cyrilzakka/clinical-trials huggingface dataset:
Cold Pressor Test is Used in This Study to Assess the Effect of PF-06305591 on Pain Intensity Evoked by Cold in Healthy Male Subjects

This study will evaluate the pharmacological activity of PF-06305591 in healthy male volunteers by assessing the effects of two dose levels of PF-06305591 on cold pain intensity evoked by keeping non-dominant hand into a water bath kept at 2+/- degrees.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
* Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Subjects unable to tolerate pre-study Cpressor testing at screening.
* Subjects with an average pain (AUC 0 to 120 sec) in the pre-study Cpressor test of less than or equal to 20.
* Broken skin on hands or forearms
Rivaroxaban Monotherapy After CYP2C19 Genotype Testing in Patients With Atrial Fibrillation and Percutaneous Coronary Intervention

Rationale: Patients with atrial fibrillation who undergo percutaneous coronary intervention for coronary artery disease are treated with antiplatelet therapy on top of a non-vitamin K oral anticoagulant. Inevitably, this is associated with a higher risk of (major) bleeding. Given the reduction of ischemic risk with low-dose rivaroxaban and advances in stent properties, implantation techniques, and post-PCI management, it may be possible to treat atrial fibrillation patients after percutaneous coronary intervention with full-dose rivaroxaban and without antiplatelet therapy.

Objective: This study will serve as a pilot to investigate the feasibility and safety of rivaroxaban monotherapy in 50 patients with atrial fibrillation after percutaneous coronary intervention.

Study design: Single-centre, single arm pilot study with a stopping rule based on the occurrence of definite stent thrombosis Study population: Patients with atrial fibrillation and an indication for a non-vitamin K oral anticoagulant who undergo optimal percutaneous coronary intervention Intervention: Rivaroxaban 20 mg once daily or 15 mg once daily, in case of moderate-to-severe kidney dysfunction, for 6 or 12 months without antiplatelet therapy Main study endpoint: The primary ischemic endpoint is the composite of all-cause death, myocardial infarction, definite stent thrombosis, and ischemic stroke at 6 months after percutaneous coronary intervention. The primary bleeding endpoint is the composite of International Society on Thrombosis and Haemostasis defined major and clinically relevant non-major bleeding at 6 months after percutaneous coronary intevention.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Successful PCI
* History of or newly diagnosed (\<72 hours after PCI/ACS) AF or atrial flutter with a long-term (≥ 1 year) indication for OAC
* Treatment with a loading dose of clopidogrel and aspirin prior to or during PCI

Exclusion Criteria:

* Known allergy or contraindication for rivaroxaban
* Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism)
* Overwriting indication for DAPT (e.g. TIA/CVA or PAD)
* Mechanical heart valve prosthesis
* Moderate to severe mitral valve stenosis (AVA ≤1.5 cm2)
* Intracardiac thrombus or apical aneurysm requiring OAC
* Kidney failure (eGFR \<15)
* Active liver disease (ALT, ASP, AP \>3x ULN or active hepatitis A, B or C)
* Active malignancy excluding non-melanoma skin cancer
* Active bleeding on randomization
* Severe anaemia requiring blood transfusion
* Pregnancy or breast-feeding women
* Planned high-bleeding risk surgical intervention within 6 months after PCI for stable CAD and 12 months after PCI for ACS
* PCI of left main disease, chronic total occlusion, bifurcation lesion requiring two-stent treatment, saphenous or arterial graft lesion, severely calcified lesions
* Participation in another trial with an investigational drug or device (i.e. stent)
Peripheral Extreme Revascularization in "No-option" Patiens With Chronic Limb Threatening Ischemia

The objective of the study is to evaluate early safety and effectiveness of the percutaneous deep foot venous arterialization performed in clinical practice, in an unselected population of patients with "no-option" CLTI.

Critical lower Limb Threatening Ischemia is the most advanced stage of lower limb arterial disease and is associated with a high risk of mortality and major amputation.Literature data indicate that about 5-10% of patients with peripheral arterial disease have a risk of developing CLTI, therefore the most advanced stage of arterial disease of the lower limbs, within 5 years and have a mortality of 20% at 6 months after diagnosis of CLTI.Despite the continuous improvement of the techniques and materials used in the revascularization of these patients, the data of the Literature show that in about 10-15% of these patients revascularization is impossible or ineffective. This condition is defined as: "no-option" CLTI.Therefore, for patients with "no-option" CLTI an alternative treatment for limb rescue may be considered the use of arterialization of the venous plexus of the foot; that is, to use to bring the arterial flow to the foot a healthy conduit, such as the vein, instead of the diseased artery and no longer usable.

The present study is designed as a multicentre, prospective, single-arm, observational study.

All eligible subjects for undergoing PiPER procedure at sites participating in the study will be considered for enrolment and will be asked to give consent prior to participating.

Subjects will be considered enrolled in the study at the time written informed consent is given to the use of their personal data. Once patients are enrolled, their demographics, medical history, disease-relevant conditions, treatment details and outcomes will be collected for up to 24 months from the procedure.

The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.

The revascularization procedure will be performed as per the current clinical practice.

After discharge all patients will attend clinic visits at 30 days (±7 days), 6 months (±14 days),12 months (±30 days), 24 months (±30 days).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patient has signed an approved informed consent form
* All patients, with non-revascularizable critical lower limb ischemia defined on the basis of 2 previous unsuccessful Percutaneous Transluminal Angioplasty (PTA) attempts or on severe Medial Artery Calcification (MAC)/Small Artery Disease (SAD) stage.
* Patient with Critical Limb Ischaemia, Rutherford category, 5 (minor tissue loss) or 6 (major tissue loss) with active trophic lesions
* Ejection Fraction \> 30%

Exclusion Criteria:

* Subject no able to perform the follow up or other factors making clinical follow-up difficult
* Patients with critical ischaemia of the lower limbs revascularizable by bypass or angioplasty, critical ischaemia characterised by rest pain (Rutherford class ≤ 4)
* Ejection Fraction \< 30%
Treatment of Venous Thromboembolism in Real-Life Patients

In a population of patients with venous thromboembolism and treated with oral anticoagulants (OAC) in routine clinical practice in Denmark this study will describe patients treated with each OAC


Eligibility Criteria:
Inclusion Criteria:

1. All patients ≥ 18 years diagnosed with incident VTE at Danish public hospitals from 2006 through 2015
2. First-time (index) VTE will be defined as an in- or out-patient diagnosis of DVT or PE among patients redeeming a prescription for anticoagulant drugs within 30 days after index date

Exclusion Criteria:

1. In the analyses on type and duration of anticoagulant use, Patients with cancer will be excluded as they typically receive low molecular heparin directly from the hospital and their use of anticoagulants can therefore not be captured by redeemed prescriptions at pharmacies.
Racial Differences in Phosphorus Metabolism

The investigators aim to study potential racial differences in renal phosphorus handling by provocatively testing urinary phosphorus excretion using parathyroid hormone infusions in healthy white volunteers compared to healthy black volunteers.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Body mass index (BMI) within 20% ideal for their age and gender

Exclusion Criteria:

* Abnormal urinalysis
* Pregnancy or breast-feeding
* Medical conditions impacting phosphorus metabolism-primary hyperparathyroidism; diabetes mellitus; gastrointestinal malabsorption disorders; hyper- or hypothyroidism
* Medications known to affect phosphorus metabolism- current use of phosphorus supplements, phosphorus binders, calcitriol or calcitriol analogues, regular antacid or laxative use, calcitonin, etidronate, anticonvulsants
* Hyper- or hypophosphatemia (≥ 4.6 mg/dl or ≤ 2.5 mg/dl respectively), hyper- or hypocalcemia (≥ 10.6 or ≤ 8.5 mg/dl respectively), or severe anemia (Hgb \< 8 g/dl for women and \< 9 g/dl for men)
Effects Of Breath And Stacking-Spirometry Incentive in Patients With Parkinson's Disease

Objective: To evaluate the effects of technical-Breath Stacking (BS) and incentive spirometry (IS) on the volume of the chest immediately after and within thirty minutes after the techniques in patients with Parkinson's disease (PD). Methods: This is a study of cross-over. The study investigated 14 patients with mild to moderate PD. The subjects performed the technique Breath-Stacking, incentive spirometry volume and participated in a phase control according to randomization. The volunteers were evaluated by opto-electronic plethysmography in four stages: before, immediately after fifteen and thirty minutes after the completion of the techniques. The investigators used a repeated measures ANOVA with post-hoc Tukey test for parametric variables, and the Friedman test with post-hoc Dunns for nonparametric variables. The level of significance was set at 5%, p \<0.05.


Eligibility Criteria:
Inclusion Criteria:

* Regular pharmacological treatment with levodopa and / or medications antiparkinsonian.

Exclusion Criteria:

* Patients who had previous lung disease;
* Altered mental status indicated by the MMSE (Mini Mental State Examination;
* A change in medication during the study;
* Demonstrated inability to perform satisfactorily any of the collection procedures of the study.
Steroids in the Maintenance of Remission of Proliferative Lupus Nephritis

There is debate as to whether long-term low-dose steroids such as prednisolone help to suppress relapses of systemic lupus erythematosus (SLE) in patients who are in remission from their lupus nephritis. If low-dose prednisolone reduces relapses, these beneficial effects may be counter-balanced by the long-term side-effects associated with prednisolone. This pilot study will determine the feasibility of conducting a larger randomized control trial that will answer the question of whether or not long-term low-dose prednisolone (5 - 7.5 mg/day) reduces the flares of SLE in patients with previous lupus nephritis.


Eligibility Criteria:
Inclusion Criteria:

* age at least 18 years
* diagnosis of SLE by ACR criteria
* diagnosis of proliferative lupus nephritis (ISN/RPS class III or IV)
* currently on prednisolone (5 to 20 mg/day)
* in partial or complete remission for at least 3 months

Exclusion Criteria:

* currently pregnant
* in end-stage renal failure
* receiving corticosteroids for an indication other than lupus nephritis
The Effects of Exercise on Some Biochemical Parameters in Patients With Rheumatoid Arthritis

Background: RA may progress with articular and non-articular involvement.Depression prevelance is found to increase for RA patients according to healthy population and to be correlated with pain, decreased quality of life, fatigue and physical disability.BDNF level was found significantly lower in RA patients with depression. Aim of this study is to investigate the variation of BDNF, VEGF, TNF- α, IL-6, IL-1β, irisin and α- Klotho levels following acute exercise.

Methods: This study included 45 RA patients and 45 age and sex matched healthy controls. Blood samples from all subjects were taken and centrifuged before and immediately after the exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients who were aged between 18-65 years,
* Patients who got diagnosed according to American College of Rheumatology criteria
* Patients who were being followed at Firat University Department of Rheumatology

Exclusion Criteria:

* Patients who had regular exercise habits, malignancy, pregnancy, incorporation,
* Patients who took anti-TNF treatment
* Patients who had changes of medical treatment in last 3 months
* Patients who diagnosed with Fibromyalgia Syndrome and Osteoarthritis for lower extremity
* Patients who had cardiac symptoms according to New York Heart Association
* Patients who had dysfunction that can prevent physical activity
Development Of A Rapid Diagnostic Test To Identify Crimean-Congo Haemorrhagic Fever At The Point-Of-Care

The goal of this medical device diagnostic evaluation study is to determine if this novel lateral flow device can detect Crimean-Congo Hemorrhagic Fever (CCHF) at the point of care in secondary health care clinics in Turkey. The main outcome is to determine the sensitivity and specificity of the tests for CCHF in samples of whole blood, serum and capillary blood compared to a gold-standard of PCR for participants that present at 4 endemic sites secondary health care clinics in Turkey in 492 adults who are suspected to have been infected with CCHF. The study aims to hopes to achieve at least the minimum required sensitivity of 90 % and specificity of 80 % as required by the WHO.


Eligibility Criteria:
Inclusion Criteria:

Participants aged 18 years or older Suspected CCHF infection that requires a RT-PCR diagnosis and venous blood draw Willingness to comply with study procedures and consent to the study Presents at 1 of 4 listed sites

Exclusion Criteria:

* In the investigators opinion should not be enrolled onto study (e.g., medical prudence or capacity)
Better Sleep Study

The overall aim of this proposal is a confirmatory efficacy trial sufficiently powered and designed to test the hypothesis that improving the relationship between biological circadian timing and waketime, a novel modifiable target, improves depression outcomes in a subgroup of adolescents with depression and a misaligned relationship between biological circadian timing and waketime utilizing a cognitive-behavioral sleep intervention.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

* mental health/behavioral symptoms that would preclude productive engagement in study assessments or intervention (e.g., active psychosis; Bipolar Disorder; drug dependence
* severe or unstable medical or psychiatric condition such that treatment has changed within the last month or is expected to change during the course of the study or that would preclude ability to adhere to study procedures (e.g. terminal end-stage cancer)
* current use of medications or herbs with known effects on sleep
* plan to undergo or have had medication change in the last 8 weeks
Effects of Early Community Services on Child and Family Development

The purpose of the current study is to evaluate the effects on early child development of early community services, including a brief nurse home visiting program. Investigators hypothesize that nurse home visiting program participants will be significantly different than non- nurse home visiting program participants on the following child and family outcomes: (a) (reduced) infant emergency room use and overnight hospital stays; (b) (increased) family use of community resources and (higher quality) child care; (c) (increased) maternal wellbeing; and (d) (increased) quality of the home environment, including home safety and supportive parenting by both parents. The study will also explore long-term differences between the nurse home visiting program recipients and non-recipients in (a) rates of official investigations for child maltreatment and (b) two indicators of early educational achievement: kindergarten readiness scores and rates of kindergarten attendance.

The purpose of the current study is to evaluate the effects on child and family development of early community services, including a brief nurse home visiting program. The proposed study will be conducted in partnership with the brief nurse home visiting program and Sinai Hospital, both located in Baltimore, MD. For the purposes of this study, Sinai Hospital will serve as the community/catchment area. Nurse home visitors enroll new mothers into the nurse home visiting program while they are still in the hospital/maternity ward. When the current study officially begins, nurse home visitors will recruit new mothers into the nurse home visiting program every other day only (on odd dates). Research staff will recruit all Baltimore City residents who give birth at Sinai Hospital, regardless of odd/even birth date, while they are still in the hospital/maternity ward.

Eligibility Criteria:
Inclusion Criteria:

* Mother and Infant are Baltimore City Residents
* Mother gave birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019
* Mother speaks English

Exclusion Criteria:

* Mother and Infant are not Baltimore City Residents
* Mother did not give birth to infant at Sinai Hospital in Baltimore, MD beginning approximately July 15, 2019
* Mother does not speak English
Improving Diabetes Care:Effectiveness of Physician Profiling and Care Coordination by a Diabetes Resource Nurse

The purpose of this study is to test the effectiveness of physician profiling and care coordination by a diabetes resource nurse in improving the quality of diabetes care.

HealthTexas Provider Network primary care practices with at least 10 Medicare diabetes patients over the age of 65 were randomized to one of 3 intervention arms: physician feedback of process measures using Medicare claims data ("Claims"); feedback of Medicare claims data plus clinical measures from medical record abstraction ("Claims+MR"); or both types of feedback plus a practice-based DRN ("DRN"). For the 12 months prior to the intervention and 12 months post-intervention, performance data on diabetes related processes of care (annual HbA1c testing, annual LDL cholesterol screening, annual hypertension screening, annual eye, foot, and renal assessment) and patient outcomes (HbA1c level, LDL cholesterol level, blood pressure) were collected from medical record abstraction and Medicare claims data. Pre-post change scores will be compared between intervention arms to examine effectiveness of physician profiling and care coordination by a diabetes resource nurse.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 65 years on January 1, 2000
* diagnosis of diabetes mellitus
* diabetes related visit to HTPN physician within the past year
* Resident of Texas
* Medicare insurance coverage

Exclusion Criteria:

* Patient chart not available for abstraction
Vascular Interaction With Age in Myocardial Infarction

The body produces a natural compound, nitric oxide (NO), which is known to improve the elasticity of blood vessels effect cardiac function and play a role in the remodeling process after a heart attack. The primary source of NO is one of the amino acids that the body uses to form new proteins, L-Arginine; although many individuals with heart disease also take medicines to increase the concentrations of NO such as nitroglycerine. The VINTAGE-MI trial is intended to investigate wether supplementation of the bodies supply of NO with oral administration of L-Arginine will improve the functional recovery of older patients who have recently suffered their first heart attack.

BACKGROUND:

As we age, both our blood vessels and heart muscle naturally become stiff and loose their ability to flex as the heart beats and blood pressure changes. This is believed to worsen both blood vessel and cardiac function in older individuals. The stiffened tissue is likely to be less able to adapt to the stresses and remodeling that occur after a heart attack (myocardial infarction) because the loss of functional heart tissue predisposes the heart to poor function and the hearts blood vessels undergo various changes in order to increase the supply of blood to the damaged areas.

DESIGN NARRATIVE:

VINTAGE-MI is a randomized, double blind study enrolling patients who have recently suffered their first heart attack. There are two recruitment clinics within the Johns Hopkins University Network, the Johns Hopkins Hospital and the Hopkins Bayview Medical Center. Following preliminary testing to establish eligibility and baseline function of both the heart and blood vessels, study participants will be randomly assigned to receive either L-Arginine or a placebo pill which is identical except that it does not contain L-Arginine. These pills will be taken orally 3 times a day for 6 months. Participants will return to the clinic 1, 3, and 6 months after they begin taking their medication to have the same functional testing repeated.

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:
Patients will have suffered their first acute Q-wave MI within 3 to 21 days with creatine kinase levels 3 times normal. All patients will have systolic blood pressure over 100 mmHg and the permission of their attending physician and the ability to give voluntary informed consent. Patients will be excluded if they have had a prior Q-wave infarction, present cardiogenic shock, unstable angina or non-cardiac disease limiting life expectancy to less than 1 year. Other exclusion criteria include significant kidney or liver disease, uncontrolled diabetes, or symptomatic cerebrovascular disease (such as stroke). Patients who have been previously shown to be non-compliant will be asked not to participate.