cyrilzakka/clinical-trials huggingface dataset:
A Comparative Study of Electric Toothbrushes for the Efficacy Plaque Removal and the Effect on Plaque Accumulation and Gingivitis.

It is well accepted that the greatest contributor to the health of the periodontium and dentition is regular and thorough dental plaque removal, typically by means of adequate toothbrushing. Although patients are typically informed about the risks of substandard oral hygiene and the contributing factors in oral/dental disease by dental professionals, research has shown that an undesirably high proportion of adults find thorough toothbrushing with a standard manual toothbrush to achieve a plaque-free state challenging, as evidenced by high worldwide levels of gingivitis and/or periodontitis.

The purpose of this study is to clinically evaluate the plaque removal efficacy of two electric powered toothbrushes after a single use, as well as the effect on plaque accumulation and gingivitis after 14 days and 30 days period. Simultaneously, a comparison against a manual toothbrush will be made.

Study design: randomised, single blinded, parallel.

After the screening procedure and based on inclusion requirements, all subjects will receive oral prophylaxis (T0) to ensure a baseline of 0 Plaque Index (PI) prior to the first appointment (T1). The subjects will be instructed not to use a tooth brush or any mechanical cleaning device until the initial PI and Gingival Indexes (GI) are taken at 24 hours after T0.

The subjects will be randomized into 3 groups, and the will be provided one of the three evaluated toothbrushes, as well as toothpaste. All subjects will be using identical toothpaste and will receive oral hygiene instructions based on the manufacturer's recommendations.

At T1 initial GI and PI will be taken prior to brushing followed by a second PI reading immediately after the first use of the power driven toothbrush.

The subjects will be instructed to brush twice a day for a period of 2 minutes (following the programmed toothbrush timer) and refrain from using dental floss, tooth pick or any mechanical oral hygiene aid for the period of the study.

On the second visit at 14 days (T2) and third visit at 30 days (T3), additional GI and PI readings will be taken and data will be recorded. All measurements and clinical examinations will be performed by a single blinded examiner. Evaluation on teeth will be made on six teeth #3,7,12,19,23 and 28 (mesio-buccal, buccal, disto-buccal and mesio-lingual, lingual, disto-lingual) following the Silness-Loe Index.

Eligibility Criteria:
Inclusion Criteria:

1. Good overall health
2. At least 20 teeth present, not including 3rd Molars
3. Non-smoker

Exclusion Criteria:

1. Poor manual dexterity or mentally handicap;
2. Presence of removable intra-oral prosthesis
3. Current orthodontic therapy
4. Severe Periodontal condition or caries teeth in need of immediate attention
5. Pregnant women
6. Subjects that use medications that may effect oral health
7. No Systemic diseases/conditions such as diabetes mellitus, heart disease.
8. Use of plaque inhibiting toothpaste, mouthwash, interdental flossing in the period of the study
Prevalence of Cognitive Disorders in Newly Diagnosed Epilepsy

A prospective prevalence study recorded that up to 50% of adult patients with newly diagnosed epilepsy had at least one cognitive impairment before initiation of antiepileptic drug (AED). Multiple factors exist and interact in the same patient. Cognitive impairments may affect psychiatric (loss of self-esteem, anxiety, depression) and social status (e.g., vocational aptitude, educational). These factors in turn influence cognitive abilities in a triangular and bidirectional relationship. In addition, the type of epilepsy, development in childhood or cerebral ageing, antiepileptic treatments (AED, surgery) and etiology also have an impact on cognitive performances. The burden of these factors differs from patient to another and must be determined individually. Longitudinal follow-up seems to be crucial because it will allow us to highlight the change in the cognitive profile of newly diagnosed patients over time.

The main objective is to compare the prevalence of cognitive impairment in patients with newly diagnosed epilepsy prior to the initiation of AED with healthy subjects matched on age, sex, manual laterality and socio-educational level. But also to compare the longitudinal evolution of the cognitive profile of patients with healthy controls (0 to 10 years) to determine, among the age of onset seizures, their etiology, the syndrome, the sex, the socio-educational level and the cognitive reserve, which one are related to the severity of cognitive disorders.


Eligibility Criteria:
Inclusion Criteria (patients):

* Individuals who have received full information about the organization of the research and have not refused to participate and to use their data.
* Person aged 16 and over
* For minor patients: the non-opposition of the parental authority holders
* Newly diagnosed epileptic patient who had never taken antiepileptic drugs.

Inclusion Criteria (normal controls):

* Individuals who have received full information about the organization of the research and have not refused to participate and to use their data.
* For minor participants: the non-opposition of the parental authority holders
* Person aged 16 and over.

Exclusion Criteria (patients):

* Person of full age who are subject to a legal protection measure or who are unable to express their consent
* Person with a progressive brain injury
* Person who regularly use psychoactive substances (cannabis, alcohol, etc.)
* Patients who started an antiepileptic treatment before the neuropsychological assessment.

Exclusion Criteria (normal controls):

* Persons of full age who are subject to a legal protection measure or who are unable to express their consent
* Person with a neurological (traumatic brain injury, stroke, etc.) and/or psychiatric (mental illness, depression, etc.) history.
* People who regularly use psychoactive substances (cannabis, alcohol, etc.).
Rapamune Improves Outcomes of Severe H1N1 Pneumonia

Severe H1N1 pneumonia with acute respiratory failure shows hyperactive immune cells infiltration of lung. Rapamune, a mTOR inhibitor, modulates the immune response by blocking activation of T- and B-cells. To investigate the clinical efficiency of rapamune in severe H1N1 pneumonia with respiratory failure, this study was conducted.

From 2009 winter to 2011 spring, patients with flu-like symptoms in Chang Gung Memorial Hospital were screened by rapid antigen test and influenza subtype was confirmed by polymerization chain reaction (PCR). 38 H1N1 patients with severe hypoxemia \[alveolar-arterial oxygen gradient, (A-a) O2 gradient, \> 200 mmHg\] requiring ventilator support were randomized to receive Rapamune (2mg/day) or not. Patients were then randomized to receive either Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days. The outcome variables include liberation of ventilator, ICU mortality, necessity of ECMO, Sequential Organ Failure Assessment (SOFA) score and complications after admission to ICU were recorded. SOFA score composed of scores from six organ systems, graded from 0 to 4 according to the degree of dysfunction/failure.

Eligibility Criteria:
Inclusion Criteria:

* H1N1 patients with severe hypoxemia \[alveolar-arterial oxygen gradient, (A-a) O2 gradient, \> 200 mmHg\] requiring ventilator support were included to randomization.

Exclusion Criteria:

* severity of illness and multiple organ dysfunction (MOD) were assessed within 24 hours of ICU admission.
Effects of Diet-induced Weight Loss in Obese Men

This study aims to compare the efficacy of a partial meal replacement diet with a conventional diet, for inducing weight loss and improving metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.

This study aims to compare the efficacy of a partial meal replacement diet with a conventional diet, for inducing weight loss, and improving metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men. Men aged 30-65 years, with body mass index (BMI) ≥ 27.5 kg/m2, will be recruited from the community in Singapore. The study will be conducted at Changi General Hospital by trained medical investigators, dieticians and sports trainers. At baseline and 12 weeks, fasting glucose and lipids, insulin, testosterone, sex-hormone binding globulin, serum C-reactive protein and interleukin-6 are measured, endothelial function is measured by the non-invasive EndoPAT method, and validated questionnaires administered to assess changes in erectile function, sexual desire, LUTS and quality of life

Eligibility Criteria:
Inclusion Criteria:

* Male, aged 30-65 years
* Body Mass Index (BMI) \>/= 27.5 kg/m2
* Waist circumference (WC) \>/= 90 cm

Exclusion Criteria:

* pituitary disease or cranial radiotherapy
* previous or current androgen replacement or deprivation therapy
* current treatment for sexual problems or LUTS
* glomerular filtration rate \< 60 ml/min
* liver disease
* alcohol intake exceeding 500 g/week in the previous 12 months
* use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors
Short-term Presurgical Study to Assess Molecular Predictors of Lapatinib's Effects in Primary Breast Cancer

To provide an in vivo measure of the activity of lapatinib. To assess the antiproliferative effects of lapatinib in breast cancer, ie how much lapatinib slows down the growth of cancer cells by measuring K167 (a marker of proliferation) in breast tumours before and after a short treatment with lapatinib.

Randomised multi centre double blind pre-surgical study in women with a histological diagnosis of breast cancer by core biopsy.

Eligibility Criteria:
Inclusion Criteria:

Patients must have a histological or cytologic diagnosis of primary breast cancer with a tumour size adequate for multiple core biopsies Informed signed consent Scheduled for primary surgery Expected to be compliant for duration of study Age\<80 ECOG performance status 0-2 (Karnofsky \>60%) Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan Eligibility of patients receiving medications known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review by the Trial Coordinator The effects if lapatinib on the developing fetus are unknown. For this reason, women of childbearing potential must agree to use adequate non-hormonal contraception for the duration of study participation.

Able to swallow and retain oral medication.

Exclusion Criteria:

Patients with prior diagnosis of malignancy except in situ disease or basal cell carcinoma of the skin.

Patients may be receiving any other investigational agents or receiving concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded.

Evidence of metastatic disease. Use of hormonal therapy such as oral contraceptives or hormonal replacement therapy within 4 weeks of study entry.

Regular use of steroid hormones or other agents that could influence study endpoints History of allergic reactions attributed to compounds of similar chemical or biologic composition to GW572016.

Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements.
Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination on Postoperative Opioid Consumption

This prospective, randomized, double-blinded study is designed to evaluate the postoperative analgesic effect of the intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing video-assisted thoracic surgery (VATS). We hypothesize that the intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity in patients with VATS.

Adult patients undergoing elective unilateral VATS wedge resection, segmentectomy, or lobectomy are randomly allocated to receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=48) or not (n=48). At the end of induction, the intervention group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 min, every 6 hours, a total of 4 times. The control group will receive intravenous normal saline with the same volume and same time points as the intervention group receives.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective unilateral VATS segmentectomy or lobectomy under general anesthesia
* American Society of Anesthesiologists (ASA)physical classification I-II
* Consent to IV-patient controlled analgesia use
* Willingness and ability to sign an informed consent document

Exclusion Criteria:

* Do not understand our study
* Allergies to anesthetic or analgesic medications
* Continuous local anesthetics infiltration for postoperative pain control
* Patients who receive mechanical ventilation more than 2 hours after surgery
* Pregnancy/Breastfeeder
* Medical or psychological disease that can affect thetreatment response
Study to Evaluate Real-world Pharmacoeconomics and Resistance Mechanisms of Panitumumab in Metastatic Colorectal Cancer Patients

This is a phase IV multicenter trial to evaluate real-world health outcomes, economic impact and resistance mechanisms of panitumumab in the treatment of patients with chemotherapy-refractory metastatic colorectal cancer (mCRC).

This study will address two anticipated issues surrounding personalized medicine and treatment with panitumumab. First, it will enable to assess the economic impact of panitumumab in a real-life setting (HEOR study). Second, it will identify new blood-based mechanisms of resistance, which may lead to new avenues for combination therapy in metastatic colorectal cancer (Blood study).

The primary objective is to collect information on quality of life and health care resource utilization by patients diagnosed with metastatic colorectal cancer. The secondary objectives are to confirm survival data, to assess the quality of life of patients and to assess the health care resource utilization of patients. The blood biomarker study objective is to determine blood-based biomarkers of response or resistance to panitumumab.

Patients with a mutated KRAS gene will be treated with standard-of-care (SOC) and will participate to the HEOR study only. Patients with a non-mutated (wild type) KRAS gene will be treated with panitumumab and will participate to the HEOR study and to the blood biomarker study.

During the course of the study, data will be collected on quality of life and work productivity. Patients will be asked to fill a set of questionnaires at their recruitment in the study and at every 3 months after treatment initiation. For patients participating to the blood study (patients with a wild type KRAS), blood samples will be collected before patients start their treatment, at every treatment and when they discontinue their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologically confirmed diagnosis of mCRC.
* Immunohistochemical evidence of EGFR expression.
* ECOG performance status of 0, 1 or 2.
* Patients refractory to fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens
* Patients with a wt KRAS scheduled to receive panitumumab as a single agent for the third-line treatment of mCRC or patients with a mt KRAS scheduled to receive SOC for third-line treatment of mCRC.
* Signed and dated IRB-approved informed consent document.
* Ability to read and understand English or French.
* 18 years of age or older.

Exclusion Criteria:

* Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease.
Ultrasound-guided Regional Anesthesia vs Local Infiltration Anesthesia With Dexmedetomidine and Ropivacaine

Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation.

Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation. Secondary objectives are: Pain assesment, Pain medication necessary, functionality of the prothesis, satisfaction, wellbeing, postoperative discomforts, complications (delirium, allergic reactions, cardiopulmonary decompensation), procedure specific time.

Eligibility Criteria:
Inclusion Criteria:

* Adult
* non pregnant
* patients with gonarthrosis who have given written consent for participation

Exclusion Criteria:

* Age below 18 years
* pregnancy
* breast-feeding patients
* allergies against study medication
* missing or denied written consent
A Comparison of Two Standard Therapies in the Management of Dementia With Agitation

The purpose of this study is to determine whether an antipsychotic medication alone or an antipsychotic medication in combination with divalproex is the most effective and safest way to treat agitation in elderly patients with dementia.

Previous researchers have attempted to establish a "target dose" for antipsychotic medications (such as risperidone, quetiapine, or olanzapine) in treating symptoms of agitation in dementia. They have tried to identify the dose with the best risk-benefit ratio for patients considering the significant side effects the medications can cause. Patients taking the doses identified respond only partially and continue to experience some symptoms of agitation, however. One study showed that in patients whose agitation symptoms were not adequately controlled by the target dose of an antipsychotic medication alone, the addition of divalproex further improved behavior in 72% of patients.

The goal of this study is to compare two standard therapies for the management of agitation symptoms in dementia patients. Subjects in this study will include patients who are admitted to the Wesley Woods Inpatient service for the treatment for dementia complicated by behavioral symptoms. After a patient reaches the target dose of risperidone (up to 1.5 mg/day), quetiapine (up to 175 mg/day), or olanzapine (up to 7.5 mg/day) and agitation symptoms are still not adequately managed, he or she will be randomized to one of two groups. Group 1 participants will continue to receive increasing doses of antipsychotic medication until symptoms are controlled or he or she is unable to tolerate the dose. Group 2 participants will continue to receive the target dose of antipsychotic medication and also receive increasing doses of divalproex until symptoms are controlled or he or she is unable to tolerate the dose. Patients will be evaluated at 4 time points during hospitalization. Patients will be evaluated using scales that measure changes in cognition, function, and behavior. Laboratory and ECG results, and scales testing for movement disorders will be done to monitor safety. The family will then be contacted about 3 months the patient's hospitalization to assess current treatment status, residential status, and health status.

Eligibility Criteria:
Inclusion Criteria:

* inpatients admitted to Wesley Woods Inpatient service for Dementia with psychosis and agitation; taking risperidone (up to 1.5 mg/day), quetiapine (up to 175 mg/day), or olanzapine (up to 7.5 mg/day)

Exclusion Criteria:

* prior sensitivity to risperidone, quetiapine, olanzapine or divalproex
The Effect of Emotional Working Memory Training on Preventing Depression Occurrence

The purpose of this study is to test whether emotional working memory training and attention bias modification training are an effective neurobehavioral therapy to prevent the occurrence of depression .That is whether emotional working memory training and attention bias modification training are superior to placebo in preventing the occurrence of depression over 1 year after training.

Attentional bias has been theorized to play a critical role in the onset and maintenance of depression. Attentional bias modification training (ABMT), an experimental paradigm that uses training to induce adaptive attentional bias, was developed to test the causal model and this has therapeutic implications in depression.To test the effect of ABMT on treatment of depressive symptoms, a randomized, double-blind, placebo and blank controlled trial is conducted in college students who are experiencing mild-to-severe symptoms of depression.

Eligibility Criteria:
Inclusion Criteria:

* A score of 14 or higher on the Beck Depression Inventory-II.

Exclusion Criteria:

* A current episode of MDD, bipolar disorder, schizophrenia or organic mental disorder;
* Any concurrent psychotherapy;
* Any concurrent psychotropic medication.
Restoration Quality in Molars Affected by Molar Incisor Hypo Mineralization

Restoration quality of molars affected by MIH using two different types of restorations direct composite and preformed crowns

MIH or molar incisor hypomineralization is one of the difficult clinical situations to be managed by dentists the aim of this study is to specify which is the better treatment among composite restorations and preformed crowns in terms of gingival health patient satisfaction pain hypersensetivity acceptability by the patienat hypersensetivity and the need for future retreatment

Eligibility Criteria:
Inclusion Criteria:

.Children with molar incisor hypo mineralization in one fully erupted molar or more.

* Age ranging from 7-12 years.
* Cooperative children
* Good general health

Exclusion Criteria:

* Patients participating in other experiments .Patients with parents planning to move away within the following year.
* Patients with only mildly affected MIH molars that do not require extensive restorative treatment.
* MIH-affected molars that have a very poor prognosis and require extraction.
* First permanent molars that are affected with other developmental defects, such as hypoplasia, dental fluorosis or amelogenesis imperfecta.
Interaction of BI 691751 With Itraconazole

Investigation of the relative bioavailability of a single dose of BI 691751 when given alone and together with itraconazole; safety and tolerability


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects
2. body mass index (BMI) of 18.5 to 29.9 kg/m2
3. Subjects must be able to understand and comply with study requirements

Exclusion criteria:

1. Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), or electrocardiogram (ECG)) deviating from normal and judged clinically relevant by the investigator.
2. Pulse rate outside 45 to 100 bpm or repeated measurements of systolic BP outside 90 to 140 mmHg or diastolic BP outside 50 to 90 mmHg.
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any alanine transaminase (ALT/GPT), aspartate transaminase (AST/GOT), or gammaglutamyltransferase (GGT) value outside the reference range at the screening examination
5. Any evidence of a concomitant disease judged clinically relevant by the investigator
6. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
7. Any history of relevant liver diseases such as disturbance of liver function, jaundice, drug induced liver injury, Dubin-Johnson syndrome, Rotor syndrome, or liver tumors