louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01684254: An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
Official title: An In-Shoe Device to Monitor Toe-Walking in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Children With Cerebral Palsy
Keywords: Cerebral Palsy
Home monitoring
Gait
Sensorized Shoe
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Peabody Foundation, Inc.
First posted: 2012-09-12
Enrollment: 7
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children diagnosed with CP

Brief summary: The present project will focus on evaluating the technical efficacy of the in-shoe gait monitoring device (ActiveGait) through laboratory based biomechanical gait assessments of children who exhibit gait deviations due to CP or idiopathic toe walking wearing the device.

Detailed description: The investigators on this protocol intend to develop the device and rely on it to propose a Toe Walk Severity (TWS) index, a novel outcome measure for quantifying changes in severity of toe walking over time and for assessing the outcome of surgical and non-surgical interventions.

Tasks include:

A.Validate data acquisition measurements in laboratory setting compared to gold-standard video analysis and field (outside of laboratory).

B.Develop multi-stage classification algorithm from subset of laboratory and field data.

C.Validate classification algorithm against random subsets of laboratory and field data.

D.Explore the development of a Toe Walking Severity (TWS) index from available biomechanical and ActiveGait data for different ambulatory conditions.

E.Perform longitudinal study of the childhood toe walking population including both laboratory analysis and at-home monitoring using ActiveGait technology.

F.Analyze statistically the sensitivity and specificity of the TWS index compared to clinical observations. Gather evidence that the TWS index provides a means to track changes in severity of toe walking over time.

Eligibility criteria: Inclusion Criteria:

* able to ambulate 50 feet on level ground without the assistance of a person
* able to ambulate on ramps and stairs without the assistance of a person
* demonstrate a toe-walking pattern at the time of enrollment
* medically stable
* able to understand directions and follow simple instructions

Exclusion Criteria:

* any cardiopulmonary, orthopedic, and neurological conditions other than CP that would prevent them from performing the motor tasks of interest

Primary outcomes:
measure: Toe Walking Severity (TWS) index
timeFrame: 1 day
Secondary outcomes:
measure: Edinburgh Visual Scale (EVS) score
timeFrame: 1 day
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00954954: Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty
Official title: Outcomes After Standard and High-Flexion Posterior Stabilized Rotating-Platform Mobile-Bearing Total Knee Arthroplasty: A Prospective Randomized Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis, Knee
Keywords: Arthroplasty
Replacement
Knee
Range of Motion
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-08-07
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective study is to compare the clinical and radiographic outcomes of standard and high-flexion posterior stabilized (PS) rotating-platform mobile-bearing (RP-MB) total knee arthroplasty. The investigators hypothesize that total knee arthroplasty performed with a high-flexion PS RP-MB design would improve range of motion, and that this would be reflected by a better clinical outcome and greater patient satisfaction.

Detailed description: A high-flexion, PS RP-MB prosthesis was designed to improve range of motion after total knee arthroplasty without compromising the theoretical advantages of the standard PS RP-MB system. To date, no study has prospectively compared the clinical and radiographic results of standard and high-flexion PS RP-MB designs.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of primary osteoarthritis of knee
* A candidate for total knee replacement arthroplasty

Exclusion Criteria:

* A diagnosis other than primary osteoarthritis
* A history of previous open knee surgery

Primary outcomes:
measure: Range of knee motion, knee scores, patients' abilities to perform deep knee flexion related activities, patient satisfaction and radiographic indices were measured.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Department of Orthopaedic Surgery
state: 28, Yongeon-Dong, Jongno-Gu
Study officials:
affiliation: Seoul National University Hospital Department of Orthopaedic Surgery
name: Myung Chul Lee, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02200354: The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab
Official title: The Safety and Efficacy of Pemetrexed Rechallenge With Bevacizumab for Patients With Advanced Non-squamous Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Non-small Cell Lung Cancer
Lead sponsor: Kobe City General Hospital
Sponsor class: OTHER
First posted: 2014-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: For patients with nonsquamous NSCLC and a good performance status (PS), pemetrexed and cisplatin has been recommended for first-line NSCLC treatment. Recently, results from the PARAMOUNT trial showed that patients with nonsquamous NSCLC who had a good PS and had not progressed after completing four cycles of pemetrexed-cisplatin induction therapy benefitted from pemetrexed continuation maintenance therapy. Furthermore, pemetrexed with bevacizumab continuous maintenance might be better treatment option, considering the results from AVAPEARL trial. Pemetrexed rechallenge has been reported to be effective in some patients. Therefore, in order to investigate the safety and efficacy of pemetrexed rechallenge with bevacizumab,we conducted this study.


Eligibility criteria: Inclusion Criteria:

* 20 Years and older
* PS0-2
* Advanced non-squamous non-small cell lung cancer; AND
* Patients who have received more than 4 cycles of pemetrexed therapy before the study

Exclusion Criteria:

* Interstitial pneumonia; AND
* Abnormal blood test

Primary outcomes:
measure: progression free survival
timeFrame: Within the study period and until tumor proression, an expected average of 16 weeks
Secondary outcomes:
measure: response rate
timeFrame: The response will be assessed while participants received the pemetrexed with bevacizumab, an expected average to the maximum response of 4 - 16 weeks
measure: overall survival
timeFrame: From date of the start of pemetrexed with bevacizumab until date of death from any cause, up to 3 years
measure: time to treatment failure (TTF)
timeFrame: From date of the start of pemetrexed with bevacizumab until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
measure: Number of Participants with Adverse Events
timeFrame: From date of the start of pemetrexed with bevacizumab until the participants stop this therapy, an expected average of 16 weeks and up to 3 years
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
Study officials:
affiliation: Kobe City Medical Center General Hospital
name: Daichi Fujimoto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00502554: Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation
Official title: Extracorporeal Photopheresis in Patients With Bronchiolitis Obliterans Syndrome (BOS) After Lung Transplantation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiolitis Obliterans
Keywords: lung function
FEV1
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Therakos
First posted: 2007-07-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation of photopheresis as new therapy regimen in patients with bronchiolitis obliterans syndrome after lung transplantation in a controlled, randomized study

Detailed description: Bronchiolitis obliterans syndrome is the major cause of mortality after lung transplantation. 5 years after lung transplantation about 50% of all patients have this syndrome. There are nearly none therapy options. Besides effective therapy of any gastrooesophageal reflux and an oral medication with azithromycin none further regimens are known. Photopheresis could show in several studies a benefit for patients with gvhd after bone marrow transplantation or for chronic rejection after any other solid organ transplantation. Just little case reports could show beneficial effect in patients with bos after lung transplantation.

This is the first controlled, randomized study with patients with bos after lung transplantation to investigate the effectiveness of this therapy in that patients.

Eligibility criteria: Inclusion Criteria:

* Single/Double lung transplantation
* at least 6 months after lung transplantation
* bronchiolitis obliterans syndrome, Stadium \> 1 (nach ISHLT 2001, FEV1 \<80% Best), none other reason for worsening lung function (eg acute rejection, infection, extrapulmonary reasons, airway obstruction)
* none gastroesophageal reflux
* medication for \> 3 months with Azithromycin with further decrease of FEV1, MEF 25-75
* bioptic prove that there is no acute rejection
* no improvement under steroid pulse therapy

Exclusion Criteria:

* tumor or hematologic disease
* acute rejection
* respiratory insufficiency (O2\>2l/min, pCO2 \>50 mm Hg)
* weight \< 40 kg
* acute infection
* colonization with multiresistant pathogens

Primary outcomes:
measure: FEV1 stabilisation
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Department Pneumology, Medizinische Hochschule Hannover
state: Niedersachsen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Dep. Pneumology
state: Niedersachsen
Study officials:
affiliation: Department Pneumology
name: Fuehner Thomas, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06352554: Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections
Official title: Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diagnosis
Gonorrhea
Resistance Bacterial
Lead sponsor: SpeeDx Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
name: Wellcome Trust
name: German Federal Ministry of Education and Research
name: Australian Research Council Research Hub to Combat Antimicrobial Resistance
First posted: 2024-04-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting with confirmed NG infections in one or both of the following anatomical sites: the urethra \& the rectum.

Brief summary: This study aims to validate a novel antibiotic susceptibility test (InSignia) for gonorrhoea in patient clinical samples.

The hypothesis is that the InSignia test will be able to detect transcriptional responses after incubation in antibiotic for susceptible strains and not resistant strains.

Furthermore, this study will also add to our understanding on the performance of this test in various clinical specimens.


Eligibility criteria: Inclusion Criteria:

* Confirmed/suspected NG infection
* Willingness to give written informed consent as well as to participate in and comply with the study.

Exclusion Criteria:

* Currently taking or having taken any antibiotics in the preceding 14 days
* English fluency below level required to understand study procedures
* Unwilling or unable to comply with study procedures

Primary outcomes:
measure: To determine the feasibility of performing antibiotic susceptibility testing (AST) for Neisseria gonorrhoeae directly from patient samples using InSignia workflow and assay against commonly used & clinically relevant antibiotics.
timeFrame: 1 year
Secondary outcomes:
measure: To study the performance of the InSignia assay in determining antibiotic susceptibility of NG against commonly used & clinically relevant agents in clinical samples with comparison to gold standard methods.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06754254: Blood Biomarkers from Internal Jugular Vein for the Diagnosis of Alzheimer's Disease
Official title: Performance of Blood Biomarkers in Different Circulation Sites on Detecting Alzheimer's Pathologies - the Delta Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cognitive symptoms or concerns were consectively recruited from memory clinics.

Brief summary: The goal of this observational study is to explore the diagnostic performance of blood biomarkers from the internal jugular vein for the diagnosis of Alzheimer's disease (AD) in patients with cognitive symptoms or concerns. The main question it aims to answer is:

Whether blood biomarkers from the internal jugular vein outperform those from the median cubital vein which is the routine site for venous blood collection?


Eligibility criteria: Inclusion Criteria:

1. age: 40-90 years old (including 40 and 90 years);
2. patients with cognitive complaints or concerns;
3. Willing and able to comply with all aspect of the protocol and provide written informed consent. If a subject lacks capacity to consent in the investigator's opinion, the subject's assent should be obtained, if required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations).

Exclusion Criteria:

1. Severe medical conditions which are not stably and could affect the subject's safety;
2. Presence of contraindications for PET examination, cerebrospinal fluid or blood collection;
3. Unwilling and refuse to participate in this study.

Primary outcomes:
measure: Diagnostic performance
timeFrame: 5 years from the enrollment of the first participant
Secondary outcomes:
measure: Correlation with CSF biomarkers
timeFrame: 5 years from the enrollment of the first participant
measure: Correlation with brain Aβ burden
timeFrame: 5 years from the enrollment of the first participant
measure: Correlation with brain Tau burden
timeFrame: 5 years from the enrollment of the first participant
measure: Effects of comorbidities on blood biomarkers and diagnostic performance
timeFrame: 5 years from the enrollment of the first participant
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital
state: Chongqing
Study officials:
References:
Clinical trial NCT00620854: A Dose Selection Study of Oral Recombinant Salmon Calcitonin (rsCT) in Normal, Healthy, Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Tarsa Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-22
Enrollment: 24
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study compares the performance of different doses of oral recombinant salmon calcitonin (rsCT).


Eligibility criteria: Inclusion Criteria:

* Postmenopausal female, in good health (at least 5 years since last menses)
* Age ≥45 and ≤70
* Weight + or - 20% of the Metropolitan Life weight table
* Plasma C-terminal telopeptide of type I collagen (CTx-1) ≥ 0.25 ng/mL
* Total calcium (Ca++), phosphorus (P), and magnesium (Mg++) within normal range
* Willing and able to comply with all study requirements
* Willing and able to sign written informed consent
* Negative urine pregnancy test at screening
* Negative Screen for Hepatitis B and C, human immunodeficiency virus (HIV) and drugs of abuse

Exclusion Criteria:

* History of parathyroid, thyroid, pituitary or adrenal diseases
* History of musculoskeletal disease
* History of gastro-esophageal reflux disease (GERD) or other significant gastrointestinal disorders
* History of cancer within 5 years of enrollment other than basal cell carcinoma
* History of regular use of non-steroidal anti-inflammatory drugs (NSAID)
* History of surgery within 60 days of enrollment
* History of hypersensitivity or allergies (other than seasonal allergies) within 5 years of enrollment including known sensitivity to the active ingredients or the excipients in the study medications
* Use of concomitant medications other than acetaminophen within 7 days of enrollment or anticipated need to use such concomitant medications during the study
* Use of bisphosphonates within 6 months, selective selective estrogen receptor modulators (SERMS), estrogen or estrogen-like drugs 2 months, or calcitonin 1 month
* Presence of any clinically significant illness
* Unwilling or unable to comply with all study requirements
* Unwilling or unable to sign written, informed consent
* History of drug or alcohol abuse
* Participation in any clinical study of an investigational drug within 60 days of enrollment
* Plasma CTx-1 less than 0.25 ng/mL

Primary outcomes:
measure: Plasma C-terminal Telopeptide of Type I Collagen (CTx-1)(% Change From Baseline)
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, and 24 hours (Fortical): 0, 2, 3, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 10, 12, 24 hours rsCTA and rsCTB
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, Inc.
state: Missouri
Study officials:
affiliation: Bio-Kinetic Clinical Applications, Inc.
name: Thomas Legg, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06148454: Study of Positive Psychology and Effects on Well-being of Anaesthesiologists in Hong Kong
Official title: Implementation of Structured Positive Psychology Interventions to Improve Well-being and Resilience Amongst Anaesthesiologists in Hong Kong
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Burn Out
Stress, Psychological
Well-Being, Psychological
Self-Compassion
Depressive Symptoms
Anxiety Disorders and Symptoms
Lead sponsor: Hong Kong College of Anaesthesiologists
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to evaluate whether positive psychology interventions via a hybrid approach will enhance well-being and resilience amongst anaesthesiologists in Hong Kong.

The main questions it aims to answer are:

* Is app-based positive psychology intervention effective in improving well-being of physicians?
* Is app-based positive psychology intervention feasible amongst busy healthcare professionals?

Participants will be randomized to one of the two groups:

* Four-week web-based interventions
* Control group

Researchers will compare the intervention and control groups to see if the participants' benefit from the positive psychology intervention compared with not receiving it.


Eligibility criteria: Inclusion Criteria:

* Fellows/members of The Hong Kong College of Anaesthesiologists

Exclusion Criteria:

* No exclusion criteria is applied

Primary outcomes:
measure: Self-reported well-being
timeFrame: 4 weeks (Change from baseline to within 7 Days post-intervention)
measure: Self-reported burnout
timeFrame: 4 weeks (Change from baseline to within 7 Days post-intervention)
measure: Self-reported psychological stress
timeFrame: 4 weeks (Change from baseline to within 7 Days post-intervention)
measure: Self-reported anxiety symptom
timeFrame: 4 weeks (Change from baseline to within 7 Days post-intervention)
measure: Self-reported depression symptom
timeFrame: 4 weeks (Change from baseline to within 7 Days post-intervention)
Secondary outcomes:
measure: Self-reported self-compassion
timeFrame: 4 weeks (Change from baseline to within 7 Days post-intervention)
measure: Self-reported work gratitude
timeFrame: 4 weeks (Change from baseline to within 7 Days post-intervention)
measure: Self-reported work meaning
timeFrame: 4 weeks (Change from baseline to within 7 Days post-intervention)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong College of Anaesthesiologists
Study officials:
affiliation: The Hong Kong College of Anaesthesiologists
name: Albert Kam Ming Chan
role: PRINCIPAL_INVESTIGATOR
References: