cyrilzakka/clinical-trials huggingface dataset:
Fissure Sealant Retention Trial

The aim of the investigators study is to compare how two different bonding agents affects retention in a preventive dental procedure of pit and fissure sealant. This study will help in deciding whether the self etch bonding agent requiring less steps in completion is as effective as the total etch bonding agent requiring multiple steps in fissure sealant placement.

Pit and fissure sealant have been hailed as a highly effective preventive dental treatment since it was introduced first in late 1970s . Sealants have traditionally placed using two step bonding agents based on acid etching with phosphoric acid followed by drying and bonding agent application and curing. Multiple steps in application of bonding agents have been associated with more chances of procedure errors and prolonged procedure time. The newer bonding agents are based on minimizing the number of steps involved with introduction of self etching bonding agents.6th generation adhesives are based on mixing of two components where as the 7th generation adhesives are based on no mix technique.

Previous studies on fissure sealants have focused on conventional etch and rinse bonding agents, there are only few published studies on effectiveness of the self etch bonding agents in retention of fissure sealants in vivo that have targeted the 6th generation adhesive. Feigal and Quelhas reported equivocal results with use of self etching bonding agents in comparison with etch and rinse bonding agents, but their study was limited by smaller sample size. Similar study was conducted by Burbridge which was based on short clinical follow up of 6 month evaluation where Xeno III by Dentsply (6th generation bonding agent) was compared with Prime \& Bond (Dentsply). Another study by Venker et al on Adper Prompt L Pop in a school sealant program was based on retrospective review of cases. In light of published literature on (6th generation) self etch bonding agent has been found to be equal or inferior to total etch bonding agents (5th generation). There are no published clinical trials on the retentiong rate comparison of total etch bonding agent with no mix slef etch bonding agents in pit and fissure sealant.

Our study is based on comparison of effectiveness of single step bonding agent (7th generation adhesives) versus two step bonding agent in fissure sealant retention.

Eligibility Criteria:
Inclusion Criteria:

* Fully erupted bilateral first or second permanent molar teeth.
* Patients requiring fissure sealant due high caries risk.
* Age group 6-25 years.
* Occlusal fissures of molar teeth.

Exclusion Criteria:

* Cases where one of the molar on either side is grossly carious or restored
* Third molars
* Uncooperative patients
* Molar teeth with antagonist tooth not present or extracted
* Mentally and physically handicapped patients
MRI-Guided Stereotactic Body Radiation Therapy in Treating Patients With Liver Metastases or Liver Cancer

This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI with SBRT may help doctors to highlight the tissues surrounding the tumor better.

PRIMARY OBJECTIVES:

I. To assess the feasibility of utilizing an MRI-guided tri-60Co teletherapy system for liver SBRT, as determined the treating radiation oncologist's ability to accurately visualize and align to the target lesion(s).

II. To assess the feasibility of using a three versus five fraction scheme, for one versus multiple (i.e., =\< 5) target lesions.

SECONDARY OBJECTIVES:

I. To determine the tumor local control (LC), disease specific survival (DSS), and overall survival (OS).

II. To gather biomarkers that may elucidate differential immunogenic responses from the three versus the five fraction SBRT regimens.

OUTLINE:

Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks.

After completion of study treatment, patients are followed up at approximately 4-6 weeks, and then every 3 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients may have either metastatic lesions from another primary site or primary hepatocellular carcinoma; patients with one histologically confirmed metastatic lesion of the liver who are presenting for local therapy for lesions concerning for metastases that cannot or should not be biopsied will also be considered for enrollment on a case by case basis; patients can simultaneously receive treatment for multiple hepatic lesions meeting the prior two requirements, at the discretion of the treating radiation oncologist
* Karnofsky performance status (KPS) \>= 70
* No active infections requiring systemic antibiotics
* If a woman is of childbearing potential, a negative urine or serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study
* Ability to understand and willingness to sign a written informed consent

Exclusion Criteria:

* Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study
* Refusal to sign the informed consent
* Patients who are participating in a concurrent treatment protocol
* Patients for whom a plan meeting institutional quality criteria cannot be designed for SBRT treatment via the MRI-guided teletherapy unit, but for whom an SBRT plan meeting institutional quality criteria can be designed for a conventional linear accelerator
Inferior Vena Cava Collapsibility Index Assessment in Predicting Post Spinal Anaesthesia Hypotension in Patients Undergoing Arthroscopic Knee Surgeries.

The aim of this study was to evaluate the role of inferior vena cava collapsibility index assessment in predicting post spinal anaesthesia hypotension in patients undergoing arthroscopic knee surgeries.

Prospective Cohort Study conducted in Ain Shams University Hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Patients: American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.
* Both Sexes.
* Aged 30 to 60 years.
* Body mass index \<35 kg/m2

Exclusion Criteria:

* Patients' refusal of procedure or participation in the study.
* Patients with contraindication to spinal anaesthesia.
* Patients with severe cardiovascular or pulmonary disease.
* Patients with pre-procedural hypotension (systolic arterial pressure less than 90 mmHg and/or mean arterial pressure less than 60 mmHg).
Urinary Cytokine Levels as a Prognostic Marker for Kidney Scarring After Pyelonephritis

The prevalence of kidney scarring after UTI is approximately 5-57%. UTIs are caused mainly by bacteria that cause local and systemic immunological reaction that are accompanied by cytokines. These cytokines are a main factor in the inflammatory process. They are produced by leukocytes, macrophages, fibroblasts, endothelial cells and epithelial cells in the kidney tissue. Interleukin 6 and 8 (IL-6 IL-8) were found in high levels in the urine of children and adults who suffer from UTIs. Other studies on animals have found a relationship between inflammatory reaction and scarring in the kidney. We hypothesize that we will find a similar relationship between the level of IL-6, IL-8 in the urine during acute pyelonephritis in children and the probability of kidney scarring.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-7
* First episode febrile UTI

Exclusion Criteria:

* Recurrent UTI
Efficacy of Different Doses of Tai Chi Chuan on Cognitive Function in Persons With Mild Cognitive Impairment

To determine the relationship between the effects of different frequencies and duration of Tai Chi Chuan in dose parameters to improve cognitive function in elderly persons with mild cognitive impairment.

Mild cognitive impairment (MCI) is regarded as a prodrome to dementia and affects 16% to 20% of people aged older than 65 years. Tai Chi Chuan is an increasingly popular multi-modal physical and mental exercise. Studies have shown that Tai Chi Chuan can effectively improve the cognitive function of elderly persons with MCI. However, the relationship between the effects of different frequencies and duration of Tai Chi Chuan to improve the cognitive function of elderly persons with MCI is not yet clear. The purpose of this study is to determine the optimal frequency and duration of Tai Chi Chuan. The investigators will conduct a single-blind, randomized controlled trial in 350 persons who meet the presence of MCI without dementia. Persons will be randomly assigned to either the Tai Chi Chuan intervention group once or twice a week for 12 or 24 weeks, or the health education control group once every four weeks for 24 weeks. All groups will be followed for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Presence of mild cognitive impairment, not demented;
2. Age ≥ 60 years old;
3. Informed consent and voluntary participation.

Exclusion Criteria:

1. Geriatric Depression Scale score ≥ 9 points;
2. Cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
3. Suffer from severe musculoskeletal system diseases and other contraindications to exercise and are not suitable for Tai Chi Chuan training, such as those who suffer from stroke, Parkinson's disease, and have a history of lower limb arthritis, hip and knee joint replacement, etc;
4. Patients with severe heart, liver, kidney failure, malignant tumors, and other major diseases;
5. Individuals with visual/auditory impairments, writing/reading impairments, illiteracy, etc. that affect training and evaluation;
6. Individuals with uncontrolled hypertension (systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg after medication);
7. Participating in other experiments that influence this study;
8. Engaged in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time).
A Study Comparing the Efficacy and Tolerability of Ziprasidone vs. Clozapine for the Treatment of Schizophrenia in Patients Who Continue to Have Symptoms on or Cannot Tolerate Other Antipsychotic Drugs

The purpose of this study is to compare the efficacy and safety of ziprasidone and clozapine in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment


Eligibility Criteria:
Inclusion Criteria:

* CGI - S ≥4
* PANSS ≥ 80
* Inpatients or outpatients

Exclusion Criteria:

* Patients with a history of myeloproliferative diseases, history of granulocytopenia, agranulocytosis due to a drug
* Diagnosis of substance dependence within previous 3 months using DSM-IV criteria
* History of seizure
* Organic mental disease, including mental retardation or epilepsy
Lansoprazole for Subgroups of Functional Dyspepsia

Pharmacotherapy for functional dyspepsia remains unsatisfactory. Previous randomized trials reported conflicting results on clinical effectiveness of proton pump inhibitor in patients with functional dyspepsia. This study aims to examine whether lansoprazole 15mg is more effective than placebo for functional dyspepsia in Taiwanese patients, and to investigate the association between subgroups of patients and therapeutic response.

This is a prospective double-blind randomized placebo-controlled trial. A total of 450 dyspeptic adult patients, who are diagnosed with functional dyspepsia in accordance with Rome III criteria, are randomly allocated in a 1:1 proportion to receive either lansoprazole 15mg or placebo once daily for 8 weeks. Primary outcome is complete relief of dyspeptic symptoms. Secondary outcomes include significant symptomatic relief, improvement of dyspepsia severity, and health-related quality of life. We use a multiple logistic regression analysis to investigate whether dyspepsia subgroups are associated with different therapeutic responses.

Eligibility Criteria:
Inclusion Criteria:

* Dyspeptic adult outpatients
* Characteristic dyspeptic symptoms according to Rome III criteria (bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning)
* Upper gastrointestinal endoscopy excluding structural diseases

Exclusion Criteria:

* aged less than 20 years old,
* organic lesions such as peptic ulcer, tumor of any kind, stricture or structural deformity, erosive esophagitis, or vasculopathy on endoscopy
* typical and predominant reflux symptoms (heartburn or acid regurgitation)
* comorbidity with malignancy, diabetes mellitus, liver cirrhosis, renal failure, or porphyria
* history of intra-abdominal surgery
* concurrent use of aspirin, non-steroidal anti-inflammatory drug or proton pump inhibitor
* history of allergy or severe side effects to lansoprazole
* pregnant or lactating women.
Recombinant Human Endostatin Continued Pumping Into Vein Combining With CCRT in Unresectable Stage III NSCLC

Resistance of hypoxic tumor cells to radiation is a significant reason of failure in the local control of tumors, especially the squamous cell carcinomas. Preclinical models have shown that Endostar may transiently "normalize" the tumor vasculature to make it more efficient for oxygen delivery, thereby providing a window of opportunity for enhanced sensitivity to radiation treatment. This study is to evaluate the safety, toxicity, and efficacy of the addition of Endostar Continued Pumping into Vein to the standard CCRT regimen in patients with unresectable stage III NSCLC.

Primary

Evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).

Secondary

Measure changes in VEGF and other angiogenic cytokines and antiangiogenic factors in plasma samples from these patients.

Evaluate the application of CT perfusion imaging to determine changes in tumor vascular mophology and function during treatment.

Eligibility Criteria:
Inclusion Criteria:

* untreated histologic or cytologic of NSCLC verified
* inoperable stage IIIA or IIIB NSCLC
* measurable disease by RECIST
* 18\~70 years of age
* an ECOG PS of 0 to 1
* absolute neutrophil count (ANC) of ≥1500/μL, hemoglobin ≥10gm/dL, platelet ≥100,000/μL
* serum creatinine ≤1.25 times of upper limit of normal (ULN), calculated creatinine clearance (CrCl) of ≥60ml/min
* bilirubin 1.5×ULN, AST and ALT less than 2.5×ULN, alkaline phosphatase less than 5×ULN
* forced vital capacity in 1 second (FEV1) higher than 0.8 L
* CB6 is normal
* Written informed consent

Exclusion Criteria:

* a history of other malignant diseases
* any contraindications for chemoradiotherapy
* distant metastasis
* malignant pleural and/or pericardial effusion
* pregnant or nursing
* preexisting bleeding diatheses or coagulopathy
Plasma Triglyceride Extraction by The Muscle

Increased accumulation of fat into the muscles is associated with what is called insulin-resistant state, which is a pre-diabetic state. The purpose of this research is to find out how fat circulating in the blood following fat consumption is taken up by the muscles in healthy people as well as people that are insulin-resistant. The investigators are specifically interested in how a hormone called insulin is involved in this process. Findings from this research will contribute to our understanding of why insulin-resistant people have increased accumulation of fat in their muscles, and ultimately help to design appropriate interventions to prevent type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI): \< 25 kg/m2 or \> 30 kg/m2;
* Insulin sensitivity index (ISI): insulin-sensitive ISI ≥ 7, insulin-resistant ISI ≤ 5.

Exclusion Criteria:

* Medication or supplements known to affect either endothelial function or lipid metabolism (i.e. arginine, protein, fish oil)
* Acute illness
* Uncontrolled metabolic disease, including liver or renal disease
* Atrial fibrillation, history of syncope, limiting or unstable angina, congestive heart failure, known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts
* Cardiac pacemaker or other medical device implanted in the body
* Pulmonary hypertension or other unstable cardiopulmonary conditions
* ECG documented abnormalities or valvular disease
* Low hemoglobin or hematocrit (i.e., lower than accepted laboratory values)
* History of hypertension or elevated blood pressure (systolic, \>140 mmHg or a diastolic, \>95 mmHg)
* History of hyperlipidemia or plasma triglyceride concentration \>200 mg/dl
* Diagnosed diabetes, or 2-h plasma glucose \>200 mg/dl during an oral glucose tolerance test
* Current participation in a weight-loss regimen, including extreme dietary practices
* Use of anabolic steroids or corticosteroids (within 3 months)
Regadenoson Combined With Symptom-Limited Exercise in Patients Undergoing Myocardial Perfusion Imaging

Not infrequently, a physician is faced with uncertainty regarding the ability of a patient to perform adequate exercise in the noninvasive evaluation of known or suspected coronary artery disease (CAD) by the use of radionuclide stress myocardial perfusion imaging. In selected patients, protocols that combine exercise (either low-level or symptom-limited) with vasodilator stress agents have been found to be safe and effective in both identification of the presence and severity of CAD as well as risk stratification for adverse cardiac outcome. However, currently utilized combined stress protocols have drawbacks. Further refinement of combined stress protocols would potentially lead to more appropriate stress protocol selection for patients while enhancing laboratory efficiency. The purpose of this prospective, randomized study will be to evaluate the relative merits of combining regadenoson with symptom-limited exercise in patients clinically-referred for vasodilator-exercise stress myocardial perfusion imaging for the assessment of known or suspected CAD. It is hypothesized that combining regadenoson with symptom-limited exercise is a safe and feasible stress testing modality which is non-inferior to that which combines symptom-limited exercise with dipyridamole.


Eligibility Criteria:
Inclusion Criteria:

* Males and non-pregnant, non-nursing females clinically referred for vasodilator stress myocardial perfusion imaging with the addition of exercise
* Age \>=30 years

Exclusion Criteria:

* Extremely limited functional capacity
* Age \<30 years
* Unable or unwilling to provide informed consent
* Pregnant or nursing females
* Current use of methylxanthines within 12 hours of testing
* Current use of dipyridamole or aminophylline within 48 hours of testing
* Uncontrolled hypertension (\>200 mmHg systolic/\>120 mmHg diastolic)
* Known hypertrophic cardiomyopathy with obstruction or severe aortic stenosis
* Decompensated congestive heart failure
* History of sick sinus syndrome or \> first degree atrioventricular block in the absence of a functioning pacemaker
* Asthma or other bronchospastic reactive airway disease
* History of percutaneous coronary intervention or coronary artery bypass grafting, or documented history of acute myocardial infarction or unstable angina within one week of testing
* Patients at risk for hypotensive reaction to regadenoson
A Study on the Use of Educational Programs Prior to Lumbar Spinal Surgery

This study evaluated the hypothesis that the implementation of an educational program that informs spine patients about their condition, treatment options, prioritization on the wait list, and post-operative care would improve functional outcome and quality of life scores following surgery

Previous literature has shown that longer waits to lumbar spine surgery can have negative effects on the patients perceived function and quality of life both pre- and post-operatively. Patients report deterioration during this long wait, commonly over 6 months in Ontario. The proposed study intends to evaluate the impact of two different educational methods for patients undergoing lumbar spine surgery. This prospective randomized clinical trial will assign patients to two different educational groups: one of solely standard care, and the other of standard care with the addition of presentation of a 10 minute educational video informing spine patients about their condition, treatment options, prioritization on the wait list and post-operative care. Outcome measures will be assessed through four different questionnaires concerning specific conditions, pain, quality of life, etc., both pre-operatively and post-operatively. Providing patients with this accurate information may coincide with positive outcome measures. The more successful educational program, as found by this study, may then be provided to all spine patients. This educational program may bring about an increase in overall well-being of spine patients by having a positive impact on the quality of life both pre- and post-operatively.

Eligibility Criteria:
Inclusion Criteria:

* Degenerative condition of the lumbar spine requiring decompressive surgery

Exclusion Criteria:

* emergent spinal condition
* acute bowel/bladder dysfunction
* cervical spine condition
* inability to participate in follow up and/or functional tests or questionnaires during study timeline (due to substance abuse, etc...)
* revision surgery
Prebiotics in Prevention of Atopy

The study objective is to evaluate whether a specific prebiotic (GOS/PDX) may have an effect in preventing atopic dermatitis, food allergy, intestinal and/or respiratory infections in infants at risk of atopy. In infants with dermatitis, the hypothesis will be tested that prebiotics reduce the severity of the disease.

This study is a prospective, double blind, randomised, 24 month study trial comparing formula with 50/50 mixture of GOS/PDX (Enfamil Premium Infant Formula 1 for children \<6 months and Formula 2 for children ≥ 6 months) versus standard formula (Enfamil Premium Formula 1 and 2).

Study population is composed by newborns at risk for allergy that will be identified at time of delivery. Infants will be eligible if at least one parent or one older sibling have a physician-diagnosed atopic disease (asthma, allergic rhinoconjunctivitis , atopic dermatitis, allergic urticaria, and food allergy as follow described. At time of enrolment (within the first 4 weeks of life) infants will be randomised 1:1 to receive once they will start formula feeding before the day of the 6th month birthday.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age \>37 and \< 42 weeks.
2. Birth weight \> 2500 gr.
3. At risk of atopy (see appendix 1).
4. Informed consent signed by the parents (see appendix 3).

Exclusion Criteria:

1. Congenital immunodeficiency
2. Severe congenital disorders or malformations
3. Born to mother with diabet
4. Long term intake (\> 7 consecutive days) of pro- or prebiotics
5. Children who have already assumed ≥ 50 mL for feeding bottle of Formulas different from the one object of this study for up to a month.
6. Parents expected not to be compliant with the study procedures