cyrilzakka/clinical-trials huggingface dataset:
Outcomes of Femoro-popliteal Disease After Stent Deployment Under Intravascular Ultrasound Guidance

This is a prospective, single-center study. The patients with peripheral arterial disease who underwent abdominal aortograms with runoff (which are arteriograms of the lower abdominal aorta and arteries in the legs) and Intravascular Ultrasound after stent deployment will be enrolled in the study. All patients who participated in the study will be treated according to standard of care.

HYPOTHESIS The higher degree of plaque burden on landing zone has an effect on restenosis on peripheral artery intervention.

SPECIFIC AIMS

1. To determine intravascular ultrasound parameters of stent deployment and outcomes of Femoro-popliteal Disease
2. To determine clinical risk factors and outcomes of Femoro-popliteal Disease
3. To obtain data that will eventually support development of a predictive model for ISR in Femoro-popliteal Disease

METHODOLOGY Visit 1: After consent is given

The subject will receive standard follow-up care. A member of the research team will collect information such as the subject's age, sex, ethnicity, and medical information from the subject's medical record.

Visits 2-5: 1 day after enrollment, and at months 3 (+- 2 weeks), 6 (+- 2 weeks), and 12 (+- 2 weeks)

The subject will complete standard follow-up appointment at TTUHSC. This may include a Doppler ultrasound.

A member of the research team will record information such as medications, ultrasounds, and need for additional care related to the subject's stent.

The subject will complete the questionnaire on leg pain and mobility.

SUBJECT POPULATION:

- The patients who have peripheral arterial disease and underwent elective abdominal aortograms with runoff with peripheral artery intervention in University Medical Center hospital, Lubbock Texas, during January 2014 to December 30, 2015.

INCLUSION CRITERIA:

* 25-89 years of age
* Admitted for elective abdominal aortograms with runoff.
* Underwent Angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease.
* Intravascular ultrasound was performed after stent deployment.

EXCLUSION CRITERIA:

* Patients who had prior Femoro-popliteal artery surgery or bypass in the same limb.
* Stent placement for lesions above inguinal ligament or below popliteal artery.
* The patient who presented with acute limb ischemia.
* Unable to follow-up in TTUHSC clinic.

Eligibility Criteria:
Inclusion Criteria:

* 25-89 years of age
* Admitted for elective abdominal aortograms with runoff.
* Underwent Angioplasty and/or atherectomy with stent placement for Femoro-popliteal disease.
* Intravascular ultrasound was performed after stent deployment.

Exclusion Criteria:

* Patients who had prior Femoro-popliteal artery surgery or bypass in the same limb.
* Stent placement for lesions above inguinal ligament or below popliteal artery.
* The patient who presented with acute limb ischemia.
* Unable to follow-up in TTUHSC clinic.
Safety and Efficacy of the SL PLUS and the SL PLUS MIA Hip Stem

Randomized controlled trial using two types of hip stems, SL PLUS MIA (control group) and SL PLUS (study group).

We compare primary and secondary stability of both hip stems for radiographic outcome using EBRA (Ein-Bild-Roentgen-Analyse) after a two year follow-up period.

Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings.

This study is a monocentric study, randomized and controlled including two types of hip stems: SL PLUS MIA (control group) and SL PLUS (study group).

Each group will include 45 patients where a number of 5 patients for each group calculated extra in case of loss.

Patients will be followed after

* 6 weeks
* 6 months
* 12 months
* 24 months. Radiographs are taken in a-p and lateral view using a standard protocol. Primary and secondary stability of both hip stems will be analyzed using the EBRA software (Ein-Bild-Roentgen-Analyse, University of Innsbruck, Austria) after the completion of the two year follow-up.

Further, we compare all differences in clinical outcome using Harris Hip Score, Oxford hip score and radiographic findings such as radiolucent lines.

Eligibility Criteria:
Inclusion Criteria:

* Patient needs primary total hip arthroplasty with SL-PLUS (standard or lateralized depending on bone morphology)
* Age at surgery : 18-80 years old
* Patient has social security number
* Patient gives Informed Consent (IC) by signing the IC form and patient is willing to attend the follow-up control

Exclusion Criteria:

* Patient's BMI is over 35
* Patient has bone tumors that can affect implant stability
* Patient needs cortical steroid treatment
* Patient needs hip revision arthroplasty
* Patient has general inflammation that could affect bone quality
* Patients classified Charnley C
Long-term Immunogenicity of a HPV Vaccine in SLE

To study the 5-year immunogenicity against a quadrivalent HPV vaccine in patients with SLE and healthy controls.

Most cases of human papilloma virus (HPV) infection are asymptomatic, transient and resolve without treatment. However, in some individuals, especially those patients who are immunocompromised because of various underlying diseases and those who are receiving long-term immunosuppressive agents, HPV infection is persistent and may result in genital warts, cervical smear abnormalities, cervical intraepithelial neoplasia (CIN) and rarely cervical cancer.

High-risk HPV serotypes are those which are oncogenic and associated with invasive cancers of the cervix and vulva. Examples are the HPV 16 and HPV 18. HPV 16 accounts for almost half of all cervical cancers whereas HPV 18 infection is present in 10-12% of all cervical cancers.

Systemic lupus erythematosus (SLE) patients are at risk of persistent HPV infection. This is because of the immune aberration related to the disease itself and the immunosuppressive state induced by various treatments. One study of 85 SLE patients revealed a 16.5% prevalence of abnormal Pap smears and 12% prevalence of cervical squamous intraepithelial neoplasia (CIN) on routine screening, which was significantly higher than those figures reported in age-matched healthy women (corresponding figures for abnormal Pap smear and CIN were 5.7% and 2%, respectively). Thus, prevention of HPV infection is important in patients with SLE in order to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run.

The investigators have conducted a case-control study on the safety and immunogenicity of the quadrivalent HPV vaccine, GARDASIL, in 2010. Fifty female SLE patients and 50 age-matched healthy controls were studied. At month 12 after vaccination, the sero-conversion rates of anti-HPV serotypes 6, 11, 16 and 18 in patients and controls were 82%, 89%, 95%, 76% and 98%, 98%, 98%, 80%, respectively. Injection site reaction was the commonest adverse event (AE) (5%), and the incidence of AEs was comparable between patients with SLE and controls.

The investigators plan to study the long-term immunogenicity (durability of the immune response) of the HPV vaccine in the same cohort of patients and controls followed for 5 years. In particular, in patients with SLE, the investigators would like to evaluate the effect of disease flares and ongoing immunosuppressive treatment on the immune response to the HPV serotypes 5 years after vaccination.

Eligibility Criteria:
Inclusion Criteria:

SLE patients

1. Female patients aged 18-35 years
2. Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE
3. Having participated in the investigators' original HPV study in 2010
4. Able to give written informed consent

Controls

1. Women aged 18-35 years, matched those of SLE patients recruited
2. No known chronic medical diseases
3. Having participated in our HPV study in 2010
Expanded Access Study of HBOC-201 (Hemopure) for the Treatment of Life-Threatening Anemia

The purpose of this expanded access study is to be able to provide treatment with HBOC-201 to patients with life-threatening anemia for whom blood is not an option.

HBOC-201 is not FDA approved for use in the United States, but is approved as an oxygen carrier in South Africa and Russia.

i. Initial Dose

For patients with a hemoglobin level less than 6 mg/dl, an initial dose of 32.5 g (one unit) of HBOC 201 is recommended, to be followed by infusion of additional units as necessary to achieve and maintain a total hemoglobin concentration above 6 g/dl, provided that the patient's circulatory volume is properly controlled and will not impose an inappropriate risk.

ii. Subsequent Doses

The need for additional dose administration should be assessed after each infusion as clinically indicated.

Dosing will be stopped if any one of the following occurs:

* resolution of critical ischemia
* death
* recovery of native Hemoglobin levels to \> 6 g/dL,
* evidence of reticulocytosis

Eligibility Criteria:
Inclusion Criteria:

1. Patients \> = 18 years of age
2. Patients with hemoglobin \< = 8g/dL with with active bleeding, physiologic evidence of critical ischemia, for example: elevated troponins, altered mental status, acute renal failure, lactic acidosis or central nervous system supply dependency
3. Patients or their Legally Authorized Representatives who are able and willing to provide informed consent

Exclusion Criteria:

1. Patients with known hypersensitivity or allergy to beef products
2. Patients with pre-existing uncontrolled hypertension, heart failure, renal failure, circulatory hypervolemia or systemic mastocytosis (on a case by case and quality of life determination)
3. Patients \> 80 years of age (on a case by case and quality of life determination)
4. Patients who are eligible for blood transfusions
A Study of the Safety and Efficacy of Anacetrapib (MK-0859) When Added to Ongoing Statin Therapy in Japanese Participants With Dyslipidemia (MK-0859-051 AM1)

This study will evaluate the effects of anacetrapib (MK-0859) on low-density lipoprotein-cholesterol (LDL-C) when compared to placebo in Japanese participants with dyslipidemia when added to an existing statin-modifying therapy.


Eligibility Criteria:
Inclusion Criteria:

* If female, cannot be of reproductive potential
* Treatment with an appropriate, stable dose of statin ± other lipid modifying therapy for at least 6 weeks and who is not at LDL-C goal per their category in the Japan Atherosclerosis Society guidelines

Exclusion Criteria:

* Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
* Homozygous and heterozygous familial hypercholesterolemia
* Severe chronic heart failure
* Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months
Effectiveness and Safety of Early Treatment With Infliximab for Hip Arthritis Associated With Ankylosing Spondylitis (AS) (P06451)

This trial is designed to measure improvement of hip involvement in patients with ankylosing spondylitis (AS) after receiving 4 doses of infliximab. Participants will receive infliximab 5 mg/kg (as an intravenous perfusion over a period of 2 hours) at Weeks 0, 2, 6, and 14, consistent with the approved dosing regimen described in the label. Participants will be evaluated for hip pain, functional capacity and stiffness before and after 14 weeks (4 doses) of treatment. Further treatment after 4 doses is based on standard clinical practice as determined by the trial site.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Ankylosing spondylitis (AS) diagnosis
* Have all 3 of the following:
* Presence of hip pain (nocturnal inflammatory pain)
* Limitation of hip mobility
* Patient's Global Assessment Visual Analog Scale (0-10 cm) ≥4 cm.
* Inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
* Eligible to be treated with Infliximab (Remicade®)

Exclusion Criteria:

* Causes of coaxalgia other than coxitis of AS, demonstrated by images or laboratory tests
* Women who are pregnant or nursing or plan to nurse or become pregnant
* Serious infections like sepsis, abscesses.
* History of or current certain infections
* History of or current certain medical conditions
A Pilot Study Assessing the Effectiveness of Use of Guided Imagery for Treatment of Pain and Symptom Management in Women With Post-mastectomy Pain Syndrome

To learn if using guided imagery and deep breathing techniques can help with pain management in patients who have post-mastectomy pain syndrome.

OBJECTIVES:

Primary objective:

-To evaluate the effectiveness of use of Guided imagery and deep breathing techniques in pain management compared to control arm in patients with post-mastectomy pain syndrome who don't receive intervention and only receive standard care.

Secondary objective:

To evaluate effectiveness of Guided imagery and deep breathing techniques in symptom cluster management including fatigue, sleep, depression, and anxiety and in general quality of life compared to control arm who don't receive intervention and only receive standard care.

Eligibility Criteria:
Inclusion Criteria:

1. Breast Cancer patients who were performed mastectomy in previous 12 months
2. Post-mastectomy pain syndrome \>4 weeks.
3. Patients who report 2-10 on the baseline pain severity score or 2-10 on the baseline pain interference score
4. Patients ≥ 18 years old and ≤ 70 years old
5. Must understand and read English, sign a written informed consent, and follow protocol requirements
6. If on medication for anxiety or depression, stable dose of medications for management of anxiety or depression symptoms for at least six weeks prior to enrollment with no plans to change medications in the subsequent four weeks. Increases or decreases allowed within drug class, but changing drug class will make patient in-evaluable

Exclusion Criteria:

1. Pending surgery during treatment
2. Suicidal ideation
3. Diagnosis of a formal thought disorder (e.g., schizophrenia)
Comparison of Two Interdental Cleaners

Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.

This study measured plaque accumulation, bleeding on probing and gingivitis using the Rustogi Modification of the Navy Plaque Index, BOP and Modified Gingival Index at baseline, 2-weeks and 4-weeks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult
* Non smoker
* Available for 4-weeks
* Able to provide written informed consent.
* Minimum of 20 natural teeth.
* Minimum requirement for plaque, gingivitis and bleeding.

Exclusion Criteria:

* Medical condition
* No antibiotics within 6 months of study start
* Not on any medication (impact oral health).
Single and Multiple Dose Evaluation of ABT-072 and to Evaluate the Effect of Food on the Pharmacokinetics of ABT-072

To assess the safety, tolerability and pharmacokinetics of the ABT-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. The effect of food on the safety, tolerability and pharmacokinetics of the ABT-072 tablet will also be evaluated.

The study consists of two substudies. Substudy 1 is a two-period, single ascending dose (SAD) and multiple ascending dose (MAD) blinded, randomized, placebo-controlled, non-fasting study. Designated groups that participate in Period 1 (SAD) will also participate in Period 2 (MAD). Substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of food on the pharmacokinetics of ABT 072.

Eligibility Criteria:
Inclusion Criteria:

* Overall healthy subjects, non-childbearing females included.

Exclusion Criteria:

* Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
* Pregnant or breast-feeding female.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
* Positive screen for drugs of abuse, alcohol, or cotinine.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.
LSA4 Protocol for the Treatment of Advanced Pediatric and Adolescent Non-Hodgkins Lymphoma

Non-Hodgin's lymphoma is curable in 76% of patients. In nonlymphoblastic lymphmas, cancer may return on average 3 months from beginning treatment and for lymphoblastic lymphomas, 6 months. To aggressively treat this cancer this study uses effective drugs in three parts:

* Induction ends on day 19
* Consolidation ends on day 38 or 42
* Maintenance may include up to 6 cycles


Eligibility Criteria:
Inclusion Criteria:

* Non-Hodgkin's Lymphoma stages III, IV, IVA with

  1. T cell lymphomas, any primary site irrespective of LDH level
  2. large cell lymphomas, any primary site irrespective of LDH level
  3. B cell lymphomas, any primary site with initial LDH of less than 500

Exclusion Criteria:

* B cell lymphomas, any primary site with initial LDH of less than 500 and initial CNS or bone involvement
A Prospective, Randomized, Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO) or Standard Care Dressings (AQUACEL Ag SURGICAL Dressing).

The primary aim of this study is to determine if the SSI rate following revision total hip and knee arthroplasty is reduced in patients treated with the PICO device compared to patients with traditional postoperative dressings. Our secondary goals include; comparing the amount of wound drainage, rate of resolution of wound drainage, length of hospital stay, functional outcomes, and economic implications of wound drainage and SSI after revision arthroplasty comparing PICO and traditional dressings.


Eligibility Criteria:
Inclusion Criteria:

1. Patient ≥18 years old
2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
3. Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty
4. Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
5. Subjects deemed able to understand and comply with study visit schedule and procedures

Exclusion Criteria:

1. Wounds that require daily inspection
2. Active bleeding within the surgical site
3. Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
4. Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic INR levels
5. Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)
6. Subjects undergoing primary total joint procedures
7. Subjects with a known history of poor compliance with medical treatment
8. Subjects who have participated in this trial previously and who were withdrawn 9 . Subjects with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
Exploratory Study of QBKPN SSI in Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the safety, tolerability, compliance and mechanism of action of study drug (QBKPN SSI) in subjects with two or more second primary pre-invasive or invasive adenocarcinoma following surgical section of Stage 1 NSCLC.

Please refer to summary above.

Eligibility Criteria:
Inclusion Criteria:

* Male or female who is at or above the age of consent
* Histologically confirmed original diagnosis of lung cancer
* Life expectancy greater than 12 months
* ECOG performance status 0, 1, or 2 at screening
* Female subjects who agree to practice two effective methods of contraception from the time of signing the informed consent form through one month after the last dose of study drug
* Male subjects who agree to practice effective barrier contraception during the entire study drug period and through one month after the last dose of study drug

Exclusion Criteria:

* Extra-thoracic lung cancer progression
* Any active malignancies
* Any uncontrolled or major organ dysfunction
* Any past or current radiation or systemic therapies for the treatment of lung cancer
* Known HIV infection or other immunosuppressive disorder
* Concurrently participating in another study with an investigational immunotherapy or have received investigational immunotherapy within 3 months prior to screening
Urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) in Invasive Cardiology

Diagnosis of acute kidney injury (AKI) relies on a late marker, namely serum creatinine (SCr). New biomarkers are considered for early and sensitive detection of CIN. In particular, uNGAL has been used for early detection of AKI in the emergency department, after cardiopulmonary bypass or following CM administration.

This study will be conducted to assess the possible value of urinary Neutrophil Gelatinase-Associated Lipocalin (uNGAL) as an early detector of contrast-induced nephropathy (CIN) in a large sized cohort of patients undergoing percutaneous coronary procedures (PCP) and whether or not uNGAL correlates with the volume of contrast medium (CM) used.

Methods. We will enroll all consecutive patients undergoing PCP with iomeprolum during a 3-month period at our institution. CIN will be defined as a ≥25% increase in SCr from baseline when measured 2-4 days after PCP. uNGAL will be measured at its peak with the Abbott ARCHITECT assay.

Eligibility Criteria:
Inclusion Criteria:

* All except patients with exclusion criteria

Exclusion Criteria:

* dialysis-dependent chronic kidney disease
* lack of written consent
The Efficacy of Tamsulosin in the Treatment of Ureteral Stones in Emergency Department Patients

The purpose of this study is to determine the efficacy of the α-adrenergic antagonist tamsulosin in the treatment of adult emergency department (ED) patients with ureteral colic secondary to lower ureteral calculus. We hypothesize that there will be no difference in outcomes for subjects treated with and without tamsulosin.

This prospective, randomized controlled trial seeks to compare outcomes for adult emergency department patients with lower ureteral calculus. Subjects will be randomized to receive treatment with ibuprofen and oxycodone alone (standard therapy) or standard therapy plus tamsulosin 0.4mg orally once daily for ten days.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older;
* able to read, write, and speak English;
* able to use the NRS pain scale; and
* computed tomography diagnosed single lower ureteral calculus

Exclusion Criteria:

* allergy or sensitivity to the study drug (tamsulosin hydrochloride \[Flomax\]);
* sulfa/sulfonamide allergy;
* inability to provide informed consent;
* lithiasis of the ureteral intramural tract;
* acute or chronic renal failure;
* fever;
* presence of multiple ureteral stones;
* peptic ulcer disease;
* liver failure;
* concomitant treatment with alpha-lytic drugs, calcium antagonists, nitrates, or vardenafil (Levitra);
* pregnancy;
* breastfeeding; or
* a history of urinary surgery or endoscopic treatment.