cyrilzakka/clinical-trials huggingface dataset:
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.

This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.

This is a global, multicenter, randomized Phase 3 study evaluating PF-06821497 (mevrometostat) in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCRPC where no systemic anti-cancer treatments have been initiated after documentation of mCRPC with the exception of ADT (androgen deprivation therapy) and first-generation anti-androgen agents. Prior treatment with any of the ARSi's enzalutamide, darolutamide, apalutamide, or abiraterone acetate, is not permitted in any setting. Chemotherapy is permitted in the castrate sensitive setting.

This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) PF-06821497 in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.

Eligibility Criteria:
Inclusion Criteria:

* Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening.
* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
* Surgically or medically castrated, with serum testosterone ≤50 ng/dL (≤1.73 nmol/L) at screening.
* Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
* Progressive disease in the setting of medical or surgical castration.
* Prior to randomization, there must be resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1.
* ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.

Exclusion Criteria:

* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Clinically significant cardiovascular disease.
* Known or suspected brain metastasis or active leptomeningeal disease.
* Participants must be treatment naïve at the mCRPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents and. Docetaxel treatment is allowed for mCSPC.
* Previous administration with an investigational product (drug or vaccine) within 30 days.
* Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study).
* Major surgery or palliative localized radiation therapy within 14 days before randomization.
* Inadequate organ function.
Impact of High Mechanical Index Ultrasound Impulses on Left Ventricular Stroke Volume With Intravenous Microbubbles

This study will investigate whether applying high mechanical index (MI) impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent (UEA) microbubble infusion will result in subclinical improvement in left ventricle systolic function.

The purpose of this study is to investigate whether applying high MI impulses from a diagnostic ultrasound transducer when using ultrasound enhancing agent(UEA) microbubble infusion will result in subclinical improvement in LV systolic function detected by left ventricular outflow tract velocity time integral (LVOT VTI).

Eligibility Criteria:
Inclusion Criteria:

age 19 years or older

Exclusion Criteria:

1. severe aortic valve stenosis
2. pregnant or lactating women
3. atrial fibrillation
4. very poor image quality despite contrast use.
5. unstable cardiac condition such as cardiogenic shock.
6. allergy to UEA
7. presence of right to left or bidirectional shunts.
8. Patients on mechanical circulatory support.
Home Based Program Physical Training in Congenital Heart Disease

Previous Studies Indicate That a Substantial Proportion of the Congenital Heart Disease Patients Has Unhealthy Lifestyle Behaviors, Such as Smoking, Lack of Physical Activity, and Inadequate Dietary Patterns, Leading to the Development of Metabolic Disorders Such as Overweight/Obesity, Metabolic Syndrome, and Chronic Diseases Such as Cardiovascular Disease. Another Highly Prevalent Risk Factor in These Patients is Sedentary Behavior; These Patients Are Not Encouraged to Engage in Sports and Exercise During Childhood Due to Their Cardiac Condition, Leading to a Progressive Decrease in Physical Capacity. Studies Have Shown That Congenital Heart Disease Patients Are Not Active Enough and That a Substantial Amount of Patients is Overweight.This Study is a Randomized Controlled Trial That Investigates the Effects of the Home Based Program Physical Training, in the Exercise Capacity, Quality of Life and Body Composition.

The objective of the study was to verify the effect of home physical training on improving physical capacity, body composition, quality of life, metabolic markers in patients with congenital heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Repaired congenital heart disease of all complexities
* Age ≥ 18 years
* New York Heart Association (NYHA) Class I or II
* Able and willing to participate in a 12-week cardiac rehabilitation program

Exclusion Criteria:

* Inability to give informed consent
* Inability to participate in an exercise training program
* Severe musculoskeletal disorders.
* Patient heart failure
* Patients who perform regular physical activities.
* Patients with Univentricular Physiology,
* Patients severe asthma,
* Patients with a pacemaker.
* Patients with atrial fibrillation;
* Exercise-induced arrhythmia and/or ischemia
* Cyanosis at rest
* Severe intellectual disability
Beat AML Core Study

In this study, DNA sequencing, computational biology modeling, and ex vivo drug sensitivity assays will be utilized to define clinically relevant gene mutations and identify potential therapeutics for patients with acute myeloid leukemia (AML).

As part of normal clinical care, patients will undergo a peripheral blood draw and bone marrow aspiration \& biopsy. Blood draws and bone marrow aspirations are performed at the time of diagnosis, after treatments , disease progression, and relapse. Under normal clinical care, patient specimens are analyzed by cytogenetics (giemsa staining), fluorescence in situ hybridization (FISH), and gene mutation profiling. Clinically, treatment can begin before these molecular diagnostics are available.

As part of this repository study, subjects are asked to:

* Allow access to banked blood and bone marrow specimens in IRB approved protocol # 532-2012.
* Donate peripheral blood specimens whenever blood is already being drawn for clinical purposes such as at times of diagnosis, relapse, refractory disease or disease progression. Additional samples may be requested at other standard of care visits in the event that initial samples are not viable for DNA sequencing, phenotyping, or functional assays for patients with AML, if disease is present.
* Donate bone marrow aspirate specimens whenever bone marrow aspiration is already being done for clinical purposes such as at times of diagnosis, relapse, refractory disease or disease progression. If bone marrow aspirate is being collected for banking protocol #532-2012, then an aliquot of the banked specimen will be accessed rather than collect an additional bone marrow aspirate for this study.
* Undergo skin biopsy and donate the skin biopsy specimen for genomic profiling.
* Allow bone marrow, peripheral blood and skin biopsy specimens to be collected for genomic profiling and ex vivo drug sensitivity testing.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) as defined by World Health Organization 2016.
* ≥ 18 years of age
* Capable of providing informed consent

Exclusion Criteria:

* 17 years of age or less
* greater than 80 years of age
Quality of Life in Patients With Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second leading cause of cancer-related mortality worldwide. Despite the recent advances in the treatment of HCC, the prognosis of HCC is still poor even after curative treatment.

Performance status has shown to be associated with long-term survival and prognosis in patients with HCC, and it is one of the important factors in the Barcelona Clinic Liver Cancer (BCLC) staging system. Recently, the researches on health-related quality of life (HRQL) of cancer patients have been progressed. The most widely used surveys to assess HRQL of cancer patients are Functional Assessment of Cancer Therapy-Generic (FACT-G) and European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30. Since those two are mainly about cancers in general, HCC specific surveys were developed.

The FACT-Hep questionnaire has 45-items specifically focusing on patients with hepatobiliary cancers. EORTC QLQ-hepatocellular carcinoma 18 (HCC 18) is an 18-item questionnaire designed to be used along with the EORTC QLQ-C30 for patients with HCC. An 18-item National Comprehensive Cancer Network (NCCN)-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI-18) is a specific questionnaire for advanced hepatobiliary and pancreatic cancers. However, there is no consensus whether it would be appropriate to adopt HRQL as a prognostic variable in HCC staging system. Moreover, there is limited information available about the impact of patients' HRQL on long-term outcome in patients with HCC.

Thus, in this study, the researchers will investigate whether HRQL can be an important factor in HCC staging system by testing the reliability and clinical validity of FACT-Hep, EORTC QLQ-HCC18, and NFHSI-18. Second, the investigators will evaluate the relation of HRQL with treatment efficacy, recurrence and survival outcome. Lastly, the investigators will suggest the suitable questionnaire module for patients with HCC.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Diagnosis of HCC
* Ability to speak, read, and write Korean
* Patient is able and willing to give informed consent

Exclusion Criteria:

* Evidence of cognitive impairment or psychiatric disturbance
* Other concurrent malignancy
* Patients involved in other clinical studies
The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus

The clinical study of the effect of highland barley diet on blood glucose in patients with type 2 diabetes mellitus

The clinical study of the effect of highland barley diet on blood glucose in patients with type 2 diabetes mellitus.

Approximately 40 patients will be enrolled in the study from China and randomized in a 1:1 ratio to one of the 2 treatment arms: highland barley diet + metformin; or +common diet metformin.

Study treatment will continue for 12 weeks. The primary efficacy measure is the change in HbA1c at 12 weeks. The study consists of 3 periods: a 1-week screening (period A), a 4-week run-in period (period B) and a 12-week treatment period (period C).

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent
2. Type 2 diabetic patients （new diagnose ）
3. HbA1c ≥7.0 % and \< 9.0 % (HbA1c \> 7.0 % and ≤ 8.0% at randomization)
4. Men and women (non-pregnant and using a medically approved birth-control method) aged ≥ 18 and ≤ 70 years
5. BMI ≥ 23 and ≤ 35 kg/m2

Exclusion Criteria:

1. Type 1 diabetes or other specific types of diabetes
2. Pregnancy, preparation for pregnancy, lactation and women of child-bearing age incapable of effective contraception methods
3. Uncooperative subject because of various reasons
4. Abnormal liver function, glutamic-pyruvic transaminase (ALT) and glutamic-oxaloacetic transaminase (AST) \> twice the upper limits of normal
5. Impairment of renal function, serum creatinine: ≥ 133mmol/L for female，≥ 135mmol/L for male
6. Serious chronic gastrointestinal diseases
7. Edema
8. Serious heart diseases, such as cardiac insufficiency (level III or more according to NYHA), acute coronary syndrome and old myocardial infraction
9. Blood pressure: Systolic blood pressure (SBP) ≥ 180mmHg and/or diastolic blood pressure (DBP) ≥ 110mmHg
10. White blood count (WBC) \< 4.0×109/L or platelet count (PLT) \< 90×109/L，or definite anemia (Hb：\< 120g/L for male, \< 110g/L for female), or other hematological diseases
11. Endocrine system diseases, such as hyperthyroidism and hypercortisolism
12. Experimental drug allergy or frequent hypoglycemia
13. Psychiatric disorders, drug or other substance abuse
14. Diabetic ketoacidosis and hyperosmolar nonketotic coma requiring insulin therapy
15. Stressful situations such as surgery, serious trauma and so on
16. Chronic hypoxic diseases such as pulmonary emphysema and pulmonary heart disease
17. Combined use of drugs effecting glucose metabolism such as glucocorticoid Tumor, especially bladder tumor and/or family history of bladder tumor and/or long-term hematuria
Safety of Preoperative Oral Administration of a High Caloric Drink With Protein

The purpose of the study is to determine whether the oral administration of a high caloric drink with protein decreases the postoperative nausea and vomiting in patients with dysgnathia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with surgery for dysgnathia

Exclusion Criteria:

* Diabetes mellitus
The Effect of a Newly Designed Presurgical Orthopedic Appliance

A randomized clinical trial to compare the effectiveness of newly designed active type of presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.

It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used, and group two a new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1. Healthy new born infants with complete bilateral cleft lip, alveolus and palate.

  2. Non-syndromic. 3. Non-operated cases.

Exclusion Criteria:

* 1. Infants with systemic syndromes. 2.Facial deformities.
Aspergillus-specific IgG Assays for the Diagnosis of Chronic Pulmonary Aspergillosis (CPA)-Multicenter Study

Aspergillus-specific IgG assays for the diagnosis of chronic pulmonary aspergillosis (CPA)

chronic pulmonary aspergillosis (CPA) is one of the most refractory pulmonary infectious diseases, and the incidence is increased rapidly in recent years. Serum detection of Aspergillus-specific IgG is considered to be the most reliable method for diagnosing CPA, however, there is no formal report on the appropriate cut-off value for Aspergillus-specific IgG assay in Chinese patients. This study aimed to establish the datum.

Besides aspergillus-specific IgG, there are two other specific antibodies IgM and IgA. IgM is associated with the acute phase of an infection and IgA is associated with mucosal immunity. Their diagnostic values in CPA are still not clear. Meanwhile, whether detection of antibody levels in bronchoalveolar lavage fluid (BALF) could be useful in diagnosis of CPA has not been investigated. In this study, the serum and BALF levels of IgG, IgM and IgA would be detected simultaneously by the commercial available kits.

The investigators will establish the cut-off values of three antibodies by proven CPA patients and negative controls. Then, the cut-off values will be assessed in participants who have a suspected CPA, and the sensitivity, specificity, positive and negative predict value of the antibodies assays will be compared with that of standard diagnostic methods.

After performing the above diagnostic tests, CPA could be diagnosed more accurately and rapidly, so that the antifungal therapy could be evaluated more correctly and timely.

Eligibility Criteria:
Inclusion Criteria:

18 years to 85 years Lesions presented as cavity, nodule，mass or "destroyed lung" caused by fibrosis in CT imaging

Exclusion Criteria:

* seriously immunocompromised patients

  1. Recent history of neutropenia (\<0.5 × 109neutrophils/L \[\<500 neutrophils/mm3\] for\>10 days) temporally related to the onset of fungal disease
  2. Receipt of an allogeneic stem cell transplant
  3. Prolonged use of corticosteroids (excluding among patients with allergic bronchopulmonary aspergillosis) at a mean minimum dose of 0.3 mg/kg/day of prednisone equivalent for \>3 weeks
  4. Treatment with other recognized T cell immunosuppressants, such as cyclosporine, TNF-a blockers, specific monoclonal antibodies (such as alemtuzumab), or nucleoside analogues during the past 90 days
  5. Inherited severe immunodeficiency (such as chronic granulomatous disease or severe combined immunodeficiency)
* antifungal drug use within 3 months of screening
* dropout
* Pregnancy or lactation
* no inform consent
Comparison of Glargine and Oral Antidiabetic Drugs (OADs) in Newly Diagnosed Type 2 Diabetes

The investigators designed this prospective, randomized control study to compare the efficacy and safety between the basal insulin glargine therapy and metformin-based OADs after correction of the glucose toxicity with a short period of intensive insulin therapy.

Detailed Description:

OBJECTIVE-Type 2 diabetes is associated with defects in insulin secretion and insulin sensitivity. Hyperglycemia may aggravate these defects, a feature known as glucose toxicity. Previous studies have shown that acute correction of hyperglycemia in subjects with long-standing type 2 diabetes gives only short-term improvement in glycemic control after discontinuation of insulin. The current study attempts to identify whether basal insulin glargine or metformin-based OADs for further management would have a long-term benefit in newly diagnosed type 2 diabetes after short-term intensive insulin therapy.

RESEARCH DESIGN AND METHODS-Newly diagnosed type 2 diabetic patients (fasting blood glucose \>200 mg/dL or random blood glucose \>300 mg/dL) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. HbA1c were measured before intensive insulin injection. After discharge, patients will be randomized to receive basal insulin injection or metformin-based OADs for further management. Patients will be followed in our clinics and adjust their medication according to their blood glucose levels. HbA1c were measured 6 months later.After the six-month intervention, these patients were continually followed up for another six months. Subjects received an oral glucose tolerance test (OGTT) after the intensive insulin therapy and at the end of the 6th and 12th month.

EXPECTED RESULTS-We will expect that basal insulin glargine,compared with metformin-based OAD treatment,could more effectively maintain adequate glycemic control in newly diagnosed type 2 diabetes after short-term intensive insulin therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed type 2 diabetic patients.
2. Drug naïve, with severe hyperglycemia (fasting plasma glucose\>11.1mmol/L or random plasma glucose \>16.7mmol/L)
3. Those who age between 30 and 70 years old and can inject insulin by themselves.

Exclusion Criteria:

1. Established type 1 diabetes or positive anti-glutamic acid decarboxylase antibody;
2. Malignancy, pregnancy or lactating;
3. History of ketoacidosis;
4. Hepatic dysfunction with alanine aminotransferase 2.5 times higher than the upper limit of normal; serum creatinine \>2 mg/dl;
5. Poor blood pressure control (SBP\>180mmHg or DBP \>110mmHg);
6. Definite coronary artery disease, heart failure, left ventricular hypertrophy;
7. Severe anemia; acute or severe chronic diabetes complications;
8. BMI\<18 kg/m2 or ≥41kg/m2;
9. History of alcohol abuse or drug abuse;
10. Mental disorder and other endocrine disorders; dysfunction of digestion and absorption;
11. Chronic diseases need long-term glucocorticoid treatment.
Demonstrating the Clinical and Economic Benefit of 5 Alpha Reductase Inhibitor Adherence in Benign Prostatic Hyperplasia

This retrospective study aims to quantify the relationship between 5-alpha-reductase inhibitor (5ARI) adherence / length of therapy and the likelihood of acute urinary retention (AUR) or prostate surgery in patients with benign prostatic hyperplasia (BPH) as well as the economic impact associated with these medical encounters. The Integrated Health Care Information Solutions (IHCIS) database will be utilized for this study (2000-2006).


Eligibility Criteria:
Inclusion Criteria:

* Male
* aged 50 years or older
* a diagnostic claim of BPH
* prescription claim for a 5ARI for at least 60 days during the observation period.
* continuously eligible for 6 months prior to and at least 6 months after index date.

Exclusion Criteria:

* prostate cancer
* any prostate-related surgical procedure prior to index date
Intra-Arterial Treatment of Pancreatic Cancer Using the RenovoCath™ RC120 Catheter

This is an observational study to assess patient survival and clinical outcomes after the RenovoCath™ RC120 catheter is used to deliver chemotherapeutic agents to pancreatic tumors.

This is an observational, registry study to assess patient survival and clinical outcomes of the RenovoCath™ RC120 catheter when used to deliver chemotherapeutic agents to pancreatic tumors. Blood samples will be drawn in a subset of patients to assess the systemic concentration of the chemotherapeutic agent.

The RenovoCath™ RC120 Catheter is an endovascular multi-lumen, two-handled catheter designed to isolate variable segments of arteries supplying the target organ using two slideable, compliant balloons. Upon inflation of the proximal occlusion balloon and the distal occlusion balloon, the catheter may isolate the selected site to specifically deliver radiopaque and therapeutic agents including, but not limited to chemotherapeutic drugs.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Diagnosed with unresectable or borderline resectable pancreatic adenocarcinoma confirmed by histology or cytology
* Without current myelotoxicity and with sufficient health status to undergo a catheterization procedure
* Willing to provide informed consent and comply with the required follow-up.

Exclusion Criteria:

* Have received prior chemotherapy and/or radiation therapy within 14 days prior to the first intra-arterial treatment.
* Currently participating in another active drug or device study or registry protocol that would interfere with this study.
* Vulnerable populations: prisoners, pregnant or breastfeeding females.