louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02785081: Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging.Magnetic Resonance Imaging
Official title: Thoracic Epidural Depth in Children Using Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Epidural
Magnetic Resonance Imaging
Keywords: Thoracic epidural
Magnetic Resonance Imaging
Children
Lead sponsor: King Fahad Medical City
Sponsor class: OTHER_GOV
Collaborators: name: Nationwide Children's Hospital
First posted: 2016-05-27
Enrollment: 109
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MRI images of children aged 1 month to 8 years undergoing Magnetic Resonance Imaging evaluation unrelated to spine pathology were studied.

Brief summary: The purpose of this study is to evaluate the thoracic skin to epidural space depth in children and define the ratio between the straight and inclined thoracic skin to epidural depth.

Detailed description: Thoracic epidural in children confers clinical benefits but are technically challenging. The prediction of thoracic skin epidural depth (SED) might increase the success rate and decrease complications. Magnetic resonance imaging (MRI) is the most comprehensive imaging modality of the spine, and the measurements derived can be more accurate.

The present study is based on Magnetic Resonance Imaging (MRI)-based measurements to evaluate the thoracic SED and define the ratio between the straight and inclined SED at the two thoracic levels (T6-7 and T9-10) in children.

Eligibility criteria: Inclusion Criteria:

Children aged 1 month to 8 years undergoing Magnetic Resonance Imaging evaluation

Exclusion Criteria:

Patients with scoliosis, myelomeningocele, tumors of the spinal cord or vertebral bodies, spina bifida, tethered cord, spinal metastasis

Primary outcomes:
measure: Depth of thoracic epidural space in children
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
Study officials:
affiliation: King Fahad Medical City, Riyadh
name: Tariq M Wani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franklin AD, Lorinc AN, Shotwell MS, Greene EB, Wushensky CA. Evaluation of the skin to epidural and subarachnoid space distance in young children using magnetic resonance imaging. Reg Anesth Pain Med. 2015 May-Jun;40(3):245-8. doi: 10.1097/AAP.0000000000000234.
citation: Kil HK, Cho JE, Kim WO, Koo BN, Han SW, Kim JY. Prepuncture ultrasound-measured distance: an accurate reflection of epidural depth in infants and small children. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):102-6. doi: 10.1016/j.rapm.2006.10.005.
Clinical trial NCT01360281: Neuromuscular Electrical Stimulation and Strength Training in Patients With Knee Osteoarthritis
Official title: Neuromuscular Electrical Stimulation and Strength Training in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Quadriceps strength
osteoarthritis rehabilitation
NMES
Lead sponsor: Universidade Gama Filho
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 34
Sex: ALL
Minimum age (years): 38
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 the efficiency of neuromuscular electrical stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and on recovering motor function of patients with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* American College of rheumatology criterion for osteoarthritis diagnosis

Exclusion Criteria:

* Patients that have done knee replacement or are about to do.
* Patients with health conditions that are not compatible with the interventions
* Patients that have done intraarticular corticoid

Primary outcomes:
measure: Change in Quadriceps strength
timeFrame: Before and after an 8 weeks intervention
measure: Change in Pain
timeFrame: Before and after an 8 weeks intervention
measure: Change in Moving function
timeFrame: Before and after an 8 weeks intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Clinica Escola de Fisioterapia da Universidade Gama Filho
Study officials:
References:
Clinical trial NCT03461081: Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers
Official title: An Open-label, Randomized, Two-sequence, Multiple-dose, Crossover Study to Evaluate Drug-drug Interaction Following Oral Administration of Telmisartan/Amlodipine and Atorvastatin in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension With Hyperlipidemia
Lead sponsor: Jeil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-09
Enrollment: 32
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: study to evaluate drug-drug interaction following oral administration of telmisartan/amlodipine and atorvastatin in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* 19\~55 years healthy male
* The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
* Subjects who agree to keep contraceptive methods during the clinical trial.

Exclusion Criteria:

* Subjects who are allergic to investigational drug.
* Subjects who have a medical history which can affect the clinical trial.
* Hypertension(Systolic BP ≥ 150mmHG or Diastolic BP ≥ 100mmHg), Hypotension(Systolic BP ≤ 100mmHg or Diastolic BP ≤ 70mmHg)
* Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.

Primary outcomes:
measure: AUCτ of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin
timeFrame: Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours
measure: Css,max of telmisartan, amlodipine, atorvastatin, 2-OH atorvastatin
timeFrame: Period I Day 1, Day 10, Day 14 and Period II Day 4 pre and post 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT01752881: Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects
Official title: Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Vaccine
Immunogenicity
Lead sponsor: Adimmune Corporation
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).


Eligibility criteria: Inclusion Criteria:

* Males or non-pregnant females and aged ≥ 18 years;
* Willing and able to adhere to visit schedules and all study requirements;
* Subjects read and signed the study-specific informed consent.

Exclusion Criteria:

-

Primary outcomes:
measure: Immunogenicity endpoint: Seroprotection rate
timeFrame: At 3 weeks after vaccination
measure: Immunogenicity endpoint: Seroconversion rate
timeFrame: At 3 weeks after vaccination
measure: Immunogenicity endpoint: Geometric mean folds increase in HAI titer
timeFrame: At 3 weeks after vaccination
Secondary outcomes:
measure: Safety: Reactogenicity events
timeFrame: 7 days after vaccination
measure: Safety: Serious and non-serious adverse events
timeFrame: Through day 21 post vaccination
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Chih-Jen Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06379581: Skin Cancer Diagnostics Using Photoacoustic Imaging
Official title: Photoacoustic Imaging for Three-dimensional Delineation of Skin Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skin Cancer
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2024-04-23
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to perform surgical excision of lesion(s) at the Clinic of Dermatology, Lund, Skåne University Hospital

Brief summary: In this clinical study, photoacoustic imaging will be used on patients with suspected skin cancer (primarily melanoma, basal cell carcinoma, and squamous cell carcinoma) to determine the tumor borders both superficially and at a depth.

Detailed description: The study will employ multispectral photoacoustic imaging in the spectral range between 680-970 nm to scan suspected skin tumors both in vivo and ex vivo. The hyperspectral data will then undergo rigorous spectral analysis with the objective to identify the spectral fingerprints associated with healthy tissue and tumor. Thereafter, a classification algorithm will be used to determine whether a pixel in the acquired image more likely identifies with healthy tissue or tumor, which is then repeated for all pixels in the images. As such, a 3D image can be reconstructed in which the tumor is visibly contrasted from healthy tissue. Achieving this goal will facilitate the diagnostic procedures and greatly reduce waiting times, clinical costs and potential patient suffering.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to perform surgical excision of lesion(s) suspected to be tumors.

Exclusion Criteria:

-

Primary outcomes:
measure: Tumor thickness
timeFrame: Enrollment is anticipated to last 1 year + final analyse 6 months
measure: Tumor size
timeFrame: Enrollment is anticipated to last 1 year + final analyse 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of Ophthamology, Lund, Skåne University Hospital
Study officials:
References:
Clinical trial NCT01522781: 10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis
Official title: 10 Year Outcome of Total Knee Replacement (TKR) Using Sigma Prosthesis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Knee Replacement
Lead sponsor: NHS Fife
Sponsor class: OTHER_GOV
Collaborators: name: DePuy International
First posted: 2012-02-01
Enrollment: 234
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing total knee replacement in Fife

Brief summary: The purpose of this study is to obtain a prospective database which will allow analysis of total knee outcomes.

Detailed description: A prospective database was set up in October 1998. Patient details are collected pre-operatively, intra-operatively and immediately post operatively. Patients are then followed up in a dedicated knee clinic at 6 months, 18 months, 3 years and 5 years. Data such as SF12 and the American knee society score has been done at each visit.

Eligibility criteria: Inclusion Criteria:

All patients undergoing total knee replacement in Fife

Primary outcomes:
measure: Clinical outcome of the Sigma knee at 10 years
timeFrame: 10 years
Secondary outcomes:
measure: Radiographic outcomes at 10 years
timeFrame: 10 years
Other outcomes:
Locations:
city: Kirkcaldy
country: United Kingdom
facility: Fife Health Board
state: Fife
Study officials:
References:
Clinical trial NCT05979181: Peripartum Cesarean Hysterectomy for Placenta Percreta
Official title: Peripartum Cesarean Hysterectomy for Placenta Percreta: a Retrospective Analysis of Cases With and Without Extrauterine Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Accreta
Keywords: PAS
Placenta previa
Placenta accreta
Cesarean hysterectomy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 73
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3) diagnosed by color flow Doppler, and confirmed intraoperatively

Brief summary: The aim of this study is to address the possible preoperative determinants of extrauterine diseases in cases of placenta previa percreta and to compare the operative and postoperative characteristics of cases with and without extrauterine disease.

Detailed description: This will be a retrospective study of the data of women who underwent cesarean hysterectomy on placenta previa percreta who were classified as Federation of Gynecology and Obstetrics (FIGO) grade 3. Women without extrauterine disease (FIGO grade 3a) will be compared to women with extrauterine disease (FIGO grades 3b and 3c)

Eligibility criteria: Inclusion Criteria:

* Women who underwent cesarean hysterectomy on placenta previa percreta (FIGO grade 3).

Exclusion Criteria:

* Medical conditions complicating pregnancy.
* Blood diseases or bleeding tendencies

Primary outcomes:
measure: Estimated amount of intraoperative blood loss
timeFrame: From start to end of operation
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Khaled S Ismail, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mahmoud M Awad, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Alhussein A Mohamed, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06293781: Application of the Web-based Acceptance and Commitment Therapy for Depression
Official title: The Efficacy and Treatment Mechanisms of the Web-based Acceptance and Commitment Therapy for Patients with Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Gachon University
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PROSPECTIVE INTERVENTION STUDY; EFFICACY OF WEB-BASED ACCEPTANCE AND COMMITMENT THERAPY

Detailed description: Acceptance Commitment Therapy (ACT) is known to help people recover from depression by improving psychological flexibility through acceptance, defusion, self-as-context, present moment, committed action, and helping them live a values-based life. This study is a randomized controlled trial to determine if web-based ACT leads to changes in the psychological flexibility and cognitive fusion. Also, through the functional MRI study, possible treatment mechanisms by which the web-based ACT exerts will be identified.

Eligibility criteria: Inclusion Criteria:

* Patients who diagnosed major depressive disorder

Exclusion Criteria:

* Patients who have serious medical problems, metal implants in their bodies, severe brain injury or brain disease
* Women who were pregnant or nursing
* Patients at high risk for suicide

Primary outcomes:
measure: Acceptance and Action Questionnaire-II
timeFrame: 6 weeks
measure: Hamilton Rating Scale for Depression
timeFrame: 6 weeks
Secondary outcomes:
measure: Cognitive Fusion Questionnaire
timeFrame: 6 weeks
measure: Functional Connectivity
timeFrame: 6 weeks
measure: Valuing
timeFrame: 6 weeks
measure: Beck Depression Inventory
timeFrame: 6 weeks
measure: Beck Anxiety Inventory
timeFrame: 6 weeks
measure: Beck Hopelessness Scale
timeFrame: 6 weeks
measure: Beck Scale for Suicide Ideation
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Kyoung-Sae Na
state: Please Incheon
Study officials:
References:
Clinical trial NCT02976181: Brady MX a Quality Improvement Study
Official title: Registry to Improve the Adoption of Consensus Treatment Guideline (Brady MX)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinus Node Disfunction
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2016-11-29
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Bradycardia symptomatic patients

Brief summary: Medtronic is sponsoring a quality improvement study called Brady MX. It is hypothesized that lack of awareness of treatment and diagnostics pathways result in lower number of referrals to implanters of IPG.


Eligibility criteria: Inclusion Criteria:

* Patient at least 18 years of age
* Patient´s heart rate meets at least one of the following:

Patient has a sinus rate ≤ 50 OR a junctional escape rhythm no faster than 50 Patient has a history of exercise intolerance

* Patient complains of general fatigue, shortness of breath, shortness of breath with exertion, syncope, light headed dizziness, palpitations, lethargy, dyspnea OR malaise within the last 30 days that are not related to other discovered causes (such as untreated hypothyroidism or anemia)
* Patient (or patient´s legally authorized representative) is willing and able to sign and date written Patient Consent Form/Data Release Form

Exclusion Criteria:

* Patient has recent history of blood loss
* Patient has a medical history leading to suspicion of neurological disorder
* Patient has a history of Chronic Atrial Fibrilation
* Patient is enrolled or planing to participate in a concurrent drug and/or device study at any time during the course of this clinical study without documented pre-approval from Medtronic study manager
* Patient is not expected to survive 12 months
* Patient is anticipated to be unwilling or unable to comply with the clinical investigation plan

Primary outcomes:
measure: Absolute Change in the Proportion of Subjects Diagnosed With SND at Pre Specific Time.
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Number of SND Subjects Receiving a Referral for an Indicated IPG Device After the Intervention
timeFrame: 3, 6, and 15 months
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Hospital General de Tijuana
state: Baja California
city: Cancún
country: Mexico
facility: Hospital General de Cancun
state: Quintana Roo
city: Hermosillo
country: Mexico
facility: Hospital General del Estado de Sonora
state: Sonora
city: Colima
country: Mexico
facility: Hospital Regional Universitario de Colima
city: Queretaro
country: Mexico
facility: Hospital General de Queretaro
Study officials:
References:
Clinical trial NCT00092781: A Study of MK0663 and an Approved Drug in the Treatment of Osteoarthritis (0663-077)(COMPLETED)
Official title: A 26-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind, 2-Part Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Patients With Osteoarthritis (Study 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Arcoxia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 500
Sex: ALL
Minimum age (years): 40
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 the safety and effectiveness of an investigational drug and an approved drug in the treatment of osteoarthritis of the knee and hip.

Detailed description: The duration of treatment is 26 weeks.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of the knee or hip which requires treatment with medication for pain relief

Exclusion Criteria:

* Any known allergies to the study drugs

Primary outcomes:
measure: Osteoarthritis of the knee & hip as assessed by WOMAC VA 3.0 pain and physical function subscales, Patient/Investigator assessments of disease and response to therapy over 12 weeks of treatment.
Secondary outcomes:
measure: Maintenance of clinical efficacy as assessed by WOMAC subscales and Patient assessments over a 26-wks of treatment. To evaluate the safety / tolerability over a 12-wk and 6-mo treatment period.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bingham CO 3rd, Sebba AI, Rubin BR, Ruoff GE, Kremer J, Bird S, Smugar SS, Fitzgerald BJ, O'Brien K, Tershakovec AM. Efficacy and safety of etoricoxib 30 mg and celecoxib 200 mg in the treatment of osteoarthritis in two identically designed, randomized, placebo-controlled, non-inferiority studies. Rheumatology (Oxford). 2007 Mar;46(3):496-507. doi: 10.1093/rheumatology/kel296. Epub 2006 Aug 27.
citation: Bingham CO 3rd, Bird SR, Smugar SS, Xu X, Tershakovec AM. Responder analysis and correlation of outcome measures: pooled results from two identical studies comparing etoricoxib, celecoxib, and placebo in osteoarthritis. Osteoarthritis Cartilage. 2008 Nov;16(11):1289-93. doi: 10.1016/j.joca.2008.04.009. Epub 2008 Jun 2.
citation: Bingham CO 3rd, Smugar SS, Wang H, Tershakovec AM. Early response to COX-2 inhibitors as a predictor of overall response in osteoarthritis: pooled results from two identical trials comparing etoricoxib, celecoxib and placebo. Rheumatology (Oxford). 2009 Sep;48(9):1122-7. doi: 10.1093/rheumatology/kep184. Epub 2009 Jul 9.