cyrilzakka/clinical-trials huggingface dataset:
Streptococcus Mutans Reduction Early Mother-infant Transmission

Evidence exists on the vertical transmission of Streptococcus mutans from the mother to her children. This transmission can be prevented by maintaining maternal oral health during pregnancy.

The aim of this study was to evaluate the enhancing effect of 1% chlorhexidine varnish together with silane fluoride re-mineralizing varnish and oral health promotion strategy on the reduction of S. mutans counts in saliva of pregnant women and the early mother-infant transmission until the first six months of age of the newborn. Methods: An open, random clinical trial of parallel groups was performed. 56 pregnant women free of caries were studied prospectively and longitudinally since the third trimester of gestation until 6 months after giving birth, the newborns were also assessed until reaching 6 months of age. Two groups were formed assigning 28 women to each intervention group. G-I received 0.1% silane fluoride applied as varnish in each visit. G-II women's teeth were coated with 0.1% silane fluoride and 1% chlorhexidine. For the primary culture, CRT Bacteria® system (Ivoclar-Vivadent™) was used for the growth and identification of cariogenic Streptococci. Identification of S. mutans was performed through PCR. The DNA of the isolates identified molecularly as S. mutans was used for a second PCR reaction using the arbitrary primer OPA-O2 to determine the homology among the samples of isolated bacteria from the mother-child pair.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the third trimester with a normal and healthy pregnancy.
* Ages ranged from 18 to 45 years
* Free of caries (if caries were present, they were treated before enrolling them in the study).

Exclusion Criteria:

-Non-pregnant women
Opioid Sparing Effect of Sphenopalatine Ganglion Block in Functional Endoscopic Sinus Surgery: a Randomized Controlled Clinical Trial.

Functional endoscopic sinus surgery (FESS) is widely recognized as a safe and preferred treatment option for various conditions, particularly nasal polyps and rhinosinusitis . This technique has been shown to improve postoperative symptoms by 86.3% in patients with chronic inflammatory paranasal sinus diseases .

The aim of this study is to evaluate the effect of adding of MgSO4 to bupivacaine via SPGB block for postoperative pain for 24 hours in patients scheduled for FESS as opioid free anaesthesia.

However, managing postoperative pain remains a significant challenge. Research suggests that 86% of surgical patients experience pain, with 75% enduring moderate to severe levels .

The Sphenopalatine Ganglion Block (SPGB) is an effective, safe, and well-tolerated method for managing craniofacial pain. The ganglion comprises both sensory and autonomic nerves, which innervate the nasal cavity, palate, and certain areas of the nasopharynx and oropharynx . SPGB involves the administration of analgesic agents into the nasal cavity, typically through an endoscopic approach due to the challenges of transnasal injection . Some complications, such as postoperative nosebleeds, and temporary numbness of the palate, have been observed following the blockade with endoscopic intervention, but these are generally temporary .

Studies evaluating the effects of the sphenopalatine block in endoscopic sinus surgery suggest that patients who received the ganglion block experienced reduced postoperative pain compared to those in the placebo group when combined with general anaesthesia .

Eligibility Criteria:
Inclusion Criteria:

* • Patients programmed for elective FESS

  * American society of anaesthesiologists (ASA) physical state I-II
  * Age over 18 years and less than 60-years-old.

Exclusion Criteria:

* • Known hypersensitivity to the study drugs.

  * Inability to accurately describe postoperative pain to investigators.
  * Opioid tolerance or dependence.
  * Patient refusal
  * History of renal, liver, cardiac, neuropsychiatric disorder problems.
  * Bleeding or coagulation abnormality.
  * Infection at the site of injection
Efficacy of Laser Acupuncture on Pruritus in Patients With Chronic Kidney Disease Undergoing Hemodialysis

Uremic pruritus is a clinically significant symptom which imposes heavy impact on the quality of life of patients with chronic kidney disease undergoing hemodialysis. In order to investigate the clinical efficacy and mechanism, the investigators designed a multiple centers, randomized, assessor- and participant-blind, controlled, cross-over clinical trial. This trial will be conducted at Taichung branch, Feng-yuan branch and the Eastern branch of CMUH.

We plan to enroll 200 volunteer patients with uremic pruritus. After the waiting period (as the waiting list group), you will be randomized to laser acupuncture and sham laser acupuncture group. Each group will include 100 patients and given intervention according to their hemodialysis frequency, i.e., BIW or TIW. The intervention will then be crossed over to the other one after 4 week of wash-our period. Outcome measurement includes questionnaires, biochemistry analysis, instrumental analysis and medication score.

Eligibility Criteria:
Inclusion Criteria:

* Age\>20y/o, ESRD patient, pruritus symptoms persist longer than 4 weeks

Exclusion Criteria:

* immunosupression agents use, undergo chemotherapy
* drug abuser
* pregnancy women
* patient with psychiological disorder
* arrhythemia, pacemaker device use
* local skin infection over laser acupuncture site
* patient allergy to laser acupuncture treament
Acute Concussion and Melatonin

In this study, the investigator plans a randomized trial of melatonin versus placebo post acute pediatric concussion. The investigator hypothesizes that patients with acute concussions managed with melatonin will have improved sleep, decreased depressive symptoms, decreased risk of prolonged concussion symptoms and faster resolution of concussion symptoms.

To compare the risk of persistent post-concussive symptoms (PPCS) between melatonin and placebo after an acute pediatric concussion.

To determine if melatonin compared to placebo reduces the risk of PPCS for pediatric patients.

This is a prospective single-blinded randomized control trial of pediatric patients in the emergency department (ED) diagnosed with an acute concussion. Patients 12-18 years old with an acute concussion diagnosis will be eligible. All participants will receive actigraphy watches to wear on their wrists and measure sleep and activity patterns. Participants in the melatonin group will be instructed to take 3 mg of liquid melatonin 1 hour prior to their habitual fall asleep time daily for 30 days. Participants in the placebo group will be instructed to take their placebo liquid 1/2 hour prior to their habitual fall asleep time daily for 30 days.

All participants will be given standardized weekly assessments to track their concussion, sleep and depressive symptoms for one month. Research assistants will also arrange follow up in the telemedicine neurology headache clinic within 4 weeks post injury. At the follow-up visit, subjects will complete the Post Concussion Symptom Inventory (PCSI), Pediatric Sleep Disturbance (PSD), and Revised Childhood Anxiety and Depression Scales (RCADS).

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with an acute concussion within 72 hours
* Patient greater than 8 and less than 19 years old

Exclusion Criteria:

* Currently taking psychiatric medication
* Cognitive delay
* Glasgow Coma Score \< 14
* positive findings on head computed tomography
* Any patient with intracranial surgery, pathology or instrumentation (e.g. ventriculoperitoneal shunt, brain tumor etc)
* Use of melatonin within the last week
Domiciliary Physiotherapy in Women Undergoing Treatment for Breast Cancer Radiation

To observe the effect of domiciliary physiotherapy on the upper limb applied during the period of radiotherapy in women submitted to surgical and radiotherapy for breast cancer. The parameters evaluated were: shoulder range of movement (ROM) and arm circumference. There was significant difference between the ipsilateral and contralateral limbs for flexion, abduction and external rotation. There was no difference in perimetry in either group


Eligibility Criteria:
Inclusion Criteria:

* be diagnosed with unilateral breast cancer;
* be submitted to surgical and radiation treatment as part of the treatment for breast cancer.

Exclusion Criteria:

* patients with neurological or orthopedic diseases that could impair the upper limb movements
* bilateral breast cancer;
* prior thoracic radiotherapy;
* presence of distant metastasis.
Vapocoolant Spray Effectiveness On Arterial Puncture Pain: Randomized Double Blind Placebo-Controlled Trial

This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed with vapocoolant spray in comparison to placebo.

Previous studies of vapocoolant sprays for reducing pain were mainly on venopuncture with inconsistent results. There was only one prospective open labeled controlled study on arterial blood gas sampling with ethyl chloride which did not show effectiveness. This study will assess the efficacy and tolerability of a topical alkane vapocoolant spray for arterial puncture in adults in comparison to control spray.

Eligibility Criteria:
Inclusion Criteria:

* age of 14 years or older,
* needs ABG as a part of their diagnosis

Exclusion Criteria:

* history of analgesic medication used within 24 hours of enrollment,
* any sign of decreased consciousness,
* history of skin hypersensitivity,
* inability to report a pain score,
* history of a known neurological problem that changes pain perception,
* history of cold related reactions (e.g. Raynaud's phenomenon, cold urticaria),
* abnormal Allen's test
Test of Novel Drug for Smoking Cessation

The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid cessation during a one-week "practice" quit period for each condition in smokers with a high interest in quitting (i.e. crossover design). Medication effects on reducing withdrawal and cognitive impairment will help assess the mechanism to support quit smoking attempts.

We aim to test the proof of principal that an alpha-7 PAM drug, JNJ-39393406, promotes smoking cessation when compared to placebo. We have developed, tested, and validated an efficient Phase 2a screening procedure that optimally combines the validity of randomized clinical trials with the practicality of lab- based medication studies. Notably, it employs a within-subject, cross-over design comparing active versus placebo effects on quitting smoking to maximize statistical power without a large sample, in contrast to the large samples needed for between-groups randomized treatment conditions. Using this procedure, we will evaluate effects of JNJ-39393406 vs. placebo on short-term smoking abstinence in smokers who already have a high interest in quitting soon. We predict that, compared with placebo, JNJ-39393406 will increase days of abstinence, identifying initial evidence of efficacy for smoking cessation. Our main dependent measure is days of very stringent biochemically validated (expired CO\<5 ppm) 24-hr smoking abstinence, with post-quit withdrawal and cognitive function as secondary measures. Potential for adverse side-effects will be assessed at each visit.

Eligibility Criteria:
Inclusion Criteria:

Healthy male and female dependent smokers wanting to quit soon

-

Exclusion Criteria:

* Use of non-smoked nicotine products
* Already enrolled in cessation program.

  * Recent alcohol or substance dependence (≤ 3 months)
  * Women who are pregnant, planning a pregnancy, or lactating; all female participants shall undergo a pregnancy test at screening and will be excluded if positive.
  * Serious or unstable medical disorder within the past 3 months
* Epilepsy

  * Current diagnosis (within last 6-months) of abnormal cardiac rhythms; unstable cardiovascular disease e.g. stroke, myocardial infarction in the last 6 months
  * Evidence impaired liver function test (LFT)
  * Evidence of kidney failure
  * Any subject with a history of hematological cancers examples: leukemia, lymphoma etc.
  * Any clinically significant hematological laboratory abnormality.
Consecutive Dual-Session tDCS in Chronic Subjective Severe to Catastrophic Tinnitus With Normal Hearing

We aimed to analyze the effect of continuous dual session tDCS in patients with severe chronic subjective tinnitus without any evidence of hearing loss in terms of relief of tinnitus perception, distress, and loudness. Also, we investigated the difference in the maintenance duration of the tinnitus suppression effect of consecutive dual session tDCS compared to other groups followed up for 2 months.

The participants were randomly allocated with three different arms (control, single-session, and dual session) using block to balance the size of each group. Pure tone audiometry, speech audiometry, tinnitogram (pitch matching, loudness, minimal masking level and residual inhibition), auditory evoked potential, THI, visual analogue scale (VAS) of loudness, awareness and annoyance, and BDI were evaluated as a baseline tests. Participants who assigned to the control group underwent dual sham stimulation per day, twice a week for 1 month. Patients were received sham and true stimulation once alternately in the single session group and two true stimulation per day in the dual session group for the same period as the control group. All subjects who enrolled this study were given a conventional treatment such as tinnitus retraining therapy, sound therapy using sound generator, and medications like clonazepam, selective serotonin reuptake inhibitors for patients who wanted to take for relief of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have experienced subjective tinnitus for over 3 months.
* Individuals with normal hearing, defined as an average pure tone threshold of less than 25 dB between 0.5-4 kHz, and the presence of the V wave at 30 dBnHL with a difference in V wave latency of less than 0.2 ms in both ears during the ABR test.
* Individuals with severe tinnitus, as indicated by a Tinnitus Handicap Inventory (THI) score of 58 or higher, and who have been assessed for symptoms of anxiety and depressive mood using the Beck Depression Inventory (BDI) questionnaire.

Exclusion Criteria:

* Those requiring treatment for neurological disorders such as epilepsy, migraine, or intracranial masses.
* Pregnant individuals on the day of providing consent and those with metal-based electric implantable prosthetics.
* Individuals with objective or somatic tinnitus, auditory hallucinations, unwillingness to provide written consent, or unwillingness to continue the trial, and those who have participated in previous trials involving tDCS for tinnitus.
Heart Failure and Preserved Ejection Fraction: Observation of Its Progression and Prognosis (HOPP-BERN)

Analysis of longitudinal data, cardiovascular magnetic resonance (CMR) imaging and health related data, of patients with heart failure and preserved ejection fraction (HFpEF) over a timeframe of 5 years per patient.

In this study routine clinical data are collected along with additional research parameters measured during CMR. CMR will occur throughout a 5-year follow-up.

Heart Failure with Preserved Ejection Fraction (HFpEF) is becoming increasingly prevalent, yet diagnostics, characterization and prognosis of the disease is still uncertain. Multiple contributing factors have been implicated in the development of HFpEF such as but not limited to myocardial fibrosis, myocardial edema, ventricular remodeling, metabolic dysfunction, coronary microvascular dysfunction, ischemia, systemic effects and associated ventricular-arterial coupling. However, how the longitudinal progression of these factors is associated with HFpEF and whether a causal effect between the pathologic features in HFpEF exist, is not fully understood.

Using cardiovascular magnetic resonance (CMR), multiple cardiac and extracardiac parameters can be investigated in a single non-invasive imaging exam. This will be a single-centre prospective observational longitudinal study with the formation of a database. Patients will undergo a comprehensive CMR exam upon recruitment, 1- and 5-years after enrolment, and also if re-hospitalisation for heart failure occurs. This exam will investigate multiple measures of cardiovascular function, myocardial deformation, edema, fibrosis and oxygenation, 4D haemodynamical assessments, along with measurements of the aorta, liver and spleen. Furthermore, clinical data will be collected for the patients for the creation of a HFpEF database (ie. patient characteristics, Kansas City Cardiomyopathy Questionnaire (KCCQ), HF and risk scores, laboratory biomarkers, diagnostic results). With this study, the investigator will be able to quantify longitudinal changes in CMR features within the HFpEF population, and investigate what features are associated with poor prognosis. The data collected will lead to a greater understanding of HFpEF, and hopefully show which clinical or imaging features can be used to identify, and better risk stratify this heterogenous population.

Eligibility Criteria:
Inclusion Criteria:

* Known Heart Failure with Preserved Ejection Fraction (HFpEF) (based on invasive measurement) or high probability of HFpEF (\>70% based on H2FPEF score ≥4)
* Ability to provide informed consent (knowledge of project languages), \>18 years

Exclusion Criteria:

* MRI incompatibility (ie. pacemakers, ICD, internal defibrillators)
* Acute myocardial infarction (\<90 days)
* Recent cardiovascular surgery or intervention (\<90 days)
* Severe valve disease
* Known infiltrative diseases (i.e. amyloidosis, sarcoidosis)
* Known hypertrophic cardiomyopathy)
* ARVC (arrhythmogenic right ventricular cardiomyopathy), non-compaction cardiomyopathy
* Heart transplant
* Treatment for chemotherapy or radiotherapy
* Pregnancy
Evaluation of a Mandibular Advancement Device in the Treatment of Obstructive Sleep Apnea Syndrome

The purpose of this study is to determine if the mandibular advancement by Herbst device is effective in the treatment of moderate obstructive sleep apnea patients.


Eligibility Criteria:
Inclusion Criteria:

* Moderate sleep apnea syndrome (10 \< Respiratory Disorder Index \< 30)
* Body mass index (BMI) \< 35 Kg/m2
* Able to give their informed consent

Exclusion Criteria:

* Pregnant women
* Professional drivers requiring continuous positive airway pressure (CPAP) treatment
* Psychiatric disorders, and patients unable to realise to study
* Severe respiratory pathology which could interfere with the study
* Morpheic epilepsy
* Benzodiazepines intake
* Chronic nasal obstruction
* Ear, nose, and throat (ENT) pathology requiring surgery
* Previous uvulopalatoplasty surgery
* Temporomandibular joint pathology
* Gum disease
* Insufficient number of teeth to apply the oral appliance
* Mobile teeth
Epidemiology of Non-syndromic Dominant Deafness

Hearing impairment is a common disorder that affects at least 7% of individuals in our countries. Even the causes of hearing impairment are numerous, genetic causes represent the main factor of sensorineural deafness. Among hereditary non-syndromic deafness autosomal-dominant inheritance is observed in about 10-20% of the cases. These forms of deafness are usually post-lingual and progressive. To date more than 41 chromosomal localisation and 21 genes associated to non syndromic dominant deafness have been described. It represents an extreme genetic heterogeneity making difficult the studies of these forms of hearing impairment. But, genetic diagnostic testing is crucial in these cases. Indeed, therapeutic research are in the way to prevent the progression of the disorder. The aim of this work is to establish the prevalence of the different genes involved in these forms of deafness.

The protocol consists first in the recruitment of 150 families with non syndromic dominant hearing impairment. The families will be recruited by the clinical investigators. The clinic and radiological characteristics of the hearing impairment will be collected by the clinical investigators. Samples of patients and healthy relatives will be sent to the referral center. A linkage study of the whole genome by SNP studies is in progress in a cohort of large families affected by autosomal dominant deafness. This work will enable us to select the loci that may be frequently implicated in our population and screen these genes in the 150 families included in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 4 years.
* Patient presenting familial dominant non syndromic hearing loss starting between 4 and 40 years old, over 2 generations
* Healthy volunteer from the same families
* Clinical and paraclinical assessment (genetic and ophthalmologic examination, audiometric tests, inner ear CT scan)
* Affiliated to the national health insurance benefit
* Signature of informed consent form

Exclusion Criteria:

* hearing loss resulting from an extrinsic reason or an associated syndrome
* Defective or insufficient samples
* No or insufficient clinical and biological description
* No informed consent form
Pain Associated With Endometriosis

This study will evaluate the efficacy and safety of an investigational medication compared with placebo in the treatment of pain associated with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Menstruating female 18-50 years of age,
* Regular cycle length of 21 to 35 days with menstrual bleeding that typically lasts no more than 7 days,
* Has pain associated with endometriosis,
* Has a documented history consistent with endometriosis,

Exclusion Criteria:

* Is pregnant or lactating,
* Has a history of or has active thrombosis
Assessment of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis

Testing the effectiveness and safety of cosmetics with niacinamide in irritant contact dermatitis: A Randomised, Controlled Trial will be conducted at USSM. Healthy volunteers will be included (at least 25) and test sites are forearms. Sodium lauryl sulphate will be used to induce contact dermatitis and participants will be measured for 7 days

The efficacy of niacinamide cosmetic product on contact dermatitis will be evaluated using Courage Khazaka device and probes for hydration, redness and transepidermal water loss

Eligibility Criteria:
Inclusion Criteria:

* young, healthy volunteers who gave written informed consent

Exclusion Criteria:

* skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior to the inclusion and during the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation
The Rule of Bupivacaine Hydrochloride in Skin Graft Donor Site

Split Thickness Skin Graft is frequently utilized for reconstructing skin loss of various causes. Unfortunately, the donor site of the STSG has an unavoidable, annoying post-operative pain

The primary objective of this study was to compare the efficacy of bupivacaine hydrochloride-soaked dressing versus bupivacaine HCL subcutaneous infiltration for postoperative donor site pain control for patients undergoing STSG procedures. The patients were divided in 3 equal groups, investigated soaked dressing vs subcutaneous infiltration vs conventional dressing .

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Physical Status classification I-II
* scheduled for STSG harvested from a single thigh donor site to reconstruct skin loss post burn or trauma

Exclusion Criteria:

* uncooperative
* refusing patient,
* under immunosuppressive treatment
* diabetics
* lower-limb neuropathy
* under corticosteroids treatment
* allergy to the study drug,
* STSG procedures performed under spinal anesthesia
* pregnancy
* had a history of opioid abuse