louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00902460: CP-690,550 and Midazolam Drug-Drug Interaction Study
Official title: A Phase 1, Randomized, 2-Way Crossover, Multiple Dose, Open Label Study Of The Effect Of CP-690,550 On Midazolam Pharmacokinetics In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: drug interactions CYP3A4 CYP3A5 midazolam anti-rheumatic agents
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: CP-690,550 and midazolam are metabolized by similar enzymes in the liver. This study is designed to assess whether co-administration of CP-690,500 and midazolam will effect the metabolism of midazolam in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female (non-child bearing potential) subjects

Exclusion Criteria:

* Clinically significant infections within the past 3 months
* History of previously untreated infection with Mycobacterium tuberculosis
* Positive screening test for hepatitis B surface antigen, anti-hepatitis C antibody, or human immunodeficiency virus

Primary outcomes:
measure: AUCinf of midazolam
timeFrame: 10 Days
Secondary outcomes:
measure: AUClast, Cmax, Tmax, t1/2 of midazolam
timeFrame: 10 Days
measure: Vital signs, laboratory tests and adverse events
timeFrame: 10 Days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01444560: miRNA Machinery in Melanoma, Melanoma Metastases and Benign Melanocytic Naevi
Official title: The miRNA Machinery in Melanoma, Melanoma Metastases and Benign Melanocytic Naevi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Melanoma
Nevi
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cutaneous melanoma, cutaneous melanoma metastases, benign melanocytic nevi

Brief summary: MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study, the investigators examines the expression profiles of miRNA machinery components such as miRNA maturation and transport factors, microprocessor complex and RISC subunits in cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi.

Detailed description: Patients with cutaneous melanoma, cutaneous melanoma metastases and benign melanocytic nevi were included in the study. Punch biopsies were harvested from the center of the tumors. The miRNA machinery components were detected by quantitative real-time reverse transcriptase polymerase chain reaction.

Eligibility criteria: Inclusion Criteria:

* cutaneous melanoma
* cutaneous melanoma metastases
* benign melanocytic nevi

Exclusion Criteria:

* other forms of malignancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
state: NRW
Study officials:
affiliation: Department of Dermatology, Venereology and Allergology, Ruhr-University Bochum
name: Falk G Bechara, PD Dr.
role: STUDY_DIRECTOR
References:
citation: Sand M, Skrygan M, Georgas D, Sand D, Gambichler T, Altmeyer P, Bechara FG. The miRNA machinery in primary cutaneous malignant melanoma, cutaneous malignant melanoma metastases and benign melanocytic nevi. Cell Tissue Res. 2012 Oct;350(1):119-26. doi: 10.1007/s00441-012-1446-0. Epub 2012 Jun 17.
Clinical trial NCT02965560: Exploring Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure
Official title: A Study on Biomarkers Predicting the Outcome of Acute-on-chronic Liver Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute-On-Chronic Liver Failure
Cirrhosis and Chronic Liver Disease
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The cohorts will be selected from Provincial General Hospital

Brief summary: Acute-on-chronic liver failure (ACLF) is an ailment with high incidence of multiorgan failure (MOF) and consequent mortality. Systemic inflammation and susceptibility to infection are characteristic pathophysiological features. Prostaglandin E2 (PGE2) could subdue systemic inflammation and alleviate liver injury in mice model. However, there are no studies evaluating PGE2 as a predictor of early mortality.This study is designed to investigate whether plasma PGE2 and its receptors are associated with development of MOF and predict short-term mortality in patients with acute-on-chronic liver failure. By the way, we will also measure several other potential predictive factors (C-reactive protein,severe hyponatremia, Second infections,Diabetes mellitus,High density lipoprotein,interleukin-10,serum bile acids,ferritin,the neutrophil to lymphocyte ratio,soluable urokinase plasminogen activator receptor,vWF-Ag levels and FVIII-to-PC ratios).


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute-on-chronic liver failure according to Asian-Pacific Association for the Study of the Liver (APASL) diagnostic criteria

Exclusion Criteria:

* Hepatocellular carcinoma(HCC)
* Portal vein thrombosis
* Pregnancy
* Human immunodeficiency virus (HIV)
* Patients who had received immunomodulator,or cytotoxic/immunosuppressive therapy within at least the preceding 12 months

Primary outcomes:
measure: all cause mortality
timeFrame: 90 days
measure: incidence of multiorgan failure
timeFrame: 90 days
measure: all cause mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wang Y, Wu F, Chen C, Xu L, Lin W, Huang C, Yang Y, Wu S, Qi J, Cao H, Li G, Hong M, Zhu H. Soluble urokinase plasminogen activator receptor is associated with short-term mortality and enhanced reactive oxygen species production in acute-on-chronic liver failure. BMC Gastroenterol. 2021 Nov 17;21(1):429. doi: 10.1186/s12876-021-02006-x.
Clinical trial NCT04703660: Effect of Cervical Mobilization on Rotator Cuff Tendinitis
Official title: Immediate and Carry Over Effect of Different Cervical Mobilization Techniques on Rotator Cuff Tendinitis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rotator Cuff Tendinitis
Lead sponsor: Egyptian Chinese University
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 45
Sex: ALL
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study aimed to investigate the effect of 3 types of cervical mobilization on the strength of shoulder abductors, external rotators and pain level in patient with rotator cuff tendinitis. the measurement will be made immediately, 10 minutes, and 30 minutes after mobilization

Detailed description: subjects will be allocated according to the inclusion and exclusion criteria from outpatient clinic at El sahel teaching hospital. they will be assigned randomly into 3 groups, each group will receive certain type of cervical mobilization. the outcome measures will be measured before, immediate, 10 minutes, and 30 minutes after treatment

Eligibility criteria: Inclusion Criteria:

* patients will be included if they have rotator cuff tendinitis

Exclusion Criteria:

* Patients will be excluded if they had recent neck trauma or acute whiplash disorder ,any intra articular injection in the gleno-humeral joint during last three months, patients with musculoskeletal disorder (any type of fracture), any history of surgery on that shoulder and tendon calcification, cervical rib, rotator cuff tear.

Primary outcomes:
measure: change in strength of shoulder abductors
timeFrame: before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization
measure: change in strength of shoulder external rotators
timeFrame: before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization
measure: change in pain level
timeFrame: before treatment, immediate, 10 minutes, and 30 minutes after cervical mobilization
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Noha Elserty
Study officials:
affiliation: Lecturer of physical therapy- Egyptian Chinese University
name: Noha S Elserty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03987360: Educational and Cultural Engagement and Incidence of Health Adverse Events
Official title: Educational and Cultural Engagement and Incidence of Health Adverse Events: Results From the Canadian Longitudinal Study on Aging
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Older Adults
Depression
Cognitive Decline
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 30000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People from Canada who participate in the Canadian Longitudinal Study on Aging. Participants who have the habits to go to museums for art classes, workshops, guided visits, and others arts activities. Participants of Canadian Longitudinal Study on Aging who are involved in art and educational activities in their communities.

Brief summary: This study evaluated if the social and cultural activities decrease the incidence of dementia and frailty conditions.

Detailed description: The past decade has been characterized by the involvement of Museums in individual health prevention and promotion by using art-based activities to improve quality of life and well-being. Visiting museum or over cultural and educational activity could be used for health prevention and promotion. For the development of appropriate educational and cultural activities, there is a need, first, to improve knowledge about social and health condition of older adult, and second to examine the effects of engagement in educational and social activity on incidence of health adverse events.

Eligibility criteria: Inclusion Criteria:

* Being 50 years and over
* Being enrolled in the Canadian Longitudinal Study on Aging
* Actively involved in social and cultural activities

Exclusion Criteria:

* Never enrolled in the Canadian Longitudinal Study on Aging
* Less than 50 years old

Primary outcomes:
measure: Depression
timeFrame: around 20 years
Secondary outcomes:
measure: Motoric cognitive risk syndrome
timeFrame: around 20 years
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01362660: A Study to Evaluate Infants With Potential Exposure to Tanezumab Before Birth
Official title: A Protocol to Monitor the Neurological Development of Infants With Exposure In-utero From Birth to Aged 15 Months in Tanezumab Clinical Studies at Investigational Sites Overseen by Schulman and Associates Institutional Review Board
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant Developmental Assessment
Keywords: post-natal monitoring
exposure in utero
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 7
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with potential exposure in utero through their parents partcipation in a tanezumab clinical study

Brief summary: This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).

Detailed description: This study will enroll infants with potential tanezumab exposure in utero at sites overseen by Schulman and Associates IRB This study will attempt to enroll all infants who qualify.

Eligibility criteria: Inclusion Criteria:

Subject is an infant born to a mother who was exposed to study drug on a tanezumab clinical study through direct maternal exposure; or is an infant born to a mother who is a partner of a male patient who was exposed to study drug in a tanezumab clinical study prior to or around the time of conception and/or is exposed during his partner's pregnancy.

Exclusion Criteria:

There are no exclusion criteria for this study

Primary outcomes:
measure: Bayley Infant Neurodevelopmental Screener
timeFrame: 0-2 Months
measure: Bayley Infant Neurodevelopmental Screener
timeFrame: 8 months
measure: Bayley Infant Neurodevelopmental Screener
timeFrame: 15 months
measure: Receptive-Expressive Emergent Language Test
timeFrame: 0-2 Months
measure: Receptive-Expressive Emergent Language Test
timeFrame: 8 months
measure: Receptive-Expressive Emergent Language Test
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Wildomar
country: United States
facility: Pfizer Investigational Site
state: California
city: Cutler Bay
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Pfizer Investigational Site
state: Utah
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06623760: Study on the Impact of Desk and Chair Adaptation Intervention on the Occurrence and Development of Myopia in Primary School Students
Official title: Intervention Study：Study on the Impact of Desk and Chair Adaptation Intervention on the Occurrence and Development of Myopia in Primary School Students
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Axial Length, Eye
Myopia
Myopia Progression
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 2100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized controlled trial of a desk and chair adaptation intervention involving primary school students and their parents or primary caregivers. We compared the myopia status of students in the intervention and control groups before and after the intervention to confirm the effect of the desk and chair adaptation intervention on the development of myopia in students.

Detailed description: In this study, two pilot schools in Anhui Province were selected , and all students were examined by ophthalmologists, and their heights and the heights of their desks and chairs were measured in order to investigate the association between desk and chair adaptations and myopia. One of the elementary school was randomly selected for a one-year desk and chair adaptation intervention to compare the occurrence of myopia and axial growth of the students before and after the intervention in the two schools.

Translated with DeepL.com (free version)

Eligibility criteria: Inclusion Criteria:

* Students and their families were informed and voluntarily participated in the study, with parents signing the informed consent form.
* Able to cooperate with eye examinations and questionnaires.

Exclusion Criteria:

* Communication barriers, unable to cooperate.
* Strabismus, amblyopia, or any other ocular or systemic diseases that may affect refractive development.
* Children currently using orthokeratology lenses or rigid contact lenses.
* Using other interventions (such as acupuncture, massage, medication, ear acupuncture, etc.) to control myopia, apart from school eye exercises.

Primary outcomes:
measure: The changes in axial length (AL) and spherical equivalent (SE) compared to baseline after one year of intervention
timeFrame: at baseline, , and at the 12th month of the intervention.
Secondary outcomes:
measure: The incidence of myopia.
timeFrame: at baseline, and at the 12th month of the intervention.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02788760: "The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures"
Official title: "The Length of Cervical Collar Treatment for Traumatic Sub-axial Fractures: Is Six Weeks as Safe as 12 Weeks? (A Randomized, Clinical Trial.)"
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Collar Treatment of Stable Subaxial Spine Fractures
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2016-06-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Most fractures of the cervical spine are considered stable and treated with a rigid cervical collar. However no studies have to date been published addressing the length of treatment. There seems to be a significant dissimilarity between hospitals within and between countries with the length of collar treatment varying from 6 to 12 weeks. At the neurosurgical department at Oslo University Hospital, Ullevål the standard length of treatment for a stable cervical fracture is 12 weeks. This study seeks to establish whether 6 weeks of collar treatment for a specific subtype of stable fractures in the cervical spine is sufficient.

Detailed description: The investigators will include 150 patients with a stable cervical fractures of vertebra C3-C7 with a Subaxial Cervical Spine Injury Severity (SLIC) Score 1-3 and randomize them in to two similar groups. One group will be treated with a cervical collar for 6 weeks and the other group will be treated for 12 weeks. There will be a clinical check up and a CT scan at 1, 6, 12 and 26 weeks after the initial injury. The investigators will compare the results between the two groups when it comes to fracture healing (CT based), level of function, pain and the length of sick leave with a total of 6 months of follow up.

Eligibility criteria: Inclusion Criteria:

* Patients with a newly diagnosed (within 5 days of injury) fracture in vertebra C3-C7 with SLIC score 1-3
* Patients must be abel to give their consent to participate in the study

Exclusion Criteria:

* Unstable cervical fractures in need of surgery
* SLIC score \>3
* Fractures of the spinous process and the transverse process in the cervical spine
* Stable fractures in in the C3-C7 vertebra combined with fractures of the C0-C2 vertebra
* Pathological fractures in the cervical spine

Primary outcomes:
measure: Fracture healing
timeFrame: 6 months
measure: Visual analogue scale - neck pain and radiculopathy
timeFrame: 6 months
Secondary outcomes:
measure: Level of function
timeFrame: 6 months
measure: Treatment failure
timeFrame: 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Neurosurgical department, Oslo university hospital, Ullevål
Study officials:
affiliation: Oslo University Hospital
name: Christina T. Høstmælingen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06448260: Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support
Official title: Outcome of a Cohort of Patients Fitted With a SYME Type Prosthesis in the Context of a Hindfoot Amputation With Distal Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation, Surgical
Walking, Difficulty
Keywords: Amputation
Prothesis
Outcome
Lead sponsor: Institut Robert Merle d'aubigné
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient treated at the institut Rober Merle d'Aubigné

Brief summary: The purpose of this study is to see outcome of patients with syme prothesis in order to comment the handfoot amputation.


Eligibility criteria: Inclusion Criteria:

* Syme or Pirogoff or ATCT or arthrodesized Chopart type amputation
* Age \> 18 years old,
* First fitting or renewal of Syme type prosthesis delivered to IRMA between January 2008 and December 2018

Exclusion Criteria:

* Refusal documented in the file that the data be used for scientific purposes,
* Congenital etiology of the condition.

Primary outcomes:
measure: The possibility of walking without a prosthesis
timeFrame: Immediatly after inclusion
measure: Walking perimeter with prosthesis
timeFrame: Immediatly after inclusion
measure: Number of re-amputation since first amputation
timeFrame: Immediatly after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Valenton
country: France
facility: Institut Robert Merle d'Aubigné
Study officials:
References:
citation: Braaksma R, Dijkstra PU, Geertzen JHB. Syme Amputation: A Systematic Review. Foot Ankle Int. 2018 Mar;39(3):284-291. doi: 10.1177/1071100717745313. Epub 2018 Jan 10.
citation: Dillon MP, Quigley M, Fatone S. Outcomes of dysvascular partial foot amputation and how these compare to transtibial amputation: a systematic review for the development of shared decision-making resources. Syst Rev. 2017 Mar 14;6(1):54. doi: 10.1186/s13643-017-0433-7.
citation: van der Wal GE, Dijkstra PU, Geertzen JHB. Lisfranc and Chopart amputation: A systematic review. Medicine (Baltimore). 2023 Mar 10;102(10):e33188. doi: 10.1097/MD.0000000000033188.
citation: Spoden M, Nimptsch U, Mansky T. Amputation rates of the lower limb by amputation level - observational study using German national hospital discharge data from 2005 to 2015. BMC Health Serv Res. 2019 Jan 6;19(1):8. doi: 10.1186/s12913-018-3759-5.