cyrilzakka/clinical-trials huggingface dataset:
Clinical Reassessment Versus Procalcitonin in Order to Shorten Antibiotic Duration in Community-acquired Pneumonia

CLINPCT study is a prospective, randomized, controlled, open intervention clinical trial including adult patients admitted in the emergency department with community-acquired pneumonia. The objective of this clinical trial is to compare two strategies: clinical reassessment and procalcitonin guided diagnostic and therapeutic strategy in patients with community-acquired pneumonia. In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America (Temperature ≤37.8°C, Heart rate ≤100 beats/min, Respiratory rate ≤24 breaths/min, Systolic blood pressure ≥90 mm Hg, Arterial oxygen saturation ≥90% or pO2 ≥60 mm Hg on room air). In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.


Eligibility Criteria:
Inclusion criteria

* written informed consent
* age ≥ 18 years
* admittance from the community or a nursing home with the main diagnosis of community-acquired pneumonia justifying urgent antibiotherapy prescription, hospitalization for at least 6 hours after randomization and chest radiograph compatible with the diagnosis of CAP( Community acquired pneumonia )

Exclusion criteria

* the inability to give written informed consent
* hospitalization \>24 hours
* aspiration pneumonia
* nosocomial pneumonia
* purulent pleurisy
* exacerbation of COPD (chronic obstructive pulmonary disease)
* neutropenia (\<1G/L cells)
* chronic infection with current antibiotherapy
* antibiotherapy before admission for the current infection
* immunosuppression (including prolonged corticotherapy (10 mg of prednisone per day for at least one month)
* active neoplastic disease, organ transplant, pregnancy, HIV diagnosis with a CD4 count\<200 cells/μL.
Comparative Assessment of Mental/Incisive and Inferior Alveolar Nerve Block Anesthesia in Root Canal Treatment of Mandibular Premolars

The goal of this clinical trial is to systematically compare the pain scores and anesthesia efficacy of IANB and MNB in the treatment of symptomatic mandibular first and second premolars. This study aims to address gaps in current evidence and clarify whether these anesthesia techniques differ in effectiveness and patient experience during endodontic procedures. The hypotheses include: (i) no difference in pain perception between IANB and MNB, (ii) no difference between first and second premolars with IANB, and (iii) no difference between first and second premolars with MNB.


Eligibility Criteria:
Inclusion Criteria:

* Individuals classified as ASA 1 or ASA 2.
* Age range of 18 to 65 years.
* No known allergies to articaine or epinephrine.
* Absence of facial paresthesia.
* No use of analgesic medications within 6 hours prior to treatment.
* No use of medications, such as tricyclic antidepressants or beta blockers, that may interfere with anesthesia.
* No pathological conditions at the planned injection site.
* Periodontal pocket depth of 3 mm or less.
* Mandibular first or second premolars diagnosed with symptomatic irreversible pulpitis.
* Teeth meeting Glickman's gingival health criteria upon periodontal examination.
* Radiographically closed root apex with no detectable pathology.
* Patients must be literate and able to comprehend the use of a pain scale to provide informed consent voluntarily.

Exclusion Criteria:

* Presence of systemic conditions contraindicating endodontic treatment. Age below 18 or above 65 years.
* Pregnancy.
* Documented allergy to articaine with 1:100,000 epinephrine.
* Evidence of periapical pathology or radiolucency observed in radiographs.
* Recent use of central nervous system depressants or analgesic medication within 6 hours prior to treatment.
* Absence of reported lip numbness 10 minutes following IANB or MINB injection. Presence of a large restoration on the affected tooth.
Exome Sequencing Study in Cardiomyopathy to Identify New Risk Variants

Genetic mutations has been proved to be associated wth the onset of cardiomyopathy. In the present study, we intend to identify new related variants or genes. From March, 2003 to November, 2017, patients diagnosed as cardiomyopathy were consecutively recruited, and their sampled were drawn from peripheral blood. Paired control group were also enrolled. The whole exome sequencing was used to find out the variants associated with the onset of cardiomyopathy and its prognosis.


Eligibility Criteria:
Inclusion Criteria:

· Patients diagnosed as cardiomyopathy according to the definition of American Heart Association

Exclusion Criteria:

* Uncontrolled hypertension significant valvular disease
* Mild ischemic heart disease
* Significant systemic infection
* Thyroid-induced cardiomyopathy
* Excessive alcohol consumption
* Precious cancer treatment including irradiation
* Refusal to participate in the study
pEEG Monitoring Effect on Delirium, Ventilator Days, and PICS

The goal of this multi-site observational study is to compare delirium rates, days on mechanical ventilation, and Post Intensive Care Syndrome (PICS) rates in adult Intensive Care Unit (ICU) patients. The study will examine patients whose sedation and analgesia infusion titration is managed with both Richmond Agitation and Sedation Scale (RASS) and Processed Electroencephalography (pEEG) monitoring vs patients who receive RASS monitoring alone.

The main questions are:

* Compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in conjunction with RASS to guide the management of sedation and analgesic in patients who are ventilated reduce the average number of delirium days, measured by Intensive Care Delirium Screening Checklist (ICDSC)?
* To determine when compared to RASS monitoring alone if the use of 4 channel pEEG monitor in conjunction with RASS to guide the management of Intravenous (IV) sedation and analgesia in ventilated patients reduces the days a patient spends on a mechanical ventilator when compared to RASS only monitoring from retrospective data.
* To determine when compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in conjunction with RASS experience lower doses of sedation and analgesia infusions?
* To determine when compared to RASS monitoring method alone, does the use of 4 channel pEEG monitor in conjunction with RASS experience less incidence and duration of PICS?

The purpose of this study is to determine the impact of using a 4 channel pEEG monitor to guide sedation and analgesia management in conjunction with RASS in ventilated patients in the ICU on length of time patients experience delirium, number of days patients spend on a ventilator, and incidence of PICS in these same patients.

Participants who are on a mechanical ventilator and on IV sedation or analgesia will be placed on a pEEG monitor on admission to ICU.

Participants will complete a battery of test at discharge, one month post discharge, and three months post discharge to assess for PICS.

Eligibility Criteria:
Inclusion Criteria:

1. Admitted to ICU
2. Receive mechanical ventilator support during ICU stay
3. Require IV sedation or analgesic while ventilated
4. Discharged home from the hospital
5. Use of pEEG for sedation or analgesic titration
6. Able to read and speak English
7. Mechanically ventilated greater than 48 hours
8. Aged 17 years +1 day or greater
9. Consent to participate
10. Participants need a computer with a keyboard, internet access, and email access for the questionnaires and assessment and be able to use computer and internet.

Exclusion Criteria:

1. Deceased during hospitalization
2. Intubated at a hospital not included within the study \> 12 hours
3. Discharge to rehabilitation facility, long term care, or other outpatient setting
4. Inability to provide informed consent
5. Currently enrolled in any other research study involving drugs or devices
6. Is unable to be screened for delirium during ICU admission.
Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy

OBJECTIVES: I. Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy.

II. Compare the frequency and severity of neurological disability of study patients with untreated historical controls.

PROTOCOL OUTLINE: This is an open label study. Patients must follow dietary instructions as provided by the investigator. Patients receive 2-4 tablespoons of a mixture of glyceryl trierucate and glyceryl trioleate oil once daily. Patients complete a neuropsychological scoring scale questionnaire to measure neurological disability. Patients undergo physical examinations including magnetic resonance imaging and magnetic resonance spectroscopy of the head.

Patients are followed monthly for 6 months, then every 3 months until they reach the age of 13 years or death.

Eligibility Criteria:
Inclusion criteria.

1. Boys between the age of 18 months and 8 years of age
2. Biochemically proven asymptomatic X-linked adrenoleukodystrophy determined by elevation of very long chain fatty acids or DNA analysis.
3. Platelet count in normal range

Exclusion criteria.

1. Abnormal MRI consistent with childhood cerebral disease
2. Boys who have undergone bone marrow transplantation
3. Other medical condition which in the opinion of the investigator prevents evaluation or treatment
PMCAN for Smokers at Smoking Hotspots

Background: Many smokers cannot quit due to nicotine withdrawal symptoms, which peak at the first week of abstinence. Proactive recruitment of smokers is needed as most smokers do not seek smoking cessation (SC) services. A smoking hotspot (SH) is defined as a public outdoor place where smokers stop/linger and smoke. We aim to include a reasonably "representative" or unbiased sample of SH at different locations from all 3 regions of Hong Kong. We will randomly select 6 eligible SH (2 in each regions) from the 15 hotspots in our previous community trial.

Methods: Two trained SC ambassadors (student helpers) and one supervisor (experienced research assistant) will be deployed for each session of intervention at a SH. Potential subjects will be approached using the "a-foot-into-the-door" method in which SC ambassador will ask if smoker would like to reduce/quit smoking and receive SC intervention or advices. Smokers will be assessed for eligibility and informed written consent will be sought. Subjects will complete a brief self-administered questionnaire (baseline) using tablet. To reduce later hang-ups of telephone interventions or surveys, SC ambassador will save contact number of the trial into subjects' mobile phones.

Discussion: The findings will provide much needed and original evidence to support a main RCT on these new, proactive, simple and low-cost interventions for improving current SC services and policy for smokers who do not actively seek help from SC services in Hong Kong and elsewhere.


Eligibility Criteria:
Inclusion Criteria:

* Adult smokers aged 18+ who smoke cigarettes daily.
* Exhaled carbon monoxide (CO) level of 4ppm or above.
* Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua)

Exclusion Criteria:

* Smokers who have contraindication for NRT use: severe angina, arrhythmia, myocardia infraction, pregnancy (or intended to become pregnant \<6 months) or breastfeeding.
* Smokers who have psychiatric/psychological diseases or regular psychotropic medications
* Smokers who are using SC medication, NRT, other SC services or projects.
Development of Predictive Biomarkers and Novel Approached to Therapy in Breast Cancer

Breast cancer is a common malignancy world-wide, and is the commonest female malignancy in Singapore, with rising trends in incidence over the last 2 decades. While there have been improvements in treatment, mortality from breast cancer remains significant. Development of biomarkers to predict treatment response and toxicity to anti-cancer agents can rationalize the choice of therapy for the individual patients to optimize treatment outcome and to reduce unnecessary toxicities. Development of novel therapies or novel approaches to therapy is also critical to improve the treatment armamentarium in breast cancer. These research strategies will have an significant impact on breast cancer treatment both in Singapore as well as globally.


Eligibility Criteria:
Inclusion Criteria:

This program will recruit mainly cancer patients, predominantly breast cancer patients. The exact inclusion criteria will vary between each individual study. Each individual component study will be submitted to DSRB for separate approval, along with the study protocol and patient informed consent sheet.

Exclusion Criteria:

The exact exclusion criteria will vary between each individual study. Each individual component study will be submitted to DSRB for separate approval, along with the study protocol and patient informed consent sheet.
Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds

This is a randomized, double-blind pivotal study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds (i.e., smile lines).

Patients with negative reaction skin test results will be randomized to receive CosmetaLife in one nasolabial fold and Control in the nasolabial fold on the opposite side of the face (split face design). Each subject will serve as his or her own control, allowing for comparison of the outcome between the contralateral sides. Patients will be followed at 2 weeks and 3, 6, 9 and 12 months post treatment for assessment of safety and effectiveness.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years of age or older
2. Patients with moderate nasolabial folds (3-4 WSRS scale)
3. Patients willing to provide written informed consent for their participation in the study
4. Patients willing to abstain from other facial cosmetic procedures through the 12 month follow-up visit

Exclusion Criteria:

1. Patients with any aesthetic facial therapy within 6 months prior to
2. Patients with an any reaction to the skin test
3. Patients with a history of autoimmune disorder, lidocaine reactions, allergy to heparin, other severe or chronic allergies
4. Patients with a current disease state that can effect the immunoresponse, or patients on immunosuppressive therapy
5. Patients with an active infection of any kind, skin disease, connective tissue disorder
6. Patients who are pregnant or lactating
7. Patients enrolled in another investigational clinical trial
General Attitudes Towards Surrogacy in Poland

The primary aim of the study is to:

- investigate the general attitudes towards surrogacy among Polish population.

The secondary aims of the study are as follows:

* assess the differences in attitudes towards traditional vs. gestational surrogacy among Polish population,
* assess the cognitive concerns about issues related to surrogacy,
* assess the acceptance of surrogate parenthood,
* assess the attitude towards the surrogate mother,
* identify factors that influence the attitudes towards surrogacy,
* examine if there are differences in attitudes among members of the general public, health care professionals, students (health/medical studies vs. non-medical studies) and people with infertility diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* no restrictions to gender
* age ≥ 18
* able to understand and complete the questionnaire in Polish
* country of residence: Poland

Exclusion Criteria:

• if at least one of the inclusion criteria is not met
Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.

This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.

This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of BG-00012 given in capsule form supplied by two different manufactures.

Eligibility Criteria:
Inclusion Criteria:

* Must give written and informed consent and any authorizations required by local law.
* Males and females 18 - 55 years old inclusive at time of consent.
* Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

* History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator.
* Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).
* Current enrollment in any other drug, biologic, or device study.
Therapeutic Effect of Tacrolimus in Combination With Low Dose Corticosteroid in Adult Patient With Minimal Change Nephritic Syndrome

The hypothesis of this study is that tacrolimus reduces the proteinuria in adult patient with minimal change nephritic syndrome.

A pilot study for comparative clinical trial on the therapeutic effect of tacrolimus (Prograf cap®) in adult patient with minimal change nephritic syndrome.

Eligibility Criteria:
Inclusion Criteria:

* from 18yrs to 80 yrs , man and women
* Minimal change disease is diagnosed by kidney biopsy
* On screening, the patient shows that the level of urine protein/creatinine ratio is over 3.0
* On screening, the patient shows that the serum albumin is below 3.0g/dL
* the patient sign on the concent form

Exclusion Criteria:

* the patient have experience to take tacrolimus or cyclosporin for 1 month
* If it is the relapse of the nephrotic syndrome, before relapse, the maintenance dose of steroid is over 0.3 mg/kg/day
* steroid dependent or steroid resistant or frequent relapse case
* uncontrolled hypertension
* pregnancy or anticipate pregnancy with 6 month
* hypersensitivity to tacrolimus or macrolide
* acute hepatitis or the level of AST or ALT is over 2 times of normal range or the level of bilirubin is over 2.0 mg/dL
Survey of the Collective 16s rRNA Genes From Bacterial Populations From Exercising and Non-exercising Participants

Poor oral health can greatly impact quality of life and can also impact overall health. For instance, research suggests that poor oral health may be associated with systemic diseases such as diabetes, heart disease, and stroke. Therefore, there is a need to investigate the causes of poor oral health.

The idea that athletes may have a propensity for dental caries has been gaining traction. There have been recent reports of high levels of dental caries, dental erosion and periodontal diseases among elite soccer players compared to the general public and in athletes from a wide range of sports. However, to date, no studies have investigated the oral microbiome of athletes.

Many factors affect the development of dental caries, including host factors, diet, and the microorganisms present in the oral cavity. More than 700 types of bacterial species have been detected in the oral cavity, and some have been identified to play a significant role in the development of oral disease. Streptococcus mutans is the main species involved in dental decay with various lactobacilli also involved in the disease process. Treponema denticola, Porphyromonas ginigivalis, and Aggregatibacter actinomycetemcomitans are the main species involved in periodontal disease. It is not currently known if changes in the collective oral microbiome foster or impede the development of these pathogens.

Complex microbe-host interactions occur to allow for the progression of oral disease, with host nutrition and hygiene playing a significant role. Endurance athletes widely consume a variety of sport drinks, gels, and energy bars for supplementation of electrolytes and carbohydrates. The consumption of these foods leads to pH drops in the oral cavity and may contribute to tooth erosion and demineralization. Oral disease may also be exacerbated by the fluid and electrolyte deficit that impedes saliva flow during exercise. However, several studies have failed to demonstrate a clear link between sports drinks and an increased risk of dental caries among athletes.

Dental caries are caused by microorganisms in the oral cavity. These microbes may be affected by host factors or nutrition in the progression of oral disease. Due to the documented prevalence of dental caries in athletes and the lack of clear connection between sports drinks and dental caries, the investigators propose to investigate any correlation that may exist between exercise and the oral microbiome.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be between the ages of 18-24 and must be willing and healthy enough to start a modest exercise program if they are chosen, at random, to do so.

Exclusion Criteria:

* Pregnant women, minors, and people over the age of 24 are excluded from the study.
* Anyone with a heart condition or other health condition that is not safely able to initiate a modest exercise program are excluded from the study.
School-based Interventions for Test Anxiety in Adolescents

This study evaluates the clinical and cost effectiveness of test anxiety as a form of selective prevention for clinical anxiety. Participants will be randomly allocated to cognitive behavioural therapy without booster sessions, cognitive behavioural therapy with two booster sessions, or a no intervention control.

Test anxiety affects a substantial proportion of adolescents, who show an increased risk of suicide, and of developing clinical anxiety and poor mental health. Externally resourced school-based cognitive behavioural therapy (CBT) interventions have been shown to be effective in treating test anxiety. Intervening in test anxiety, a sub-clinical anxiety, may prevent anxieties from developing into a clinical disorder. The primary outcomes are test anxiety, clinical anxiety, and wellbeing, measured at baseline, post-intervention, and 6 and 12-month follow-up. In addition, to identify treatment mechanisms additional measures are taken of uncertain control, metacognition, and emotional regulation.

Eligibility Criteria:
Inclusion Criteria:

* Participants are aged 14-16 years of age
* In the upper 66th percentile of test anxiety scores

Exclusion Criteria:

* Participants are receiving other treatment for anxiety
* Participants have a diagnosis of clinical anxiety depression or Attention Deficit Hyperactivity Disorder