louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00855933: A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Official title: A Controlled Clinical Study to Determine the Gingivitis Benefit of Flossing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gingivitis
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, examiner-blind, parallel group, four week clinical study comparing brushing plus flossing to brushing alone in healthy adults with mild-to-moderate gingivitis.


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age;
* physically able to floss his/her teeth;
* refrained from performing oral hygiene the morning of the Baseline visit;
* have measurable gingivitis on at least 5 test sites;
* in good general health.

Exclusion Criteria:

* severe periodontal disease
* atypical discoloration or pigmentation in the gingival tissue;
* meaningful malocclusion of the anterior teeth;
* fixed facial orthodontic appliances;
* use of antibiotics within two weeks of the baseline visit and at any time during the study;
* any diseases or conditions that could be expected to interfere with the subject safely completing the study.

Primary outcomes:
measure: Whole Mouth Lobene Modified Gingival Index Between the Brushing Only Group and the Brushing + Flossing Group [30 Days] Units on the MGI Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Dr. Geza Terézhalmy, DDS , MA
state: Texas
city: Guatemala City
country: Guatemala
facility: Luis R. Archila, DDS
Study officials:
affiliation: Procter and Gamble
name: Aaron Biesbrock, DMD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03030833: Dysfunctional Hemoglobin Pulse Oximetry
Official title: Dysfunctional Hemoglobin Pulse Oximeter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carbon Monoxide Poisoning
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2017-01-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy male and females.

Brief summary: The purpose of the study is to assess device performance in the presence of carbon monoxide.


Eligibility criteria: Inclusion Criteria:

* The subject is male or female.
* The subject is of any racial or ethnic group.
* The subject is between 18 years and 50 years of age (self-reported).
* The subject does not have significant medical problems (self-reported).
* The subject is willing to provide written informed consent and is willing and able to comply with study procedures.
* Exclusion Criteria:
* Has a BMI greater than 30.0 (calculated from self-reported weight and height).
* Has had any relevant injury at the sensor location site (self-reported).
* Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).
* Has a known respiratory condition (self-reported).
* Is currently a smoker (self-reported).
* Has a known heart or cardiovascular condition (self-reported).
* Is currently pregnant (positive serum pregnancy test at screening visit or positive urine POC test on day of study).
* Is female and actively trying to get pregnant (self-reported).
* Has a clotting disorder (self-reported).
* Has Raynaud's Disease (self-reported).
* Is known to have anemia (hemoglobin value below lower range of normal for gender)
* Is known to have a hemoglobinopathy such as sickle-cell anemia or thalassemia (abnormal hemoglobin electrophoresis).
* Is known to have a inherited or congenital methemoglobinemia (self-reported).
* Has unacceptable collateral circulation from the ulnar artery (based on exam).
* Is unwilling or unable to provide written informed consent to participate in the study.
* Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.

Primary outcomes:
measure: Carboxyhemoglobin accuracy
timeFrame: Through study completion, an average of 3 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: HPPL Duke Univeristy
state: North Carolina
Study officials:
affiliation: Duke University
name: David B MacLeod, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03185533: Reducing Length of Stay in the Emergency Department
Official title: Reducing Length of Stay in the Emergency Department: Analyzing the Factors and Quality Improvement Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Length of Stay
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 72000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients were registered in the ED of the Hsin-Chu branch from Jan, 2015 to Dec, 2015.

Brief summary: Emergency department (ED) crowding has become an international challenge in the recent decades.

Length of stay (LOS) is a useful marker to monitor ED crowding. Searching for the possible causes and reducing barriers may have the greatest impact on EDLOS.

Therefore, the investigators assembled a multidisciplinary team for improvement of the ED process, to undergo assessments of ED patient flow with the spirit of lean-sigma methodologies. The objectives of this study were to evaluate a Lean-sigma-based initiative to lessen EDLOS.

Detailed description: Lean aims to smooth out the workflow and to eliminate wastes. In the ED settings, lean principles can display the process of the ED patient flow. Six sigma, a complementary strategy, has the merit to compensate the potential weakness of Lean through a data-driven process. Currently, a combination of Lean and Six sigma methodologies develops to solve the problems of workflow.

It became clear that concurrent multifaceted interventions were needed to reduce EDLOS. Therefore, the investigators assembled a multidisciplinary quality improvement team for improvement of the ED process, to undergo assessments of ED patient flow with the spirit of lean-sigma methodologies. The objectives of this study were to evaluate a Lean-sigma-based initiative to lessen EDLOS.

Eligibility criteria: Inclusion Criteria:

* the patients were registered in the ED from Jan, 2015 to Dec, 2015.

Exclusion Criteria:

* the patients were excluded because of left without seeing a physician.

Primary outcomes:
measure: length of stay for ED admissions.
timeFrame: 12 months
Secondary outcomes:
measure: boarding time for ED admissions
timeFrame: 12months
measure: decision time for ED admissions
timeFrame: 12 months
measure: the percentage of LOS over 24 hours in all ED patients.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01817933: Integrated Rehabilitation Program for Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Humeral Neck Fracture
Vertebral Fracture
Distal Radial Fracture
Hip Fractures
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2013-03-26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The recovery of range of motion and muscle power after surgical intervention of the fracture will mostly affect patient's daily activities. So postoperative rehabilitation program will play the important role. Correct and effective physical therapy will reduce the functional impairment of limbs after long term casting or surgical fixation, and accelerate to recover the independent daily activities. There is no consensus between immediate or delay and the duration of continue physical therapy will improve the shoulder function、muscle power and degree of satisfaction( physiological function、social function、mental health、 pain、 general health status ) after surgical fixation of fractures. This study will evaluate the patients of the fracture that including of the humeral neck fracture, vertebral fracture, distal radial fracture and hip fractures after surgical fixation, to see the difference of fracture healing time, function recovery and pain sensation after intervention of physical therapy at different time point.

From this study, we hope to discriminate the timing of intervention and duration of physical therapy which is the key factors for postoperative prognosis of fractures fixation, and to set up the perfect rehabilitation program in ChangHua Christian Hospital. The results of this study will improve the discomfort of fracture patient's recovery or reduce the complications rate, and set up the standard treatment policy of our hospital , also was the model of other hospitals.


Eligibility criteria: Inclusion Criteria:

* patients with humeral neck fracture, vertebral fracture, distal radial fracture or hip fractures after surgical fixation

Exclusion Criteria:

* no

Primary outcomes:
measure: Change in pain degree
timeFrame: 1 month after surgical fixation
Secondary outcomes:
measure: Change in range of motion at the fracture area
timeFrame: 1 month after surgical fixation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01863433: A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
Official title: A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2013/2014 Formulation of a bioCSL Split Virion, Inactivated Influenza Vaccine in Healthy Volunteers Aged 18-60 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated influenza vaccine containing the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged between 18 and 60 years.


Eligibility criteria: Inclusion Criteria:

* Males or females aged between 18 and 60 years at the time of vaccination.
* Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Exclusion Criteria:

* Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
* Clinical signs of an active infection.
* A clinically significant medical condition.
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
* Females who are pregnant or lactating.

Primary outcomes:
measure: The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
timeFrame: Approximately 21 days after vaccination
measure: The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
timeFrame: Approximately 21 days after vaccination
measure: The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
timeFrame: Approximately 21 days after vaccination
Secondary outcomes:
measure: Type and Frequency of Any Solicited Adverse Events (AEs)
timeFrame: During the 4 days after vaccination (Day 0 plus 3 days)
measure: Type and Frequency of Any Unsolicited AEs
timeFrame: After vaccination until the end of the study; approximately 21 days.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Study Site
Study officials:
affiliation: Seqirus
name: bioCSL Head of Clinical Operations
role: STUDY_DIRECTOR
References:
Clinical trial NCT05847933: Influence of Temporo-occipital Transcranial Magnetic Brain Stimulation on Aversive Episodic Memory Performance
Official title: A Pilot Study on the Influence of Temporo-occipital Transcranial Magnetic Brain Stimulation on Aversive Episodic Memory Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Memory, Episodic
Keywords: memory
Transcranial magnetic brain stimulation
emotional valence
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2023-05-08
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: A pilot study, examining the effect of repeated transcranial magnetic brain stimulation (rTMS) on the formation of memories with negative valence. The investigators hypothesize that an effective rTMS protocol to reduce memory performance for adverse events can be found.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Generally healthy
* Normotensive (BP 90/60mmHg - 140/90mmHg)
* BMI: 19 - 30 kg/m2
* Age: 18 - 30 years
* Fluent German-speaking

Exclusion Criteria:

* Metal in the brain, skull or elsewhere in the body (e.g., splinters, fragments, clips, etc.)
* Implanted neurostimulator (e.g., DBS, epidural/subdural, VNS)
* Cardiac pacemaker or intracardiac lines
* Medication infusion device
* Nonremovable Piercings in the head area, pivot teeth (retainers are no exclusion criterion)
* Tattoos (head area) less than 3 months old or older than 20 years
* Condition after neurosurgery
* Hearing problems or tinnitus
* Not able to sit still due to tremor, tics, itching
* History of repeated syncope
* Head trauma diagnosed as concussion or associated with loss of consciousness
* diagnosis of epilepsy, or a convulsion or a seizure in the past of the participant or his/her close family
* TMS in the past showing problems
* Surgical procedures to spinal cord
* Spinal or ventricular derivations
* Alcohol or drug intake 48 hours before start of visits
* Regular intake of any medication or CNS-active medication 48h before visit
* rMT above the limits of rTMS device.

Primary outcomes:
measure: memory recall performance
timeFrame: On average 1 hour after intervention
Secondary outcomes:
measure: Working memory performance
timeFrame: On average 1 hour after intervention
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel, Division of Cognitive Neuroscience
state: BS
Study officials:
affiliation: University of Basel, Research Platform Molecular and Cognitive Neuroscience
name: Dominique de Quervain, Prof. MD
role: STUDY_CHAIR
References:
Clinical trial NCT04055233: Reduction of Postoperative Wound Infections by Antiseptica?
Official title: Reduction of Postoperative Wound Infections by Antiseptica?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Site Infection
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm prospective randomized single center interventional trial. 1:1 randomization into experimental arm (irrigation with polyhexanide) and control arm (irrigation with saline).
Primary purpose: TREATMENT

Brief summary: Wound infections are a frequent complication in abdominal surgery. The investigators hypothesize that the antiseptic solution 0.04 % polyhexanide (serasept) may reduce occurrence of postoperative wound infections compared to NaCL (saline) solution in a prospective randomized setting.

Detailed description: Invstigator initiated monocenter randomized controlled trial. Intraoperative irrigation of subcutaneous tissue with NaCl (saline) solution or antiseptic solution 0.04 % polyhexanide (Serasept) in elective abdominal surgery. Primary endpoint: SSI 30 days postoperatively according to CDC criteria.

Eligibility criteria: Inclusion Criteria: - planned laparotomy for visceral surgery

Exclusion Criteria:

* Age under 18 years
* allergy against polihexanid
* laparoscopic surgery
* emergency surgery
* lack of understanding of the trial

Primary outcomes:
measure: surgical site infection
timeFrame: 30 days postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin-Steglitz
country: Germany
facility: Charité Campus Benjamin Franklin
state: Berlin
Study officials:
affiliation: Charité-University Medicine (Berlin, Germany)
name: Johannes C Lauscher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strobel RM, Leistner R, Leonhardt M, Neumann K, Eschlbock SM, Lee LDG, Seifarth C, Schineis CHW, Kamphues C, Weixler B, Beyer K, Lauscher JC. Is There an Association between Intra-Operative Detection of Pathogens in Subcutaneous Tissue and Surgical Site Infections? Results from a Prospective Study. Surg Infect (Larchmt). 2022 May;23(4):372-379. doi: 10.1089/sur.2021.154. Epub 2022 Mar 9.
citation: Strobel RM, Leonhardt M, Krochmann A, Neumann K, Speichinger F, Hartmann L, Lee LD, Beyer K, Daum S, Kreis ME, Lauscher JC. Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial. Ann Surg. 2020 Jul;272(1):55-64. doi: 10.1097/SLA.0000000000003645.
Clinical trial NCT03839433: The Mannitol-Asthma-Ciclesonide-Study
Official title: Ciclesonide for the Treatment of Airway Hyperresponsiveness: The Mannitol-Asthma-Ciclesonide-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma, Bronchial
Keywords: Asthma
Lead sponsor: Cantonal Hosptal, Baselland
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Response of a 4 weeks treatment with daily once 320 µg ciclesonide on airway hyperresponsiveness assessed with mannitol.

Hypothesis: Treatment with inhaled ciclesonide reduces airway hyper-responsiveness in 80% of hyper-responsive patients compared to 20% only in the placebo group and the group without airway hyper-responsiveness.


Eligibility criteria: Inclusion Criteria:

* Referred to the pulmonology department of the university hospital Basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness.
* Asthma symptoms partly controlled according to GINA (Global Initiative for Asthma, October 2006) 1 week prior to randomization
* FEV1 ≥ 70% predicted

Exclusion Criteria:

* Smoker and ex-smoker with \>10 pack years
* COPD (chronic obstructive pulmonary disease)
* Upper respiratory tract infection within the past 4 weeks.
* ICS or oral steroids during the previous month before inclusion
* beta-blockers within the past 4 weeks
* Current treatment with medication as defined in section concomitant medication (ICS other than study medication, ß-blockers)
* Pregnancy
* Known malignancy

Primary outcomes:
measure: Change of hyperresponsiveness to mannitol by measuring PD15 FEV1 after 4 weeks (improvement of more than at least 1.5 doubling dose)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in PD20 FEV1 methacholine (Responsiveness to metacholine)
timeFrame: 4 weeks
measure: Change in FeNO (Nitric Oxide)
timeFrame: 4 weeks
measure: Change in ACQ (Asthma Control Questionnaire)
timeFrame: 4 weeks
measure: AQLQ (Asthma Quality of Life Questionnaire)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04930133: Retrospective Multi-cohort Study of Frontline Afatinib Followed by 2nd Line Therapy Including Osimertinib, Chemotherapy or Other Therapy
Official title: Totality Outcome of Afatinib Sequential Treatment in Patients With EGFR Sensitizing Mutation-positive NSCLC in South Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC
Keywords: T790
afatinib
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2021-06-18
Enrollment: 737
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: non-interventional, multi-center, multi-cohort

Brief summary: The T790M mutation is highly sensitive to osimertinib, which is approved in this setting following failure of gefitinib, erlotinib or afatinib. In contrast to first- and second-generation EGFR TKIs, no predominant resistance mechanism to first-line osimertinib has been clearly defined yet. The most common mechanisms of resistance were c-MET amplification only for 15% of patients and the emergence of the EGFR C797S mutation in 7%, while \> 60% of patients were still with no identifiable mechanisms of resistance. As a result, targeted treatment options following first-line osimertinib failure remain limited. Thus, interest on sequential administration of EGFR TKIs in patients with EGFR mutation-positive NSCLC has been growing. So, here in this study, we intend to investigate treatment outcome (TOT) along with the several treatment options starting from the first line EGFR TKI treatment to various second line treatments including 3rd generation TKI and chemotherapy and others.


Eligibility criteria: Inclusion Criteria:

1. Age more than 18 years
2. Stage IIIB/IIIC/IV/IVA/IVB NSCLC patients treated with first-line afatinib for EGFR sensitizing mutations (Del19, L858R, G719X, S768I, or L861Q etc.)
3. Afatinib treatment was started 13 month prior to data collection date to reduce premature censoring of patients. Data cutoff date will be determined before data entry starts.

Exclusion Criteria:

1. Patients who received drug(s) other than afatinib (Giotrif®) as the first-line treatment
2. Patients who received drug(s) other than 3rd-generation EGFR TKI osimertinib as the second-line in "Cohort A'

Primary outcomes:
measure: Total TOT
timeFrame: Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).
Secondary outcomes:
measure: objective response rate (ORR-1 & ORR-2's)
timeFrame: Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).
measure: overall survival time
timeFrame: Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin Hyoung Kang
Study officials:
affiliation: Seoul St. Mary's Hospital, The Catholic University of Korea
name: Jin Hyoung Kang
role: STUDY_CHAIR
References: