cyrilzakka/clinical-trials huggingface dataset:
Adjunctive Use of Salvadora Persica in Chronic Periodontitis

A randomized controlled triple blinded study to evaluate the effectiveness of Salvadora Persic (SP) as an adjunct to Scaling and Root Planing (SRP) in chronic periodontitis by comparing the basic parameters of periodontitis, radiographs and bacterial levels with a controlled group (SRP only).

Sixty-six subjects with untreated, moderate-to-severe chronic periodontitis will be selected by convenience sampling. The participants will be randomly divided into 2 groups:

1. Test group: SRP + SP gel
2. Control group: SRP only

Each participant will undergo treatment in the following steps:

1. QUESTIONNAIRE:

   All participants will complete a structured baseline questionnaire provided by one trained interviewer that will include the data regarding; (a) age; (2) gender; (3) education status; (4) occupation; (5) medical status
2. INFORMED CONSENT:

   All eligible subjects will be thoroughly informed of the nature, potential risks and benefits of their participation in the study.
3. ASSESSMENT OF PARAMETERS:

   1. CLINICAL PERIODONTAL PARAMETERS Full-mouth plaque index (PI), bleeding on probing (BOP), probing depth (PD), and clinical attachment loss (CAL) will be recorded on baseline, 6th week and 12th week for all the patients that pass the inclusion criteria.
   2. RADIOGRAPHIC ANALYSIS The depth of bony defects (BD) will be evaluated at baseline, 6 and 12 weeks using image analysis software (Scion Image Analyzer, Scion, Frederick, MD, USA).
   3. ANALYSIS OF PLAQUE MICROORGANISM Subgingival plaque will be collected at baseline and 12 weeks from the deepest PD (\>4mm) of each patient.
4. SCALING AND ROOT PLANING After baseline recordings, thorough SRP will be performed by a single clinician. The SRP procedure will be carried out in two sittings, comprising of ultrasonic scaling in the first, and manual instrumentation and root debridement in the second.
5. APPLICATION OF SP GEL In the test group, areas with PPD greater than 4 mm will be marked on the periodontal chart. In these areas SP gel will be placed following root planing procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are \>30 years old
2. Minimum of 20 teeth , excluding third molars
3. Systemically healthy patients with moderate (PD of 5 to 6 mm or clinical attachment loss CAL of 4 to 6 mm) or deep pockets (PD ≥7mm or CAL of 6 to 9 mm) and vertical bone loss ≥3 mm on intraoral periapical radiographs (Armitage 1999)

Exclusion Criteria:

1. Presence of systemic conditions that could modify the progression of periodontitis such as diabetes mellitus, metabolic syndrome, cardiovascular disease or immunologic disorders
2. Systemic antimicrobials in the previous 6 months
3. Aggressive periodontitis
4. Pregnancy or lactation
5. Inability to provide informed consent
Otologic and Rhinologic Outcomes in Children With Clef Palate

OBJECTIVE:

To compare otologic and rhinologic outcomes in patients with cleft palate according to surgical protocols and type of cleft.

DESIGN:

Monocentric retrospective and prospective analysis of medical reports.

PATIENTS, PARTICIPANTS:

All consecutively treated patients affected by a cleft palate, born between December 2006 and December 2009 and followed in the Montpellier University Hospital, at the age of 10 years.

INTERVENTIONS:

Results of audiometry, tympanometry, otoscopy, tubomanometry and rhinomanometry and orofacial tomodensitometry done at the age of 10 were evaluated.

MAIN OUTCOME MEASURE(S):

The history of ventilation tubes inserted, and the results at the EDTQ test were analyzed.


Eligibility Criteria:
Inclusion criteria :

* 10 yo children with operated clefts followed in the universitary hospital of Montpellier
* who went to the ENT check up

Exclusion criteria :

* Thoses who skip the check up
Efficacy and Tolerability of Angeliq in Thai Women

To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with hot flushes

Exclusion Criteria:

* Women with a contraindication for Hormone Replacement Therapy (HRT)
Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults

A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young adults, and to evaluate the immunogenicity of a booster dose.

Healthy undergraduate students aged 16 to 25 years with anti-HAV negative were randomly divided into three groups. Group A and B were administrated with one-dose inactivated and live attenuated hepatitis A vaccines respectively; Group C was immunized with two doses of an inactivated vaccine with 6 months apart. Blood samples were collected at month 1, and 12, 24 and 36 for anti-HAV titers determination. Safety observation in 30 minutes' duration after vaccinations and injection-site reactions and systemic reactions for three consecutive days were recorded to assess the safety of investigational vaccines. At Month 36, subjects who received one dose of inactivated or live attenuated HAV were administrated a booster dose and then were taken blood samples one month later for anti-HAV titers determination.

Eligibility Criteria:
Inclusion Criteria:

* Healthy undergraduate students aged 16 to 25 years
* Sign the informed consent
* Provide ID

Exclusion Criteria:

* Axillary temperature \> 37.0 centigrade at the time of dosing
* Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
* Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
* Autoimmune disease or immunodeficiency
* Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
* Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
* History or family history of convulsions, epilepsy, brain disease and psychiatric
* History of any blood products within 3 months
* Administration of any other investigational research agents within 30 days
* Administration of any live attenuated vaccine within 30 days
* Administration of subunit or inactivated vaccines within 14 days
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
* anti-HBsAg positive
* anti-HAV positive
* Pregnancy test result is positive
Cannabis and Cancer, an Online Training for Oncology Nurses

The purpose of this study is to evaluate the preliminary effects and impacts of a digital educational intervention to support nurses' professional practice regarding safe cannabis use by young adults (18-39 years) diagnosed with cancer.

This online pilot randomized controlled trial with parallel groups is conducted in Quebec (Canada). Moodle learning management system will be used to train nurses working in oncology.

After accepting the conditions and consenting, participants will enroll in the study by providing an email address. Each participant will be validated through an email address check. After their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire.

After completing the baseline questionnaire, participants will be randomly assigned by a research assistant to the digital educational intervention (Cannabis \& Cancer) or to a control group (official public websites and scientific articles).

Four weeks after the baseline questionnaire, participants will complete the online questionnaires again.

Eligibility Criteria:
Inclusion Criteria:

* Work in an oncology department (eg, radio-oncology, outpatient clinics)
* Work with people diagnosed with cancer, including young adults
* Understand, read, and write French

Exclusion Criteria:

* None
Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis

The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.


Eligibility Criteria:
Inclusion Criteria:

* aortic valve replacement or heart transplant as part of standard care decided by the local Heart Team
* pre-surgical computed tomography angiography
* informed consent
Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus

This trial was designed to evaluate the effectiveness of the dialogue-based online intervention covivio, which was designed to improve diabetes self-management in patients with type 2 diabetes.

The study aims to test the hypothesis that covivio has a greater positive impact on glycemic control than treatment as usual. Patients with type 2 diabetes mellitus will be randomized and allocated to either an intervention group, receiving covivio in addition to treatment as usual, or a control group, which receives only treatment as usual. The primary endpoint is the HbA1c value six month after baseline.

The aim of this clinical trial is to investigate the effectiveness of the self-guided digital therapeutic covivio in 268 patients with type 2 diabetes mellitus (T2DM). Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive access to covivio in addition to treatment as usual (TAU, n = 134), or to a control group, in which they will receive only TAU (n = 134).

The primary endpoint of this trial will be the between-groups difference of the HbA1c in the intervention and control group at six months adjusted for the baseline HbA1c. In order to show the course of change over time, two timepoints for assessment of effects are planned at four (T1) and six months (T2) after the baseline assessment (T0). The primary endpoint will be the HbA1c at six months post-allocation. Secondary endpoints will be depression, diabetes self-management (DSM), BMI, and quality of life. Figure 1 (section 6.1) summarizes the design of the clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of T2DM (submission of a medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses of T2DM: E11.20, E11.30, E11.40, E11.50, E11.60, E11.72, E11.74, E11.80, E11.90)
* HbA1c value ≥ 7.0% (53 mmol/mol)
* BMI ≥ 23 kg/m2
* Consent to participate
* Sufficient knowledge of the German language

Exclusion Criteria:

* diagnosis of type 1 diabetes mellitus (T1DM)
* change in medication, frequency of use or dosage (planned within 4 weeks before T0 or during the study period)
Help With Early Detection of Postoperative Neuropathic Pain Using SMS After Ambulatory Surgery

Chronic post-operative pain is generally defined by persistent pain more than 2 months after surgery. General reviews on chronic post-operative pain describe an overall incidence of 30%, of which 5 to 10% are described as severe. Different risk factors have been identified: pain and preoperative opioid use, anxiety - depression, catastrophism, type of surgery, intensity and duration of postoperative pain, genetic factors.

If postoperative pain is essentially pain caused by excess nociceptive stimulation, investigators realize that a neuropathic component is far from being exceptional and that this can be demonstrated quickly after surgery. In addition, these neuropathic pains respond little or no to the usual analgesics and in particular to opioids, which can be the cause of misuse or death from overdose. Early detection of pain of a neuropathic nature would allow appropriate therapy to be put in place and may therefore reduce the risk of chronic postoperative pain.

The concept of ambulatory surgery assumes that postoperative pain will be minimal and can be controlled at home by the administration of oral pain relievers. However, following the development of surgical techniques and the improvement in the quality of care, the number and complexity of procedures that can be performed in ambulatory surgery have increased considerably. Consequently, a significant number of patients will probably develop chronic post-operative pain without the possibility of early detection. The prevalence of chronic post-operative pain in ambulatory surgery has been studied by a single team. The authors conclude that it is underestimated and variable depending on the surgery between 15 and 32%.

For the past few years, the GHPSJ has been using an ambulatory surgery algorithm that sends SMS messages to warn and follow up on patients. The principle is simple: patients scheduled for outpatient surgery receive text messages the day before their intervention to remind them of the instructions to be followed and the meeting times and, the day after the operation, the algorithm sends SMS to ask patients if all is well or if they have pain, nausea or vomiting, discharge from the scar. In postoperative monitoring, this technology has shown promising results.

This technology has not been used in the screening of persistent pain. The objective of this work is to assess the effectiveness of an SMS algorithm in the early detection of postoperative neuropathic pain after surgery performed on an outpatient basis.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years
* Patient hospitalized on an outpatient basis within the Paris Saint Joseph Hospital Group in the following different surgical specialties: orthopedics, digestive, vascular, gynecological, plastic and restorative
* French speaking patient
* Patient with smartphone
* Patient affiliated to a social security scheme
* Patient having given oral, free, informed and express consent

Exclusion Criteria:

* Patient under guardianship or curatorship
* Patient deprived of liberty
System Interventions to Achieve Early and Equitable Transplants (STEPS) Study

This project will study how kidney care for everyone despite race can reduce racial differences in care and improve access to kidney transplants, and specifically living donor kidney transplants (LDKT), for individuals with chronic kidney disease. A study focused on equality and patient needs (called 'STEPS') will 1) create a program to identify people who may need a kidney transplant ('STEPS Surveillance') and find people in health systems who may be able to receive kidney transplants early in their care and (2) study how well the 'STEPS Outreach' program works (comprised of transplant social workers and transplant coordinators who focus on equality and patient needs) compared to usual care to improve access to kidney transplants among Black and non-Black individuals as well as to improve access to transplants for everyone.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide oral informed consent
* Male or female, aged 18 to \<=75 years
* Presence of CKD (2 eGFRs \<60, 90 days apart) and at least 1 of the following: most recent eGFR less than 30 or KFRE greater than 10%
* English speaking with adequate ability to hear and understand questions over the phone
* Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Male or female, aged \<18 or \> 75 years
* Non-English speaking
* Lack of ability to hear and comprehend verbal communication.
* Patients on dialysis
* Deceased
* Hospice/palliative care
* Prior kidney transplant
* Currently waitlisted at any transplant center
* Self-reported terminal illness or receipt of hospice services
Validation of Ella Platform for Serum Nfl And GFAP Measures In Multiple Sclerosis Patients

Serum neurofilament-light chain (NfL) and glial fibrillary acidic protein (GFAP) measured by single molecule array (SIMOA) are novel biomarkers of multiple sclerosis patients (MS) activity and progression. Its use is limited due to low availability and high costs. ELLA is a cheaper platform with increasing availability. Recently, we compared SIMOA and ELLA platforms to assess serum NfL levels in 203 MS patients from the OFSEP-HD study. There was a strong correlation (Spearman r = 0.86, p \< 0.0001) between both platforms. As for SIMOA, serum NfL levels measured by ELLA were correlated with age and EDSS and were significantly higher in active MS, suggesting that these assays are equivalent and can be used in any center for routine care. However, the accuracy of local measures acquired with ELLA has not been determined. The aim os this study is to assess the concordance of multi-site ELLA instruments, accuracy of GFAP measures as compared to SIMOA, and the predictive value of NfL and GFAP measured by ELLA in MS.


Eligibility Criteria:
Inclusion Criteria:

* Patients from the OFSEP HD cohort.
* At least one native (no thaw-freeze cycle) serum sample in local or in centralized Biological Resource Center

Exclusion Criteria:

* No bio-collection or insufficient sample volume
* No OFSEP minimal sheet at baseline
Effectiveness of the Routine Use of Extubation Protocol on the Incidence of Occurrence of Failures Number of Extubation in Pediatric Resuscitation

The failure of extubation in pediatric resuscitation is most often described as the need for reintubation within 48 hours after extubation. The failure rate of extubation in pediatric intensive care varies in the literature there is between 4 and 22% failures. These failures result in increased mortality, morbidity with a use of larger tracheostomy, a prolonged residence time. The extubation is codified in adult resuscitation and tends to be increasingly in pediatric resuscitation. In the pediatric intensive care unit of Hautepierre, a extubation protocol already exists for some time, and was prepared to go. the current literature data. It allows the harmonization of practices in service (previously left to the discretion of each doctor).

The investigators are looking to see if the protocol used systematically in the service enables a reduction in the incidence of occurrence of failures of extubation.


Eligibility Criteria:
Inclusion Criteria:

* Children hospitalized in pediatric intensive care, under 18 years, intubated, ventilated for more than 2 hours and for which planning extubation or intubated children for whom an unplanned extubation just happened.
* Children whose holding parental authority are not opposed to the use of clinical data from their child for research purposes.

Exclusion Criteria:

* Refusal to participate in the study
Bioequivalence Study for Acarbose / Metformin FDC

To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI): 18 to 28 kg/m2 (inclusive)
* Results of Glycosylated Hemoglobin A1c (HbA1c) value are within the normal range (4.3-5.6%, inclusive)
* Results of the 75 g oral glucose tolerance test (OGTT) during screening show:

  * Blood glucose before OGTT \<110 mg/dL.
  * Blood glucose 1 hour after glucose loading \<180 mg/dL
  * Blood glucose 2 hours after glucose loading \<140 mg/dL

Exclusion Criteria:

* A history of relevant diseases of internal organs (diabetes mellitus, Ileus, Ileus-like symptoms, diseases that may significantly jeopardize body systems
* Febrile illness within 1 week before drug administration
* Family history of diabetes (within the second degree of relationship)
* Known drug hypersensitivity or idiosyncrasy
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Habitual medication including Chinese herbal drugs
* Intake of any drugs within 2 weeks of drug administration of period 1
* Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form
* Donation of more than 150 mL of blood within 4 weeks before the screening examination
* Participation in another clinical trial within 4 weeks before the screening examination
Effect of Anti-inflammatory Diet in Rheumatoid Arthritis

In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with rheumatoid arthritis, and the role of microbiome and circulating metabolites.


Eligibility Criteria:
Inclusion Criteria:

* Patients with low or moderate disease activity (defined as Clinical Disease Activity Index ≤ 22) and without changes in disease activity or therapy during the previous 3 months, who are interested in dietary intervention, and are able to provide consent and attend to follow up visits.

Exclusion Criteria:

* Pregnancy or lactating. Patients that will become pregnant during the study will be remove from the study.
* Food allergies
* Subjects with significant other comorbidities and /or medication use which in physician's clinical judgment might difficult the interpretation of the results
Clinical Investigation to Assess the Safety and Efficacy of the Laser for the Treatment of Vulvovaginal Atrophy

The purpose of this study is to assess the safety and the efficacy of a laser in the treatment of vulvovaginal atrophy (VVA), that is to assess the change in the severity of the vaginal dryness symptom, by means of a visual analogic scale (10 cm VAS).

The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece. Subjects will receive a total of three (3) treatments every six (6) weeks (+/-1 week). Subjects will return one week (+/- 3 days) post the first treatment, as well as three (3) months (+/- 2 weeks) and twelve (12) months (+/- 2 weeks) post the third treatment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smoking post menopausal women with absence of menstruation of at least 12 months
* Exhibiting VVA symptoms
* Prolapse staged \< II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
* Have not had procedures in the anatomical area through 6 months prior to treatment
* Understand and accept the obligation and is logistically able to present for all scheduled follow-up visits

Exclusion Criteria:

* • Acute or recurrent urinary tract infection (UTI), or genital infection (e.g. herpes candida).

  * Prolapse staged ≥ II, according to the pelvic organ prolapse quantification (ICS-POP-Q) system
  * Any serious disease, or chronic condition, that could interfere with the study compliance
  * Previously undergone reconstructive pelvic surgery
  * Have used vaginal creams, moisturizers, lubricants or homeopathic preparations for at least 3 months
  * A history of thrombophlebitis
  * A history of acute infections
  * A history of heart failure
  * Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti inflammatories within 2 weeks pre treatment
  * Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
  * Taking medications that are photosensitive
  * A history of keloid formation