cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse

This study aims to investigate the impact of a bromelain pre-rinse adjunct on oral plaque removal in orthodontic subjects. The study's null hypothesis states that there is no statistically significant difference in visual plaque scores among orthodontic subjects with or without proteolytic enzyme rinse aid.

Bromelain, a naturally occurring cysteine protease, from pineapple stalks, is used in food and medical industries and listed on the FDA's "Generally Recognized As Safe" (GRAS) list. In vitro bromelain study demonstrated antibacterial effect on oral pathogens. Bromelain was found to prevent biofilm formation by interfering with bacteria-bacteria adhesion and/or adhesion to enamel surface. Clinical trials with toothpaste containing bromelain demonstrated improved plaque and gingivitis scores and extrinsic enamel stain removal capabilities. The impact of bromelain application prior to traditional mechanisms of plaque removal have not been clearly evaluated.

Eligibility Criteria:
Inclusion Criteria:

* male or female
* 10 to 25 years of age
* willing to consent to participation
* able to follow study instructions
* in active orthodontic treatment with fixed orthodontic appliances

Exclusion Criteria:

* unwilling/unable to follow study instructions
* documented/suspected pineapple allergy
* proteolytic enzyme allergy
* food dye allergy
* smoker
Single-cycle Remote Ischemic Preconditioning and Postconditioning (SCRIP) Trial

This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning in patient undergoing coronary angioplasty.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for percutaneous coronary intervention (elective and emergency cases)
* Age \> 18-year-old
* Informed consent

Exclusion Criteria:

* Previous CABG
* Previous PCI in 1 week / treatment with thrombolysis within 30 days
* Peripheral arterial disease / A-V shunt of upper extremities (AVF for hemodialysis)
* Paresis of upper limb
* Unstable patient such as cardiogenic shock / vasopressor / IABP / cooling (hypothermia)
* Fatal cardiac arrhythmia (VT / VF)
* Chronic hypoxia
"EFFECTS OF KINESIO-TAPING ON PAIN, POSTURAL STABILITY AND FUNCTION IN PERSONS WITH DISCOGENIC LOW BACK PAIN"

Low back pain is the leading cause of disability worldwide, the prevalence of low back pain can be as high as 43%. Past research has shown the positive effects of Kinesio taping in patients with chronic and nonspecific low back pain in pain reduction, improvement in postural stability, and improvement in function. However, no study has yet evaluated the effects of KT in persons with discogenic LBP. If found to be effective KT can be prescribed as a conservative \& cost-effective treatment for patients with discogenic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Age20-45 years.
* Positive straight leg raise (SLR)
* Posterolateral disc bulge, herniation or prolapse indicated by MRI.
* Positive centralization and peripheralization phenomenon.

Exclusion Criteria:

* Participants having spondylolisthesis, fractures, tumors, osteoporosis, infection, or spinal stenosis.
* History of lumbar spine surgery and patients that are already receiving any physical therapy or exercise
* Skin allergy or sensitivity to the tape.
* Neurological, rheumatologic, or psychiatric disease
Validation of a Predictive Model to Estimate the Risk of Conversion to Clinically Significant Macular Edema and/or Vision Loss in Mild Nonproliferative Diabetic Retinopathy in Diabetes Type 2

This project aims to validate a predictive model of diabetic retinopathy progression to clinically significant macular edema (CSME) needing photocoagulation and/or vision loss. The Coimbra Predictive Model (CPM), based on retinal thickness, microaneurysms number, HbA1C and LDL levels, established on a set of 52 diabetic patients, will be tested on a population of 400 patients/eyes to be enrolled into the study. These patients will perform 2 visits at 6-month interval (V0 and V6) to classify each patient into one of the 3 previously established phenotypes. Two years after (V24) patients will be reexamined. The occurrence of end-points, achieved by the patients, are expected to validate our predictive model.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 2 according to 1985 WHO criteria.
* Age between 35 and 75 years.
* Mild non-prolipherative retinopathy (based on ETDRS criteria)
* Best Corrected Visual acuity \>20 /25
* Refraction with a spherical equivalent less than 5 Dp.
* Inform consent

Exclusion Criteria:

* Cataract or other eye disease that may interfere with fundus examinations
* Glaucoma
* Vitreous syneresis or posterior vitreous detachment
* Other retinal vascular disease
* Recent intraocular surgery
* Previous laser therapy
* Dilatation of the pupil \< 5 mm
RFA for Treatment of Intermediate Stage HCC

In Egypt, chronic hepatitis C virus (HCV) is the most prevalent cause of hepatoma. The study aims to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC). The present study was a single-center, prospective non-randomized, controlled clinical trial in the Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals, between October 2018 and August 2021. Abdominal ultrasonography and triphasic computerized tomography (CT) abdomen were used to diagnose HCC. The abdominal ultrasonography and a dynamic CT scan were performed six weeks following the ablation to assess treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Patients were early and intermediate-stage HCC (BCLC stage A and B).
* Patients accepted to be treated by percutaneous radiofrequency ablation in the Interventional Ultrasonography Unit.
* Patients with early-stage-HCC should have up to 3 tumors, all smaller than 3 cm with a Child-Pugh A score.
* Patients with intermediate-stages-HCC should have multinodular HCC (\>3 nodules \<3 cm) or single focal lesion more than 3 cm, with Child-Pugh Score A or B liver cirrhosis, international normalized ratio (INR) less than 1.7, and platelet count more than 50,000/cm.

Exclusion Criteria:

* Patients with HCC with and vascular spread (portal vein thrombosis), lymph node metastasis or distant metastasis, subcapsular lesions, or lesions with close vicinity to the gall bladder, bowel, or portal vein.
* Patients with clinically decompensated liver disease (Child-Pugh Score C liver cirrhosis).
Brain Nicotine Receptor Density & Response to Nicotine Patch

Even though the health risks and societal costs of cigarette smoking are well-known, roughly 19.8% of American adults continue to smoke. While most smokers endorse a desire to quit, very few (\< 5%) will actually quit in a given year without treatment, and only about 20-25% achieve abstinence after 6 months or more of effective treatment. Therefore, there continues to be a vital need to improve outcomes for cigarette smokers seeking treatment. Current first-line medications for Tobacco Dependence include nicotine replacement therapies (such as the patch, gum, lozenge, nasal spray, and inhaler), varenicline HCl (Chantix), and bupropion HCl (Zyban), with the current standard of care in most treatment settings being to choose specific medications based primarily on availability, ease of use, and patient preference. The goal of the proposed research is to improve the delivery of smoking cessation treatment by determining if pre-treatment nicotine receptor density in cigarette smokers is associated with smoking cessation outcome with the standard nicotine patch taper. The study's main hypothesis is that cigarette smokers with less pre-treatment upregulation of nicotine receptors will have a greater likelihood of quitting smoking from a standard course of nicotine patch treatment than smokers with more up-regulation of these receptors. Positron emission tomography (PET) will be used to test this hypothesis.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult who is a tobacco dependent smoker (smokes 10-30 cigarettes per day) meeting criteria for Nicotine Dependence as defined by DSM-IV criteria
* Has the desire to quit smoking
* Ability to read, write, and give voluntary informed consent
* An exhaled CO greater than or equal to 8 ppm during the study screening visit to verify smoking status

Exclusion Criteria:

* Any history of an Axis I psychiatric diagnosis other than Nicotine Dependence (including other substance abuse/dependence and mood, anxiety, and psychotic disorders)
* Any current medication or any history of a medical condition that might affect the central nervous system at the time of scanning (e.g., current treatment with a psychotropic medication, or history of severe head trauma or epilepsy).
* Unstable cardiovascular disease, liver disease, or renal insufficiency. Routine history and physical examination will be performed at the initial screening visit to insure that participants meet study criteria
* Pregnancy (urine pregnancy tests will be obtained on all women of child-bearing potential) due to the theoretical risk of radiation exposure to the fetus. Pre-menopausal women will only be scanned during the early follicular phase (by participant report) of the menstrual cycle because hormonal levels have been shown to affect nicotine metabolism.
* Caffeine dependence, as evidenced by withdrawal symptoms temporally associated with caffeine ingestion.
Foresee Home for Monitoring Age Related Macular Degeneration (AMD)

The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

Eligibility Criteria:
Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed as CNV under treatment or Intermediate AMD in at least one eye
* Did not perform more then 10 anti- VEGF injections
* Age \>50 years
* VA with habitual correction \>6/45 in the study eye
* Computer users

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
Molecular Mechanisms Underlying Prostate Cancer Disparities

The purpose of this study is to further elucidate the molecular mechanisms underlying prostate cancer disparities. In previous work the investigators have identified a set of differentially deregulated genes in African American versus Caucasian American prostate cancer. Based on these findings, they hypothesize that they will be able to validate these targets, originally identified in the previous work conducted at The George Washington University Medical Center, in an independent Duke University Medical Center cohort of prostate cancer specimens. In addition, the investigators hypothesize that they will be able to discover novel targets in the Duke University Medical Center cohort of prostate cancer specimens because of regional differences.

Individual patient African American and Caucasian American prostate biopsy cores or surgical specimens will be obtained from the following procedures: transrectal ultrasound biopsy of the prostate (TRUSBxP), MR fusion biopsy, intra-operatively (IO) at the time of prostatectomy. Using cellular DNA and RNA, isolated from prostate cancer and patient-matched normal prostate biopsy cores or surgical specimens, the investigators will perform ancestral genotyping, exon arrays, targeted RNA sequencing, and epigenetic analyses. As controls, blood will also be collected. Genomic data from blood and tumor tissue will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Suspected malignancy of prostate cancer
* Self-reported race of African American or Caucasian American
* Age \>/= 18 years
* Able to read, understand and sign an informed consent document

Exclusion Criteria:

* Collected tumor tissue is inadequate for DNA and RNA analysis and/or is not positive for adenocarcinoma of the prostate.
* Patients with prior systemic therapy will not be eligible for the study, i.e. radiation or chemo or immunotherapy.
Predictors of Response to Cognitive Remediation in Schizophrenia

The purpose of this study is to determine which variables predict improvement on a cognitive training task battery, used for patients with schizophrenia, and to determine the proportion of patients whose performance returns to normal following cognitive training

It has been suggested that level of cognitive function is a "rate-limiter" for the efficacy of other psychosocial treatments in schizophrenia. Cognitive remediation, which entails training and practice of successively more difficult cognitive exercises, has shown efficacy in improving cognitive function. However, the rate of improvement has not been uniform among patients receiving this intervention. Given the time- and cost-intensiveness of cognitive remediation, it is important to examine variables that will predict response to this treatment, as well as to examine the clinical significance of any improvement.

The current proposal has two aims: 1) to determine which neuropsychological, demographic, and illness variables predict response to cognitive remediation training; and 2) to determine the proportion of patients whose performance returns to normal following cognitive remediation training. For the first part of the proposed study, 50 outpatients diagnosed with schizophrenia spectrum disorders will be invited to participate in an 8-week trial of cognitive remediation training. Detailed neuropsychological, demographic, symptom and illness course variables will be collected prior to training, at the conclusion of training, and 4 months from study intake. In order to answer the second question, additional data on the computerized task performance for healthy controls will be collected, and compared to patient data, in order to determine what constitutes normal-range performance

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia spectrum disorder
* English speakers
* Clinically stable
* No substance abuse in past 30 days

Exclusion Criteria:

* Traumatic brain injury
* Neurological disease
* Diagnosis of mental retardation
Light Reflection on Human Skin in Whole-Body Photobiomodulation Therapy

Photobiomodulation therapy (PBMT) is based on exposing biological tissues to low-intensity light, with effects depending on the light-tissue interaction. When irradiated without skin contact, part of the incident light is reflected and lost. In this context, the amount of reflected light in PBMT applied without skin contact, as well as the influence of skin phototype, has not yet been established. Objective: To quantify the reflection of light from PBMT on the skin of men and women aged 18 to 30 years, considering skin phototypes. Methodology: Participants will be divided into three groups based on skin phototype (Group 1: phototypes I and II; Group 2: phototypes III and IV; Group 3: phototypes V and VI) and sex. They will be subjected to whole-body PBMT with red light (660 nm; 31.85±3.85 mW; 45.50±5.07 mW/cm²) and infrared light (850 nm; 25.29±2.99 mW; 36.13±4.27 mW/cm²) at 20 cm from the light-emitting source, with measurement of light reflection in the regions of the brachial biceps, abdomen, lumbar, anterior and posterior thigh, and calf using a power and energy analyzer (powermeter PM100D and sensor S130C, 0.7 cm²). Data will be analyzed for normality and groups were compared with a significance level of 5%


Eligibility Criteria:
Inclusion Criteria:

* male and female
* age between 18 and 30 years
* body mass index (BMI) between 18.5 and 29.9 kg/m2.

Exclusion Criteria:

* tattoo in the light reflection assessment areas
* history of skin cancer
* skin lesions such as open wounds in the mid-thigh, abdomen, biceps brachii, back and calf
* patients with cognitive difficulty reporting thermal sensation
Efficacy and Safety of Polyethylene Glycol Compared With Sodium Picosulphate for Bowel Preparation Before Colonoscopy

Patients intended for ambulatory colonoscopy will be randomized into 2 groups


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients scheduled for elective colonoscopy
* Age 18-80

Exclusion Criteria:

* Renal insufficiency (serum creatinine ≥2.0 mg/dl)
* Symptomatic congestive heart failure
* Recent myocardial infarction
18F-FES PET/CT's Additional Clinical Value in ER+ BC

To figure out whethetr 18F-FES PET/CT could influence the staging and management of newly diagnosed Oestrogen Receptor-positive Breast Cancer Patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed immunohistochemical confirmed oestrogen receptor (ER)-positive breast cancer
* Patients underwent both 18F-FES PET/CT and 18F-FDG PET/CT in Fudan University Shanghai Cancer Center within 1 week after diagnosis
* Patients with available medical history

Exclusion Criteria:

* Patients with incomplete medical history
Clinical Research of Intravenous Thrombolysis for Ischemic Stroke in Northeast of China

This research is based on clinic treatment of intravenous thrombolysis for patients with acute ischemic stroke.By building up a database of these patients, the investigators aim to find some significance between groups by analyzing population information, clinical status and such for better evaluation and optimal treatment decision.

With the highest incidence rate,the population in northeast of China is severely tormented by stroke, especially ischemic stroke. The investigators lunch this project by building up a database of detailed information of patients that fits the criteria of intravenous thrombolysis therapy.Including biochemical markers,imaging and follow-up,investigators intend to analysis these data,find factors that contributes to better prognosis,so as to push forward the prevention and control work.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of ischemic stroke causing measurable neurological deficit
2. Onset of symptoms \<4.5 h before treatment begins
3. Age ≥18 y

Exclusion Criteria:

1. Significant head trauma or prior stroke in the previous 3 mo
2. Symptoms suggest SAH
3. Arterial puncture at noncompressible site in previous 7 d
4. History of previous intracranial hemorrhage
5. Intracranial neoplasm, AVM, or aneurysm
6. Recent intracranial or intraspinal surgery
7. Elevated blood pressure (systolic \>185 mm Hg or diastolic \>110 mm Hg)
8. Active internal bleeding
9. Acute bleeding diathesis, including but not limited to
10. Platelet count \<100 000/mm3
11. Heparin received within 48 h resulting in abnormally elevated aPTT above the upper limit of normal
12. Current use of anticoagulant with INR \>1.7 or PT \>15 s
13. Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
14. Blood glucose concentration \<50 mg/dL (2.7 mmol/L)
15. CT demonstrates multilobar infarction (hypodensity \>1/3 cerebral hemisphere)
16. Relative exclusion criteria
17. Recent experience suggests that under some circumstances, with careful consideration and weighting of risk to benefit, patients may receive fibrinolytic therapy despite ≥1 relative contraindications. Consider risk to benefit of intravenous rtPA administration carefully if any of these relative contraindications is present
18. Only minor or rapidly improving stroke symptoms (clearing spontaneously)
19. Pregnancy
20. Seizure at onset with postictal residual neurological impairments
21. Major surgery or serious trauma within previous 14 d
22. Recent gastrointestinal or urinary tract hemorrhage (within previous 21 d)
23. Recent acute myocardial infarction (within previous 3 mo)
Empagliflozin Versus Vildagliptin in CAD Patients With T2DM

We compared the cardioprotective effects of empagliflozin, an SGLT2 inhibitor, with those of vildagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, focusing on various inflammatory biomarkers lipid profile, and cardiac function, in patients with type 2 diabetes mellitus (T2DM).

This was a prospective, randomized, double-dummy, parallel-group trial that enrolled 120 patients with T2DM. The patients were randomized 1: 1 for 6 months administration of empagliflozin or vildagliptin. by using consecutive ascending randomization numbers in the treatment blocks allocated to each study site. The randomization was stratified by the presence or absence of statin and oral antidiabetic therapy. The randomization list was produced using an automated random number generator.

Clinical parameters, assessment of atrial myocardial function, LVEF%, LA diameter, glycemic and lipid profile, adiponectin, high-sensitivity C-reactive protein, and Sortilin levels will be determined at baseline and after the 6 months of treatment period.

Patient compliance was evaluated by the counting of pills by a physician at selected time-points. In addition, patients were provided with individual diary cards to record administration of the study medication on a daily basis. These cards were checked regularly by site staff.

The study will be approved by the local ethics committee and was conducted in accordance with the Declaration of Helsinki and its amendments. All included patients provided written informed consent.

Eligibility Criteria:
Inclusion Criteria:

1. T2DM patients with chronic stable angina.
2. patients with glycated hemoglobin (HbA1c) levels of 6.0-10.0%.
3. patients aged 20-80 years.
4. patients with a body mass index of ≥ 22 kg/m2.
5. patients who provided written informed consent.

Exclusion Criteria:

1. patients with type 1 diabetes mellitus or secondary diabetes mellitus.
2. patients with renal dysfunction (estimated glomerular filtration rate \< 45 mL/min/1.73 m2).
3. patients with left ventricular ejection fraction (LVEF) \< 30%.
4. patients with untreated cancer.
5. patients with hepatic cirrhosis.
6. patients with liver failure that was virus-, autoimmune- or drug-induced.
7. patients with alcoholism.
8. pregnant or breastfeeding patients, or those planning to become pregnant during the course of the study.
9. patients allergic to empagliflozin or vildagliptin.
10. patients with anemia (hemoglobin \< 12 g/dL).