cyrilzakka/clinical-trials huggingface dataset:
A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases

This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.

This drug(YH35324) is currently under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 exhibits high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophils, thereby inhibiting histamine release via degranulation following allergen exposures. In addition, YH35324 suppresses autoantibody-dependent effector cell activation by blocking anti-FcεRIα autoantibodies. This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following a single subcutaneous injection of YH35324 in subjects with various allergic diseases.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged ≥ 19 to ≤ 75 years

\[Parts 1 and 2 only\]

* Diagnosis of CSU

\[Part 2 only\]

* Experience of inadequately uncontrolled CSU despite use of omalizumab

\[Part 3 only\]

* Diagnosis of chronic inducible urticaria (cold urticaria)

Exclusion Criteria:

* History of malignancy within 5 years from screening
* Aspartate transaminase (AST) or alanine transaminase (ALT) level \&amp;gt; 2 X the upper limit of normal

\[Parts 1 and 2 only\]

* Chronic urticaria with clear etiology other than CSU

\[Part 3 only\]

* Chronic urticaria other than studied chronic inducible urticaria (cold urticaria)

The above information is not intended to contain all considerations relevant to a patient potential participation in a clinical trial.
Evaluation the Intracranial Volume Pressure Response in Increased Intracranial Pressure

The purpose of this study is to discover a mathematic equation to express the intracranial pressure-volume (P-V) curve and a single indicator to reflect the status of the curve.

Monitoring of intracranial pressure (ICP) has been used in the management of patients with increased ICP, or in whom increased ICP was suspected. ICP depends on the relative constancy of total volume inside the skull, comprising cerebrospinal fluid (CSF), blood, and brain tissue. The changes of CSF volume affect the ventricular fluid pressure and defined it as volume pressure response (VPR). The shape or curve of the intracranial volume-pressure (V-P) relationship is well known in daily neurosurgical practice. If the P-V curve can be expressed by mathematic manner, then there should be an indicator to reflect the status of the curve. This study is conducted in order to understand the difference of each P-V curve in patients with increased intracranial pressure. The individual VPR values have been tested with three mathematical models (linear, parabolic and exponential regression equation).

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe brain damage
* Underwent bilateral external ventricular drainage (EVD)

Exclusion Criteria:

-
An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy

Purpose:

The purpose of the correlative studies is to evaluate levels of serum factors of circulating VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at baseline and over the course of initial treatment in order to explore relationships with baseline patient factors, measurable disease response and clinical progression.

Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or sorafenib.

It is recognized that the measurable disease RECIST criteria response rate with mTOR inhibition is likely to be low and that the benefit of such therapy will also include effects on disease stabilization. Disease stabilization is difficult to interpret in the phase II setting. Thus, it is desirable to develop biomarkers which will provide additional information on novel treatment effects and how they might relate to disease progression

Eligibility Criteria:
Inclusion Criteria:

* All patients enrolled from Canadian centres for the Wyeth Pharmaceuticals sponsored multicenter, open-label phase III study evaluating second line therapy with either temsirolimus or sorafenib in patients progressing after sunitinib therapy, are eligible for this correlative studies protocol.
* Patients must provide written informed consent.
Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents

A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.

This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). The primary endpoint consists of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The nominated powered secondary endpoint is the change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Outpatient at least 12 years of age
* Both genders; females of child bearing potential must be willing to use approved birth control method
* Pre-bronchodilator FEV1 of 40-90% predicted
* Reversibility FEV1 of at least 12% and 200mLs
* Current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks prior to first visit

Exclusion Criteria:

* History of life threatening asthma
* Respiratory infection or candidiasis
* Asthma exacerbation within 6 months prior to first visit
* Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drug excipients, medications related to study drugs
* Taking another investigational medication or medication prohibited for use during this study
Use of a Training Video to Teach Medical Students About Health Literacy

1. Briefly describe the purpose of this protocol: This study is designed to evaluate the effectiveness of an educational training video on the topic of health literacy for medical students.
2. Briefly summarize how participants are recruited: OHSU medical students attending mandatory trainings on the topic of health literacy during the 1st and 2nd years of medical school will be invited to participate in the study.
3. Briefly describe the procedures subjects will undergo: Completion of a short self-administered anonymous survey before and after viewing a 23-minute video about health literacy.
4. If applicable, briefly describe survey/interview instruments used: A 12-item pre-test questionnaire and 13-item post-test questionnaire designed to assess individuals' knowledge about health literacy, and intended clinical practices with respect to health literacy.
5. If this is a clinical trial using an experimental drug and/or device, or an approved drug and/or device used for an unapproved purpose, briefly describe the drug and/or device: n/a
6. Briefly describe how the data will be analyzed to address the purpose of the protocol: Demographics and responses to individual items will be reported as frequencies and percentages within the sample. The investigators will use a chi-square analysis to stratify responses by demographic groups and t-tests to measure possible changes over time.


Eligibility Criteria:
Inclusion Criteria:

* 1st-year medical student at OHSU

Exclusion Criteria:
Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or augmentation


Eligibility Criteria:
Inclusion Criteria:

* Over 22 years of age
* Subjects who want breast augmentation reconstruction following breast cancer, congenital or accidental unbalanced breast size
* Negative pregnancy test in fertile women
* Subjects who voluntarily decided the participation of the study and signed the informed consent
* Subjects who can understand and comply with the instructions and participate during the entire period of the trial

Exclusion Criteria:

* previous breast reconstruction or augmentation history
* self -immune disease
* uncontrolled active infectious disease
* unable to insert beast implant due to radiotherapy
* Patients who have recurrent breast cancer or do not treat effectively their cancer
* Keloid
* Abnormal blood test or ECG result for general anesthesia
* Patients who cannot MRI scan due to having Metallic substance in the body or Claustrophobia
* Aesthetic addiction, drug abuse, alcohol abuse
* Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator
Exercise Rehabilitation in Veteran Cancer Survivors

Exercise rehabilitation has the potential as a non-pharmacological approach to reduce persistent neuropathic pain in Veterans with lung cancer. By examining the effects of exercise training in Veteran cancer survivors with NSCLC, there is the potential to revolutionize care for a: common, debilitating, and inadequately treated symptom in a growing population. This could lead to a larger investigation to fill critical gaps in the literature and at the same time help discover a new model of care for Veterans with chronic pain. The ultimate goal is to reduce this type of pain for the growing population of cancer survivors while simultaneously reducing the need for problematic opioid management.

Persistent or chronic neuropathic pain, either post-thoracotomy persistent pain (PTPP) or chemotherapy-induced peripheral neuropathy (CIPN) occurs in a majority of lung cancer patients. Thus, not only is this neuropathic pain widespread; there is no way to prevent its development, and long-term use of opioids for control of symptoms could result in addiction. Ultimately, PTPP and CIPN can lead to long-term suffering and disability during the post-treatment phase.(NSCLC), which represents about 85% of lung cancer cases.This is the first project of its kind and the potential impact of this research is large, because exercise training will be a prescription and the first approach for which NSCLC survivors can self-manage chronic neuropathic pain. The ultimate goal of the investigators' work is to reduce neuropathic pain for the growing population of cancer survivors while simultaneously reducing the need for problematic pharmacologic management. Therefore, results of this study have potential for high impact on symptom care because it will allow effective neuropathic pain treatment to be in full control of the Veteran, and likely restore function that is lost during the chronic pain experience.

Specific Aims:

1. To determine the feasibility of conducting an exercise rehabilitation intervention in Veterans with NSCLC and PTPP or CIPN.
2. To determine the effects of a VAMHCS-supervised activity rehabilitation program on chronic pain compared to delayed control.
3. To assess changes in fitness, strength, physical function, fatigue, and quality of life (QoL) after activity-based rehabilitation compared to control period.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with lung cancer
* History of treatment with either thoracotomy procedure or neurotoxic chemotherapy or both
* Completion of thoracotomy or chemotherapy \> or = 6 months
* Ability to walk on a treadmill
* Karnofsky performance status \> 70
* Score \> 1 Neuropathic Pain Scale

Exclusion Criteria:

* Presence of metastatic (stage IV)
* Life expectancy \< 6 months
* Musculoskeletal or medical conditions which preclude participation in an exercise program
Cognitive-Behavioral Therapy With Exercise Training in Adolescent Females With Elevated Depression Symptoms

PURPOSE: To Study the Effect of Cognitive-behavioral therapy combined with exercise training in adolescent females with elevated depression symptoms

BACKGROUND: Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers" are preying on them. Teenagers are more likely than any other age group to experience psychological issues due to depression, Adolescents have gotten active attention from society for their mental health difficulties since they are a high-level reserve talent stratum in society. Adolescent depression rates have increased in recent years, and "silent killers"

RESEARCH QUESTION: Is there is an effect of exercise on depression in adolescent girls.

The interventions start after assessment of depression to know the level of depression by using the Center for Epidemiological Studies Depression Scale for Children (CES-DC), and the exercise intervention consist of physical activity combined with Cognitive behavioral therapy. Group - A perform regular physical activity in addition to cognitive therapy, Group - B perform irregular physical activity in addition to cognitive therapy, Group - C cognitive therapy only

Eligibility Criteria:
Inclusion Criteria:

* 1. Depression adolescent girls 2. All patients should be in school

Exclusion Criteria:

1. obesity
2. malignant diseases
3. psychotic disorders or psychosis.
4. Permanent long-term psychiatric medication
Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.

Compare the efficacy and safety of endoscopic resection a full thickness (EFTR) with Full Thickness Resection Device (FTRD) System versus endoscopic submucosal dissection (ESD) in the treatment of Laterally Spreading Tumor Non Granular Type (LST-NG), "no lift" lesions colon and residual / relapse on scars from previous resections endoscopic colon. The dimensional cut off of these lesions is ≤30mm


Eligibility Criteria:
Inclusion criteria:

* patients of age \>18 years
* Laterally Spreading Tumor Non Granular Type (LST-NG) ≤ 3cm in diameter
* "no-lift" colic injuries ≤ 3cm in diameter
* residual / recurrence on the scar of previous endoscopic resections of the colon ≤ 3cm in diameter

Exclusion criteria:

* pregnant women
* failure to accept or understand the consent to participate in the study
* patients with severe coagulopathies
* patients with short life expectancy (Charlson comorbidity index ≥8)
* patients with expired general clinical conditions (American Society of Anesthesiologists score ≥3)
Safety of ADSTEM Injection in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

This study aims to evaluate safety in subjects with over moderately subacute and chronic atopic dermatitis after an intravenous injection of ADSTEM Inj. Since this is an observational study of patients participated in Phase 1 clinical trials, no drug is administered in this study.

Participants will be followed-up for adverse events on each visit. Visits will be on 6, 12, 18, 24, 30, 36, 48, 60months after treatment of ADSTEM Inj.

Time perspective is both retrospective and prospective.

Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in Phase I clinical trials
* Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

* Patients who can not follow-up from the end of the phase 1 clinical trial to the end of the study
Glucose Control In Hematopoetic Stem Cell Transplant

To determine whether intensive glucose control results in improved mortality and reduced hospital stay length by performing a randomized trial of intensive glucose management (blood glucose goal 110 mg/dl) using continuous IV insulin and glucose vs. non-intensive glucose management (goal 200 mg/dl)

TO determine whether there are fewer infections, days without a fever, days on antibiotics given for an infection and time to marrow engraftment are improved by intensive glucose management; and to determine whether there is evidence of a reduction in measures of inflammation in patients randomized to intensive glucose management and whether reduction of inflammation is associated with outcome.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18
* Must meet standard criteria for HSCT
* If patient is known diabetic at admit the may be maintained on home sulfonylurea and insulin if randomized to the conventional arm

Exclusion Criteria:

* If on intensive arm patient must stop all oral hyperglycemic meds
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults

This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.

16 subjects will be allocated to 2 groups. The test group will consist of 8 female patients with moderately impaired hepatic function meeting the Child-Pugh Class B severity criteria, while the control group will consist of 8 healthy female adult volunteers. During Stage I, all subjects will receive a single oral dose of 25mg of Proellex® (fasting state) and be followed in a Clinical Research Unit (CRU) for about three days. Only subjects who do not experience serious adverse events (SAEs) or adverse events (AEs) that are determined by Investigator to be possibly, probably or definitely related to the treatment will participate in Stage II. The dose will be increased to a single dose of 50mg of Proellex® (fasting state) and subjects will be followed in a Clinical Research Unit (CRU) for about three days. Subjects will undergo blood draws at several time points.

Eligibility Criteria:
Inclusion Criteria:

* Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
* Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, are preferred; however, subjects up to 62 years old, inclusive, may participate;
* Subjects with moderate hepatic insufficiency must meet the Class B level of the Child-Pugh criteria;
* Subjects must have evidence of stable hepatic impairment;
* If on medications for treatment of the complications of liver disease, and other concomitant chronic illnesses, subjects must have been taking the medications at a stable dose for at least 10 days prior to the first dosing date and are then to be continued at the same dose for the duration of the study;
* Non-smokers are preferred, but light to moderate smoking will be allowed (no more than 10 cigarettes/day)
* Subject is willing to remain in the clinic for the screening visit and for two treatment visits (approximately 3 days for each treatment visit);
* Other inclusion criteria may apply

Exclusion Criteria:

* Past or present history of an allergic reaction to the formulations administered in this study, or in the opinion of the Investigator, suggesting an increased potential for an adverse hypersensitivity;
* Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study;
* A physical illness within three (3) months of the study that would interfere with the study as determined by the Investigator;
* An acute illness within five (5) days of study medication administration;
* Positive urine drug screen at the screening visit based on laboratory testing;
* Other exclusion criteria may apply
Intensified Treatments for Patients With Locally Advanced Nasopharyngeal Carcinoma With Detectable EBV DNA After One Cycle GP Regime Neoadjuvant Chemotherapy

The goal of this multicenter randomized non-inferior study is to compare the additon of camrelizumab or nimotuzumab to neoadjuvant chemotherapy followed by concurrent chemoradiotherapy in locally advanced nasopharyngeal carcinoma patients whose EBV DNA remained detectable after one cycle neoadjuvant chemotherapy using GP regimen. The main question it aims to answer is: whether the addition of carrilizumab or nituzumab improve the treatment outcomes in the relatively poor prognostic patients identified by the response of EBV DNA. Participants will be randomized to the combination of carrilizumab and standard treatment , the combination of nituzumab and standard treatment or the standard treatment alone if their EBV DNA didn't decrease to undetectable level post first cycle of neoadjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, type of WHO II or III, EGFR+.
2. Age 18-70 years.
3. Clinical stage III-IVa (based on the 8th American Joint Committee on Cancer\[AJCC\] edition).
4. Patients with detectable pre-treatment plasma EBV DNA which remained detectable after one cycle neoadjuvant.
5. ECOG (Eastern Cooperative Oncology Group) score: 0-1
6. Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109 /L, platelet (PLT) ≥100×109 /L.
7. Liver function: Alanine transaminase(ALT), Aspartate aminotransferase(AST)\< 1.5 times the upper limit of normal value (ULN), total bilirubin \<1.0×ULN.
8. Renal function: serum creatinine \<1×ULN.
9. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedule.

Exclusion Criteria:

1. Histologically confirmed keratinizing squamous cell carcinoma (WHO I)
2. Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously.
3. Receiving radiotherapy or chemotherapy or targeted therapy previously
4. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
5. Patients with significantly lower heart, liver, lung, kidney and bone marrow function.
6. Severe, uncontrolled medical conditions and infections.
7. At the same time using other test drugs or in other clinical trials.
8. Refusal or inability to sign informed consent to participate in the trial.
9. Emotional disturbance or mental