cyrilzakka/clinical-trials huggingface dataset:
The Clinical Study to Evaluate Immunogenicity of Epodion® in Anemia Associated With CKD Patients

The study was conducted to assess safety and immunogenicity of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority.

This study consisted of a screening period (4 weeks) and treatment period (52 weeks). Evaluation for immunogenicity effect using ADA (Anti Drug Antibody) detection will be done at weeks 0, 24, and 52 and blood sampling for Routine Hematological tests as supporting data will be conducted every month following hospital regulation. For each subject, the end of the study is the last day of the Blood sample will be drawn In the case of a subject that has left the study (withdrawn), the exit date will be the end of the study. The safety evaluation was conducted based on the incidence of the adverse events local and systemic reactions.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have anemia associated with Chronic Kidney Disease (CKD) under hemodialysis treatment.
* Male or female patients aged ≥18 years.
* Patients with mean Hb concentration when screening is around ≤10 g/dL.
* Patients on stable, adequate dialysis for at least three months (defined as no clinically relevant changes of hemodialysis regimen and/or 23/42 ©EMEA 2007 dialyzer).
* Has ever been using Epodion treatment in the at least last 1 month.
* Haemodialysis patients who likely to remain on Epodion treatment for 52 weeks.
* Informed consent given in a written form after being provided with detailed information about the nature, risks, and scope of the clinical trial as well as the expected desirable and adverse effects of the drug.

Exclusion Criteria:

* History of Pure Red Cell Aplasia (PRCA) or anti-epoetin antibodies.
* Contraindications for ESA therapy.
* Systemic immunosuppressive medication or any other drugs known to adversely affect the hemoglobin level.
* History of uncontrolled hypertension (defined as systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg during screening).
* Any blood transfusion within the last 2 weeks prior to screening period.
* Major surgery within 3 months prior to screening period.
* Myelodysplastic syndrome.
* History bleeding disorders (e.g. Hemophilia, Von Willebrand, and any conditions that result when the blood cannot clot properly).
* Known bone marrow fibrosis (osteitis fibrosa cystica).
* Known epilepsy.
* Liver cirrhosis with clinical evidence of complications (portal hypertension, splenomegaly, ascites).
* Systemic lupus erythematosus.
* Previously diagnosed with HIV or acute hepatitis infection.
* History of malignancy of any organ system within the last 5 year.
* Pregnancy or lactation period in female patients.
* Heavy smoker (who smoke over 20 cigarettes daily in average).
PREDICT: Thinking About Pregnancy Risk in Women With Kidney Disease

Currently, there is no robust evidence about how women with Chronic Kidney Disease (CKD) perceive pregnancy risk. The aims of this research are to understand women with CKD's perception of risk in pregnancy. In order to provide appropriate pre-pregnancy and antenatal counselling including accurate presentation of risk of pregnancy outcomes, it is important to establish how do women with CKD perceive their risk in pregnancy. In addition, to facilitate discussion about pregnancy for women with CKD, it is critical to understand key psychosocial factors influencing their risk perceptions.

This study will be conducted in two phases. In phase one, risk perceptions in women with CKD who are contemplating pregnancy will be quantitatively measured with potential influencing psychosocial factors including their illness perceptions, quality of life, anxiety, depression and perceived social support. Demographic, pregnancy-intentions, medical and pregnancy histories will also be collected. Phase one findings will establish to what extent do women with CKD perceive their pregnancy risk.

In phase two, perception of risk, pregnancy intention and behaviour, will be qualitatively explored in women with CKD who perceive high and low degrees of risk. This sub-study will facilitate understanding about which factors and experiences impact risk perception and their relationship with pregnancy intentions and behaviour.

The objectives for this research are:

1. To understand how women with CKD perceive their pregnancy risk.
2. To examine the associations between biopsychosocial factors (demographics, psychosocial factors, renal and pregnancy history) and women with CKD's perception of risk in pregnancy.
3. To examine the relationship between pregnancy-related intention and perception of pregnancy risk in women with CKD.
4. To gain an in-depth understanding of the biopsychosocial factors which influence risk perception and pregnancy-related behaviour, in women with CKD who perceive high and low risk perceptions.

To achieve these objectives this study is divided into two phases:

Phase 1: Quantitative assessment of risk perception and biopsychosocial factors in women with CKD Phase 2: Qualitative exploration of risk perception in women with CKD with high and low risk perception scores

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CKD stages 1-5 according to KDOQI guidelines)

  * ≥18 years old
  * Planning a pregnancy
  * Adults who have the capacity/capability to provide fully informed consent for the study

Exclusion Criteria:

* Already established on haemodialysis or peritoneal dialysis
* Women \< 18 years old or \>50 years old
* Inability or unwilling to give informed consent
* Does not speak English
Expanded Access to Convalescent Plasma for the Treatment of Patients With COVID-19

This expanded access program will provide access to investigational convalescent plasma for patients in acute care facilities infected with SARS-CoV-2 who have severe or life-threatening COVID-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease.


Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years
* Laboratory confirmed diagnosis of infection with SARS-CoV-2
* Admitted to an acute care facility for the treatment of COVID-19 complications
* Severe or life threatening COVID-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease
* Informed consent provided by the patient or healthcare proxy

Severe COVID-19 is defined by one or more of the following:

* dyspnea
* respiratory frequency ≥ 30/min
* blood oxygen saturation ≤ 93%
* partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
* lung infiltrates \> 50% within 24 to 48 hours

Life-threatening COVID-19 is defined as one or more of the following:

* respiratory failure
* septic shock
* multiple organ dysfunction or failure

Exclusion Criteria:

* None
Efficacy and Tolerance Evaluation of a Topical "Revitalizing" Face Day Cream

Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the "revitalizing" activity of a face cream applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by healthy female volunteers aged 45-55 years with face ritidosis and women aged 55-65 years not habitual user of antiage-creams.

The study foresaw the comparison within subjects of the study product versus placebo (half face method).

It was also aim of this study to evaluate products efficacy and cosmetic acceptability by the volunteers and tolerance both by investigator and volunteers.


Eligibility Criteria:
Inclusion Criteria:

* female healthy subjects
* age 45-55 years
* women aged 55-65 years who are not habitual user of antiage-creams
* presence of moderate face ritidosis
* agreeing to present at each study visit without make-up
* accepting to not change their habits regarding food, physical activity, face cleansing and make- up use
* accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study
* accepting to sign the Informed consent form

Exclusion Criteria:

* pregnancy
* lactation
* change in the normal habits regarding foods, physical activity, face cleansing and make-up use during the month preceding the test
* sensitivity to the test products or theirs ingredients
* subjects whose insufficient adhesion to the study protocol is foreseeable
* participation in a similar study actually or during the previous 3 months
* change in the normal life habits during the month preceding the inclusion
* dermatological disease (dermatitis; presence of cutaneous disease on the tested area, as lesions, scars, malformations; recurrent facial/labial herpes)
* clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.)
* diabetes
* endocrine disease
* hepatic disorder
* renal disorder
* cardiac disorder
* pulmonary disease
* cancer
* neurological or psychological disease
* inflammatory/immunosuppressive disease
* drug allergy
* drugs/cutaneous medical or surgical procedures at level of the tested area during the previous 3 months
* anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with except of contraceptive or hormonal treatment starting from at least 1 year);
* assumption of drugs able to influence the test results in the investigator opinion
Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer

Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

Upon determination of eligibility, all patients will be receive:

Gemcitabine + Epirubicin + Docetaxel

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Adenocarcinoma of the breast confirmed by biopsy
* Female Patients \>18 years of age
* Normal cardiac function
* Ability to perform activities of daily living with minimal assistance
* Chemotherapy naïve or have received prior chemotherapy \> 5 years ago
* Adequate bone marrow, liver and kidney function
* Be informed of the investigational nature of this study
* Sign an informed consent form
* Sentinel lymph node and/or axillary dissection prior to enrollment

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Life expectancy of \< than 6 months
* History of significant heart disease
* Prior chemotherapy or hormonal therapy
* Concurrent Trastuzumab therapy
* History of significant psychiatric disorders
* History of active uncontrolled infection

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
DEB-TACE With Visualable Microspheres Versus PVA Microspheres for HCC

This study will evaluate the safety and efficacy of DEB-TACE with visualable embolization microspheres versus PVA microspheres for hepatocellular carcinoma.

This study is a prospective, multicenter, randomized controlled, non-inferior trial to evaluate the safety and efficacy of DEB-TACE with visualable microspheres or PVA microspheres for hepatocellular carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* CNLC Ia-IIIa HCC patients who require transarterial chemoembolization (TACE) and are not suitable for or refuse surgical resection, liver transplantation, or ablation Liver function classification of Child-Pugh A or B
* ECOG PS score of 0-2
* With measurable lesions that had not been embolized (if there are more than 3 lesions, select the three largest lesions as target lesions, and the maximum diameter of target lesion is ≤10cm)
* Agree to participate in this trial and voluntarily sign the informed consent form

Exclusion Criteria:

* Target lesions were embolized, or will require concomitant ablation or radiotherapy after TACE treatment(s)
* With diffuse liver tumor or extrahepatic metastasis, expected survival \<6 months With sepsis or multiple organ dysfunction
* Severe liver dysfunction (Child-Pugh C) , or severerenal dysfunction (blood creatinine \>2 mg/dL)
* Significant reductions in white blood cells or platelets (white blood cells \<3.0×10\^9/L, platelets \<50×10\^9/L, hemoglobin\<60g/L) that cannot be corrected (except splenomegaly or chemotherapy-induced bone marrow suppression) Uncorrectable coagulation dysfunction (PT prolonged by \>3 seconds above the upper limit of normal)
* With severe infection (\>5 times the upper limit of normal white blood cells) The main portal vein was completely embolized by tumor thrombus without collateral blood supply
* With risk of ectopic embolization (uncorrected arteriovenous fistula or portal venous fistula) in the target lesion supplying arteries
* Angiography shows vascular anatomy obstruction or vasospasm that will affect the catheter placemenr embolic agent injection
* Known allergy to iodine-containing contrast agents, polyvinyl alcohol materials or anthracycline t ochemotherapy drugs
* Pregnant or lactating women
* Patients who are participating in other trial(s)
* Unsuitable for participation in this trial deemed by the researchers
Horse-assisted Intervention, Heart Rate Variability & Stress

In this study, the effects of an animal-assisted intervention on people with increased stress levels are investigated. The data collected will be compared with those of participants with high stress levels but without animal-assisted intervention (participants only observe nature) and with a control group consisting of people without stress exposure.

The study will be performed in the following setting: Questionnaire examination on chronic stress, questionnaire on current well-being and heart rate variability (HRV) measurement before the horse-assisted intervention, one HRV measurement and one questionnaire examination (POMS) on current well-being after the horse-assisted intervention, one questionnaire (POMS) on current well-being 5 days after the horse-assisted intervention.

The early recognition of chronic stressors, which are often neglected by those affected until physical symptoms appear, is of essential importance. In addition to psychopharmacological therapy modalities, complementary methods such as animal-assisted intervention should also be considered in order to expand the therapeutic spectrum and thus prevent stress-associated consequential harms as early as possible.

Stress has gained importance in recent years not only in the medical context, but also due to its economic relevance. Chronic stress in particular leads to numerous medically relevant secondary diseases and to increased sick leaves and even permanent incapacity to work. One possible intervention to reduce stress could be animal-assisted intervention.

Primary hypothesis: The use of animal-assisted intervention in people diagnosed with chronic stressful situations will lead to measurable increases in heart rate variability.

Secondary hypothesis: The use of animal-assisted intervention in people diagnosed with chronic stressful situations leads to improved well-being (target parameter: POMS questionnaire)

Eligibility Criteria:
Inclusion Criteria:

* Male, female and diverse
* Age between 18-75 years

Exclusion criteria:

* Animal hair allergies (especially horse hair allergies, fear of horses)
* Acute severe psychiatric conditions (e.g. psychosis)
* Persons, unable to give signed informed consent,
* All persons, who have not signed the informed consent form.
Emergency Radiotherapy in Metastatic Spinal Cord Compression of Patients With Non-small Cell Lung Cancer

Acute neurological deficit in metastatic spinal cord compression is an emergency condition in radiation oncology. Despite some reports about the high efficacy of radiation treatment for oncological emergencies, a standard of care is not well defined, especially the time interval of immediate RT after deficit, and neurological outcome with respect to poor survival in non-small cell lung cancer patients. The objective of this trial is to investigate neurological outcome after emergency radiotherapy in metastatic spinal cord compression of non-small cell lung cancer patients with acute neurological deficit.

Subjects and recruitment 15 consecutive patients with histologically confirmed non-small cell lung cancer and bone metastases of the thoracic or lumbar segments of the vertebral column will be screened for this trial in the Radiooncology Department of the Heidelberg University Clinic. Inclusion criteria are an age of 18 to 80 years, acute neurological symptom caused by metastatic spinal cord compression, no radiotherapy in this spinal area before, and written consent to participate.

Design and procedures This is a prospective, controlled, explorative trial to investigate the neurological outcome after emergency radiotherapy in metastatic spinal cord compression of non-small cell lung cancer patients with acute neurological deficit. RT start within 12 hours after onset of neurological symptoms. The target parameters will be measured at the start of radiotherapy (t0), and six weeks after radiotherapy (RT) (t1). The target parameters comprise the documentation and completion of the ASIA Impairment Scale (AIS), and the recording of patient-specific data.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria are an age of 18 to 80 years, acute neurological symptom caused by metastatic spinal cord compression, no RT in this spinal area before, and written consent to participate.

Exclusion Criteria:

* neurological symptom more than 12 hours before
Therapeutic Merit of Solifenacin in the Mitigation of Ureteral Stent-induced Pain and Lower Urinary Tract Symptoms

Most ureteral stent insertions follow ureteroscopy procedures for stone management. Stents are essentially designed to prevent the blockage of the ureter. Such blockage is often a result of inflammation caused by ureteroscopy procedures. The stent provides a secure passageway for urine as it travels from the kidneys to the bladder, circumventing potential urinary retention. In our community, only one kind of stent is used, and it is manufactured by Bard. Standard protocol involves the removal of the stent 5 to 8 days following insertion. If stenting is required for greater than 8 days, special accommodations will be made for you in this study.

Unfortunately, pain and lower urinary tract symptoms are often associated with the insertion and removal of stents. It is our goal to determine whether VESIcare is capable of relieving such symptoms.

As a prospective member of this study, you will be asked to complete three surveys. The first survey will ask you about your experiences of urinary urgency and pain before your surgery. If you are an emergency patient, you will be asked to remember your condition before the surgery, completing this questionnaire at your first post-op visit. If you are not an emergency patient, this survey will be completed before your surgery. If your stent is removed within 5 to 8 days of surgery, you will be asked to complete the second survey at the time of removal. You will then complete the final survey at a scheduled post-operative check-up 4 to 5 weeks later. If your stent remains inserted for greater than 8 days after surgery, you will be asked to complete the second survey 3 to 4 days after your stent was inserted. You will then complete the final survey, 7 to 8 weeks post-op.

Throughout this study, both VESIcare and non-VESIcare patients will be important in determining whether VESIcare truly is capable of relieving stent pain. As such, you will be randomly assigned to one of the two groups, those receiving VESIcare, and those who are not.


Eligibility Criteria:
Subject inclusion criteria.

1. Post-ureteroscopy for stone management.
2. Stent inserted for more than 5 days.
3. No significant flank pain or LUTS prior to kidney stones/stent insertion.
4. Complete agreement with and signing of Informed Consent form.

Subject exclusion criteria.

1. Significant flank pain or LUTS prior to kidney stones/stent insertion.
2. Currently taking antimuscarinics or α1 blockers.
3. Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.
Impact of Enhanced External Counterpulsation (EECP) on Cardiac Force Index

Regular exercise can prevent cardiovascular disease, but there is also a risk of sudden cardiac death. Exercise-related sudden death often occurs unconsciously and there is no relevant monitoring mechanism. The patent of the Cardiac Force Index (CFI), invented by Professor Chu, is a method to detect the state of cardiac motion. Recent studies have confirmed Enhanced External Counterpulsation (EECP) can increase cardiopulmonary fitness and maximal oxygen consumption. Our aim is to investigate the differences and effects of CFI between two groups with and without 4 weeks of EECP intervention, therefore, to find out the relationship between CFI and maximum oxygen consumption (VO2max).

Methods: A pre and post-test control group was designed. A total of 53 military students (33 males and 20 females) were recruited and divided into intervention and control groups. A 2000-meter running and maximum oxygen consumption tests were performed pre and post-test. The intervention group was conducted a 4 week (3 times per week/30 minutes) EECP intervention.


Eligibility Criteria:
Inclusion Criteria:

* can walk.

Exclusion Criteria:

* disabilities.
Bitter Taste and Weight Loss in Women

Individual food preferences are not considered in designing weight-loss therapies. This project will determine if short-term weight-loss is improved by matching participants with diets that reflect their genetically-determined food preferences.

Dislike of the diet is a common complaint in weight loss therapy that contributes to poor outcomes. Ironically, individual food preferences are rarely taken into account in designing weight-loss interventions. In the proposed research, we will utilize genetically-determined differences in food preferences, indexed by PROP bitter taste phenotype to develop a novel approach to weight loss therapy. The overall goal of this project is to determine if weight loss following a 6 month intervention can be substantially improved by matching participants with diets that reflect their genetically-determined food preferences. The study is designed as a randomized clinical weight-loss intervention trial in women in which PROP non-tasters and super-tasters. will be randomized to either the low-carbohydrate or the low-fat diet condition

Eligibility Criteria:
Inclusion Criteria:

Body mass index (BMI) between 27 and 40 kg/m squared No weight loss for 3 months prior to the study Stable hypertension, dyslipemia or Type 2 diabetes - with permission from primary care provider Oral therapy to treat Type 2 diabetes - with permission from primary care provider.

Able to walk 2 block without stopping

Exclusion Criteria:

Pregnant, lactating or planning to become pregnant during the trial History of cardiovascular disease (infarct, angina, arrhythmia or stroke) Recent chemotherapy or radiation therapy Liver, renal or thyroid disease Concurrent or recent (last 6 months) participation in any other weight loss intervention Insulin injection Medications to control appetite or weight Major psychiatric illnesses