cyrilzakka/clinical-trials huggingface dataset:
Effect of Ile-Pro-Pro (IPP) on Endothelial Function in Patients With Coronary Artery Disease

This study will investigate whether the lacto-tripeptide Ile-Pro-Pro (IPP) improves the function of the endothelium in patients with coronary artery disease. The study has a crossover design. Participants will be treated with a protein hydrolysate rich in IPP for 12 weeks and placebo for 12 weeks with a four-week rest period between treatment periods. The investigators will use ultrasound to test the function of the endothelium in the brachial artery before, after 6 weeks, and after 12 weeks of each treatment. Blood will be collected before and after each treatment. The investigators hypothesize that IPP will improve endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease

Exclusion Criteria:

* Treatment with an ACE inhibitor or ARB
* Pregnancy
* Other major illness
* Treatment with an investigational drug within 4 weeks
Hero: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) and Pharmacodynamics (PD) of ION269 in Participants With Down Syndrome (DS) at Risk for Alzheimer's Disease (AD)

The primary purpose of this study is to evaluate the safety and tolerability of ION269 in adults with Down syndrome with evidence of brain amyloid positivity.

This is a phase 1b multi-center, open-label, single ascending dose (SAD) study in adult participants with Down syndrome with evidence of brain amyloid positivity. Participants will be examined in 3 separate cohorts and will receive a single dose of study drug during the 36-week treatment period, followed by a 4-week follow-up period.

Eligibility Criteria:
Inclusion criteria:

1. Has a reliable study partner, that is, a parent, sibling, or caregiver ≥ 21 years of age, who has known the participant for \> 6 months (i.e., a reliable and competent individual with a close relationship with the participant) and is capable of providing accurate information about the participant's history, can attend all scheduled study visits and provide feedback regarding the participant's symptoms and performance as described in the protocol, and can comply with all study requirements and activities.
2. Has a diagnosis of Down syndrome and has an intelligence quotient (IQ) ≥ 45.
3. Has evidence of amyloid pathology on amyloid-positron emission tomography (PET) scan.
4. Is assessed as being cognitively stable.
5. Is in good health as evidenced by medical history, physical, and neurological examination, and with no diagnosis of dementia or mild cognitive impairment.

Exclusion criteria:

1. Has unstable psychiatric illness, including psychosis, or untreated major depression within 90 days before Screening, as determined by the Investigator.
2. Has any unstable medical condition likely to hamper the evaluation of safety and/or efficacy of the Study Drug (e.g., moderate or severe untreated obstructive sleep apnea, medical history of clinically significant B12 or folate deficiency that is currently uncontrolled, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per Investigator's judgment.
3. Is unable to complete MRI and amyloid/tau-PET procedures or has any contraindications to having a brain MRI (e.g., MRI-incompatible pacemaker, aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed without requiring general anesthesia).

Note: Other protocol defined inclusion/exclusion criteria may apply.
Development of a Scale for Cancer Patients' Willingness to Voluntarily Participate in Drug Clinical Trials

The goal of this observational study is to develop a scale for cancer patients' willingness to voluntarily participate in drug clinical trials and evaluate its reliability and validity.

Inclusion Criteria:

1. Age 18-80 years old (including boundary values).
2. Tumor patients with clear diagnosis.
3. Whether they finally sign the informed consent form of one drug clinical trial or not, and whether they are finally enrolled in one drug clinical trial or not, patients who have undergone the informed consent process of drug clinical trials conducted by clinicians can be enrolled in this study.
4. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Patients with unclear consciousness.
2. Patients who are unable to correctly understand and answer questions.
3. Vulnerable subjects include: students and subordinates of researchers, military personnel, prisoners, patients with incurable diseases, patients in critical situations, those admitted to welfare institutions, homeless individuals, minors, and those who are unable to provide informed consent.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-80 years old (including boundary values).
2. Tumor patients with clear diagnosis.
3. Whether they finally sign the informed consent form of one drug clinical trial or not, and whether they are finally enrolled in one drug clinical trial or not, patients who have undergone the informed consent process of drug clinical trials conducted by clinicians can be enrolled in this study.
4. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Patients with unclear consciousness.
2. Patients who are unable to correctly understand and answer questions.
3. Vulnerable subjects include: students and subordinates of researchers, military personnel, prisoners, patients with incurable diseases, patients in critical situations, those admitted to welfare institutions, homeless individuals, minors, and those who are unable to provide informed consent.
Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition.

The primary objective of this study is to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality, myocardial infarction (MI), and ischemia-driven revascularization (IDR).


Eligibility Criteria:
Inclusion Criteria:

Angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronary intervention (PCI) with or without stent implantation and diagnosis of Acute Coronary Syndrome (ACS) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogram changes + age \> 65 or diabetes.

Exclusion Criteria:

1. Not a candidate for PCI
2. ST-segment elevation myocardial infarction (STEMI) within 48 hours of randomization
3. Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (\<1 month) trauma or major surgery \[including coronary artery bypass graft (CABG) surgery\]; currently receiving warfarin, active bleeding
4. Impaired hemostasis: known International Normalized Ratio (INR) \>1.5 at screening; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count \<100,000/µL) at screening
5. Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization
6. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
7. Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding randomization
8. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours \[applicable to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients\]
Tiotropium + Procaterol vs Tiotropium + Placebo in COPD Patients

Study compares the efficacy and safety of tiotropium + a beta agonist (procaterol) vs. tiotropium alone among patients with moderate chronic obstructive pulmonary disease

This study aims to determine the efficacy and safety of tiotropium plus procaterol in comparison to tiotropium plus placebo in Filipino patients seen in Manila, with moderate COPD.

After a 1-week wash-out period, 6-minute walk test, and St. George's Respiratory Questionnaire (SGRQ) will then be administered prior to a run-in period of 1 week wherein all patients will be started on tiotropium alone. The patients will then be randomly allocated to either of the two arms for a two-week treatment, followed by one week washout, and crossed-over to the other treatment for another two weeks. The procaterol or placebo dose is given 2 hrs after the tiotropium dose.

Eligibility Criteria:
Inclusion Criteria:

1. GOLD criteria for moderate COPD (post-bronchodilator)

   * FEV1/FVC \< 70%
   * 50% ≤ FEV1 \< 80% predicted
   * With or without symptoms
2. Willing to undergo the treatment protocol with signed informed consent

Exclusion Criteria:

1. Exacerbation within 1 month prior to run-in period
2. Significant hypoxemia and/or desaturation at rest and during exercise.
3. Significant cardiac, renal, or other systemic disease
4. History of adverse reaction to any of the two test drugs (tiotropium and procaterol)
Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).


Eligibility Criteria:
Inclusion Criteria:

* Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is not due to malignant cancer.
* Taking oral, transdermal, intravenous, or subcutaneous opioids.
* Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.

Exclusion Criteria:

* History of chronic constipation before the initiation of opioid therapy.
* Other GI disorders known to affect bowel transit.
* Women who are pregnant, breast feeding, or plan to become pregnant.
The Right Heart During and After Pregnancy - an Echocardiographic Study

The main goal is to establish echocardiographic reference values of the right heart for pregnant women, assuming they differ significantly from those of non pregnant women of same age.

Therefore the investigators will use existing reference values published by American society of echocardiography and European Association of Echocardiography. As side arms the investigators want to explore, whether illness of either fetus or mother is connected with right heart affection.

A lot of lung diseases affect the heart, too - especially the right heart. Well known examples are pulmonary embolism or pulmonary hypertension. But rather unknown is the fact, that right heart function presents as a prognostic parameter in a lot of (left heart) diseases, for example myocardial infarction, atrial fibrillation, left heart failure, but also in chronic obstructive pulmonary disease (COPD) or may be even diabetes mellitus. Since the left part of the heart has been studied by researchers more than fifty years, the right heart has moved into scientific focus not long ago.

The tool of choice to examine the living heart is echocardiography. There are no relevant risks or complications.

During an echocardiographic examination a lot of parameters are collected. To judge data in a clinical way reference values belonging to healthy persons are essential. Those values are highly dependant on sex, body size, age etc.

Since pregnancy changes a lot in the human body, reference values from non pregnant woman of same age (published by American society of echocardiography and European Association of Echocardiography) are presumably not representative. So the investigators want to establish echocardiographic reference values of the right heart for pregnant women. Therefore an echocardiographic examination will be applied within each trimester of pregnancy and after delivery. As side arms the investigators want to explore, whether illness of either fetus or mother is connected with right heart affection.

Eligibility Criteria:
Inclusion Criteria:

* pregnant
* 18years or older

Exclusion Criteria:

* acute illness demanding instant therapy
* poor or none sonographic results
Effect of Evidence-Based Eye Care Protocol in Intensive Care Units

In intensive care patients, normal eye protection mechanisms such as tear production, blinking and keeping the eyes closed are impaired.

If eye-related complications are not diagnosed and treated in time, they can cause microbial keratitis and vision loss. This study was planned as a randomized controlled experimental study to examine the effect of using an evidence-based protocol on eye care on ophthalmologic complications. Patients who meet the inclusion criteria will be randomized, and one eye of the patients will be assigned to the intervention group (experimental group) and the other to the control group. When the study reaches 40 patients, G\*Power analysis will be applied and the sample size will be decided according to the result.


Eligibility Criteria:
Inclusion Criteria:

* Patients connected to mechanical ventilator,
* Newly intubated patients,
* Patients who have not been diagnosed with keratopathy and keratoconjunctivitis as of hospitalization,
* Patients who have not been diagnosed with burns and facial injuries,
* Patients without chronic lagophthalmos and eye trauma before ICU admission

Exclusion Criteria:

* Patients who have received topical drug therapy other than ocular lubrication
* Patients with muscle weakness as a result of cranial nerve VII (facial) nerve palsy
* Patients with chronic lagophthalmos and eye infections
* Those with rheumatological diseases
* Those with neurological/neuropathic disease that will affect eye closure
Improving Engagement in HIV and Cancer Care in Zimbabwe

In Zimbabwe, people who have cancer and HIV may have a difficult time staying engaged in their HIV care while they are being treated for cancer. This is because HIV and cancer care are usually provided at different health facilities, which can result in barriers to accessing clinical care for both HIV and cancer at the same time. It is important to remain engaged in HIV care, and continue taking medication to treat HIV throughout cancer treatment. The goal of this project is to identify barriers that make it difficult to stay engaged in HIV care and continue HIV treatment during cancer treatment and develop strategies to address them. We will accomplish this by first observing a group of 150 people with cancer and HIV who are receiving cancer treatment at Parirenyatwa Hospital, in Harare, Zimbabwe. We will measure barriers to accessing HIV care, and disruptions to HIV care engagement during cancer treatment. Next, we will work with experts and key stakeholders to develop strategies that can be put in place at Parirenyatwa Hospital to better support engagement in HIV care during cancer treatment. We will work with the cancer ward at the hospital to implement these strategies. Finally, we will observe a second group of 150 people with cancer and HIV, who begin their cancer treatment at Parirenyatwa Hospital after the strategies have been put in place. We will measure acceptability of these strategies to both patients and hospital staff. We will also measure barriers to accessing HIV care and disruptions to HIV care engagement in the second group. We will compare barriers to HIV care and HIV care engagement in the second group to the first group, to determine whether the strategies make it easier for people with cancer and HIV to remain engaged in HIV care during cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Registered patient at Parirenyatwa Hospital Radiotherapy Centre, receiving cancer treatment for a new diagnosis
* HIV-positive

Exclusion Criteria:

* Benign diagnosis or cancer recurrence
The Effects of Gyngerlean Supplementation on Energy Expenditure

The goal of this randomized controlled study is to asses the effects of a ginger containing supplement on energy expenditure and substrate utilization in healthy men. The main questions it aims to answer are"

* The effects of Kaempferia parviflora extract on energy expenditure
* The effects of Kaempferia parviflora extract on substrate utilization


Eligibility Criteria:
Inclusion Criteria:

* Active adults. Active is defined as exercising 3 or more times a week for 30 minutes.

Exclusion Criteria:

* Participants must not be diabetics, have Celiac disease, or individuals with pre-existing heart or kidney disease.
LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes

Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes


Eligibility Criteria:
Inclusion Criteria:

* Non-ST segment elevation ACS and ST segment elevation ACS who receive optimal reperfusion therapy

Exclusion Criteria:

* Previous Q-wave infarct within the last 4 weeks
* CK elevation not caused by myocardial injury
* uncontrolled hypertension at time of randomization
Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest

In this clinical study, a total of 1500 patients with out-of-hospital cardiac arrest in Seattle/King County will be enrolled. This will be a randomized clinical trial and patients will receive either two different doses of IV sodium nitrite (45 mg or 60 mg) or placebo during resuscitation in the field by paramedics. The primary outcome will be proportion of patients surviving to hospital admission.

The hemodynamic effects of the optimal dose of IV nitrite administered in patients with cardiac arrest are unknown. A significant negative hemodynamic effect from nitrite would decrease the proportion of patients admitted to the hospital, increase rate of re-arrest, or increase the need for vasopressor support in the field. In Seattle/King County, typically 40% of out-of-hospital cardiac arrest patients attended to by paramedics have Return of spontaneous circulation (ROSC) and are admitted to the hospital. In this study, 1500 patients with out-of-hospital cardiac arrest who are undergoing resuscitation by paramedics will be randomized to receive placebo (n=500) or 45 mg IV (n=500) or 60 mg dose (n=500) of sodium nitrite. The study will have 80% power to detect an absolute increase in hospital admission rate of 8% (1-sided .05 level test for each of the two comparisons (45 mg vs placebo and 60 mg vs placebo, no adjustment for multiple comparisons), with a hospital admission rate of 40% in the placebo group and with one interim analysis and stopping only for potential futility and/or harm). The investigators will examine the proportion of patients who survive to discharge as a secondary measure of efficacy.

Patients will be eligible for this study if:

1. Intravenous access (IV)/intraosseous access(IO)
2. Cardiac arrest, either Ventricular Fibrillation (VF) or non-VF patients receiving Advanced Cardiac Life Support (ACLS) by Seattle/King County paramedics.
3. Age 18 years or older
4. Comatose

Exclusion Criteria

1. Traumatic cause of cardiac arrest
2. Prisoner, pregnancy, age less than 18 (special population/vulnerable population)
3. Known DNAR
4. Drowning as cause of arrest.

Eligibility Criteria:
Inclusion Criteria:

* Cardiac arrest, either VF or non-VF, patients receiving ACLS by paramedics
* IV or IO access
* Comatose

Exclusion Criteria:

* traumatic cause of cardiac arrest
* prisoner, pregnancy
* known DNAR
Diagnostic Performance of Two Tools

Developing new tools for early detection of AKI in open-heart surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing on-pump coronary artery bypass graft (CABG) surgery of both sexes

Exclusion Criteria:

* Age less than 18 years old and more than 80 years old. Patients with (CKD), chronic liver disease, heart failure, and not on diuretics or other medications that may affect renal function.
Traditional Indigenous Foods Diet and Health Study

The purpose of this research is to determine whether eating a diet made up of Traditional Indigenous Foods from the Northern Great Plains area will spontaneously result in an increase in physical activity by American Indians, and whether the diet improves metabolic measures of health, mood and self-regulation of healthy eating and engaging in physical activity.

The primary aim of the current study is to determine whether consuming a healthier more Traditional Indigenous Foods diet produces non-targeted simultaneous changes in physical activity of American Indians. Coaction or dual behavior change refers to a spontaneous change in a nontargeted behavior when producing a change in a targeted behavior. A benefit of coactivation is that two healthy behaviors change when targeting just one. Physical activity was chosen as a primary non-targeted behavior because American Indians and Alaska Natives are 34% more likely to report physical inactivity than non-Hispanic Whites. Physical inactivity and sedentary behavior have negative health consequences. Chronic health conditions such as obesity, cardiovascular disease, Type 2 diabetes, and mental health disorders are more prevalent in people who are physically inactive and/or engage in greater sedentary behavior. A unique aspect of the proposed research is that it will develop a traditional indigenous foods diet based on historical research of several tribes (Mandan, Hidatsa, and Arikara (MHA) Nation, Lakota Sioux, Western and Eastern Dakota Sioux, Ojibwa, and Chippewa tribes) that lived in the Northern Great Plains. The nutrient content of the diet will be based on the 2020 Dietary Guidelines for Americans (DGA) Healthy U.S.-Style Dietary Pattern. However, because bovine dairy is not native to the U.S., alternative foods will be used to ensure adequate intake of the nutrients commonly provided by the dairy food groups. Calcium concentration of participants will be carefully monitored. This study will use a personalized trial approach that focuses on understanding individual responses of American Indians living with a heritage from the Northern Great Plains to a Traditional Indigenous Foods diet on behavioral, psychological, and clinical biochemistry outcomes.

Eligibility Criteria:
Inclusion Criteria:

* American Indian
* Body mass index (BMI) of 18.5-42.0 kg/m2

Exclusion Criteria:

* Health condition that impairs mobility or ability to safely be physically active
* Fasting Blood glucose ≥ 126 mg/dl
* Currently taking anti-inflammatory medications
* Pregnant, breast feeding or lactating
* Currently on a regulated diet
* Currently exercising for 60 minutes or longer greater than 2 times per week
* Allergic to any of the study foods shown in the menu and list of ingredients
* Strong aversion to any of the study foods
* Taking one of the following medications: blood thinning drugs, insulin, biologics, chemotherapy or on immune suppressant medications, and those who have started a new hyperglycemic, hypercholesterolemia, anti-depressant, anti-anxiety, or anti-psychotic medication(s) in the last two months.