cyrilzakka/clinical-trials huggingface dataset:
Comparison of Conventional Dose Regimen and New Dose Regimen of Pregabalin

The purpose of this study is to propose a new flexible dose regimen starting from 75mg using the low dose pregabalin 25 mg and 50 mg comparing the side effect and compliance with the conventional flexible dose regimen staring from 150mg using the pregabalin 75mg.

Pregabalin has been shown to be effective as a first-line medication for neuropathic pain but it appears to have several side effects such as dizziness, drowsiness, and edema, which lowers compliance with medications. A way to reduce side effects is the flexible dose regimen, which reaches the target dose to treat the drug. The proposed flexible dose regimen is a regimen that begins with twice the prevalence of 75 mg. However, dizziness is the most common side effect up to 20% in conventional flexible dose regimen. Therefore, the aim of this study was to propose a new flexible regimen starting at a dose less than the existing dose and to compare compliance with pregabaline according to both methods

Eligibility Criteria:
Inclusion Criteria:

* Pain score NRS ≥3 Patients complaining of neuropathic pain (except neuropathic pain due to chemotherapy)
* Adult patients aged 19 to 85 years
* Patients who pre-agreed to the study

Exclusion Criteria:

* Patients complaining of severe pain (NRS ≥ 8)
* Creatinine clearance of \<30 mL / min, the liver was more than 3 times normal
* Patients complaining of dizziness, patients with definite orthostatic hypotension
* Pregnant or lactating patients
* Patients who previously experienced side effects after administration pregabalin.
Safety and Efficacy Study of L-FMAU in Chronic HBV Patients of L-FMAU-201 Placebo Group

The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who received placebo in L-FMAU-201 study
2. Female of childbearing potential with a negative serum (beta-HCG) pregnancy test within 14 days of starting therapy.
3. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
4. Patients who met the following criteria after completion of the Week 48 visit were to have additional follow-up visits at Weeks 54 and 60:

1)had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a \>= 1 log10 decrease from baseline in HBV DNA at Week 48

Exclusion Criteria:

1. Patient with HBeAg seroconverted to anti-HBe at the last 2 consecutive visits (one month apart) in L-FMAU-201 study.
2. Patient who was currently receiving antiviral, immunomodulatory or corticosteroid therapy.
3. Patient who was treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
4. Patient who had a history of ascites, variceal hemorrhage or hepatic encephalopathy.
5. Patient who was co-infected with HCV, HDV or HIV.
6. Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein)Evaluation was based on alpha-fetoprotein primarily. If alpha-fetoprotein level was suggestive of cirrhosis or hepatocellular carcinoma, confirmation was made with ultrasonography etc.
7. Patient who was pregnant or breast-feeding.
8. Patient who was unwilling to use an "effective" method of contraception during treatment period and for up to 3 months after cessation of therapy. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal or using at least a medically acceptable barrier method of contraception (i.e., IUD, barrier methods with supermicide or abstinence)
9. Patient who had a clinically relevant history of abuse of alcohol or drugs.
10. Patient who had a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
11. Patient who had creatinine clearance less than 60mL/min as estimated by the following formula:

(140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.


Eligibility Criteria:
Inclusion Criteria:

* Participants legally competent to sign and give informed consent
* Males and females ages 18 years and older (inclusive)
* Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
* Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
* In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
* Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

* Planned excessive exposure of treated area(s) to either natural or artificial sunlight or tanning bed.
* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
* Previous treatment with roflumilast cream or its active ingredient
* Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
* Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
* Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
Lifestyles Of Health And Sustainability for Breast Cancer Survivors

The purpose of this study is to examine the effects of exercise program on health-related physical fitness and biomarkers among breast cancer survivors.

Patients and survivors of breast cancer present impaired physical fitness and various complications including acute and chronic pain, severe fatigue, limited range of motion, and bone loss attributable to anticancer treatments. Therefore, regular exercise during and following cancer treatments has been recommended to enhance physical capabilities and relieve side-effect severities, leading to an improved quality of life. Despite the known general benefits to patients with cancer, the effects of exercise on cancer-related biomarkers and their modulators remain unclear.

PRIMARY OBJECTIVES:

I. To determine whether a 12-week exercise intervention will improve components of health-related physical fitness by measuring cardiorespiratory fitness, muscular exercise capacity and flexibility in breast cancer survivors.

II. To determine whether a 12-week exercise intervention will improve risk parameters of metabolic disease by measuring changes in body composition, waist circumference, blood pressure, and circulating levels of glucose, insulin, lipids components and C-reactive protein in breast cancer survivors.

III. To determine whether a 12-week exercise intervention will conduce to changes of cancer-related biomarker by measuring in serum levels of dickkopf-related protein 1 (DKK1), secreted frizzled-related protein 1 (SFRP1), sclerostin, osteoprotegerin, osteopontin, growth differentiation factor 15 (GDF-15), insulin like growth factor 1 (IGF-1), and IGFBP-3 in breast cancer survivors.

IV. To determine whether a 12-week exercise intervention will result in a improvement in inflammatory cytokines and adipokines by measuring in serum levels of interleukin 1 beta (IL-1β), IL-10, IL-11, tumor necrosis factor alpha (TNFα), leptin and adiponectin in breast cancer survivors.

V. To determine whether a 12-week exercise intervention will conduce to changes of myokines by measuring in serum levels of brain-derived neurotrophic factor (BDNF), IL-8, IL-15, fatty acid-binding protein 3 (FABP3), leukemia inhibitory factor (LIF), follistatin, fractalkine, fibroblast growth factor 21 (FGF-21), osteonectin and irisin in breast cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Have diagnosed as a stage of I-III breast cancer
* Have undergone a lumpectomy or mastectomy
* Have completed neoadjuvant/adjuvant chemotherapy and able to initiate Exercise program
* Nonsmokers (i.e., not smoking during previous 12 months)
* Able to provide physician clearance to participate in exercise program for 12 weeks

Exclusion Criteria:

* History of chronic disease including diabetes, uncontrolled hypertension or thyroid disease
* Weight reduction \>= 10% within past 6 months
* Metastatic disease
* Participate in more than 60 minutes of exercise per week in the past 6 months
* Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity
Registry for Upper Gastrointestinal Bleeding

This project aims to evaluate the data on all patients undergoing endoscopic therapy for upper gastrointestinal bleeding.

This project is being performed to evaluate the outcomes of patients undergoing endoscopic procedures for upper gastrointestinal bleeding at all AdventHealth hospitals in Central Florida. This information will enable quality control of patients undergoing treatment for upper gastrointestinal bleeding across all campuses in the AdventHealth system in Central Florida and hence improve the delivery ot care extended to the investigator's patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years of age or greater
* Patient is undergoing endoscopic treatment for upper gastrointestinal bleeding

Exclusion Criteria:

* Under the age of 18
* Patient not undergoing endoscopic treatment for upper gastrointestinal bleeding
Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?

The purpose of this study is to compare the levels of immune and inflammatory markers among HIV-1, HSV-2 co-infected adults achieving plasma HIV RNA suppression to \<50 copies/mL, between those randomized to valacyclovir and placebo, over a twelve-week intervention period.

Highly active antiretroviral therapy (HAART) has dramatically reduced HIV-1 infection (herein referred to as 'HIV') related morbidity and mortality, transforming an invariably fatal disease into a manageable, chronic condition. Yet even HAART-treated HIV infection is characterized by chronic systemic inflammation and immune activation. This systemic inflammatory response is composed of multiple components, and can be quantified by measuring markers of immune activation, inflammatory cytokines, acute phase reactants, endothelial activation markers, and markers of microbial translocation. This inflammation is clinically relevant, as it may contribute directly to HIV disease progression and non-AIDS related morbidity and mortality in HIV-infected patients. Because this inflammation persists even in the context of suppressive HAART, albeit at modestly decreased levels, adjunctive therapeutic strategies to attenuate this persistent inflammatory response are therefore needed. Herpes simplex virus type 2 is a common, clinically important co-infection seen in individuals living with HIV infection, and may contribute to this ongoing inflammation. This pilot trial will investigate whether short-term valacyclovir for HSV-2 suppression can decrease systemic inflammation in HAART-treated, HIV-1, HSV-2 co-infected individuals.

Eligibility Criteria:
Inclusion Criteria:

* adult (aged 18 years or older)
* documented HIV-1 infection (determined by EIA and Western blot)
* documented HSV-2 seropositivity (determined by ELISA during screening)
* no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study
* sustained plasma HIV RNA\<50 copies/mL on HAART for at least 12 months
* no active opportunistic infection for at least 12 months

Exclusion Criteria:

* hepatitis C co-infection
* hepatitis B co-infection
* pregnancy or actively planning to become pregnant
* receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, TNF-alpha antagonists, etc.)
* Estimated creatinine clearance \<30 mL/min
* Other medical condition likely to cause death within 24 months
* Enrolled in any other interventional clinical trial
Surgical Management of Knee Septic Arthritis

Surgical excisional debridement is the mainstay of management in septic arthritis with necessary decompression, lavage, debridement, and partial synovectomy. However, there has been considerable debate over the optimal modality. Most surgeons perform an open arthrotomy or arthroscopic debridement, although serial aspiration can be considered as an option in very limited circumstances with patients who cannot tolerate surgery. While open arthrotomy has been often utilized, there has been an increasing number of proponents for arthroscopic treatment citing lower re-infection rates and better functional outcomes. However, there has been a lack of well-designed prospective studies comparing surgical treatment modalities for native knee septic arthritis. The goals of this present study are to determine if arthroscopic management of septic arthritis in the native knee resulted in a lower number of surgeries and a shorter length of stay compared to open arthrotomy. Secondary outcomes included differences in postoperative pain and improvements in Lysholm knee scores.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years old)
* Have a diagnosis of septic arthritis of the native knee (synovial WBC \>50k or acrystalline elevated synovial WBC \>25,000 with high clinical suspicion)
* Willingness to participate in the study

Exclusion Criteria:

* Unwilling to participate in the study
* Acrystalline elevated synovial WBC \< 25,000
* Crystalline arthropathy with elevated synovial WBC but \< 50,000
* Have a history of a prior knee prosthesis (hemiarthroplasty, total knee arthroplasty)
Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients

Primarily, this clinical investigation compared the efficacy of tamoxifen + aminoglutethimide vs. tamoxifen alone in terms of prognosis (overall survival) in postmenopausal patients with potentially curative, operated hormone receptor-positive breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal patients with histologically verified, locoradically treated, invasive or minimally invasive breast cancer
* Hormone receptor-positive status
* More than 6 histologically examined lymph nodes
* Laboratory parameters

  1. hematopoiesis: \> 3500/µl leucocytes, \> 100,000/µl thrombocytes
  2. renal function: creatinin \< 1.5mg%
  3. hepatic function: GOT \< 2.5 x UNL
  4. bilirubin: \< 1.5mg %
  5. metabolic parameters: Na, Ca, K in normal range, normal level of blood sugar
* Concluded healing process following surgery
* Less than 4 weeks interval since surgery
* Informed consent

Exclusion Criteria:

* Premenopausal patients, non-determinable menopausal status
* Previous radiotherapy, chemotherapy or endocrine treatment
* Generalized disease (as verified by lung X-ray, skeletal X-ray, liver ultrasound)
* Contraindications against tamoxifen or anastrozole
* T4 tumors; carcinoma in situ
* Lacking compliance or understanding of disease
* Karnofsky Index \< 3
* Serious concomitant disease
* Septic complications, systemic infections or infectious local processes
* Bilateral ovariectomy or ovarian irradiation
* Second carcinoma or status post second carcinoma (except for treated squamous cell carcinoma of the skin or cervical carcinoma in situ)
Interned-delivered Intervention Based on Acceptance Principles

The main objectives for the online intervention were the following:

Designing and implementing an internet-delivered prevention program based on acceptance principles, to support LGBT participants to tackle emotional difficulties more effectively and to become more resilient;

Helping LGBT individuals to remain out of the clinical level of depression and anxiety;

Creating this primary prevention program as a suitable strategy for LGBT individuals to confront emotional difficulties by targeting key risk factors before they evolve further.

This study is part of a research project which addresses a topic under the thematic area of "social sciences and humanities, including gender studies and social inclusion studies." The study targets a particularly disadvantaged group known as the LGBT (lesbian, gay, bisexual, and transgender) community.

The psycho-social and socioeconomic status, in a broader sense, encompasses more than just financial, educational, and occupational aspects. This status also includes the quality of life, an attribute that is consistently dependent on physical and psychological health.

Evidence suggests that people who identify as LGBT are susceptible to various inequalities, including differences in incomes, workplace, and social discrimination. The participants also may suffer from marginalization, poorer mental and physical health, and even legal discrimination (e.g., no recognition of same-sex unions).

This study aims at implementing evidence-based interventions meant to improve the quality of life within the LGBT community. The investigators will also provide mental health support for young LGBT people to cope with potential adverse events.

The implementation of the study will contribute in achieving the three objectives presented above. For instance, by developing and validating an online intervention meant to increase the identity self-acceptance among LGBT participants, the investigators will provide an easily accessible tool to apply the research results with expected positive mental health outcomes for this target group.

Eligibility Criteria:
Inclusion Criteria:

* be fluent in Romanian,
* be at least 18 years of age,
* sexual orientation: gay or bisexual,
* having low or moderate symptoms for at least one of the following self-report scales: generalized anxiety - GAD7 between 5 - 14; social anxiety - SPIN between 21 - 40; depression - PHQ9 between 5 and 14; alcohol - AUDIT between 8 and 14

Exclusion Criteria:

* suicidal ideation (i.e., if exceed a score of 1 on suicide item 9 from PHQ9);
* changes in the dosage if psychotropic medication during the last month (if present),
* have bipolar disorder or psychosis (according to medication status),
* have an alcohol/substance abuse and/or dependence (i.e., AUDIT score \> 15),
* have high/clinical levels of anxiety, social anxiety or depression (above the cut-off range - see above)
* currently take part in other psychological treatment,
* obvious obstacle to participation (i.e., no current Internet access, long travel plans during the treatment period etc.)
Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC)

This is a phase II study of an investigational drug, Axitinib following prior antiangiogenic therapy in patients with advanced hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a primary cancer of the liver. Angiogenesis is a physiological process involving the growth of new blood vessels from pre-existing vessels. A tyrosine kinase is an enzyme that can inhibit angiogenesis. In this study, patients with advanced HCC who have failed prior antiangiogenic therapy, will receive Axitinib in cycles of 4 weeks. Axitinib is an oral, potent and selective inhibitor of angiogenesis. This study will evaluate the response rate of HCC following treatment with Axitinib as well as safety, feasibility, overall survival of patients, progression-free survival, and quality of life in persons with unresectable HCC. The study also compares response determined by RECIST to response determined by Choi Criteria.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable and/or metastatic Hepatocellular Carcinoma
* Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
* Life expectancy of ≥12 weeks
* At least one tumor lesion
* At least 2 weeks since the end of prior systemic treatment
* No evidence of pre-existing uncontrolled hypertension
* ECOG 0 or 1
* Adequate organ function
* Not appropriate for curative therapy
* Child A or B7 cirrhosis
* CLIP score ≤ 4

Exclusion Criteria:

* Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment
* Major surgery \<4 weeks or radiation therapy \<2 weeks of starting the study treatment
* Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma
* Severe acute or chronic medical or psychiatric condition
* Need for treatment with prohibited drugs
* Has received local therapy to all measurable lesions
* Stage B8 or higher liver cirrhosis
* Ascites refractory to diuretic therapy
* Clinically significant ECG abnormality