cyrilzakka/clinical-trials huggingface dataset:
Honolulu Heart Program-Study of Stroke and Dementia

To clarify the relationship of the arterial lesions to aging, define the influence of the arterial changes on the development of stroke, brain infarction, and dementia, and provide a better understanding of vascular dementia.

BACKGROUND:

Morphologic delineation of the arterial lesions will assist the use of experimental models to study molecular mechanisms underlying the lesions and the development of pharmacologic methods for controlling these mechanisms. Further examination of risk factors for the arterial lesions will indicate opportunities for prevention or modifying their evolution.

DESIGN NARRATIVE:

The study was based on data including risk factors and autopsy brain sections from deceased men from the Honolulu Heart Program. In this cohort, medial and intimal lesions of brain parenchymal arteries were significantly associated with brain infarction and three times more common in men dying of stroke than of non-cardiovascular causes. The specific aims of the study were 1) delineation of the morphologic characteristics of the brain parenchymal artery lesions, their regional anatomic distribution, and their relationship to changes in adjacent brain parenchyma and the degree of atherosclerosis in the major intracranial arteries; 2) characterization of the relationship in men between the arterial lesions and advancing age; 3) characterization in men over 60-65 years of age of the relationship of the arterial lesions to stroke, brain infarction or hemorrhage, and dementia; 4) identification of additional risk factors associated with the arterial lesions. The arterial lesions and adjacent brain parenchyma were examined with conventional histologic stains and immunohistochemical markers for specific cellular and extracellular components of the arterial wall. The prevalence and extent of each type of arterial lesion were determined at three anatomic sites. Baseline risk factors thought to be related to stroke and brain infarction were examined for association with the arterial lesions. Statistical tests of association were based on univariate and multivariate linear and logistic regression models controlled, when necessary, for age.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Evaluation of the DPP HIV 1/2 Test and the HIV 1/2 Stat Pak Test Using Oral Fluid

This protocol is intended to test the feasibility of using the HIV 1/2 STAT-PAK and the DPP HIV 1/2 test (with and without the DPP Handheld Reader) to detect HIV antibodies in oral fluids.

The objective of this study is to evaluate the feasibility of using fresh oral fluid specimens, from known HIV-positive individuals, to test for HIV-1 antibodies using both the DPP HIV 1/2 and HIV 1/2 STAT-PAK tests. Two oral fluid collection devices will be used and compared (MPC and Chembio collection devices) and the results obtained from oral fluids will be compared with those obtained from whole blood and plasma using paired samples from the same participants. The comparison between oral fluid, whole blood and plasma will be made in both Chembio devices (HIV 1/2 STAT-PAK and DPP HIV 1/2).

Eligibility Criteria:
Inclusion Criteria:

* Participants with known HIV infection who are willing to participate in the study and who sign an informed consent (or assent), will be included in the study.
* Patients on HAART treatment for HIV will be included, but this information as well as the dates (duration) of treatment will be obtained through the interview of study participants; a medical record review is not necessary or required. The study participant's responses will be recorded by study staff on a Data Collection Form.
* Patients with immunosuppressive conditions other than HIV will be included if available, but will be limited to \< 25% of the total test population. Immunosuppression will also be assessed through interview of study participants and/or through verbal confirmation by the treating physician; a medical record/chart review is not required.
* Patients must be willing to undergo venipuncture to donate one tube of EDTA whole blood (not more than 10cc), and to provide three oral fluid samples.

Exclusion Criteria:

* Patients who do not consent, withdraw consent, or for whom the investigator determines that venipuncture or gum swabbing may create a health risk will be excluded from the study.
* Participants who have been enrolled in HIV vaccine studies will be excluded from the study. This will be ascertained through interview of study participants.
* Participants who have been enrolled once in this study will be excluded from repeat enrollment.
* Participants must not have introduced any substance into their oral cavity (gum, food, beverage, candy, lozenges, mouthwash, etc.) for 30 minutes prior to providing an oral fluid sample. This will be ascertained through interview of study participants.
The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency

The trial was designed in a single dose, open, non-randomized, multi-dose parallel control group. The study of patients were mild and moderate renal insufficiency, and matched healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 (including 18 and 75 years old), both male and female;
2. Weight: male ≥ 50 kg, female ≥ 45 kg; BMI in the range of 18 to 30 kg/m2 (including 18 and 30 kg/m2);
3. During screening, the glomerular filtration rate (GFR) met the staging criteria of renal insufficiency or normal renal function in the corresponding group;
4. The subjects can communicate well with the researchers, fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent.
5. During screening, the investigators judged that the kidney disease of the subjects was stable from 4 weeks before screening to the end of the study, and GFR did not change significantly;
6. Patients who had not taken or were on stable medication for renal insufficiency and/or other comorbiditions during the 4 weeks prior to screening and agreed to continue treatment during the study period;
7. Patients with diabetes who have not used hypoglycemic drugs in the 4 weeks prior to screening, or who are receiving stable antidiabetic therapy (including lifestyle interventions, use of stable doses of drugs, except for prohibited drugs described in the trial protocol) and agree to continue treatment during the study period.

Exclusion Criteria:

1. People who are known to be allergic to DPP-4 inhibitors or drug excipients in this study;
2. Previous medication history:

   1. Use of DPP-4 enzyme inhibitors or similar within 2 weeks prior to screening;
   2. Inhibitors or inducers of the CYP 2D6 enzyme used within 30 days prior to screening or required during the trial;
3. Vaccination within 4 weeks prior to screening;
4. Pregnant or lactating women; The subject and his or her spouse or partner have plans to become pregnant, or plan to donate sperm or eggs, or do not agree to an acceptable and effective method of contraception within 3 months of dosing;
5. Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, HIV antigen antibody composite test any item is positive。
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon

The purpose of this research study is to test the safety, tolerability, and effectiveness of Topical AmphiMatrix with Nitroglycerin (MQX-503) to relieve Raynaud's symptoms and increase blood flow to the fingers.

The purpose of this clinical study is to determine, in a controlled fashion, the ability of Topical AmphiMatrix formulation with Nitroglycerin (MQX-503) to improve the patient's health assessment as indicated by patient and physician assessments, decrease the frequency of Raynaud's events, decrease the duration of Raynaud's events, and decrease the symptoms (pain, tingling, numbness) in the fingers of Raynaud's patients. The study will include patients with moderate to severe primary Raynaud's phenomenon and with Raynaud's phenomenon secondary to autoimmune diseases such as scleroderma.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients, 18 years to 70 years.
* Patients with a clinical diagnosis of Raynaud's phenomenon.
* Patients who are willing to discontinue current vasodilator therapies.
* Patients who agree not to use any other investigational medications or approved therapies to treat Raynaud's phenomenon and its symptoms while participating in this study.
* Negative pregnancy test in fertile women.
* Patients who are able to give written informed consent and comply with all study requirements.

Exclusion Criteria:

* Patients who concurrently use any nitrate medication or medications known to interact with Nitroglycerin.
* Patients who concurrently use any medication or device which might interfere with the study medication.
* Patients who have a known allergy to Nitroglycerin or common topical gel ingredients.
* Patients with a history of headaches.
* Patients who have a history of an unstable medical problem.
* Patients with cognitive or language difficulties.
* Patients who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
* Patients who participated in a study of any investigational drug within four weeks prior to Visit 1.
* Patients who have screening laboratory values which are 20% or greater of the upper or lower limit of normal.
* Patients who have had major surgery within six months of Visit 1.
* Patients with interfering skin conditions.
* Pregnant or nursing women.
Evaluation of the Effect of Immune Modulating Enteral Nutrition Formula

The aim is to compare the efficacy and tolerability of an immune modulating enteral nutrition formula versus the regular formula on the outcomes of critically ill septic patients by assessment of clinical outcomes, immune profile, tolerability and enteral nutrition intolerance and laboratory markers

Nutritional formulas are considered important sources of the dietary components that the body requires. They contain the sources of fats, proteins and carbohydrates and compensate any vitamin and mineral deficiency.

There is a special type of formulas called the "immune-enhancing formulas", they supplement the body not only with the energy sources but also, they boost the body's immune system as they contain multiple types of amino and fatty acids.

There is an ongoing debate around the efficacy of the immune-enhancing formulas, some studies show that they make a significant difference in enhancing the clinical outcomes compared to traditional formulas while other studies showed no significant difference between the traditional formulas and immune-enhancing formula.

The immune-enhancing nutritional formula is used in enteral and oral feeding for critically ill patients. It's mainly indicated in cases of malnutrition, post surgeries and traumas and immunocompromised patients.

Its composition:

Composition in approximate %w/w Maltodextrin 42.44% Sodium caseinate 18.25% MCT oil 6.28% Arginine 5.21% Poly-dextrose 4.00% Corn oil 3.48% Glutamine 2.61% Fish oil 2.32% Minerals 1.96% Vitamins 0.86% Artificial flavor (vanilla)

This study analyzed prospectively the clinical and laboratory outcomes of critically ill sepsis patients taking regular enteral nutrition versus immune modulating formulas.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with sepsis according to guideline criteria AND
* Age ≥18 years

Exclusion Criteria:

* Gastrointestinal tract complications or intestinal failure or any contraindications to receive enteral nutrition
* Hemodynamic instability on admission
Care For The Cancer Caregiver: A Meaning-Based Workshop To Help Manage Caregiver Burden

The purpose of this study is to gather information on how easy it is to implement the workshop, as well as whether individuals find this workshop helpful. In this study, participants will be assigned at random to one of the two study groups. Based on the information we obtain, we hope to develop an easily accessible support service for caregivers.


Eligibility Criteria:
Inclusion Criteria:

* As per self report, a current caregiver to a patient with any site or stage of cancer
* Age 18 or over
* A score of \> 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role
* In the judgment of the investigators and/or consenting professional, able to comprehend English to complete study assessments
* Able to perform informed consent
* Enrollment is open to caregivers with their own current/past cancer histories

Exclusion Criteria:

* Significant psychiatric or cognitive disturbance sufficient, in the investigator's judgment, to preclude providing informed consent.
* As per self report, unable to access a computer with Internet or unable to use a computer with Internet provided by the study
* Participated in the development and refinement of the CCC Workshop (prospective exemption X14-006)
Effects of Manual Therapy on Autonomic Nervous System's Balance, Pain and Well-being in Patients With Fibromyalgia.

Scientific literature dealing with patients with fibromyalgia conveys they suffer from an abnormal response of the autonomic nervous sýstem, where a marked sympathetic hyperactivity and a decrease in heart rate variability are emphasized. It is important to know what manual therapy techniques may manage to decrease the sympathetic activity and balance the sympathetic-vagal tone, therefore improving pain and life quality.

This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.

Scientific literature dealing with patients with fibromyalgia conveys they suffer from an abnormal response of the autonomic nervous sýstem, where a marked sympathetic hyperactivity and a decrease in heart rate variability are emphasized. It is important to know what manual therapy techniques may manage to decrease the sympathetic activity and balance the sympathetic-vagal tone, therefore improving pain and life quality.

This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.

The authors expect a stronger decrease in the sympathetic nervous system activation; a greater reduction in pain, and a bigger improvement in well-being and anxiety in those patients treated with active mobilization of soft tissues than passive mobilization group.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatologic diagnosis of fibromyalgia, chronic fatigue labels, sleep disorders, recurrent cervical pain associated with fibromyalgia

Exclusion Criteria:

* Smokers, blood pressure superior to 160/100 mm/Hg, coronary artery disease, peripheral vascular disease, presence of Diabetes I or II, being pregnant, psychiatric disorder established, any trauma suffered in the last 6 months, diagnosis of osteoarthritis, consumption of caffeine, alcohol or other stimulating substance at least 24 hours before the experimental intervention, performing moderate-intense physical activity 2 hours before the experimental intervention.
Treatment of Psoriasis With Parathyroid Hormone

This is a clinical study in two phases. The first phase compares the effect of an ointment containing parathyroid hormone (PTH) with the effect of a placebo ointment (inactive ointment without PTH) on psoriasis lesions. Neither the study participants nor the researchers will know who is receiving PTH ointment and who is receiving placebo until the end of this first study phase. The second phase is a study of the PTH ointment on large areas of psoriasis to find out how long the effects last.

Patients with active plaque psoriasis will be withdrawn from systemic and topical medications. After washout, we will select active psoriatic lesions of at least 25 square cm in size to receive either placebo ointment or a proprietary ointment containing PTH for 8 weeks. We will see the patients every 2 weeks. We will evaluate the lesions by examination and digital photography at each visit and measure parameters of calcium metabolism periodically during the 8 weeks.

At the conclusion of the 8 weeks, we will obtain punch biopsies from the treated lesions and from one lesion without treatment. If the patients elect, we will transition them into an open label trial with the PTH ointment including up to 1000 square cm of psoriatic lesions and monitor them for duration of effect and changes in parameters of calcium metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Active plaque psoriasis at least 10 percent BSA (body surface area)
* Age 18-70

Exclusion Criteria:

* Abnormalities of calcium metabolism
Determining the Effect of Abacavir on Platelet Activation

HIV positive patients have a two fold increased risk of developing cardiovascular disease (such as heart attacks and strokes). Cardiovascular disease appears to be due in part to both HIV and the side effects from anti-HIV medications.

Abacavir (an important component of current HIV treatment regimens) is one medication shown to be associated with an increase the risk of heart attacks in some studies. The mechanism by which abacavir does this is unknown.

We hypothesise that abacavir is leading to heart disease by interacting with platelets, which then form blood clots within the arteries supplying the heart, the subsequent blockage of the artery causing a heart attack.

This study aims to determine if abacavir increases the activity (or "stickiness") of platelets, and thus provide evidence as to how it may be promoting heart attacks.

It will consist of 23 HIV positive men who currently have well controlled HIV. Participants will take abacavir for 15 days in addition to their usual anti-HIV medications. A blood sample to assess platelet activity will be taken at baseline, following the 15 days of therapy (i.e. at the time of maximal abacavir effect) and again after a 28 day washout period (to determine if any effects are reversible).


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Male
* HIV positive
* Stable non-abacavir containing anti-retroviral regimen
* Undetectable HIV Viral load

Exclusion Criteria:

* HLA-B\*57\*01 allele positivity
* Previous allergy to abacavir
* Known cardiovascular disease
* High Baseline cardiovascular risk (Framingham risk score \> 20%)
* Current or recent antiplatelet therapy
* Pre-existing platelet or bleeding disorder (i.e. Thrombophilia, Thrombocytopenia, Von willebrands disease, Haemophilia)
* Significant Chronic liver disease
* Current Methadone use
FIH Ph 1 Study of TRPC5 Channel Inhibitor GFB-887 in Healthy Subjects

The study will comprise primarily a single-ascending dose (SAD) escalation component.

Double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7 cohorts of healthy participants.

Eligibility Criteria:
Healthy Participant Cohorts - Key Inclusion Criteria:

1. Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
2. Body mass index between 18.0 and 32.0 kg/m\^2, inclusive, at Screening.
3. Systolic blood pressure of between 90 and 140 mmHg, diastolic blood pressure between 60 and 90 mmHg, and heart rate between 40 and 100 bpm at Screening.
4. Female participants will be post-menopausal or surgically sterile (as confirmed by medical history).
5. Male participants will agree to use contraception while on study drug and for at least 90 days after the final follow-up visit.
6. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
7. Participants must be in good health.

Healthy Participant Cohorts - Key Exclusion Criteria:

1. Females of childbearing potential.
2. Significant history or clinically significant manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
3. History of alcoholism or drug/chemical abuse within 2 years prior to (first) Check-in.
4. Use of tobacco or nicotine-containing products within 60 days prior to (first) dosing, or positive cotinine at Screening or Check-in.
Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives

The investigators are conducting a research study to understand how cells responsible for fighting infection (immune cells) are affected by hormonal contraceptive use. The investigators hypothesize that progestin-containing hormonal contraceptives (i.e., Depo-Provera) inhibit host response to infection. To test this hypothesis, the investigators will collect blood and genital tract samples from women before and after their initiation of a hormonal contraceptive (either birth control pills, Depo-Provera, or Mirena).


Eligibility Criteria:
Inclusion Criteria:

1. 15-25 years of age (inclusive)
2. History of regular menstrual cycle
3. Not pregnant
4. No plan to become pregnant in the next 3 months
5. Interested in beginning use of OC, DMPA, or LNG-IUD
6. Able to read and provide written informed consent (and consent from a parent/guardian if the participant is a minor)

Exclusion Criteria:

1. Anticipated move out of area that prevents return for a follow-up visit
2. Unavailability for follow-up visit
3. Less than 90 days post-partum or post-abortion
4. Sexually transmitted infection (STI) diagnosed less than 30 days prior to enrollment
5. Use of OC, contraceptive ring or patch, single rod implant, LNG-IUD, or copper-containing IUD less than 3 months prior to enrollment
6. DMPA injection less than 6 months prior to enrollment
7. History of immunosuppressive condition of current use of immunosuppressive medications
8. History of a cervical malignancy
9. Detection of cervical anatomic pathologic conditions that preclude cervical biopsy procurement
10. Intolerance or contradiction to use of OC, DMPA, or LNG-IUD