louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03730766: Analysis of the Impact of Helicobacter Pylori on Salivary Microbiome in Adults
Official title: Analysis of the Impact of Helicobacter Pylori Infection and Eradication on Salivary Microbiome in Adults by 16S Pyrosequencing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: helicobacter pylori, saliva microbiota
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Helicobacter pylori (H. pylori), a bacteria transmitted from human to human through upper digestive tract as well as fecal-oral transmission, had infected more than half of people around the world. However, the quantity of H. pylori in oral cavity and its influence on oral microbiota remains to be unclear. The aim of the present study was to examine the effects of H. pylori infection as well as its eradication on oral microbiota.


Eligibility criteria: Inclusion Criteria:

* Participants with non-ulcer functional dyspepsia or peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* Received both endoscopy and 13C urea breath test (13C-UBT) before enrolled

Exclusion Criteria:

* Less than 18 years old
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
* The use of antibiotics or PPI within 2 months before the study
* The presence of dental carious or any untreated cavitated carious lesions and oral abscesses

Primary outcomes:
measure: Change of saliva microbiota after eradication
timeFrame: Two months after completion of therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Hong Lu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ji Y, Liang X, Lu H. Analysis of by high-throughput sequencing: Helicobacter pylori infection and salivary microbiome. BMC Oral Health. 2020 Mar 20;20(1):84. doi: 10.1186/s12903-020-01070-1.
Clinical trial NCT04980066: Evaluation of Sticky Bone With or Without EDTA for Treatment of Gingival Recession
Official title: Evaluation of Sticky Bone With or Without EDTA Root Surface Biomodification for Treatment of Gingival Recession: Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gingival Recession
Keywords: i-PRF
EDTA
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Gingival recession is a common clinical finding in periodontal disease which is frequently associated with esthetic concerns, root hypersensitivity, and root caries. Many surgical therapeutic approaches have been developed to predictably obtain root coverage of gingival recession defects. Injectable PRF (I-PRF) is the liquid form of PRF. I-PRF is a bioactive agent obtained by low-speed centrifugation, and it has the capacity to stimulate tissue regeneration. At high concentrations, PRF may stimulate the secretion of several growth factors and trigger fibroblast migration. I-PRF is generally used in regenerative treatments, with good outcomes. Ethylenediaminetetraaceti acid (EDTA) is a chelating agent that could enhance the attachment of connective tissue to the root surface by exposing collagen and, as a consequence, enhance root coverage. EDTA works at neutral pH, and this property has been reported to preserve adjacent tissue vitality. The present study will be carried out to evaluate the effect of sticky bone with or without EDTA root surface biomodification for treatment of gingival recession.


Eligibility criteria: Inclusion Criteria:

* Miller I/II isolated maxillary recession defects.
* No abrasion, caries, or cervical restorations and presence of identifiable cementoenamel junction (CEJ).
* No occlusal interferences.
* Full-mouth plaque index (PI) and gingival index (GI) scores of \< 1.
* Non-smokers.

Exclusion Criteria:

* Pregnant patients
* Presence of systemic disease or taking medication that interfere with periodontium

Primary outcomes:
measure: clinical evaluation of root coverage
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr El-sheikh
country: Egypt
facility: Faculty of Dentistry, Kafrelsheikh University
Study officials:
affiliation: Kafrelsheikh University
name: Dalia R Issa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364766: Continuous Glucose Monitor Use in School
Official title: The Impact of Continuous Glucose Monitor Use in the Classroom/School Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone with diabetes mellitus who is wearing a continous glucose sensor and is in school.

Brief summary: The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. We will be asking the subject,subject's parent and subject's teachers to complete a short survey/questionnaire. The survey will take approximately 10-15 minutes.

Detailed description: The purpose of this study is to find the impact of continuous blood glucose sensors use in the classroom/school environment. Recent technological advancements in diabetes management have resulted in increased use of devices during class/school. Although many studies have examined the quality of life and the impact on the family and subject of these devices, to our knowledge this is the first study that will examine the impact of the continuous glucose monitor during class/school. To our knowledge, this is first study to involve the teachers. The results of this study is particularly important since the future of diabetes therapy will be to use continuous glucose monitors and insulin pumps to develop a closed loop system of insulin therapy or "artificial pancreas."

Eligibility criteria: Inclusion Criteria:

Diabetes use continuous glucose monitor in school

Exclusion Criteria not using a continuous glucose monitor

Primary outcomes:
measure: CGM usefulness score
timeFrame: 1 yr
Secondary outcomes:
measure: Diabetes Comfort score
timeFrame: 1 yr
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Tandy Aye MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benassi K, Drobny J, Aye T. Real-time continuous glucose monitoring systems in the classroom/school environment. Diabetes Technol Ther. 2013 May;15(5):409-12. doi: 10.1089/dia.2012.0314. Epub 2013 Mar 26.
Clinical trial NCT05388266: Effect of Paratracheal Pressure on Mask Ventilation
Official title: Effect of Paratracheal Pressure on Mask Ventilation in Anesthetized Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study aims to evaluate the effect of paratracheal pressure on mask ventilation in anesthetized obese patients in terms of expiratory tidal volume, and peak inspiratory pressure.


Eligibility criteria: Inclusion Criteria:

* Adult patients with a body mass index ≥ 30 kg.m-2 undergoing general anesthesia for elective surgery

Exclusion Criteria:

* Structural abnormalities or diseases in the face, neck, upper airway, or esophagus
* Increased risk of aspiration (pregnancy)
* Carotid artery stenosis, cerebrovascular disease

Primary outcomes:
measure: Expiratory tidal volume
timeFrame: For 2 min of mask ventilation after the induction of anesthesia
Secondary outcomes:
measure: Peak inspiratory pressure
timeFrame: For 2 min of mask ventilation after the induction of anesthesia
measure: Inadequate tidal volume
timeFrame: For 2 min of mask ventilation after the induction of anesthesia
measure: Incidence of hypoxia
timeFrame: For 2 min of mask ventilation after the induction of anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Government Seoul National University Boramae Medical Center
Study officials:
References:
Clinical trial NCT03789266: Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique
Official title: Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Hip Arthroplasty
Drain Insertion Site
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison of ablation technique of drains


Eligibility criteria: Inclusion Criteria:

1. Patients admitted to the orthopedic surgery department for surgery for a total hip arthroplasty
2. Signed inform consent form

Exclusion Criteria:

1. Drain in non-aspirating mode at the time of medical ablation prescription
2. Administration of analgesic III in the 12 hours preceding the inclusion

Primary outcomes:
measure: Evaluate the pain felt by the patients at the time of the removal of the drain, using the pain visual analogue scale
timeFrame: 20 minutes
Secondary outcomes:
measure: Presence of haematoma after ablation
timeFrame: Day 2 post ablation
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Mylène BONNAIRE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00310466: Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever
Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled Parallel Group Clinical Trial to Investigate the Efficacy and Safety of Specific Sublingual Immunotherapy With SLITone Birch in Patients With Seasonal Birch Pollen Induced Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2006-04-04
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

Detailed description: Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events

Eligibility criteria: Inclusion Criteria:

* A history of birch pollen allergy
* Positive skin prick test to birch
* Positive conjunctival test to birch
* Positive specific Immunoglobulin E (IgE) to birch

Exclusion Criteria:

* Forced expiratory volume in 1 second (FEV1)\<70% of predicted value
* History of seasonal allergy interfering with study
* History of symptomatic perennial allergy
* History of emergency visit or admission for asthma in the previous 12 month

Primary outcomes:
measure: Daily Rhinoconjunctivitis Symptom Score
timeFrame: Birch pollen season 2006
measure: Daily Rhinoconjunctivitis Rescue Medication Score
timeFrame: Birch pollen season 2006
Secondary outcomes:
measure: Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects
timeFrame: Birch pollen season 2006
measure: Adverse Events
timeFrame: Birch pollen season 2006
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Klinik für Dermatologie, Venerologie und Allergologie
Study officials:
affiliation: ALK-SCHERAX Arzneimittel GmbH
name: Hendrik Wolf, PhD
role: STUDY_DIRECTOR
affiliation: Charite University, Berlin, Germany
name: Margitta Worm, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01961466: Diabetes and Psychological Profile
Official title: Prospective Study on the Influence of Psychosocial Variables (Stress, Type A Behaviour Pattern, Quality of Life of the Diabetic) on Glycemic Balance in Patients With Type 1 and 2 Diabetes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 or 2 Diabetes
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 592
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 or 2 Diabetes

Brief summary: This study is based on the analysis of psychological and social questionnaires filled in by diabetic patients whose glycemic balance will be assessed by measuring blood levels of glycated haemoglobin. The aim is to compare glycemic balance by measuring HbA1c in diabetic patients (type 1 and 2) according to whether they have a Type A or B psychosomatic profile evaluated by the Bortner self-questionnaire.


Eligibility criteria: Inclusion Criteria:

* patients who have been given information about the research
* patients with National Health Insurance
* diabetic patients (type 1 or 2)
* patients \> 18 ans

Exclusion Criteria:

* Adult patients under guardianship or intellectually dependent
* patients without National Health Insurance

Primary outcomes:
measure: Correlations between glycemic balance (HbA1c) and the score on the Bortner self-questionnaire
timeFrame: At 1 year
Secondary outcomes:
measure: Scores on the scales
timeFrame: At 1 year
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon
Study officials:
References:
Clinical trial NCT01081366: Drug Eluting Pantera Lux Catheter Registry
Official title: Evaluation of the Safety Profile of the Pantera Lux Paclitaxel Releasing Balloon for Coronary Arteries in Daily Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2010-03-05
Enrollment: 1064
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All comers registry. Patients treated with the Pantera Lux Paclitaxel releasing balloon catheter are enrolled consecutively to represent a typical set of patients at each site.

Brief summary: All comers registry - Evaluation of the safety and efficacy of the Pantera Lux Paclitaxel releasing balloon for coronary arteries in daily clinical practice.

Detailed description: All patients are treated with the Pantera Lux Paclitaxel releasing balloon.

Clinical follow ups at 1, 6 and 12 months after coronary intervention.

Eligibility criteria: Inclusion criteria:

* Signed Patient Informed Consent / Data Release Form
* Patient eligible for percutaneous coronary intervention (PCI)
* Patient is older than 18 years of age

Exclusion Criteria

* Patient has a known allergy against appropriate anticoagulation / antiplatelet therapy
* Patients with known allergy against paclitaxel or BTHC
* Patients with a target lesion that was previously treated by brachytherapy
* Pregnant woman or lactating woman

Primary outcomes:
measure: Major Adverse Cardiac Events (MACE)
timeFrame: 6 M
Secondary outcomes:
measure: MACE
timeFrame: 12 M
measure: All MACE
timeFrame: 1, 6, and12 M
measure: Clinically driven TVR
timeFrame: 1, 6 and 12 M
measure: Acute success
timeFrame: Post procedure
Other outcomes:
Locations:
city: Bad Segeberg
country: Germany
facility: Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH
Study officials:
affiliation: Herz-Kreislauf-Zentrum, Segeberger Kliniken GmbH, Am Kurpark 1, 23795 Bad Segeberg, Germany
name: Raph Toelg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toelg R, Merkely B, Erglis A, Hoffman S, Bruno H, Kornowski R, Slagboom T, Naber C, Witzenbichler B, Graf K, Richardt G, Hehrlein C; DELUX investigators. Coronary artery treatment with paclitaxel-coated balloon using a BTHC excipient: clinical results of the international real-world DELUX registry. EuroIntervention. 2014 Sep;10(5):591-9. doi: 10.4244/EIJV10I5A102.
Clinical trial NCT03273426: Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.
Official title: Prediction of Pathologic Complete Response by Multiple Core Needle Biopsy or Vacuum Assisted Biopsy Before Surgery in Breast Cancer With Complete Clinical Response After Neoadjuvant Chemotherapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of pathological findings for residual tumor between minimally-invasive biopsy procedure and subsequent wide excision of the biopsied area
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the ability of preoperative biopsy to predict correctly pathologic complete response in breast cancer patients with complete clinical response after neoadjuvant chemotherapy.

Detailed description: Breast cancer patients who received neoadjuvant chemotherapy and is predicted to have achieved pathologic complete response (pCR) on MRI will enrolled. The enrolled patients will undergo either US-guided multiple core needle biopsy or US-guided vacuum-assisted biopsy of the tumor bed where it had been marked with an indicator (clip). The patient will undergo subsequent wide excision of the tumor bed. Histopathologic findings of the biopsy and the surgical specimen will be compared for pCR, and the ability of preoperative biopsies to predict pCR will be evaluated.

Eligibility criteria: Inclusion Criteria:

Patients

* with unilateral primary cancer pathologically confirmed before neoadjuvant chemotherapy (NAC)
* who received NAC
* with detectable lesion / clip marker on ultrasound
* with cT1-T3 tumors
* clinical and imaging complete or near-complete response on MRI
* with informed consent

Exclusion Criteria:

* Multifocal cancer
* Residual microcalcification
* Contralateral breast cancer

Primary outcomes:
measure: Negative Predictive Value
timeFrame: 2 weeks
Secondary outcomes:
measure: False Negative Rate
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Wonshik Han, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfob A, Sidey-Gibbons C, Lee HB, Tasoulis MK, Koelbel V, Golatta M, Rauch GM, Smith BD, Valero V, Han W, MacNeill F, Weber WP, Rauch G, Kuerer HM, Heil J. Identification of breast cancer patients with pathologic complete response in the breast after neoadjuvant systemic treatment by an intelligent vacuum-assisted biopsy. Eur J Cancer. 2021 Jan;143:134-146. doi: 10.1016/j.ejca.2020.11.006. Epub 2020 Dec 8.
Clinical trial NCT02298426: Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population
Official title: Body Constitution Classification Based Comprehensive Health Management Intervention on Obese Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Keywords: Body Constitution Classification
Health Management
Obese Population
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 1452
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population.

Detailed description: This study aims to explore the effectiveness of body constitution classification based comprehensive health management intervention on obese population, compare the differences in effectiveness between body constitution classification based management vs usual health management, and explore the influence of different food composition on the effectiveness of body constitution classification based comprehensive health management intervention on obese population.

Eligibility criteria: Inclusion Criteria:

* Social characteristics:

  * 20-55 year old,
  * had lived in a city for more than one year,
  * kept a watchful eye on losing weight or bodybuilding,
  * practitioner engaged in non- sensitive sectors.
* Physiological characteristics:

  * met the obesity diagnostic criteria suggested by "Prevention and control Guidelines for overweight and obesity of Chinese adults in 2006". Subjects with a BMI between 24 to 28 kg/m2 were defined as overweight, while those with a BMI greater than 28kg/m2 were obese.
  * met the constitution classification standards of Traditional Chinese Medicine. According to the constitution questionnaire formulated on the base of the Chinese Medical Association standard "Chinese constitution classification and determination" (ZYYXH/T157-2009), the subjects were divided into phlegm-damp type, qi deficiency type and phlegm stasis block type.

Exclusion Criteria:

* with the following major organic disease,
* secondary obesity caused by diseases,
* none of phlegm-damp type, qi deficiency type or phlegm stasis block type,
* women who were planning to become pregnant, pregnant or lactating.

Primary outcomes:
measure: BMI
timeFrame: Baseline,1year
Secondary outcomes:
measure: Body fat percentage
timeFrame: Baseline,1year
measure: Fatty liver
timeFrame: Baseline,1year
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University Health Science Center
state: Beijing
Study officials:
affiliation: Peking University
name: Jun Ma
role: PRINCIPAL_INVESTIGATOR
References: