louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02753153: Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®
Official title: Extraction Socket Management Using Connective Tissue Graft Versus Mucograft®: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tooth Lost
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at assessing the hard and soft tissues remodelling of the alveolar crest after extraction socket managements in the aesthetic areas:

* 3D radiographic evaluation (CT scan) was performed post extraction and 3 months after at the time of implant placement. (Outcomes 1: Hard tissues analyses )
* Impressions, models and 3D analyses of the treated area allowed studying external soft tissue remodeling at different time points after extraction. (Outcomes 2: Soft tissues analyses )


Eligibility criteria: Inclusion Criteria:

* Patients needing an extraction in the aesthetic area to be replace with an implant (incisive, canine or premolar)
* Good general health (ASA 1, 2)
* Controlled periodontitis
* No age restriction

Exclusion Criteria:

* Extraction socket with buccal bone defect / buccal bone wall dehiscence
* Smokers \> 10 cigarettes per day
* Immune system disease
* Bone disease or treatment by medicines interfering with bone metabolism

Primary outcomes:
measure: Bone remodeling of the buccal and palatal walls using radiographic measurements
timeFrame: 1year
Secondary outcomes:
measure: Soft tissue contours measurements by 3D image analyses.
timeFrame: 6months
Other outcomes:
measure: Explants will be analyzed by X-ray computed microtomography
timeFrame: 1year
measure: Explants will be processed for non-decalcified histology using polymethacrylate (PMMA) resin
timeFrame: 1year
measure: Bone formation histomorphometric evaluation using a semiautomatic image analyzer
timeFrame: 1year
Locations:
Study officials:
References:
Clinical trial NCT01343953: Cord Blood Transplantation in Severe Aplastic Anemia
Official title: A Prospective Phase II Study to Evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse After Immunosuppressive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hereditary Diseases
Acquired Aplastic Anemia
Relapse
Absence of an HLA Identical Donor
Keywords: severe aplastic anemia
cord blood transplantation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 26
Sex: ALL
Minimum age (years): 3
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in the absence of an HLA identical donor;

Detailed description: This is a Prospective Phase II Study to evaluate Cord Blood Transplantation in Inherited or Acquired Severe Aplastic Anemia Refractory or in Relapse after Immunosuppressive Therapy in the absence of an Human Leucocyte Antigen (HLA) identical donor; 26 patients will be recruited, according to a one step Fleming design

Eligibility criteria: Inclusion Criteria:

* Age: 3-55 years old
* inherited aplastic anemia (with severe aplastic anemia criteria) or acquired aplastic anemia in relapse or treatment failure after immunosuppressive therapy without clonal evolution
* Karnovsky Index \>= 60%
* Informed consent

Exclusion Criteria:

* HLA identical donor

Primary outcomes:
measure: Overall survival
timeFrame: 1 year
Secondary outcomes:
measure: Graft versus host disease
timeFrame: 2 years
measure: Infectious episodes
timeFrame: 1 year
measure: treatment related mortality
timeFrame: 100 days
measure: overall survival
timeFrame: 5 years
measure: adverse events
timeFrame: 1 year
measure: karnofsky scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: saint Louis
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Regis Peffault de la Tour, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peffault de Latour R, Chevret S, Jubert C, Sirvent A, Galambrun C, Ruggeri A, Gandemer V, Cornillon J, Rialland F, Dalle JH, Forcade E, Bruno B, Paillard C, Rorlich PS, Salmon A, Furst S, Sicre de Fontbrune F, Rubio MT, Bay JO, Mohty M, Larghero J, Gluckman E, Socie G; Francophone Society of Bone Marrow Transplantation and Cellular Therapy. Unrelated cord blood transplantation in patients with idiopathic refractory severe aplastic anemia: a nationwide phase 2 study. Blood. 2018 Aug 16;132(7):750-754. doi: 10.1182/blood-2018-01-829630. Epub 2018 May 14.
Clinical trial NCT00835653: Efficacy of Median Nerve Block Performed Using Echographic Guidance
Official title: Efficacy of Median Nerve Block Performed Using Echographic Guidance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Orthopedic
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2009-02-03
Enrollment: 70
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: patients scheduled for hand surgery

Brief summary: Observational study of the efficacy of median nerve blocks performed using echographic guidance in patients presenting with or without carpal tunnel syndrome.


Eligibility criteria: Inclusion Criteria:

* short surgical procedure (less than 30 minutes) on the hand,
* regional anesthesia at the elbow involving the median nerve.

Exclusion Criteria:

* age less than 18 years,
* pregnant woman
* mental incapacity,
* poor understanding of French.

Primary outcomes:
measure: light touch sensibility
timeFrame: 30 minutes following block performance
Secondary outcomes:
measure: ice touch sensibility
timeFrame: 30 minutes following block performance
measure: motor block
timeFrame: 30 minutes following block performance
measure: paresthesia
timeFrame: during nerve block procedure
measure: vascular puncture
timeFrame: during nerve block procedure
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
city: Trappes
country: France
facility: Hôpital Privé de l'Ouest Parisien
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01571453: Study of Vortioxetine (Lu AA21004) in Major Depressive Disorder in Asian Countries
Official title: Randomised, Double-blind, Parallel-group, Active-comparator (Venlafaxine Extended Release), Fixed-dose Study of [Vortioxetine] Lu AA21004 in Major Depressive Disorder in Asian Countries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: MDD
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 437
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: This study will be conducted with the aim of investigating the efficacy, safety and tolerability of 10 mg/day Vortioxetine in Asian patients compared to an approved active comparator (venlafaxine extended release 150 mg/day).


Eligibility criteria: Inclusion Criteria:

* The patient suffers from recurrent MDD as the primary diagnosis according to DSM-IVTR™ criteria. The current Major Depressive Episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI)
* The patient has a MADRS total score ≥26
* The patient has a CGI-S score ≥4
* The reported duration of the current MDE is ≥3 months.

Other inclusion criteria may apply.

Exclusion Criteria:

- The patient meets any of the exclusion criteria listed in the protocol or, in the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any reason.

Primary outcomes:
measure: Change From Baseline in MADRS Total Score at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Change in CGI-S Score From Baseline to Week 8
timeFrame: Baseline and Week 8
measure: CGI-I Score at Week 8
timeFrame: Week 8
measure: Change in HAM-A Total Score From Baseline to Week 8
timeFrame: Baseline and Week 8
measure: MADRS Response at Week 8 (Response Defined as a ≥50% Decrease in the MADRS Total Score From Baseline)
timeFrame: Week 8
measure: Remission at Week 8 (Remission Defined as a MADRS Total Score ≤10)
timeFrame: Week 8
measure: Number of Adverse Events
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Wang G, Zhao K, Reynaud-Mougin C, Loft H, Ren H, Eriksen HF, Ettrup A. Successfully treated patients with vortioxetine versus venlafaxine: a simplified cost-effectiveness analysis based on a head-to-head study in Asian patients with major depressive disorder. Curr Med Res Opin. 2020 May;36(5):875-882. doi: 10.1080/03007995.2020.1723072. Epub 2020 Feb 13.
citation: Wang G, Gislum M, Filippov G, Montgomery S. Comparison of vortioxetine versus venlafaxine XR in adults in Asia with major depressive disorder: a randomized, double-blind study. Curr Med Res Opin. 2015 Apr;31(4):785-94. doi: 10.1185/03007995.2015.1014028. Epub 2015 Feb 19.
Clinical trial NCT06658353: Phase III Clinical Study of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors
Official title: Single-arm, Open, Multi-center Phase III Clinical Study to Assess the Safety and Effectiveness of VC004 in Patients With Localized Advanced/ Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Locally Advanced Solid Tumor
Lead sponsor: Jiangsu vcare pharmaceutical technology co., LTD
Sponsor class: INDUSTRY
First posted: 2024-10-26
Enrollment: 54
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Study is a single arm, open label, multicenter phase III clinical trial to evaluate the safety and efficacy of VC004 in patients with locally advanced/metastatic solid tumors.


Eligibility criteria: Inclusion Criteria:

* All subjects or legal representatives are willing and able to sign ICF approved by the ethics committee before starting any screening procedures；
* Male or female, age ≥12 years old;

Exclusion Criteria:

* Patients have undergone major surgery within 4 weeks prior to the first dose or are expected to undergo major surgery during the trial (excluding vascular access establishment procedures, biopsy procedures);
* Adverse reactions caused by previous treatment have not recovered to ≤1 grade (evaluated by the investigator);
* Patients had been treated with a strong CYP3A inhibitor or inducer within 7 days prior to the first administration of the study drug.

Primary outcomes:
measure: Objective response rate(ORR)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
name: yuankai Shi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06585553: Atrophic Gastritis and OLGIM Stage
Official title: Patients with Intestinal Metaplasia in the Lesser Curvature of the Gastric Corpus Require OLGIM Staging: a Secondary Analysis of a Prospective Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intestinal Metaplasia
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 2121
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who receive the gastrointestinal endoscopy examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study

Brief summary: Three clinical research coordinators recruited patients aged 40-75 who underwent screening endoscopy at the Digestive Endoscopy Center of Qilu Hospital from July 1, 2022, to July 30, 2024. All participating patients provided written informed consent. Baseline information such as height, weight, age, sex, smoking and alcohol consumption status, HP status, and family history of gastrointestinal tumors were recorded before endoscopy. During endoscopy, the endoscopist observed and photographed the lesser and greater curvature of the antrum, corpus, and incisura, performed the Kimura-Takemoto classification, and classified those with a Kimura-Takemoto score of C0 as non-atrophic gastritis and those with C1-O3 as atrophic gastritis. Patients with atrophic gastritis received free multiple-site biopsies for pathological assessment, including targeted biopsies of suspected IM areas and random biopsies from Sydney classification sites. At least four biopsies were taken from the lesser and greater curvature of the antrum and corpus for pathological evaluation, and OLGIM staging was calculated based on the results.


Eligibility criteria: Inclusion Criteria:

Inclusion criteria were patients aged 40-75 undergoing painless screening endoscopy

Exclusion Criteria:

1) previous gastric surgery; 2) inability to undergo biopsy due to anticoagulant use; 3) refusal to sign informed consent; 4) history of radiotherapy or chemotherapy; 5) new diagnosis of advanced gastric cancer during endoscopy; 6) failure to complete multiple-site biopsy for atrophic gastritis; and 7) diagnosis of non-atrophic gastritis during endoscopy.

Primary outcomes:
measure: Diagnostic Performance of IM at Different Sites
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT00454753: Expanded Access for Dasatinib
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-04-02
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an expanded access designed to provide access to dasatinib for eligible participants.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb, Korea
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05984953: Rosuvastatin and Evolocumab for Coronary Artery Disease
Official title: Effect of Statins and Evolocumab on Peripheral Blood Mononuclear Cell Gene Expression in Patients With Coronary Artery Disease: Yellow V
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with coronary artery disease who underwent cardiac catheterization with or without PCI

Brief summary: The aim of the retrospective study is to characterize the molecular mechanisms responsible for the effect of statins and evolocumab in patients with stable coronary artery disease. The research team will retrieve and review intravascular imaging and gene expression data previously collected in the catheterization laboratory during the following time-period: 8/1/2013-4/14/2015 and 5/4/2021 - 10/28/2022.

Detailed description: The researchers will use the previously collected transcriptomic and intravascular imaging data collected from subjects between 8/1/2013-4/14/2015 (statin group) and subjects who participated in YELLOW III study (evolocumab group). The analyses will allow us detect common and unique pathways for each drug. The researchers will use intravascular imaging findings (optical coherence tomography, OCT) to characterize patient's individual response to treatment as beneficial, if OCT fibrous cap thickness (FCT) increased at follow-up and develop machine-learning models to predict the individual response using baseline gene expression.

The researchers hypothesize that the analyses will uncover unique gene panels predicting beneficial response to statin and evolocumab allowing to select the best treatment approach for an individual patient. The total number of subjects will be 195. Transcriptomic profile of PBMC at baseline and follow-up will be compared between the groups to establish the common and distinctive molecular mechanisms of the effect of statins and evolocumab.

Eligibility criteria: Inclusion Criteria:

* Subjects with coronary artery disease who underwent cardiac catheterization with or without PCI
* Patients from 8/1/2013-4/14/2015 and YELLOW III with both visits available, baseline and follow-up

Exclusion Criteria:

* patients from 8/1/2013-4/14/2015 and YELLOW III lost to follow-up

Primary outcomes:
measure: Expression levels of mRNA in blood cells
timeFrame: 18 month
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Annapoorna Kini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00966953: Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Official title: Development of Clinical Method to Determination Triclosan Retention in Plaque Following Brushing.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingival Diseases
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2009-08-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment


Eligibility criteria: Inclusion Criteria:

* Male or female volunteers 18-65 years of age.
* Good general health.
* Must sign informed consent form.
* Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Medical condition which requires pre-medication prior to dental procedures/visits.
* Medical condition which precludes eating/drinking for 12 hrs.
* History of allergy to common dentifrice ingredients.
* Subjects unable or unwilling to sign the informed consent form.
* Moderate or advanced periodontal disease.
* Two or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that can currently affect salivary flow.
* Current use of antibiotics.
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 30 days prior to enrollment into this study.
* Use of tobacco products.
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy).

Primary outcomes:
measure: Plaque Index
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Eastman Dental Center - University of Rochester
state: New York
Study officials:
name: Yanfang Ren, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06684353: Clinical Presentation and Outcome of COPD Patients With Acute Exacerbation Attending Sohag University Hospital
Official title: Clinical Presentation and Outcome of COPD Patients With Acute Exacerbation Attending Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients aged more than 18 years with a confirmed COPD diagnosis according to (GOLD) guidelines, presented with acute exacerbation

Brief summary: Chronic obstructive pulmonary disease (COPD) is a worldwide public health challenge because of high prevalence and related disability and mortality (1).

Acute exacerbation of COPD (AECOPD), defned as the worsening of respiratory symptoms and requirement of additional clinical treatment, it reduces lung function and quality of life, and is accompanied by an increased disease-related burden, high hospital mortality and poor outcome (2).

Chronic obstructive pulmonary disease frequently coexists with other chronic diseases, namely comorbidities. They negatively impact prognosis, exacerbations and quality of life in COPD patients. Local and systemic inflammation have been proposed as having a potential role in explaining the association between COPD and these comorbidities (3).


Eligibility criteria: Inclusion Criteria:

patients with a confirmed COPD diagnosis according to (GOLD) guidelines, presented with acute exacerbation

Exclusion Criteria:

* Stable COPD
* Any other chronic chest diseases; Bronchial asthma or bronchiectasis

Primary outcomes:
measure: Clinical Presentation and Outcome of COPD Patients With Acute Exacerbation Attending Sohag University Hospital
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fabbri LM, Boschetto P, Mapp CE; Global Initiative for Chronic Obstructive Lung Disease; Global Initiative for Asthma Management and Prevention. COPD guidelines: the important thing is not to stop questioning. Am J Respir Crit Care Med. 2007 Sep 15;176(6):527-8. doi: 10.1164/rccm.200706-854ED. No abstract available.
citation: Bateman ED, Feldman C, O'Brien J, Plit M, Joubert JR; COPD Guideline Working Group of the South African Thoracic Society. Guideline for the management of chronic obstructive pulmonary disease (COPD): 2004 revision. S Afr Med J. 2004 Jul;94(7 Pt 2):559-75.
citation: Corrections. Lancet Respir Med. 2017 Oct;5(10):e30. doi: 10.1016/S2213-2600(17)30336-3. Epub 2017 Sep 14. No abstract available.
citation: Nakai T, Ueda M, Takeda R. Effects of calcium and magnesium ions on the interaction of corticosterone with rat brain cytosol receptor(s). Endocr Res Commun. 1978;5(2):81-90. doi: 10.3109/07435807809089010.
citation: Hand D. National Boards lose control of funding. Nurs Stand. 1991 Feb 13-19;5(21):20. No abstract available.