cyrilzakka/clinical-trials huggingface dataset:
A Switch-Over Study of the Safety and Efficacy of ISU302 in Patients With Type 1 Gaucher Disease

The purpose of this study is to evaluate the safety and efficacy of ISU302 in patients with Type 1 Gaucher disease previously treated with Imiglucerase.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with type-1 Gaucher disease
* Patient who was stably treating Gaucher disease with Cerezyme® and who was maintaining the usage and dosage of Cerezyme® for at least 6 months prior to study drug administration
* Patient aged 2 years or higher
* Female patient with contraception during the study period (oral or injectable contraceptive hormones, intrauterine device, physical devices using condom, sponge form, jelly, and femidom, and abstinence)
* Patient who signed the informed consent form after hearing the detailed explanation about this study

  * Definition of the stable treatment of type-1 Gaucher disease:
* No neurologic deficit
* Normal hemoglobin concentration, and platelet count that has increased to ≥100,000/㎣, or maintained to 100,000/㎣
* Normal or no deteriorated bone mineral density
* Normal or no deteriorated splenomegaly or hepatomegaly

Exclusion Criteria:

* Patient who participated in other clinical studies within 90 days before study drug administration
* Patient with unstable hemoglobin and platelet counts for at least 6 months before study drug administration
* Patient with hypersensitivity to Cerezyme®
* Patient positive to HIV antibody, hepatitis B antigen, and hepatitis C antibody
* Patient with Fe, folic acid, or vitamin B12-deficcient anemia
* Patient who received miglustat within 6 months before study drug administration
* Patient who received erythrocyte growth factor or chronic systemic corticosteroids within 6 months before study drug administration
* Patient who had clinically significant splenic obstruction within 12 months before study drug administration
* Pregnant or lactating patient
* Patient who had serious concurrent diseases such as infectious diseases or drug-addicted patient
* Patient who was considered inappropriate for this study by the investigators or sub-investigators
Effects of Virtual Reality Exercise on Promoting Physical Activity and Health Among College Students

The purpose of this research is to examine the effectiveness of a 4-week immersive-virtual reality (VR) exercise bike intervention on college students' physiological outcomes (physical activity levels, cardiovascular fitness, and body composition) and psychological outcomes (situational motivation, situational interest, mood states, and depressive symptoms).


Eligibility Criteria:
Inclusion Criteria:

* College students age from 18 to 35 years old who are currently enrolled in the university
* College students without diagnosed physical and/or mental disabilities
* Must be willing to provide informed consent and compete the PA Readiness Questionnaire (PAR-Q)
* Must be willing to be randomized into an intervention or control group
* no self-reported motion sickness symptoms during immersive VR-based exercise

Exclusion Criteria:

* Students under the age of 18 or over the age of 35 years old or not currently enrolled in the university
* Having self-reported physical and/or mental disabilities
* Contradictions to PA participation as determined by PAR-Q responses
* having motion sickness reaction when exercising under VR-based condition.
Local Therapy for ER/PR-positive Oligometastatic Breast Cancer

Randomized phase 2 trial to evaluate the efficacy of local therapy for oligometastasis from ER/PR-positive breast cancer. The study hypothesis is that local therapy in addition to systemic therapy improves progression-free survival in comparison with systemic therapy alone.

Patients with estrogen receptor/ progesterone receptor-positive oligometastatic breast cancer with disease controlled after at least six months of systemic therapy will be enrolled in the study. Patients will be randomized to receive local therapy for oligometastatic sites in addition to systemic therapy or systemic therapy alone. Local therapy strategies will include surgery, radiotherapy, and radiofrequency ablation.

Eligibility Criteria:
Inclusion Criteria:

* Female sex
* ≥ 18 years of age
* Histologically confirmed invasive breast cancer, with oligometastatic disease defined as one of the following criteria: 1) One to four bone lesions; 2) One to four lung and/ or hepatic lesions; 3) Distant metastasis limited to ipsilateral cervical lymph nodes; 4) Distant metastasis limited to contralateral axillary lymph nodes
* Oligometastatic sites amenable to treatment with a local therapy modality, including surgical resection, stereotactic radiotherapy, or radiofrequency ablation
* Estrogen receptor-positive and/ or progesterone receptor-positive breast cancer
* Partial response or stable disease after at least six months of systemic therapy for breast cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Measurable or non-measuble disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
* Life expectancy of at least 12 weeks
* For women in childbearing age, negative pregnancy test until 21 days before the date of study enrollment.
* Signed informed consent form
* Disposition and aptitude to fulfill the study protocol during the study duration

Exclusion Criteria:

* HER2-positive breast cancer
* Progressive disease during the last systemic treatment received for metastatic disease
* Previous local therapy for distant metastasis
* Current or previous history of severe diseases, such as clinically relevant heart failure, acute myocardium infarction in the last six months, chronic obstructive lung disease, HIV infection, chronic active hepatitis B or C infection, current serious uncontrolled infections or other severe diseases that may impact patients' expected survival)
* Current or previous history of other invasive malignancy within the last five years, excluding non-melanoma skin cancer
DC Vaccination for Post-remission Therapy in AML

This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients.

Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.

20 patients with AML who are in remission (ELN criteria by Döhner et al 2017) receive WT1/PRAME autologous DC vaccine by intradermal injection once per week during the first 4 weeks and 1 per month thereafter for 23 consecutive months.

Primary objective is to assess the safety and tolerability of the DC vaccine in the aforementioned population and the feasibility.

Secondary objectives include evaluation of clinical response and exploratory immune monitoring assessments.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Acute Myeloid Leukemia (AML)
* Age 18 - 75 years
* Morphologic remission (CR) with or without hematological recovery (CRi) following induction chemotherapy
* WT1 with or without PRAME positivity by qPCR
* Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose
* Negative HIV 1 and 2 test, Hepatitis B and C test and negative Syphilis test at screening
* Informed consent signed prior to any trial related activities

Exclusion Criteria:

* Patients suitable for allogeneic stem cell transplantation
* AML M3 (acute promyelocytic leukemia)
* Patients not in complete remission (CR or CRi), bone marrow blast count ≥ 5 %
* Active immunodeficiency syndromes
* Concurrent active second malignancy other than non-melanoma skin cancers
* Clinically relevant autoimmune disease
* Prior immunotherapy
* Severe organ dysfunction precluding the apheresis procedure:
* Creatinine \> 200 mmol/l
* Bilirubin, ALAT and ASAT \> 3 x upper normal limit
* Respiratory insufficiency with pO2 \< 60 mmHg
* Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart failure \> grade II NYHA
* Recent cerebral hemorrhage
* Known allergies to substances used in the generation of DCs
* Other severe acute or chronic medical psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or the administration of the investigational product
* Use of corticosteroids
* Active CMV infection (Antibody-positivity due to previous, now inactive infection is accepted)
* Inability to comply with the trial protocol
* Participation in other clinical trials that, according to the investigator's discretion, may interfere with this trial
Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON

The purpose of this study is to determine whether levodopa/benserazide dispersible is effective in the adjunctive treatment of Parkinson's disease (PD) patients with delayed ON.

Delayed ON is one of the motor complications of advanced PD patients that effect of anti-parkinsonian medication is delayed more than 40 minutes after intake. In the most severe cases, the effect does not appear even until next medication schedule, so called "No ON" status. It is important to manage delayed ON properly because it can interfere motor functions and quality of life of PD patients.

Levodopa/benserazide dispersible can be absorbed rapidly in the intestine, so theoretically it can break the poor response to conventional treatment of PD patients with delayed ON. However, this has not been proven by clinical trials till now.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients between 31 and 80 years
* Parkinson disease (PD) was diagnosed by United Kingdom Parkinson disease brain bank criteria
* Patients receiving stable Levodopa treatment at least 2 weeks prior to baseline visit
* Delayed ON was confirmed by a specialized PD diary that records change in motor symptoms 90 minute after the first morning dose. Delayed ON is defined as delay of more than 40 minutes after the first morning dose for resolution of OFF state or experience of no ON state at least 1 per week.

Exclusion Criteria:

* Existence of cognitive decline hard to participate in the clinical trial or K-Minimental Status Exam score 24 or less
* Any contraindication of blood sampling
* Subjects with clinically significant psychiatric illness
* Subjects with a cancer or severe medical illness
* Lactating, pregnant, or possible pregnant
* History of malignant melanoma
* Subjects with narrow-angle glaucoma
* Subjects with hypersensitivity to levodopa or benserazide
* Subjects treated with non-selective monoamine oxidase (MAO)-B inhibitors
* Subjects with peptic ulcer, colitis, or gastrointestinal disease
Effect of Atmospheric Pollution on Obstructive Lung Diseases

Several studies have demonstrated the association between atmospheric pollution and chronic respiratory diseases. The magnitude of this association and its dependence of local factors are still unknown in Argentina, particularly for obstructive lung diseases like asthma and chronic obstructive pulmonary disease (COPD). The objective of this study is to assess the effect of atmospheric pollution due to particulate matter (PM) on asthma and COPD exacerbations in adults. A prospective cohort study will be carried out in patients attending the pulmonary service of a public hospital located in San Nicolas, Buenos Aires province, Argentina. Patients will be followed for 12 months after recruitment. The outcome variables will be the frequency of hospitalizations or emergency department consults for asthma or COPD exacerbations and related conditions, and the impact of COPD on a person's life as measured by the COPD assessment test (CAT) questionnaire. The exposure will be the pollution level in the particular address, measuring PM10 concentrations with portable equipment. Other variables as air temperature, humidity, and individual patient risk factors will be considered as potential confounders or effect modifiers. The associations will be estimated through regression models, i.e. logistic and Poisson regressions and recurrent event survival analysis. The results of this study should provide elements to estimate the risk of chronic respiratory diseases associated with atmospheric pollution, and to evaluate strategies for risk assessment in the local community.


Eligibility Criteria:
Inclusion Criteria:

* Patients with asthma or COPD attending the pulmonary service.

Exclusion Criteria:

* Patients who refuse to participate in this study or to sign the informed consent document.
Bioequivalency Study of 50 mg Cilostazol Tablets Under Fasting Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Cilostazol Tablets, 50 mg, to PLETAL® Tablets, 50 mg (OTSUKA Pharmaceuticals) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Cilostazol or any comparable or similar product.
Evaluating Contact Lens Optics

This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens


Eligibility Criteria:
Inclusion Criteria:

* Able to read and understand the informed consent document
* 18 to 39 years of age (inclusive)
* Best corrected visual acuity of 20/25 or better in the right eye
* Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)

Exclusion Criteria:

* Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens
* History of ocular trauma or surgery causing abnormal or distorted vision
* Current Rigid Gas Permeable (RGP) contact lens wearers
* Unwilling to have contact lens fit photographed
* Pregnant and/or lactating females, by self-report
Liposomal Bupivacaine in Bariatric Surgery

The aim of this study is to perform a randomized controlled trial for patients undergoing bariatric surgery, comparing the need for opiates with and without administration of a transversus abdominis plane (TAP) block using the long acting local anesthetic, liposomal bupivacaine (Exparel®). From this study, the investigators will assess whether use of long acting local anesthetic can reduce the need for opiates in the bariatric population.

A prospective randomized controlled trial investigating the use of long acting local anesthetic for transversus abdominis block in patients undergoing bariatric surgery at Montefiore Medical Center. Patients will be randomized to either receive an intraoperative TAP block with LB, an intraoperative TAP block with RB, or no TAP block. All participants will receive standard post-operative analgesia regimen. Pain scores will be recorded by the nursing staff as reported by the patients for 24-36 hours post surgery. Patients will be monitored for secondary post-operative complications up to the 2-week mark following intervention.

Eligibility Criteria:
Inclusion Criteria:

* Obese patients undergoing bariatric surgery (LSG or LRYGB)
* Patients 18 years of age and older
* Surgical treatment between 01/01/2018 and 12/31/2018 over a 1 year period

Exclusion Criteria:

* Patients under the age of 18 years old
* Patients taking any opiates within 30 days of enrollment in the trial
* Patients with a history of chronic pain.
* Patients taking pregabalin or gabapentin.
* ASA IV
* Prior laparotomy
* Body Mass Index ≥ 60 kg/m2
* History of cardiac arrhythmia
* History of Seizure
* Psychiatric Diagnosis currently on antipsychotic medication
Men Undergoing Radical Prostatectomy

The purpose of this study is to see if the protein pattern in your blood can predict whether or not your prostate tumor is aggressive. We will use a new and very sensitive technique, called mass spectroscopy, to measure hundreds of pieces of protein in your blood. A computer will make a picture of the protein pattern. We will do this in 500 men before their prostate surgery and see if there is a pattern that predicts what the tumor looks like under the microscope. We will also check the protein pattern in your blood 6 weeks to 12 months after the surgery to see if your pattern changes.

In this pilot study, we propose to address the question: is there a small peptide mass proteomic profile/pattern in blood that can distinguish men with a clinically insignificant/latent prostate cancer from men with more advanced pathological features? We will obtain a pre-operative blood sample from men with clinically localized prostate cancer undergoing radical prostatectomy and determine their preoperative small peptide mass proteomic profile. The pathological features of the radical prostatectomy will be determined and the patient will be classified as having either a pathologically insignificant/latent prostate cancer or a significant cancer. We will then analyze whether or not the small peptide mass proteomic profile in blood can distinguish these groups before radical prostatectomy. In addition, each of these patients will have a blood sample collected at least 6 weeks to 12 months after surgery to evaluate and compare changes that occur as a result of radical prostatectomy. This will determine the effect of radical prostatectomy on the small peptide mass proteomic profile in blood and determine if the proteomic profiles in blood collected prior to radical prostatectomy can identify men at increased risk for recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 18 years or older with clinically localized prostate cancer (cT1- T2NxM0)
* Scheduled for radical prostatectomy
* Prostate biopsy at least 6 weeks prior to scheduled radical prostatectomy
* Signed, informed consent
* Patient must be able to attend both the preoperative and postoperative blood draws.

Exclusion Criteria:

* A period of less than 6 months prior/current treatment with hormonal therapy (LHRH agonist/antagonist, antiandrogen, 5-alpha-reductase inhibitor).
* A period of less than 6 months prior/current treatment with an alpha-blocker
Arsenic Methylation Enzymes, Cigarette Metabolites, DNA Repair Enzymes, Inflammatory Factors and Urothelial Carcinoma

1. To investigate the relationship between arsenic methylation enzymes (AS3MT, PNP,GSTO1, and GSTO2) genetic polymorphism and UC risk.
2. To explore the relationship between cigarettes metabolites (NNK, NNAL, HBA, NNAL-Gluc, O6-Methylguanine, and N7-Methylguanine) and UC risk.
3. To examine the relationship between cigarette metabolic enzymes (CYP2A6, CYP2A13, and UGT2B7) genetic polymorphism and UC risk.
4. To elucidate the relationship between DNA repair enzymes (MGMT, XPD, XRCC1, and XRCC3) gene polymorphism and 8-OHdG or between DNA repair enzymes and UC risk.
5. To examine relationship between COX-2 (-1195G/A、-765G/C 和8473C/T), IL-6, IL-8, and TNF-α gene polymorphism and 8-OHdG or between COX-2, IL-6, IL-8, and TNF-α gene polymorphism and UC risk.
6. To examine the risk factors of the environment-environment, gene-environment, and gene-gene interaction on the risk of UC.

Urothelial carcinoma (UC) arises exclusively from the urothelium including the renal pelvis,ureter, bladder and urethra, with bladder transitional cell carcinoma (TCC) being the most common form. Arsenic is a well-established human carcinogen of the skin and lung. Recent studies have well documented that the long-term exposure to inorganic arsenic through ingestion and inhalation is associated with an increased risk of bladder cancer, especially TCC.

However, the carcinogenic mechanism of arsenic-induced UC is still unclear. Recently our study found that cigarette smoking interacts with the urinary arsenic profile in modifying the UC risk. In addition, we also found that DNA damage marker 8-hydroxydeoxyguanine (8-OHdG) levels significantly higher in UC patients compared to healthy controls. The mechanism of the interaction between arsenic methylation and cigarette on UC risk is unknown. In addition, whether 8-OHdG is related to DNA repair enzymes or to inflammatory factors or not does need to explore, therefore the specific aims of this project are:

1. To investigate the relationship between arsenic methylation enzymes (AS3MT, PNP, GSTO1, and GSTO2) genetic polymorphism and UC risk.
2. To explore the relationship between cigarettes metabolites (NNK, NNAL, HBA, NNAL-Gluc, O6-Methylguanine, and N7-Methylguanine) and UC risk.
3. To examine the relationship between cigarette metabolic enzymes (CYP2A6, CYP2A13, and UGT2B7) genetic polymorphism and UC risk.
4. To elucidate the relationship between DNA repair enzymes (MGMT, XPD, XRCC1, and XRCC3) gene polymorphism and 8-OHdG or between DNA repair enzymes and UC risk.
5. To examine relationship between COX-2 (-1195G/A、-765G/C 和8473C/T), IL-6, IL-8, and TNF-α gene polymorphism and 8-OHdG or between COX-2, IL-6, IL-8, and TNF-α gene polymorphism and UC risk.
6. To examine the risk factors of the environment-environment, gene-environment, and gene-gene interaction on the risk of UC.

Eligibility Criteria:
Inclusion Criteria:

* project recruited 420 UC patients in Taiwan University Hospital

Exclusion Criteria:

-
A Study of Mirikizumab (LY3074828) Injection in Healthy Participants

This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. Each participant will be in the study for about 18 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter squared (kg/m²), inclusive
* Have medical test results that are acceptable for the study
* Must be willing to make oneself available for the whole study and be willing to follow study procedures

Exclusion Criteria:

* Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
* Have known allergies to compounds or drugs similar to Mirikizumab
* Have previously participated or withdrawn from this study
* Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Ultrasound Guided Versus Standard Paravertebral Blockade in Breast Surgery

The aim of this study is to compare conventional and ultrasound guided paravertebral blocks to with respect to efficacy, patient satisfaction and complication rates.

Adequate pain control is important in breast cancer surgery. In addition to benefits to patients, effective pain management strategies also facilitate day case surgery. Regional anaesthetic techniques, and paravertebral blocks in particular, are valuable in this sphere. The conventional method of administering this block is blind and depends on anatomical landmarks for placement. Performing the block under US guidance provides real time imaging while advancing the needle. This might allow for a more accurate placement and hence a more effective block which would enhance pain relief and minimise complications.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing resectional breast surgery
* Benign or malignant indications for surgery

Exclusion Criteria:

* Previous spinal surgery
* Severe coagulopathy
* Allergies to local anaesthesia
* Localised infection at site of injection