louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01636830: The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized Clinical Trial
Official title: The Incidence of Gingival Fissures _ a Crossover Single-blinded Randomized
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Wounds and Injuries
Keywords: Toothbrushing
gingival recession
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
First posted: 2012-07-10
Enrollment: 35
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to evaluate the incidence of gingival fissures according to the type of brush used, soft and medium.

Detailed description: Gingival recession constitute a functional and aesthetic problem that affects much of the population. One of the possible causes refers to a traumatic brushing. Individuals who have an excessive tooth brushing can cause injuries to your gums, such as abrasions and fissures. These lesions have been considered subrogated outcomes of gingival recession noninfectious. The literature only reports and case series showing the gingival fissures, which were once associated with traumatic occlusion.

This is the first clinical trial to evaluate the gingival fissures according to the type of brush used.

Eligibility criteria: Inclusion Criteria:

* good/ excellent health;
* idade de 14 a 20 anos;
* at least 20 teeth without a history of destructive periodontal disease, absence of gingival bleeding;
* absence of loss of attachment/recession ≥2mm in molars and pre-molars in the buccal areas.

Exclusion Criteria:

* were unable to provide consent or comply with the sudy protocol;
* smokers;
* pregnant women;
* persons under orthodontic treatment or with dental or implant prosthesis, presence of cervical abrasions, restorations or caries;
* need of antibiotic prophylaxis associated with dental procedures.

Primary outcomes:
measure: Gingival Fissures associated with toothbrushing
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
References:
citation: Greggianin BF, Oliveira SC, Haas AN, Oppermann RV. The incidence of gingival fissures associated with toothbrushing: crossover 28-day randomized trial. J Clin Periodontol. 2013 Apr;40(4):319-26. doi: 10.1111/jcpe.12072. Epub 2013 Feb 21.
Clinical trial NCT00279825: Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Parkinson's Disease
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2006-01-20
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.

Detailed description: IPX054 contains two different drugs called levodopa and carbidopa in one tablet.

* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's disease.
* Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
* Must experience "wearing OFF" between doses of medication.

Exclusion Criteria:

* Diagnosed with atypical parkinsonism.
* Allergic or non-responsive to previous carbidopa-levodopa therapy.
* Active or history of narrow-angle or wide-angle glaucoma.
* History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizures.
* Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
* Treatment with any dopaminergic blocking agent within the previous 3 months.

Primary outcomes:
measure: Alternate tapping of keys
timeFrame: single dose
Secondary outcomes:
measure: Timed walking
timeFrame: single dose
measure: Tremor score
timeFrame: single dose
measure: Dyskinesia rating scale
timeFrame: single dose
Other outcomes:
Locations:
city: Bingham Farms
country: United States
facility: Quest Research Institute
state: Michigan
city: Portland
country: United States
facility: Oregon Health Sciences University - Parkinson's Center of Oregon
state: Oregon
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01689025: An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)
Official title: A Randomised, Placebo-controlled, Double-blind, Multiple-dose, Dose-escalation Trial Investigating the Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Inflammation
Systemic Lupus Erythematosus
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-09-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate the safety and tolerability of NNC0114-0006 in subjects with systemic lupus erythematosus (SLE) concomitantly treated with stable background therapies.


Eligibility criteria: Inclusion Criteria:

* Men and women (not pregnant and not nursing)
* Subjects with SLE meeting the American College of Rheumatology (ACR) criteria, with a disease duration of at least 6 months
* Subjects with clinically active SLE defined as a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of at least 6 and positive for antinuclear antibody (ANA) and/or Anti-double-stranded DNA antibody (anti-dsDNA)
* If taken, background medication must be stable

Exclusion Criteria:

* Presence or history of active lupus nephritis (LN) within the last 4 months or active central nervous system (CNS) disease within the last 12 months
* Body mass index (BMI) below 18 kg/m\^2 or above 38 kg/m\^2

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: From first administration of the trial product and up to week 26
Secondary outcomes:
measure: PK endpoint from serum NNC0114-0006: Terminal elimination half-life (t½)
timeFrame: After the last dosing (Week 6)
measure: PK endpoint from serum NNC0114-0006: Accumulation based on the concentration
timeFrame: 2 weeks after the first (week 2) and the last dose (week 8)
measure: Change in serum levels of total IL-21 (Interleukin-21)
timeFrame: Week 0, week 26
measure: Change in disease activity (SELENA-SLEDAI)
timeFrame: Week 0, week 12
measure: Change in corticosteroid usage
timeFrame: Week 0, week 12
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
city: Houston
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: Texas
city: Szeged
country: Hungary
city: Poznan
country: Poland
city: Belgrade
country: Serbia
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01011725: Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Efficacy of MK0773 in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability, pharmacokinetics, and pharmacodynamic efficacy of MK0773 in healthy postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Subject is a nonsurgical postmenopausal female
* Subject is neither grossly overweight nor underweight for her height
* Subject is in good health
* Subject is willing to avoid excess alcohol and strenuous physical activity during the study
* Subject agrees to refrain from consuming St. John's Wort, grapefruit or grapefruit juice during the study

Exclusion Criteria:

* Subject has significant drug allergies
* Subject has donated blood or taken an investigational drug in another clinical trial within the last 4 weeks
* Subject is a regular user or past abuser of any illicit drug (including alcohol)
* Subject drinks excessive amounts of caffeinated beverages
* Subject has a history of cancer

Primary outcomes:
measure: Number of Participants with Serious Clinical Adverse Events
timeFrame: From date of enrollment through 12 weeks of study
measure: Number of Participants with Nonerserious Clinical Adverse Events
timeFrame: From date of enrollment through 12 weeks of study
measure: Number of Participants with Serious Laboratory Adverse Events
timeFrame: From date of enrollment through 12 weeks of study
measure: Number of Participants with Nonserious Laboratory Adverse Events
timeFrame: From date of enrollment through 12 weeks of study
measure: Number of Participants Who Discontinued Due to Any Adverse Event
timeFrame: From date of enrollment through 12 weeks of study
measure: Number of Participants Who Withdrew Consent and Discontinued the Study
timeFrame: From date of enrollment through 12 weeks of study
measure: Least Squares Mean Change in Lean Body Mass
timeFrame: From baseline, at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05205525: Delayed Antibiotic Therapy in Non-severe Ventilator Acquired Pneumonia (VAP)
Official title: Aggressive Versus Restrictive Initiation of Antimicrobial Treatment in Critically Ill Patients With Suspected Ventilator Acquired Pneumonia Without Severity : a Before and After Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator Associated Pneumonia
Critical Care
Antibiotic Therapy
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patient under mechanical ventilation in intensive care with suspected ventilator acquired pneumonia

Brief summary: This retro-prospective monocentric observational study compare the impact of the implementation of a restrictive (delayed) versus aggressive (immediate) antibiotic strategy for Ventilator Acquired Pneumonia suspicion without severity symptoms.

Detailed description: Ventilator acquired pneumonia (VAP) is the leading cause of nosocomial infection in intensive care patients, and has been associated with increased antibiotic consumption, increased morbidity and mortality. VAP diagnosis is difficult due to subjective or non-specific criteria. Delaying antibiotic treatment for VAP suspicion without severity symptoms raises question since the probability of VAP diagnosis, as well as the risk of delaying treatment, is very uncertain. It may nonetheless limit the environmental impact of antibiotic use which is a public health concern. We compared antibiotic sparing and patient outcome, before and after the implementation of a restrictive (delayed) antibiotic strategy versus an aggressive (immediate) antibiotic strategy in VAP suspicion without severity symptoms.

Eligibility criteria: Inclusion Criteria:

* Under mechanical ventilation from more than 48 hours
* Suspected for a ventilator acquired pneumonia, requiring a distal pulmonary bacterial sample

Exclusion Criteria:

* New or worsening shock requiring vasopressor
* New or worsening severe hypoxemia (PaO2/FiO2\<150 in FiO2≥60% and peep 10)
* Patient under veno-veinous extracorporeal membrane oxygenation
* Neutropenia \<1G/L or immunosuppressive treatment (including corticosteroids \>6 months or \>0.5mg/kg/j)
* Disease (endocarditis, spondylodyscitis, deep abcedation...) requiring prolonged antibiotic therapy

Primary outcomes:
measure: antibiotic-free days
timeFrame: 28 days
Secondary outcomes:
measure: Mechanical ventilation free days
timeFrame: 28 days
measure: Intensive care unit stay length
timeFrame: 28 days
measure: Intensive care unit mortality
timeFrame: 28 days
measure: Hospitality mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Nantes Hospital
Study officials:
References:
Clinical trial NCT03943225: What we Think About the Do-not-resuscitate Order: Survey Study
Official title: What we Think About the Do-not-resuscitate Order: Survey Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knowledge, Attitudes, Practice
Keywords: The do-not-resuscitate order, end of life, medical ethics
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Health workers and non health workers who are able to complete the questionnaire

Brief summary: The do not resuscitate (DNR) order is a decision taken by the patient or other people about medical care in the end stages of life to withhold CPR in event of respiratory or cardiac arrest and allow natural death to occur. There is currently no related article of law to DNR order in Turkey. It was aimed to evaluate the health workers(HW) and the non health workers'(NHW) knowledge, attitude, and behavior related to the do-not-resuscitate (DNR) order in Turkey.

Detailed description: The do not resuscitate (DNR) order is a decision taken by the patient or other people about medical care in the end stages of life to withhold CPR in event of respiratory or cardiac arrest and allow natural death to occur. There is currently no related article of law to DNR order in Turkey. A questionnaire with 25 questions has been distributed to health workers and non-health workers.

It was aimed to evaluate the health workers(HW) and the non health workers'(NHW) knowledge, attitude, and behavior related to the do-not-resuscitate (DNR) order in Turkey.

Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years of age
* People who are able to complete the questionnaire

Exclusion Criteria:

-

Primary outcomes:
measure: Health workers' and Non-health workers' knowledge about the DNR order
timeFrame: 20-30 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yadigar Yılmaz
Study officials:
affiliation: Sultan Abdulhami̇d Han Eği̇ti̇m Ve Araşti̇rma Hastanesi̇
name: Yadigar Yılmaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03689725: The Effect of Music on Preterm Infant's Brain Development
Official title: The Effect of Music on Functional Processing and Structural and Functional Development of the Preterm Infant's Brain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prematurity
Lead sponsor: Pediatric Clinical Research Platform
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 63
Sex: ALL
Minimum age (years): 33
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Studying the effect of music intervention on preterm infants' brain development by MRI and neurodevelopmental assessments


Eligibility criteria: Inclusion Criteria:

* Preterm infants: 33 weeks \< gestational age \< 37 weeks
* Full-term newborns: 37 weeks gestational age \< 42 weeks

Exclusion Criteria:

* Neurological issues or malformations (such as III-IV stade Intraventricular hemorrhage, micro or macrocephaly, hydrocephaly...)
* Because of the high noise caused by nasal continuous positive airway pressure (nCPAP), preterm newborns without at least nCPAP pause before 32 6/7 gestational age will be excluded

Primary outcomes:
measure: Compare structural maturation in the three groups using structural MRI and DTI
timeFrame: 40 weeks gestational age
measure: Compare resting state maturation in the three groups using resting state fMRI
timeFrame: 40 weeks gestational age
Secondary outcomes:
measure: Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using fMRI
timeFrame: 40 weeks gestational age
measure: Functional responses to known and unknown music in preterm infants with music intervention will be compared to no-intervention groups responses using EEG
timeFrame: 40 weeks gestational age
measure: The music intervention effect on cognitive language and motor development at one and two years of age
timeFrame: at 1 and 2 years of age
measure: The music intervention effect on emotion and temperament at one and two years of age
timeFrame: at 1 and 2 years of age
measure: The music intervention effect on effortful control at one and two years of age
timeFrame: at 2 years of age
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Prof. Petra S. Hüppi
Study officials:
References:
Clinical trial NCT06471725: Effectiveness of Adding Pilates Exercises to Sports Hernia Rehabilitation:a Comparative Clinical Trial
Official title: Effectiveness of Adding Pilates Exercises to Sports Hernia Rehabilitation:a Comparative Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pilates Exercises
Sports Hernia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 94
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2X2 model
Primary purpose: TREATMENT

Brief summary: The study recruited male sports hernias patients referred for physical therapy by an orthopedist or general practitioner from Damietta General Hospital. Participants had to be between 18 and 45 years old, have had sports hernia for two to ten weeks, and be willing and able to attend and stick to the Pilates exercise program for the trial's entire duration

Detailed description: The study recruited male sports hernias patients referred for physical therapy by an orthopedist or general practitioner from Damietta General Hospital. Participants had to be between 18 and 45 years old, have had sports hernias for two to ten weeks, and be willing and able to attend and stick to the Pilates exercise program for the entire trial. Exclusion criteria were applied to patients with preexisting injuries or conditions that could affect Pilates exercise participation and those with contraindications or exacerbating conditions from such exercises. Further criteria were currently participating in other intensive exercise or rehabilitation programs and inability to give informed consent due to cognitive or communicative issues

Eligibility criteria: Inclusion Criteria:

* Participants had to be between 18 and 45 years old,
* have had sports hernia for two to ten weeks
* be willing and able to attend and stick to the Pilates exercise program for the trial's entire duration

Exclusion Criteria:

* patients with preexisting injuries or conditions that could affect Pilates exercise participation
* those with contraindications or exacerbating conditions from such exercises.
* currently participating in other intensive exercise or rehabilitation programs
* inability to give informed consent due to cognitive or communicative issues.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Lower Extremity Functional Scale
timeFrame: 12 weeks
measure: Harris Hip Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of physical therapy, Delta university for science and technology
state: Dakahlia
Study officials:
References:
citation: Elabd OM, Etoom M, Jahan AM, Elabd AM, Khedr AM, Elgohary HM. The Efficacy of Muscle Energy and Mulligan Mobilization Techniques for the Upper Extremities and Posture after Breast Cancer Surgery with Axillary Dissection: A Randomized Controlled Trial. J Clin Med. 2024 Feb 8;13(4):980. doi: 10.3390/jcm13040980.
Clinical trial NCT01904825: Use of Sentinel Cells for the Development of Molecular Tests to Control the Quality of Cryopreservation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Aneurysm of the Abdominal Aorta
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Only patients of the CHU Dijon and Strasbourg

Brief summary: The aim is to set up tools that will serve as quality tracers for cryopreservation procedures.

To meet this objective, we have chosen to develop reference samples (sentinel cells) that, in the medium term, can be used as controls to guarantee the quality of preservation for biological samples.

The biological tools and an optimised follow-up strategy will make it possible to validate preservation procedures at the CRB in order to guarantee the perfect stability of samples and the validity of clinical studies.


Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years
* All patients presenting an abdominal aorta diameter of at least 5 cm at the time of discovery and who have surgery

Exclusion Criteria:

* Patients who do not have aneurysm of the abdominal aorta
* Refusal to sign the consent form for participation
* Patients who do not wish to have their operation in Dijon or Strasbourg CHU

Primary outcomes:
measure: Quality sentinel cells
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU Dijon - Biological Resource Center
name: Alain BONNIN
role: PRINCIPAL_INVESTIGATOR
References: