louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03277443: Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite
Official title: Accuracy of Computer Guided Surgery (vs) Conventional Model Surgery in Treatment of Skeletal Open Bite: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apertognathia
Keywords: Skeletal open bite
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: SM and VSM
Primary purpose: TREATMENT

Brief summary: In patient with skeletal open bite, Dose computer-aided surgery enhances the clinical outcomes and accuracy versus conventional model surgery

Detailed description: P Adult Patients with skeletal open bite.

I Computer guided surgery.

C Conventional articulating model surgery

O Outcome measure:

Outcome Name Measuring Device Measuring Unit (mm)

O1 Accuracy

Computer guided: Super-imposition of virtual surgery over the post- operative CT Scan composite models ( millimeter mm)

Conventional : Super-imposition of scanned articulator with mounted casts in the pre-planned mock surgery over post-operative scanned mounted occlusion ( millimeter mm)

O2 Anterior open Bite Closure

Standardized Multi Scan CT (millimeter mm)

Eligibility criteria: Inclusion Criteria:

* Patients suffering from skeletal open bite caused by vertical posterior maxillary excess and/or short mandible ramus.
* Patients should be free from any systemic disease that may affect normal healing, and predictable outcome.
* Required two jaws orthographic surgery

Exclusion Criteria:

* Patients with any systemic disease that may affect normal healing
* Intra-bony lesions or infections that may retard the osteotomy healing.
* Patient with bad oral hygiene.
* Uncontrolled Diabetes mellitus.

Primary outcomes:
measure: Accuracy of movement of surgical segments in millimeter
timeFrame: up to 4 months
Secondary outcomes:
measure: Anterior open Bite Closure (positive overbite in millimeter)
timeFrame: up to 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Moustafa K Ezz, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02695043: MMEPT for Traumatic Brain Injury
Official title: Multimedia Multicultural Educational Program for Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this research is to increase adherence to outpatient rehabilitation of chronically underserved individuals with traumatic brain injury (TBI). The intervention will be a TBI rehabilitation-focused education tool suitable for use with a wide variety of patients, including those with poor literacy skills and those with Limited English Proficiency (LEP), hereafter referred to as the Multimedia Multicultural Educational Program for TBI (MMEPT).


Eligibility criteria: Inclusion Criteria:

* A medically documented (e.g., EMS report, hospital record, physician record) TBI as a result of a blow to the head requiring admission to an acute inpatient rehabilitation unit, meeting at least one of the following criteria for moderate to severe TBI:

  1. PTA \> 24 hours
  2. Trauma related intracranial neuroimaging abnormalities
  3. Loss of consciousness exceeding 30 minutes
  4. GCS in emergency department of less than 13 (unless due to intubation, sedation or intoxication)
* Proficient in Chinese (Mandarin or Cantonese), Spanish or English,
* Willing to engage in the MMEPT and complete questionnaires,
* Agreeing to participate (i.e., completion of informed consent and HIPAA documents).

Exclusion Criteria:

* Preferred language (language with greatest proficiency) other than English, Chinese or Spanish,
* In minimally conscious or vegetative state,
* Significant symptoms of receptive aphasia, and
* Any acute medical condition that, in the investigator's opinion, makes the person unsuitable or unable to participate. Participants enrolled in the study who are ultimately not discharged to the community at the completion of acute inpatient rehabilitation will be removed from the study.

Primary outcomes:
measure: Difference in Rate of Retention
timeFrame: Up to One Week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Tamara Bushnik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05838443: Mindfulness Surgical Pain Outcomes
Official title: Pragmatic Randomized Controlled Trial Evaluating Efficacy of Presurgical Provider-directed Behavioral and Self-directed Mindfulness Interventions in Pediatric Patients Undergoing Major Elective Surgical Procedures on Postoperative Pain Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Surgical Pain
Surgery
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: The Society for Pediatric Anesthesia
First posted: 2023-05-01
Enrollment: 92
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This will be a prospective randomized study to evaluate novel, clinically feasible, easily deliverable, pragmatic ways of preemptively modifying known CPSP and behavioral risk factors for acute to chronic pain transitions in adolescents before surgery. In addition, it will provide mechanistic insights and build a strong foundation for future large scale interventional studies that can impact outcomes positively in children undergoing surgery.


Eligibility criteria: Inclusion Criteria:

1. Aged 10-18 years
2. English speaking
3. Ability to provide assent/consent/parent permission
4. Scheduled to undergo elective major musculoskeletal surgeries including spine fusion (idiopathic scoliosis only), abdominal surgeries, thoracic surgery including pectus repair, and major orthopedic joint surgeries.

Exclusion Criteria:

1. Previous exposure to psychological interventions
2. Surgery within 1 year
3. Developmental delay
4. Chronic opioid use within 6 months prior to surgery
5. Severe systemic disease

Primary outcomes:
measure: Functional Disability Index (FDI)
timeFrame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 4 months.
Secondary outcomes:
measure: Child and Adolescent Mindfulness Measure (CAMM)
timeFrame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
measure: Child Anxiety Sensitivity Index (CASI)
timeFrame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
measure: Electronic Pain Diary and PainDETECT
timeFrame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
measure: Perioperative Opioid use
timeFrame: Postoperative inpatient (if applicable), 1 week, 2 weeks and 3-4 months postoperatively.
measure: PROMIS pain interference-short form
timeFrame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months.
measure: Pain Coping Efficacy
timeFrame: Baseline pre-intervention, post-operatively at 1 week, 2 weeks and 3-4 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center (CCHMC)
state: Ohio
Study officials:
References:
Clinical trial NCT02110043: Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by tDCS
Official title: Modulation of Visual-Spatial Learning in Patients With Mild Cognitive Impairment (MCI) by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Keywords: mild cognitive impairment (MCI)
tDCS
LOCATO task
visual-spatial learning
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement in learning and memory in patients with mild cognitive impairment (MCI) and to examine the underlying neuronal mechanism.


Eligibility criteria: Inclusion Criteria (MCI patients):

* right handedness
* amnestic and amnestic plus MCI with:

  1. subjective memory impairment;
  2. objective memory difficulties, at least 1 SD below gender, age and education adjusted standard values;
  3. relatively normal performance in other cognitive domains;
  4. no constraints in activities of daily livings
  5. age: 50-90 years

Exclusion Criteria:

* severe internal or psychiatric disease
* epilepsy
* other severe neurological diseases, e.g. previous major stroke or brain tumor
* DMS-IV manifest dementia
* contraindication for MRT (claustrophobia, metallic implants, tattoos)

Primary outcomes:
measure: Performance in LOCATO task (Visual-spatial learning and memory) after a combination of intensive visual-spatial training and tDCS
timeFrame: immediately after end of a 3-day period of training in tDCS condition vs sham condition
Secondary outcomes:
measure: long term effects
timeFrame: after 1 month vs baseline
measure: functional changes: Connectivity
timeFrame: end of 3-day cognitive training vs baseline
measure: cortical excitability
timeFrame: at baseline
measure: Quality of Life
timeFrame: after 1 month vs baseline
measure: memory
timeFrame: immediately after end of 3-day of cognitive training, after 1 month vs. baseline
measure: affective state
timeFrame: immediately after the end of 3-day cognitive training, after 1 month vs. baseline
measure: genotyping of learning related polymorphisms
timeFrame: once
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kulzow N, Kerti L, Witte VA, Kopp U, Breitenstein C, Floel A. An object location memory paradigm for older adults with and without mild cognitive impairment. J Neurosci Methods. 2014 Nov 30;237:16-25. doi: 10.1016/j.jneumeth.2014.08.020. Epub 2014 Aug 28.
Clinical trial NCT04815343: Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
Official title: Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cochlear Hearing Loss
Lead sponsor: Advanced Bionics AG
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparision of different conditions with-in subject. (10 bimodal, 10 bilateral CI users)
Primary purpose: OTHER

Brief summary: In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of Naída Link M90 hearing aid and Naída CI M90 sound processor on sound perception. This design was shown to be successful in previous studies for the evaluation of sound coding strategies. Furthermore, a within-subject comparison decreases the variance in the results allowing for fewer subjects when the population that uses the investigational device is not large in general.


Eligibility criteria: Inclusion Criteria:

* CI users with a CII, HiRes90K (Advantage) or HiRes Ultra implant system

  * Bilateral users: two implant systems
  * Bimodal users: hearing aid contralateral
* Minimum of 18 years of age
* Minimum of six months experience with their implant system
* Minimum of six months experience with the Naída CI Q-Series sound processor
* Ability to give feedback on sound quality
* Speech intelligibility with the HSM sentence test in noise at 10 dB SNR \> 10% as obtained during previous visits in the clinical routine
* Fluent in German language

Exclusion Criteria:

* Difficulties additional to hearing impairment that would interfere with the study procedures
* Concurrent participation in other study
* Pregnant and breast-feeding women

Primary outcomes:
measure: Difference in speech perception in noise with AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices
timeFrame: 6 weeks
Secondary outcomes:
measure: Differences in speech perception in noise threshold measured in Decibel [dB]
timeFrame: 6 weeks
measure: Differences in speech perception in quiet threshold measured in Decibel [dB]
timeFrame: 6 weeks
measure: Differences in mono/stereo identification measured in % correct
timeFrame: 6 weeks
measure: Differences in speech understanding in noise measured in % correct
timeFrame: 6 weeks
measure: Differences in music enjoyment ratings measured in rating score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (MHH)
state: Niedersachsen
Study officials:
References:
Clinical trial NCT04101643: PCSK9 Inhibitor Treatment for Patients With SPG5
Official title: PCSK9 Inhibitor Treatment for Patients With Hereditary Spastic Paraplegia Type 5
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hereditary Spastic Paraplegia Type 5
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Spastic paraplegia type 5 (SPG5) is a rare subtype of hereditary spastic paraplegia, a highly heterogeneous group of neurodegenerative disorders defined by progressive neurodegeneration of the corticospinal tract motor neurons. SPG5 is caused by recessive mutations in the gene CYP7B1 encoding oxysterol-7a-hydroxylase. This enzyme is involved in the degradation of cholesterol into primary bile acids. CYP7B1 deficiency has been shown to lead to accumulation of neurotoxic oxysterols. Oxysterols were found to impair metabolic activity and viability of human cortical neurons at concentrations found in SPG5 patients, indicating that elevated levels of oxysterols might be key pathogenic factors in SPG5. Monoclonal antibodies that inhibit proprotein convertase subtilisin-kexin type 9 (PCSK9) have emerged as a new class of drugs that effectively lower cholesterol levels. Evolocumab, a member of this class, is a fully human monoclonal antibody that reduces LDL cholesterol levels by approximately 60%. We thus performed this interventional trial with Evolocumab 420 mg for SPG5 patients.


Eligibility criteria: Inclusion Criteria:

* Age 14-80 years
* Probands with clinically manifest hereditary spastic paraplegia
* Genetically confirmed diagnosis of SPG5

Exclusion Criteria:

* Comprised treatment with statins 3 months prior to enrolment
* Contraindications to PCSK9 inhibitor therapy
* Pregnancy was excluded in women of childbearing age

Primary outcomes:
measure: The change of 27-hydroxycholesterol (27-OHC)
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology , First Affiliated Hospital Fujian Medical University
Study officials:
affiliation: First Affiliated Hospital Fujian Medical University
name: Wan-Jin Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02461043: Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Adjuvant Chemotherapy in the Treatment of the Lymph Node Positive Thoracic Esophageal Squamous Cell Carcinoma
Official title: Adjuvant Chemotherapy With Paclitaxel and Cisplatin in Lymph Node-Positive Thoracic Esophageal Squamous Cell Carcinoma: A Randomized Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Esophageal Cancer
Keywords: esophageal cancer
adjuvant chemotherapy
esophageal surgery
paclitaxel
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2015-06-03
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Esophageal cancer is a highly aggressive malignancy with a poor overall outcome.

* Five year survival rate after radical esophagectomy is modest at about 40%.The patients with regional lymph node metastases have worse outcome than those without lymph node metastases.
* No standard postoperative adjuvant chemotherapy has ever been established.


Eligibility criteria: Inclusion Criteria:

* ability to give informed consent
* histological proof of thoracic esophageal squamous cell carcinoma with negative proximal and distal margins
* node-positive and pathologic stage M0
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients were enrolled 4 to 10 weeks after surgery
* Adequate organ function was required in 2 weeks of registration and was defined as: serum creatinine within normal institutional limit, and creatinine clearance (CrCl) ≥60ml/minute. Aspartate aminotransferase and bilirubin\<2 times of upper normal institutional limits

Exclusion Criteria:

* prior chemotherapy or concurrent radiation therapy before esophagectomy
* R1 or R2 resection
* clinically significant hearing loss or symptomatic peripheral neuropathy during initial examination

Primary outcomes:
measure: 3 year relapse free survival
timeFrame: 5 years
Secondary outcomes:
measure: 3 year overall survival
timeFrame: 5 years
Other outcomes:
measure: 5 year overall survival
timeFrame: 8 years
Locations:
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study officials:
References:
Clinical trial NCT03698643: Impact of New Interventional Imaging Modality Use on Patient Radiation Exposure in Transarterial Chemoembolization
Official title: Impact of New Interventional Imaging Modality Use (Angio-CT) on Patient Radiation Exposure in Transarterial Chemoembolization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatic Tumor
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: TACE sessions performed on adult patients with primary or secondary liver tumor(s) after multidisciplinary tumor meeting approval

Brief summary: Transarterial chemoembolization (TACE) is the most performed endovascular interventional radiology (IR) procedure. TACE procedures are performed in an IR suite, most of which are equipped with floor-based flat-panel robotic C-arm allowing two-dimensional imaging. Cone-beam computed tomography (CBCT) has been developed to allow three-dimensional navigation but has several limitations such as reduced signal to noise ratio and small field-of-view, and seems to have negative impact on patient radiation exposure. Another option to perform 3D imaging is called angio-CT which combines a CT-scan and a floor-based flat-panel robotic C-arm in a single IR suite. Even if some publications have shown benefit of angio-CT in TACE procedures in Japan, no study about angio-CT in liver IR procedures has been conducted in the occidental world so far. The purpose of our study was to assess the impact of angio-CT use on patient radiation exposure and treatment quality in TACE procedures compared to CBCT.

This before-after study consisted of a review of consecutive TACE procedures performed between January 2016 and September 2017 in our institution with two different imaging modalities, defining two study groups (C-arm with CBCT versus angio-CT).


Eligibility criteria: Inclusion criteria:

* Age \> or = 18 years
* primary or secondary liver tumor(s)
* TACE approved by multidisciplinary tumor meeting

Exclusion criteria:

- TACE not performed

Primary outcomes:
measure: Patient effective radiation dose per TACE
timeFrame: 1 day
Secondary outcomes:
measure: Air kerma per TACE
timeFrame: 1 day
measure: Fluoroscopy time per TACE
timeFrame: 1 day
measure: Number of CBCT acquisitions per TACE
timeFrame: 1 day
measure: Number of CT acquisitions per TACE
timeFrame: 1 day
measure: Treatment targeting
timeFrame: 1 day
measure: Tumor response
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: BORIS GUIU, PU-PH
role: STUDY_DIRECTOR
References: