louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01875536: rTMS and Conventional Physical Therapy After Stroke
Official title: Efficacy of Coupling Repetitive Transcranial Magnetic Stimulation and Conventional Physical Therapy to Reduce Upper Limb Spasticity in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Keywords: transcranial magnetic stimulation
spasticity
physiotherapy
Rehabilitation
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Given previous evidence that non invasive brain stimulation enhances the effects of conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed to determine if the repetitive transcranial magnetic stimulation (rTMS)combined with conventional physical therapy (VRT) would be superior to physical therapy in improving upper limb function and quality of life with chronic stroke individuals.


Eligibility criteria: Inclusion Criteria:

* stroke onset ≥ 6 months;
* muscle tone at the wrist with a modified Ashworth scale (MAS) score between 1+ and 3;
* minimum age of 30 years old and maximum age of 75 years;
* absence of cognitive impairment, as determined by the cut-off scores on the Mini-mental state exam

Exclusion Criteria:

* history of seizure or cerebral aneurism;
* antispasticity drugs within 6 months before enrollment;
* previous surgery involving metallic implants;
* unstable vital signs;
* other neurological diseases
* aphasia

Primary outcomes:
measure: Change from Modified Ashworth scale
timeFrame: at baseline, 1 month and 2 months
measure: change from spinal excitability via Hoffmann reflex of the median nerve
timeFrame: at baseline, 1 month and 2 months
Secondary outcomes:
measure: change from Fugl-Meyer assessment
timeFrame: at baseline, 1 month and 2 months
measure: change from cortical excitability via single transcranial magnetic stimulation
timeFrame: per-session: at baseline and one hour (after physical therapy)
Other outcomes:
measure: change from stroke specific quality of life scale
timeFrame: at baseline, 1 month and 2 months
Locations:
city: Recife
country: Brazil
facility: Applied Neuroscience Laboratory-LANA
state: Pernambuco
Study officials:
References:
Clinical trial NCT05822336: Duration of IM Injection and Pain Intensity
Official title: The Relationship Between Pain Intensity and Intramuscular Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Measurement
Keywords: Intramusculer Injection
Nurse
Pain Intensity
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Repeated measure
Primary purpose: OTHER

Brief summary: This study was a single-group crossover clinical trial, where each participant acted as their own control. The study aimed to describe the relationship between perceived pain and the duration of intramuscular injections

Detailed description: The study was a single-group crossover clinical trial, where each participant acted as their own control. The study sample included 50 patients aged 25 to 55 who met the inclusion criteria of signing an informed consent form and requiring administration of a specific antibiotic via intramuscular injection, as prescribed by physicians.

Two intramuscular injections into the right and left Dorsal Gluteal Region (DRG) were recorded for each participant. One was administered by a nurse, according to the unit's routine, and took 5 seconds to complete. A day after, the same nurse gave the other injection in the opposite DGR, taking 40 seconds to administer. The five-second injections were considered the control group, while the 40 seconds injections were the intervention group. The order of interventions was randomized. The pain level was determined and recorded immediately after each injection.

The study was conducted between September 2019 to November 2019 in the emergency unit of an educational hospital in Istanbul. The data was collected using a Demographic Form, Facial Expressions Scale, and Visual Comparison Scale. Statistical analysis was performed using the Kolmogorov-Smirnov test, Mann-Whitney U test, Wilcoxon test, and Spearman correlation analysis, with a significance level of p \< 0.05.

Eligibility criteria: Inclusion Criteria:

Having a condition leads to prescribing Clindamycin 600 mg/4 ml intramuscularly Having no pain in the area of injection Absence of any tissue damage history at the site of injection

Exclusion Criteria:

Asking for withdrawal after signing the informed consent Intensifying the disease/condition at the time of the second injection Taking any analgesic medication before the application.

Primary outcomes:
measure: Facial Pain Expressions Scale
timeFrame: after implamention in 1-2 seconds
measure: Visual Pain Comparison Scale
timeFrame: after implamention in 1-2 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Leman Şenturan
state: Zeytinburnu
Study officials:
References:
Clinical trial NCT00723736: Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)
Official title: Non-Interventional Study of the Safe Use of Aerius in Pediatric Patients With Allergic Rhinitis or Chronic Idiopathic Urticaria.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis
Urticaria
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric clinics around Hungary.

Brief summary: The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria. The patients will receive 2.5 ml (1.25 mg) once daily.

Detailed description: Pediatric patients aged 1-5 years

Eligibility criteria: Inclusion Criteria:

* Patients with allergic rhinitis or chronic idiopathic urticaria
* Aged 1-5 years old
* Caregiver's consent to participate

Exclusion Criteria:

* Healthy individuals
* Younger or older than the 1-5 year old age range

Primary outcomes:
measure: Proportion of Patients With Adverse Events
timeFrame: Follow-up visit at 3 - 5 weeks after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04662736: Tedizolid Suppressive Antimicrobial Therapy in a Reference Center
Official title: Tedizolid Suppressive Antimicrobial Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Keywords: bone and joint infection
tedizolid
suppressive antibiotic therapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having an osteo-articular infection treated with tedizolid as a suppressive antibiotic therapy managed at the CRIOAc LYON, Croix-Rousse Hospital

Brief summary: the aim of the study is to describe the management and outcome of patients having an osteo-articular infection treated by tedizolid as a suppressive antibiotic therapy.


Eligibility criteria: Inclusion Criteria:

* patients having an osteo-articular infection treated with tedizolid as a suppressive antibiotic therapy

Exclusion Criteria:

-

Primary outcomes:
measure: rate of patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy
timeFrame: between 2016 and 2021
measure: rate of failure in patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic
timeFrame: 2 years
measure: rate of adverse event in patients having had a BJI/PJI treated with tedizolid as a suppressive
timeFrame: through study completion, an average of 1 year
measure: Description of patients having had a BJI/PJI treated with tedizolid as a suppressive
timeFrame: 2 years
measure: Description of BJI/PJI treated with tedizolid as a suppressive
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT06503536: A Study to Assess Treatment Patterns, Clinical Outcomes, and Healthcare Resource Utilization in Chinese Participants Receiving Upadacitinib for Atopic Dermatitis (AD) Through Chart Review
Official title: REAL-world Patient characterISTICs, Treatment Pattern, Clinical Outcomes, and Healthcare Resource Utilization in Chinese Patients Receiving Upadacitinib for Atopic Dermatitis: A Retrospective Chart Review Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis (AD)
Keywords: Atopic Dermatitis (AD)
Upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Atopic Dermatitis (AD) receiving Upadacitinib undergoing chart review in China

Brief summary: Atopic Dermatitis (AD) is a common, chronic, and flaring systemic inflammatory skin disorder characterized by intensely pruritic and distressing skin eruptions. This study will assess treatment patterns, treatment outcomes, healthcare resource utilization in Chinese participants receiving Upadacitinib for Atopic Dermatitis (AD) undergoing chart review.


Eligibility criteria: Inclusion Criteria:

* Participants with at least one primary diagnosis of atopic dermatitis with ICD-10 code of L20.900 \[atopic dermatitis, unspecified\] or physician-confirmed atopic dermatitis documentation within the study period
* Participants with at least one documented health record of upadacitinib prescription that has a primary diagnosis of atopic dermatitis within the study period
* Participants with at least one atopic dermatitis severity measures (i.e., EASI) in the follow-up period including up to 6 months after the index date

Exclusion Criteria:

• Participants who did not fulfill the inclusion criteria will be excluded

Primary outcomes:
measure: Number of participants who achieve a composite endpoint post-index score of Eczema Area and Severity Index (EASI) < =7
timeFrame: Up to 3 months
measure: Number of participants who achieve a composite endpoint post-index score of Investigator's Global Assessment (IGA) × Body Surface Area (BSA) < = 30
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital affiliated to Fudan University /ID# 268259
state: Shanghai
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05031936: : Intravascular Injection Rates During Cervical Medial Branch Block
Official title: Comparison of Intravascular Injection Rates During Cervical and Lumbar Medial Branch Block Using Touhy or Quincke Type Needle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Complications
Keywords: intravascular injection
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare using Toughy needle has an advantage of reducing intravascular injection rates during cervical medial branch block.

Detailed description: In previous reports, the use of Toughy needle was thought to reduce the incidence of intravascular injection as low as 2.9% during lumbar transforaminal injection.

Blunt needles with a pencil point tip, such as Whitacre needles, are not as sharp at their tip as are Quincke needles, which have bevels. Toughy or blunt needles may therefore be less likely to penetrate a vessel during a procedure. Hence, we postulated the incidence of intravenous uptake would be significantly lower using a Toughy needle than using a Quincke needle for lumbar medial branch block. To confirm the intravascular injection rates, we used the real time fluoroscopy after injection of contrast medium.

The goal of this study was to compare the incidence of intravascular injection rate betweeen Toughy and Quincke needles using real time fluoroscopy during cervical medial branch block

Eligibility criteria: Inclusion Criteria:

* facet joint arthropathy

Exclusion Criteria:

* allergy to local anesthetics or contrast medium
* pregnancy
* spine deformity
* neurologic abnormality

Primary outcomes:
measure: incidence of intravascular injection
timeFrame: 1 minute after finishing cervical medial branch block
Secondary outcomes:
measure: time required to complete cervical medial branch block
timeFrame: Baseline, 1 second after the completion of cervical medial branch block
measure: radiation amout to complete cervical medial branch block
timeFrame: Baseline, 1 second after the completion of cervical medial branch block
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Hong ji HEE
Study officials:
affiliation: Keimyung University
name: Ji Hee Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05151536: Effects of Different Doses of Epinephrine on Biomarkers of Nervous System Ischemia-reperfusion Injury in Patients With Stanford Type A Dissection
Official title: To Explore the Impact of Epinephrine on Biomarkers of Nervous System Ischemia-reperfusion Injury in Patients With Stanford Type A Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenaline; Aortic Dissection; Drug Dose; Nervous System; Ischemia Reperfusion Injury
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The TAAD patients aged 18-75 years old

Brief summary: Aortic dissection is the most common aortic disease leading to death. Among them, patients with Stanford type A dissection (TAAD) are prone to dissection rupture in the early stage, and their condition deteriorates rapidly. They need immediate surgical treatment after admission.In this study, the detection data of biomarkers of nervous system Ischemia / Reperfusion (I/R)injury in patients with Stanford type A dissection were retrospectively analyzed, and the effects of different doses of adrenaline on biomarkers of nervous system I/R injury were evaluated by statistical methods.The information of 132 patients with Stanford type A aortic dissection who underwent sun's operation in the Department of cardiovascular surgery of the first medical center of the PLA General Hospital from January 2012 to January 2019 was retrospectively analyzed.


Eligibility criteria: Inclusion Criteria:

* The patient's age was 18-75 years old; TAAD was diagnosed by aortic CTA before operation; Sun's operation was performed within two weeks of onset; Deep hypothermic circulatory arrest (DHCA) and selective unilateral cerebral perfusion via right axillary artery were used for brain protection; Adrenaline was used after operation

Exclusion Criteria:

* Nervous system disease and mental system disease before operation; Recent acute coronary syndrome; Recent cardiac arrest; Recent poor perfusion of visceral or peripheral organs; Recent hypoxemia; Previous history of cardiac surgery; Intraoperative death and death within 48 hours after operation; Neurological or psychiatric symptoms occurred within 48 hours after operation; Adrenaline was not used after operation

Primary outcomes:
measure: Biomarkers of nervous system ischemia-reperfusion injury
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06487936: Real-World Registry Study on Patient Satisfaction With TransLoc 3D SI Joint Fusion
Official title: A Multi-Center, Real World Prospective/Retrospective Registry to Evaluate Patient Satisfaction With the TransLoc 3D SI Joint Fusion System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sacroiliac Joint Dysfunction
Sacroiliac; Fusion
Lead sponsor: CornerLoc
Sponsor class: INDUSTRY
First posted: 2024-07-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have already received the TransLoc 3D System \> 1 year postoperatively \< 18 months, at the time of consent.

Brief summary: This is a multi-center, consecutive enrollment registry study to evaluate patient satisfaction post SI Fusion with the TransLoc 3D SI Fusion System.


Eligibility criteria: Inclusion Criteria:

* Age 18 year or older
* Confirmed Implant of the Transloc 3D Fusion System
* Did not have Transloc device removed or another manufacturer device implanted post Transloc
* Does not have other manufacturer's titanium or metal implant
* Patient may be included with prior allograft implant
* Willing to participate and give written consent
* Must have or planned CT post ≥1 year per standard of care

Exclusion Criteria:

* Patient is younger than 18 years
* Patient is unable to sign the Informed Consent
* Implant of other manufacturer's titanium or alternative metal implant
* Revision with another manufacturer's implant
* Fracture or unresolved trauma of implant side after implantation of TransLoc
* Patient unwilling to participate in Patient Satisfaction Survey
* Patient has not returned for Standard of Care follow-up

Primary outcomes:
measure: Patient Satisfaction Survey
timeFrame: Prospective 12 to 18 months post surgery
Secondary outcomes:
measure: Visual Analogue Scale (VAS) of pain
timeFrame: Baseline up to 1 year post surgery
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline up to 1 year post surgery
measure: SAEs
timeFrame: Time of surgery up to 90 days post surgery
measure: CT Scan Second Read (Radiological Overread)
timeFrame: 12 to 18 months post fusion surgery
Other outcomes:
Locations:
city: Port Charlotte
country: United States
facility: Advanced Orthopedic Center
state: Florida
Study officials:
affiliation: Advanced Orthopedic Center
name: Lee James, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01268436: Cohort Comparison of Dental Nerve Block With Other Forms of Analgesia in Alleviating the Pain of Toothache
Official title: Cohort Comparison of Dental Nerve Block With Other Forms of Analgesia in Alleviating the Pain of Toothache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tooth Pain
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2010-12-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients identified by ED providers as having dental pain will be screened for enrollment.

Brief summary: Toothache is a common source of pain for Emergency Department patients. There are several common ways to control the pain of toothache. But we do not know if any one of them is more effective than another. It is also possible that how we take care of your pain in the Emergency Department will influence the level of pain you experience one or two days from now. This study seeks to answer these questions.


Eligibility criteria: Inclusion Criteria:

* \> 18 years, pain in any tooth

Exclusion Criteria:

* duration of pain \> 96 hours
* oral trauma within 96 hours of presentation
* facial or neck swelling
* pericoronitis
* visual impairment to less than finger counting within three feet

Primary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Before and After treatment of tooth pain
Secondary outcomes:
measure: Need for additional treatment
timeFrame: while in the Emergency Department
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
References:
Clinical trial NCT04644536: Retrospective Collection of Safety and Performance Data
Official title: Retrospective Collection of Safety and Performance Data
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bone Defects
Lead sponsor: Bioceramed
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study patients will be extracted from current patient population.

Brief summary: This is a retrospective post market clinical follow-up study to compile real world clinical data on safety and efficacy of the synthetic bone graft substitutes in a commercial clinical setting in long bone and extremity defects and in spinal fusion procedures.


Eligibility criteria: Inclusion Criteria:

* Patients treated with Bioceramed bone substitutes at the Center.
* Long bone \& extremities: bone grafting after post-traumatic or surgically created bone defects.
* Spine: degenerative disc disease or trauma who require spinal fusion of 1 or more vertebral bodies.

Exclusion Criteria:

Serious infection within two months before surgery, active malignancy, cellulitis, osteomyelitis, diseases interfering with bone metabolism (primary hyperparathyroidism, severe renal or hepatic insufficiency, non-treated hyperthyroidism), other bone metabolic diseases (osteomalacia, Paget disease, osteogenesis imperfecta), bone metastasis, primary bone tumors.

Primary outcomes:
measure: Bone healing, observable by x-ray/MRI
timeFrame: 6 months
measure: Bone healing, observable by x-ray/MRI
timeFrame: 12 months
Secondary outcomes:
measure: Number and description of any adverse event during the follow-up
timeFrame: 6 - 12 months
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital Lusíadas Lisboa
Study officials:
affiliation: Hospital Lusíadas Lisboa
name: Nuno A Ribeiro, MD
role: PRINCIPAL_INVESTIGATOR
References: