cyrilzakka/clinical-trials huggingface dataset:
Post Market Surveillance to Observe Safety of Prevenar13™ in Adults

The purpose of this study is to assess safety profile of Prevenar 13™ when used among Korean adults in the routine clinical setting, as required for any new drug approved by Korea Food and Drug Administration (KFDA).

non-randomization, non-probability sampling

Eligibility Criteria:
Inclusion Criteria:

Korean adults aged 18 years and older; provided the conditions pertaining to contraindications, warnings, precautions, and interactions stated in the local product document do not apply.

* Evidence of a personally signed and dated informed consent document indicating that the subject(or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Subjects who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.
XuanwuH Acute Ischemic Stroke Registry

Acute ischemic stroke registry--Xuanwu Hospital(XSR) is an academic, independent, prospective, single center, observational registry study. Consecutive acute ischemic stroke patients assessed in stroke "green channel" of Xuanwu Hospital(China) will be enrolled in our study. Patients receive regular treatment and data will be collected as part of clinical routine. Baseline clinical and procedural information as well clinical follow-up information during in-hospital stay, and up to 90 days of stroke onset are collected. Data collected include demographics, National Institute of Health Stroke Scale (NIHSS) on admission, pre-treatment ASPECTS, information on timing and success of thrombolysis or thrombectomy, procedural complications, intracranial hemorrhage, and functional outcome.The study aim to investigate the real situation of assessment, diagnosis and treatment of acute ischemic stroke patients in "green channel",and verify the effect of the improvement of "green channel" process in the diagnosis and treatment of patients with acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute ischemic stroke or transient ischemic attack(TIA)
* Age \>18 years
* Ethic approval in process
* Receiving assessment in stroke "green channel" of Xuanwu Hospital

Exclusion Criteria:

* Non-acute ischemic stroke
Comparison of Drugs on Headache Treatment After ECT Treatment

Electroconvulsive treatment (ECT) is still actual for treatment of psychiatric symptoms. Headache is a very common symptom after this application. The investigators compare the effect of two different drugs for the treatment of headache after ECT.

Electroconvulsive treatment (ECT) is used as an alternative application instead of drug therapy for psychiatric symptoms. ECT application is repeated 8-12 times according to the treatment of the patient. This treatment is done in 2 or 3 days intervals. The most adverse effects of ECT are headache, memory disorders, myalgia, nausea and vomiting, cardiovascular problems. The most common seen adverse effect is headache with approximately 60% incidence. The main drugs used for the treatment of headache related to ECT are NSAIs and paracetamol. The aim of the current study is to compare the effect of paracetamol and dexketoprofen trometamol on headache treatment after ECT.

Eligibility Criteria:
Inclusion Criteria:

* All patients who were admitted for ECT and gave informed written consent were included in the study.

Exclusion Criteria:

* Exclusion criteria included patients who gave a history of allergy to acetaminophen, lacked capacity to give informed consent and developed complications such as delirium following ECT.
Decitabine in Treating Patients With Melanoma or Other Advanced Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients with stage III or stage IV melanoma or other advanced cancer that has not responded to previous therapy.

OBJECTIVES: I. Identify dosage level(s) of decitabine (DAC) that show biologic activity and acceptable side effects. II. Describe the side effects and toxicity of DAC at the doses studied. III. Determine the steady state DAC serum levels at the doses studied. IV. Document any clinical responses to DAC.

OUTLINE: A dose escalation schedule for the administration of decitabine (DAC) is being used to determine the MTD and biologically active dose. Patients are given two 12 hour continuous infusions per day, for 3 days at each dose level. A minimum of 3 patients are enrolled at each dose level until dose limiting toxicity (DLT) or biologic activity is observed. If DLT or biologic activity is observed at a particular dose level, an additional 3 patients are enrolled, for a total of 6. If 2 or more patients experience DLT, dose escalation is ceased.

PROJECTED ACCRUAL: Approximately 24 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Stage III (nonresectable) and IV melanoma, or any other advanced metastatic malignancy for which all standard therapy has failed Must have at least two cutaneous, mucosal or lymph nodal lesions that can be biopsied or one lesion large enough to be biopsied twice

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9.0 g/dL Platelet count at least 100,000/mm3 WBC at least 3500/mm3 Absolute granulocyte count at least 1500/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT and SGPT less than 2.5 times normal Renal: Creatinine no greater than 1.8 mg/dL Other: Not pregnant Not HIV or hepatitis BsAg positive No major systemic infections No coagulation disorders No major illness of cardiovascular or respiratory systems No symptomatic CNS disease or evidence of cerebral edema

PRIOR CONCURRENT THERAPY: No therapy for cancer within the past month
Distinguishing Retroperitoneal Fibrosis and Sarcoma from Other Retroperitoneal Diseases Via Radiomics

A retrospective study utilizing archived CT scans of patients diagnosed with retroperitoneal fibrosis, sarcoma or other malignancies (i.e. lymphoma, germ cell tumors, metastasis, infections, ganglioneuromas) in order to implement a radiomics algorithm which is able to differentiate between these malignancies.

The aim of this project is to develop a radiomics algorithm that can reliably identify retroperitoneal fibrosis (Ormond's disease) and retroperitoneal sarcomas, automatically segment them and differentiate them from other retroperitoneal diseases. Radiomics is a technique that uses artificial intelligence to extract characteristics from radiological image data that are not visible to humans and to identify image morphological patterns of diseases. As it is difficult to differentiate between diseases using image data alone, clinical data such as symptoms and laboratory values are to be correlated with the image data and utilized by the algorithm. Among other things, this should increase the sensitivity, accuracy and specificity of image-based diagnostics in order to enable faster, non-invasive diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age or gender.
* CT scans confirming the presence of a retroperitoneal mass.
* Confirmed diagnosis of retroperitoneal fibrosis, sarcoma or other malignancies (i.e. lymphoma, germ cell tumors, metastasis, infections, ganglioneuromas) through pathology reports or clinical follow-up.

Exclusion Criteria:

* Poor quality CT scans where the region of interest is not clearly visible.
* Previous treatments or surgeries that might alter the radiomic features of the tumors.
Steps to Health: Targeting Obesity in the Health Care Workplace

The proposal of this study is to compare the effectiveness of two worksite weight management programs at Duke: Steps to Health (STH) ('usual standard of care') and the more extensive Steps to Health Plus! (STH+). We have added an additional follow-up, by invitation only, for participants in the study who agreed to be contacted for future research.

Steps to Health and Steps to Health Plus! aim to help Duke employees achieve weight loss and maintain healthy weights. We will be following participants in these programs over a two year period. These two groups will be compared with an observational comparison group of employees who meet eligibility criteria but do not take part in the randomized controlled trial. We will assess whether the two programs decrease obesity-related injuries in the workplace and estimate the net costs of the two programs relative to their effectiveness more broadly.

In the additional follow-up, we will be assessing factors that may be related to program success. This will include a survey as well as some focus group data.

Eligibility Criteria:
Inclusion Criteria:

* Completion of a Health Risk Assessment
* BMI ≥ 30
* Able to read and understand study materials which are presented in English
* No plans to leave Duke in the next year
* Enrolled in one of the Duke health plans
* Not currently pregnant

Exclusion Criteria:

* Enrolled in the other available individual intervention programs (hypertension, cholesterol or pre-diabetes)
* Enrolling in one of the LFL weight management programs in order to qualify for bariatric surgery
Comprehensive Investigation of Opiates, Neuropeptides, Barrier Function, Scratching and Sleep Physiology

The purpose of this research is to study the sleep patterns of people with moderate to severe atopic dermatitis and how itching affects those patterns. This study will also measure your body's activity during sleep using non-invasive tests described below.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women who are between 18 and 50 years of age
* Diagnosis of moderate to severe atopic dermatitis including involvement of the forearm confirmed by published consensus diagnostic criteria57 (except for healthy control subjects)
* Subjects must be in general good health with no other skin disease, disease state or physical condition which would impair evaluation of their skin or which would increase their health risk by study participation
* Subjects must be willing to stay overnight in the sleep laboratory and/or to undergo dermal microdialysis
* Women of child bearing age will be required to have a negative pregnancy test in order to enroll in the study and will be required to maintain adequate birth control throughout the study.

Exclusion Criteria:

* Adults over age 50
* Children less than 18 years of age.
* Unable to complete the required measures
* Diagnosis with other skin diseases that would affect the measurement of transepidermal water loss (TEWL) as determined by the investigators
* Currently enrolled in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy and patients undergoing treatment with another investigational drug or approved therapy for investigational use within 28 days prior to study participation
* Evidence of depression based on the Beck Depression Inventory (BDI \> 10)
* Evidence of sleep apnea based on the results of the Epworth Sleepiness Scale score (ESS \> 10)
* Evidence of insomnia based on the Insomnia Severity Index (ISI) that is determined by the principal investigator to be unrelated to atopic dermatitis
* Individuals who work shifts between 8 pm and 6 am because such night shifts can alter subjects' circadian rhythms.
* Typically sleep less than 5 hours per night
* Reported habitual bedtime earlier than 9pm or later than 1 am (\> 2 times per week on screening diaries)
* Reported habitual rising time later than 9 am (\> 2 times per week on screening diaries
* Diagnosis of sleep apnea, periodic limb movement disorder, or restless leg syndrome 58
* Consumption of more than 3 alcoholic beverages per day
* Consumption of more than 4 caffeinated beverages per day 59-61
* Chronic pain judged to be a significant sleep-disturbing factor as determined by the investigators62
* Current treatment with lipophilic beta blockers, opioids, glucocorticoids, theophylline, or other medications known to interfere with sleep as determined by the investigators 63-69
* Uncontrolled asthma or COPD 70-73
* Uncontrolled thyroid disease 74,75
* Poorly controlled diabetes mellitus
* Poorly compensated congestive heart failure 76
* Use of herbal or naturopathic treatments for sleep
* Habitual smoking between 11 pm and 7 am 77,78
* Use of illicit drugs
Rehabilitation After Fast-track Total Knee Arthroplasty

BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in Denmark. The results after TKA is in general very good, the investigators have, however, discovered that patients following fast-track TKA still have a deficit 12 months postoperatively of 5-10% in health-related quality-of-life and 15-20% in activity and participation when compared to age- and gender matched population. A postoperative rehabilitation intervention has the potential to reduce or remove this observed deficit. The current evidence of postoperative rehabilitation after TKA is, however, scares and conflicting, and no studies have shown a lasting effect beyond 3 months postoperatively.

PURPOSE The purpose of this study is to investigate if a 6-weeks postoperative rehabilitation intervention is more effective than supervised home training, and furthermore to investigate the cost-effectiveness of the intervention in a societal perspective.

MATERIALS \& METHODS The study is performed as a randomized clinical trial. In total 140 patients are included in the study. Inclusion criteria are age above 18 years, patients diagnosed as having knee arthrosis, patients receiving primary elective TKA, and patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps. Exclusion criteria are unicompartmental or revision arthroplasty, any neurological disease, knee infection, and substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start. Primary endpoint is 6 months postoperatively and primary outcome measure is change in total score by using the knee specific questionnaire Oxford Knee Score.


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years
* patients diagnosed as having knee arthrosis
* patients receiving primary elective TKA and
* patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps

Exclusion Criteria:

* unicompartmental or revision arthroplasty
* any neurological disease
* knee infection and
* substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start
Preventive Application of Single-use Negative Pressure Wound Therapy (sNPWT) in the Postoperative Course of Radiotreatated Limb Sarcoma Surgery

Patients will be recruited at the time of the pre-admission visit. During the screening visit the patient will undergo a physical examination and his medical history will be collected. Oncological history and tumor characteristics will be considered and CT-scan imaging will be analysed. ECOG performance status will be reported. If inclusion criteria are respected, the patient will be randomized. The application of the PICO14 study device or standard dressing (dry gauze and plaster) will then be carried out on the day of surgery. For subjects randomized to the treatment arm (Arm A), dressing change with the application of the new PICO14 will occur at day 4+1, day 8±1, and day 14±2. For subjects randomized to the control arm (Arm B), the standard dressing with gauze and plaster is applied. Regardless of the randomization arm the wound assessment via ASEPSIS score will occur at day 4+1, 8±1 and 14±2. During FUP, the dressing can be changed autonomously by the patient if necessary. The information will be recorded on the occasion of the next visit or an extraordinary visit. On day 21, sutures will be removed.

On day 30±2, the total ASEPSIS score will be calculated, in order to evaluate the wound healing.

From day 14±2, regardless of the randomization arm all patients will be treated with standard dressing.

Follow-up visits can be scheduled up to 90 days after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* diagnosis of primary high-grade (grade III) soft tissue sarcoma of the limbs (confirmed histopathologically)
* performed neoadjuvant radiotherapy (short or long-term)
* candidates for wide radical excision surgery
* negative CT scan staging for distant metastasis
* Signing of Informed consent

Exclusion Criteria:

* diagnosis of benign neoplasm
* diagnosis of retroperitoneal or trunk sarcomas;
* candidates to hindquarter or forequarter amputation surgery;
* incomplete wide excision;
* vascular resection;
* other loco-regional treatments (e.g. isolated limb perfusion or electrochemotherapy).
This Study Uses Ultrasound to Determine Whether Atorvastatin or Pravastatin Effects the Progression of Coronary Plaque.

This study was designed to assess the effects on coronary artery plaque using aggressive lipid-lowering therapy versus moderate lipid-lowering therapy. A substudy will examine the effect of these treatments on brachial artery vasoactivity.


Eligibility Criteria:
Inclusion Criteria:

* Angiographic evidence of coronary artery disease as defined by a lesion that has at least 20% reduction in luman diameter by visual (angiographic) estimation in any native coronary artery. LDL cholesterol equal to 125mg/dl - 210mg/dl.

Exclusion Criteria:

* Patients who are anticipated to undergo coronary bypass surgery or cardiac transplantation during the course of the study. Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction.
Visual Field Defect Estimation Using Sequentially Optimized Reconstruction Strategy on Healthy and Glaucoma Subjects

Perimetry is a well-established method that is used to measure the visual field functions of humans. Commercially available products, such as the OCTOPUS 900 (Haag-Streit AG, Koeniz, Switzerland), are commonly used for assessing the visual field. Such devices are of critical value for patients suffering of glaucoma and neuro-ophthalmic conditions. The operating principle is to sequentially present light stimuli of different intensity at different locations within the visual field in an automatic way. Algorithms that select what locations and intensities to present over time are called strategies. These have the goal to provide both a fast and accurate estimation of the visual field function.

Recently, new strategies were developed that are faster and equally accurate as the strategies used today. The technological advancement of these new methods lies primarily in the ability to estimate location sensitivities without observing them directly but by leveraging previously queried locations. For this the investigators plan to implement the next generation of perimetry strategies into an OCTOPUS 900 and to test it in healthy subjects and glaucoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Cataract yes or no
* Age range 40 - 80 years
* Normal visual field (MD: \< +2 dB)
* Refractive error within ±5 dpt. spherical equivalent
* Astigmatism of \< -3 dpt.
* Visual acuity of ≥0.3 logMar (decimal ≥0.5)
* Experience in perimetry (history of at least one perimetry examination)
* False positive or negative errors each less than 20% in each examination
* Primary open-angle/ pseudoexfoliation/ primary angle-closure glaucoma
* Early to moderate visual field loss (MD: +2 to +12 dB)
* Written informed consent

Exclusion Criteria:

Exclusion criteria are children (\<18 years old), inability to follow the procedure, insufficient knowledge of project language, the history of other ocular diseases than glaucoma or cataract or other conditions that might affect visual field testing (e.g. pituitary lesions, demyelinating diseases).
North American Study for the Treatment of Refractory Ascites (NASTRA)

The NASTRA Clinical Trial is a multi-center, randomized, controlled clinical trial designed to determine if treatment with transjugular intrahepatic portasystemic shunts (TIPS) is superior to high volume paracentesis (total paracentesis, TP) for the treatment of refractory ascites due to cirrhosis. Only patients with clinically tense symptomatic ascites (shortness of breath, umbilical hernia, abdominal pain and/or distension, and/or limitation of activity) who have either diuretic-resistant ascites or diuretic-intractable ascites are being studied.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis as documented by biopsy or clinical/laboratory parameters WITH
* Tense symptomatic ascites and need for paracentesis (10 L) within last 2 months AND
* Failure of medical therapy as defined by the inability to lose at least 3.3 lbs/week while on maximum doses of diuretics or diuretic related complications (severe hyponatremia, hypercalcemia, azotemia or encephalopathy)

Exclusion Criteria:

* Causes of ascites other than cirrhosis and portal hypertension
* Terminal liver failure
* Portal vein thrombosis
* Congestive heart failure
* Acute renal failure
* Active encephalopathy
* Alcoholic hepatitis
* Pregnancy
Evaluation of Laser Treatment for Benign Pigmented Lesions by Non-invasive, Cellular Resolution Optical Coherence Tomography

In recent years, with the maturity of laser technology, laser therapy is one of the popular options for the treatment of pigment diseases. The absorption spectrum of melanin ranges from 300 to 1,000 nm. In past studies, the 532 nm Q-switched Nd:YAG laser is effective for the treatment of superficial melanin. But there are still some side effects in laser treatment, such as post-inflammation pigmentation (PIH), depigmentation, skin redness, etc., and PIH is particularly likely to occur on darker skin. However, there is still no good evidence as to what factors or laser treatments can cause PIH.

Therefore, in this study, we will use ApolloVue® S100 Image System (ApolloVue® S100 Image System is a medical device class II) to scan before and after skin of laser treatment to observe the changes in the skin condition. By observing and analyzing these changes, as a evaluation of predictors or prognostic factors after laser treatment and whether PIH will occur.


Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 20
* Both gender are accepted
* Subject with pigmented diseases
* The pigmented lesions which participating the trial were not treated in the last 12 months
* Accepts not to expose the face to sunlight or artificial UV rays during the study
* Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits
* During the trial period, willing to use the maintenance and sunscreen products provided in this trial for care

Exclusion Criteria:

* Pregnant woman or woman wishing to be pregnant during the study, or during breastfeeding period
* Has any condition which, in the investigator's opinion, would make it unsafe for participating in this research study
* Has systemic skin disorders or infections
* Is enrolled or accepted other investigational drug or medical device