cyrilzakka/clinical-trials huggingface dataset:
A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)

The purpose of this study is to evaluate the ability to identify individuals with dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from Alzheimer's disease (AD) and control subjects.


Eligibility Criteria:
Inclusion Criteria DLB:

* Male or female \> 50 years of age
* Meet the diagnostic criteria for probable DLB as established by the DLB Consortium (McKeith et al., 2005)

Inclusion Criteria AD:

* Male or female \> 50 years of age
* Meet the NINCDS criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive

Inclusion Criteria PD:

* Male or female \> 50 years of age
* Have probable PD according to the following criteria (Gelb et al., 1999):

  * Presence of 2 of the following 3 features: rest tremor, rigidity, bradykinesia;
  * Documented history of a sustained (\>6 months) improvement to Levodopa (L-DOPA) or a dopamine agonist
  * Absence of atypical clinical features or other possible signs or symptoms suggesting another cause of parkinsonism such as a history of frequent falls as a prominent early feature, localized brain lesion(s) or neuroleptic use
  * Asymmetric onset
* A diagnosis of PD made within the 4 years prior to enrollment

Normal subjects:

* Are males or females \> 50 years of age
* Have a MMSE score \> 29, and are cognitively normal on the psychometric test battery at screening
* Have no signs or symptoms of clinically meaningful parkinsonism

Exclusion Criteria:

* Have a history or current diagnosis of other neurologic disease
* Have evidence of clinically significant cerebrovascular disease
* Have evidence from MRI or other biomarker studies that suggests the presence of a CNS pathology other than that associated with the study diseases
Radical Colorectal Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Colorectal Cancer

The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial is that radical colorectal resection plus HIPEC is superior to only radical colorectal resection in terms of overall survival.

To determine the efficacy of HIPEC in the treatment of locally advanced colorectal cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical colorectal resection with lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical colorectal resection with lymphadenectomy. Patients in both groups receive 8 cycles of postoperative chemotherapy (XELOX) and are followed up for 5 years or until death.

The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Eligibility Criteria:
Inclusion Criteria:

* Histological proved diagnosis of locally advanced colorectal cancer.
* No evidence of distant metastases or peritoneal metastases.
* Preoperative examination (CT/MRI) demonstrated resectable colorectal cancer with T3-T4 stage.
* Eligible for radical colorectal resection with lymphadenectomy.
* Have not received cytotoxic chemotherapy or radiotherapy.
* Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

* Existence of distant metastasis or peritoneal metastasis during surgery (M1).
* Any previous chemotherapy or radiotherapy
* Active systemic infections
* Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
* Female patients who are pregnant or breast feeding
Drug-Drug Interaction Study to Assess the Effects of Steady State Pitavastatin 4 mg or Rosuvastatin 40 mg on Steady-State Warfarin in Healthy Adult Volunteers

This is a Phase 4, single center, open label, 4 period, 2 treatment, crossover, drug-drug interaction study.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy adult male or female volunteer aged 18 to 45 years, inclusive
* Subject has a body mass index of 18 to 32 kg/m2, inclusive
* Subject is able and willing to abstain from alcohol, grapefruit, caffeine
* Subject has no clinically relevant abnormalities on the basis of medical history, physical examination, and vital signs

Exclusion Criteria:

* Subject has clinically relevant out-of-range prothrombin time (PT), activated partial thromboplastin time, fibrinogen, protein C, or protein S
* Subject has abnormal prolongation of bleeding time at Screening
* Subject has hematuria on urinalysis
* Subject has personal or family history of coagulation or bleeding disorders
Post Approval Study of the remedē System

Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.

This Post Approval Study is a multi-center, prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System from the remedē System Pivotal Trial. Only subjects who were implanted and actively being followed as part of the remedē System Pivotal Trial are eligible. An individual subject's participation is expected to continue to five years post remedē System implant.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who were previously implanted with the remedē System and participated in the remedē System Pivotal Trial
* In the investigator's opinion, willing and able to comply with all study requirements
* Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent (including Health Insurance Portability and Accountability Act \[HIPAA\] authorization in the US)

Exclusion Criteria:

* There are no criteria by which a subject would be excluded
FHA: Characterization of Metabolic Status, Brain Circuitry, and Stress-Reactivity

Functional Hypothalamic Amenorrhea (FHA), the spontaneous cessation of the menstrual cycle for at least 6 months after menstrual cyclicity has been established, is a common and reversible form of anovulation not due to discernible organic causes. Whereas animal studies suggest an interaction of metabolic and psychosocial stress in the genesis of FHA, the distinct central mechanisms in humans are not clear. On a behavioral level, FHA appears to depend on a complex interplay between individual stress susceptibility, stressful life events, and enduring metabolic challenge due to inappropriate attitudes towards eating and body image. We will use a comparison group of ovulatory, eumenorrheic women (EW) and a contrast group of lean women with polycystic ovary syndrome (PCOS). Although women with FHA and PCOS present with anovulation, each condition differs markedly in pathobiology (and health burden). Contrasting women with FHA to those with PCOS will afford an opportunity to understand more about the interaction between metabolism, stress, and reproduction and to determine the extent to which differences between FHA and EW are attributable to reproductive compromise (anovulation) per se versus specific to the pathogenesis of FHA or PCOS. We have used this approach to great advantage in the past to show that hypercortisolemia was confined to FHA and not PCOS (Berga 1997) and that dysfunctional (unrealistic) attitudes and decreased coping skills were reported more often in FHA than in PCOS and more in PCOS than EW. Further, this approach of comparing 3 groups will allow us to improve therapeutic approaches for two principle causes of anovulatory infertility in women. To accomplish this, we will study women with FHA, PCOS, and normal ovulatory women. The study will take place over 2 months and women will make 4-5 outpatient visits to the Clinical Integration Network Center and will have one overnight stay for frequent blood sampling.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for participation are a gynecological age (age since menarche) \> 5 and \< 25 years, and chronological age \> 18 years, within 90-110% of ideal body weight as determined by the 1983 Metropolitan height and weight table for women, and exercise \< 10 h/wk and run \< 10 mi/wk, day-awake/night-asleep schedule.
* Women in the FHA and PCOS groups have to fulfill the diagnostic criteria of FHA or PCOS and to have all other causes of amenorrhea and anovulation excluded.

Exclusion Criteria:

* Exclusion criteria are smoking, medications, including psychotropic or illicit drugs, medical, neurological, or ophthalmologic disease except acuity problems, a weight loss or gain of \> 10 lb within a year preceding or since the onset of amenorrhea, a major Axis I disorder other than depression, parturition in the last 12 months and/or lactating in the last 6 months.
Telemedicine's Utility for Augmenting Clinical Trials and Informed Consent TACTIC

This is a 6 year, Phase I, Clinical Research Protocol to study the feasibility of using a telemedicine system for performing research in a remote hospital system.

The UCSD Telemedicine system is a digital video camera system, which can transfer video and audio images from a clinic or emergency room to a remote place where a physician can review images in real time (as they happen). The system uses site independent software to access the camera system from multiple locations. This research study will determine if it is feasible to obtain informed consent for various types of research trials (hypothetical, non-invasive, invasive trails) via telemedicine. Inpatient assessments on participants to complete clinical research case report forms by telemedicine will also by performed.

Eligibility Criteria:
Inclusion Criteria:

* Male/Female, age 18 years or older
* Clinical neurological focal deficits consistent with stroke
* Time of onset 3-24 hours and with stable neurological deficit
* Signed Informed Consent

Exclusion Criteria:

* Deficits known to be due to non-stroke etiology
* Time of onset less than 3 hours
* Patients unable to give consent
Effect of Tamoxifen on Breast Density in Premenopausal Women With Breast Cancer or High Risk for Breast Cancer

RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Tamoxifen may be effective in reducing breast density by decreasing estrogen levels.

PURPOSE: This phase I trial is studying how well tamoxifen works in reducing breast density in premenopausal women with breast cancer or at high risk of developing breast cancer.

OBJECTIVES:

Primary

* Determine whether breast density, as measured by digital mammography, decreases in premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk reduction.
* Determine whether breast density, as determined by a trained mammographer, decreases in patients treated with this drug.
* Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary steroids in patients treated with this drug.

Secondary

* Determine the effect of this drug on salivary steroids in regularly cycling and amenorrheic patients.
* Correlate changes in breast density with tamoxifen-induced alterations in sex steroid levels, as measured in the saliva, of patients treated with this drug.

OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast cancer (patients undergoing risk reduction).

Patients undergo mammography to determine breast density at baseline, at 6 and 12 months, and then annually for 4 years. Patients also collect daily salivary samples during the 30-day periods surrounding the imaging studies to measure salivary estradiol and progesterone levels. The results of the salivary hormone studies are correlated with density changes at study completion.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Initiating tamoxifen as the sole systemic treatment for breast cancer OR for breast cancer risk reduction
* Undergoing mammography at least annually
* No bilateral breast cancer or stage IV breast cancer
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age

* 20 to 45

Sex

* Female

Menopausal status

* Premenopausal

  * No change in menstrual patterns within the past 6 months

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* Not pregnant or nursing

  * No planned pregnancy within the next 5 years
* No medical or psychiatric disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for breast cancer

Endocrine therapy

* See Disease Characteristics
* No prior tamoxifen for more than 1 month in duration

Radiotherapy

* Not specified

Surgery

* Not specified
Identification and Validation of Biomarkers for Infections in Burns

In this prospective, multi-center study, 200 patients from four participating Texas burn hospitals will be enrolled from admission to discharge. The clinical research study team will collect approximately 11 serum samples and clinical data related to sepsis and infection predictors from severely burned adult patients, ages 18-80 years old. All serum samples from participating sites will be shipped to the lead site, University of Texas Medical Branch. The University of Texas Medical Branch will then validate previously identified biomarkers while simultaneously identifying novel biomarkers through discovery proteomics.

The burn literature is replete with suggested biomarkers of infections for identifying sepsis or other infections in burn patients, however, these reports are largely untested. In order for incorporation of infection biomarker assessment to become the standard of care, validation of these markers in a multi-center prospective study is necessary. As the majority of these biomarkers have been chosen because of success in other patient populations, or ease of measurement, it is possible that the best biomarkers of infection have not yet been discovered in this patient population. Prospective identification and validation of novel biomarkers may also improve early identification of infections in burn patients. Early treatment of infections and sepsis directly correlated with improved survival and reduced costs of care.

In this prospective, multi-center study, 200 patients from four participating Texas burn hospitals will be enrolled from admission to discharge. The clinical research study team will collect approximately 11 serum samples and clinical data related to sepsis and infection predictors from severely burned adult patients, ages 18-80 years old. All serum samples from participating sites will be shipped to the lead site, University of Texas Medical Branch. The University of Texas Medical Branch will then validate previously identified biomarkers while simultaneously identifying novel biomarkers through discovery proteomics.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-80 years old
* Greater than 20% Total Body Surface Area burn
* Patient arrival to the burn center within 7 days of burn injury

Exclusion Criteria:

* Known history of acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC), human immunodeficiency virus (HIV)
* History of cancer within 5 years
* Pregnancy
* Burn injury due to chemical burns or deep electrical injury
* Inability to obtain informed consent
* Decision not to treat due to burn injury severity or futility as deemed by the clinical team at the time of admission (Note: This is a clinical determination of futility beyond which survival is rare. These are typically patients whose sum of Total Body Surface Area % burn and age (Baux score) exceeds 140 or 120 with severe inhalation injury.)
* Presence of anoxic brain injury that is not expected to result in complete recovery
Caudal Epidural Catheterization in Pediatric Renal Transplant: Effect on Hemodynamics and Pain After Surgery

pain control in pediatric renal transplant is a major concern. the main goal during anesthesia of renal transplant in pediatrics is to maintain hemodynamics in a range close to that of the adult donor. epidural analgesia is thought to be very effective in pain control. this study emphasises the ease of application of epidural catheter via the caudal route to the lower thoracic level; avoiding possible complications that may arise from lumbar or thoracic routes, and its effects on hemodynamics when using analgesic doses of local anesthetics and narcotics.


Eligibility Criteria:
Inclusion Criteria:

* 3-12 years
* end stage renal disease
* no known allergy to bupivacaine
* both sexes

Exclusion Criteria:

* known allergy to bupivacaine
* inflammation at caudal area
* spinal cord deformity
A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser

The LenSx 550 laser system is a femtosecond laser intended for use in performing anterior capsulotomy during cataract surgery. The anterior capsulotomy creates a circular opening in the anterior surface of the capsular bag that contains the cataractous crystalline lens. The objective of this study is to evaluate the ability of the LenSx 550 laser to successfully perform anterior capsulotomy during cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
* Must be at least 24 years of age.
* Must be willing and able to return for scheduled follow-up examinations.
* Subjects must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

* Corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
* Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally are excluded.
* Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye are excluded.
* History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP\>21 mm Hg in either eye.
* Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
* Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
* Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
* Known sensitivity to planned study concomitant medications.
* Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
* Subjects presenting any contraindications to cataract surgery.
HDL-C in Cardiac Syndrome X

High density lipoprotein cholesterol (HDL-C) is in the centrum of the process of reverse cholesterol transport from peripheral cells to the liver\[10\]. HDL-C promotes endothelial generation of nitric oxide (NO) and improves endothelial function and arterial vasoreactivity\[11\]. In several studies, lower HDL-C level was reported to be associated with increased coronary artery disease (CAD) risk\[12-14\]. HDL-C also has anti- inflammatory and anti-oxidant activities\[15,16\]. Concerning anti-inflammatory activity, HDL-C inhibits the activation of monocytes/macrophages and neutrophils\[17,18\] and inhibits the expression of endothelial adhesion molecules, such as vascular cell adhesion molecule-1 (VCAM-1) and E-selectin\[15\].

In this study we aimed to investigate the relation of HDL-C level with systemic inflammatory markers in patients with cardiac syndrome X (CSX).


Eligibility Criteria:
Inclusion Criteria:

* Must be able to get exercise stress test
* Must be able to have coronary angiography
* Clinical diagnosis of typical anginaduring rest or effort
* Abnormal test result for exercise ECG or myocardial perfusion scintigraphy
* Must have of angiographically normal epicardial coronary arteries

Exclusion Criteria:

* Patients with valvular heart disease (mitral stenosis and moderate to severe mitral regurgitation
* Patients with moderate to severe aortic stenosis and regurgitation including mitral annular calcification)
* Patients with heart failure (left ventricular ejection fraction \<50%)
* Patients with congenital heart disease, cardiomyopathy, left ventricular hypertrophy, right ventricular hypertrophy
* Patients with cardiac surgery
* Patients with thyroid disease
* Patients with anemia
* Patients with pulmonary diseases
* Patients with infectious diseases (locally or systemic)
Imatinib + MTC in Relapsed / Refractory Acute Myeloid Leukemia (AML)

The purpose of this study is to show superiority in complete responses of combination therapy MTC plus Glivec in patients with refractory or relapsed AML compared to a historical control which was treated with MTC alone.


Eligibility Criteria:
Inclusion Criteria:

* Refractory AML after primary therapy
* First relapse after a safe previous diagnosis of de novo or secondary AML
* Age \> 18 years
* Serum bilirubin \< 2.0 mg/dl
* Serum creatinine \< 1.5 times the normal value or a creatinine clearance \> 60 ml/min
* ECG and heart echography prior to start of therapy without severe findings
* Overall condition \< 2 according to ECOG criteria
* Life expectancy \> 6 weeks
* Written informed consent by patients with full legal capacity

Exclusion Criteria:

* Serious secondary disease (clinically relevant cardiac disease, chronic- obstructive pulmonary disease, hepatic dysfunction, renal insufficiency)
* Active secondary neoplasia (exception: adequately treated basalioma or epidermoid cancer and cervical carcinoma)
* Known hypersensitivity to topoisomerase-I inhibitors
* Overall condition \> 2 according to ECOG criteria
* Pregnant/breast feeding women
* Serious intercurrent infections
Internet-administrated Treatment of Anxiety Disorders

The purpose of this study is to determine whether tailored internet-administered cbt is a feasible treatment for anxiety disorders in clinical settings.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* fulfill the criteria for at least one anxiety syndrome

Exclusion Criteria:

* ongoing psychological treatment
* suicidal prone
* ongoing alcohol addiction
Ciclosporin in the Management of Steroid Resistant Type 1 Reactions in Leprosy

Study 1B: Ciclosporin in the management of steroid resistant Type 1 Reactions in Leprosy

Objective: A pilot study assessing the efficacy and safety of Ciclosporin as a second -line drug in patients with Type 1 Reactions who have not responded to a 12 week course of Prednisolone.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with clinical evidence of Type 1 Reaction who have not responded to 3 months Prednisolone Treatment
* Aged 18-65
* Weigh more than 30Kg

Exclusion Criteria:

* Unwillingness to give informed consent
* Patients with severe active infections such as tuberculosis
* Pregnant or breastfeeding women (see Appendix II)
* Those with renal failure, abnormal renal function, hypertensive
* Patients taking thalidomide currently or within the last 3 months
* Patients not willing to return for follow-up
* Women of reproductive age not willing to use contraception for the duration of the study ( see Appendix II)
* HIV positive