cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Effectiveness of FluMist Vaccination in a School-Based Intervention Program

To measure the effectiveness of influenza vaccination in school children by comparing, between target(i.e., children are offered FluMist) and control (i.e., children are not offered FluMist) school families.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children enrolled in the target schools.
* Written informed consent obtained from the child's parent(s) if they agree to participate.

Exclusion Criteria:

* History of severe hypersensitivity (anaphylactic response) to egg products or previous FluMist
* FluMist is licensed exclusively for use in healthy individuals age 5-49 years. Therefore children for whom annual receipt of inactivated influenza vaccine for specific medical condition(s) is recommended will not be eligible. These conditions include:
* Asthma, other chronic pulmonary diseases, kidney disease, metabolic disease, heart disease, or hemoglobinopathy
* Immunosuppression of child
* Severe immunosuppression of a household member
* Pregnancy
* Past history of Guillian-Barre Syndrome
* Aspirin therapy within 1 month prior to FluMist or the anticipated use of aspirin containing products for one month after FluMist administration
* Administration of any inactivated vaccine within 2 weeks or any live vaccine within 4 weeks prior to receipt of FluMist
* Received anti-influenza medication in the past 48 hours
* Fever in the past 72 hours
* Moderate to severe nasal congestion (inability to breathe through the nose) or acute phase URI symptoms until the congestion has improved
Inhaled Bicarbonate Therapy in Cystic Fibrosis

The purpose of this study is to see if inhaled bicarbonate will increase the ability to cough up mucus in a person with cystic fibrosis.

There is evidence that people with CF may have differences in the liquid that lines the surface of their lungs from people without CF. There are two things that are known to be different. One is called bicarbonate secretion, which is the movement of a salt called bicarbonate that is normally present in the blood and lung fluid in all people. The abnormal movement of bicarbonate appears to cause a second abnormality - the liquid in the breathing tubes has more acid than the liquid in patients without CF. These differences may affect the stickiness and thickness of the mucus and limit how well the hairs that line the breathing tubes (cilia) move mucus out of the lungs.

Recent studies in a group of patients with chronic cough looked at the effects of giving an inhaled bicarbonate solution (sodium bicarbonate instead of sodium chloride) on the study subjects' ability to cough up mucus. Compared to the group given inhaled saline, the patients given inhaled bicarbonate were able to cough up approximately three times as much mucus. No clinical studies have looked at whether inhaled bicarbonate improves the ability of the lung in a person with CF to move mucus out of the lung or how this treatment affects lung function in patients with CF.

Eligibility Criteria:
Inclusion Criteria:

* age 12 or older
* Forced expiratory volume in one second (FEV1) \>40% predicted
* Ability to expectorate sputum

Exclusion Criteria:

* pregnancy
* pulmonary exacerbation or initiation of inhaled or oral antibiotics, steroids, or aerosol treatments within the last four weeks
* oxygen saturation \<92%, or requirement for supplemental oxygen
Quality Of Life After Eye Surgical Removal

Studies have shown that health-related quality of life (HRQOL) was worse among patients who underwent surgical eye removal compared to the general population in Denmark.

A third of eye amputated patients suffered from anxiety and depression. Most of the available evidence on the subject is based on retrospective studies that interviewed patients several years after surgery, which can potentially introduce biases.

Moreover, in the literature, there are no data concerning postoperative psychological and visual impact.


Eligibility Criteria:
Inclusion Criteria:

* Patient who underwent an eye removal surgery: evisceration, enucleation or exenteration

Exclusion Criteria:

* Patient who underwent bilateral eye removal surgery
Detection of Plaque Inflammation by Positron Emission Tomography (PET)-Effects of Simvastatin on Plaque Inflammation

The purpose of this study is to determine whether FDG-PET is capable of detecting atherosclerotic plaque inflammation and monitoring the effects of statins on plaque inflammation. The usefulness of FDG-PET in risk stratification is also investigated.

There is increasing evidence that inflammation plays a role in progression and destabilization of atherosclerotic plaque. However, currently, no non-invasive method is available for detecting plaque inflammation in clinical practice. FDG-PET can visualize activated metabolic levels of not only tumor cells but also inflammatory cells. Thus, it is possible that FDG-PET can detect atherosclerotic plaque inflammation and that, if so, FDG-PET can monitor the direct effect of statins on plaque inflammation. Additionally, monitoring the plaque inflammation by FDG-PET may be useful for determining the risk stratification of atherosclerotic patients.

Originally, we sought to compare patients with FDG-positive plaque with patients with plaque but not with FDG uptake, patients with FDG-positive plaque receiving statin therapy, and patients with FDG-positive plaque receiving diet management therapy. However, because patient number enrolled in the study was too small, the comparison was performed between FDG-positive patients with and without any statin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Protocol 1: patients who had carotid atherosclerosis detected by carotid ultrasound.
* Protocol 2: patients who underwent FDG-PET for cancer screening and had vascular FDG uptakes

Exclusion Criteria:

* Active inflammatory diseases
* Dyslipidemia under medications
* Uncontrolled diabetes mellitus, vasculitis, symptomatic coronary artery disease, symptomatic cerebrovascular diseases
* Known systemic disorders such as hepatic, renal, hematopoietic, and malignant diseases
The Effects of Mirabegron and Tadalafil on Glucose Tolerance in Prediabetics

The investigator hypothesizes that treatment with the ß3 agonist mirabegron results in improved glucose metabolism, including a reversal of prediabetes in obese, insulin-resistant human research participants, and this is further improved by combination therapy with tadalafil. The investigator will comprehensively analyze glucose homeostasis in prediabetic patients treated for 14 weeks with mirabegron, tadalafil or both drugs as compared to a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Hemoglobin A1C between 5.7 and 6.4
* Body mass index between 27 and 45

Exclusion Criteria:

* Diabetes
* Chronic use of any antidiabetic medications
* Any unstable medical condition
* Use of steroids or daily use of NSAIDS
* History of chronic inflammatory conditions
* Use of anticoagulants
* Contraindications to the use of mirabegron or tadalafil
* Any condition deemed risky by the study physician
Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions

Executive functions are cognitive processes that have been frequently related to adequate academic performance in the scientific literature. Current research aimed at training executive functions has found promising results using the modern board game as a cognitive tool in children. Considering the growing interest of teachers in this playful and possibly educational and cognitive resource, a game program for cognitive purposes has been designed to be used in primary classrooms. The main objective of the present study is to test the efficacy of a cognitive training program in the classroom based on modern board games in primary school students from ordinary schools (6 to 12 years old). For this, there will be an experimental group that will carry out the game program "Conectar Jugando" in the classroom implemented by the teachers of the participating centers, and a control group that will be on standby and will be compensated by carrying out the game program at the finalize the post-intervention evaluation. The classes of each school stage will be randomly assigned to an experimental group and a passive control group in each of the participating schools.

As hypotheses, it is established that: i) the experimental group will present a significantly greater improvement in the neuropsychological tasks that measure executive functions compared to the passive control group after the intervention; ii) the experimental group will present a significantly greater improvement in the tests evaluated by their parents / teachers after the intervention compared to the passive control group; iii) the experimental group will present a significantly greater improvement in academic tests after the intervention compared to the passive control group. All hypotheses will be controlled for age, estimate of IQ and socioeconomic status, as well as previous experience in board games and other cognitive activities.

Eligibility Criteria:
Inclusion Criteria:

* be enrolled in an ordinary educational center, whether public, private or subsidized
* provide informed consent from both parents and the participant's agreement to participate in the study

Exclusion Criteria:

* comprehension difficulties due to language reasons
* sensory difficulties that make it impossible to carry out the program activities
Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer

This study is a single-arm, open-label, phase II study, comparing the efficacy and safety of pyrotinib plus trastuzumab and aromatase inhibitors, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor receptor 2) + MBC and inoperable LABC patients.

This is a exploratory, single-arm, open-label,multicenter phase II trial. Our primary purpose is to compare that PFS of patients with pyrotinib plus trastuzumab and AI for HER2-positive and hormone receptor-positive MBC or locally advanced breast cancer (LABC).

In treatment period, patients will be administrated pyrotinib plus trastuzumab and aromatase inhibitors, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.

The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years,≤70 years, female;
2. Postmenopausal or pre-menopausal with ovarian function suppression;
3. with or without measurable lesion evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1;
4. Metastatic or inoperable local advanced Invasive breast cancer;
5. HER2-positive breast cancer;
6. HR-positive breast cancer;
7. LVEF ≥55%;QT interva\<470 ms;
8. Eastern Cooperative Oncology Group(ECOG) scale 0-1;
9. Life expectancy ≥3 months;

Exclusion Criteria:

1. Previous systemic non-hormonal anticancer therapy in the metastatic or advanced breast cancer setting;
2. Received endocrine therapy within 7 days before randomization;Uncontrolled central nervous system metastases;
3. Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months.
4. Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma.
5. Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
6. Severe organ dysfunction as assessed by signs and symptoms, laboratory studies and rapid progression of disease, which leading to a clinical indication for chemotherapy.
7. History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia);
8. History of myocardial infarction within 6 months of randomization;
9. History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy;
10. Pregnant or lactating women;
11. QT interval\>470 ms;
12. Serious concomitant diseases (including severe hypertension, severe diabetes, active infection, thyroid disease, etc.) that are harmful to the patient's safety or affect the patient's completion of the study;
Wii-Fit For Balance And Gait In Elderly Veterans

Falls are a major public health problem. They are the leading cause of injuries and injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly. Despite the many proven benefits of exercise, many older adults in the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit as an exercise program.

Objectives/Rationale Falls are a major public health problem. They are the leading cause of injuries and injury-related deaths in those aged over 65 years. Balance and gait abnormalities are major reasons for falls in elderly. Exercise interventions improve gait and balance in the elderly. Despite the many proven benefits of exercise, many older adults in the US remain sedentary. This study targets at improving balance and gait with use of Wii-Fit as an exercise program.

Specific aims

1. To establish the safety, feasibility, and efficacy of an 8-week Wii-Fit program to improve measures of balance, and gait in older adults, compared to a cognitive remediation program, Brain fitness.
2. To compare the effect of an 8-week Wii-Fit program to Brain fitness program, on measures of biomechanical assessment, adherence, safety, physical activity, fear of fall, enjoyment, functional status, cognition and quality of life.

Design 8-week, randomized, parallel group, active intervention study Methods Patients will be recruited via IRB approved flyers posted in various locations of the Little Rock and North Little Rock CAVHS campuses and via referrals from the CAVHS providers. Thirty elderly Veterans will be randomly assigned to Wii-Fit arm or Brain fitness arm. Both groups will participate in the intervention for approximately 45 minutes 3 days a week for 8 weeks. Outcome measures will be assessed at baseline, and approximately week 4 and after completion of week 8. Balance and gait will be assessed by Berg Balance Scale. Secondary outcome measures include biomechanical testing for gait and balance, Safety, Adherence, measures of functional status, cognition, quality of life, fear of falling, physical activity and physical activity enjoyment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age ≥ 60 years
* Fall risk as measured by Berg Balance Scale (BBS) is ≤ 52
* Normal cognition as measured by Mini Mental State Exam (MMSE ≥ 24)
* Able to consent

Exclusion Criteria:

* Subjects using wheel chair or walkers for mobility
* Subjects with absolute contraindications per ACSM guidelines
* Any medical condition (per the relative contraindications per ACSM guidelines below) that in the opinion of the study physician is likely to compromise their ability to safely participate in the exercise program.
Impact of Suture Technique on Wound Healing in Ankle Fracture Surgery: A Randomized Controlled Trial

Our primary aim is to compare the complication rates of patients with ankle fractures who underwent skin closure using a running subcuticular suture pattern compared to an interrupted suture pattern. At the time of the operation, participants will be assigned to either the Subcuticular Suture Group (SSG) or the Simple Interrupted Suture Group (SISG) using computer-generated randomization programs. The surgeon will perform the assigned closure technique using standardized techniques. Running subcuticular Vicryl 3-0 sutures will be placed on patients in the experimental group while simple interrupted Monocryl 3-0 sutures patients in our control group.

Patients will be followed up at the two-week and eight-week postoperative mark where we will use the Patient and Observer Scar Assessment Scale (POSAS) to evaluate and compare wound healing. Additionally, photographs of the scars will be captured to visually assess the healing progression.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 years or older with isolated ankle fractures requiring surgical intervention and who consent to participate.

Exclusion Criteria:

* Patients that will be excluded from this study include those with complex ankle fractures, open fractures, a history of wound healing disorders, and/or those unable to provide consent.
Antibodies to Digoxin for Bipolar Disorder

Subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will receive intravenously only one dose of Digoxin antibodies (Fab). Their response to this therapy will be measured accordingly.Previous medications will be not changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after Fab therapy.

Patients also will be followed using clinical and psychological tests

Twenty subjects suffering from bipolar disorders treated with specific medications will give their informed concent and will included in the study. All will receive in an open study only one intravenously dose of Digoxin antibodies (Fab). Their response to this therapy will be measured accordingly.Previous medications will be not changed A base line serum Endogenous Digitalis-like Compounds (DLC)levels will be measured using a specific laboratory technique and these compounds will be measured at 6 and 24 hours after Fab therapy.

Patients also will be followed using clinical and psychological tests

Eligibility Criteria:
Inclusion Criteria:

* Admitted patients suffering from Bipolar Disorder
* abillity to give informed concent

Exclusion Criteria:

* Allergy to Digoxin Antibodies
* Renal and Liver function impairment
* Liver Cirrhosis
* Asthma
* Patients on Digoxin or Digitoxin
* Patients receiving Aldactone therapy
* Heart A-V Block
* Hypo or Hyperkalemia on admission
* Potential Suicidal Behaviour
Treatment of Melasma Using Q-switched Nd: YAG Laser and Fractional CO2 Laser Separately and in Combination

* All participants will be divided into 2 groups : Group A \& Group B.
* Group A will be subjected to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& fractional co2 laser to the other side of the face with one month interval between sessions.
* Group B will be subjected also to 3 consecutive sessions of Q-switched 1,064 nm Nd: YAG laser to one side of the face \& an additional fractional co2 laser to the other side of the face using the above mentioned parameters with one month interval between sessions.
* Response to treatment will be assessed using the Melanin Index (MI) score, Melasma Area and Severity Index (MASI) score, spectrophotometer ( Derma catch, colorix, Neuchatel, Switzerland ) and a subjective self-assessment method.


Eligibility Criteria:
Inclusion Criteria:

* melasma patients above 18 years

Exclusion Criteria:

* Pregnancy.
* Usage of chemical peeling 1 month prior to the study.
* Isotretinoin intake 6 months prior to the study.
* Any laser procedure related to melasma lesions 1 month prior to the study.
* Active herpetic lesions.
* Any concurrent active skin disease within the treated area.
* Photosensitive skin conditions such as systemic lupus erythematous.
* History of delayed wound healing.
* Keloid formation.
* Bleeding diathesis.
* Medical conditions such as diabetes mellitus \& autoimmune diseases.
A Phase Ⅳ Study of Decitabine in Myelodysplastic Syndrome

The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.

Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18;
* The diagnosis of MDS patients comply WHO2008 standards;
* IPSS score≥0.5;
* WHO classification for patients RCUD, RARS and transfusion-dependent RCMD;
* ECOG PS score: 0-2;
* Expected survival≥3 months;
* Serum bilirubin≤1.5\*ULN, serum ALT and AST≤2.5\*ULN, serum Cr≤1.5\*ULN;
* Subjects signed informed consent form in line with GCP requirements.

Exclusion Criteria:

* Can not marrow biopsy;
* Previously diagnosed AML;
* Received azacitidine or decitabine treatment any time before;
* Being diagnosed with other malignancies in the prior 12 months;
* Pregnant or lactating women;
* Failure to control systemic fungal, bacterial or viral infection;
* Known or suspected allergy to decitabine;
* Known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection;
* Have a history of neurological or psychiatric disorders, including epilepsy or dementia;
* CTCAE 3 or 4 degree peripheral neuropathy;
* According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study in patients;
* Using other experimental drugs or participating in other clinical trials in the prior one months.
Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy

Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.

To figure out the value of oral ciprofloxacin medication in ameliorate the outcome of renal nephrolithiasis extraction via the endoscope as regard the sepsis.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patient 18 years or older
* Stones ≥ 2 cm and/or mild to moderate hydronephrosis
* Sterile mid urine stream

Exclusion Criteria:

* Patients with a stent, nephrostomy tube or indwelling catheter
* Renal failure
* Fever before surgery
* Previous manipulation/procedure
* Concomitant bladder stone or tumour
* Patients with active UTI
* Contralateral renal/ureteric stone