louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03046082: Anaerobic Antibiotic Usage for Pneumonia in the Medical Intensive Care Unit
Official title: Anaerobic Antibiotic Usage for Pneumonia in the Medical Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the intensive care unit with a diagnosis of pneumonia.

Brief summary: Observation of prescription usage of anaerobic antibiotics for patients admitted to the ICU with pneumonia.

Detailed description: Pneumonia is a common admitting diagnosis in the intensive care unit (ICU). When aspiration is suspected, antibiotics to cover anaerobes are frequently used , but in the absence of clear risk factors, current guidelines have questioned their role. It is unknown how frequently these guidelines are followed.

Eligibility criteria: Inclusion Criteria:

* ICU patients with diagnosis of pneumonia

Exclusion Criteria:

* patients with abdominal infections such as c diff.

Primary outcomes:
measure: Usage of anaerobic antibiotics
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04548882: Calypso Knee System Clinical Sub-study, OUS Continued Evaluation
Official title: Continued Evaluation of the Calypso Knee System for Symptom Relief in Subjects With Medial Knee Osteoarthritis, OUS
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Moximed
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 0
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
Intervention model description: Single-arm study design
Primary purpose: TREATMENT

Brief summary: Calypso Knee System Clinical Study, OUS for subjects with symptomatic osteoarthritis of the medial compartment of the knee. The sub-study will achieve continued evaluation of the safety and clinical effectiveness of the Calypso Knee System.

Detailed description: This sub-study will be a single-arm, prospective, multi-center sub-study for continued evaluation of the safety and clinical effectiveness of Calypso Knee System using an additional measure of post-operative activity improvement.

Eligibility criteria: Inclusion Criteria:

1. Participants age - 25 to 65 years
2. Body Mass Index (BMI) of \< 35, Weight \< 300 lbs
3. Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment

Exclusion Criteria:

1. Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee
2. Knee ligament or meniscal instability
3. Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease, Charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results

Primary outcomes:
measure: The primary endpoint of this pilot study is the rate of individual subject success at 24 months. A subject will be declared a clinical success if all of the following conditions are met
timeFrame: Change at 24 months relative to baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Moximed
name: Alexandra Kraenzlin
role: STUDY_DIRECTOR
References:
Clinical trial NCT00813982: Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses
Official title: Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.


Eligibility criteria: Inclusion Criteria:

* Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day
* On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses
* Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

* Requires concurrent ocular medication
* Eye injury or surgery within twelve weeks immediately prior to enrollment
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
* Any active corneal infection
* Any use of medications for which contact lens wear would be contraindicated
* History of corneal refractive surgery
* Wears toric contact lenses
* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Overall Vision
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02344082: Pharmacists Provide Telemedicine in Addition to Clinic Visits to Improve Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This prospective study will include both an intervention and control arm. The control arm will receive face-to-face pharmacy clinic visits per standard of care. The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up. Patients with a hemoglobin A1c in the last 3 months greater than 9% will be eligible. Eligible patients must have a primary care physician at Johns Hopkins Outpatient Center (JHOC) or East Baltimore Medical Center (EBMC).

Purpose: To compare the change in hemoglobin A1c over the 3 month study period in the intervention group in which patients participate in telemedicine, to a control group in which they do not


Eligibility criteria: Inclusion Criteria:

* Adult patients with a primary care provider at JHOC or EMBC
* Patients have seen primary care provider within last 6 months
* Patients with hemoglobin A1c greater than 9%

Exclusion Criteria:

* Patients \<18 years of age
* Patients with previously established care with JHH ambulatory care pharmacist
* Patients with communication barriers who do not have a caregiver
* Patients with new diagnosis of diabetes
* Patients who are pregnant or planning to become pregnant during the time of the study
* Patients followed by Endocrinology or Diabetes Center

Primary outcomes:
measure: Change in hemoglobin A1c
timeFrame: 3 months
Secondary outcomes:
measure: Patient adherence to office visits (# visits attended/# of visits scheduled)
timeFrame: 3 months
measure: Pharmacist interventions (Number of pharmacist interventions (lifestyle or medication changes) made)
timeFrame: 3 months
measure: Patient satisfaction (Based on survey results)
timeFrame: 3 months
measure: Telemedicine in Usual Care (Percent of patients who receive telephone call under usual care)
timeFrame: 3 months
measure: Telemedicine Adherence (Percent of telephone encounters completed in intervention arm)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04743882: A Comparison of the Analysis of the Force on the Supporting Legs of Female Athletes of Different Levels Playing Football
Official title: A Comparison of the Analysis of the Force on the Supporting Legs of Female Athletes of Different Levels Playing Football
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Condition Angle, Angular Velocity, Linear Velocity, Moment, Ground Reaction Force, Hip Joint, Knee Joint, Ankle Joint
Lead sponsor: Universidad Politecnica de Madrid
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy female athletes with good kicking skills

Brief summary: In this study, we grouped athletes into different training levels, and tested the force on the supporting legs of female athletes at different times when they kicked the ball.

Detailed description: In this study, first we divided the subjects into three levels: A, B, and C. After fully warming up, we asked the subjects to perform five full kicks. The kicking process was captured with a Vicon high-speed camera. The data captured by the motion capture system was then analyzed to analyze the angles, angular velocity, linear velocity, and ground reaction force of the hip, knee, and ankle joints of the hip, knee, and ankle supporting legs of female athletes of different levels during full kicks. Finally, the subjects of different levels are analyzed to find the significant differences in the supporting legs of female football players of different levels.

Eligibility criteria: Inclusion Criteria:

* Master kicking skills Have not suffered any injury of lower limbs in the past six months

Exclusion Criteria:

* Unable to complete the kick Has suffered a lower limb injury in the past six months

Primary outcomes:
measure: hip
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: UPM
Study officials:
References:
Clinical trial NCT06576882: 7 Days vs. 14 Days of Vonoprazan-based Triple Therapy for H. Pylori Eradication
Official title: 7-day Versus 14-day Vonoprazan-based Triple Therapy for Eradication of H. Pylori in Adolescents: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Gastritis
Vonoprazan
Adolescents
Keywords: Helicobacter pylori
Vonoprazan
Triple therapy
Adolescent
Eradication rate
Children
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 326
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 assignment.
Primary purpose: TREATMENT

Brief summary: The study aims to test the efficacy of 7 days vs. 14 days of Vonoprazan-triple therapy in the eradication of Helicobacter Pylori infection in adolescents and young children.

Detailed description: After being informed about the study details, all eligible participants (or their legal guardians) will give informed written consent to be involved. After a one week screening, eligible participants will be randomized to Vonoprazan plus Amoxicillin plus Clarithromycin triple therapy for either 14 days (group 1), or 7 days (group 2) at a 1:1 ratio. After the end of therapy, H. Pylori eradication will be evaluated after 4 weeks.

Eligibility criteria: Inclusion Criteria:

1. Participants in the age group (10-18 years), both genders, referred with dyspeptic complaints such as heartburn, dyspepsia, nausea, and epigastric pain who are positive for H. Pylori infection by a standardized diagnostic test.
2. Pediatric patients with a clinical, laboratory, and endoscopic diagnosis of H.P.-positive gastritis and the other conditions necessary for H.P. eradication, according to the Maastricht V consensus report .

Exclusion Criteria:

1. allergy to any of the drugs used in the study
2. previous attempts to eradicate H.P.
3. receipt of antibiotics, PPIs, bismuth, H2 antagonists or probiotics within 4 weeks of the study.
4. Children with the diagnosis of any condition that might affect the absorption of drugs such as celiac disease or Crohn's disease.
5. hepatic impairment or kidney failure.
6. symptoms suggestive of functional disorders.

Primary outcomes:
measure: H. Pylori eradication rate
timeFrame: 4 weeks after completion of treatment
Secondary outcomes:
measure: Adverse events during treatment.
timeFrame: From first dose of treatment until 7 or 14 days of treatment regimen assigned.
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine, Alexandria University.
Study officials:
affiliation: Alexandria University
name: Sameh A Lashen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03521882: Timed Interval Measurement of Eotaxin in Stroke Study
Official title: Timed Interval Measurement of Eotaxin in Stroke Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Lead sponsor: Royal Devon and Exeter NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals presenting to hospital with focal neurological symptoms suggestive of stroke aged over 18 years.

Brief summary: Stroke is caused by sudden changes in blood flow in the brain. This can be fatal or can result in permanent disability. A fast diagnosis is essential to initiate effective interventions and optimize benefits to patients. There are other diseases that can look like a stroke and these are called "stroke mimics". The quicker that stroke mimics can be ruled out the faster a stroke can be diagnosed and treatment can be given. The investigators may be able to use chemicals in the blood to rapidly confirm that a person has had a stroke. One such chemical is called eotaxin. Eotaxin has been found to be changed in sufferers of a stroke but not in those with stroke mimics. However, more research is needed to confirm the usefulness of eotaxin. This feasibility study aims to provide the foundations to allow a large scale trial of this test. The study aims to recruit participants that have had a stroke or a stroke mimic from the Acute Stroke Unit and Stroke clinic at the Royal Devon and Exeter Hospital. Up to 6 blood samples will be taken from each participant at different times over one week. Eotaxin will be measured in these samples and in participant's leftover samples taken for clinical care. This is needed because the investigators know that the amount of eotaxin changes in the blood after a stroke but we do not know how quickly this change happens and for how long the change occurs. The study will also allow the investigators to understand how many participants will be needed for a large scale trial and the challenges that may be faced in recruiting participants.


Eligibility criteria: Inclusion Criteria:

* Presenting with focal neurological symptoms suggestive of stroke
* Aged over 18 years

Exclusion Criteria:

* Presenting later than 12 hours after symptom onset
* Under 18 years of age
* History of cardiovascular disease (Healthy Controls)
* History of neurological disease (Healthy Controls)
* History of stroke mimics (Healthy Controls)

Primary outcomes:
measure: Primary Outcome
timeFrame: 0 to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: Royal Devon & Exeter NHS Foundation Trust
state: Devon
Study officials:
affiliation: Royal Devon and Exeter NHS Foundation Trust
name: Salim Elyas, PhD MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06115382: Sing For Your Saunter Part 2 R33
Official title: Sing for Your Saunter: Using Self-Generated Rhythmic Cues to Enhance Gait in Parkinson's
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2023-11-03
Enrollment: 74
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare to rhythm-based walking interventions to enhance gait in people with Parkinson's disease. The main questions it aims to answer are:

* How does rhythm-based training influence walking performance?
* How does brain activity change following rhythm-based training? Participants will perform walking to music and walking while singing, and will train on the use of these rhythms for 12 weeks. The investigators will compare the effects of training with music to training with singing.


Eligibility criteria: Inclusion Criteria:

1. at least 30 years of age
2. diagnosis of idiopathic, typical Parkinson disease according to the UK Brain Bank Criteria
3. Hoehn \& Yahr stages 2-3 (mild to moderate disease severity)
4. evidence of walking impairment (score at least 1 on gait item of MDS_UPDRS)

4) stable on all Parkinson disease medications for at least 2 months prior to study entry 5) willing and able to provide informed consent 6) right-handed

Exclusion Criteria:

1. diagnosis of any other neurological condition
2. a score of 2 or greater on item # 3 on the freezing of gait questionnaire
3. significant cognitive impairment
4. unstable medical or concomitant illnesses or psychiatric conditions which, in the opinion of the investigators, would preclude successful participation
5. cardiac problems that interfere with ability to safely participate
6. orthopedic problems in the lower extremities or spine that may limit walking
7. contraindications for magnetic resonance imaging
8. unable to walk for 10 continuous minutes independently
9. left-handed
10. uncontrolled tremor or dyskinesia

Primary outcomes:
measure: Gait speed
timeFrame: Baseline and 12 weeks
measure: MRI Bold Beta Weights
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT01565382: Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)
Official title: Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Evaluation of Inter-reader Reliability Using Images From Subjects With a Clinical Presentation of AD or MCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).


Eligibility criteria: Participants:

* Inclusion Criteria AD:

  * Male or female \>=50 years of age
  * Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD with Mini-Mental State Examination (MMSE) score of 10-24
* Inclusion Criteria MCI:

  * Male or female \>=50 years of age
  * Have a Clinical Dementia Rating (CDR) of 0.5
  * MMSE \>24
* Exclusion Criteria:

  * Have a history or current diagnosis of other neurologic disease
  * Have had or currently have a diagnosis of other neurodegenerative disease
  * Have participated in experimental therapy targeted to amyloid plaque

Readers:

•Private nuclear medicine physicians with no prior training in reading florbetapir-PET scans

Primary outcomes:
measure: Inter-reader Agreement - Median Kappa Statistic
timeFrame: 50-60 min after injection
Secondary outcomes:
measure: Overall Inter-reader Agreement - Fleiss' Kappa
timeFrame: 50-60 min after injection
Other outcomes:
Locations:
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT01622582: Engraftment Syndrome After Autologous Stem Cell Transplant: Retrospective Review in Patients With Multiple Myeloma
Official title: Engraftment Syndrome After Autologous Stem Cell Transplant: Retrospective Review in Patients With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma, Engraftment syndrome
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 796
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Multiple Myeloma, developing engraftment syndrome

Brief summary: Engraftment Syndrome after Autologous Stem Cell Transplant: Retrospective Review in Patients with Multiple Myeloma

Detailed description: A retrospective chart review series will be performed fpr subjects enrolled from 1/1/2006.

Eligibility criteria: Inclusion Criteria:

* Patients with Multiple Myeloma, developing engraftment syndrome

Exclusion Criteria:

* Patients with Multiple Myeloma, with no features of engraftment syndrome

Primary outcomes:
measure: number of patients developing Engraftment syndrome following stem cell transplant
timeFrame: 6 months post-transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: UAMS
name: Senu Apewokin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05106582: Assessment of the Learning Curve of Total Thoracoscopic Mitral Valve Repair
Official title: Assessment of the Learning Curve of Total Thoracoscopic Mitral Valve Repair Using Cumulative Sum Analysis (CUSUM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Thoracoscopic Mitral Valve Plasty; Minimally Invasive; Learning Curve
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 150
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: age over 18 years who underwent total thoracoscopic MVP without concurrent cardiac Surgery

Brief summary: Total thoracoscopic mitral valve plasty (MVP) is characterized by minimal trauma, minimal bleeding, and short postoperative recovery time. The learning curve of any new procedure needs to be evaluated for learning and replication.Using Cardiopulmonary bypass (CPB) time and Aortic clamping (AC) time as evaluation variables, we visualized the learning curve for total thoracoscopic MVP using Cumulative sum analysis. We also analyzed important postoperative variables such as postoperative drainage, duration of mechanical ventilation, ICU stay and postoperative hospital stay.

The retrospective study comprised 150 consecutive patients who underwent total thoracoscopic MVP from October 2017 to July 2021.


Eligibility criteria: Inclusion Criteria:

* age over 18 years who underwent total thoracoscopic MVP without concurrent cardiac Surgery

Exclusion Criteria:

* data miss greater than 10%

Primary outcomes:
measure: Cardiopulmonary bypass (CPB) time
timeFrame: Intra-operative
measure: Aortic clamping (AC) time
timeFrame: Intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General hospital
Study officials:
References: