cyrilzakka/clinical-trials huggingface dataset:
HanYang University Medical Center (HYUMC) Registry

The HYUMC registry is a two-center, real-world registry of percutaneous coronary intervention in patients with coronary artery disease. From January 2012, PCI-treated patients from Hanyang University Seoul Hospitals and Hanyang University Guri Hospitals were enrolled in this registry.

The aim of this registry is to examine the long-term clinical outcomes and identify predictors of adverse outcomes following percutaneous coronary intervention conducted at academic hospitals.

In the HYUMC registry, the researchers have gathered and assessed various demographic, laboratory, echocardiographic, and angiographic measurements (both on-admission and during follow-up), as well as conducted questionnaires among patients who underwent percutaneous coronary intervention. The primary focus of this registry is to examine the effects of these parameters on long-term clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

Consecutive patients with CAD who underwent PCI one or more drug eluting stent (DES) with from 2012 at the Division of Cardiology of Hanyang University Seoul Hospital and Hanyang University Guri Hospital, Korea.

Exclusion Criteria:

* second or subsequent hospitalization records of patients with multiple admissions
* patients who died during index hospitalization
* patients who treated with first-generation drug eluting stent
* patients with an outpatient follow-up record of less than 6 months
* patients with insufficient medical records.
Membranous Nephropathy-associated Serological Antibody Predict the Prognosis of Idiopathic Membranous Nephropathy

Idiopathic membranous nephropathy (IMN) remains a common cause of the nephrotic syndrome in adults and one of the leading known causes of end-stage renal disease. Identification of circulating autoantigens provide potential biomarkers for diagnosis and therapy of idiopathic membranous nephropathy. M-type phospholipase A2 receptor (PLA2R) and Thrombospondin type-I domain-containing 7A (THSD7A) were identified as the target antigen in membranous nephropathy with high specificity and the concentration of serum anti-PLA2R antibody and anti-TSHD7A antibody were helpful for predicting disease activity. In our prospective cohort study, hospitalized patients diagnosed as IMN are prospectively studied. Circulating anti-PLA2R antibody and anti-THSD7A antibodies were recently screened by using enzyme-linked sorbent assay(ELISA). This study aims to analyse the difference of clinicopathological characteristics for different concentrations of serum anti PLA2R antibody and anti TSHD7A antibody, and analyze the association between baseline concentrations of serum antibody and disease activity. This study also explored the prediction effects of serum antibody concentrations with different types of therapeutic regimen in IMN and compare the curative effects of different types of therapeutic regimen in different serum antibody concentrations.


Eligibility Criteria:
Inclusion Criteria:

* (1) Patients who provided informed consent
* (2) Patients who are diagnosed as membranous nephropathy by renal biopsy
* (3) 18 years of age or older, male or female

Exclusion Criteria:

* (1) identification of Secondary factors such as infectious diseases, rheumatic diseases, tumors, drugs and so on
* (2) Previous medicine history of immunosuppressive medication and corticosteroids
* (3) Patients who are not expected to complete 6 months of follow-up
Effect of Lithotomy Position on Optic Nerve Sheath Diameter

In this study, the effect of increased venous return and increased intra-abdominal pressure on intracranial pressure in the lithotomy position was evaluated.

In the lithotomy position, it is possible that venous return in the lower extremities increases and intra-abdominal pressure increases due to the position. At the same time, it is possible that the intracompartmental pressure in the extremities increases because the venous structure is compressed by placing the lower extremities on supports. Considering both conditions, it is predicted that there may be an increase in the optic nerve sheath diameter due to increased intracranial pressure in patients placed in the lithotomy position. The aim of this study is to investigate the effect of the position on intracranial pressure by ultrasonographically evaluating the optic nerve sheath diameter in the lithotomy position.

Eligibility Criteria:
Inclusion Criteria:

* Patients who give informed consent
* Patients who will undergo retrograde intrarenal surgery
* Patients who are fully oriented and cooperative
* ASA I-II patients
* Patients between the ages of 18-65

Exclusion Criteria:

* Disoriented and uncooperative patients
* Patients with BMI\>30
* Patients who have had previous intracranial surgery
* Patients who have had eye surgery before
* Patients allergic to the pharmacological agents used in the study
A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma

The study evaluates whether ASN-002 is safe and effective in the treatment of nodular basal cell carcinoma (nBCC) in patients aged 18 years or over.

The participants will receive weekly injections of ASN-002 alone or in combination with 5-FU for 3 weeks and undergo surgical excision of the tumor.

The primary purpose of this study is to determine whether ASN-002 alone or in combination with 5-FU is safe and effective in the treatment of nodular basal cell carcinoma (nBCC).

Patients aged 18 or over, who have been diagnosed with nodular Basal Cell Carcinoma (nBCC), may be eligible to join this study.

Study details:

ASN-002 is an immunotherapeutic product that is injected into the BCC spot to be treated. It is made from modified adenovirus serotype 5 (also called Ad5). Adenoviruses are common in nature worldwide and can cause mild colds and respiratory infections from which people usually recover without treatment. The Ad5 used in this study has been modified so that it cannot grow in the body or cause an infection. The modified Ad5 in this study will deliver artificially made genetic material into the cancerous and surrounding cells. This genetic material will produce human interferon which is normally produced by the body to stimulate the immune system. It is hoped that injected ASN-002 will cause the body's own cells to produce interferon and stimulate the immune system to attack the cancerous cells and reduce the size of or eliminate the nBCC. Participants will attend the study centre weekly for an injection of ASN-002 alone of in combination with 5-FU into the nBCC. The participants recruited will have 3 injections over 3 weeks, and then undergo surgical excision of the tumor.

Patient outcomes will then be assessed using a tumour sample collected during surgery and by the incidence of adverse events which occur throughout the study.

It is hoped that the findings of this trial will provide information on the safety and efficacy of using ASN-002 alone or in combination with 5-FU for nBCC, particularly for patients in whom the standard treatment of surgery is not possible or not recommended.

Eligibility Criteria:
Inclusion Criteria:

1. Low risk nodular basal cell carcinoma
2. Biopsy of any other skin tumor
3. Willingness to have injection therapy followed by surgery
4. Written informed consent

Exclusion Criteria:

1. No or only minimal symptoms
2. Known or suspected metastatic disease.
3. Pregnant or Lactating females
4. Clinically active or uncontrolled skin disease
5. Immunocompromised or receiving immunomodulating agent
6. treatment with psoralen plus Ultraviolet A or Ultraviolet B light therapy within 6 months
7. Any serious or active medical or psychiatric illness
8. Recreational or therapeutic drug or alcohol use
9. Taking any investigational product within 1 month of first dose of ASN- 002.
Modulation of Remifentanil-induced Postinfusion Hyperalgesia

In addition to alleviate pain there is growing evidence that µ-opioids enhance pain. This problem is known as opioid induced hyperalgesia(OIH).The NMDA receptor is involved in opioid induced hyperalgesia it may be possible to block OIH by cyclooxygenase inhibitors. This has been demonstrated with parecoxib, a COX-II inhibitor, in a experimental pain model.Both COX-1 and COX-2 are expressed in the spinal cord. It would be of interest to investigate whether a COX-1 preferring inhibitor like ketorolac also can reduce opioid induced hyperalgesic in this experimental pain model.

Remifentanil is an fast acting opioid which has become very popular to use during surgery.

There are studies, both experimental 1-3 and clinical 4;5, which indicate that remifentanil after end of infusion trigger enhanced pain experience and enhanced opioid consumption postoperatively.

Therefore it is important to look at possibilities to block this enhanced pain experience (opioid induced hyperalgesia - OIH). Ketamin has demonstrated to block this effect 5;6 through the NMDA receptor. Unfortunately ketamin has some seriously side-effects like hallucinations, and is therefore not suitable in ordenary clinical use.

Recently, it has been demonstrated that parecoxib (a COX-2 inhibitor) can prevent remifentanil-induced postinfusion hyperalgesia in a study on healthy volunteers.7 COX-2 inhibitors have some disadvantages because of the longterm adverse effects like cardiac arrest. Therefore it would be of interest to look at a COX-1 preferring NSAID, like ketorolac, to see if also non-selective NSAIDs can partly block remifentanil-induced postinfusion hyperalgesia.

To investigate this and to provoke pain and secondary hyperalgesia we use an intradermal electrical pain model which is well established.1;7-9 Detailed description of this model look at reference 7. H0 : Parecoxib prevents remifentanil postinfusion secondary hyperalgesi. Ketorolac does not prevent remifentanil postinfusion secondary hyperalgesi HA : Parecoxib and ketorolac prevent remifentanil postinfusion secondary hyperalgesi.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Allergy to the drugs used in the study
Surgical Pulmonary Vein Isolation Efficiency Study

A substantial proportion of patients undergoing elective coronary artery bypass grafting have a history of paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation has adverse short-and long term postoperative effects. Pulmonary vein isolation (PVI) seems to be effective treatment for paroxysmal atrial fibrillation. PVI can be done concomitantly with coronary artery bypass grafting, aortic valve replacement for aortic stenosis and combination of them. Procedure is well defined and safe.

There is a lack of convincing evidence of the effect on postoperative atrial fibrillation burden, quality of life and symptoms especially in correlation with atrial fibrillation paroxysms.


Eligibility Criteria:
Inclusion Criteria:

* American College of Cardiology (ACC)/ American Heart Association (AHA) -Indications for CABG
* At least 2 ECG-verified (12-channel ECG, Holter telemetry) symptomatic paroxysmal atrial fibrillation episodes within last 12 months
* Duration of the atrial fibrillation episode must not exceed 1 week and it must reverse to sinus rhythm spontaneously or by cardioversion
* written and verbal consent

Exclusion Criteria:

* Prior cardiac surgery
* Active pacemaker treatment
* Active anti-arrhythmic treatment(AAD) class I and III
* Contraindication to oral anticoagulant/heparin treatment
* Ejection fraction less than 30 % (EF \< 30 %)assessed by transthoracic echocardiography
* Left atrial diameter less than 55mm assessed by transthoracic echocardiography
* Renal insufficiency requiring dialysis
* Heart valve disease requiring invasive treatment
* Heart anomaly requiring regular controls and/or invasive treatment
Reducing Isolation and Feeling of Loneliness During Critical Illness

The trial is a pilot-randomized trial testing feasibility and limited-efficacy of delivering social engagement using technologic strategies to reduce periods of social isolation.

Patients with critical illnesses such as sepsis and acute respiratory failure (ARF) who require an ICU stay are at high risk of developing anxiety, depression, post-traumatic stress disorder, and cognitive deficits. Risk factors for emotional and cognitive impairments after ICU include underlying systematic illness, as well as consequences of life-saving therapies. In brief, patients are frequently restricted and even restrained to the bed, provided high dosages of sedatives, develop delirium, and are isolated from family and staff for extended periods of time. Moreover, the ICU environment including lights, noises, and the social isolation have a serious negative impact on cognitive function and emotional health status. Prospective data from the ICU demonstrate that critically ill patients in ICU spend two-thirds of their time completely alone.

Patients who have survived describe their ICU experience as a traumatic event similar to war, and testimonials for the ICU Recovery clinic frequently resemble: "I felt like I was being held captive in an unknown basement." Periods of social isolation in daily life as well as in the hospital have a significant negative impact on patient-centered outcomes including increased risk of disability, frailty, and mortality. Our study will examine the feasibility of delivering social engagement interventions using technology such as virtual reality (VR) to reduce feelings of isolation and loneliness. There have been a handful of projects to reduce anxiety and depression using a myriad of delivery techniques including journaling in a diary, emotional-behavioral therapy, face-to-face social engagement and family engagement using face-time and VR. These projects, however, have not examined the impact of social engagement on reducing periods of isolation and loneliness. We hypothesize that social engagement delivered using VR technologies will reduce periods of social isolation and thus improve anxiety, depression, and post-traumatic stress disorder (PTSD).

Eligibility Criteria:
Inclusion Criteria:

* adult
* admitted to ICU with acute respiratory failure (ventilation via tube or mask or HFNC)

Exclusion Criteria:

* previous cognitive or emotional health condition
* inability to follow commands
A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer

To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer


Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18 to 75 (inclusive)
2. HER2 positive (IHC3+ or ISH+) unresectable or metastatic breast cancer confirmed by histology or cytology.
3. ECOG score is 0 or 1
4. An expected survival of ≥ 12 weeks
5. At least one measurable lesion according to RECIST v1.1 criteria
6. Have adequate renal and hepatic function
7. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. Have other malignancies within the past 5 years
2. Active central nervous system metastasis without surgery or radiotherapy
3. In (neoadjuvant) adjuvant therapy phase, the interval from the end of systemic therapy (excluding endocrine therapy) to the detection of recurrence/metastasis ≤12 months
4. Presence with uncontrollable third space effusion
5. Have undergone other anti-tumor treatment within 4 weeks before the first dose
6. A history of immune deficiency
7. Clinically significant cardiovascular disorders
8. Known or suspected interstitial lung disease
9. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
10. Known hereditary or acquired bleeding tendency
11. Active hepatitis and liver cirrhosis
12. Presence of other serious physical or mental diseases or laboratory abnormalities
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer

The purpose of this study is to investigate safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per RECIST v1.1
* Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting if such a therapy exists
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Ability to swallow tablets
* Adequate bone marrow and organ function, as defined by the protocol

Exclusion Criteria:

* Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll)
* Ocular melanoma
* Any significant acute or chronic medical illness
* Prior malignancy
* Other active malignancy requiring concurrent intervention
* Prior organ allograft or allogeneic bone marrow transplantation
* Participants with active, known, or suspected autoimmune disease
* Requirement for daily supplemental oxygen
* Uncontrolled or significant cardiovascular disease
* Pre-existing liver disease
* Gastrointestinal disease known to interfere with absorption

Other protocol defined inclusion/exclusion criteria could apply
Beta Amyloid PET/CT in Various Aβ-Related Disease

To evaluate the potential usefulness of 18F-92/AV45, 11C-PIB positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various Tau-related disease patients.

Subjects with various Tau-related disease patients underwent 18F-92/AV45, 11C-PIB PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-92/AV45, 11C-PIB PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Aβ PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
A Randomized Air Filter Intervention Study of Air Pollution and Fetal Growth in a Highly Polluted Community

The purpose of this study is to use an air filter intervention to evaluate the relationship between particulate matter air pollution exposure during pregnancy and fetal growth. We hypothesize that: 1) portable high efficiency air (HEPA) filters will produce major reductions in home indoor concentrations of particulate matter and 2) pregnant women whose exposures to particulate matter are reduced by this intervention will give birth to children with greater mean body weight for gestational age.

In an extended follow-up of this cohort, we aim to evaluate the relationship between use of portable air purifiers during pregnancy and the growth and development of children from birth to age four years. In particular, the follow-up study will focus on children's physical growth, respiratory symptoms, and behavioral, social and neurocognitive development.


Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years)
* Pregnant woman in first trimester (\<14 weeks)
* Single gestation pregnancy
* Non-smoker

Exclusion Criteria:

* Multiple-gestation pregnancy
* Current smoker
* Currently operating an air filter in the home
* Currently living in a ger (traditional Mongolian felt-lined yurt)
* Plan to give birth outside of a hospital or clinic in Ulaanbaatar
Gene Therapy in Treating Patients With Unresectable, Recurrent, or Refractory Head and Neck Cancer

Participant with squamous cell cancer of head and neck are invited to participate in this study. In this study the investigators will be Inserting the gene for interleukin-12 into a person's cancer cells with the anticipation to make the body build an immune response to kill more tumor cells.

This is a Phase I/II trial to study the effectiveness of gene therapy in treating patients who have unresectable, recurrent, or refractory head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

* Females must be non-pregnant and non-lactating and either surgically sterile (via hysterectomy or bilateral tubal ligation), at least one year post-menopausal, or using acceptable methods of contraception for the duration of the study.
* Male subjects must be surgically sterile or using an acceptable method of contraception for the duration of the study.
* Disease: biopsy-proven unresectable or recurrent/refractory squamoussell_eareinoma_of_the:head-and-neck-(usualLy -Stage-Di-or-IV) -
* Tumor accessible to direct injection
* Karnofsky performance of at least 70%
* Life expectancy of at least three months
* Able to give written informed consent

Exclusion Criteria:

* Infection (concurrent or within previous 2 weeks)
* Active or clinically-relevant viral illnesses.
* Use of corticosteroids, high-dose non-steroidal antiinflammatory, or immunosuppressive drugs
* Chemotherapy, radiotherapy or immunotherapy within 28 days of study entry or during the course of study
* Respiratory disease sufficient to influence oxygenation of arterial blood
* Active liver disease with transaminases \>3 times the upper limit of normal
* Previous history of liver disease
* NYHA Class EU or greater heart failure
* Serum creatinine of greater than 1.5 times the upper limit of normal
* Polymorphonuclear neutrophilic leukocyte count \<3,000/mm3
* Platelet count \<50,000/mm 3
* Tumor involving major blood vessels or obstructing the airway
* Previous treatment with viral-based gene therapy, recombinant DNA products, or bacterial plasmids
* Use of an investigational drug within 30 days of screening
* Other malignancies requiring treatment during the study
* Scheduled surgical resection
* History of autoimmune disease, including rheumatic disease, Crohn's disease, etc. ,
* Known allergy to polyvinylpyrrofidone (PVP) or related products
* History of psychiatric disabilities or seizures.
Pharmacokinetics and Hepatic Safety of EGCG

A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.

This will be a randomized, multi-center, pharmacokinetics and hepatic safety trial of EGCG with 36 total patients in 3 treatment arms. 36 women will be randomized to one of the following groups: EGCG daily alone, EGCG daily with clomiphene citrate and EGCG daily with letrozole. The randomization scheme will be stratified for age groups 18-29 and 30-40 and presence of uterine fibroids. The pharmacokinetics and hepatic safety of EGCG with clomiphene citrate and letrozole are unknown. The trial conducted in women with and without fibroids will allow comparisons between these groups. The results of this study will be used to confirm hepatic safety for the larger multi-center FRIEND study.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy women ≥18 to ≤40 years of age with or without uterine fibroids
2. Must use a double-barrier method for contraception

Exclusion Criteria:

1. Subjects using green tea/EGCG within 2 weeks prior to study enrollment
2. Known liver disease (defined as AST or ALT\>2 times normal, or total bilirubin \>2.5 mg/dL).
3. History of alcohol abuse (defined as \>14 drinks/week) or binge drinking of ≥ 6 drinks at one time).
4. Subject using hormonal contraceptives
5. Subjects who are pregnant or breastfeeding
6. Known hypersensitivity to the study drugs
7. Any chronic disease