louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06484517: Is HugeMed Video Laryngoscope Superior to McGrath in Pediatric Patients
Official title: Is HugeMed Video Laryngoscope Superior to McGrath in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Difficult Intubation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Videolaryngoscopes improve laryngeal visualization in children under 3 years. In this study we aimed to compare Hugemed and McGrath videolaryngoscopes regarding their Cormach-Lehane (CL) and percentage of glottic opening (POGO) scores. Furthermore, tracheal intubation success rates, need for cricoid pressure and optimization maneuvers, and hemodynamic changes are compared.


Eligibility criteria: Inclusion Criteria:

total of 40 elective surgical patients under the age of 3, classified as ASA 1-3 risk group, who underwent general anesthesia with no anticipated difficult airway.

Exclusion Criteria:

Patients who could not obtain parental consent, those classified as ASA 4 and above, individuals with serious cardiac and respiratory problems, and patients anticipated to have a difficult airway were not included in the study.

Primary outcomes:
measure: Success of intubation
timeFrame: Procedure (At the time of the intubation of the patient.)
Secondary outcomes:
measure: Percentage of glottis opening (POGO)
timeFrame: Procedure (At the time of the intubation of the patient.)
measure: Need for optimization maneuvers
timeFrame: Procedure (At the time of the intubation of the patient.)
measure: Degree of hemodynamic changes
timeFrame: Procedure (At the time of the intubation of the patient.)
measure: blood pressure
timeFrame: Procedure (At the time of the intubation of the patient.)
measure: Success of intubation
timeFrame: Procedure (At the time of the intubation of the patient.)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Research and Training Hospital
Study officials:
affiliation: Marmara University Department of Anesthesiology and Reanimation
name: Gamze Çabaklı
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00505817: GnRH Agonist and Antagonists in an Oocyte Donation Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Effect of Two Protocols of Ovarian Stimulation on Oocyte Quality
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2007-07-25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The primary purpose of this study is to evaluate the effect of the two different protocols (long protocol vs antagonist protocol) on oocyte / embryo quality.

Detailed description: The cycles with antagonists of the GnRHa present a series of advantages with respect the GnRHa in an oocyte donation program: treatment cycles are simpler and shorter, a lower amount of dose of gonadotrophins is needed for stimulation, and most important, a decreased rate of ovarian hyperstimulation syndrome is observed. Nevertheless, several clinical trials relate their use to a greater rate of abortion and worse oocyte/ embryo quality. In order to discriminate the endometrial factor from the quality of oocyte cohort, the best strategy is the oocyte donation model. In the present study, for the first time, the effect of different protocols (long versus antagonist protocol) will be studied in the same donor, acting as its own control, undergoing COH. We will compare the COH´s parameters and IVF outcome obtained in the same donor submitted to, firstly, GnRH antagonist protocol (Cetrorelix- n= 45) versus another consecutive cycle with long protocol (Ac. Leuprolide- n= 45).

Eligibility criteria: Inclusion Criteria:

* oocyte donors with age range: 18 - 34; BMI: 18 - 29 kg/m2;

Exclusion Criteria:

* PCO

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Instituto Valenciano de Infertilidad Spain
Study officials:
affiliation: Instituto Valenciano de Infertilidad
name: Marco Melo, MDPhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03044717: Nutrition Education in Fellows
Official title: How Nutrition Education in Cardiology Fellows and Faculty Affects Clinical Practice Over a Six-Month Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Education
Keywords: Nutrition Education
Cardiology Fellows
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 32
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiology fellow, faculty, internal medicine, residents, fellows

Brief summary: The purpose of this research study is to assess comfort of cardiology fellows and faculty with nutrition and its role in cardiovascular disease and to determine if increasing education in this arena will change clinical practice.

Detailed description: The aim of this project is to educate the fellows and faculty about nutrition. This will be done with a 3-hour nutrition module provided by the Gaples Institute. The Gaples Institute is a non-profit organization advocating natural strategies balanced with conventional medicine. The module will be provided free of charge for this education. There will also be a prevention education conference once every five weeks.

The secondary aim is to affect change in clinical practice among fellows and faculty. With an intensive nutrition education spanned over six months, the goal is to see if investigators can affect change in clinical practice. The nutrition module online will be available to those who participate in the study. The study participants are required to complete the 3-hour nutrition module prior to the six month completion of this study.

Eligibility criteria: Inclusion Criteria:

* All general cardiology fellow, faculty, internal medicine, residents, fellows will be asked to be part of this study.
* Male or females, 25 years or older

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in behavior will be measured by method of Nutrition Survey
timeFrame: Change from Baseline, 3 months, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Monica Aggarwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05122117: Impact of Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment on Clinical and Biochemical Parameters Among Patients Having Mild Rheumatoid Arthritis With Periodontitis
Official title: Impact of Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment on Clinical and Biochemical Parameters Among Patients Having Mild Rheumatoid Arthritis With Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Chronic Periodontitis
Keywords: photodynamic therapy
biomarkers
inflammation
Rheumatoid arthritis
chronic periodontitis
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Purpose: To evaluate the efficacy of photodynamic therapy (PDT) as an adjunct to non-surgical periodontal therapy on the clinical periodontal and biochemical parameters among patients with rheumatoid arthritis (RA) having periodontitis.

Methods: A total of 50 RA patients with periodontitis were included. The subjects were equally divided into two groups: Group A - scaling and root planning (SRP) + PDT; Group B - SRP only, respectively. Plaque score (PS), bleeding on probing (BOP), pocket depth (PD) and clinical attachment level (CAL) were estimated. The biochemical parameters included the assessment of interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and rheumatoid factors (RFs). Multiple comparisons were established by employing the Bonferroni's post-hoc test for both clinical and laboratory biomarker data. The Mann-Whitney test was used to compute the p-value for intergroup comparisons. For intra-group comparisons, the p-value was computed with the help of Wilcoxon signed ranks test.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥25 years
* Satisfying the 2010 ACR/EULAR categorization criteria (with active RA with ≥6 joint involvement and under anti-RA medication ≥3 months)
* Patients having \>20 teeth diagnosed with generalized (\>30% of sites) chronic periodontitis with PD ≥ 4mm and/or CAL ≥ 4mm and vertical bone loss of at least 4 mm on radiography.

Exclusion Criteria:

* Patients who had underwent periodontal therapy or antimicrobial therapy in the last 6 months
* Any joint replacement
* Pregnancy/lactating mothers
* Patients having other forms of systemic diseases such as diabetes mellitus, hypertension or acquired immunodeficiency syndrome (AIDS)

Primary outcomes:
measure: Probing depth
timeFrame: 12 weeks
measure: Clinical attachment level
timeFrame: 12 weeks
Secondary outcomes:
measure: Bleeding on probing
timeFrame: 12 weeks
measure: Plaque index
timeFrame: 12 weeks
measure: Interleukin-6
timeFrame: 12 weeks
measure: Tumor necrosis factor alpha
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
References:
Clinical trial NCT00681317: AZD6280 Multiple Ascending Dose Study
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6280 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase I
Pharmacokinetics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-21
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD6280 after single and repeated ascending doses.


Eligibility criteria: Inclusion Criteria:

* Female subjects must be of non-child bearing potential.

Exclusion Criteria:

* Clinically significant illness within 2 weeks before the study start.
* Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
* Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Primary outcomes:
measure: To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs
timeFrame: Assessments are made at each visit, at least daily, during the study.
Secondary outcomes:
measure: Evaluation and characterization of the pharmacokinetics of AZD6280
timeFrame: Blood samples will be taken during the study.
measure: Evaluation of the pharmacodynamic effects of AZD6280
timeFrame: Test batteries will be performed at specified times both before and following study drug administration
measure: Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6280.
timeFrame: A single blood sample will be obtained.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, US
name: Sylvan J. Hurewitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05276817: Perio. Maint. With Diode LBR
Official title: Microbiological Evaluation of Diode Laser Bacterial Reduction as Adjunct to Periodontal Maintenance Treatment: A Pilot Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Periodontitis
Lead sponsor: Biolase Inc
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Split mouth study. For each patient, each quadrant is assigned to a randomized treatment. 4 treatment arms.
Primary purpose: TREATMENT

Brief summary: The primary aim of this pilot study is to determine whether the test methods described feasibly achieve the goal defined for a future clinical study. The purpose is a quantitative assessment of the bactericidal effect of two adjunctive treatments compared to that of conventional periodontal maintenance debridement. Patients who meet eligibility criteria and are enrolled in the study will receive the standard of care, whole mouth periodontal maintenance treatment using ultrasonic scalers to debride deposits within the gingival sulcus. Subsequently, each of three of the quadrants will be randomly assigned to a test group (keeping the fourth quadrant as the control), thus, a "split-mouth" study design. Microbial samples will be collected using sterile paper points inserted into each tooth site involved in the study at baseline (S1) before test treatment and one week after test treatment (S2). Samples will be analyzed with real time qPCR to identify and quantify specific periodontal pathogens. Data analysis will compare the post-treatment results to baseline, the control treatment arm to the test treatment arm, and the test treatments among each other.


Eligibility criteria: Inclusion Criteria:

* • Adults, over 30 years old

  * At least one site in each quadrant having CAL 4-6mm and/or PPD 5-7mm (at least 4 sites per patient) with all adjacent sites having PPD\<5mm
  * Patients who received SRP treatment in the past 12 months, who are returning for routine periodontal maintenance debridement, whose pockets are stable at PPD 5-7mm (not showing improvement or decline)

Exclusion Criteria:

* • Patients who have had periodontal surgery within 12 months

  * A site adjacent to the potential study site having either an implant placed or a PPD\>7mm
  * Patients taking systemic antibiotics or immunosuppressants during or within 3 months of the study
  * Chronic smokers or smokeless tobacco users

Primary outcomes:
measure: Bacteria concentration measured by qPCR
timeFrame: 1 week
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: San Mateo
country: United States
facility: Stephen John, DDS
state: California
Study officials:
References:
Clinical trial NCT06955117: McKenzie vs Manual Therapy for Low Back Pain
Official title: Comparative Study of McKenzie Technique and Manual Therapy for Pain and Function in Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 52
Sex: ALL
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two parallel groups: one receiving McKenzie Technique and the other receiving Manual Therapy. Both groups will receive interventions independently to compare outcomes on pain and function in low back pain patients.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A comparative study evaluating the effectiveness of the McKenzie technique versus manual therapy in patients with nonspecific low back pain. The study aims to assess which intervention is more effective in reducing pain and improving functional mobility.

Detailed description: The study compares McKenzie Method, a directional preference-based approach involving repeated movements and posture correction, against Manual Therapy, which includes hands-on techniques such as mobilizations and manipulations. Patients with nonspecific low back pain will be randomly assigned to one of the two groups and treated over a defined period. Outcomes will be measured using pain and disability scores.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of nonspecific low back pain lasting more than 4 weeks
* Willing to participate and comply with the study protocol

Exclusion Criteria:

* History of lumbar spine surgery
* Presence of spinal fracture, tumor, or infection
* Pregnant women
* Severe osteoporosis or spinal deformity

Primary outcomes:
measure: To assess the change in pain intensity
timeFrame: 6 Months
Secondary outcomes:
measure: Disability score
timeFrame: 6months
Other outcomes:
measure: lumbar range of motion
timeFrame: 6 months
Locations:
city: Malakand
country: Pakistan
facility: Riphah international University Malakand
state: KPK
Study officials:
affiliation: Riphah International University Malakand Campus
name: Dr.Nadeem Ahmad, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01950117: Complete Removal of Neoplastic Large Colorectal Polyps: a Prospective Randomized Comparison of Endoscopic Mucosal Resection or Conventional Polypectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Polyps
Keywords: nonpedunculated
neoplastic
colorectal
polyps
Lead sponsor: Showa Inan General Hospital
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recently, it was reported that the incomplete resection rate of neoplastic large polyps after conventional polypectomy was markedly high in clinical practice. The incomplete resection rate of neoplastic large polyps after endoscopic mucosal resection (EMR) is not known.

The aim of this study is to compare the incomplete resection rate of neoplastic large polyps after EMR or conventional polypectomy. The EMR technique is preferable to conventional polypectomy for the complete resection of the large polyps (\>15 mm in diameter)


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter.

Exclusion Criteria:

* less than 20 years old, history of previous colorectal surgical resection, American Society of Anesthesiologists class III and IV, allergic to propofol used or its components (soybeans or eggs), or poor bowel preparation.

Primary outcomes:
measure: The incomplete resection rate of neoplastic polyps as determined by the histopathologic examination.
timeFrame: Two weeks
Secondary outcomes:
measure: Postpolypectomy bleeding requiring endoscopic intervention within two weeks after polypectomy
timeFrame: Two weeks
Other outcomes:
measure: the procedure time
timeFrame: One day
Locations:
city: Komagane
country: Japan
facility: Showa Inan General Hospital
state: Nagano
Study officials:
References:
Clinical trial NCT03339817: Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose En Plaques (SEP) Sévère
Official title: Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose En Plaques (SEP) Sévère
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Respiration Disorders
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-11-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).


Eligibility criteria: Inclusion Criteria:

* Diagnosis criteria of multiple sclerosis (MS) fulfilling revised McDonald criteria (2010)
* EDSS score from 6.5
* no relapse during the 3 last months
* Informed consent prior to any study procedure

Exclusion Criteria:

* Any severe Chronic Obstructive Pulmonary Disease (III or IV)
* Pregnancy or woman with childbearing potential
* contraindication to MRI

Primary outcomes:
measure: Polysomnography
timeFrame: Baseline only_during one night
Secondary outcomes:
measure: Respiratory function testing
timeFrame: Baseline only
measure: Respiratory function testing
timeFrame: Baseline only
measure: Respiratory function testing
timeFrame: Baseline only
measure: Respiratory function testing
timeFrame: Baseline only
measure: Respiratory function testing
timeFrame: Baseline only
measure: Cerebral and cervical spine MRI
timeFrame: Baseline only
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Baseline only
measure: BICAMS
timeFrame: Baseline only
Other outcomes:
Locations:
city: Paris
country: France
facility: Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière
Study officials:
affiliation: Hopital de la Pitié Salpétrière
name: Maillart Elisabeth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeidan S, Redolfi S, Papeix C, Bodini B, Louapre C, Arnulf I, Maillart E. Unexpected REM sleep excess associated with a pontine lesion in multiple sclerosis. J Clin Sleep Med. 2021 May 1;17(5):1117-1119. doi: 10.5664/jcsm.9114.