cyrilzakka/clinical-trials huggingface dataset:
Different Modes of Universal Adhesive in Smokers and Non-Smokers

The aim of the study was to evaluate the influence of smoking on the clinical performance of a universal adhesive used with different application modes in non-carious cervical lesions.

Forty-seven patients (having at least three noncarious cervical lesions) were participated in this study. After allocation of patients into 2 groups according to their smoking habits (non-smokers; 24, smokers;23), lesions in each patient were restored with a resin composite, (Essentia, GC) using a universal adhesive G-Premio Bond and phosphoric acid (i-Dental) in three different application modes (etch\&rinse, selective-etch or self-etch). The restorative treatments were performed by single operator. Two experienced and calibrated examiners evaluated the restorations for retention, marginal discoloration, marginal adaptation, color match, postoperative sensitivity and secondary caries at one week (baseline), at 6-, 12, and 18 months using modified USPHS criteria.While the USPHS criteria measure the clinical performance of the restorative material, it scores according to three different degrees;Alpha:The restoration is clinically perfect. Bravo:All features of the restoration are sufficient, need not be renewed. Charlie: the restoration is clinically unsuccessful, unacceptable. The gingival and plaque index were also assessed with a periodontal probe.

Eligibility Criteria:
Inclusion Criteria:

* Patients were 18 years of age or older,
* good general health,
* acceptable oral hygiene level,
* no possible health problems (such as allergies) related to resin-based restorations,
* at least three non-carious cervical lesions with at least 20 teeth in the occlusion.
* The depth of the lesions should be at least 1 mm, without carious, not previously restored, having teeth with vital, enamel and dentin tissue.
* Patients who smoke at least 10 cigarettes per day, however patients in non-smokers have never smoked before.

Exclusion Criteria:

* Participant had fewer than 20 teeth,
* having poor oral hygiene,
* uncontrolled periodontal disease,
* xerostomia,
* diagnosis of bruxism,
* pregnancy or breastfeeding possible health problems (such as allergy) related to resin-based restorations
* having severe systemic disease,
* having bleaching treatment or orthodontic treatment.
Rehabilitation Gaming System for Cerebral Palsy

In this study the investigators evaluate the effectivity of Virtual Reality-based rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Children and Adult patients between 12- 50 years old diagnosed with CP according to Gross Motor Function Classification System (GMFCS). Level of disability between I and IV.
* Ashworth modified clinical scale \< 3 (Ashworth, 1964, Bohannon Bohannon and Smith, 1987).

Exclusion Criteria:

* Severe visual impairment.
* Severe cognitive impairment such as mental retardation which impedes the understanding of the task.
The Effects of Health Education About Human Papilloma Virus and Cervical Cancer Prevention on Knowledge, Attitudes, Beliefs and Behaviors

Aim: To determine the effects of health education about Human Papilloma Virus infection and cervical cancer prevention on knowledge, attitudes, beliefs and behaviors of adolescent girls and their mothers.

Background: To combat with cervical cancer, it is urgent that prevention Human Papilloma Virus related disease all around the world.

Design: A randomized trial with a control group (n=108) and an intervention group (n=108).

Methods: The study was applied between January to June 2019 in the two different adolescent outpatient clinics in Turkey. The outpatient clinics were randomly assigned as intervention and control groups by numbering and opaque and sealed envelopes. Based on the intention-to-treat principle, all participants were analyzed according to the group they were assigned to, regardless of whether they received the intervention or not. In addition to the routine clinical practice, the adolescent girls and their mothers who participated in the intervention group were given health education twice in the first interview and in the fifth week. Follow-up continued for 12 weeks. The adolescent girls and their mothers in the control group received routine clinical practice. The effects of health education were evaluated with Human Papilloma Virus Knowledge Scale and Health Belief Model Scale for Human Papilloma Virus and its Vaccination.

Impact: Human Papilloma Virus vaccine, which has an important place in primary protection from cervical cancer, is expected to provide effective results by facilitating access to vaccine accompanied with health education.


Eligibility Criteria:
Inclusion Criteria:

To be a girl between the ages of 9 and 18, to be a mother of a girl between the ages of 9 and 18, to be fluent in Turkish, to be literate

Exclusion Criteria:

to be male, to have previously received Human Papilloma Virus vaccination, to have hearing, speech impairment and mental disorder, not to follow the study regularly, to use medication due to psychotic treatments, to be an adolescent with sexual experience
Transfusion Prediction in Major Abdominal Surgery

The transfusion nomogram, integrating preoperative variables, may effectively predict intraoperative transfusion in major abdominal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older who underwent major abdominal surgery

Exclusion Criteria:

* Patients with known hematologic disease or coagulopathy
* Patients who received a blood transfusion before surgery
* Patients with incomplete data or missing laboratory values
A Study of WX390 Combined With Toripalimab in Patients With Advanced Solid Tumors

The goal of this clinical trial is to evaluate the safety and preliminary efficacy of WX390 combined with Toripalimab in patients with advanced solid tumors. The main questions it aims to answer are:

* the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of WX390;
* safety and preliminary in combined therapy. Participants will be treated with WX390 orally and Toripalimab intravenously, and follow the efficacy and safety evaluation according to the protocol.

This study will be an open-label, multicenter phase Ib/IIa clinical trial. After being informed about the study and potential risks, all patients giving written informed consent will undergo a 4-week screening period to determine eligibility for study entry. And then patents will be administered for 8 cycles treatment and 8 weeks safety follow up after the last dose of treatment. The efficacy and safety measures will be conducted and collected every cycle.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Histological or cytological confirmed advanced solid tumor, standard regimen failed or no standard regimen available
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Life expectancy of more than 3 months
* At least one measurable lesion according to RECIST 1.1
* Adequate organ function，
* Signed and dated informed consent

Exclusion Criteria:

* Anti-cancer therapy within 30 days prior to the initiation of investigational treatment
* Major surgery within 30 days prior to the initiation of study treatment
* Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
* Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)
* Patients who are suffering active interstitial lung disease
* Evidence of ongoing or active serious infection
* History of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection
* Inability to take medication orally
* Abuse of alcohol or drugs
* People with cognitive and psychological abnormality or with low compliance
* Pregnant or lactating women
A Study to Collect Information on the Characteristics of Elderly Belgian Patients With NVAF That Are Treated With a NOAC for This Indication With a Special Focus on Their Fear of Bleeding While Using a NOAC vs the Clinical Benefit of a NOAC of Thrombosis/Stroke Prevention.

Atrial fibrillation is a heart condition that causes an abnormal and fast heart rate. For people with non-valvular atrial fibrillation (NVAF), this is caused by problems such as high blood pressure and diabetes. NVAF happens more often in elderly people and can lead to stroke, heart failure, and death. Doctors are currently able to give patients a type of treatment called an anticoagulant. Anticoagulants work by making the blood thinner. They are thought to help reduce the risk of stroke and death caused by NVAF. In this study, researchers wanted to learn more about what elderly people think of taking anticoagulants that do not have any vitamin K in them. These are called non-VKA oral anticoagulants (NOACs).

This study will include up to about 150 Belgian men and women aged 75 years and over who have NVAF and have been treated with NOACs. The study will also include about 10 doctors who have treated these patients.

In this study, there will be no required tests or visits. Instead, patients will answer a paper questionnaire about their use of NOACs. The researchers will ask the doctors questions about how they treat their patients using NOACs. The main types of questions the researchers will focus on are:

* The patient characteristics of the elderly with NVAF who are treated with NOACs
* The level of fear of the elderly about bleeding while using a blood thinner and the fear of stroke/thrombosis.
* The geriatrician's thoughts about using NOACs to treat NVAF in elderly patients
* Those patient characteristics geriatrician's find most important when deciding on the anticoagulation treatment in the elderly patients.

The information from this study will be collected between February and April 2021. But, the whole study will take about 6 months to finish and is expected to end in July 2021.


Eligibility Criteria:
Inclusion Criteria:

* Male or female elderly patients (defined as ≥ 75 years old) diagnosed with NVAF
* Elderly patients treated with a NOAC
* Ambulatory patients visiting the geriatrician

Exclusion Criteria:

* Contra-indications according to the local marketing authorization
* Patients suffering from dementia who are, according to the geriatrician's opinion, not able to understand and answer the questions
* Hospitalized patients
NeoChord TACT Post-Market Surveillance Registry

To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System


Eligibility Criteria:
Inclusion Criteria:

* Grade 3+ or 4+ mitral valve regurgitation

Exclusion Criteria:

* Heavily calcified valves
* Valvular retraction with severely reduced mobility
* Active bacterial endocarditis
* Complex mechanism of MR (leaflet perforation, etc.)
* Significant tethering of leaflets
* Inflammatory valve disease
Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry

The purpose of this project is to improve quality of care for dental patients in the state of Michigan. This will be achieved through educating dentists about best practices for opioid prescribing and includes three continuing education (CE) credits and one (or two) academic detailing (AD) visits. The cohort of 90 dentists who are enrolled to the CE will be randomized into two groups upon enrollment. One of these groups, half of the cohort, will receive the academic detailing. A report will be written highlighting key findings from this project and best practices for treating patients after dental care.The quality of care for dental patients will be improved by sharing this information with both participating and non-participating dental providers statewide through reports, manuscripts, and presentations. These data will inform best practice with the potential for future academic detailing and educational interventions for dentists and oral surgeons.


Eligibility Criteria:
Inclusion Criteria:

* Dentists in the state of Michigan with an active drug enforcement agency (DEA) license.

Exclusion Criteria:

* All oral Surgeons in Michigan. Michigan dentists who have a significant (\>5%) population living outside of Michigan (self-reported), as the prescription drug monitoring program (PDMP) data we will obtain from Michigan Automated Prescription Service (MAPS) will only cover those prescriptions filled in the state of Michigan.
Effects of Different Doses of Aspirin on Pathophysiological Markers in Type 2 Diabetes

This study was set up to assess the effects of different doses of aspirin when compared with placebo (dummy drug), used sequentially over a 2 week study period with a 2 week wash-out (rest period) in between, in people with type-2 diabetes and high cardiovascular risk. Specifically, its effects on different factors which are thought to contribute to diabetes such as insulin resistance (body's ability to effectively use insulin), dysglycaemia (excess glucose in the blood), oxidative stress (effects from accumulation of by-products of metabolism), endothelial function (function of lining of blood vessels) and inflammation were studied.


Eligibility Criteria:
Inclusion Criteria:

* diabetes type 2
* age \> 18 and \< 70
* high cardiovascular risk

Exclusion Criteria:

* presence of active/established cardiovascular disease (ischaemic heart disease, cerebrovascular disease or peripheral vascular disease)
* insulin treatment
* patients with known peptic ulcer disease or those on anti-coagulation
* significant renal impairment
* aspirin intolerance
* use of anticoagulants
* significant liver disease
A Trial of a Multi-component Individualized Telephone-based Support Intervention for Adult-child Caregivers Caring for Parents With Dementia

This is the first randomized controlled trial exploring the implementation of a multi-component individualized telephone-based support intervention for adult-child caregivers caring for parents with dementia in China. Results hold the potential to inform the further development of family caregiver supportive services.

The objectives of this study are to evaluate the efficacy and feasibility of a multi-component individualized telephone-based support intervention (HEART) for adult-child caregivers caring for parents with dementia in China.

The primary hypothesis to test is whether the HEART is more efficacious in reducing caregiver burden than the follow-up as usual (FU) in dementia adult-child caregivers.

Secondary hypotheses include the following:

1. The HEART is more efficacious in improving health related quality of life than the FU in dementia adult-child caregivers.
2. The HEART is more efficacious in protecting reciprocal Filial Piety than the FU in dementia adult-child caregivers.
3. The HEART is more efficacious in relieving CR's behavioral and psychological symptoms of dementia (BPSD) than the FU in dementia adult-child caregivers.
4. The HEART group has a higher satisfaction with the intervention than the FU group.

In addition, two research questions will be answered by qualitative data from process evaluation for the feasibility of the HEART intervention. The research questions are as follows:

1. To what extent can the HEART intervention be delivered as planned?
2. What are the barriers to and facilitators of the HEART intervention?

Eligibility Criteria:
Inclusion Criteria:

* Primary caregivers being adult children (age 18 or older) who have spent at least 2 hours per day over the last 3 months caring for a parent with a diagnosis of dementia.
* Must have telephone access.
* Caregivers will not end their primary caregiving role within 6 months of study enrollment.

Exclusion Criteria:

* Cognitive impairment or intellectual disability.
* Those who are providing care for another relative with chronic physical or mental diseases.
* Pregnant women (Because it is unlikely that this group would be primary caregivers except in exceptional circumstances, the consideration of which was beyond the scope of this research).
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer

Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.

OBJECTIVES:

I. Determine the maximum tolerated dose of R115777 when administered with trastuzumab (Herceptin) in patients with advanced or metastatic adenocarcinoma.

II. Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population.

III. Determine the antitumor activity of this treatment regimen in these patients.

IV. Determine the relative biologic endpoints of this regimen and correlate them with toxicity and pharmacokinetic parameters in these patients.

OUTLINE: This is a dose escalation, multicenter study of R115777.

Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.

Patients are followed every 30 days until toxicity resolves.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed advanced or metastatic adenocarcinoma
* Expression of +1 to 3+ HER2/neu on immunohistochemical or immunocytochemistry staining
* No brain metastases unless all of the following is true:

  * Previously treated
  * Asymptomatic
  * Stable dose of decadron
* No evidence of edema

PATIENT CHARACTERISTICS:

* Age: 18 and over
* Performance status: ECOG 0-2
* Life expectancy: At least 12 weeks
* Absolute granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9.0 g/dL
* Bilirubin no greater than 1.5 mg/dL
* AST/ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver involvement)
* Creatinine no greater than 1.5 mg/dL
* LVEF at least 50% by RVG or MUGA
* No uncontrolled unstable angina
* No history of congestive heart failure or cardiac ischemia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No concurrent active infection or serious systemic disorder that would preclude study
* No allergies to imidazole compounds

PRIOR CONCURRENT THERAPY:

* No prior trastuzumab (Herceptin) No other concurrent immunotherapy
* At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered
* No other concurrent chemotherapy
* No concurrent hormonal cancer therapy except LHRH agonists for prostate cancer
* No concurrent radiotherapy
* No other concurrent experimental medications
Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia

Fibromyalgia causes long term pain where mostly women are affected. It is not entirely clear how vitamin B12 affects the human pain system, there are however many primary studies that indicate different interesting approaches. Considering that the receptor of NMDA is involved in both long-term pain and vitamin B12 deficiency its of most importance to evaluate whether vitamin B12 decreases the pain sensitivity and the experience of pain i.e hyperalgesia and allodynia, at persons with fibromyalgia.The aim of this study is therefore to evaluate the effect of Mecobalamin (vitamin B12), and describe lived experiences of pain, health, suffering and well-being in women with diagnosed fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 20-70 years
* Swedish-speaking
* Diagnosis of fibromyalgia
* Safe method of contraception
* Cobalamin / p (vitamin B12) should be \>250 pmol/L \< 800 pmol/L
* Given consent to participate.

Exclusion Criteria:

* Previous treatment with B12
* Known hypersensitivity to the active substance Mecobalamin or an additive
* Vegan as veganism can lead to B12 deficiency
* Neuroleptics
* Known heart, kidney or liver disease
* Reynaud's phenomenon (white fingers)
* Known neuropathy (impaired sensation)
* Breastfeeding
* Pregnancy or plan pregnancy
The Effects of Contact Lenses With Experimental Dye on Visual Function

This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.


Eligibility Criteria:
Inclusion Criteria:

- Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol
3. Between 18 and 65 (inclusive) years of age at the time of screening.
4. Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
5. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.
6. The subject has a best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or breastfeeding.
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Multifocal, toric or extended wear contact lens correction.
8. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
9. History of binocular vision abnormality or strabismus.
10. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
11. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
12. Any ocular infection.
13. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.