louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02656251: Efficacy of Two Chlorhexidine Solutions to Control the Initial Subgingival Biofilm Formation
Official title: Efficacy of Two Clorhexidine Formulations to Control the Initial Subgingival Biofilm Formation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Keywords: biofilms
cross over trial
chlorhexidine
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of the study is to compare the effect of a suspension containing chlorhexidine and alcohol and another one containing clorhexidine with no alcohol in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).

Detailed description: This is a double blind, cross over, randomized clinical trial. 35 volunteers will stop mechanical supragingival biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for a minute a Solution containing chlorhexidine and alcohol or a solution with chlorhexidine alcohol-free or placebo. Every 24h the presence of deposits will be registered with special attention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.

Eligibility criteria: Inclusion Criteria:

* age from 18 years;
* non-smokers;
* have good general health;
* present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis.

Exclusion Criteria:

* • positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation;

  * positive history of allergies at using Triclosan;
  * pregnant or lactating patients;
  * patients in use of fixed orthodontic appliance.

Primary outcomes:
measure: Efficacy of two clorhexidine formulations to Control the Initial Subgingival Biofilm Formation assessed by the plaque free zone index.
timeFrame: 24hours
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: University of Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Patricia Weidlich, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01878851: Characterization of Blood Drawn From the Pulp of Primary Molar Undergoing Pulpotomy or Pulpectomy.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Inflammatory Markers
Pulpotomy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 0
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing pulpotomy during regular dental treatment

Brief summary: Following medical history and clinical examination the children which are scheduled for treatment with suspected pulpary involved primary teeth will be selected. During the regular treatment if a pulp of primary teeth is opened and before the regular pulpotomy procedure is performed the blood that is flowing out of the pulp will be collected and stored until analyzed for the present of inflammatory markers. Clinical and radiographic evaluation will be obtained in follow up appointments if the child will remain in regular treatments in our clinic.


Eligibility criteria: Inclusion Criteria:

- Pulpal involved primary teeth with a vital pulp of which a certain amount of blood can be obtained.

Exclusion Criteria:

* systemic disease
* pulp necrosis
* permanent teeth

Primary outcomes:
measure: Detection of specific inflammatory markers
timeFrame: one year
Secondary outcomes:
measure: Pulpotomy failure
timeFrame: 1 year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT03809351: UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy
Official title: UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Alzheimer Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-01-18
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing \[C-11\]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors.


Eligibility criteria: Inclusion Criteria:

1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.
2. Enrollment in the UAB-ADC amyloid-PET substudy under a separate IRB-approved research protocol. The amyloid-PET study does not have to have been completed prior to enrollment and participation in this tau-PET study.
3. Negative urine or serum hCG test within 2 days of \[F-18\]AV-1451 administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.

Exclusion Criteria:

1. Meets any exclusion criteria for the UAB-ADC study.
2. Inability or contraindication for undergoing MRI and/or PET imaging
3. Inability to participate in the imaging studies due to severity of dementia

Primary outcomes:
measure: Measurement of pathological tau deposition in the brain.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
References:
Clinical trial NCT03059251: Observational Study: Safety and Effectiveness of Obinutuzumab in Chronic Lymphocytic Leukemia in Argentina
Official title: An Observational Study of the Safety and Effectiveness of Obinutuzumab in Patients With Chronic Lymphocytic Leukemia Treated in Argentina
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL, obinutuzumab, treatment
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-02-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with chronic lymphocytic leukemia (CLL) who have received the indication for treatment with Obinutuzumab as per routine clinical practice in Argentina.

Brief summary: This observational study aims to study the effectiveness and safety of Obinutuzumab in common clinical practice settings in Argentina. The study population comprises all patients with chronic lymphocytic leukemia (CLL) that have received the indication for treatment with Obinutuzumab as per routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Have received at least one dose of Obinutuzumab as per local label and clinical practice.

Exclusion Criteria:

* Included in clinical trial

Primary outcomes:
measure: Overall Response Rate
timeFrame: Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Complete Response Rate
timeFrame: Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)
measure: Partial Response Rate
timeFrame: Up to 2 months after completion of 6 treatment cycles (up to approximately 8 months)
measure: Progression-free Survival (PFS)
timeFrame: After the completion of treatment, at 12 and 24 months after start of treatment
measure: Median Duration of Response
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Clínica Peuyrredón
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Municipal Teodoro Alvarez
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02907151: Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education
Official title: Evaluation of the Contribution of a Pre-consultation Questionnaire on the Therapeutic Education of Patients on Anticoagulants During a Routine Inspection by the Cardiologist.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Under Oral Anticoagulation Patients
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients scheduled for cardiac consultation treated with oral anticoagulation

Brief summary: To assess the value of a dedicated knowledge questionnaire, filled by the patient prior consultation. Indeed, it could allow to target specific shortcomings of patients first, and help the cardiologist to prioritize the other therapeutic education, targeting specifically the information provided.

Detailed description: The main objective is to study the impact of a pre-consultation questionnaire on the knowledge gained by the patient on anticoagulant treatment at the exit of cardiology consultation.

The assumption is that this questionnaire would help educate patients about their shortcomings and educate cardiologists lack of knowledge of his patient.

The secondary objectives are :

* Target specific areas in which patients have the greatest lack of information
* Assess the impact of educational level on information
* Assess the impact of age on information
* Evaluate the satisfaction of the information delivered
* Assess patient anxiety vis-à-vis their treatment
* Evaluate the failure rate of the questionnaire to know the number of patients refusing to participate in the study

Eligibility criteria: Inclusion Criteria:

* Patient monitoring Cardiology Consultation at University Hospital of Montpellier, whatever the reason
* Patients on oral anticoagulant therapy (warfarin or AOD) for over a month.

Exclusion Criteria:

* Severe cognitive disorders, making it impossible to understand the patient on therapeutic education.
* Disorders of the important vision.

Primary outcomes:
measure: number of correct answers
timeFrame: 3 months
Secondary outcomes:
measure: Score information
timeFrame: 3 months
measure: Score on the provision of additional information
timeFrame: 3 months
measure: anxiety score
timeFrame: 3 months
measure: Score information based on subgroups
timeFrame: 3 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Leclercq
Study officials:
affiliation: University Hospital, Montpellier
name: Florence Leclercq, MD PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00378651: Use of the Stethoscope to Confirm Breathing Tube Placement
Official title: Differentiation Between Esophageal and Tracheal Intubation Utilizing Neck Auscultation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Endotracheal
Keywords: Intubation, Endotracheal
Anesthesia, General
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2006-09-20
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is intended to validate the use of neck auscultation with an electronic stethoscope during intubation to confirm tracheal tube placement.

It is hypothesized that the ability to confirm correct tube placement with this technique will be similar to that of the end-tidal CO2 monitor, the current gold-standard device for confirming tracheal intubation.

Detailed description: Unrecognized esophageal intubation results in disastrous consequences. Fortunately, a variety of techniques have been cited to confirm placement of the endotracheal tube. However, even end-tidal CO2 monitoring, considered to be the gold standard, has been associated with false positive and false negative results. In addition, use of this monitor requires ventilation through the tube, resulting in gastric distention if the esophagus has been intubated.

When the lateral neck is auscultated during insertion of an endotracheal tube, there is a distinct difference between the sounds generated by a tube placed in the esophagus compared to a tube inserted into the trachea. Stethoscopes are readily available in any OR setting, and ventilation and release of cricoid pressure need not occur prior to confirmation of tube placement. However, this technique has yet to be validated.

A series of sounds heard at the lateral neck during both tracheal and esophageal intubation will be recorded using an electronic stethoscope. These sound files will be played to a group including both experienced and inexperienced intubators, who will be asked to identify which sounds represent tracheal and esophageal intubation. Overall accuracy will be determined for the group of listeners.

Eligibility criteria: Inclusion Criteria:

* Elective surgery requiring general anesthesia with endotracheal intubation

Exclusion Criteria:

* Anticipated difficult intubation
* Contraindication to esophageal intubation

Primary outcomes:
measure: Group accuracy: Correct identification of tube placement based on series of 30 sound files
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: St. Boniface General Hospital
state: Manitoba
Study officials:
affiliation: Department of Anesthesia, University of Manitoba
name: Wei-Shuen Tan, BSc(Hon), MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Boniface Hospital
name: Chris Christodoulou, MBCHB, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01867151: Effect of Gluten Free Diet in Patients With Burning Mouth Syndrome
Official title: Effetto Della Dieta Priva di Glutine in Soggetti Con BMS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burning Mouth Syndrome
Keywords: Burning Mouth Syndrome
Gluten
Gluten Free Diet
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2013-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gluten free diet (GFD) is now being tested in patients affected by schizophrenia, autism and multiple sclerosis, making GFD a possible therapeutic weapon not only for celiac disease or gluten sensitivity. In this protocol we investigate the effect of GFD in patients affected by burning mouth syndrome (BMS), a disease of unknown origin characterized by oral and especially tongue burning sensation, deeply decreasing the quality of life of patients


Eligibility criteria: Inclusion Criteria:

-Primary BMS

Exclusion Criteria:

* Celiac Disease
* Psychiatric Disorders
* intestinal autoimmune diseases
* Ongoing cancer

Primary outcomes:
measure: oral pain
timeFrame: 28 days
Secondary outcomes:
measure: Quality of Life
timeFrame: 28 days
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda
Study officials:
affiliation: Fondazione IRCCS Cà Granda
name: Luca Elli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01471951: Single Human Embryo Transfer in Assisted Reproduction Programs
Official title: Single Human Embryo Transfer: Comparison of Morphologic and Morphometric Parameters for Day 2 Embryo Selection Before Transference.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Multiple Pregnancies
Lead sponsor: Fundacion Para La Investigacion Hospital La Fe
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Embryo selection based on the use of morphometric parameters should increase the implantation success rate.

One of the most important issues of "Assisted Reproduction Technologies (ART)" is the possibility of multiple pregnancies which carries a significant risk for maternal-fetal health. These risks can be reduced by restricting the number of embryos transferred.

To do this, it is essential to improve current techniques of embryo selection by developing new tools that would allow the selection of the embryos with higher implantation potential. In previous works (Molina et al 2011) the investigators have demonstrated greater efficacy for the embryo classification systems based on the use of the morphometric variables. The investigators have also developed a profile of embryo implantation using these morphometric variables. In this project the investigators intend to validate the clinical validity of this new embryo classification system by conducting a prospective study of single embryo transfer (SET) in young women at risk of multiple pregnancies.


Eligibility criteria: Inclusion Criteria:

* Personal and family history without interest, not toxic habits.
* Less than 35 years at the time of IVF-ICSI cycle
* Sterility of unknown origin or tubal obstruction.

Exclusion Criteria:

* Repeat nonvoluntary abortions
* Endometriosis
* Polycystic ovary syndrome (criteria Rotterdam 2004)
* Severe male factor (REM \<1 million sperm / ml)

Primary outcomes:
measure: Implantation rate
timeFrame: 6 weeks after the embryo transference
Secondary outcomes:
measure: Morphologic embryo selection
timeFrame: 48 hours post insemination (day 2)
measure: Morphometric embryo selection
timeFrame: 48 hours post insemination (day 2)
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitari La Fe
Study officials:
affiliation: Director of the deparment of Biología Funcional y Análisis de Imagen
name: Jose J Pertusa, Ph.D.
role: STUDY_CHAIR
affiliation: Head of Gynecology and Obstetrics
name: Antonio A Pellicer, Ph.D.
role: STUDY_DIRECTOR
affiliation: Embryologist of the Human Reproduction Unit
name: Inmaculada I Molina, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03623451: Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to Polycystic Ovary Syndrome
Official title: Serum Metabolomics Study of Traditional Chinese Medicine Formula （Shen Qi Tiao Ti Formula） Intervention to Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 105
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Polycystic ovary syndrome (PCOS) is a most common, heterogeneous, complex endocrinopathy disease.Traditional Chinese medicine (TCM) has been used in the treatment of PCOS for many years. However, the mechanism underlying TCM remains obscure and challenging.In the present study, a metabolomics approach based on ultra-high-performance liquid chromatography (UPLC) coupled with linear ion trap Orbi-trap mass spectrometer (LTQ Orbi-trap MS) is used to investigate serum metabolic changes of TCM intervention to PCOS.


Eligibility criteria: Inclusion Criteria:

* PCOS diagnostic criteria: According to the diagnostic criteria revised by the European Society of Human Reproduction and Embryology and the American Society for Reproductive Medicine at the Rotterdam in 2003, PCOS patients can be diagnosed if two of the three criteria are present after excluding congenial adrenal hyperplasia, Cushing's syndrome, androgen secreting tumors, or other related disorders. The three criteria are (1) oligo- and/or anovulation; (2) clinical and/or biochemical signs of hyperandrogenism (clinical manifestations of hyperandrogenism include presence of acne, hirsutism, and androgenic alopecia); (3) polycystic ovaries by ultrasound examination: presence of 12 or more follicles in each ovary measuring 2-9 mm on diameter and/or ovarian volume\>10 ml.
* Age between 14 and 40 years.
* 2 years after menarche

Exclusion Criteria:

* Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
* Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
* Patients with known severe organ dysfunction or mental illness.

Primary outcomes:
measure: The fatty acid amides (FAAs) metabolite changes
timeFrame: 3 months
Secondary outcomes:
measure: The sulfated steroids metabolite changes
timeFrame: 3 months
Other outcomes:
Locations:
city: Harbin
country: China
facility: First Affiliated Hospital, Heilongjiang University of Chinese Medicine
state: Heilongjiang
Study officials:
References: