cyrilzakka/clinical-trials huggingface dataset:
Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)

This is a pilot, multicenter, real-world, single-visit, low risk, phase IV interventional study to efficiently identify new cases of heart failure (HF) Stage C in subjects who are at risk of cardiovascular (CV) disease in high-volume ambulatory primary care settings in 3 countries in Central America.

Subjects with 2 or more CV risk factors will be identified and will undergo an NYHA score assessment. If the NYHA score is ≥ II, the serum NT-proBNP concentration will be determined on-site on the same day. If the serum NT proBNP concentration is ≥ 125 pg/mL, the subject will be referred to a country specific central echocardiography laboratory for a transthoracic echocardiogram to measure the left ventricular ejection fraction (LVEF) and relevant structural heart disease.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Male or female patients aged \> 60 years at the time of informed consent
3. Presence of at least 2 or more of the following risk factors for HF (CV risk factors already diagnosed prior to study visit according to the usual medical practice criteria and listed in the medical chart):

   1. Hypertension
   2. Dyslipidemia
   3. Obesity
   4. Vascular disease, including coronary artery disease, cerebrovascular disease, and peripheral vascular disease
   5. Type 1 or 2 diabetes mellitus
   6. Chronic kidney disease
   7. Arrhythmia requiring therapy
   8. Moderate to severe valvular disease
   9. History of alcohol abuse,
   10. History of smoking,
   11. History of cancer chemotherapy, or

   i. History of thoracic radiotherapy l. Abnormal findings in the most recent ECG or m. Abnormal findings in the most recent thoracic X-ray
4. Attendance at a primary care consultation for reasons not related to HF

Exclusion Criteria:

1. Previous diagnosis of HF
2. Diagnosis of terminal cancer (malignant tumor that may cause the subject's death in a short period: days, weeks, or a few months)
3. Echocardiogram performed within the 12 months before the primary care consultation
Dual Trigger Versus GnRHa Trigger Combined With Luteal HCG Administration

Comparing the reproductive outcomes of intracytoplasmic sperm injection (ICSI) cycles in women at risk of ovarian hyperstimulation syndrome (OHSS) subjected to gonadotropin releasing hormone (GnRH) antagonist protocol followed by trigger with concomitant GnRH agonist (GnRHa) and low-dose human chorionic gonadotropin (HCG) administration (dual trigger), GnRHa trigger with single luteal low-dose HCG or GnRHa trigger with multiple luteal low-doses HCG

The GnRH antagonist fixed protocol will be used for controlled ovarian hyperstimulation (COH). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of the follicular growth (folliculometry). When there will be at least 3 leading follicles \> 18 mm in diameter, women will be randomized into 3 groups; group A (dual trigger group), group B (single low-dose HCG group) and group C (multiple low-doses HCG group). In group A, final oocyte maturation will be triggered by dual administration of 0.2 mg of GnRHa preparation (Triptorelin) SC and 1500 IU of HCG preparation IM. In group B, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will by administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval). In group C, final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then 3 IM boluses of 500 IU HCG will be administered day 1, day 4 and day 7 after oocyte retrieval. In all women, oocyte retrieval will be performed 34-36 hours after trigger and endometrial preparation for embryo transfer (ET) will be started on the day of oocyte retrieval by giving 400 mg vaginal natural progesterone supplement once daily plus 4 mg oral estradiol valerate once daily.

Eligibility Criteria:
Inclusion Criteria:

* Women subjected to ICSI through controlled ovarian hyperstimulation (COH) with pituitary downregulation by GnRH antagonist.
* Presence of risk for development of OHSS: 1) previous moderate or severe OHSS; 2) PCOS or polycystic ovary on ultrasound scan; 3) antral follicle count (AFC) \> 14 in both ovaries; 4) basal serum AMH level \> 3.36 ng/ml; 5) \> 14 follicles with diameter of ≥ 11 mm on the day of triggering of oocyte maturation; 6) E2 level \> 3000 pg/ml on the day of triggering of oocyte maturation.

Exclusion Criteria:

* Age \< 20 years or \> 35 years.
* BMI \< 19 kg/m2 or \> 35 kg/m2.
* Moderate or severe endometriosis.
* Hydrosalpinx.
* Uterine abnormalities or myoma.
* Previous uterine surgery.
* Use of alternative techniques to minimize the risk of OHSS.
SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study

Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose inhalation.

Study Design: Pharmacokinetic open study


Eligibility Criteria:
Inclusion Criteria:

1. Subjects judged to be appropriate for the study by the attending physician
2. can provide signed informed consent.

   aPAP patient must meet the following
3. aPAP patient aged over 20 and below 80 years old (as of the date of registration)
4. aPAP severity is mild or moderate. (not severe)

   Healthy volunteer must meet the following
5. Japanese healthy male subject aged over 20 and below 45 years old (as of the date of registration).
6. BMI (Body mass index) is between 18 and 25.

Exclusion Criteria:

1. WBC of 12,000/mcl or more
2. Fever of 38 degree celsius or more
3. History of malignant disease within recent 5 years (not applied to the treated cases of local basal cell carcinoma)
4. Complication of severe cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc.
5. Complication of respiratory diseases such as pulmonary infectious disease(incl. pulmonary tuberculosis), interstitial pneumonitis, lung fibrosis or bronchiectasis, in which the evaluations of safety of GM-CSF therapy are considered to be difficult.
6. History or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks.
7. liver dysfunction
8. renal dysfunction
9. Previous experience of severe and unexplained adverse events during aerosol delivery of any kind of medicinal product
10. Positive for HIV-Ab, HBs-Ag, HCV-Ab, STS or TPHA
11. allergic to GM-CSF.
12. addicted to illegal drugs
13. Participation to other clinical trials within 12 weeks before registration.
14. smoking within 5 years
15. cannot follow the procedure defined in this protocol

    aPAP patient must exclude the following
16. Pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period
17. Patients who have been treated with whole-lung lavage, repeated segmental-lung lavage, GM-CSF or rituximab within 6 months before the start of the study.
18. taking other inhalation.

    Healthy volunteer must exclude the following
19. taking any medicines (incl. OTC).
Effects of Desoximetasone Spray 0.25% on Moderate to Severe Plaque Psoriasis

efficacy study in patients with moderate to severe plaque psoriasis.

A Double-Blind, Vehicle-Controlled, Randomized, Parallel Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone 0.25% Topical Spray in Patients with Moderate to Severe Plaque Psoriasis

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female 18 years of age or older.
* Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA).
* Have a combined total lesion severity score (TLSS) of ≥ 7 for the Target Lesion.
* Have a plaque elevation score ≥ 3 of (moderate) for the Target Lesion.
* The Target Lesion must have an area of at least 5 cm².
* Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.

Exclusion Criteria:

* Patient has current diagnosis of other types of psoriasis other than stable plaque psoriasis (i.e. acute, guttate, erythrodermic, exfoliative or pustular psoriasis) or has psoriasis of any kind of the face or scalp that will require active treatment during the study. Nonprescription antipsoriatic shampoos will be allowed during the study when applied solely to the scalp.
* Patient has a history of psoriasis that has been unresponsive to topical corticosteroid therapy.
* In the Investigator's opinion, the patient has other dermatological conditions, such as atopic or contact dermatitis, that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
* Patient has a history of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
* Patient has been treated within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
* Patient has received any systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study.
* Patients who have used any topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study.
* Receipt of any drug as part of a research study within 30 days prior to first dosing.
Virtual Reality Intervention for Patients Undergoing BMT

The goal of this research study is to test the feasibility and preliminary efficacy of using a virtual reality (VR) psychosocial intervention for improving quality of life and psychological distress in patients hospitalized for bone marrow transplantation (BMT). Participants will be randomly assigned into one of the study groups: the virtual reality psychosocial intervention (BMT-VR) + usual care versus usual care alone.

The BMT-VR intervention has several components:

1. Psychoeducation to enhance preparedness, manage expectations, and mobilize social supports.
2. Psychosocial skill building to promote effective coping and facilitate acceptance while living with uncertainty of treatment outcomes.
3. Self-care to promote effective coping and enhance patient's sense of control as they transition from inpatient to outpatient care

Patients undergoing BMT endure substantial physical and psychological symptoms during a prolonged hospitalization with significant risk of complications, which negatively impact their overall quality of life. There is a critical need to develop innovative supportive care interventions to improve the quality of life and care of patients undergoing BMT.

This is a single-center, randomized, controlled research study to test the feasibility and preliminary efficacy of BMT-VR for improving quality of life and reducing psychological stress for patients undergoing BMT. BMT-VR is a self-administered virtual reality psychosocial intervention to address the supportive care needs of patients undergoing BMT.

Participants will be recruited and randomized in 1:1 fashion to BMT-VR + usual care versus usual care alone, stratified by transplant type (autologous vs. allogenic BMT)

Participants randomly assigned to BMT-VR group will receive usual transplant care by their BMT team and will also be given a virtual reality headset to engage with BMT-VR during their BMT hospitalization. Participants will complete six sections focused on educating them about BMT and helping them manage the physical and emotional symptoms with the BMT process.

Participants randomly assigned to the usual care group will receive usual transplant care by their BMT team and will not be given access to the BMT-VR intervention.

In both groups, participants are asked to complete questionnaires (in-person, over the computer or telephone, or by mail) at baseline, 2, 4, 12, and 24 weeks after enrolling in the study.

It is expected about 80 participants will take part in this study.

Rocket VR Health, Inc. is supporting this research study by providing funding.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age \> 18 years) with hematologic malignancy admitted for autologous or allogeneic BMT
* Ability to comprehend, read, and respond to questions in English as BMT-VR is only available in English

Exclusion Criteria:

* Patients undergoing BMT for benign hematologic conditions
* Patients undergoing outpatient BMT
* Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures
Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?

Non-cardiac chest pain (NCCP) is a common disorder whose pathophysiology is poorly understood. Some evidence suggests it may be related to sustained esophageal contractions (SECs) of longitudinal smooth muscle. The investigators have previously shown that acid is a trigger for SECs and results in shortening of the esophagus. In this study, the investigators plan to prospectively evaluate esophageal shortening responses to acid in a group of patients with NCCP compared to controls. The investigators will use high resolution esophageal manometry coupled with acid infusion to evaluate shortening. The investigators hypothesize that at least a subset of patients with NCCP will have an exaggerated esophageal shortening response to acid which correlates with symptom production. If our hypothesis proves true, this may lead to a future therapeutic target in the treatment of these patients.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers:
* free of esophageal symptoms
* not on any acid suppressing medications
* Non Cardiac Chest Pain Patients:
* Angina like chest pain occuring at least once per month
* Coronary artery disease ruled out by stress test or angiogram

Exclusion Criteria:

* pre existing motility disorder of the esophagus
* connective tissue disease
* pregnancy
* taking calcium channel blockers, Nitrates, Gabapentin, Narcotics, Tricyclic antidepressants, Anti seizure medications
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery

To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.


Eligibility Criteria:
Inclusion Criteria:

* A signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
* Patients (men and women) over 18 years old.
* Patients who have received at least one dose of apixaban for prevention of stroke and systemic embolism with non-valvular atrial fibrillation with one or more of the following stroke risk factors: prior stoke or transient ischaemic attack; age \>75; hypertension; diabetes mellitus; symptomatic heart failure (NYHA class \>II); or for prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery.
* Subjects who are willing and able to comply with all scheduled visits.

Exclusion Criteria:

* Patients who have received apixaban in a clinical trial.
* Patients who received apixaban for another indication locally approved or have a contraindication according to the information to prescribe of the product in Mexico.
* Hypersensitivity to the active substance or to any of the excipients.
* Active clinically significant bleeding.
* Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.
* Lesion or condition considered a significant risk factor for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
* Concomitant treatment with any other anticoagulant agent e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), and oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc.) except under specific circumstances of switching anticoagulant therapy. Concomitant medication with Nonsteroidal anti-inflammatory drugs (NSAIDs ).
* Pregnancy and breast-feeding.
* Severe acute or chronic psychiatric condition and other significant medical condition.
Physical Activity and Cognitive Function in Older Adults: A Novel Role for GPLD1

The investigators are conducting a cross-sectional, observational study to investigate whether plasma GPLD1 concentrations are associated with higher cognitive function and better brain structure and function in two groups of older adults with high or low levels of physical activity.

This is a cross-sectional, observational study which will enroll up to 28 healthy, older adults (65-85 y, BMI 20-35 kg/m2), and stratify by current self-reported physical activity level (equal inactive vs. equal highly active).

Aim 1: Investigate whether physical activity level is associated with GPLD1.

Aim 2: Investigate whether cognitive function and brain structure/function are associated with GPLD1.

Eligibility Criteria:
Inclusion Criteria:

* Ages 65-85 y (inclusive)
* Body mass index (BMI) of 20-35 kg/m2 (inclusive)
* Willing to have blood and data stored for future research use

Exclusion Criteria:

* History of clinically diagnosed diabetes (Type 1 or 2) or a fasting blood glucose \>126 mg/dL
* Diagnosed Alzheimer's disease, dementia, or related-brain diseases
* Chronic use of atypical antipsychotic or bipolar medications
* Initiation of novel pharmacotherapy agents (such as antidepressant, hypertension, or dyslipidemia) within the last 3 months
* Uncontrolled hypertension (blood pressure \>160 systolic or \>110 diastolic)
* Asthma that limits the ability to participate in moderate to vigorous physical activity or requiring systemic glucocorticoid administration
* Emphysema that limits the ability to participate in moderate to vigorous physical activity or requiring systemic glucocorticoid administration
* Current alcohol use exceeding 14 drinks per week in women, exceeding 21 drinks per week in men, having treatment for alcohol abuse in the last year, or having treatment for alcohol abuse more than 1 year ago (but with inability to refrain from alcohol in the past year)
* Use of illegal drugs or marijuana within 1-month of completing a Screening Visit; treatment for drug addiction in the 1-year or having treatment for drug addiction \>1-year ago, but with an inability to refrain from the drug of addiction in the 1-year
* Unwilling to abstain from illegal drugs and marijuana for the duration of the study
* Contraindication for MRI (e.g., metal objects, claustrophobia, etc.)
* Psychotic mental illness (e.g., schizophrenia, bipolar, on-and- off use of anti-psychotic medication)
* History of cardiovascular disease (or diseases of the heart, lungs, or blood) that limits participation in moderate to vigorous physical activity
* History of liver, blood, kidney, thyroid or other diseases that limits moderate to vigorous physical activity at the time of enrollment
* Cancer that limits moderate to vigorous physical activity
* Treatment with systemic immunosuppressant medication
* Taking adrenergic stimulants (e.g., amphetamine) or adrenergic blockers (e.g., Propanolol) that will alter metabolic rate
* Have plans to substantially alter their current level of physical activity over the next 1-month
Using Calcium Dobesilate to Treat Chinese Patients With Mild to Moderate Non-proliferative Diabetic Retinopathy

Calcium dobesilate has been recommended to treat diabetic retinopathy due to its potential in protecting against retinal vascular damage. However, there was limited evidence exploring its efficacy in combating diabetic retinopathy progression. This study, a single-blind, multicenter, cluster-randomized, controlled superiority trial, was designed to evaluate whether calcium dobesilate could prevent diabetic retinopathy progression into an advanced stage among Chinese patients with mild to moderate non-proliferative diabetic retinopathy.

A total of 1,200 patients with mild to moderate non-proliferative diabetic retinopathy will be enrolled and randomly assigned at a ratio of 1:1 into the control group (that is, conventional treatment group) and the intervention group (that is, conventional treatment plus calcium dobesilate \[500 mg, 3 times per day\] for 12 months). The severity of diabetic retinopathy will be assessed by the Early Treatment Diabetic Retinopathy Study scale.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with mild to moderate diabetic retinopathy
* Being older than 18 years
* Being willing to attend this trial.

Exclusion Criteria:

* Being allergic hypersensitive to experimental drugs or comparator drugs
* Having alanine aminotransferase or aspartate aminotransferase ≥2 times higher than the upper limit of normal value, or total bilirubin ≥1.5 times higher than the upper limit of normal value upon the exclusion of mild fatty liver disease
* Having severe renal insufficiency (defined as an estimated glomerular filtration rate ≤30 mL/min/1.73 m\^2)
* Having malignant tumor and some other life-threatening diseases
* Being in pregnancy, expecting pregnancy, or breast feeding
* Being with unstable conditions, such as: uncontrolled high blood pressure (e.g., blood pressure \>180/100 mmHg); hemoglobin A1c \>8.0% or uncontrolled high blood glucose or hypoglycemia; acute cardiovascular events like unstable angina, congestive heart failure, stroke, transient ischemic attack, or myocardial infarction within the previous 3 months; uncontrolled infection; and diabetic ketoacidosis or hyperosmolar state in the past 1 month
* Being with glaucoma, cataracts, or other opacities that may interfere with retinal examination and fundus photography
* Receiving laser treatment, cryo-coagulation, or vitrectomy
* Taking drugs such as diabetic retinopathy or traditional Chinese medicine that may help to improve micro-vascular function in the past 2 weeks
* Receiving vascular endothelial growth factor therapy in the past 4 months or will be judged to take vascular endothelial growth factor therapy because of disease progression
* Having attended other clinical trials in the past 1 month, being attending some clinical trials, or some other conditions that were judged unfit for this trial by investigators