cyrilzakka/clinical-trials huggingface dataset:
Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation

The purpose of this study is to determine the effect of topical aminocaproic acid on the immune system by assessing the levels of antimicrobial peptides in the skin of patients with rosacea. It is hypothesized that aminocaproic acid applied topically will alter the body's immune system in patients with rosacea by inhibiting activation of antimicrobial peptides.


Eligibility Criteria:
Inclusion Criteria:

* Subject is male or non-pregnant female, 18 - 70 years of age.
* Subjects willing and able to give informed consent.
* Subjects willing and able to comply with the requirements of the study.
* Subject has the clinical diagnosis of at least mild/moderate papulopustular rosacea (3-20 papulopustules) and at least mild erythema.
* Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study
* Subject is in general good health in the opinion of the investigator.
* Subject has a calculated creatinine clearance 100% of normal range.
* Subject has normal baseline labs or in the opinion of the investigator are values are not clinically significant and would not inhibit the ability to monitor the patient for both safety and efficacy throughout the study.

Exclusion Criteria:

* Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans)
* Subject has a history of Carcinoid, Pheochromocytoma, Serotonin Syndrome or other systemic flushing causes.
* Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days
* Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days.
* Subject has had laser or light-based treatment for rosacea within the prior 3 months.
* Subject has had systemic retinoids and retinoid derivatives over the past 6 months
* Subject has an active or recent history of any coagulation (hyper or hypo) disorder, genitourinary bleeding, myopathy, cardiomyopathy, rhabdomyolysis or evidence of clinically significant hepatic disease in the opinion of the investigator,
* Subject is taking any medicines or supplements that interfere with blood clotting such as Coumadin, Plavix, or ASA (\>81mg/day).
* Subject has a known hypersensitivity or allergy to aminocaproic acid or components of the vehicle.
* Subject is pregnant or lactating or planning a pregnancy during the duration of the study
* Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study
* Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation.
Prognosis Of Patients With Aggressive B-Cell Lymphoma, Treated With Rituximab+Anthracycline Regimen

This study is a retrospective analysis of an homogeneous population of patients with aggressive B-cell lymphoma and treated upfront with R-CHOP or R-CHOP like regimens to reassess the prognostic factors and hopefully to identify more accurate prognostic subgroups with a clinical and therapeutical relevance.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed newly diagnosed aggressive B-cell lymphoma according to the current World Health Organisation Classification, from 2001 to 2007.
2. Any stage of disease.
3. Treatment with R-CHOP or R-CHOP like regimens (+/- transplant).
4. Age at least 18 years.
5. Availability of tissue biopsy at diagnosis for a possible centralized revision.
6. Availability of data on clinical involvement, laboratory, treatment and follow up.

Exclusion Criteria:

* None
Evaluation of Postoperative Ascites After Somatostatin Infusion Following Hepatectomy for Hepatocellular Carcinoma

Most patients undergoing hepatectomy for hepatocellular carcinoma (HCC) suffer from underlying liver disease and are exposed to the risk of postoperative ascites, with subsequent morbidity, liver and renal failure, the need for specific treatments and prolonged hospital stay. Postoperative ascites is favored by an imbalance between portal venous inflow and the diminished hepatic venous outflow. Finding a reversible, non-invasive method for modulating the portal inflow would be of interest: it could be used temporarily during the early postoperative course to prevent acute portal hypertension. Somatostatin, a well-known drug already used in several indications, may limit the risk of postoperative ascites and liver failure by decreasing portal pressure after hepatectomy for HCC in patients with underlying liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with HCC diagnosed by histology or by imaging findings according to the Barcelona Clinic Liver Cancer Group
* Patients with a single or multiple HCCs deemed to be resectable with a curative intent at the preoperative evaluation
* Patients for whom an indication for hepatectomy has been decided and approved by multidisciplinary board:
* by laparotomy
* by coelioscopy with resection of at least 2 liver segments
* Patients with any underlying liver disease with or without proven cirrhosis, regarding histological features (including F2-F3-F4 fibrosis with or without cirrhosis) or with other evidence of a diseased liver if no biopsy has been performed preoperatively (dysmorphic liver or evidence of portal hypertension at imaging findings, oesophageal varices at endoscopy)
* Age ≥ 18 years
* Patients with ability to understand and sign a written inform consent form
* Patients who will be available for follow-up

Exclusion Criteria:

* Patients participating in another interventional research in progress or including an exclusion period still in progress at pre-inclusion (except interventional research with minimal risks and constraints that do not interfere with the judgement criteria of the study according to the judgement of the coordinating investigator).
* Patients with evidence of a healthy liver at biopsy

Disease-associated non-inclusion criteria include:

* Another histologic type of hepatic tumor besides HCC
* Distant extra-hepatic metastases, including peritoneal carcinomatosis
* The existence of complete portal thrombosis of the main portal trunk

Operative technique-associated non-inclusion criteria include:

- Indication of coelioscopy with resection of less than 2 liver segments
Intravitreal Bevacizumab for Management of Active Progressive Proliferative Diabetic Retinopathy (PDR)

To evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in cases with the signs of active progressive PDR


Eligibility Criteria:
Inclusion Criteria:

* Cases of active progressive PDR with history of scatter laser photocoagulation

Exclusion Criteria:

* history of vitrectomy
Acute Cardiac Ischemia in Women in the ACI/TIPI Trial

To conduct a series of five inter-related studies on acute cardiac ischemia (ACI) in women.

BACKGROUND:

Acute cardiac ischemia (ACI), including acute myocardial infarction (AMI) and unstable angina pectoris, is the leading cause of death in women in the US. Despite growing interest in ischemic (coronary) cardiac disease in women, little research has focused on women in the most common site of ACI initial evaluation and care: the emergency department (ED). Improving medical care quality and outcomes for ACI in women will require an understanding of gender's influence on initial ED presentation, diagnosis, triage, treatment, and outcomes.The detail of prospectively-collected data and number of patients available for this project with the resulting large statistical power (while savings the cost of the $1.8 million ACI-TIPI Trial data collection effort) and the experience of the CCHSR in over a decade of related studies of factors influencing the triage, treatment, and outcome of ED patients with ACI, provide this project with substantial promise of new and useful results.

DESIGN NARRATIVE:

The five studies included. STUDY I: Were women's emergency department (ED) presentations of ACI different from men's? STUDY II: Were there differences between women and men in the ED diagnosis and triage of patients with chest pain and other symptoms suggestive of ACI? STUDY III: Were there differences between women and men in the use of non-invasive and invasive treatments among patients presenting to the ED with ACI? STUDY IV: Were there significant differences between women and men in medical outcomes during the acute event and within 30 days following ED presentation with ACI? STUDY V: Had differences between women and men in their ED presentation, diagnosis, and/or triage for chest pain or other symptoms compatible with ACI changed over the past 10-15 years? In studying the impact of gender, these studies also included analyses for primary and interaction effects related to patient sociodemographic features, ED presenting clinical features, physician type and training, hospital type and ED setting, health insurance type, and include adjustments for patients' probabilities of having ACI as well as their likelihood of acute cardiac mortality.

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
Interoception and Eating Behaviors in Children

The purpose of this study is to examine how individual differences in interoception (the ability to sense, interpret, and act on bodily feelings like hunger, fullness, thirst, hot, cold, etc.) relate to eating behaviors in children ages 7-10 years. Findings will inform whether interventions targeting interoceptive awareness may be helpful for prevention of obesity and related chronic diseases.

The overall goal of this project is to examine if interoception (the process by which internal bodily states, like hunger and fullness, are sensed, integrated, interpreted, and regulated) is associated with BMI and obesity-related eating behaviors in children age 7-10 years. The specific aims are:

Aim 1: Determine associations between interoception and non-homeostatic eating H1: Multi-systems measures of interoceptive awareness (e.g., heartbeat perception, gastric interoception, self-reported interoceptive awareness) will be inversely associated with intake (kcal) in the eating in the absence of hunger (EAH) task

Aim 2: Assess salivary ghrelin and leptin as interoceptive signals of hunger/satiety H1: Children with greater postprandial suppression of ghrelin will eat less in the EAH task H2: Children with greater postprandial suppression of ghrelin will have better interoceptive awareness H3: Children with higher leptin will exhibit less sensitivity to changes in ghrelin

Aim 3 (Exploratory): Identify interoceptive phenotypes that may predict obesity risk Using k-means cluster analysis, we aim to identify subgroups of individuals who exhibit different combinations of interoceptive variables. We will then examine differences in eating behavior and weight between clusters.

Participants will attend two study visits at the Clinical Research Center at Penn State University Park campus. At the first visit, children will have their height, weight, and body composition measured, complete measures of interoception, and complete surveys/interview. Parents will complete a survey. At the second visit, children will eat a meal, taste snacks, provide saliva samples, and play cognitive games on a tablet.

Eligibility Criteria:
Inclusion Criteria:

* Child must be 7-10 years of age
* Participating parent must be at least 18 years of age, but there is no upper age limit
* Able to understand and answer questions in English

Exclusion Criteria (all applicable to child only):

* BMI for age \<5th percentile
* Monogenic obesity condition (e.g., Prader Willi syndrome)
* Autism/autism spectrum disorder
* Developmental delay
* Eating disorder
* Diabetes
* Heart condition
* Taking medications impacting appetite (e.g., stimulants, weight control medications)
* Any other condition significantly impacting growth, eating behavior, or cardiac function
* Allergy or dietary restriction to study foods
* Severe/untreated oral/dental health problems
* Orthodontic procedure or adjustment of braces within the past omonth
* Oral surgery or major oral/dental procedure within past month
* Had an x-ray within the past month
AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation

A pharmacokinetics and pharmacogenetics study to complement the current knowledge of tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after renal transplantation.

Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus immediate release (Prograf®)

Multicentre open-labeled randomized pharmacokinetic (PK) and pharmacogenetic (PG) study to compare Advagraf and Prograf immediate post-transplantation (Day 8) and steady-state (Day 84) systemic exposure.

Tacrolimus PK profile, tacrolimus systemic exposure assessed by Limited Samples Strategies (LSS) (i.e.: Bayesian estimators (BE) and Multilinear Regressions (MLR)), and impact of CYP3A5 and ABCB1 genetic polymorphisms on tacrolimus PK will also be determined to improve the optimal dose of Advagraf® for kidney transplant patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult recipients aged between 18 to 70
* Primary renal transplantation
* Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type.
* absence of anti-LHA antibodies in lymphocytotoxicity and Luminex
* Negative cross-match in cytotoxicity
* Negative pregnancy test for female patients of childbearing potential, and agreement to practice effective birth control during the study

Exclusion Criteria:

* Combined transplantation
* Renal bigraft
* History of any other transplantation
* Receiving a graft from a non-heart-beating donor.
* Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation
* Patient who received within one month prior to study an inductor of CYP50 3A or requiring during the study an inhibitor of CYP50 3A or of P-gp.
* Significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
* Subject or donor known to be HIV positive
* Active viral hepatitis (VHB, VHC) at randomisation
* Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, or mycophenolate mofetil or any of the product excipients
* Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully.
* Current participation in any other clinical study
* Any clinical condition which, in the opinion of the investigator, would not allow safe completion of the study
* Patient not able to comply with the study procedures
* Breast-feeding mother
Pre-Surgical Intervention for Targeted Therapies for Breast Cancer

The purpose of this study is to determine the feasibility of a short term administration of a targeted therapy (i.e., anastrozole) in women with newly diagnosed early invasive or non invasive breast cancer during the interval between their breast biopsy and surgery. Anastrozole is a form of hormonal therapy which is part of the standard treatment for hormone sensitive breast cancer in postmenopausal women. This clinical model is being used to evaluate the biologic effects of this drug on a specific molecular pathway called the PI3K/AKT signaling pathway.

Several clinical models are being explored for use in the phase I/II evaluation of targeted therapies for breast cancer. Biological markers can be measured in early stage invasive cancers in a presurgical model involving a short term intervention. In this model, women with newly diagnosed early invasive breast cancer receive a study drug during the interval between diagnostic breast biopsy and surgical resection. Tumor tissue obtained from the biopsy and surgical specimens are used to measure pre and post treatment molecular markers, respectively. The main advantages of this model include the ability to obtain direct information on molecular response in tumor tissue and elucidate drug mechanisms of action, the large patient population to draw from with early stage breast cancer, and the lack of unnecessary invasive procedures.

We plan to conduct a pilot study of 10 postmenopausal women with newly diagnosed estrogen receptor (ER) positive invasive or non invasive breast cancer who will receive oral anastrozole 1mg daily for two weeks in the interval between diagnostic breast biopsy and definitive breast surgery. Patients will be identified by the breast surgeon or mammographer performing the breast biopsy. Patients with histologically confirmed ER+ invasive or non invasive breast cancer will be recruited by the medical oncologist and will start anastrozole two weeks prior to their scheduled surgery. The primary objective of this study is to demonstrate the feasibility of this presurgical model for evaluating targeted therapies for breast cancer. Secondary endpoints include changes in tissue levels of the proliferation marker Ki67 and proteins involved in PI3K/AKT signaling.

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed operable ER+ and/or PR+ invasive breast cancer or ductal carcinoma in situ (DCIS), who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
* Postmenopausal status defined as cessation of menses for \>1 year or FSH \> 20 mIU/mL (within the past month)
* Age ≥ 21 years
* No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
* Signed informed consent

Exclusion Criteria:

* Treatment with other investigational drugs within 6 months of study entry
* Other serious intercurrent medical illness
Efficacy and Safety of Dexamethasone Nanoparticles Eye Drops in Diabetic Macular Edema

Anti-inflammatory or anti-angiogenic drugs play an ever- increasing role in the treatment of diabetic macular edema (DME). The drug delivery systems, such as injections of corticosteroid and or vascular endothelial growth factor (VEGF) antibodies into the vitreous cavity or slow release drug capsules surgically implanted in the eyes run the risk of surgical complications including infections, hemorrhages and cataracts and place a huge demand on eye care resources significantly increase the risk of cardiovascular events and death.

A non-invasive drug delivery platform with steroid eye drops, reaching the back of the eye to treat DME and other retinal diseases would circumvent most of these problems.

A novel drug delivery platform is required for ocular therapy. Oculis ehf. has developed a drug delivery platform, which is based on cyclodextrin nanoparticles that dissolve in the tear fluid to form water-soluble drug/cyclodextrin complex nanoparticles. Animal and initial clinical testing has shown the potential for this technology to increase the drug concentration in the eye tissues including the retina and therefore treat retinal diseases like DME.


Eligibility Criteria:
Key Inclusion Criteria:

1. Had DME of less than 3 years duration since diagnosis with presence of intraretinal and/or subretinal fluid in the study eye, with CMT of ≥ 310 µm by SD-OCT at baseline (Visit 2) (as measured by the Investigator).
2. Had definite retinal thickening in the study eye due to DME involving the central macula based on the Investigator's clinical evaluation and by SD-OCT;

   ...

Key Exclusion Criteria:

1. Had macular edema considered to be due to a cause other than DME;
2. Had a decrease in BCVA due to causes other than DME (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, previous vitreoretinal surgery, central serous retinopathy, non-retinal condition, substantial cataract, macular ischemia) that is likely to be decreasing BCVA by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if eye was otherwise normal).

   ...
Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS) is a severe neurodegenerative condition, mainly characterized by progressive weakness and wasting of the limbs, the respiratory and bulbar muscles. Respiratory insufficiency leads to a fatal outcome after a mean diseases duration of only three to five years. The disease is characterized by pathological accumulations of a protein called TDP-43, which can be found large cortical and sub-cortical areas of post-mortem ALS brains.

No causal treatment for this condition is known to date, and there is a large unmet need to develop new strategies in order to halt or slow down its progression.

The aim of this study is to test the safety and tolerability of Tideglusib, a treatment that is already in clinical trials for other neuromuscular conditions, in patients with ALS. It is assumed that this drug may have a significant therapeutic benefit in this population due to his mode of action: In the ALS mouse model, Tideglusib decreases significantly the amount of accumulated TDP-43 proteins within the cells.


Eligibility Criteria:
Inclusion Criteria:

* Possible, probable (clinically or laboratory supported) or definite ALS according to the revised version of the El Escorial criteria
* Disease duration \< 18 months
* Vital capacity of more than 60% of normal (defined as slow vital capacity, best of three measurements)
* Age more than 18 years
* On a stable dose of riluzole for at least four weeks or not taking riluzole
* On a stable dose of edaravone for at least four weeks or not taking edaravone
* Capable of thoroughly understanding all information given and giving full informed consent according to GCP

Exclusion Criteria:

* Previous participation in another clinical study within the preceding 12 weeks
* Proven SOD1- or FUS - mutation
* Tracheostomy or assisted ventilation of any type during the preceding three months
* Pregnancy or breast-feeding females
* Any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
* Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
* Evidence of a major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
* Alcoholism
* Cardiovascular disorder/arrhythmia
* Impaired kidney function, defined as creatinine levels of 2.5 x upper limit of normal (ULN)
* Impaired liver function, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) of 3 x ULN
* Liable to be not cooperative or comply with trial requirements as assessed by the investigator, or unable to be reached in the case of emergency