louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02507258: PMCF Study for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components
Official title: Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Am Femoral Components and PROCOTYL® O HA Coated Acetabular Components
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Joint Disease
Keywords: osteoarthritis
avascular necrosis
correction of functional deformity
painful hip dysplasia
protrusio acetabuli
rheumatoid arthritis
ankylosis
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been previously implanted with a PROFEMUR® Am Femoral Stem and PROCOTYL® O HA-Coated Acetabular Component

Brief summary: MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) and resurfacing components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.


Eligibility criteria: Inclusion Criteria:

Subject has undergone primary THA for any of the following:

* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis; or
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments

Exclusion Criteria:

* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
* Subjects implanted with non-MPO components (femoral stem, femoral head, acetabular liners) in the enrolled THA
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or having pending incarceration

Primary outcomes:
measure: Component Survivorship
timeFrame: 10 years post-operative
Secondary outcomes:
measure: Patient functional outcomes (hip specific)
timeFrame: Early (2-5 yrs), Midterm (5-7 yrs), and Long-term (10 yrs + 3 mos) beginning with first available follow-up interval
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hopital Joseph Ducuing
Study officials:
affiliation: Hopital Joseph Ducuing
name: Gérard Giordano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04049058: Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context
Official title: Evaluation of Quality of Life After Orthognathic Surgery in a Cleft Lip and Palate Context
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Palate, Cleft
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cleft lip and palate with malocclusion and indication of orthognathic surgery.

Brief summary: The purpose of this study is to compare, prospectively, the quality of life of patients with cleft lip and palate before and after orthognathic surgery. This is done through two validated questionnaires: OHIP-14 (Oral Health Impact Profile) and OQLQ (Orthognathic Quality of Life Questionnaire) Improving the quality of life is the goal of any functional treatment. The demonstration of its improvement would validate the validity of this additional surgery for patients with cleft lip and palate.


Eligibility criteria: Inclusion Criteria:

* Man and woman ; Age: adolescents (12-17 years) and adults; Specific medical conditions: cleft lip and palate, malocclusion
* Non-opposition of the patient
* Patient willing to comply with all procedures of the study and its duration

Exclusion Criteria

* Cancellation of orthognathic surgery
* Impossibility to receive enlightened information, impossibility to participate in the totality of the study, impossibility to complete only the questionnaire

Primary outcomes:
measure: Change of the OQLQ (Orthognathic Quality of Life Questionnaire) questionnaire score between the preoperative assessment and at 6 months postoperatively.
timeFrame: between the preoperative assessment and at 6 months postoperatively.
Secondary outcomes:
measure: Change of OHIP-14 questionnaire score (Oral Health Impact Profile) between preoperative evaluation and at 6 months postoperatively.
timeFrame: between the preoperative assessment and at 6 months postoperatively.
measure: Change of OQLQ (Orthognathic Quality of Life Questionnaire) by type of orthognathic surgery
timeFrame: at 6 months
measure: Change of OHIP-14 (Oral Health Impact Profile) by type of orthognathic surgery
timeFrame: at 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHU
Study officials:
affiliation: University Hospital, Lille
name: Romain Nicot, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00208858: A Pilot Study of the Neural Correlates of Treatment Effect on Nicotine Craving
Official title: Nicotine Craving: Neural Correlates of Treatment Effect - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2005-09-21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to gather pilot data to determine feasibility of and guide the development of a larger clinical trial investigating the effects of topiramate as an adjunct to nicotine replacement therapy and behavioral counseling in smoking cessation treatment. It is hypothesized that topiramate will decrease nicotine craving and result in improved outcomes for smoking cessation.


Eligibility criteria: Inclusion Criteria:

* Male, between ages of 18-55
* Meets DSM-IV criteria for nicotine dependence
* Smoke at least 20 cigarettes per day
* Motivated to quit smoking

Exclusion Criteria:

* Serious or unstable medical conditions
* Current psychiatric disorder requiring medication or treatment
* Taking medication that create risk of interaction with study drug
* Current participation in another smoking cessation treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
Study officials:
affiliation: Emory University, Atlanta VA Medical Center
name: Karen Drexler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06547658: The Effect of Mouth Closure on Airflow in OSA
Official title: The Heterogeneous Effects of Mouth Closure on Airflow in Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypopnea, Sleep
Keywords: Obstructive sleep apnea
Mouth breathing
Upper airway
Drug-induced sleep endoscopy
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Massachusetts Eye and Ear Infirmary
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-08-09
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Mouth breathing is associated with increased airway resistance, pharyngeal collapsibility, and obstructive sleep apnea (OSA) severity. It is commonly believed that closing the mouth can mitigate the negative effects of mouth breathing during sleep. However, we propose that mouth breathing serves as an essential route bypassing obstruction along the nasal route (e.g., velopharynx). The present study investigates the role of mouth breathing as an essential route in some OSA patients and its association with upper airway anatomical factors.

Participants underwent drug-induced sleep endoscopy (DISE) with simultaneous pneumotach airflow measurements through the nose and mouth separately. During the DISE procedure, alternating mouth closure (every other breath) cycles were performed during flow-limited breathing.

We evaluated the overall effect mouth closure on inspiratory airflow, and the change in inspiratory airflow with mouth closure across three mouth-breathing quantiles. We also evaluated if velopharyngeal obstruction was associated with mouth breathing and a negative airflow response to mouth closure.


Eligibility criteria: Inclusion Criteria:

* Diagnosed obstructive sleep apnea (AHI \> 5 events/h).
* Scheduled to undergo clinical drug-induced sleep endoscopy.

Exclusion Criteria:

* pregnancy
* age under 18 years
* poor general health
* allergy to propofol or dexmedetomidine
* history of surgical treatment for sleep apnea, such as palate, tongue base, or epiglottis surgery.

Primary outcomes:
measure: Total inspiratory flow
timeFrame: 1 day - the intervention of mouth closure on the outcome is applied acutely on alternating breaths, such that the effect of mouth closure is assessed based on the experiment which occurs in a single day.
Secondary outcomes:
measure: Change in total inspiratory airflow with mouth closure
timeFrame: 1 day - the intervention of mouth closure is applied acutely on alternating breaths, such that the effect of mouth closure on the outcome is assessed based on the experiment which occurs in a single day.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00952458: Bispectral Index Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
Official title: Bispectral Index Monitoring as an Adjunct to Standard Monitoring of Sedation During Endoscopic Retrograde Cholangiopancreaticography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Endoscopy
Sedation
Keywords: Safety
Midazolam and propofol sedation
ERCP
Bispectral Index monitoring
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2009-08-06
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This randomized study investigates the benefits of an additional Bispectral Index monitoring of depth of sedation during endoscopic retrograde cholangiopancreaticography. A bispectral index (BIS) monitor is a neurophysiological monitoring device which continually analyses a patient's electroencephalograms during general anaesthesia to assess the level of consciousness during anaesthesia.


Eligibility criteria: Inclusion Criteria:

* Indication for ERCP (Endoscopic Retrograde Cholangiopancreatography) with midazolam and propofol sedation

Exclusion Criteria:

* Missing informed consent
* ASA V
* Preexisting neurological deficit
* Known pregnancy
* Hypotension (RRsys\<90mmHg), bradycardia (HR\<50/min), hypoxia (SaO2\<90%)

Primary outcomes:
measure: Cardiopulmonary complications of sedation
timeFrame: 1-4 hours
Secondary outcomes:
measure: Efficacy of sedation
timeFrame: 1-4 hours
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar der Technischen Universität München
name: Stefan von Delius, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Delius S, Thies P, Rieder T, Wagenpfeil S, Herberich E, Karagianni A, Frimberger E, Meining A, Ludwig L, Ebert MP, Schulte-Frohlinde E, Neu B, Prinz C, Schmid RM, Huber W. Auditory evoked potentials compared with bispectral index for monitoring of midazolam and propofol sedation during colonoscopy. Am J Gastroenterol. 2009 Feb;104(2):318-25. doi: 10.1038/ajg.2008.73. Epub 2009 Jan 20.
Clinical trial NCT02479958: An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
Official title: A Randomized in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dental Caries
Keywords: Photochemotherapy
Bacteria
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-06-24
Enrollment: 58
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite of the decline of dental caries, this disease is still common in polarized groups affecting children. Therefore, the aim of this randomized blind in vivo study was to compare the antimicrobial effect of two antimicrobial therapies in deciduous carious dentin. Thirty two patients aging from 5 to 7 years old had partial caries removal in deep carious dentin lesion in deciduous molar and were divided in three groups: 1. Control - chlorhexidine and resin modified glass ionomer cement (RMGIC); 2. LEDTB - antimicrobial photodynamic therapy (APDT) with LED (light emission diode) associated with toluidine blue orto dye solution and RMGIC; 3. LMB - APDT with laser associated with methylene blue dye solution and RMGIC. The patients were submitted to initial clinical and radiographic examination and demographic features were evaluated by biofilm, gingival, and dmft/dmfs indexes, besides clinical and radiographic follow up at 6 and 12 months after the treatments. The carious dentin was collected before and after each treatment and the number of Streptococcus mutans, Streptococcus sobrinus, Lactobacillus casei, Fusobacterium nucleatum, Atopobium rimae and total bacteria were established by quantitative PCR.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria consisted of good general health, without syndromes or chronic systemic diseases. They should also have at least one primary molar with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits.

Exclusion Criteria:

* Children whose parents refused to sign the informed consent document, who did not cooperate with the clinical exams, whose teeth had the treatment choice changed (pain or evolution to irreversible pulpits), who did not attend to the appointments for the scheduled treatments, or who needed antibiotics treatment for other medical reasons were excluded from the study without prejudice.

Primary outcomes:
measure: Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)
timeFrame: 15 days after dentin collection
Secondary outcomes:
measure: Tooth Pain
timeFrame: 6 months
measure: Tooth Pain
timeFrame: 12 months
measure: Restoration Quality
timeFrame: 6 months
measure: Restoration Quality
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01415258: Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre
Official title: Screening for Vulnerability in the Elderly Supported at the Oscar Lambret Centre
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumor
Keywords: cancer
vulnerability
frail
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Hôpital Gériatrique Les Bateliers, CHRU Lille
First posted: 2011-08-11
Enrollment: 209
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study concerns elderly patients (≥70 years) with solid tumors

Brief summary: The objective of this study is to uncover the prevalence of vulnerability among patients aged ≥ 70 coming to the medical oncology division of the Oscar Lambret Centre, according to the short screening test Vulnerable Elders Survey 13 (VES-13).

The objective is to better understand the value of routine screening of patients before the consultation, it was proposed as a secondary objective of this study to assess the correlation between the identification of the vulnerability in the screening test VES-13 and the identification made by the clinician during the consultation. The correlation between VES-13 and opinion of the clinician for three categories of patients (self - intermediate - fragile) will also be studied.


Eligibility criteria: Inclusion Criteria:

* patient aged ≥ 70
* coming for a first visit, whatever the purpose and the disease stage

Exclusion Criteria:

* neglect or refusal to answer to the VES-13 test

Primary outcomes:
measure: To assess the Vulnerable Elders Survey score (VES-13)
timeFrame: Within 3 months after recruitment
Secondary outcomes:
measure: To assess the correlation between the VES-13 score and the vulnerability judged by a clinical expert
timeFrame: Within 3 months after recruitment
measure: To measure the muscle strength using the grip strength test
timeFrame: Within 3 months after recruitment
Other outcomes:
Locations:
city: Lille cedex
country: France
facility: Oscar Lambret Anti-Cancer Centre
Study officials:
affiliation: Oscar Lambret Anti-Cancer Centre
name: Véronique SERVENT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00246558: Tight Achilles Tendon, Hyperpronation and Anterior Knee Pains
Official title: Is There a Connection Between a Tight Achilles Tendon, Hyperpronation of the Foot and Pain in the Anterior Part of the Knee
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Anterior Knee Pain Syndrome
Keywords: Tight Achilles Tendon
Hyperpronation of the foot
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2005-10-30
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: The purpose of the study is to investigate the prevalence of pain in the anterior part of the knee, amongst youngsters between 16 and 18 years of age.

Furthermore, this trial intends to study the connection between the pain, hyperpronation of the foot and tight Achilles tendon.

We want to find out if there is a need of an early effort in terms of information, training and/or support for the shoes.

Detailed description: All students (around 300) between 16 and 18 years of age from one Gymnasium, receives a questionnaire. They are asked to answer whether they have had pain in the anterior part of their knee within the last month. If so they are invited to participate in a scientific study. An equivalent group with no pain are invited to participate as a control group.

In both groups navicular drop and drift will be measured together with the dorsal flexion. The investigations are made single-blinded as the investigators do not know if the "patient" has pain or not.

Eligibility criteria: Inclusion Criteria:

* Informed consent, and for those being under 18 years of age, their parents signature.
* Anterior knee pain syndrome and for the control group: no knee pain syndrome

Exclusion Criteria:

* Former knee surgery
* Any form of arthritis
* Diagnosed meniscus or other injuries in the knee

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division, Klinik Aalborg
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division, Denmark
name: Ole Simonsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01205958: The Effect of East-West Collaborative Medicine on Chronic Cervical Pain
Official title: Clinical Trial to Evaluate the Effect of East-West Collaborative Medicine on Chronic Cervical Pain: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Neck Pain
Keywords: Cervical pain
Neck pain
western medicine
oriental medicine
acupuncture
needle
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
First posted: 2010-09-21
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effect of East-West collaborative medicine on chronic cervical pain.

Detailed description: Design: This is a randomized, controlled study.

Participants: 45 participants with chronic cervical pain are recruited and randomly assigned to three groups.

Intervention: Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks

Eligibility criteria: Inclusion Criteria:

- presence of Chronic neck pain

Exclusion Criteria:

* Cancer
* Spinal infection
* ankylosing spondylosis
* myelopathy
* moderate hypertension or more
* serious mental disease
* other skeletomuscular disease
* history of operation or acupuncture treatment about spinal disease

Primary outcomes:
measure: Pain Scores on the Visual Analogue Scale(VAS)
timeFrame: 7 week
Secondary outcomes:
measure: Neck disability index
timeFrame: 7 week
measure: Beck depression inventory
timeFrame: 7 week
measure: SF-36
timeFrame: 7 week
measure: EQ-5D(EuroQol-5 dimension)
timeFrame: 7 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee University East West Neo Medical Center
Study officials:
affiliation: Department of Oriental Rehabilitation Medicine/College of Oriental Medicine/Kyung Hee University
name: Jun-Hwan Lee, OMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho JH, Nam DH, Kim KT, Lee JH. Acupuncture with non-steroidal anti-inflammatory drugs (NSAIDs) versus acupuncture or NSAIDs alone for the treatment of chronic neck pain: an assessor-blinded randomised controlled pilot study. Acupunct Med. 2014 Feb;32(1):17-23. doi: 10.1136/acupmed-2013-010410. Epub 2013 Oct 30.
Clinical trial NCT02712658: Role of K+ and Ca2+ in Development of Muscle Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skeletal Muscle Fatigue in Humans
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2016-03-18
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate the role of K+ and Ca2+ in development of muscle fatigue in trained young men.


Eligibility criteria: Inclusion Criteria:

* physical active healthy men
* aged 18-40 years

Exclusion Criteria:

* smokers
* allergy towards terbutaline
* chronic disease

Primary outcomes:
measure: Change in time to fatigue during knee-extensor exercise
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports
Study officials:
References: