louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01449474: Accuracy of MRI-based Patients Matched Instruments vs Jig-based Instruments in Total Knee Arthroplasty (TKA)
Official title: Accuracy of MRI-based Patients Matched Instruments and Jig-based Instruments in Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Knee
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total knee arthroplasty (TKA) is the common and effective procedure for treatment of end-staged knee osteoarthritis. Postoperative alignment of TKA is one of the important factors which effects on survival of prosthesis. High percentage of misalignment has been reported in conventional technique with using the jig based instruments. Several methods and devices were established to solve this problem. Customized or patient matched instruments were the novel technology that made from magnetic resonance imaging (MRI) of lower limb. With using special software to calculate the alignment axis, it was thought that accurate alignment can be achieved by using this instruments. Therefore, the study aimed to compare the accuracy of MRI based patient matched instruments and jig based instruments in TKA.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed primary osteoarthritis of knee and planned to undergo total knee arthroplasty

Exclusion Criteria:

* Previous complex surgery of the affected knee
* Metalic implant in the affected lower limb
* Patients who unable or contraindicated to perform MRI
* Extra-articular deformities of the affected lower limb
* Extensive bone loss of distal femur or/and proximal tibia
* More than 30 degrees of knee flexion contracture
* Unable to perform TKA within 12 weeks after MRI

Primary outcomes:
measure: The alignment of mechanical axis after TKA
timeFrame: Within 1 month after operation
Secondary outcomes:
measure: The alignment of femoral and tibial components after TKA
timeFrame: Within 1 month after operation
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Keerati Charoencholvanich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chareancholvanich K, Narkbunnam R, Pornrattanamaneewong C. A prospective randomised controlled study of patient-specific cutting guides compared with conventional instrumentation in total knee replacement. Bone Joint J. 2013 Mar;95-B(3):354-9. doi: 10.1302/0301-620X.95B3.29903.
Clinical trial NCT01341574: Early Versus Delayed Treatment of Unilateral Neglect After Stroke
Official title: Influence of Prism Adaptation on Spatial Neglect in the Early Versus Delayed Phase After Stroke: a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spatial Neglect After Stroke
Keywords: spatial neglect
stroke
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
First posted: 2011-04-25
Enrollment: 100
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: 'Unilateral neglect' is a disorder that occurs regularly after stroke. It is caused by right- as well as left-sided brain lesions, but more often by right-sided lesions. Patients with this disorder neglect the contralesional side of space and/or their body. Their body axis is often shifted ipsilesionally. A specific disorder that can appear in neglect patients is 'contraversive pushing': a postural deviation to the neglected side because the patient pushes himself away from the ipsi- to the contralesional side.

One of the most promising neglect interventions is prism adaptation (PA): inducing an optical shift of the visual field by means of prism glasses. This results in a modulation of brain areas involved in neglect and in an improvement of the neglect symptoms and postural deviation.

Research questions:

1. Which period is best suited to maximize therapeutic effects? In this respect the effects of early and delayed PA will be compared, regarding neglect-, postural and cerebral measures.
2. Which factors lead to a less favorable treatment outcome or to therapy resistance for PA?
3. Will the impact of PA be larger if postural factors are taken into account in the prism therapy?


Eligibility criteria: Inclusion Criteria:

* male or female
* \> 17 years of age
* stroke patients with clinical neglect, demonstrated by neglect tests

Exclusion Criteria:

* severe ocular abnormalities
* not being able to perform prism adaptation or neglect tests

Primary outcomes:
measure: effect of prism adaptation
timeFrame: Briefly after and 3 months after therapy cycle.
Secondary outcomes:
measure: The degree of well-being.
timeFrame: Briefly after and 3 months after therapy cycle.
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Rehabilitation Hospital "Hof ter Schelde"
city: Ghent
country: Belgium
facility: Ghent University Hospital, Center for Locomotor and Neurological Rehabilitation
city: Ghent
country: Belgium
facility: Ghent University Hospital, Department of Neurology
Study officials:
affiliation: University Ghent
name: Guy Vingerhoets, Ph.D., Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03587974: Randomized Controlled Trial to Test an Alzheimer's Family Caregiver Intervention in Vietnam
Official title: Cluster Randomized Controlled Trial to Test the Feasibility, Acceptability and Preliminary Effectiveness of a Psychosocial Intervention to Support Alzheimer's Family Caregivers in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Caregivers
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a cluster randomized controlled trial to determine the feasibility and preliminary effectiveness of culturally adapted psychosocial intervention for Alzheimer's family caregivers in Vietnam. The psychosocial intervention is being compared with an enhance control condition.


Eligibility criteria: Inclusion Criteria:

* Family member providing care to someone in household with Alzheimer's disease or a related dementia

Exclusion Criteria:

* Cognitively impaired

Primary outcomes:
measure: Zarit Burden Inventory-4
timeFrame: 3 months
Secondary outcomes:
measure: Patient Health Questionnaire-4
timeFrame: 3 months
measure: Alzheimer's Disease Knowledge Scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vietnam National Geriatric Hospital
Study officials:
affiliation: UC Davis
name: Ladson Hinton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen TA, Nguyen H, Pham T, Nguyen TH, Hinton L. A cluster randomized controlled trial to test the feasibility and preliminary effectiveness of a family dementia caregiver intervention in Vietnam: The REACH VN study protocol. Medicine (Baltimore). 2018 Oct;97(42):e12553. doi: 10.1097/MD.0000000000012553.
Clinical trial NCT05784974: Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
Official title: An Open-label, Single-center, Phase II Study of Cadonilimab Monotherapy as Neoadjuvant Therapy for Resectable II-IIIA Squamous Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cadonilimab, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of Cadonilimab monotherapy as neoadjuvant therapy for patients with resectable stage II-IIIA squamous cell lung cancer.


Eligibility criteria: Key Inclusion Criteria:

Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA Squamous cell lung cancer.

Have at least one measurable lesion per RECIST 1.1 assessed by investigator. Have adequate organ function.

Key Exclusion Criteria:

Mixed adenocarcinoma and small cell lung cancer histology. Patients with other active malignancies within 5 years prior to enrollment. Known active autoimmune diseases. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.

Presence of other uncontrolled serious medical conditions.

Primary outcomes:
measure: Major Pathological Response (MPR) Rate
timeFrame: After surgery (approximately 7 weeks)
Secondary outcomes:
measure: Pathological Complete Response (pCR) Rate
timeFrame: After surgery (approximately 7 weeks)
measure: Complete (R0) Resection Rate
timeFrame: After surgery (approximately 7 weeks)
measure: Objective Response Rate (ORR)
timeFrame: At the end of 2 cycles of neoadjuvant therapy (each cycle is 21 days)
measure: Disease Free Survival (DFS)
timeFrame: Up to approximately 5 years
measure: Adverse Events (AEs)
timeFrame: From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01930474: Analysis of Plasma Tumor DNA in Lung Cancer Patients
Official title: Analysis of Mechanism of Resistance to Chemotherapy by Sequencing of Plasma DNA
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer Patients
Keywords: lung cancer, plasma DNA, free DNA, EGFR, ALK
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-08-29
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: The non-small cell lung cancer patients who will be or have been treated with chemotherapy (including target agents)

Brief summary: The presence of genetic alterations in the tyrosine kinase domain of the oncogene (eg. EGFR and ALK) is associated with the clinical response to tyrosine kinase inhibitors (TKIs) in patients with non-small cell lung cancers. Therefore, the detection of altered genetic alterations is useful for predicting the treatment response for TKIs in non-small cell lung cancer patients. However, good quality tumor tissues are available only in \<50% of patients with inoperable lung cancer for mutation analysis. In this study, the investigators will detect and quantify the genetic alterations in plasma. the investigators will investigate if the serial measurement of cancer-derived genetic alterations in plasma can provide a means for monitoring disease progression, as well as treatment response. In addition the investigators will analysis the resistant mechanism of TKIs and chemotherapy with plasma tumor DNA.


Eligibility criteria: Inclusion Criteria:

* Have a histologically or cytologically confirmed diagnosis of non-small cell lung cancer
* Have molecular evidence of genetic alterations in tumor sample (eg. EGFR mutations, ALK fusions)
* Patients must have given written informed consent

Exclusion Criteria:

* Patients who refuse the blood samplings

Primary outcomes:
measure: Detection of genetic alterations (including EGFR and ALK) in plasma samples
timeFrame: 60 months
Secondary outcomes:
measure: Quantifying circulating tumor DNA in serially collected plasma specimens
timeFrame: 60 months
Other outcomes:
measure: Analysis of genetic alterations related with drug-resistance with next generation genome sequencing
timeFrame: 24 months
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hyun Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01808274: Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
Official title: Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Valve Disease
Keywords: Transcatheter Aortic Valve Replacement
Aortic Stenosis
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
Collaborators: name: Medstar Health Research Institute
name: European Cardiovascular Research Center
name: University of British Columbia
First posted: 2013-03-11
Enrollment: 34
Sex: ALL
Minimum age (years): 19
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 assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

Detailed description: This is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in Europe. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years

Eligibility criteria: Inclusion Criteria:

1. High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15.
2. NYHA ≥ II.
3. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
4. Study patient is an adult of legal consent age.
5. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.

Exclusion Criteria:

1. Acute myocardial infarction ≤ 30 days before the intended treatment.
2. Untreated clinically significant coronary artery disease requiring revascularization.
3. Aortic valve is a congenital unicuspid or congenital bicuspid valve.
4. Mixed aortic valve disease (with predominant aortic regurgitation).

Primary outcomes:
measure: All-cause mortality rate
timeFrame: 30 days post-index procedure
Secondary outcomes:
measure: device success
timeFrame: 30 days
measure: device success
timeFrame: 1 year
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Herzzentrum Universitaet Bonn
city: Hamburg
country: Germany
facility: Asklepios Klinik St Georg Hamburg
city: Leipzig
country: Germany
facility: Heart Center Leipzig
city: Bern
country: Switzerland
facility: Inselspital Bern
Study officials:
affiliation: Inselspital Bern (Switzerland)
name: Prof. Windecker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Leipzig, Rhön Herzentrum (Germany)
name: Prof. Mohr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06895174: Comparison of the Post-operative Efficacy of Arch Bar With Single Plate and Two Plate Fixation in Mandibular Parasymphsis Fracture.
Official title: Efficacy Of Mandibular Parasymphysis Fracture Treatment With Two Miniplates Versus One Miniplate With Arch Bar
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mandible Fracture
Lead sponsor: HITEC-Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is designed to compare post-operative infection, symptoms of paresthesia, inferior border misalignment and operating time of one plate with arch bar against standard two miniplates in mandibular parasymphysis fracture in order to achieve the treatment which is beneficial for the patients. This study will contribute to literature for the betterment of patient.

The objective of this study is to compare the post-operative efficacy of arch bar with single plate and two plate fixation in mandibular parasymphsis fracture.


Eligibility criteria: Inclusion Criteria:

* All patients with mandibular unilateral parasymphysis fracture

Exclusion Criteria:

1. Mandibular defect fractures.
2. Grossly comminuted fractures.
3. Medically compromised patient.(e.g uncontrolled metabolic disease

   * immunocompromised patient, patient receiving radiation and chemotherapy).
4. Multiple fracture of Mandible.

Primary outcomes:
measure: Osseous alignment
timeFrame: Final Alignment will be checked after one month
Secondary outcomes:
Other outcomes:
Locations:
city: Taxila
country: Pakistan
facility: Dental College Hitec Institute Of Medical Sciences Taxila Cantt
state: Punjab
Study officials:
References:
Clinical trial NCT02168374: Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline
Official title: Biological and Physicomechanical Properties of Glass Ionomer Cements Associated With Chlorhexidine or Doxycycline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries
Keywords: Glass ionomer cement
Indirect pulp therapy
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-06-20
Enrollment: 18
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assessed the clinical performance of a resin-modified glass ionomer cement containing different concentrations of chlorhexidine digluconate and doxycycline hyclate.

Detailed description: This study aimed to evaluate the in vivo microbiologic action of the best concentration of chlorhexidine and doxycycline associated with the resin-modified glass ionomer cement applied on remaining dentine after indirect pulp treatment.

Eligibility criteria: Inclusion Criteria:

* an active deep carious lesion at the internal half of the dentine thickness of a primary molar that had not been previously restored and that involved the occlusal or occlusoproximal surface;
* the absence of signs of irreversible damage to the pulp
* the absence of radiolucencies at the interradicular or periapical region or thickening of the periodontal spaces, absence of internal and external root resorption, absence of calcification of the pulp tissue
* children presenting no systemic disease or those not using medications.

Exclusion Criteria:

* presence of signs of irreversible damage to the pulp
* children presenting systemic disease or those using medications.

Primary outcomes:
measure: Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.
timeFrame: up to 3 months
Secondary outcomes:
measure: Indirect Pulp Treatment using GIC associated with 1.25% CHX or 4.5% DOX.
timeFrame: up to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Piracicaba Dental School, Unicamp
name: Aline RF Castilho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Castilho AR, Duque C, Negrini Tde C, Sacono NT, de Paula AB, de Souza Costa CA, Spolidorio DM, Puppin-Rontani RM. In vitro and in vivo investigation of the biological and mechanical behaviour of resin-modified glass-ionomer cement containing chlorhexidine. J Dent. 2013 Feb;41(2):155-63. doi: 10.1016/j.jdent.2012.10.014. Epub 2012 Oct 30.
Clinical trial NCT04542174: PMCF 8 Year Results TRJ®
Official title: Prospective Non-Interventional Post Market Clinical Follow-up Study TRJ® - 8 Years Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Hip
Follow-Up Study
Keywords: Trochanter retaining joint replacement
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2020-09-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

Brief summary: The intention of this Post Market Clinical Follow-Up study is to obtain mid-term results of the TRJ® endoprosthesis. Aim is to include those patients that have received a TRJ® Total Hip Arthroplasty in 2012 and already did participated in a clinical study taking place in 2014 to obtain 2 years results


Eligibility criteria: Inclusion Criteria:

* patients have received a TRJ® prosthesis in 2012
* Patient did participate in the 2 years results evaluation 2014
* Patient gave his written consent for study participation

Exclusion Criteria:

* patient is pregnant
* patient \< 18 years

Primary outcomes:
measure: Survival rate of the stem
timeFrame: at follow-up examination approximately 8 years after primary intervention
Secondary outcomes:
measure: Hip Dysfunction and Osteoarthritis Outcome Score (HOOS)
timeFrame: at follow-up examination approximately 8 years after primary intervention
measure: Harris Hip Score (HHS)
timeFrame: at follow-up examination approximately 8 years after primary intervention
measure: Rate of Adverse and Serious Adverse Events
timeFrame: at follow-up examination approximately 8 years after primary intervention
measure: Pain Assessment
timeFrame: at follow-up examination approximately 8 years after primary intervention
measure: Radiological Outcome: Inlay wear
timeFrame: at follow-up examination approximately 8 years after primary intervention
measure: Radiological Outcome: Bony Osseointegration or conspicuous features of the cup
timeFrame: at follow-up examination approximately 8 years after primary intervention
measure: Radiological Outcome: Migration of the stem in mm
timeFrame: at follow-up examination approximately 8 years after primary intervention
measure: Radiological Outcome: Bone resorption at the medial stem neck
timeFrame: at follow-up examination approximately 8 years after primary intervention
measure: Radiological Outcome: Bone resorption at the Trochanter Major
timeFrame: at follow-up examination approximately 8 years after primary intervention
measure: Radiological Outcome: Evaluation of bony osseointegration or conspicuous features of the stem
timeFrame: at follow-up examination approximately 8 years after primary intervention
measure: Radiological Outcome: Heterotopic Ossification
timeFrame: at follow-up examination approximately 8 years after primary intervention
Other outcomes:
Locations:
city: Köln
country: Germany
facility: Dreifaltigkeitskrankenhaus Köln
Study officials:
References: