cyrilzakka/clinical-trials huggingface dataset:
Regular Home Use of Dual-light Photodynamic Therapy on Oral Health in Adolescents Undergoing Fixed Orthodontic Treatment

This study is designed to determine the efficacy of the Lumoral method on oral health in adolescents undergoing fixed orthodontic treatment. Improved supragingival plaque control can help to also sustain the subgingival plaque management in the long term. In addition, the device might have a photobiomodulation effect on periodontal tissues.

Orthodontic treatment is one of the most common dental treatments in children and adolescents. The use of fixed orthodontic appliances makes it difficult for the patients to keep their oral hygiene to an optimum level of cleanliness. Poor oral hygiene attracts significant plaque accumulation around the fixed orthodontic treatment appliances, and subsequent white spot lesions can occur rapidly, usually on the cervical and middle third of the buccal surfaces of bracketed teeth. Patients with the fixed orthodontic treatment appliances have an increased risk of caries and gingivitis.

The Lumoral is a CE-marked medical device developed to provide a potent, targeted antibacterial action on dental plaque in a home environment. The device mechanism of action is antibacterial photodynamic therapy (aPDT). The device is used by swishing a mouth rinse, which has a strong adherence to dental plaque. The plaque-adhered photoactive mouth rinse can be activated by a simple to use light applicator. Preliminary results have shown a promising anti-inflammatory response in addition to plaque reduction.

Forty (40) subjects undergoing fixed orthodontic treatment are randomized to the Lumoral treatment group or the control group. All subjects shall receive polishing and oral hygiene instruction. All patients shall be assessed for the clinical measurements including visible plaque index (VPI), bleeding on probing (BOP), and orthodontic plaque index (OPI) at baseline and at 4 weeks and 12 weeks after baseline. In addition, microbiological analyses shall be performed at baseline and at 12 weeks after baseline.

Eligibility Criteria:
Inclusion Criteria:

* age of 15-18 years old
* starting fixed orthodontic treatment
* good oral hygiene according to the dentist's assessment
* absence of periodontal disease and lack of oral lesion
* signed a written consent form, including information to caregivers.

Exclusion Criteria:

* any chronic diseases
* medications that could influence the study (according to the dentists' assessment)
* active caries or a supposed high risk of caries
* gingivitis (bleeding on probing \>10%)
* use of antiseptic mouthwashes
* smoking
* use of antibiotics or anti-inflammatory therapy within 3 months before entering the study or during the study
* unable to cooperate with the protocol.
* pregnancy or lactation
Acute Effects of Waterpipe Smoking on Cognitive Measures and Cardiorespiratory Parameters

Title: Acute effects of waterpipe smoking (WPS) on cognitive measures and cardiorespiratory parameters

Objectives: To evaluate the acute effect of one cession of water pipe smoking on:

1. executive functions which evaluated by cognitive tests administered included the digit span subtest Wechsler Adult Intelligence Scale (WAIS)-version III hebrew battery, and the Paced Auditory Serial Addition Test (PASAT)
2. Cardiorespiratory parameters included vital signs, spirometry parameters and lung clearance index (LCI) value
3. serum carboxyhemoglobin, nicotine, and cytokines

Design: Prospective study evaluating these parameters before and after 30 minutes of water pipe smoking (WPS).

Sample size: 55 participants (35 study group, 20 control group) Participant selection: Adults subjects who regularly smoke water pipe. Intervention: Each subject will undergo evaluation including cognitive tests, Cardiorespiratory parameters, carboxy- hemoglobin levels, nicotine levels, serum cytokines levels.

All measurements will be evaluated before and after one cession of 30 minutes water pipe smoking

The effect of repeated testing 30 minutes apart without water pipe smoking (WPS) was evaluated in a group of 20 volunteers (age and sex matched).

Primary outcome parameter: Change in cognitive tests scores Secondary outcome parameter:Change in Cardiorespiratory parameters included vital signs, spirometry parameters and lung clearance index (LCI) value, serum carboxyhemoglobin, nicotine, and cytokines, before and after water pipe smoking

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 18 years or older who previously experienced WPS.

Exclusion Criteria:

* pregnant or lactating women
* acute viral or bacterial illness
* oral or intravenous steroid treatment in the previous two weeks
* WPS during the previous 24 hours
* cigarette smoking during the previous 6 hours
* massive exposure to fire smoke during the previous 24 hours.
Blood Conservation in Patients (3.5-12kg) Undergoing Congenital Cardiac Surgery

To evaluate if there is any clinical difference in patients 3.5-12kg who undergo cardiac surgery with cardiopulmonary bypass that do and do not receive blood products as part of their procedure. The main hypothesis of the study is that the patients undergoing bloodless cardiac surgery will have decreased morbidity and mortality when compared to the cohort that did receive blood as well as a shorter ICU and hospital length of stay.


Eligibility Criteria:
Inclusion Criteria:

* Patient weight 3.5-12kg
* Elective and urgent cardiac surgery with cardiopulmonary bypass
* Cases within the STS STAT categories of 1-4

Exclusion Criteria:

* Patients who weigh more than 12kg or less than 3.5kg.
* Patients undergoing emergency surgery.
* STAT category 5 cases.
* Patients whose surgery does not require cardiopulmonary bypass.
* Patients presenting preoperatively in shock.
* Patients with known blood dyscrasias.
Effectiveness of Conversion to Sirolimus Versus Calcineurin Inhibitor (CNI) Reduction in Renal Transplant Patients With Prostate Cancer

The purpose of this study is to evaluate the role and effectiveness of conversion to sirolimus versus CNI reduction in renal transplant patients with prostate cancer.

This study is designed to support the optimal use of mTOR-inhibitor by providing data for the safe and effectiveness use with sirolimus. This study will take into account effectiveness aspects such as malignancy-free survival cancer by reducing the overall exposure to calcineurin inhibitor.

Eligibility Criteria:
Inclusion Criteria:

* Male patients ≤ 50 years in their post renal transplant follow-up;
* Biopsy confirmed prostate cancer;
* Stable renal function with GFR ≥ 40 mL/min.

Exclusion Criteria:

* Patients with metastatic disease;
* Uncontrolled hyperlipidemia;
* Proteinuria \> 500 mg/day;
* Biopsy evidence of acute rejection within the past 3 months;
* Existence of any surgical or medical condition, other than the current transplant, which in the opinion of the investigator might significantly alter the absorption, distribution, metabolism or excretion of study medication;
* Patients with mental illness;
* Inability to cooperate or communicate with the investigator or unable to complete self administered questionnaires.
Comparison of Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult ED

The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population.

We hypothesize that a single intravenous dose of ondansetron is more effective in reducing nausea than a single IV dose of metoclopramide, promethazine or normal saline placebo in undifferentiated adult emergency department patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients age 18 or older who present to the ED with a complaint requiring antiemetic treatment who do not meet the exclusion criteria.

Exclusion Criteria:

* Patients less than 18 years of age
* Unstable patients with SBP \< 90
* Patients with a stated or documented allergy to any of the study medications
* Patients whose nausea rating if \< 40 on the pretreatment VAS scale
* Patients who have received a commonly accepted antiemetic within the previous 24 hours
* Patients unwilling or unable to complete the assessment tool before and 30 minutes after study drug dosing
Micropulse 810 Nanomolar (nm), Diode Laser for Diffuse Diabetic Macular Edema

Objective: To compare micropulse 810nm diode laser photocoagulation versus argon laser photocoagulation for treatment of diabetic macular edema. Micropulse laser technique will be determined by an initial clinical trial comparing single versus double density laser photocoagulation techniques for treatment of diabetic macular edema.The single density is based on the Early Treatment Diabetic Retinopathy Study (ETDRS) grid photocoagulation technique and the double density increases the number of spots.

Methods: Patients with diabetic macular edema will be assigned to receive either micropulse 810nm diode laser photocoagulation or argon laser photocoagulation therapy. First, in a smaller clinical trial, patients will be assigned to single or double density micropulse 810nm diode laser to determine best strategy for this therapy. Visual acuity, fundus photographs and fluorescein angiography, and optical coherence tomography measurements , autofluorescence and mfERG were obtained at baseline and at 1, 3 and 6 months and 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus (type 1 or 2)
* Diabetic macular edema in study eye associated to diabetic retinopathy
* Diffuse macular edema defined as macular thickening determined by biomicroscopy and fluorescein angiography.
* Best corrected visual acuity between 34 (20/200) and 68 letters (20/50).
* Macular thickness greater than 300 mcm on OCT.

Exclusion Criteria:

* Uncontrolled systemic disease
* Start of medical therapy for diabetes or change in treatment from oral to insulin four months before initial visit.
* HbA1c levels greater than 10%
* Presence of retinal venous occlusion, cystoid macular edema,or other condition that would contribute to macular edema.
* Presence of epiretinal membrane
* Presence of vitreomacular traction in the study eye.
* Neovascularization of disc or elsewhere in the study eye.
* History or presence of choroidal neovascularization in the study eye.
* Presence of rubeosis irides in the study eye.
* Eye opacity that interfere with clinical documentation and photography.
* Intra-ocular surgery 90 days before initial visit.
* Scheduled surgery for study eye.
* Patients with known allergies to fluorescein.
Client-Centered Counseling During Routine/Opt-Out HIV-Testing in Uganda

This study pilot tests and intervention to help individuals reduce their risk for acquiring or transmitting HIV. The intervention is implemented when people are tested for HIV in an outpatient clinic in rural Uganda. Approximately half of participants will receive the intervention and the other half will receive the usual counseling provided during HIV counseling and testing.


Eligibility Criteria:
Inclusion Criteria:

1. at least 18 years of age,
2. have come to the outpatient clinic for a medical concern (e.g., cough, malaria, but not those seeking voluntary HIV-counseling and testing,
3. sexually active within the prior 3-months,
4. not currently pregnant,
5. no confirmed HIV-positive test result prior to the present HIV-test, and
6. live not more than 30km from Gombe Hospital in Uganda (to facilitate follow-up)

Exclusion Criteria:

* less than 18 years of age,
* having come to the clinic seeking voluntary HIV-counseling and testing,
* not sexually active in prior 3 months,
* currently pregnant,
* confirmed prior HIV positive test,
* live more than 30km from the hospital
T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum

RATIONALE: Patients with xeroderma pigmentosum are more likely to develop skin lesions in sun-affected areas. These skin lesions, such as actinic keratoses, can develop into skin cancer. T4N5 liposome lotion may reduce actinic keratoses or other sun-induced skin damage in patients with xeroderma pigmentosum.

PURPOSE: Randomized double-blinded phase III trial to compare treatment using T4N5 liposome lotion with treatment using placebo in reducing actinic keratoses and other sun-induced skin damage in patients with xeroderma pigmentosum.

OBJECTIVES: I. Compare the safety and efficacy of T4N5 liposome lotion vs. a placebo lotion in reducing the incidence of actinic keratoses and protecting against other ultraviolet skin damage in patients with xeroderma pigmentosum.

OUTLINE: Randomized, double-blind study. Groups of 6 patients are randomly assigned in a 2:1 ratio to Arms I and II, respectively. Arm I: Chemoprevention. Lotion composed of T4 endonuclease V protein encapsulated in liposomes and suspended in phosphate-buffered saline in a hydrogel base, T4N5 Liposome Lotion, T4N5. Arm II: Control. Liposomes suspended in phosphate-buffered saline in a hydrogel base, Placebo, PLCB.

PROJECTED ACCRUAL: 6-30 patients will be entered in this multicenter study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of xeroderma pigmentosum confirmed by unscheduled DNA synthesis assay At least one histologically confirmed actinic keratosis All actinic keratoses removed prior to treatment No associated syndromes, e.g., Cockayne's syndrome or trichothiodystrophy

PATIENT CHARACTERISTICS: Age: 1.66 to 60 Other: Good general health and mental capacity No illegal drug use No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: See Disease Characteristics
Implementation of a Novel Computerized Physician Order Entry System

The objective of this prospective study is to build a real-time interactive platform where doctors and pharmacists may communicate and solve patients' drug-related problems (DRP) immediately and document accordingly. This study will also design a computerized physician order entry (CPOE) system utilizing default protocol for chemotherapy order entry.

To err is human. Most errors are caused by problems in the system. Punishing health personnel cannot prevent the same mistakes. The only solution is a good medication system. CPOE system can prevent prescribing errors. The CPOE system is always the major step in some studies concerning reducing prescribing errors, dispensing errors or administering errors. In this user-friendly and convenient era, improvement in the CPOE system is an immediate need.

Eligibility Criteria:
Inclusion Criteria:

* NTUH pharmacists

Exclusion Criteria:

* NTUH pharmacists who have never recorded drug related problems
X-Ray Computed Tomography and Blood Reactive Oxygen Species Level

The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body \[ref. 1-5\]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS concentration. Therefore, we wish to conduct this study to clarify if the routinely applied X-ray computed tomography examination may induce a higher concentration of ROS in the peripheral blood.

Study subjects will be participants of health check program at our hospital. The only enrollment condition will be a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases) of the study subject. Another 20 participants receiving health check program without X-ray computed tomography examination will be included as the control group. The formal consent will be delivered to the participants of health check program several days before their admission for health check and will be retrieved before the proceeding of health check.

Measurements and comparison of ROS concentration will be performed in the sampled peripheral blood before and after the performance of X-ray computed tomography examination during a regular health check program. Totally 120 blood samples will be collected from included 60 study subjects within 3 months. Reactive oxygen species（ROS）levels will be measured by a chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).


Eligibility Criteria:
Inclusion Criteria:

* Participants of health check program at our hospital who will receive a scheduled X-ray computed tomography examination for either lung (20 cases) or heart (20 cases).

Exclusion Criteria:

* Those whose age are under 50 or above 70 year-olds will be excluded.
Impact Evaluation of GAIN Egg Campaign in Two Nigerian States

Improved infant and young child feeding, including dietary quality and diversity, is important for child health and development. In the 2013 Nigeria Demographic and Health Survey, only 18% of children 6-23 months of age received at least 4 food groups in the previous 24 hours. In Kaduna, one of the poorest states, dietary diversity is low and consumption of eggs is infrequent, with households reporting consuming eggs only one day per week. Eggs are a nutrient-dense food, which can contribute enormously to a child's dietary quality. This study evaluates whether a 14-month behavior change intervention about eggs can increase the procurement and consumption of eggs in children 6-59 months of age living in Nigeria. The intervention includes delivery of messages about the health benefits of eggs through Above-the-line methods and Below-the-line methods. The intervention is evaluated using a longitudinal quasi-experimental design in two states in Nigeria with pre- and post-test questionnaires designed to assess changes in acquisition and consumption of eggs.

The Global Alliance for Improved Nutrition (GAIN) seeks to improve dietary quality among children under-five years of age in Kaduna by increasing the demand for eggs through above-the-line and below-the-line behavior change interventions incorporating mass media, social media, and point-of-sale (POS) marketing. Above-the-line (ATL) interventions include television, radio, celebrity ambassadors and out-of-home (OOH) advertising (e.g., billboards). Below-the-line interventions (BTL) include interpersonal communication (IPC) activation, trade promotions, point-of-sale materials, food demonstrations and giveaways and door-to-door activation.

GAIN conducted a quasi-experimental longitudinal study of a demand creation campaign, using ATL and BTL interventions, among families of children 6-59 months of age to determine the impact on egg consumption among children and egg acquisition. Kaduna state was chosen as the intervention arm, and Kano state as the comparison arm. Within Kaduna state, the Kaduna North and Chikun local government areas (LGAs) were selected to receive ATL and BTL demand creation interventions. The comparison state, Kano, received no demand creation campaign.

The principal comparison for measuring the effect of demand creation interventions will be across states, comparing the combined effects of ATL and BTL interventions with the comparison areas which received no intervention.

Investigators also set out to determine the impact of this intervention on mediating outcomes in the hypothesized causal framework. Proximal mediators included caregivers' attitudes and beliefs toward eggs and willingness to pay for eggs.

Eligibility Criteria:
Inclusion Criteria:

* Living in the project areas

Exclusion Criteria:

* Vulnerable families (i.e., families headed by children, homeless families living on the street in the community, families with a severely mentally unstable head of household)
Use of Pedometers to Measure and Increase Walking Among Patients With ESRD

Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.


Eligibility Criteria:
Inclusion Criteria:

* on hemodialysis for ≥ 3 months
* able to walk
* able to give informed consent and willing to participate

Exclusion Criteria:

* unable to walk
* unable to understand directions or give informed consent
Evaluation of Two Different Methods of Resin Composite Application In Class II Restorations

Three clinical groups will be evaluated. Each group of patients will undergo one method of Resin Composite application (multi-layer technique 'control group' - bulk-fill Technique - Sonicfill technique). The restored teeth will be followed-up till one year. A comparison is going to be made between the three groups in relation to the modified United Sates Public Health Service (USPHS) criteria of good restorations.

The modified USPHS criteria include the evaluation of seven characteristics of the restorations: color match, marginal integrity, surface texture, wear of both restoration and antagonist, recurrent dental caries, fracture or detachment, and gingivitis around the abutment.

Eligibility Criteria:
Inclusion Criteria:

1. Cooperated patients.
2. Good general health.
3. Good oral hygiene.
4. Aged 15 to 60 years.
5. Class II restoration (upper or lower)
6. Full erupted teeth.
7. Caries value D3 -D4 according to Daignodent.

Exclusion Criteria:

1. If the caries value according to Daignodent is less than D3 -D4.
2. If the tooth is partially erupted.
3. Class II box-like cavity only without any extensions.
4. Patient outside the required age range (15-60 years).
5. Bad oral hygiene.