cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Different Candies Against Bad Breath

This study is to analyze whether the candies can relieve or eliminate bad breath, both subjectively and objectively.

This study is to systematically examine an existing candy, which is easily available and is intended to relieve or eliminate bad breath. The main aim of the study is to determine the effectiveness of the candies on the subjective perception of bad breath. The secondary outcome of the study is to investigate whether there is actually a decrease in volatile sulphur compounds (VSC) in the exhaled air and also a decrease in bad breath during organoleptic measurement.

The purpose of the study is to investigate whether the different candies can relieve or eliminate bad breath, both subjectively and objectively.

Eligibility Criteria:
Inclusion Criteria:

* Non- smoker
* No general medical illness or medication

Exclusion Criteria:

* Allergies/intolerances to ingredients of the products used
* Chronic diseases
* Smoker
* Pregnancy
ANI and Remifentanil in Skull Pin Fixation.

Forty patients were enrolled, and all patients used total intravenous anesthesia (remifentanil-propofol based total intravenous analgesia) as anesthesia induction and maintenance. According to the preliminary data of this department, patients who underwent intracranial surgery for skull pin fixation used remifentanil 5.0-6.0 ng/ml, while the hemodynamics is relatively stable. Therefore, when this plan is implemented, the patient needs to be under the same depth of anesthesia (monitored by electroencephalography, maintaining a value of 40-60), first start with remifentanil 6.0 ng/ml, and use the up and down method as adjust 0.5 ng/ml of concentration of remifentanil each time. An Analgesia Nociception Index(ANI) lower than 30 and hyperdynamics (the increased heart rate(HR) and mean blood pressure(MBP) up 20% of baseline or HR\>100bpm and arterial blood pressure(ABP)\>180/100mmHg) indicates insufficient analgesia, therefore increase it by 0.5 ng/ml; an ANI higher than 30 and stable hemodynamics (the changes of HR and MBP within 20% of baseline or HR\<50bpm and ABP\<90/50mmHg) indicates that analgesia is acceptable, and the next patient will decrease it by 0.5 ng/ml during skull pin fixation.

Data collection: Heart Rate, Measure blood pressure, Analgesia Nociception Index, Bispectral index, concentrations of propofol and remifentanil before 2 mins, during, 5, and 15 mins of skull pin fixation were recorded and analyzed.


Eligibility Criteria:
Inclusion Criteria:

1. Must be at least 20 years old and less than 80 years old
2. With anesthesia risk grade below grade three (including grade three) (ASA I\~III)
3. Patients who are expected to undergo intracranial surgery for skull pin fixation

Exclusion Criteria:

1. Those with anesthesia risk classification ASA class IV or higher
2. Those who are allergic to opioid analgesics or propofol drugs
3. Emergency patients
The Effect of Nebulization of Alkaline Solution on Treating XDRAB Pneumonia With C/S Plus Minocycline

The mortality of pneumonia with extensively drug resistant Acinetobacter baumannii (XDRAB) is still high, even if these patients received certain strong anti-infection treatment such us the combination of cefoperazone-sulbactam (C/S) and minocycline. Health airway lining fluid is mildly alkaline but airway acidification usually appears for the infection of XDRAB. The hypothesis is offered that the biologic activity of XDRAB might be inhibited if the circumstance including pH is changed. In the vitro study we observed that the inhibit effect of antibiotics on XDRAB growth was improved significantly by alkaline solution within the scope of physiology. So the aim of this clinical study is to explore the effects of nebulization of alkaline Solution on C/S plus minocycline on the pneumonia with XDRAB.

Pneumonia patients with XDRAB are eligible for this multicenter study, do not meet the exclusion criteria and will sign the informed consent. They will received the anti-infection protocol with Cefoperazone/ sulbactam 3.0g（intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h). All enrolled patients were randomly divided into three groups according to the difference in pH value of aerosol inhalation with sodium bicarbonate solution. Group one is blank-control and patients will received usual antibiotic treatment without inhalation. The pH value in group two is 7.4 and that in group is 7.8. Each time the volume of aerosol solution is 5ml, q8h. The average course of treatment will be two weeks. Clinical indexes will be collected including vital signs, pulmonary rales, cough level, expectoration level, sputum color,blood count, arterial blood gas, biochemical parameters, chest X-ray score, APACHE II score, clinical pulmonary infection score, ECG, sputum culture, et al.The primary endpoints are pathogenic clearance rate and recovery rate. The secondary end point is adverse reaction rate.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18 to 75 years old, male or female
* The pneumonia patients met the diagnostic criteria, and clinical pulmonary infection score (CPIS) ≥ 5;
* The sputum bacteriology detection only prompted Acinetobacter baumannii culture for pathogens concentration meets the diagnostic criteria of the Chinese hospital-acquired pneumonia diagnosis and treatment guidelines, 2002 edition of "Acinetobacter baumannii and susceptibility results show only 1 to 2 sensitive to antimicrobial drugs (polymyxin, minocycline or tegafur doxycycline);
* Cephalosporins or tetracyclines drug treatment without a history of allergies and contraindications;
* Be able to accept inhalation therapy.
* Informed consent gained

Exclusion Criteria:

* Refused to accept inhalation therapy
* Renal insufficiency, creatinine clearance (Cockcroft-Gault formula) (CLcr) 15 ml / min or less;
* Liver dysfunction, defined as Child-Pugh score B or C
* Within one week before the start of cefoperazone sulbactam, minocycline treatment.
Study Evaluating the Potential Impact of a Hemorrhagic Risk Stratification Score in Patients With Mild Head Trauma

Head injuries are a common reason for consultation in emergency departments. The clinical severity of head injury is assessed using the Glasgow Coma Scale (GCS). Between 71% and 97.5% of patients with head trauma seen in the emergency department are considered minor, that is to say with an initial GCS 13 and the consequences are quite variable. Three to 10% of patients will have short, medium or long-term health consequences. According to the studies, there are between 2.1 and 8% of intracranial bleeding immediate or delayed (up to one month), with about 1% of them, the need to resort to neurosurgery.

Following a minor head trauma, it is recommended, in the absence of clinical signs of severity, to realize a brain scan (cerebral computerized tomography scan (CT scan): reference imaging examination) within 6h (between 4 hours and 8 hours according to studies), a hospital surveillance of 24h, with the realization of a control scanner within 12 hours to 24 hours in case of treatment by anticoagulants or antiaggregation.

In December 2015, Journal of the American Medical Association published an article evaluating two clinical algorithms across the Atlantic, the New Orleans Criteria (NOC) and the Canadian CT Head Rule, to identify a group of patients with a very low risk of severe brain damage.

The performance of this score is unquestionably, however, it does not include patients treated with antiplatelet or anticoagulant drugs; risk factors having a decisive impact on the incidence of intracranial bleeding.

In this context, various studies have been carried out retrospectively in Angers to assess the incidence and risk factors of the occurrence of an immediate or delayed intracerebral hemorrhage in patients with minor head trauma with or without anti-thrombotic treatment.


Eligibility Criteria:
Inclusion Criteria:

* patient \> 18 years old
* head injury
* Glasgow Coma Scale \> or = 13

Exclusion Criteria:

* Refusal of participation,
* Indication of a scanner for a reason other than minor head injury
* follow-up not possible
* pregnant woman or breastfeeding
* patients in life-threatening emergency situations.
Respiratory Physiotherapy After Cardiac Surgery

Although incentive spirometry is commonly used to avoid pulmonary complications in cardiac surgery patients, the breath-stacking technique has been proposed as an alternative to increase pulmonary volumes in the post-operative period.

Objective: To compare inspiratory volume and electromyographic activity of respiratory muscles during breath stacking technique and incentive spirometry in patients undergoing cardiac surgery.

The purpose of the present study are:

1. to evaluate and compare the inspiratory volume during the course of Breath Stacking and Incentive Spirometry techniques in patients submitted to myocardial revascularization surgery.
2. to compare the electromyographic activity of the scalene, sternocleidomastoid (SCM) and diaphragm muscles during both techniques.

Eligibility Criteria:
Inclusion Criteria:

* patients submitted to myocardial revascularization surgery

Exclusion Criteria:

* cognitive impairment or incoordination to perform IS
* face mask intolerance during BS
* level of consciousness incompatible to perform IS
* hemodynamic complications \[arrhythmia, intraoperative myocardial infarction, major blood loss (defined as a loss of ≥20% of total blood volume), mean arterial pressure \<70 mmHg and reduce cardiac output requiring the use of an intra-aortic balloon pump or vasoactive drugs)
* intubation for more than 72 h after admission to the Intensive Care Unit
* the need for reintubation.
HCC Screening Using DNA Methylation Changes in ctDNA

Hepatocellular Carcinoma (HCC) is the fifth most common cancer world-wide. It is particularly prevalent in Asia, and its occurrence is highest in areas where hepatitis B is prevalent, indicating a possible causal relationship. Follow up of high-risk populations such as chronic hepatitis patients and early diagnosis of transitions from chronic hepatitis to HCC would improve cure rates. In most cases HCC is detected late resulting in increased mortality and morbidity.

The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC and circulated tumor DNA in hepatocellular carcinomas patients.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of HCC by EASL-EORTC guidelines
* Confirmed hepatitis B diagnosis for HepB patients using AASLD practice guidelines.

Exclusion Criteria for HCC:

* Cirrhosis, any other known inflammatory disease (bacterial or viral infection with the exception of hepatitis B or C, diabetes, asthma, autoimmune disease, active thyroid disease) which could alter T cells and monocytes characteristics
* Other cancers.

Exclusion Criteria for HepB:

* Diagnosis of HCC or any other cancer.

Exclusion Criteria for Healthy Controls:

* Any known inflammatory or infectious disease including HepB and HepC
* Chronic diseases,
* Cancer
* Medications or drug use
Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment

To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in predicting and monitoring early neoadjuvant treatment response compared to pathological response.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to receive neoadjuvant chemotherapy for the treatment of newly diagnosed, locally advanced breast cancer or scheduled to receive neoadjuvant endocrine therapy with the eventual goal of surgery of newly diagnosed clinical stage II-III ER+ HER2- breast cancer (for the endocrine therapy cohort)
* At least 18 years of age
* Female
* Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria:

* Pregnant and/or breastfeeding
* Prior history of breast cancer
* Prior history of chest wall radiation
* Prior history of breast reconstruction, reduction, or augmentation
Efficacy of Music on Reduction of Sedative Drugs in Mechanically Ventilated Intensive Care Unit Patients

Major objective: a three-days interventional cross-over trial \[one day music on, one day wash-out, one day music off\]\[two periods of listening/day\], to evaluate:

1. Impact on sedative drug consumption.
2. Alteration of stress neuropeptide blood concentrations.

Population: mechanically-ventilated ICU patients

The investigators hypothesize the music will decrease the need of sedative drugs and reduce the concentration of neuropeptides in circulation.

The study will imply patients mechanically ventilated for more than 3 days, that require sedation with benzodiazepine and narcotics.

There will be two groups both of exposed to music and placebo (headphones without music). The study will be simple blind.

Sedation scale will be followed regularly. Vitals signs and adjustment of sedation will be recorded by the nurse on the ward. Blood test will be taken before and after placement of headphones in the morning. We will measure IL-6, cortisol, copeptin, prolactin, CRP.

We will analyse the total reduction dose of sedation and analgesia on a daily basis. We will consider a fall of 20% of medication to be significative.

Eligibility Criteria:
Inclusion Criteria:

* adults older than 18 years old
* expected time of mechanical ventilation of more than 72 hours
* sedation needs for a scale of Sedation-Agitation Scale (SAS) more than 1

Exclusion Criteria:

* hearing impairment
* pregnancy
* needs of vasopressin
* needs of curarisation
A Health Promotion Campaign Targeting Caregivers of Young Children

This project will evaluate the effectiveness of the Take TIME health promotion campaign. The Take TIME (Tobacco free, Injury free, Moving daily, Eating healthy) campaign will target parents and caregivers of children up to 8 years of age.

The study will help answer the following research questions

1. Are community organizations able and willing to deliver a health-promotion campaign targeting young children?
2. What impact does the Take TIME campaign have on the readiness of the community to support healthy childhoods?
3. What impact does the Take TIME campaign have on awareness and achievement of healthier lifestyles for young children?
4. Can health promotion initiatives be "institutionalized" within the Municipality and community organizations so that the campaign will continue beyond the study period?
5. Are changes in awareness and/or behaviour related to exposure to the Take TIME campaign?

The Take TIME initiative will be developed and delivered in conjunction with the Township of Uxbridge and the Heart and Stroke Foundation of Ontario. The Durham Region Health Department, the Ministry of Health Promotion and Sport, and 35 schools and community organizations have also agreed to collaborate on project activities. The health promotion campaign will occur from October 15, 2010 until May 31, 2011. The campaign activities were developed from the input of parents and programme/care providers gathered during the planning phase of this research.

The impact of the Take TIME campaign will be evaluated in two ways. The overall readiness of the community to support healthy childhoods will be evaluated using the Community Readiness Model, which relies on a series of interviews with key individuals in leadership positions. Awareness and current behaviour among community members will be assessed through the completion of telephone surveys of randomly selected households. Each of these evaluations will be completed twice, before and after delivery of the Take TIME campaign. The pre-campaign evaluations will be completed in September 2010. The post-campaign evaluations, using the same procedures, will be completed in June 2011.

Eligibility Criteria:
Inclusion Criteria:

* Parent(s) or caregiver(s) of young children (8 years of age and younger) will be eligible for the pre- and post- intervention telephone surveys.
* Intervention activities will target parents and caregivers of young children and children 8 years of age and younger, although the events, information and policies may also influence other residents of the community.

Exclusion Criteria:

* Children and adults who are not parents or caregivers for young children 8 years of age or younger are not eligible to complete the random telephone survey.
Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke

This study aims to evaluate the safety and usability of a motorized mobility assistance exoskeleton (MAK). The procedure explores the use of the MAK exoskeleton during the static and dynamic rehabilitation sessions with the intention to evaluate the safety and usability of the device in the studied population. The protocol has been focused on defining how the device can be used appropriately in this population in a safe manner by rehabilitation specialists.The study also aims to assess the safety of clinicians implementing the intervention, as well as possible benefits derived from the use of the device. As a secondary outcome, efficacy measurements will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* Weight \< 100 kg
* Height between 1.5 and 1.9 meters
* Anthropometric measurements to fit in the exoskeleton:
* Distance from the center of the knee joint to the ground: 42 - 55 cm
* Distance from the center of the knee to the groin fold: more than 28 cm.
* Perimeter in thigh (midpoint trochanter - epicondyle): 40 - 63 cm.
* Perimeter in calf (point of greater volume): 30 - 44 cm.
* Ability to follow simple commands and communicate basic needs
* Presence of unilateral hemiparesis
* Diagnosis of stroke confirmed with imaging tests.
* Sub-acute or chronic patients (time since diagnosis 1 month or more)
* Score on FAC scale from 1 to 4
* Sufficient postural control to maintain standing posture and to take a step with the weight on the affected lower limb, manual assistance or technical aids being allowed

Exclusion Criteria:

* Spasticity \> 3 in lower limbs according to the MAS scale
* Skin alterations in the contact areas with the exoskeleton
* Planned surgical intervention during the duration of the study
* Two or more osteoporotic fractures in the lower limbs in the last 2 years
* Presence of other pathologies that cause exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, Parkinson's, severe lung disease)
* Surgical operation in the 3 months prior to the start of the study on the lower limbs
Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease

The hypothesis underlying this study is that nasally administered calcitonin will stabilize or improve bone mineral density in young patients with ulcerative colitis or Crohn's disease. Patients who participate will receive either calcitonin or placebo and will have their bone mineral density measured at the start, at nine months, and at 18 months of study. Participants will also receive age appropriate doses of vitamin D and calcium supplements. Other serological measures of vitamin D status will be obtained every 3 months during the study.

This is an institutional, randomized, placebo-controlled, double-blind clinical trial to compare the efficacy of intranasally administered calcitonin (plus oral supplements of age-appropriate doses of calcium and vitamin D) with that of placebo nasal spray (plus oral supplements of age-appropriate doses of calcium and vitamin D) in maintaining or improving bone mineral density. Study subjects will be 8 to 22 year old patients with the diagnosis of inflammatory bowel disease (ulcerative colitis and Crohn's disease) and low bone mineral density defined as DXA z score lower than -1.0 SD. Study end-point will be at 18 months after the continuous administration of nasal calcitonin or placebo and supplements as above. Bone mineral density will be measured by dual energy X-Ray absorptiometry (DXA) at the beginning of the study, and then at 9 and 18 months. The study subjects will be evaluated clinically and nutritionally at the beginning of the study, as well as every 3 months for the duration of the study. Laboratory values relevant to calcium homeostasis and bone turnover will be obtained every 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Low bone mineral density as defined
* Age 8 to 22 years
* Diagnosis of Crohn's disease or ulcerative colitis

Exclusion Criteria:

* Receiving calcitonin or biphosphonates, androgens or growth hormone
* Steroid induced fracture in the past
* Pregnant
* Diagnosis of kidney failure, polycystic ovaries syndrome, or malignancy
A Study to Assess BMS-986453 in Participants With Relapsed and/or Refractory Multiple Myeloma

The purpose of this study is to assess BMS-986453 in participants with relapsed and/or refractory multiple myeloma (RRMM).


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of multiple myeloma with relapsed and/or refractory disease.
* Participants must have confirmed progressive disease on or within 12 months (measured from the last dose) of completing treatment with the last anti-myeloma treatment regimen before study entry.
* Participants in Part A and Part B Cohort 1 must have received at least 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent.
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Participants must have adequate organ function.

Exclusion Criteria:

* Participants must not have any known active or history of central nervous system (CNS) involvement of multiple myeloma.
* Participants must not have active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis.
* Participants must not have a history or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, or cerebellar disease, or presence of clinically active psychosis.

Other protocol-defined inclusion/exclusion criteria apply