cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy and Safety of Entelon Tab. 150mg in Patients With Osteoarthritis of Knee

This clinical trial is planned to prove Entelon tab. arm is not inferior to Celebrex cap. arm in terms of the efficacy and safety through the change of K-WOMAC's total score sum in patients with osteoarthritis of knee.


Eligibility Criteria:
Inclusion Criteria:

1. both gender,35 years ≤ age ≤ 75 years
2. patients with a diagnosis of OA(osteoarthritis) of the knee within 3 months prior to study participation, as determined by the American College of Rheumatology clinical and radiographic criteria as follows.

   1. knee arthralgia
   2. more than one case among

      * 50 years or over

        * morning stiffness less than 30 min

          * friction sound
   3. osteophyte in radiography
3. Kellgren and Lawrence Scale Grade II\~III
4. total sum of K-WOMAC Scale more than 30
5. negative results in pregnancy test of urine in screening period
6. if women in childbearing age, medically reliable contraception or menopause
7. patients who give written consent of agreement to voluntarily participate in the clinical study
8. patients who can read and understand written instructions

Exclusion Criteria:

1. patients whose total sum of K-WOMAC in visit 2 is less than that in visit 1
2. fibromyalgic, anserine bursitis, infectious arthritis, rheumatoid arthritis, ankylosing spondylitis, gout or pseudogout
3. knee OA with secondary causes including major dysplastic or congenital malformation, ochronosis, acromegaly, Hemochromatosis, Wilson's disease or primary osteochondromatosis
4. anatomical malformation, disease of vertebra or other lower extremities or other disease of orthopedics which can disturb the evaluation of the target joint
5. wound, inflammation or avascular necrosis of the target joint or arthroscopy within 6 months prior to study participation
6. patients with administration of injectable hyaluronic acid to the target joint within 6 months prior to study participation
7. severe ischaemic heart diseases, peripheral artery disease and/or cerebrovascular disease, congestive heart failure, active bronchial asthma
8. medical history of malignant tumor
9. active peptic ulcer, gastrointestinal tract bleeding or inflammatory bowel disease
10. hypersensitivity with aspirin, celecoxib, corticosteroid, acetaminophen, sulfonamide derivatives or vitis vinifera or intolerance with fructose, glucose or galactose
11. continuously(1 week or more) oral or intraarticular administration of corticosteroids within 12 weeks prior to study participation
12. pregnant or lactating women
13. patients who have experience to participate in other clinical trial within 4 weeks prior to study participation
14. ALT, AST and Serum Creatinine ≥ 2×UNL
15. drug administration after diagnosing as alcoholic or psychical disease
16. patients whom the investigators judge as improper to participate in this clinical trial
Early Detection of Relapses in Stage IV Colorectal Cancer Patients

This study is a prospective, multicenter, observational study on metastatic, operable colorectal cancer to evaluate the proof of concept of the cfDNA analysis for the early detection of recurrences


Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmed adenocarcinoma of the colon or rectum with synchronous metastatic disease (localized in liver or in liver and lung) eligible for surgery immediately or after neo-adjuvant treatment.
2. Planned primary treatment at one of the REDCLOUD participating hospital centers.
3. Evidence of at least one measurable lesion, as per RECIST 1.1.
4. Male or female ≥ 18 years of age at time of informed consent.
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. No prior chemotherapy neither for localized nor for metastatic disease.
6. No major comorbidities that would preclude the compliance with the planned therapeutic program as judged by the Investigator.
7. Life expectancy \> 3 months.
8. Availability of biological samples (blood and tumor tissue).
9. Patients enrolled in local prospective protocols, in which samples have been collected according REDCLOUD procedures may be included.
10. Signed and dated informed consent.

Exclusion Criteria:

1. Any physical or medical condition that would contraindicate chemotherapy and/or surgery.
2. Any other metastatic site, except for liver and lung metastases
3. Transplant recipients
4. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing will only be conducted in jurisdictions specifically requiring it.
5. Known active hepatitis B or hepatitis C infection.
6. Pregnant or lactating women
7. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ adequately treated
Study to Observe the Safety and Efficacy of Etanercept (Enbrel®) in Patients With Moderately Active Rheumatoid Arthritis in Every Day Clinical Practice in Austria

This is a prospective non-interventional observational study to evaluate the treatment of moderately active RA patients in every day clinical practice in Austria. Patients will be observed over 52 weeks. The primary endpoint will be percentage of patients who reach CDAI remission after 24 weeks.

Non-interventional observational study, national, multicenter prospective non-interventional study (NIS) as defined by the Austrian Drug Law § 2a Section 3 N/A

Eligibility Criteria:
Inclusion Criteria:

1. The patient is eligible to receive Etanercept treatment according to the Austrian SmPC.
2. The decision to treat the patient with Etanercept has been made independently by the physician and is clearly separated from the decision to include the patient in the study. The treatment decision was made in advance and is not dependent on the protocol.
3. The patient was informed about the study and gave his/her consent and signed an Independent Ethics Committee (IEC) submitted written Informed Consent form on use of the data.
4. The patient has moderately active RA, defined as a disease activity of CDAI \>10 and ≤22 and/or DAS28 (CRP)\>3.2 and ≤ 5.1

Exclusion Criteria:

1. Any contraindication according to the Austrian SmPC, which includes:

   A hypersensitivity to any component of Etanercept, active tuberculosis or any other serious infection.
2. Patient has previously participated in this study.
Hepatocyte-specific Versus Extracellular Contrast Agents for Liver MRI: Prospective, Intra-individual Comparison of Diagnostic Performance for Hepatocellular Carcinoma

Adult patients with chronic hepatitis B and cirrhosis of any etiology who are found to have suspected liver cancer are potentially eligible for the study. All enrolled patients will undergo two MRI scans using two different contrast agents. The type of contrast agent for the 1st MRI will be performed using hepatocyte-specific contrast agent. The participant will undergo the 2nd MRI using extracellular contrast agent. The MRI examinations will be independently interpreted by two different radiologists. The radiologists will evaluate focal hepatic lesions and categorize them according to the LI-RADS v2018 and EASL 2018. Once the diagnosis is made, the participants will be provided with the standard of care. After the initial treatment, the participants will be followed up with multi-phasic dynamic contrast-enhanced CT every 3 or 6 months for at least 2 years. Based on the prospectively written radiology reports, the diagnostic performances will be calculated and compared between MRI with hepatocyte-specific contrast agent and MRI with extracellular contrast agent, using the pathology and clinical criteria as the reference standard.


Eligibility Criteria:
Inclusion Criteria:

1. Older than 20 years
2. HBsAg (+) with chronic hepatitis or cirrhosis, anti-HCV (+) with cirrhosis, or cirrhosis of any etiology

   * The presence of cirrhosis will be determined based on the histologic or radiologic findings, including liver surface nodularity, margin blunting, segmental hypertrophy/atrophy, and findings secondary to portal hypertension (i.e., splenomegaly, esophageal or gastric varices, ascites, or reverse portal vein flow).
3. Child-Pugh class A or B
4. Up to three suspicious focal lesions between 10 mm and 30 mm found on US, CT, or MRI

   * Patients with a history of HCC treated by surgery or tumor ablation could be included, but only new nodules at a distance of \> 2 cm from previously treated lesions were considered.

Exclusion Criteria:

1. Currently pregnant or lactating
2. Risk group for the use of gadolinium-enhanced MRI including severely decreased renal function (stage 4 or 5 chronic renal failure with eGFR ˂ 30 mL/min/1.73 m2), claustrophobia
3. Patients with history of chemoembolization or systemic treatment for liver cancer
A Randomized Controlled Trial To Evaluate The Use Of Botox In Breast Reconstruction With Tissue Expanders

Investigation of whether injection of the pectoralis muscle with 100 units botulinum toxin during breast reconstruction with tissue expanders results in decreased pain using a blinded, randomized, controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral mastectomy with immediate tissue expander reconstruction

Exclusion Criteria:

* Unwilling to receive study injections
Comparative Study of Cycloplegic Refraction and Subjective Refraction With Fogging in School Age Children

A thorough ophthalmic examination of a child must include a refraction and this is often done with cycloplegia. In our study, we aim to determine at which age group a non-cycloplegic refraction technique closely correlates with a cycloplegic refraction and hence, would obviate the need for cycloplegic refraction in our routine clinical practice.

The accommodative response in young phakic patients has been known to result in over-estimation of myopia and subsequently inappropriate prescriptions. Therefore, the rationale for cycloplegia is to inhibit the accommodative response in order to obtain a true measurement of the refractive error.

Different cycloplegic agents have been in common use for the last five decades. Cyclopentolate is widely used and is commercially available in concentrations of 0.5% and 1%. Tropicamide is another widely used cycloplegic agent and is available in 0.5% and 1% concentrations.

The advantages of a non-cycloplegic technique would be firstly, the avoidance of any possible harmful effects from the cycloplegic agents used. Secondly, it would vastly reduce waiting times for parents and children and allow for a much more efficient clinical service. Finally, there may be a significant cost-saving feature involved if these cycloplegic agents are no longer required.

This will be a prospective clinical audit/survey involving children between the ages of 4 years and 13 years who attend the paediatric ophthalmology clinics in KK Women's and Children's Hospital as well as the Singapore National Eye Centre.

All eligible children will have had a cycloplegic refraction and a non-cycloplegic refraction with fogging. A survey of children between the ages of 4 and 13 years who have had refraction with both these techniques will be undertaken and the difference in spherical error between the 2 techniques will be recorded for each child. We aim to accumulate 15 children from each age group.

Eligibility Criteria:
Inclusion Criteria:

1. As part of the ophthalmic evaluation, will undergo non-cycloplegic and cycloplegic refraction.
2. Informed consent has been obtained from a parent or guardian.
3. Aged between 4 years and 13 years old.
4. Able to cooperate with examination(s) as stated.

Exclusion Criteria:

1. Known allergy or adverse reaction to cyclopentolate.
2. Unable to cooperate with examination(s) stated.
3. Parent or guardian objection.
Non-inferiority Trial Between Sotair® Device Attached to Manual Resuscitator Versus Mechanical Ventilation

Effective respiratory ventilation is achieved by moving the right amount of air in and out of the lungs while keeping the pressures at a safe level. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery. In this non-inferiority study, we will perform a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation.

Poor manual ventilation technique is a well-documented problem which occurs irrespective of a provider's qualifications or experience. A disposable safety device, Adult Sotair®, was created to improve manual ventilation delivery among providers. The device is attached to a bag valve mask (i.e. manual resuscitator) and employs a flow limiting valve mechanism to minimize excessive pressure in the airway system without venting air by capping peak flow rates at 55 L/min. For an average adult with normal lung compliance and resistance, this corresponds to a maximum airway pressure of approximately 20 cmH2O which minimizes air entry into the stomach. In this non-inferiority study, a pre-post study design (single group, within-group comparison) to test the non-inferiority of the Adult Sotair® device compared to mechanical ventilation with respect to airway pressure.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who are scheduled for non-emergency surgery with general anesthesia at Rhode Island Hospital.
* American Society of Anesthesiologists physical status 1 and 2

Exclusion Criteria:

* ASA PS \>3 (e.g., respiratory disease)
* Oropharyngeal or facial pathology
Effects of Imatinib Mesylate in Polycythemia Vera

The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.

The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.

Hematocrit \<45% in men or \<42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
* Age \>18 years
* Signed written informed consent form

Exclusion Criteria:

* Pregnancy or breast-feeding
* Creatinine \>3 max NV
* Bilirubin \>3 max NV
* AST/ALT \>3 max NV
* Concomitant and severe psychiatric disorder
* Concomitant neoplastic disease
Evaluation of the Performance of Chembio's DPP(R) Syphilis Screen & Confirm Rapid Test System

This study has been designed to evaluate the performance of the Chembio Diagnostics Systems, Inc. DPP® Syphilis Screen and Confirm rapid test. The device is intended to qualitatively and simultaneously detect the presence of antibodies to Non-treponemal and Treponema pallidum antigens in whole blood (capillary and venous), serum or plasma.

Syphilis is a sexually transmitted disease (STD) caused by the spirochete Treponema pallidum. It is a chronic bacterial infection that remains a public health concern worldwide, especially in resource poor settings. Syphilis can be transmitted from infected women to their unborn children during pregnancy. Worldwide 12 million individuals are diagnosed with syphilis each year, 90% of them in developing countries. Diagnosed individuals are also at risk of becoming infected with and transmitting HIV \[1\].

Early and appropriate diagnosis and treatment prevents the transmission and development of severe complications. A rapid serologic test for specific antibodies to non-Treponemal and T. pallidum antigens is important in the early diagnosis and treatment monitoring of syphilis patients. In turn, this monitoring allows for the formulation of a more successful public health strategy. Various serologic tests are currently available such as Venereal Disease Research Laboratory (VDRL), rapid plasma reagin (RPR), fluorescent Treponemal antibody absorption (FTA-ABS) test, T. pallidum hemagglutination (TPHA) test, immunoenzymatic assay (EIA), Treponema pallidum particle agglutination (TPPA) test and Western blot (WB) test \[2- 5\]. The Chembio DPP Syphilis Screen \& Confirm Assay is a unique non-Treponemal and Treponemal rapid point-of-care test, which is simple and easy to use. The DPP Syphilis Screen \& Confirm Assay is a qualitative immunoassay for the detection of antibodies to the non-Treponemal and T. pallidum antigens in serum, plasma and whole blood.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 13 years of age (no upper age limit).
* Must be willing and able to receive post-test counseling, if applicable.
* Must sign (and be given) a copy of the written Informed Consent form and or Assent form (if applicable).
* Must be able to sustain fingersticks and venipuncture from the arm or hand only.

Exclusion Criteria:

* Persons who are under 13 years of age
* Persons who are unable to sustain venipuncture (as determined by investigator)
* Have previously participated in this clinical trial
* Persons who do not provide an informed consent, or withdraw consent.
Massage Therapy for Cancer-Related Fatigue

The purpose of this study is to develop methods for studying the effect of bodywork therapy on symptoms of fatigue in patients undergoing cancer chemotherapy.

The proposed project is a randomized pilot trial of a Swedish-style massage therapy intervention for the treatment of fatigue in patients who are undergoing cancer chemotherapy. Fatigue is the most common complaint of patients receiving treatment for cancer, but is often difficult to treat and causes a substantial decrement in patients' quality of life. Massage therapy is a non-invasive intervention used in many patients with cancer for symptom control. Prior small studies have suggested some efficacy of bodywork therapies in conditions characterized by fatigue, such as fibromyalgia and chronic fatigue syndrome. Based on these results, massage therapy may provide an important adjunct in ameliorating fatigue and enhancing cancer patients' well being.

The proposed study is a 12-week, randomized, three-arm, parallel-comparison clinical trial comparing the effects of a Swedish-style massage regimen to a sham bodywork control and a usual-care group for fatigue reduction in cancer patents undergoing chemotherapy. Patients with breast, ovarian, prostate, or colo-rectal cancer will be enrolled; the primary outcome measure is a quantitative assessment of fatigue symptoms. This study will determine efficacy, functioning, perceptions of fatigue, and quality of life. This study should provide not only important data on the potential efficacy of massage therapy for the treatment of fatigue, but also advance the methodology for studying CAM interventions for difficult-to-treat symptomatic conditions.

Eligibility Criteria:
Inclusion criteria:

* Confirmed tissue diagnosis of cancer of the breast, ovary, prostate or colo-rectum
* Have an anticipated completion of chemotherapy no more than 2 weeks before the last bodywork session.
* Have a primary oncologist
* Currently receiving chemotherapy or completed chemotherapy treatment within the past 6 months

Exclusion criteria:

* Active skin rash or open cutaneous lesions.
* History of venous thrombosis (or symptomatic varicosity)
* Identification of a thrombosis using an ultrasound test of the legs.
* Long term (\> 3 months) steroid medications for other medical conditions in past 5 years
* Plans to move out of the study region within 6 months
* Thyroid-stimulating hormone (TSH) level above the upper limit of normal
* Hematocrit \<25%
* Platelet count of \< 50,000
* Patients who have been receiving regular (i.e. at least twice a month) bodywork over the past 6 months.
Adenoid Vegetations in Adult Patients

In this observational cross-sectional study " the clinical characteristics of adenoid vegetations in adulthood will be investigated.

Adenoid vegetations typically appear in childhood and are well described in this population. However, in adulthood, adenoid vegetations appear rarely and their characteristics have not been described.

The clinical characteristics of adenoid vegetations in adulthood will be investigated, and compared with clinical characteristics of adenoid vegetations in childhood.

Eligibility Criteria:
Inclusion Criteria:

* patient with adenoid vegetations

Exclusion Criteria:

* other concomitant otorhinolaryngological diagnoses
* hypertrophy of the tonsils
* oropharyngeal carcinomas
* chronic sinuitis
* allergic rhinitis
Psychoeducational Groups for Adults With ADHD

This pilot study aims to assess patient satisfaction and preliminary efficacy of a psychoeducational group treatment, using a randomized waitlist-controlled trial, at two different outpatient clinics in mid-Norway. All participants will receive standard treatment during the intervention period. Assessment of client satisfaction (CSQ 8), general self-efficacy (GSE-6), ADHD-related quality of life (AAQoL) symptoms of ADHD (SCL-9; ASRS), and work participation will be conducted at time of recruitment prior to randomization (T0), pre- (T1), post-treatment (T2), with a 10 week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* confirmed ADHD diagnosis
* speaking a Scandinavian language

Exclusion Criteria:

* not able or willing to give informed consent
* psychosis
* severe learning difficulties
Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets

This is an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients treated with Glucophage tablets.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 2 diagnosed (Baseline Glycemia \> 7,0 mmol/L (126 mg/dL) or overload Glycemia \> 11,0 mmol/L (198 mg/dL)
* On treatment with metformin tablets
* Patients with at least 2 treated co-morbidities
* Established dose of Metformin \> 1.700 mg/day
* Age \> 18 years old
* Given informed consent

Exclusion Criteria:

* Patients not able to take medication orally
* According to Summary of Product Characteristics (SmPC)
* Participating in another clinical trial 30 days prior to randomization
* Any other illness or medical or psychiatric condition, severe and uncontrolled that could interfere in the patient's participation or in the assessment of the study results
Phenylephrine Versus Ephedrine in Pre-eclampsia

Phenylephrine administration is associated with reductions in CO and SctO2 compared with ephedrine when used for blood pressure management in women with pre-eclampsia undergoing cesarean delivery under spinal anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* Age ≥18 yrs
* Pre-eclampsia (mild, or severe)
* Non-laboring women
* CD under spinal anesthesia

Exclusion Criteria:

* Height \< 5'0"
* Allergy to phenylephrine or ephedrine, or any other standardized medication
* Severe Cardiac disease in pregnancy with marked functional limitations (NYHA Class III and IV)
* Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
* History of recent amphetamine or cocaine use.
* Subject enrollment in another study involving a study medication within 30 days of CD
* Any other physical or psychiatric condition which may impair their ability to cooperate with study data collection