louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04579809: Results of Flexor Tendon Repair of the Hand in Children Below Six Years of Age
Official title: Results of Flexor Tendon Repair of the Hand in Children Below Six Yera Sof Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Flexor Tendon Rupture
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective cohort study
Primary purpose: TREATMENT

Brief summary: The incidence of flexor tendon injuries in pediatric patients has remained largely undocumented, with a frequency of 3.6 per 100 000 persons per year.The pediatric literature demonstrates a higher prevalence of flexor tendon injuries in men, caused by sharp objects (glass or knife)

Detailed description: The diagnosis of flexor tendon injuries is more challenging in younger children than in adults . and delayed diagnosis in children is common . An innocuous appearing skin wound and a subtle functional deficit may hinder both presentation and identification of the injury.Pediatric flexor tendon injuries heal rapidly and contractures are rare, as long as the joint has not been injured. but Inadequate management can result in loss of hand function .

Data involving children rehabilitation remain unclear, with some studies showing no difference between early rehabilitation protocols and four weeks of cast immobilization . Some studies claim that protocols are not necessary in children younger than six years of age, and that only immobilization is required and some studies show transition to a more aggressive early motion protocol .

Although the incidince of flexor tendon injury in children is not low but the reported cases below the age of six years remains low Which makes reported results less trustworthy. This created the need for a better designed and larger number study to report results in this age group.

Eligibility criteria: Inclusion Criteria:

* Acute flexor tendon injuries of the hand in both genders. All flexor zones are included. Cooperative patients aged between 0-6 years.

Exclusion Criteria:

* Uncooperative patients such as psychologically disturbed patients , who will not be able to follow the strict of protocol
* Age more than six years old .
* Associated fractures close to the tendon injury.
* Vascular injury requiring revascularization

Primary outcomes:
measure: range of motion of flexor tendon after repair according total active motion criteria
timeFrame: follow up the patients up to one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Piper SL, Wheeler LC, Mills JK, Ezaki M, Oishi SN. Outcomes After Primary Repair and Staged Reconstruction of Zone I and II Flexor Tendon Injuries in Children. J Pediatr Orthop. 2019 May/Jun;39(5):263-267. doi: 10.1097/BPO.0000000000000912.
Clinical trial NCT06694909: Glutamate Modulation of tDCS Over Premotor Cortex Combined With Peripheral Nerve Stimulation Promoted Observation-execution-related Cortical Excitability and Motor Learning
Official title: Glutamate Modulation of tDCS Over Premotor Cortex Combined With Peripheral Nerve Stimulation Promoted Observation-execution-related Cortical Excitability and Motor Learning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Stimulation
Peripheral Nerve Stimulation
Motor Observation
Cortical Excitability
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 33
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aimed to investigate whether concurrent tDCS over the PMC and PNS during action observation enhance observation-execution-related motor cortex excitability and improve motor performance, and to explore the underlying mechanism


Eligibility criteria: Inclusion Criteria:

* normal or corrected-to-normal vision
* right-handed

Exclusion Criteria:

* pregnancy
* a history of epilepsy
* implanted medical devices
* history or presence of neurological, psychiatric or musculoskeletal disorders, other medical conditions, and left-handedness

Primary outcomes:
measure: Motor-evoked potentials
timeFrame: Before interventions, and immediately after interventions
measure: intracortical facilitation assessed by transcranial magnetic stimulation
timeFrame: Before interventions, and immediately after interventions
measure: short-interval intracortical inhibition assessed by transcranial magnetic stimulation
timeFrame: Before interventions, and immediately after interventions
measure: Reaction times of action execution blocks
timeFrame: immediately after interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Sport University
state: Haidian
Study officials:
References:
Clinical trial NCT04613609: Vaporized Nicotine and Autonomic Control
Official title: Vaporized Nicotine and Autonomic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Electronic Cigarette Use
Keywords: E-cigarette
Autonomic Control
Muscle Sympathetic Nerve Activity
Lead sponsor: Michigan Technological University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Repeated Measures
Primary purpose: BASIC_SCIENCE

Brief summary: E-cigarettes are marketed as an alternative to smoking for those who want to decrease the health risks of tobacco. Tobacco cigarettes increase heart rate (HR) and arterial pressure, while reducing muscle sympathetic nerve activity (MSNA) through sympathetic baroreflex inhibition. The acute effects of e-cigarettes on arterial pressure and MSNA have not been reported: our purpose was to clarify this issue. Using a randomized crossover design, participants inhaled on a JUUL containing nicotine (59 mg/ml) and a similar placebo e-cigarette (0 mg/ml).


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

* Individuals with a history of hyperthyroidism
* Women currently taking oral contraceptives, are pregnant or breast-feeding, or trying to become pregnant
* Individuals currently taking prescription drugs.
* Individuals with respiratory illnesses (e.g., asthma, chronic obstructive pulmonary disease, reactive airway disease, etc.)
* Individuals with hypertension (systolic \>130 and/or diastolic \> 80).
* Individuals with a history of tobacco or vaporized nicotine use.
* Individuals who have been diagnosed with diabetes
* Individuals who are under the age of 18 or over the age of 40

Primary outcomes:
measure: Blood pressure (measured from the finger)
timeFrame: Experiments were separated by one month. Beat-to-beat arterial pressure was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged.
measure: Muscle sympathetic nerve activity (measured with the microneurography technique)
timeFrame: Experiments were separated by one month. MSNA was recorded for ten minutes at rest, during ten minutes of e-cigarette use, and for ten minutes during recovery. The last 5 minutes of each section were averaged.
Secondary outcomes:
Other outcomes:
Locations:
city: Houghton
country: United States
facility: Michigan Technological University
state: Michigan
Study officials:
References:
Clinical trial NCT01188109: Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision
Official title: Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of Excision Repair Cross Complementation Gene 1 (ERCC1) in Treatment Decision
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Neoplasms
Pancreatic Cancer
Keywords: Pancreatic Neoplasms
Pancreatic cancer
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2010-08-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if the investigators can use a specific marker in the pancreatic tumor itself to determine which patients will benefit from receiving combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a pancreatic cancer.

The investigators will also investigate if there is any benefit to receiving both chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the tumor.

Detailed description: The study will specifically be looking at ERCC1 expression in pancreas cancer with regards to its prognostic and predictive value as a biomarker for patients receiving Gem / Cis as adjuvant therapy after resection.

Eligibility criteria: Inclusion Criteria:

1. Adults (≥ 18 years) at the time of signing informed consent form
2. Understand and voluntarily sign informed consent form
3. Able to adhere to study visit schedule and other protocol requirements
4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
5. Absolute neutrophil count ≥ 1500 / mm³
6. Platelet count ≥ 100,000 / mm³
7. Resectable pancreatic adenocarcinoma
8. Pathologic diagnosis of pancreatic adenocarcinoma

Exclusion Criteria:

1. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing informed consent form
2. A history of renal dysfunction (serum creatinine \> 1.8 mg/dL)
3. Presence of active infection
4. Untreated second malignancy
5. Pregnant or breast feeding females (A urine pregnancy test will be obtained in all women of child-bearing age at initial screening prior to study enrollment and administration of chemotherapy.)

Primary outcomes:
measure: Recurrence-free Survival as Measured by CT Scan
timeFrame: Every 3 months and then every 6 months for 2 more years after resection
Secondary outcomes:
measure: Immunohistochemistry to Determine Status of Excision Repair Cross Complementation Gene-1 (ERCC1) Expression
timeFrame: At the time of resection
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: Shishir Maithel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05742009: iCare ST500 Clinical Trial
Official title: Clinical Validation of a Slit Lamp Mounted Rebound Tonometer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Lead sponsor: Icare Finland Oy
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Clinical validation of iCare ST500 tonometer per ANSI Z80.10:2014 standard


Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years old

Exclusion Criteria:

1. Subjects with only one functional eye
2. Subjects having poor or eccentric fixation in the study eye(s)
3. High corneal astigmatism \>3D in the study eye(s)
4. Central corneal scarring
5. History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye(s)
6. Microphthalmos
7. Buphthalmos
8. Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
9. Dry eyes (clinically significant)
10. Lid squeezers - blepharospasm
11. Nystagmus
12. Keratoconus
13. Any other corneal or conjunctival pathology or infection relevant to this study
14. Central corneal thickness greater than 600 μm or less than 500 μm in the study eye(s)
15. Cataract Extraction within last 2 months in the study eye(s)

Primary outcomes:
measure: Demonstrate compliance with ANSI Z80.10:2014-Ophthalmics-Ophthalmic Instruments-Tonometers
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health/Dalhousie University
state: Nova Scotia
Study officials:
References:
Clinical trial NCT00560209: Study of ONO-1101 in Patients Scheduled for Coronary Angiography
Official title: Study of ONO-1101 in Patients Scheduled for Coronary Angiography, a Double-Blind, Randomized,Placebo-Controlled, Parallel Group, Multi-Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: ONO-1101
Coronary Artery Disease
Multi-slice CT
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 183
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for coronary angiography, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.


Eligibility criteria: Inclusion Criteria:

* 20 years of age or older
* Heart rate less than 90 beats/min and more than 70 beats/min at entering the CT room

Exclusion Criteria:

* Previous allergic reactions to contrast agent
* Renal failure
* Asthma
* Concomitant beta-receptor blocking agent

Primary outcomes:
measure: CT image quality
timeFrame: one day
Secondary outcomes:
measure: Heart rate
timeFrame: For less than one month
measure: CT diagnostic accuracy
timeFrame: For less than one month
Other outcomes:
Locations:
city: Kinki
country: Japan
facility: Kinki Region
Study officials:
affiliation: Ono Pharmaceutial Co., Ltd
name: Shinichi Kikawa
role: STUDY_DIRECTOR
References:
citation: Jinzaki M, Hirano M, Hara K, Suzuki T, Yamashina A, Ikari Y, Iino M, Yamaguchi T, Kuribayashi S. A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting beta1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease. Int J Cardiovasc Imaging. 2013 Jun;29 Suppl 1(Suppl 1):7-20. doi: 10.1007/s10554-013-0253-3. Epub 2013 Jun 20.
Clinical trial NCT00902109: Study to Compare Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE) Using a New Fast German Adaptive Threshold Estimation (GATE) in Glaucoma Patients
Official title: Pilot Study to Compare the Humphrey Field Analyzer (HFA) 30-2 Swedish Interactive Threshold Algorithm (SITA) Standard Perimetry With the New Scotoma-Oriented Perimetry (SCOPE), Using a New Fast GATE (German Adaptive Threshold Estimation) in Glaucoma Patients Under Topic Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Open Angle Glaucoma (POAG)
Keywords: visual field
perimetry
progression
POAG
glaucoma
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2009-05-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: University Eye Hospital

Brief summary: The purpose of this study is to compare the two psychophysical perimetric techniques regarding progression of the visual field.


Eligibility criteria: Inclusion Criteria:

* primary open angle glaucoma (POAG)
* spherical ametropia max. ± 8 dpt
* cylindrical ametropia max. ± 3 dpt
* distant visual acuity \> 10/20
* pupil diameter \> 3 mm

Exclusion Criteria:

* diabetic retinopathy
* asthma
* history of epilepsy or significant psychiatric disease
* medications known to effect visual field sensitivity
* infections (e.g., keratitis, conjunctivitis, uveitis)
* severe dry eyes
* miotic drug
* squint
* nystagmus
* albinism
* any ocular pathology, in either eye, that may interfere with the ability to obtain visual fields
* keratoconus
* intraocular surgery (except for uncomplicated cataract surgery) performed \< 3 month prior to screening
* history or signs of any visual pathway affection other than glaucoma
* history or presence of macular disease and/or macular edema, ocular trauma, medications known to affect visual field sensitivity

Primary outcomes:
measure: Comparison of rate of progression
timeFrame: 36 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: Institute for Ophthalmic Research
Study officials:
affiliation: University Hospital Tuebingen
name: Ulrich Schiefer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schiefer U, Pascual JP, Edmunds B, Feudner E, Hoffmann EM, Johnson CA, Lagreze WA, Pfeiffer N, Sample PA, Staubach F, Weleber RG, Vonthein R, Krapp E, Paetzold J. Comparison of the new perimetric GATE strategy with conventional full-threshold and SITA standard strategies. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):488-94. doi: 10.1167/iovs.08-2229. Epub 2008 Dec 5.
Clinical trial NCT04111809: Study of 4 Bone Turnover Markers in Patients With Multiple Myeloma Treated With Intravenous Bisphosphonate in Routine Care
Official title: Assessment of 4 Bone Turnover Markers (C-terminal Telopeptides of Type I Collagene (CTX), Amino-terminal Telopeptide of Type 1 Collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in Multiple Myeloma Patients Treated With Intravenous Bisphosphonate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
intravenous bisphosphonate
bone markers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Intergroupe Francophone du Myelome
First posted: 2019-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: no description

Brief summary: The aim of this study is looking at the Kinetics of bone turnover markers (C-terminal telopeptides of type I collagene (CTX), amino-terminal telopeptide of type 1 collagen (NTX), Dickkopf-1 (DKK-1) and Sclerostin (SOST)) in serum and urine until 12 months in Patients with Multiple Myeloma Treated With intravenous bisphosphonates in routine care.


Eligibility criteria: Inclusion Criteria:

1. Patient aged 65 to 75 years of age
2. Patient with symptomatic multiple myeloma as defined by the criteria of the IMWG
3. Need to introduced an antiresorptive bone treatment by intravenous bisphosphonate with bone imaging mapping (PET-scanner preferentially) in routine care
4. Ability and willingness to follow scheduled visits with requested biological samples

Exclusion Criteria

- Patients previously treated with intravenous biphosphonate

Primary outcomes:
measure: Changes in bone turnover markers
timeFrame: Baseline, then every 2 months in 12 months
Secondary outcomes:
measure: time to maximum variation of bone turnover markers
timeFrame: Baseline, then every 2 months in 12 months
measure: Doses of intravenous bisphosphonate
timeFrame: Up to 12 months
measure: Rate of intravenous bisphosphonate
timeFrame: Up to 12 months
measure: evolution of bone lesions by imaging
timeFrame: Up to 12 months
measure: Number of new bone events
timeFrame: Up to 12 months
measure: Number of adverse events likely to be related to bisphosphonate
timeFrame: Up to 12 months
measure: Changes in Monoclonal protein
timeFrame: Baseline, then every 2 months in 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker Hospital, Adult haematology department
Study officials:
References:
Clinical trial NCT01117909: Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
Official title: Effects of Talocrural Joint Mobilizations in the Treatment of Subacute Lateral Ankle Sprains
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ankle Sprain
Keywords: ankle sprain
athletic injury
arthritis
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: American Physical Therapy Association
First posted: 2010-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal is to determine if standard therapy including joint mobilizations of the ankle performed 3 times per week for 2 weeks will increase self-reported function and decrease pain in patients with mild lateral ankle sprains.

Detailed description: The purpose of this protocol is to assess the effects of grade IV anterior to posterior joint mobilization on self-reported function, dorsiflexion range of motion and talar glide on subjects suffering from lateral ankle sprain in the past 2-10 days and exhibit 5 degree dorsiflexion deficit in range of motion or a restriction in posterior glide of the talus.

Eligibility criteria: Inclusion Criteria:

* Incomplete tear of lateral ligaments with mild laxity as measured by anterior drawer test and talar tilt
* Slight reduction in function
* Anterolateral ankle tenderness
* Dorsiflexion ROM asymmetry greater than 5° compared to uninvolved limb
* Posterior talar glide restriction greater than 5° compared to uninvolved limb; or
* Posterior talar glide less than 19°, which is one standard deviation (7°) from our previously established normative values (26°)9, 10
* Suffered from grade 1 or 2 lateral ankle sprain within the last 48hr - 8 days

Exclusion Criteria:

* A history of ankle surgery that involves intra-articular fixation,
* Syndesmotic ankle sprain (to be ruled out based on clinical examination),
* History or signs of reflex sympathetic dystrophy,
* Have received manual therapy for the ankle sprain prior to enrollment
* Grade III ankle sprain.

Primary outcomes:
measure: Change in self-reported function
timeFrame: Baseline and four weeks
measure: Change in self-reported pain
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Change in ankle dorsiflexion range of motion
timeFrame: Baseline and 4 weeks
measure: Change in ligamentous laxity
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Terry Grindstaff, PhD, DPT
role: PRINCIPAL_INVESTIGATOR
References: