cyrilzakka/clinical-trials huggingface dataset:
The Benefits and Risks of Different Menopausal Hormone Replacement Therapy Regimes in the Treatment of Menopause Syndrome

A prospective, open-label, randomized controlled clinical trial to compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy .

This is a prospective, open-label, randomized controlled clinical trial compare the benefits and risks of half-dose or standard-dose conjugated equine estrogens(CEE) plus natural progesterone or dydrogesterone in menopausal hormone therapy during window phase. 120 Healthy postmenopausal women with intact uterus seeking treatment for menopausal symptoms are enrolled in this study.Participants are randomized into three groups, the CEE 0.3 mg/micronized progesterone (MP) 100 mg group; CEE 0.625 mg/MP 100 mg group; CEE 0.625 mg/dydrogesterone 10 mg group,metabolic parameters,body composition,bone mineral density,breast cancer risk factors and life quality will be measure at baseline,one year and two year intervention.The investigators hypothesize there may be differences of these parameters measured among three groups after intervention.

Eligibility Criteria:
Inclusion Criteria:

1. 40 and 60 years old;
2. natural amenorrhea for more than 6 months but less than 5 years;
3. suffered by menopause symptoms and seeking for treatment;
4. serum follicle-stimulating hormone levels \>40 IU/L and serum estradiol \<30 pg/ml.

Exclusion Criteria:

1. contraindications for menopausal hormone therapy;
2. complications including: uterine myoma more than 3 centimeter in diameter, endometriosis, uncontrolled hypertension or diabetes mellitus, thromboembolic disease history or high risk for developing thromboembolic disease, epilepsy, asthma, hyperprolactinemia, first degree relative has breast cancer;
3. cardiovascular, chronic liver, thyroid or kidney diseases; a history of cancer; a disease or condition that could influence the participants' ability to follow the study protocol;
4. alcohol or drug abuse within the last 3 months;
5. use of hormone therapy in the past 3months;
6. endometrial thickness more than 5mm even after progestin withdrawal;
7. abnormal cervical scraping smear;
8. allergic to any ingredient of the drugs;
9. participation in other clinical trials within the last 6 months.
Montelukast Added to Standard Therapy for Acute Asthma in Children Age 6-14 Years

Oral montelukast is helpful in chronic asthma. The purpose of this pediatric study was to investigate whether the addition of oral montelukast to standard therapy for acute asthma exacerbations results in further improvement in breathing function over three hours.

We hypothesized that children with moderate acute asthma exacerbations receiving oral montelukast in addition to standard therapy will have at least 12% greater FEV1 improvement in three hours than those receiving standard therapy alone.

In this randomized double-blind placebo-controlled study, we enrolled emergency patients aged 6-14 years with moderate acute asthma exacerbations (initial PEFR 40-70% predicted). Subjects received montelukast 5-mg or placebo orally then standard therapy consisting of weight-based doses of nebulized albuterol, nebulized ipratropium bromide, and oral corticosteroids. We measured FEV1 before study medication administration and hourly for three hours.

We conducted a planned an interim analysis after approximately one-half of the estimated sample had been enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Seeking care in ED for acute asthma exacerbation
* Age 6-14 years inclusive
* Initial FEV1 = 40-70% predicted (defined as moderate severity)
* Consent to participate in study

Exclusion Criteria:

* Severe exacerbation requiring immediate therapy as determined by treating clinician
* Pregnancy by history
* Cystic Fibrosis by history
* Tuberculosis
* Gastroesophageal reflux disease requiring medications
* Acute or chronic liver disease
* Bronchopulmonary dysplasia
* Premature \<34 weeks gestational age by history
* Having used leukotriene-modifying medication within 48 hours
* Having used theophylline within four weeks
* Unable to perform FEV1
Study to Evaluate the Efficacy and Safety of Genexol-PM Once a Week for Gynecologic Cancer

Dose-dense paclitaxel (Genexol®-PM) once a week in combination with carboplatin every 3 weeks for gynecologic cancer (adult solid tumor): a phase I trial.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who aged 20 years or older and under 80 year old female
2. Patients who were diagnosed histologically or cytologically or who were scheduled to reccur as an gynecologic cancer (epithelial ovarian cancer , fallopian tube cancer, primary peritoneal cancer, cervical cancer, uterine corpus cance, etc)
3. Patients seemed appropriate for Paclitaxel and Carboplatin combination therapy for the treatment
4. Patients whose ECOG performance score are 0-2
5. Patients who have adequate blood, kidney and liver function on screening within 14 days before the administration of the test drugs

   * Hb ≥ 10g/dl: Patients with less than 10g/dl of hemoglobin level were not allowed to use the test drugs unless they were recovered to 10g/dl or more.
   * ANC ≥ 1500/mm3
   * Platelet Count ≥ 100,000/mm3
   * Serum AST and ALT ≤ 2.5 X ULN
   * Serum ALP ≤ 2.5 X ULN
   * Serum creatinine ≤ 2.5 X ULN
6. Patients who participated voluntarily and who provided written informed consent before participating in the study

Exclusion Criteria:

1. Patients with the history of carcinoma in the past 5 years other than gynecologic cancer
2. Patients who received radiotherapy at abdominal cavity or pelvis
3. Patients who were receiving immunotherapy or hormone therapy
4. Patients who received a major surgery other than debulking surgery within 2 weeks before the screening
5. Patients with a past or present medical history of metastasis in central nervous system (CNS)
6. Patients with NCI CTCAE V4.0 Grade 1 or more sensory or motor neuropathy
7. Patients with severe comorbidities as follows

   * medical or mental condition impossible to understand the clinical trial and provide a written informed consent, based on the investigators' decision
   * severe cardiovascular disease (such as ischemic heart disease requiring medical therapy, myocardial infarction within the last 6 months, and grade 2\~4 congestive heart failure defined by New York Heart Association criteria)
   * uncontrolled active infectious disease
   * hypersensitivity to the test drugs or the vehicle
8. Patients who participated in another study within 4 weeks before the screening
9. Pregnant, lactating women or Patients who do not use contraceptive methods that can be medically accepted to the possibility of pregnancy in female volunteers
Determining the Optimal Cut-off Point of PEA by Corsens Device for Discriminating Between MI and Non-MI Subjects

Acute Myocardial Infarction (MI) is still the leading cause of death in the western world. Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In average it takes between 2-3 hours from the beginning of the chest pain. The damage to the heart in these 2 hours is critical and often irreversible. Thus an early warning test or device is highly warranted.

Corsens has developed a noninvasive device using several sensors applied to the chest and a detection system able to recognize the ischemic origin of chest pain. This clinical study is intended for evaluating the safety and efficacy of the Corsens technology while use for myocardial infarction detection


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the cardiac care unit (CCU) with ST elevation acute MI (STEMI) within 4 hours from beginning of chest pain.
* Male or female subjects aged 18 years or more (with no upper limit), of any race.
* Subjects willing to participate as evidenced by signing the written informed consent.

Exclusion Criteria:

* Obese patients with BMI\>35.
* Subjects with cardiac arrhythmias including atrial fibrillation. Previous MI.
* Patients after coronary artery bypass grafting
* Unstable hemodynamic condition.
* Patient that can't or do not wish to sign the Inform Consent Form
Human Biological Responses to Low Level Ozone

To investigate if low level ozone exposure will cause measurable inflammation in nasal cells.

Air pollutants including ozone have been implicated in affecting health outcomes. In particular, high level ozone exposure has been shown to affect pulmonary function and cause pulmonary inflammation. Troubling community-based work has implicated high ozone levels as being correlated with increased pediatric asthma emergency room visits. Because of adverse health effects, EPA standards for safe ozone levels have been set, currently at 0.07 ppm. Still, it is estimated that 100 million Americans live in areas where ozone levels periodically remain above the EPA standard. And while this EPA standard had been set based on available data, it remained unclear at the time whether naturalistic low-level ozone exposure, such as fluctuations between 0.06-0.08 ppm throughout the day, might affect health as well.

This group previously examined lung function and inflammatory response in adults exposed to low-level ozone, 0.06 ppm exposure for 6.6 hours, while undergoing intermittent moderate exercise. The investigators found that in response to low-level ozone exposure (0.06 ppm) with exercise, lung function declines and neutrophilic airway inflammation is observed. What remains unclear, is whether low-level ozone alone - without exercise - will cause similar health effects.

To mimic exposure to ozone on a typical summer day in a polluted city, the investigators will expose subjects to a varying level of ozone, form 0.06 ppm to 0.08 ppm, rather than a constant 0.07ppm. The variation from 0.06ppm to 0.08ppm, then back to 0.06ppm will occur each hour.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 50 years of age.
* Vital signs within normal limits on admission to the study: Peripheral oxygen saturation (SpO2) \> 94%, systolic blood pressure between 150-90 mm Hg, diastolic blood pressure between 100-60 mm Hg, afebrile.
* Forced Expiratory Volume (FEV1) of at least 80% of predicted.

Exclusion Criteria:

* Any chronic medical condition considered by the PI as a contraindication to the exposure study, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, or kidney disease.
* Use of systemic or inhaled steroids.
* Use of NSAID or aspirin within 7days of each study visit, and inability to withhold these medications prior to each session of the study.
* Pregnant or nursing women
* Use of cigarettes or other inhaled nicotine products within the past year, or more than a lifetime 5 pack year history of cigarette smoking.
Supplementation of Phosphatidylserine (PS) and n-3 Long Chain Fatty Acids (EPA, DHA) in Children With ADHD

To determine whether supplementation of omega-3 long-chain polyunsaturated fatty acid conjugated to phosphatidylserine rather than triglycerides (fish oil) could affect Attention-deficit/hyperactivity disorder symptoms in children.

BACKGROUND Attention-deficit/hyperactivity disorder (ADHD) encompasses a broad constellation of behavioral and learning problems, clinically describes inattentive, impulsive, and/or hyperactive children. These patients are characterized by low blood LC-PUFA (LC-PUFA) levels; however the LC-PUFA supplementation effect on ADHD symptoms is not clear.

METHODS Eighty-three ADHD children (3:1 boys:girls), 8-13 years old, were assigned in a randomized, double-blind, placebo-controlled parallel design to receive 250 mg/d of eicosapentaenoic acid + docosahexaenoic acid provided as phosphatidylserine (300 mg/d PS-Omega3), or fish oil or placebo for 3 months. Stimulant medication or other dietary supplements were prohibited. The measured outcomes were inattention and impulsivity, evaluated by Test of Variables of Attention (TOVA) and blood lipids profile.

Eligibility Criteria:
Inclusion Criteria:

* 8 and 13 years of age; diagnosed as having ADHD; otherwise healthy;

Exclusion Criteria:

* significant sensory or neurological limitations, epilepsy, mental retardation, psychosis, or pervasive developmental disorder; medications with known central nervous system effects such as tranquilizers, antidepressants, stimulants (including methylphenidate and amphetamines), sedating antihistamines and some asthma medications and dietary supplements but vitamins
Shared Medical Visits for Spanish-speaking Patients With Type 2 Diabetes

The investigators seek to apply a shared medical visit model and interdisciplinary approach to Spanish-speaking patients. The investigators will evaluate the patient's hemoglobin A1c as a marker of glycemic control and evaluate their mood with PHQ screening tools. The investigators seek to improve diabetes care for this group of underserved patients. Potential participants will be selected from the UNMC diabetes registry. Eligibility criteria includes adult patients over the age of eighteen years old with Type 2 diabetes, HgbA1c greater than 8%, whose preferred language is Spanish. Exclusion criteria include pregnancy, residency at a nursing home or other facility, substance abuse, and physician recommendation that study is not appropriate for the patient.

Type 2 diabetes is an expanding epidemic, which is particularly pervasive in the Hispanic community. In 2014, the CDC reported that 21.9 million adults have been diagnosed with diabetes, a number which has nearly quadrupled since 1980.

Diabetes is a particularly challenging chronic disease due to the need for self-management. This research study plans to explore how shared medical visits with Spanish-speaking patients with diabetes can improve their control of diabetes, develop self-management behaviors, and enhance overall perspective of having a chronic disease.

The investigators will model this project after an ongoing with English speakers and they have demonstrated improvements in hemoglobin A1c levels and quality of life, and will now apply this model to Spanish-speaking patients.

Eligibility and exclusion criteria are detailed in the brief summary. Eligible participants will be recruited for the study through use of phone call in Spanish, letter writing in Spanish, word of mouth, and direct referral from their providers throughout UNMC. Once the list of potential subjects is compiled, those patients will be contacted and the details of the study will be explained in Spanish. All the participating staff in the study speak Spanish. The participants, at any time, can withdraw from the study.

Participants will receive education in diabetes health and lifestyle education. This will be a quantitative study using pre- and post-intervention measures to evaluate the outcomes of HgbA1c levels, scores on the validated 2-item and 9-item Patient Health Questionnaires (PHQ-2 and PHQ-9), and questionnaire which measures improvements in self-management behaviors.

Researchers will to follow-up with the participants in the week following the visit to discuss lab results. At the end of the study, researcher will send a detailed letter to the patient's primary care provider regarding progress and management in shared medical visits.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over the age of eighteen years old with Type 2 diabetes
* HgbA1c greater than 8%
* Preferred language is Spanish

Exclusion Criteria:

* Pregnancy
* Residency at a nursing home or other facility
* Substance abuse
* Physician recommendation that study is not appropriate for the patient
Optimizing Patient Selection for Watch-and-wait Approach Using Pathological Response Analysis Following Neoadjuvant Treatment in Locally Advanced Rectal Cancer

The goal of this interventional non-randomized prospective trial is to determine the feasibility, efficacy and safety of the endoscopic resection of the residual scar or superficial residual adenomatous tissue following neoadjuvant treatment in locally advanced rectal cancer, as well as to evaluate if the pathological profile analysis after endoscopic resection following neoadjuvant treatment can enhance patients' selection for a "watch-and-wait" strategy.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Signed informed consent
* Patients diagnosed with locally advanced rectal cancer showing complete clinical response after neoadjuvant therapy without evidence of invasive disease (\>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.
* Patients diagnosed with locally advanced rectal cancer showing near-complete clinical response after neoadjuvant therapy without evidence of invasive disease (\>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.
* Patients diagnosed with locally advanced rectal cancer showing incomplete response with presence of superficial adenomatous lesions, without features of malignancy on endoscopic evaluation, without evidence of invasive disease (\>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.
* Without previous medical history of rectal cancer or rectal surgery

Exclusion Criteria:

* Previous medical history of rectal cancer
* Previous rectal surgery
Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical coherence tomography (OCT) images was analyzed to gain insights into predictive factors for disease progression and the possibility of reduced monitoring was assessed in Year 2. The results of this open-label study provided long-term safety and efficacy data to further guide recommendations on the use of ranibizumab in this indication.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Diagnosis of visual impairment exclusively due to ME secondary to CRVO
* BCVA score at Screening and Baseline between 73 and 19 letters Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent of 20/40 and 20/400)

Exclusion Criteria:

* Uncontrolled blood pressure defined as systolic value of \> 160 mm Hg or diastolic value of \> 100 mm Hg at Screening or Baseline.
* Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye
* Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye
* Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline (eg, sorafenib \[Nexavar®\], sunitinib \[Sutent®\], bevacizumab \[Avastin®\])
Prospective Cohort Study of Association of Insulin Resistance/Steatosis With Hepatic Fibrosis in CHB and NAFLD

Hepatic steatosis and insulin resistance are associated with severity of fibrosis in non-alcoholic fatty liver disease (NAFLD) and chronic hepatitis C. However, clinical significance of steatosis and insulin resistance on fibrosis in chronic hepatitis B (CHB) is not well established. The aim was to investigate the relationship between insulin resistance, hepatic steatosis, and fibrosis in patients with CHB.

acoustic radiation force impulse elastography

Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis B patients
* With evidences of hepatic steatosis on ultrasonography or pathology

Exclusion Criteria:

* significant alcohol consumption or other known liver diseases
Axitinib Pharmacokinetics in Chinese Healthy Volunteers

As part of the global clinical development program for AG-013736, studies are ongoing (and planned) in cancer patients in China. An assessment of AG-013736 pharmacokinetics in Chinese subjects, as required by the Chinese Health Authorities, is therefore warranted.

In the current study the single dose pharmacokinetics of AG-013736 will be characterized at 3 doses (5 mg, 7 mg and 10 mg).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (of nonchildbearing potential) Chinese (individuals currently residing in mainland China who were born in China and have both parents of Chinese descent) subjects between the ages of 18 and 45 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.)
* Body Mass Index (BMI) of 19 to 24 kg/m2; and a total body weight \>50 kg (110 lbs). A BMI lower limit of 18.5 kg/m2 may be rounded up to 19.0 kg/m2; a BMI upper limit of 24.5 kg/m2 may be rounded down to 24.0 kg/m2 and will be acceptable for inclusion.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Drug dependency, a positive urine drug screen, or alcohol dependency.
* History of regular alcohol consumption exceeding 28 or more units per week. (One unit=285 mL of beer or 25 mL of spirits or 125 mL of wine).
* Use of tobacco- or nicotine-containing products (or a positive urine cotinine test).
* Treatment with an investigational drug within 3 months (or as determined by local regulations) or 5 half-lives preceding the first dose of study medication.