855
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 60 days after the last dose of omalizumab
* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study