louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00942032: Clinical Experience With the Hindfoot Arthrodesis Nail for the Surgical Treatment of Ankle and Hindfoot Pathologies
Official title: Clinical Experience With the Hindfoot Arthrodesis Nail (HAN) for the Surgical Treatment of Ankle and Hindfoot Pathologies. A Retrospective Case Series.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hindfoot Arthrodesis
Hindfoot Pathologies
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
Collaborators: name: Synthes Inc.
First posted: 2009-07-20
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be identified from the study sites' medical records, information systems, and OR logs. The responsible local investigator or co-investigator at each study site will approach patients by letter or phone, and inquire about their interest in participating in this study.

Brief summary: The aim of this observational study is to collect and evaluate the current clinical experience gained from the Hindfoot Arthrodesis Nail (HAN) for ankle and hindfoot fusions.

Detailed description: The HAN (Synthes) is a newly designed, titanium nail for trans-calcaneal, retrograde hindfoot fusion. The lateral bend allows an entry site in the center of the lateral column of the calcaneus, thus minimizing the risk of iatrogenic injury of the plantar neurovascular bundle.

Eligibility criteria: Inclusion Criteria:

* HAN fusion procedure ≥ 12 months before entering the study.
* Written or oral informed consent.

Primary outcomes:
measure: The aim of this observational study is to collect and evaluate the current clinical experience gained from the Hindfoot Arthrodesis Nail (HAN) for ankle and hindfoot fusions.
timeFrame: More than 1 year
Secondary outcomes:
measure: Technical and surgical details Patient-centered endpoints (e.g., function as assessed by AAOS Foot and Ankle Outcomes Questionnaire (AAOS-FAOQ) score and the SF-36 Health Survey)
timeFrame: More than 1 year
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Eisenhower Medical Center
state: California
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Berlin
country: Germany
facility: Charité Berlin, Campus Virchow Klinikum
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Stockholm
country: Sweden
facility: Stockholms Fotkirurgklinik Sophiahemmet
Study officials:
affiliation: Ao Clinical Investigation and Documentation, Davos, Switzerland
name: Beate P. Hanson, MD
role: STUDY_DIRECTOR
affiliation: St. Vincent's Hospital, Foot and Ankle Surgery
name: Andrew K. Sands, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03704532: Nonoperative Treatment of Acute Achilles Tendor Rupture
Official title: Nonoperative Treatment of Acute Achilles Tendor Rupture in Central Finland: Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Achilles Tendon Rupture
Keywords: achilles tendon rupture
nonoperative treatment
functional rehabilitation
operative treatment
biomechanical measurements
Lead sponsor: Central Finland Hospital District
Sponsor class: OTHER
Collaborators: name: University of Jyvaskyla
First posted: 2018-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients having sustained an acute achilles tendon rupture and referred for either operative or nonoperative treatment with functional rehabilitation at our institution.

Brief summary: A prospective, non-randomised, observational study to investigate the clinical and biomechanical outcomes and prevalence of reruptures after operative or nonoperative treatment of acute achilles tendon rupture.


Eligibility criteria: Inclusion Criteria:

* acute achilles tendon rupture with clear onset of symptoms
* closed rupture
* resides in the catchment area of our hospital district

Exclusion Criteria:

* avulsion fractures in the calcaneus
* unwillingness to participate
* inability to communicate using Finnish language

Primary outcomes:
measure: Rerupture rate
timeFrame: 1 year
Secondary outcomes:
measure: Physical Activity Level
timeFrame: 1 year
measure: University of California, Los Angeles (UCLA) score
timeFrame: 1 year
measure: Achilles tendon rupture score (ATRS)
timeFrame: 1 year
measure: Functional Score
timeFrame: 1 year
measure: Foot inversion
timeFrame: 1 year
measure: Foot flexion-extension
timeFrame: 1 year
measure: Heel-raise test
timeFrame: 1 year
Other outcomes:
measure: Muscle strength
timeFrame: 1 year
measure: Gastrocnemius muscle cross-sectional area
timeFrame: 1 year
measure: Tendon length
timeFrame: 1 year
measure: Research ANd Development (RAND-36) quality of life
timeFrame: 1 year
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Hospital
state: Keski-Suomi
Study officials:
affiliation: Central Finland Health Care District
name: Juha Paloneva, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01507532: Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients
Official title: Pharmacokinetic Assessment of Ceftazidime in Intermittent Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Renal Failure
Lead sponsor: Midwestern University
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Ceftazidime is a broad spectrum cephalosporin with high activity against a variety of Gram-negative pathogens, including Pseudomonas aeruginosa. An open-label study of intravenous ceftazidime pharmacokinetics will be performed in patients undergoing intermittent hemodialysis at Northwestern Memorial Hospital to determine the clearance of ceftazidime in high flux hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Eligible patients are male or female adults ≥18 years of age with an expected hospital stay of at least 48 hours, who have end-stage renal disease and been receiving intermittent hemodialysis for at least 90 days.
* Eligible patients will additionally have either central or peripheral intravenous access, and will already be prescribed ceftazidime per their primary providers.
* Written informed consent in a form approved by Northwestern Memorial Hospital, Northwestern University Institutional Review Board, and Midwestern University Institutional Review Board will be completed by the patient prior to enrollment.

Exclusion Criteria:

* Patients that only receive one dose of ceftazidime in total
* Patients with potentially altered pharmacokinetic parameters (pregnant patients, burn patients, and those that are morbidly obese (BMI ≥ 40 kg/m2).
* Not meeting inclusion criteria

Primary outcomes:
measure: Determine clearance of ceftazidime in hemodialysis
timeFrame: time 0 = end of infusion) up to 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Midwestern University
name: Marc H Scheetz, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04423432: Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis
Official title: Effects of Creatine and Glucoseamine/ Chondritin Sulfate Co-Supplementation in Addition to Exercise and Physical Therapy in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
Collaborators: name: Isra University
First posted: 2020-06-09
Enrollment: 36
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis is the 11th highest contributor to disability world wide. In terms of conservative management of patients with knee osteoarthritis, Resistance exercise has been shown to be an effective intervention for reducing pain and cartilage degeneration and improving muscle strength, joint biomechanics and physical functioning. But, research shows that co supplementation can further augment the effects of resistance exercise. However, it is imperative to point out that the existing evidence is majorly focused on the individual effects of resistance exercise training and non-pharmacological supplementation, and is still deficient in the effects of co-supplementation in addition to resistance exercise training in patients with knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Age 40-70 years
* Knee OA with history not less than three months.
* Radiological evidences of grade III or less on Kellgren classification.
* Knee pain on VNRS no more than 8/10

Exclusion Criteria:

* Neuromuscular conditions that may lead to fatigue such as multiple Sclerosis
* Signs of serious pathology (e.g., malignancy, inflammatory disorder, infection).
* History of trauma or fractures in lower extremity.
* Signs of lumbar radiculopathy or myelopathy.
* History of knee surgery or replacement.
* Patients on intra-articular steroid therapy within two months before the commencement of the study.
* Impaired skin sensation.
* Impaired renal function

Primary outcomes:
measure: Knee Pain: Numeric Pain Rating Scale
timeFrame: 4 weeks
measure: Knee Range of Motion
timeFrame: 4 weeks
measure: Knee Isometric Muscle Strength
timeFrame: 4 weeks
measure: Six Minute Walk Test
timeFrame: 4 weeks
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 4 weeks
measure: Body Composition
timeFrame: 4 weeks
measure: Fall Risk
timeFrame: 4 weeks
measure: Postural Stability
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University Institute of Rehabilitation Sciences
state: Federal
Study officials:
affiliation: Foundation University Institute of Rehabilitation Sciences
name: Muhammad Osama, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01659632: Gastric Cancer Screening and Alarm Symptoms in Early Gastric Cancer
Official title: Gastric Cancer Screening and Alarm Symptoms in Early Gastric Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Gastric Cancer
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: gastric cancer patients in St.mary's hospital

Brief summary: Most of the early gastric cancer are asymptomatic. Symptoms of advanced gastric cancer are weight loss, abdominal pain, nausea, vomiting, anorexia dysphagia, gastrointestinal bleeding. Gastric cancer found according to warning symptoms such as gastrointestinal bleeding, weight loss usually can not be cured. Therefore, early gastric cancer can not be detected and impossible to treatment if endoscopy is performed according to the warning signs. National gastric cancer screening is conducted in men and women of more than 40 years old. The purpose of screening for gastric cancer is discovering a case of possible cure, so increasing the survival rate. The purpose of this study is review of the feasibility of screening for gastric cancer.


Eligibility criteria: Inclusion Criteria:

* gastric cancer patients in St.mary's hospital

Exclusion Criteria:

* gastric lymphoma, gastric GIST patients in St.mary's hospital

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: St. mary's hospital
Study officials:
References:
Clinical trial NCT01125332: Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric Ear Nose Throat (ENT)Consultation
Official title: Evaluation of Topic Anaesthesia for Laryngoscopy With Fibroscopy During Paediatric ENT Consultation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Nasofibroscopy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 1
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this work is to estimate the efficiency in terms of pain of the application of a local anesthetic (xylocaïne viscous 2%®) during the realization of an examination in naso-fiberscopy in consultation of ENT at the child from 3 to 7 years old.


Eligibility criteria: Inclusion Criteria:

* Subjects from 4 to 7 years old (old enough to answer the test of self-assessment, the scale of faces)
* Appearing at the consultation of pediatric ENT, requiring an indirect laryngoscopy in the naso-fiberscope for a laryngeal evaluation.
* Subjects girls or boys

Exclusion Criteria:

* All the criteria dissuading the employment of a local anesthetic
* Naso-fibroscopie realized within the framework of a nasal obstruction, or of a balance sheet of the gulp.
* Patients having already been examined by naso-fiberscopy, so that their reactions and their answers are not influenced by the previous experience of the examination.
* Not consent of one of both holders of the parental authority

Primary outcomes:
measure: efficacity of local anesthetic
Secondary outcomes:
measure: pain's scale
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assisatnce Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: RICHARD NICOLLAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03282032: Preconditioning of One-lung Ventilation
Official title: Preconditioning of One-lung Ventilation for Lung Protection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: One Lung Ventilation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 136
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To observe the effect of one-lung ventilation (OLV) preconditioning on perioperative oxygenation during thoracic surgery.

Detailed description: For lung isolation and better surgical view, one-lung ventilation(OLV) is essential for thoracic surgery. However, OLV may cause serious pulmonary complications due to intraoperative hypoxia.

Animal studies showed a positive effect of OLV preconditioning (Intermittent OLV before surgical intervention) on perioperative pulmonary oxygenation.

Thus, we designed a study to observe the effect of OLV preconditioning on perioperative oxygenation during thoracic surgery

Eligibility criteria: Inclusion Criteria:

* Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position

Exclusion Criteria:

* Patients with severe cardiopulmonary disease, COPD, previous surgical history of pulmonary disease
* Thoracic surgery for pneumonectomy

Primary outcomes:
measure: Incidence of hypoxemia
timeFrame: during one-lung ventilation, up to 5 hours
measure: P/F ratio
timeFrame: 30min after surgical incision
Secondary outcomes:
measure: Pulmonary complications
timeFrame: 6, 24, 48 hours after surgery, during hospital stay.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jeong-Hwa Seo, PhD
role: STUDY_CHAIR
References:
citation: Benumof JL. Intermittent hypoxia increases lobar hypoxic pulmonary vasoconstriction. Anesthesiology. 1983 May;58(5):399-404. doi: 10.1097/00000542-198305000-00001.
Clinical trial NCT01975532: Evaluation of Diffusion MRI as a Tool in Planning Deep Brain Stimulation (DBS)
Official title: Evaluation of MRI Based Fiber Tracking as a Tool in Deep Brain Stimulation for Movement Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Movement Disorders
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2013-11-03
Enrollment: 13
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 screened and deemed eligible for treatment with Deep Brain Stimulation

Brief summary: The purpose of this study is to explore the relationship between deep brain stimulation implantation site and DTI (diffusion tensor imaging) derived measures for the region and later compare this to the clinical treatment outcomes.


Eligibility criteria: Inclusion Criteria:

* Deep Brian Stimulation surgery

Exclusion Criteria:

* DBS treatment stopped before 12 month followup

Primary outcomes:
measure: UPDRS (unified parkinson disease rating scale) score
timeFrame: patients will be followed from pre-surgical evaluation to 1 year after surgery, roughly 13-14 months
Secondary outcomes:
measure: Cognitive scores on neuropsychological exam
timeFrame: patients will be followed from per-surgical evaluation to 1 year after surgery, roughly 13-14 months
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Mikkel Petersen, phd-student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06929832: Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions
Official title: Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration During Lower Extremity Tibial Interventions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral Arterial Disease
Lead sponsor: Protexa Endovascular, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 20
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: Subjects being treated for PAD with standard of care interventions

Brief summary: Post-Market Evaluation of Active Thrombectomy and Proximal Aspiration during Lower Extremity Tibial Interventions

Detailed description: This is a prospective, multi-center, non-randomized, open label, single arm post-market clinical study to gather data on the use of the Protexus catheter for temporary blood vessel occlusion while standard of care treatment with other therapeutic devices is conducted in patients undergoing infrapopliteal treatment for peripheral arterial disease (PAD).

Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years of age
2. Subject or authorized representative has signed a written Informed Consent
3. Subject is willing to comply with the protocol requirements
4. Rutherford classification 4-6
5. Planned intervention of the native infrapopliteal arteries using balloon angioplasty, atherectomy, and endovascular procedures.
6. Reference vessel diameter for intended location of the distal tip funnel deployment for the Protexus catheter is ≥3.5mm and ≤6.0mm by visual estimate
7. Inflow arteries have ≤30% stenosis. Inflow arteries can be treated at the time of the study procedure to achieve ≤30% stenosis

Exclusion Criteria:

1. Prior intervention within 30 days of treatment in the planned deployment site for the Protexus catheter
2. Presence of a stent in the planned deployment site for the Protexus catheter
3. Has perforation, dissection, or other injury of the access vessel or Protexus catheter deployment site requiring additional stenting or surgical intervention before enrollment
4. History of bleeding diathesis or coagulopathy and unable to receive standard anticoagulation during the index procedure
5. Acute limb ischemia defined as onset of symptoms within two weeks of the planned intervention
6. Inflow arteries have \>30% stenosis after treatment at the time of the study procedure
7. Pregnant female subject or subject that has a positive pregnancy test within the previous 7 days
8. Known hypersensitivity or allergy to nitinol
9. Target blood vessels are infected, have extreme tortuosity, or are occluded with calcified material

Primary outcomes:
measure: Primary Endpoint
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06899932: Survival Study of the Genutech® Total Knee Arthroplasty
Official title: Survival Study of the Genutech® Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Keywords: Total Knee Arthroplasty
Knee Osteoarthritis
Lead sponsor: Hospital de Sant Rafael
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 500
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: Patients referred to the investigators' Institution by Primary Care centres to receive Orthopaedic care

Brief summary: Prospective cohort sudy of patients undergoing a Genutech® total knee arthroplasty

Detailed description: A prospective cohort study will be performed collecting patient's data before and after the total knee arthroplasty surgical procedure at one, five and ten years. The main goal of this work is to prospectively study the results obtained with the implantation of the knee prosthesis currently used in the Orthopaedic Service of Sant Rafael Hospital of Barcelona (Genutech®). The main outcome of the study is the survival of the implant, that is, having no revision surgeries in the follow-up. The secondary objective is the clinical and radiological evaluation of the implants measured by outcome measueres: Oxford Knee Score (OKS), SF12 questionnaire and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire. OKS and SF12 scores are higher with good results and lower with bad results. WOMAC expresses results the other way around.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years with knee osteoarthritis that had not responded to conservative treatment
* capable of providing informed consent
* patients who receive a Genutech® total knee prosthesis at the investigators' Institution.

Exclusion Criteria:

* having received a prior total knee arthroplasty in the same joint
* inability to provide informed consent
* not willing to participate in the study

Primary outcomes:
measure: Number of patients without revision surgery
timeFrame: 5 and 10 years
Secondary outcomes:
measure: Oxford Knee Score
timeFrame: one, 5 and 10 years
measure: SF12 questionnaire
timeFrame: 1, 5 and 10 years postoperatively
measure: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) questionaire
timeFrame: One, 5 and 10 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Sant Rafael
Study officials:
References: