louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03240666: Protozoans in Biofilm From Patients With Periodontitis
Official title: Multicentric Clinical Trials on the Prevalence of Entamoeba Gingivalis and Its Associated Bacterial Flora in Patients With Periodontitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontitis, Adult
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nice
name: University Hospital, Toulouse
First posted: 2017-08-07
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting to periodontal department of CHRU (Nancy-Nice- Toulouse) presenting at least two PPD of 5mm and more, without any medecines which could modify microbiota were included in this study

Brief summary: The buccal cavity is colonized by numerous microorganisms whose the number and composition could be modified with medical background (diseases and drugs) and the level of oral hygiene of the patients. Among all microorganisms identified in the periodontium, few of them are implicated in the etiopathogenesis of periodontal pathologies. To date, four major bacteria are identified for their ability to degrade periodontal tissues.

Although the periodontitis is established to be the consequence of bacterial virulence and immune dysfunction, these factors fail to explain the refractory periodontitis of some patients to etiologic treatment .

Others microorganisms such as protozoans could have an impact on this disease.


Eligibility criteria: Inclusion Criteria:

* Adults \> 18 years-old
* consulting in periodontal department of CHRU
* Patients with moderate to severe periodontitis
* At least 2 periodontal sites with PPD ≥ 5mm and one healthy site
* No scaling root planing in the last 6 months
* Patients insured under the Franch social security system

Exclusion Criteria:

* Pregnants patients
* Patients with antibiotic therapy and/ or all medecines which could modify the buccal microbiota in the last 6 months
* Tooth with endodontics periapical lesion
* Patients having a scaling root planing in the last 6 months
* Patients with guardianship

Primary outcomes:
measure: presence of protozoans
timeFrame: 6 months after the last inclusion: DNA samples were frozen and identified later.
Secondary outcomes:
measure: Periodontal pocket depth (PPD in mm)
timeFrame: One day: measure realised during examination of the patient for periodontal treatment.
measure: Clinical attachment Loss (CAL in mm)
timeFrame: One day: measure realied during clincal examination of patient.
measure: Plaque and gingival index
timeFrame: One day: measure of index during the clinical examination of patient.
measure: Mobility of tooth
timeFrame: One day: measure of tooth mobility during the clinical examination of patient.
measure: Bleeding On Probing (BOP)
timeFrame: One day: measure of BOP during the clinical examination of patient.
Other outcomes:
Locations:
city: Nancy
country: France
facility: Catherine BISSON
Study officials:
References:
Clinical trial NCT01920126: The Effect of Sodium Bicarbonate on Postoperative Renal Function in Infective Endocarditis Patients Undergoing Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Keywords: sodium bicarbonate, renal function, infective endocarditis, open heart surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 70
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: PREVENTION

Brief summary: The purpose of study is to test whether perioperative sodium bicarbonate infusion can prevent acute kidney injury following open heart surgery in infective endocarditis patients.


Eligibility criteria: Inclusion Criteria:

* adult patients over the age of 20 scheduled for open heart surgery for infective endocarditis

Exclusion Criteria:

* end stage renal disease (serum creatinine concentration \> 300 μmol/L)
* on dialysis
* chronic moderate to high dose corticosteroid therapy (\> 10 mg/day prednisolon or equivalent)
* preoperative severe hypernatremia (Na+ \> 150 mmol/L), alkalemia (PH \> 7.50), or pulmonary edema
* neurocognitive dysfunction

Primary outcomes:
measure: Comparison of the the peak creatinine level during the postoperative 48h by more than 0.3 mg/dL between two groups.
timeFrame: postoperative 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Cho JS, Soh S, Shim JK, Kang S, Choi H, Kwak YL. Effect of perioperative sodium bicarbonate administration on renal function following cardiac surgery for infective endocarditis: a randomized, placebo-controlled trial. Crit Care. 2017 Jan 5;21(1):3. doi: 10.1186/s13054-016-1591-z.
Clinical trial NCT05722626: The Effects of Intra-articular Platelet-Rich Plasma Injection on The Severity of Knee Osteoarthritis
Official title: The Effects of Intra-articular Platelet-Rich Plasma Injection on The Severity of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Universitas Bali Internasional
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 106
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, randomized control trial The aim of this study is to compare PRP with placebo as the treatment of knee OA Conducted at Puri Raharja Hospital Bali in January-June 2022 Sample consisted of 106 patients with knee OA grades 2-3 Kellgren-Lawrence, randomized into PRP group and placebo group Samples were injected with 2 ml PRP or normal saline twice at one-week interval The severity of knee OA was assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) before injection and two weeks after the first injection.


Eligibility criteria: Inclusion Criteria:

patients with knee pain for at least three months, aged between 40 to 80 years old, and whose results of radiological examination of the knee indicated OA grades 2-4 based on the Kellgren Lawrence classification

Exclusion Criteria:

polyarticular rheumatic disease; knee arthroscopy \<1 year; intra-articular injection of hyaluronic acid (HA) or steroids in the past three months; current infection, diabetes, rheumatoid arthritis, coagulopathy disorders, anticoagulant or antiplatelet aggregation therapy, immunodeficiency disease, taking non-steroidal anti-inflammatory drugs (NSAIDs) two weeks prior to the procedure, knee trauma; inflammation; and tumors around the knee

Primary outcomes:
measure: WOMAC
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Puri Raharja Hospital
state: Bali
Study officials:
affiliation: Warmadewa University
name: Anak Agung Sagung Mirah Prabandari, dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01180426: Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia
Official title: The TOPAZ Study: A Long-Term Extension Study in Elderly Subjects With Relapsed/Refractory Acute Myeloid Leukemia to Allow Continued Therapy With Tosedostat
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Relapse Refractory Acute Myeloid Leukemia
Lead sponsor: Chroma Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.

Detailed description: Extension protocol to the OPAL Study (CHR-2797-038).

Study mimics normal clinical practice; few procedures and visits are therefore mandated by the protocol. Timing of bone marrow assessment is also left at the investigator's discretion.

Eligibility criteria: Inclusion Criteria:

* Signed, informed consent
* Completion of Visit 11 in the OPAL Study (Month 6 Visit)
* Investigator's opinion that the subject would benefit from continued therapy with tosedostat.

Exclusion Criteria:

* Any co-existing medical condition that in the Investigator's opinion will substantially increase the risk associated with the subject's participation in the study
* Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
* Administration of any (other) investigational agent within 14 days of entry into TOPAZ.

Primary outcomes:
measure: Safety and Tolerability of extended treatment with tosedostat
timeFrame: Protocol mandated visits every 12 weeks
Secondary outcomes:
measure: Efficacy of extended treatment with tosedostat
timeFrame: Protocol-mandated visits every 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Division of Hematology/Oncology
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Hackensack
country: United States
facility: John Theurer Cancer Center
state: New Jersey
city: New York
country: United States
facility: New York Presbyterian Hospitacl
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
References:
Clinical trial NCT01145326: Functional Microarray Augmentation of Skin Treatment With Lidocaine
Official title: Functional Microarray Augmentation of Skin Treatment With Lidocaine (FAST Lidocaine)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Pain Perception
Phlebotomy
Keywords: venipuncture
phlebotomy
pain perception
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2010-06-16
Enrollment: 0
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: The purpose of this study is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided. A secondary goal is to determine whether the depth of anesthesia is enhanced.

Detailed description: The study's primary goal is to determine whether co-application of a functional microarray of needles (FMA) speeds the rate at which topical anesthesia is provided by lidocaine gel 4% (LG4). A secondary goal is to determine whether the depth of anesthesia is enhanced.

Eligibility criteria: Inclusion Criteria: age at least 18 years, must provide voluntary consent, weight at least 50 kg, no allergies to lidocaine, no skin disease, inflammation, or infection at the venipuncture sites to be tested

Exclusion Criteria: cannot have any major dermatologic disease history, known liver abnormalities, women who are currently breastfeeding

Primary outcomes:
measure: Venipuncture pain levels
timeFrame: 1 hour
Secondary outcomes:
measure: Undesirable side effects
timeFrame: 1 day
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Oklahoma Schusterman Clinic
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Stephen H. Thomas, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04977726: Resilience Curriculum for Novice Physicians-in-training
Official title: Resilience Curriculum for Novice Physicians-in-training: a Randomized Controlled, Feasibility Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Emotional
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Western University
First posted: 2021-07-27
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To determine the feasibility of delivering a structured resilience curriculum to novice physicians-in-training, we propose a pilot study to evaluate recruitment rates, course attendance and compliance with follow-up surveys. If our study can demonstrate feasibility in course delivery, further engagement of postgraduate specialty programs will facilitate conduct of an appropriately powered randomised controlled trial.


Eligibility criteria: Inclusion Criteria:

* All first and second year medical residents enrolled in the Schulich School of Medicine \& Dentistry Anesthesia \& Emergency Medicine postgraduate residency programs.

Exclusion Criteria:

* None

Primary outcomes:
measure: Participant Recruitment Potential
timeFrame: 9 months
measure: STRIVE Course Completion
timeFrame: 9 months
measure: Follow-up Survey Compliance
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
measure: Self-Reported Resilience at 3 months
timeFrame: 9 months
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT01557426: Soft Tissue Ultrasound of Infections
Official title: Soft Tissue Ultrasound of Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Soft Tissue Infections
Cellulitis
Abscess
Keywords: skin
soft tissue
infection
cellulitis
abscess
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2012-03-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Objectives:

This study aims to characterize severe skin and soft tissue infections (SSTIs) in the emergency department through the acquisition of ultrasound images. A wide range of SSTIs will be imaged and recorded, leading to a registry of these infections. The registry will show whether ED (emergency department) sonographers can accurately characterize these infections, as compared to the final hospital diagnosis. The registry will also provide data for a case-control study comparing ultrasonographic characteristics of necrotizing skin and soft tissue infections (NSTIs) to those of non-necrotizing SSTIs.

Research procedures:

In this study, the investigators will approach patients who present to the Emergency Department with a possible skin and/or tissue infection. Study subjects must be ED patients requiring admission to the hospital for the primary problem of an SSTI due to the need for follow-up. If the patient consents to participating in the study, the investigator will obtain and record an ultrasound image of the infected area. An ultrasound image of an uninfected area of skin will also be recorded for comparison. Patient information regarding personal history, physical examination, blood tests and x-rays will also be gathered from participants.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Ability to understand risks/benefits and consent to participation in the study
* Ability to read and understand English or Spanish
* Primary diagnosis for admission is SSTI, including cellulitis, abscess, fasciitis, myositis
* Requiring admission to an inpatient service

Exclusion Criteria:

* Patients in custody of law enforcement
* Patients on a psychiatric hold

Primary outcomes:
measure: Discharge diagnosis
timeFrame: 2 years
Secondary outcomes:
measure: Disposition after admission
timeFrame: 2 years
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Otto Liebmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05460026: Effects Of Power Ball Exercises In Addition To Routine Physical Therapy In Patients With Carpal Tunnel Syndrome
Official title: Effects Of Power Ball Exercises In Addition To Routine Physical Therapy On Pain, Grip Strength And Functional Disability In Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Physical therapy
Median Neuropathy
Power Ball Exercise
Carpal Tunnel Syndrome
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-07-15
Enrollment: 86
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose for doing this study is to determine that whether use of Power Ball in form of resistance training will be effective in increasing grip strength in carpel tunnel syndrome patient and possible benefits of the regime as effective means of rehabilitation for wrist and hand injuries. Moreover for increasing grip strength it can be used as an adjunct for physical therapy treatment.


Eligibility criteria: Inclusion Criteria:

1. Age group 45-60 years
2. Both male and female
3. Clinically diagnosed carpal tunnel syndrome
4. Carpal Tunnel Syndrome for a duration of more than 02 months
5. Tingling sensation and numbness over the dorsal surface of thumb, index, middle, and lateral 1/3rd of ring fingers
6. Positive Tinel's sign
7. Positive Phalen's Maneuver

Exclusion Criteria:

1. Any previous trauma, fracture, subluxation, dislocation, surgery or bony abnormalities around wrist joint in the past 5 years.
2. Symptomatic Arthritis of wrist joint
3. Cervical radiculopathy
4. Corticosteroid injection within 3 months

Primary outcomes:
measure: Pain Intensity
timeFrame: Change in pain will be measured at initial visit, at sixth session and at the twelfth session.
measure: Grip Strength
timeFrame: Change in grip strength will be measured at initial visit, at sixth session and at the twelfth session.
measure: Functional Disability
timeFrame: Change in functional disability will be measured at initial visit, at sixth session and at the twelfth session.
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Ashfaq Ahmed, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03926026: Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
Official title: A Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation, Phase 2 Study Evaluating the Safety and Tolerability of NCX 4251 (Fluticasone Propionate Nanocrystal) Ophthalmic Suspension, 0.1% QD and BID for the Treatment of Acute Exacerbations of Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blepharitis
Lead sponsor: Nicox Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: sequential dose-escalating cohorts -- Cohort 1 (2 parallel groups) and Cohort 2 (2 parallel groups)
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2 study evaluating the safety and tolerability of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD and BID for the treatment of acute exacerbations of blepharitis. The study will be performed in two sequential dose escalating cohorts.

The study is designed to select the dose(s) of NCX 4251 to advance into the next stage of development, and to assess the safety and tolerability of NCX 4251 Ophthalmic Suspension.


Eligibility criteria: Inclusion Criteria:

* history of blepharitis and meet qualifying criteria for an acute exacerbation of blepharitis in both eyes at Screening and Baseline/Day 1 Visits
* have a qualifying best-corrected visual acuity

Exclusion Criteria:

* abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid surgery
* IOP \> 21 mmHg at Screening or Baseline/Day 1 Visits
* use of steroids in the past 30 days or retinoids in the past 12 months
* uncontrolled systemic disease

Primary outcomes:
measure: COHORT 1 and 2 COMBINED: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis
timeFrame: 14 days
Secondary outcomes:
measure: COHORT 2: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis
timeFrame: 14 days
measure: COHORT 1: Mean Change From Baseline to Day 14 in the Composite (Sum) Score of Signs & Symptoms of Blepharitis
timeFrame: 14 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Texan Eye
state: Texas
Study officials:
affiliation: Nicox Ophthalmics, Inc.
name: Nicox Ophthalmics
role: STUDY_DIRECTOR
References:
Clinical trial NCT03209726: Assessment of S-ICD Eligibility With 12-Lead ECG
Official title: Assessment of Subcutaneous Implantable Cardioverter Defibrillator Eligibility With 12-lead Electrocardiogram
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implantable Defibrillator User
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing ICD implantation for currently approved indications.

Brief summary: The primary objective of this study is to develop an approach to determine eligibility for subcutaneous ICD by analyzing routine clinical 12-lead electrocardiogram.


Eligibility criteria: Inclusion Criteria:

* medical condition, predisposing patient to life-threatening ventricular arrhythmias, eligible for currently approved ICD indications for primary or secondary prevention of sudden cardiac death

Exclusion Criteria:

* Acute medical condition (e.g. acute myocardial infarction, severe trauma, post-surgery, admitted to ICU)
* End stage organ failure
* Pregnancy
* Patient, legal guardian or authorized representative is unable or unwilling to cooperate or give written informed consent

Primary outcomes:
measure: Amplitudes of R- and T-waves (and R/T ratios) on a special precordial ECG
timeFrame: at the day of ECG recording (cross-sectional study)
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References:
citation: Thomas JA, Perez-Alday EA, Hamilton C, Kabir MM, Park EA, Tereshchenko LG. The utility of routine clinical 12-lead ECG in assessing eligibility for subcutaneous implantable cardioverter defibrillator. Comput Biol Med. 2018 Nov 1;102:242-250. doi: 10.1016/j.compbiomed.2018.05.002. Epub 2018 May 8.
citation: Wang L, Javadekar N, Rajagopalan A, Rogovoy NM, Haq KT, Broberg CS, Tereshchenko LG. Eligibility for subcutaneous implantable cardioverter-defibrillator in congenital heart disease. Heart Rhythm. 2020 May;17(5 Pt B):860-869. doi: 10.1016/j.hrthm.2020.01.016.