louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01503060: Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain
Official title: Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain: A Longitudinal Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain
Keywords: pediatrics
Pain
Immunization
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-01-02
Enrollment: 352
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.


Eligibility criteria: Inclusion Criteria:

1. Healthy infants undergoing vaccination.

Exclusion Criteria:

1. preterm birth (\<37 weeks gestation)
2. prior hospitalization/surgery (other than postnatal care),
3. documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,
4. mother plans to breastfeed or to use topical anesthetics or sugar water during injection.

Primary outcomes:
measure: Hypersensitivity to pain
timeFrame: At 15 month vaccination (Visit 5)
Secondary outcomes:
measure: Effectiveness of interventions
timeFrame: At 2,4,6,12 month vaccinations (Visit 1-4)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Outpatient Clinic
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Dave M, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. A Longitudinal Randomized Trial of the Effect of Consistent Pain Management for Infant Vaccinations on Future Vaccination Distress. J Pain. 2017 Sep;18(9):1060-1066. doi: 10.1016/j.jpain.2017.04.002. Epub 2017 Apr 26.
citation: Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Malini D, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. Relative effectiveness of additive pain interventions during vaccination in infants. CMAJ. 2017 Feb 13;189(6):E227-E234. doi: 10.1503/cmaj.160542. Epub 2016 Dec 12.
Clinical trial NCT06576960: Caries Inhibitory Effect of Nano Silver and Tri Calcium Phosphate Varnishes Among Visually Impaired Children
Official title: Caries Inhibitory Effect of Nano Silver Varnish Versus Tri Calcium Phosphate Varnish Among Children With Visual Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2024-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Assessment of pH,streptococcus mutants count, lactobacillus count and immunoglobulin A among visually impaired children after nano silver varnish application it tri calcium phosphate phosphate varnish application

Detailed description: Sixty children will be randomly divided into three equal treatment groups, composed of 20 children each, according to the type of material used as follows:

* Group I: children will receive oral health education and nano silver fluoride varnish.
* Group II: children will receive oral health education and tri calcium phosphate varnish.
* Group III: children will receive oral health education

for all children ,Assessment of pH, streptococcus mutants count, lactobacillus count and immunoglobulin A will be assessed at baseline, one day , 3 months and 6 months after application

Eligibility criteria: Inclusion Criteria:

Visually impaired children

Exclusion Criteria:

* uncooperative children or children not willing to participate in the study.
* Children with systemic diseases
* Children with bronchial asthma.
* Children who were on antibiotic or medications that might affect oral flora or salivary flow taken within the previous 3 months
* History of fluoride treatment in the past 3-4 weeks.

Primary outcomes:
measure: Salivary PH
timeFrame: 6 months
measure: Salivary streptococcus mutants count
timeFrame: 6months
measure: Lactobacillus count
timeFrame: 6 months
measure: Immunoglobulin A
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of dentistry
state: Tanta City
Study officials:
affiliation: Faculty of dentistry . Tanta university
name: Hatem Amin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04412460: Echocardiography in Patients With Covid-19
Official title: Echocardiography in Patients With Covid-19 Undergoing Intensive Care Therapy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COVID
ARDS, Human
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 0
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: Adults admitted for ICU therapy due to severe Covid-19

Brief summary: Prospective observational study of patients treated due to Covid-19 disease. Observation and analysis of echocardiographic studies performed in the intensive care setting.


Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Covid-19 disease
* invasive Ventilation

Exclusion Criteria:

* none

Primary outcomes:
measure: ICU Mortality
timeFrame: up to 90 days
Secondary outcomes:
measure: ICU length-of stay
timeFrame: up to 90 days
measure: ICU ventilator free days
timeFrame: up to 90 days
measure: Hospital length-of-stay
timeFrame: up to 90 days
Other outcomes:
Locations:
city: Tubingen
country: Germany
facility: University Hospital Tubingen
state: BW
Study officials:
References:
Clinical trial NCT05627076: Analytical Validation of the abioSCOPE Device With the IVD CAPSULE PSP Test: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.
Official title: Comparison of PSP Values Measured With Venous Whole Blood and Those Measured With Arterial Whole Blood.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Sepsis Bacterial
Keywords: Abionic
Pancreatic Stone Protein
Point-of-care device
Immunoassay
IVD
Lead sponsor: Abionic SA
Sponsor class: INDUSTRY
First posted: 2022-11-25
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted at the hospital

Brief summary: Abionic has developed a targeted, rapid test for pancreatic stone protein (PSP) in human K2-EDTA venous whole blood using the abioSCOPE instrument.

Currently no PSP study comparaison has been done between venous and arterial whole blood. Abionic would like to confirm the equivalence of the PSP between venous whole blood and arterial whole blood.


Eligibility criteria: Inclusion Criteria:

1. Provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis;
2. Male or female, 18 years of age or older;
3. Patient admitted to hospital
4. Need for venous and arterial blood samples as part of standard of care
5. Covered by a social security scheme.

Exclusion Criteria:

1. Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;
2. Subject under juridical protection.

Primary outcomes:
measure: Primary assessment
timeFrame: through study completion, an average of 1.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU Limoges, Réanimation Polyvalente
Study officials:
References:
Clinical trial NCT00242476: A Study to Assess the Effectiveness of an Investigational Drug in Elderly Subjects With Low Vitamin D Levels (0822A-009)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Study to Assess the Effect of Vitamin D3 8400IU Once Weekly on Body Sway and Neuromuscular Function in Men and Women Aged 70 Years or Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vitamin D Deficiency
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-10-20
Enrollment: 216
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effectiveness of an investigational drug in elderly subjects with low vitamin D levels.


Eligibility criteria: Inclusion Criteria:

* Man or a woman 70 years old or older in general good health

Exclusion Criteria:

* Having any form of neurological impairments that may impair motor function.

Primary outcomes:
measure: Mediolateral body sway at 16 weeks.
timeFrame: at 16 weeks
Secondary outcomes:
measure: Functional status assessed using the Short Physical Performance Battery Test determined at 16 weeks. General safety and tolerability at 16 weeks.
timeFrame: at 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lips P, Binkley N, Pfeifer M, Recker R, Samanta S, Cohn DA, Chandler J, Rosenberg E, Papanicolaou DA. Once-weekly dose of 8400 IU vitamin D(3) compared with placebo: effects on neuromuscular function and tolerability in older adults with vitamin D insufficiency. Am J Clin Nutr. 2010 Apr;91(4):985-91. doi: 10.3945/ajcn.2009.28113. Epub 2010 Feb 3.
Clinical trial NCT06841276: Impact of QoLibri Medical Device on the Consequences of Chronic Pain: a Randomized Controlled Trial
Official title: Evaluation of the Impact of the QoLibri Digital Therapy for Primary Care Patients with Chronic Pain: a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: pain, quality of life, functional impact, psychological impact, digital therapy
Lead sponsor: Novesia
Sponsor class: INDUSTRY
First posted: 2025-02-24
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A superiority study evaluating the impact of the QoLibri Software as Medical Device on functional and psychological consequences of chronic pain in primary care patients. A prospective, cluster-randomized, wait list, controlled multicentre study whose main objective is to evaluate the effectiveness of the QoLibri Digital Therapy on Quality of Life improvement in patients living with chronic pain.


Eligibility criteria: Inclusion Criteria:

* Patient experiencing at least moderate pain (on the Categorical Pain Scale) for more than 3 months
* Patient with a BPI interference score ≥ 3 in at least 3 out of 7 dimensions
* Patient with a smartphone and an internet connection at the place of use
* Patient affiliated with a social security system or benefiting from such a system

Exclusion Criteria:

* Patient opposing participation in the study
* Patient with severe anxiety and/or depressive disorders (especially a suicidal risk)
* Patient presenting one or more barriers to the initiation of cognitive-behavioral therapy (significant social difficulties, low adherence to current care, insufficient memory or cognitive abilities, lack of time, lack of motivation...),
* Adult patient under legal protection measures (guardianship, legal safeguard, psychiatric care, or deprived of liberty by judicial or administrative decision)

Primary outcomes:
measure: Effectiveness of QoLibri Digital Therapy
timeFrame: month 3
Secondary outcomes:
measure: Impact on Quality of life
timeFrame: day 0, month 6
measure: Pain's impact
timeFrame: day 0, month 3, month 6
measure: Organizational impact
timeFrame: day 0, month 3, month 6
measure: Global Impression of Change
timeFrame: month 3, month 6
measure: Evaluation of the perceived user experience
timeFrame: month 3, month 6
measure: Evaluation of the perceived severity of pain
timeFrame: day 0, month 3, month 6
measure: Evaluation of pain self efficacy
timeFrame: day 0, month 3, month 6
Other outcomes:
Locations:
city: Nailloux
country: France
facility: Maison de santé Nailloux / Saint-Léon
Study officials:
name: Antoine Elyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06821776: Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study
Official title: N-of-1 Trial Comparing Prolonged Gastric Feeding to Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Feeding Intolerance
Keywords: BPD
Lead sponsor: Le Bonheur Children's Hospital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Hospitalized infants with severe bronchopulmonary dysplasia (BPD) and feeding intolerance will be randomized to 2 weeks of continuous gastric feeding or continuous transpyoloric feeding. Subjects will crossover after 2 weeks and receive 4 weeks of each feeding mode. Respiratory status will be assessed to determine the optimal feeding mode for each infant.


Eligibility criteria: Inclusion Criteria:

* Patients born \<32 weeks' gestation
* Currently admitted to the Le Bonheur NICU
* Grad 2 or 3 BPD (positive pressure or intubated at 36 weeks PMA)
* Signs of gastroesophageal reflux, chronic aspiration, or other feeding intolerance.

Exclusion Criteria:

* Known gastrointestinal anomalies
* Unable to tolerate ≥100mL/kg/day enteral feeding
* Congenital anomalies likely to alter feeding techniques
* Surgical feeding tube in place or expected within the next 8 weeks
* Expected to remain hospitalized \<8 weeks

Primary outcomes:
measure: Respiratory Severity Score (RSS)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Mark Weems, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lillie EO, Patay B, Diamant J, Issell B, Topol EJ, Schork NJ. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Per Med. 2011 Mar;8(2):161-173. doi: 10.2217/pme.11.7.
citation: Baker CD, Liptzin DR, Eldredge LC. Transpyloric feeding in severe BPD: a call for prospective trials. J Perinatol. 2024 Jul;44(7):1079. doi: 10.1038/s41372-024-01919-1. Epub 2024 Mar 2. No abstract available.
citation: Levin JC, Kielt MJ, Hayden LP, Conroy S, Truog WE, Guaman MC, Abman SH, Nelin LD, Rosen RL, Leeman KT. Transpyloric feeding is associated with adverse in-hospital outcomes in infants with severe bronchopulmonary dysplasia. J Perinatol. 2024 Feb;44(2):307-313. doi: 10.1038/s41372-024-01867-w. Epub 2024 Jan 13.
citation: Jensen EA, Zhang H, Feng R, Dysart K, Nilan K, Munson DA, Kirpalani H. Individualising care in severe bronchopulmonary dysplasia: a series of N-of-1 trials comparing transpyloric and gastric feeding. Arch Dis Child Fetal Neonatal Ed. 2020 Jul;105(4):399-404. doi: 10.1136/archdischild-2019-317148. Epub 2019 Nov 4.
Clinical trial NCT05685576: Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement
Official title: Evaluation of a Combined Ridge Expansion Technique With Simultaneous Dental Implant Placement in Narrow Posterior Mandible
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Process Atrophy
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-01-17
Enrollment: 8
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with long span, narrow edentulous ridge in the posterior mandible underwent piezotomed ridge splitting and osseodensification with simultaneous implant placement.

Detailed description: This study is a single arm clinical trial. Patients of both genders, who are indicated for ridge splitting, were recruited from the outpatient clinic, Faculty of dentistry, Alexandria University.

The PICO question: "What is the effect of piezotomed ridge splitting and osseodensification on implant placement in narrow posterior mandibular ridges?"

Ethical approval for the study was obtained from the regional Ethical Review Board of the Faculty of Dentistry. All patients were informed about the procedure details, and each participant signed a written consent.

Ridge expansion was accomplished by piezotomed ridge splitting and osseodensification. Simultaneous implant placement was done in the same procedure.

Implant stability was assessed. Also, bone width gained and bone density were measured around the dental implants using cone beam computed tomography.

Eligibility criteria: Inclusion Criteria:

* Patients with good oral hygiene
* Patients with long-span, narrow posterior edentulous mandibular area
* Age limit range \[25 - 66 years\]
* Patients who accept to participate in the study
* Minimum height 10mm from the crest of the ridge till the upper border of inferior alveolar canal
* Minimum ridge thickness = 3mm at the crestal region
* If the patient is diabetic, should be controlled.

Exclusion Criteria:

* Immunosuppressive/ autoimmune disease patients
* Patients with osteoporosis
* Lack of sufficient amount of keratinizing mucosa at the crest of the edentulous saddle
* Patients with bleeding disorder disease
* Ridge width less than 3 mm
* Smokers
* Patients having periodontal disease
* The presence of a pathological lesion in the area of ridge splitting

Primary outcomes:
measure: The score of primary implant stability
timeFrame: immediately at time of implant insertion
Secondary outcomes:
measure: The width of bone gained
timeFrame: 3 months postoperative
measure: The mean bone density around dental implants
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT03292276: Improving Hand Motor Function After Stroke: Role of Robotics
Official title: Improving Hand Motor Function After Stroke: Role of Robotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: It is Possible That Amadeo Will Guarantee a Greater Clinical Improvement as Compared to an Occupational Therapy Thanks to the Strengthening of Brain Plasticity
Lead sponsor: IRCCS Centro Neurolesi Bonino Pulejo
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Two recent randomized clinical trials reported a significant contribute of Amadeo toward the recovery of hand motor function in acute stroke patients in association with physiotherapy and/or occupational therapy. However, no data are available in patients with chronic stroke, and the neurophysiological mechanisms underlying such clinical improvement need to be elucidated. Given that robotic devices harness brain plasticity to foster motor function recovery, a deeper understanding of the neurophysiological bases of Amadeo training could help clinician to realize patient-tailored rehabilitative training based brain plasticity knowledge. We planned a pilot randomized-controlled observer trial aimed at evaluating the effects of intensive robot-assisted hand therapy compared with intensive occupational therapy in chronic phase after stroke. We estimated that 40 patients per group will be required to demonstrate a greater effect of Amadeo as compared to occupational therapy, with an effect size of 0.5. Twenty chronic stroke patients (at their first-ever stroke) will be enrolled and randomized into two groups. The experimental group will be provided with Amadeo training. The Control group will be provided with occupational therapy executed by a trained physiotherapist.


Eligibility criteria: Inclusion Criteria:

* chronic stroke patients at their first-ever supratentorial stroke

Exclusion Criteria:

* presence of severe medical, psychiatric and cognitive abnormalities as to interfere with the treatment.
* controindications to the device use.

Primary outcomes:
measure: Nine hole peg test
timeFrame: by 5 minutes
Secondary outcomes:
measure: cortical modifications related to movement preparation and execution after robot-assisted training
timeFrame: about 30 minutes
Other outcomes:
Locations:
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi "Bonino-Pulejo"
Study officials:
affiliation: IRCCS Neurolesi
name: Placido Bramanti
role: STUDY_CHAIR
References:
Clinical trial NCT03583476: The Impact of Antibiotics MIC Value on the Efficacy of Treatment Regimens for Helicobacter Pylori Infection.
Official title: The Impact of Antibiotics MIC Value on the Efficacy of Treatment Regimens for Helicobacter Pylori Infection.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Resistance
Minimal inhibitory concentration
Treatment efficacy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 1821
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical Center

Brief summary: Clarithromycin (CLA)、amoxicillin (AMO)、metronidazole (MET)、levofloxacin (LEV) and tetracycline (TET) are commonly used antibiotics for Helicobacter pylori (Hp) therapy. However, the efficacy of treatment for Helicobacter pylori infection has decreased due to increasing resistance to CLA, MET and LEV. Studies had reported that beside antibiotics resistance, other factors such as age, sex, underlying disease, etc. may also affect the treatment efficacy. In some cases, when the MIC values were beyond the breakpoint, H. pylori strains with lower MIC value had better eradication than the ones with higher MIC value. However, few study investigated the relationship between MIC values and treatment outcome.

The investigators aimed to analyze the impact of influencing factors, especially minimal inhibitory concentration (MIC) value, on the efficacy of different treatment regimens.


Eligibility criteria: Inclusion Criteria:

* patients (aged ≥ 20 years old) with H. pylori infection between Jan. 1994 to Mar. 2018

Exclusion Criteria:

* without antibiotics susceptible test result, without treatment outcome, history of any gastrointestinal surgery, serious concomitant (renal failure, liver cirrhosis, heart failure and disease need immunosuppressant for therapy.

Primary outcomes:
measure: Relationship between eradication rate (%) of therapy regimen and influencing factors (eg. sex, age, diagnosis, MIC).
timeFrame: 4 weeks after treatment finished.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Tzu-Chi Lai
state: No.33, Linsen S. Rd., Zhongzheng Dist
Study officials:
References: