cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants

A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
2. Provided legal identification for the sake of recruitment.
3. Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents.
4. Birth weight more than 2500 grams

Exclusion Criteria:

1. History of Hand-foot-mouth Disease
2. Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
4. Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
5. Epilepsy, seizures or convulsions history, or family history of mental illness
6. Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
7. History of asthma, angioedema, diabetes or malignancy
8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
9. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
10. Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
11. Acute illness or acute exacerbation of chronic disease within the past 7 days
12. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
13. History of any blood products within 3 months
14. Administration of any live attenuated vaccine within 28 days
15. Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 days
16. Axillary temperature \> 37.0 centigrade before vaccination
17. Abnormal laboratory parameters before vaccination
18. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
IL-6 and IL-8 Level of Blood and Pleural Effusion During Chemotherapy in Metastatic Breast Cancer

Change of IL-6 and IL-8 level in blood and pleural effusion before and after chemotherapy correlate with the prognosis of the disease

To assess the correlation between the disease prognosis and the level of IL-6 and IL-8 in blood and pleural effusion before and after chemotherapy in patients with metastatic breast cancer

Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 70 years old;
* Patients with histologic proved metastatic breast cancer;
* Pleural effusion with the volume of more than 1000ml, as documented by CT, X ray or ultrasound;
* There are no other diseases which cause the elevation of IL-6 or IL-8, such as cirrhosis of liver, anaphylactoid purpura, acute pancreatitis;
* With at least one measurable disease according to RECIST criteria,
* Normal laboratory results:ANC≥2.0×109/L,Hb≥80g/L,plt≥100×109/L,TB\<UNL (\<1.5 x UNL in patients with liver mets),ALT/AST\< 1.5 x UNL (\<2.5x UNL in patients with liver mets),AKP\<5 x UNL(except bone mets),Cr\<UNL;
* Normal functions with heart, liver,renal and bone marrow;
* Got ICF before enrollment;
* Life expectancy more than 12 weeks.

Exclusion Criteria:

* Pregnant or breast-feeding women or positive serum pregnancy test;
* Uncontrolled brain metastases;
* No recovery from previous radiation or accepted radiation within 4 weeks before enrollment;
* Participation in any investigational drug study within 4 weeks preceding treatment start;
* Concurrent other malignancy at other sites or previous other cancer within the last 5 years, with the exception of adequately treated in situ carcinoma of cervix uteri or basal or squamous cell carcinoma of the skin;
* Serious uncontrolled intercurrent infections;
* Poor compliance.
Testing an Internet-Based Intervention for Preventing Eating Disorders

This study will examine the ability of an Internet-based program to prevent college-aged women from developing eating disorders.

Approximately 2% to 4% of college-aged women suffer from eating disorders (EDs), and many more are at risk of developing them. A previous Internet-based intervention called Student Bodies (SB), which focused on body image concerns, was effective in reducing risk factors for EDs among college-aged women. However, the original SB program did not account for certain other risk factors, such as depression and compensatory behaviors like self-induced vomiting, over-exercising, or use of diuretics. Image and Mood (IaM) is an enhanced version of the SB program and takes into account depressive symptoms and the use of compensatory behaviors. This study will examine whether IaM will reduce ED risk factors in a large population of college women who are at high risk of developing EDs.

Participation in this study will last 10 weeks. Participants will be randomly assigned to either receive the IaM program or be placed on a wait list. The IaM program, which will be delivered through the Internet, will provide information about nutrition, exercise, body image, and coping skills-including examples and exercises. It will also include an online message board monitored by a study psychologist. Each week the IaM participants will monitor their behavior, keep a journal about their experiences, and answer self-report questionnaires. Assessments of eating disorder symptoms; weight and shape concerns; depressive symptoms; and incidence of substance abuse, anxiety, or depressive disorders will be completed post-treatment and at 1- and 1.5-month follow-ups. Those assigned to the wait list will complete these assessments and then receive the IaM program after the last follow-up.

Eligibility Criteria:
Inclusion Criteria for Primary Aim:

* Access to a computer with an Internet connection
* Weight Concerns Scale score greater than or equal to 47
* Presence of one additional risk factor, including a history of teasing, a history of depression, or low levels of compensatory behaviors (defined as less than four times per month)

Inclusion Criteria for Secondary Aim:

* Access to a computer with an Internet connection
* Weight Concerns Scale score greater than or equal to 47

Exclusion Criteria for Both Primary and Secondary Aims:

* Current diagnosis of an eating disorder
* Treated for an eating disorder within the past 6 months
* Currently receiving psychological treatment for an eating disorder or depressive disorder
* Started a new psychiatric medication within the past 2 months
* Exhibiting a level of psychopathology that would interfere with participation (e.g., acutely suicidal)
Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis).

The corneal cross-linking technique has been shown to strengthen the cornea and resist degradation by the body's own enzymes. The use of highly-resistant donor corneas is meant to eliminate the serious post-operative complication of corneal melting (keratolysis) that repeatedly occurs in Boston KPro patients with severe ocular burns, autoimmune and cicatrizing diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide written informed consent and comply with study assessments for the full duration of the study.
2. Age \> 18 years.
3. A negative urine pregnancy test.
4. Candidate for a Boston Keratoprosthesis/Corneal transplant.
5. Generally good stable overall health.
6. Patients with an eye at risk for a cornea sterile ulcer which includes:

   * Chemical injuries.
   * Autoimmune diseases (ocular cicatricial pemphigoid, Stevens Johnson Syndrome, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune diseases).
   * History of previous sterile corneal ulceration requiring a cornea transplant.

Exclusion Criteria:

1. Age \< 18 years.
2. Inability to provide written informed consent and comply with study assessments for the full duration of the study.
3. Pregnant or lactating women.
4. No or minimal tear production.
5. Ocular or periocular malignancy.
6. Inability to wear a contact lens due to lid abnormalities or shortened fornix.
7. Signs of current infection, including fever and current treatment with antibiotics.
8. Participation in another simultaneous medical investigation or trial
Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension

This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Written informed consent must be obtained before any study assessment is performed.
* Males and females of non-childbearing potential and of legal age (at least 18 years or older as defined by local law).
* Asian patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy with up to two drugs.

Key Exclusion Criteria:

* Women of child-bearing potential.
* History of angioedema, drug-related or otherwise
* History of hypersensitivity to LCZ696, valsartan, or drugs of similar chemical classes.
* Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period.
* History or evidence of a secondary form of hypertension,
* Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
* History of myocardial infarction, coronary bypass surgery or percutaneous coronary intervention (PCI) during 12 month prior to screening.
* Current or history of hypertensive retinopathy.
* Previous or current diagnosis of heart failure (NYHA Class II-IV).
* Clinically significant valvular heart disease at screening.

Other protocol defined inclusion/exclusion criteria may apply
Brinzolamide-brimonidine Fixed Combination for Preventing IOP Elevation After Intravitreal Anti-VEGF Injections

This study aims to evaluate the effect of topical prophylaxis with brinzolamide-brimonidine fixed combination on short-term intraocular pressure (IOP) elevation after intravitreal injections of anti-vascular endothelial growth factors (anti-VEGF).

Patients scheduled for treatment with intravitreal injections of anti-VEGF will be randomly divided into two groups. In control group no prophylactic medication will be used, whereas in case group one drop of brinzolamide-brimonidine fixed combination will be instilled two hours before the injection. IOP will be measured before the injection, 1 minute after the injection, 10 minutes and 30 minutes post-injection in all eyes. In case group, the pre-injection IOP will be measured prior to the administration of the fixed combination of brinzolamide-brimonidine. The iCare (IC200) tonometer will be used for IOP measurements at all time points.

The intravitreal anti-VEGF (ranibizumab, bevacizumab, pegaptanib and aflibercept) are commonly used in the treatment of diabetic macular edema, neovascular age-related macular degeneration and other pathologies characterized by retinal or choroidal neovascularization. Intravitreal injections οf anti-VEGF agents result in an immediate and transient increase in IOP, which returns to normal within a short period of time, typically within thirty minutes. Repeated intravitreal injections and prolonged treatments seem to be associated with sustained elevation of IOP, leading to the initiation of ocular hypotensive medication and glaucoma filtration surgery. A fixed-dose combination of brinzolamide 1%, a carbonic anhydrase inhibitor, and brimonidine 0,2%, an alpha 2 adrenergic receptor agonist, represents a safe and effective drug in glaucoma treatment and its ocular hypotensive effect has been demonstrated similar to or better than the unfixed combinations of its component drugs.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for treatment with intravitreal injections of anti-vascular endothelial growth factors

Exclusion Criteria:

* history of glaucoma or ocular hypertension
* use of topical medications (e.g. IOP-lowering medication, corticosteroids)
* pseudoexfoliation
* pigment dispersion syndrome
* corneal diseases
* active intraocular inflammation
* any intraocular surgery in the last 6 months
QST in Context With Conditioned Pain Modulation

Conditioned Pain Modulation (CPM) is a phenomenon which isn't examined enough. Many factors of influence such as gender, age and psyche are already known - but the duration of such effects, their reliability and the correlation between standardized Quantitative Sensory Testing (QST) and CPM is still unknown.

In this study the investigators expect to find parameters in QST that correlate with the efficacy of Conditioned Pain Modulation. Knowing factors that indicate high or low potential CPM could help finding patients-at-risk and adapting their therapy.

Conditioned Pain Modulation was firstly found in rats by electrical stimulation of their spinal cord and called Diffuse Noxious Inhibitory Controls. In humans such experimental settings are impossible. That is why we need two noxious stimuli for provoking such an endogenous pain inhibition.

Before the CPM setting begins, we will investigate our 32 healthy probands by basic QST following the protocol of DFNS (German Research Network on Neuropathic Pain). This assessment helps us to create a sensory profile for every proband and to look for correlations between QST parameters and CPM efficacy. Then the CPM setting follows. In our experimental design we use a test stimulus (TS) on the dominant forearm by thermode (normally 45-47°C, depending on the pain rating, we need scores \>NRS 60) and a conditioned stimulus (CS) on the other hand by cold water bath (10°C). Both stimuli must be rated on the numerical rating scale (NRS) 0-100 alone and in combination. A positive effect can be seen, if the difference between TS alone and TS in combination with CS is \>0. To learn more about the duration of CPM effects we decided to repeat four QST parameters (cold detection threshold, warm detection threshold, mechanical detection threshold and mechanical pain threshold) within 30 minutes after finishing the CPM part to detect changes of time.

The whole study design will be repeated 24-72h hours later to increase the test-retest-reliability.

Eligibility Criteria:
Inclusion Criteria:

* healthy probands \>18 years
* right-handedness
* informed consent
* no chronic pain
* no drugs (but oral contraceptives)
* no neurological diseases
* no psychiatric diseases

Exclusion Criteria:

* no informed consent
* language deficits
* left-handedness
* not enough pain intensity by thermode or cold water bath
* psychiatric disease, neurological diseases other chronic disease
* chronic pain syndromes
* pregnancy or lactation
* permanent drug use, drug use in the last 14 days
Sport-specific Endurance Training on Cardiorespiratory Fitness

The football players require a number attributes for excellent performance. These attributes include cardiovascular fitness, muscle strength, muscular Endurance, flexibility, agility, Coordination, skill and tactical knowledge. In young male football players, the most important attributes are high levels of skill in passing, shooting, dribbling, and heading. A long-term commitment to endurance training is necessary to reach and maintain a player full physical potential. There are two primary objectives of the endurance program are to prevent injury and enhance the abilities to play the game.

The football players require a number attributes for excellent performance. These attributes include cardiovascular fitness, muscle strength, muscular Endurance, flexibility, agility, Coordination, skill and tactical knowledge. In young male football players, the most important attributes are high levels of skill in passing, shooting, dribbling, and heading. A long-term commitment to endurance training is necessary to reach and maintain a player full physical potential.

In sport-specific endurance running on cardiorespiratory fitness endurance, 26 male football players with age group of 16-25 are selected. The participants have never undergone surgery or accident and do not possess any lethal disease. The participants will be allocated into control group with 13 participants and experimental group with 13 participants respectively. The sample will be taken in study setting of Pakistan Sports Board. Control group will follow their daily warm up activities. Interventional group will follow the endurance-based running protocol. Sport-specific endurance-running (duration \[in minutes\], total distance \[in meters\], mean speed \[in meters per minute\], high-speed running \>15 km·h-1, and relative high-speed running \[\>75% and \>85% of maximal velocity\]) will be given to the experimental group. Athletes will run in excess of 15 km of total distance (TD) and 4 km of high-speed (\>15 km·h-1) distance per session 3 to 4 running-based endurance sessions per week for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male Football players
* Age Group: 16-25 years
* Already working on endurance based exercises

Exclusion Criteria:

* Female Football players
* Players undergone surgery or accident
* Any malignant disease or chronic disease
RiSPECT: Risperdal Safety Protocol Evaluation Consta Treatment, a Post Authorization Safety Survey to Obtain Information on the Safety and Efficacy of Risperidone When Used in Routine Clinical Practice

The purpose of this research study is to gather information on the safety and efficacy of risperidone when used in routine clinical practice.

This post-authorisation safety survey (PASS) is an international, multicentre, naturalistic, descriptive survey to confirm safety of risperidone in daily practice. This is a single-arm, prospective, observational survey to compare the safety profile between groups defined by existing risk or disease factors or patient characteristics. The study duration is 6 months with 4 patient visits. The primary objective of this PASS is to confirm safety, as identified in phase III clinical trials of risperidone, by collecting data when the drug is used under marketed conditions in routine clinical practice. A secondary objective is to evaluate effectiveness and reasons for initiating risperidone. Each investigator is to document data for 4-10 treated patients for whom risperidone long-acting injectable (RLAI) treatment is determined to be clinically indicated. Risperidone long-acting injectable (RLAI) is given as intramuscular injections every 2 weeks. The starting dose of RLAI will be in accordance with the product label (usually 25 mg). If necessary, the dosage of the injection may be increased gradually. Treatment duration is 26 weeks. To ensure continued antipsychotic coverage until the main release of risperidone from the microspheres, previous antipsychotic therapy will be continued concomitantly during the first three weeks of the study.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated with long-acting injectable risperidone as decided after agreement between the physician and the patient, in accordance with the local Summary of Product Characteristics (SmPC), are eligible for inclusion in this survey. According to the global SmPC, long-acting injectable risperidone is indicated for the treatment of schizophrenia and schizoaffective disorder

Exclusion Criteria:

* According to the SmPC, long-acting injectable risperidone is contraindicated in patients with a known hypersensitivity to the product or any of its components. These patients must be excluded from the survey
911 Nurse Triage Line

Each year, millions of Americans call 911 for time-sensitive issues that don't require Emergency Medical Services (EMS). In need of medical help, these callers may treat 911 as an entry point into the healthcare system, yet an ambulance to the emergency department can harm both their own long-term health and the health of others. In a field experiment in Washington, DC, the investigators randomly assign nurses directly into 911 calls in order to triage low-acuity calls. While other 911 reforms have denied callers access to alternative resources, this effort reforms 911 by offering appropriate care.


Eligibility Criteria:
Inclusion Criteria:

* Low-acuity call

Exclusion Criteria:

* Incarcerated
The Fibrin Pad Cardiovascular Study

This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass;
* Subjects must be willing to participate in the study and provide written informed consent.

Exclusion Criteria:

* Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products;
* Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 30 day follow up period after surgery.
* Female subjects who are pregnant or nursing.
TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

Primary objective:

To determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible HIV-related tuberculosis (TB).


Eligibility Criteria:
Inclusion Criteria

* Clinical diagnosis of pulmonary \&/or extrapulmonary TB confirmed by a positive culture and susceptibility to rifampin. Patients having isoniazid or pyrazinamide (PZA)-resistant isolates are eligible to continue in the study on a modified regimen
* Evidence of HIV infection confirmed by a positive serologic test (ELISA and Western Blot).
* Absolute neutrophil count \>500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed)
* \> 18 years of age
* Willingness to practice effective contraception if applicable
* Signed informed consent

Exclusion Criteria

* Pregnancy or breastfeeding
* AST \> 10 times the upper limit of normal
* Bilirubin \> 3.0 times the upper limit of normal
* Creatinine \> 3.0 times the upper limit of normal
* Intolerance to any of the study drugs except isoniazid or pyrazinamide
* Concomitant disorder that is contraindication to the use of the study drugs
* More than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy
* Bone/joint tuberculosis or silicotuberculosis