louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06976411: Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials
Official title: Prospective Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Root Perforation at the Bifurcation Area
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2025-05-16
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate healing potentiality of MTA and bioceramics materials as a root perforation repair material.

The main questions it aims to answer are:

is there is a significant difference in healing potentiality of MTA and bioceramics materials as a root perforation repair material?

Participants will:

enrollment will be from out-patients clinic of endodontic department, faculty of dentistry, Ain Shams university with root perforations. perforation repair will be done using either bio-ceramic or MTA repair material and preoperative or immediate postoperative CBCT and postoperative CBCT will be taken to compare healing.


Eligibility criteria: Inclusion Criteria:

1. Patients with root perforation in lower molars.
2. Patients had anon contributory medical history.
3. Patients of age categories between 15 to 50 years old.
4. No sex restriction.
5. Small to medium size perforation.

Exclusion Criteria:

1. Patients with generalized chronic periodontitis.
2. Teeth with difficult isolation.
3. Non restorable teeth.
4. Medically compromised patients.
5. Patients with history of allergies to any of the medications to be used during or after the treatment.

Primary outcomes:
measure: Radiographic success in terms of healing
timeFrame: 1 year
measure: patients with clinical success
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry ain shams university
Study officials:
References:
Clinical trial NCT00949611: Wiser Choices in Osteoporosis Choice II: A Decision Aid for Patients and Clinicians
Official title: Wiser Choices In Osteoporosis Choice II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Osteopenia
Fragility Fractures
Keywords: Decision Aid
Shared Decision Making
Shared Medical Decision Making
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Foundation for Informed Medical Decision Making
name: Olmsted Medical Center
First posted: 2009-07-30
Enrollment: 79
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Emphasis in treating osteoporosis has been on T-scores rather than overall fracture risk. Fracture Risk Assessment Tool (FRAX) supports a risk sensitive approach to osteoporosis treatment by providing an absolute fracture risk. FRAX combined with a decision aid may promote a shared decision making approach with patients, allowing the clinician and patient to weigh potential fracture risk (without treatment), versus risk reduction with medication (including side effects and costs). OSTEOPOROSIS CHOICE II will test the effectiveness of:

* FRAX
* FRAX + decision aid
* Usual care (no decision aid and no FRAX given to clinician)


Eligibility criteria: Inclusion Criteria:

* Peri and Postmenopausal Caucasian, Black, Hispanic and Asian women, aged 50-90
* Bone mineral density (BMD) T-Score \< 1.0
* Have appointment with clinician to discuss test results and treatment options
* Patients with FRAX \<20% risk who have taken a bisphosphonate for \< 5 years.

Exclusion Criteria:

* Unable to speak or read English

Primary outcomes:
measure: Medication start/stop, knowledge, and patient involvement.
timeFrame: Baseline and at 6 months
Secondary outcomes:
measure: Decisional quality.
timeFrame: Baseline and at 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Victor M. Montori, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: LeBlanc A, Wang AT, Wyatt K, Branda ME, Shah ND, Van Houten H, Pencille L, Wermers R, Montori VM. Encounter Decision Aid vs. Clinical Decision Support or Usual Care to Support Patient-Centered Treatment Decisions in Osteoporosis: The Osteoporosis Choice Randomized Trial II. PLoS One. 2015 May 26;10(5):e0128063. doi: 10.1371/journal.pone.0128063. eCollection 2015.
citation: Wyatt KD, Branda ME, Inselman JW, Ting HH, Hess EP, Montori VM, LeBlanc A. Genders of patients and clinicians and their effect on shared decision making: a participant-level meta-analysis. BMC Med Inform Decis Mak. 2014 Sep 2;14:81. doi: 10.1186/1472-6947-14-81.
Clinical trial NCT03164811: GDFT Based on PPV Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: RCT
Official title: Goal Directed Fluid Therapy Based on Pulse Pressure Variation Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spine Disease
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will do the Goal directed fluid therapy by protocolized fluid management in the experimental group, using PPV to guide the fluid administration, compare with standard fluid management in patients undergoing complex spine surgery.


Eligibility criteria: Inclusion Criteria:

* ASA 1-3
* elective surgery
* thoracic/lumbar spine surgery \>= 3 levels and duration \>= 3 hours

Exclusion Criteria:

* Cr \>2 mg/dl or eGFR \< 60 ml/min
* coronary artery disease, congestive heart failure or cardiac arrhythmia
* BMI \>30 kg/m2
* hemodynamic unstable, preoperatively
* uncontrolled hypertension
* respiratory system compliance \< 30 ml/cmH2O

Primary outcomes:
measure: episode of intraoperative hypotension
timeFrame: intraoperative
Secondary outcomes:
measure: unit of blood transfusion
timeFrame: intraoperative and up to 24 hours postoperatively
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
References:
Clinical trial NCT06876311: Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®
Official title: Sponsor-initiated, Retrospective, Monocentric, Non-interventional Clinical Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Degenerative Cervical Disc Disease
Degenerative Lumbar Diseases
Lead sponsor: Silony Medical GmbH
Sponsor class: INDUSTRY
First posted: 2025-03-14
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population is defined by Inclusion and exclusion criteria.

Brief summary: Post-operative clinical outcome data on the devices used to treat spinal diseases are collected and evaluated in order to analyze the safety and performance of the implants used.


Eligibility criteria: Inclusion Criteria:

- Indications according to IFU

Surgical implantation of STALIF® C or M FLX device for 1 or 2 levels between:

* STALIF® C FLX: C2-T1 (cervical)
* STALIF® M FLX: L2-S1 (lumbar)
* STALIF® L FLX: L2-L5 (lumbar)

Surgical implantation of FORTOS-C® for the fusion of up to 3 levels between:

* FORTOS-C®: C2 - T1 (cervical)
* Age: ≥ 21 years
* For the evaluation of the questionnaires (NDI or ODI, VAS neck and VAS arm or VAS leg and VAS back), only patients with the questionnaire available at the time of admission (pre-op) and at least at 12-months FU will be included

Exclusion Criteria:

* Relative and absolute contraindications according to IFU

Primary outcomes:
measure: Neck Disability Index
timeFrame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Oswestry Disability Index
timeFrame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Radiological assessment
timeFrame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
measure: Complications
timeFrame: Baseline, 3 months postoperative, 6 months postoperative, 12 months postoperative, 24 months postoperative
Other outcomes:
Locations:
city: San Ramon
country: United States
facility: Golden State Orthopedics and Spine
state: California
Study officials:
References:
Clinical trial NCT00862511: Serum Metal Ion Concentration After Total Knee Arthroplasty (TKA)
Official title: A Prospective Randomized Comparison of Serum Metal Ion Levels After Implantation of Coated and Uncoated Knee Prostheses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Metal Ion Levels
Keywords: metal ion concentration
total knee arthroplasty
metal hypersensitivity
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: Aesculap AG
First posted: 2009-03-17
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All metal implants release metal ions because of corrosion. Total knee arthroplasty implants have large metal surface areas and therefore substantial potential for corrosion. It is planned to compare changes in serum levels of metal ions in patients after implantation of cemented unconstrained total knee arthroplasty covered with or without a passivating surface. Serum concentrations of chromium, cobalt, molybdenum and nickel will be analyzed and compared between the two groups, as well as with those of 130 control patients without implants.


Eligibility criteria: Inclusion Criteria:

* Indication for TKA in primary oder secondary osteoarthritis of the knee
* Patient's consent

Exclusion Criteria:

* Additional Implants present
* Allergy against constituents of implant or cement
* Any malignancies
* Renal insufficiency
* Any additional serious disease complicating the participation in this study

Primary outcomes:
measure: Metal ion concentration in serum after TKA (Cr, Co, Mb, Ni)
timeFrame: 1 y and 5y
Secondary outcomes:
measure: Hypersensitivity against metal
timeFrame: 1 y
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Dresden, Orthopaedic Department
Study officials:
affiliation: University Hospital Dresden, Orthopaedic Department
name: Jörg Lützner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Dresden, Orthopaedic Department
name: Stephan Kirschner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lutzner J, Beyer F, Lutzner C, Thomas P, Summer B. Increased inflammatory response is associated with less favorable functional results 5 years after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2023 Apr;31(4):1316-1322. doi: 10.1007/s00167-021-06836-w. Epub 2022 Feb 11.
citation: Lutzner J, Dinnebier G, Hartmann A, Gunther KP, Kirschner S. Study rationale and protocol: prospective randomized comparison of metal ion concentrations in the patient's plasma after implantation of coated and uncoated total knee prostheses. BMC Musculoskelet Disord. 2009 Oct 14;10:128. doi: 10.1186/1471-2474-10-128.
Clinical trial NCT05045911: An Endoscopic Barbed-clips Suturing for Colorectal ESD
Official title: A Novel Endoscopic Barbed-clips Suturing for Mucosal Defect Closure After Endoscopic Submucosal Dissection of Colon
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Endoscopic submucosal dissection (ESD) was developed to allow en bloc resection of colorectal neoplasm. Although colorectal ESD has been widely accepted as a minimally invasive treatment option for early colorectal neoplasm, post-ESD bleeding is one of the major adverse events. After ESD procedure, endoscopists close the defects with devices to prevent complications. A novel endoscopic barbed-clips suturing has been developed to simplify endoscopic closure. In this study, the endoscopic barbed-clips will be evaluated when closing defects in the colon after ESD.

Detailed description: Endoscopic submucosal dissection (ESD) has emerged as a new endoscopic technique that allows en-bloc resection of GI lesions, irrespective of size. The most common complications of the ESD techniques are bleeding and perforation. Several reports have shown that if prophylactic closure of a mucosal defect with clips would reduce the risk of bleeding following endoscopic intervention by ESD. With the advancements in endoscopic therapy, various techniques for prevention of post-ESD complications have been reported. However, there have some limitations including their inability to close large defects and the complexity of the approaches and the need for expensive equipment to complete the procedure. To address these issues, we have devised a novel endoscopic barbed-clips suturing method for mucosal defect closure after endoscopic submucosal dissection of colon. In this study, we assessed the technical feasibility of this novel technique.

Eligibility criteria: Inclusion Criteria:

* aged≥20 years with a single clinically or histologically diagnosed colorectal lesions of 20-50mm eligible for which fulfilled criteria for ESD;

Exclusion Criteria:

* Patients with coagulopathy (platelet count \< 5 × 10\*4, prothrombin time international normalized ratio \> 2,
* medical conditions requiring the continuous use of antithrombotic agents
* prior abdominal surgery or radiation.

Primary outcomes:
measure: The technical success rate
timeFrame: 1 day
Secondary outcomes:
measure: Endoscopic barbed-clips suturing closure time
timeFrame: 1 day
measure: Rate of patients reported with bleeding/perforation post-ESD procedure
timeFrame: 7 days
measure: Clips used post-ESD
timeFrame: 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: The Fifth Medical Center of Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: The First Medical Center of Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02799511: Biomarkers for the Diagnosis of Transient Ischemic Attack
Official title: Biomarkers for the Diagnosis of Transient Ischemic Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebrovascular Disorders
Ischemic Attack, Transient
Keywords: biological markers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A transient ischemic attack (TIA) should be considered an emergency prevention opportunity in order to avoid recurrence as cerebral infarction (CI) serious (fatal or disabling). Indeed, about 20% of patients who have IC had in previous days or weeks, a TIA, which can be defined as a brief episode of cerebral dysfunction (or eye) do not result in permanent brain damage and thus no sequelae. Moreover, about 20% of ischemic events observed in practice are AIT. Despite the progress achieved in the treatment in the acute phase of an IC, prevention remains the most effective way to fight against this disease. This prevention can be put in place before the occurrence of a first IC, or after a first IC, especially when minor as a TIA.

However, the diagnosis of TIA remains particularly difficult and it is necessary now to identify new tools for the diagnosis of transient ischemic attack. Our study focused on the identification of one or more molecules (called biological markers or biomarkers) present in the bloodstream of patients, which will serve to facilitate the differential diagnosis of patients with TIA.


Eligibility criteria: Inclusion Criteria:

* TIA lasting 18h
* NIHSS \< 0
* MRI diffusion hypersignal less than 5 ml
* follow up during 3 month
* written informed consent prior to any study procedures

Exclusion Criteria:

* Pregnant or breastfeeding women
* major comorbidity (cancer, chronic infection)
* recent trauma (less than 30 days) (cranial or extracranial)
* Surgical or endovascular recent surgery(within 30 days).
* Any old brain injury
* Any acute pathology likely to induce inflammation, hemostasis disorders ...
* Contraindications to MRI: Patients with a pacemaker, an implanted material activated by an electrical, magnetic or mechanical carriers hemostatic clips intracerebral aneurysms or carotid arteries, bearing orthopedic implants, claustrophobic ...
* Patient under guardianship

Primary outcomes:
measure: change in proteomic analysis from MPs or from plasma.
timeFrame: baseline and 72h after TAI and 90 days after TAI
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT05914311: Use of Dermabond in Mitigation of Spinal Cord Stimulation (SCS) Trial Lead Migration
Official title: Use of Dermabond in Mitigation of Spinal Cord Stimulation Trial Lead Migration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Keywords: Spinal Cord Stimulation (SCS)
chronic pain
stimulator
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: During the typical SCS trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement

Detailed description: Spinal Cord stimulator trials require precise placement of leads to get appropriate distribution of pain.1 Since the leads are not anchored into the tissue, migration of the leads can occur and result in suboptimal trial. Migration (or movement in the epidural space after placement) of the leads can result in up to 2.49 mm to 3.24 mm migration in the leads depending on trial length . During the trial the leads remain outside of the skin and can be prone to migration. The leads are typically secured in place with suture, tape, or a combination of both. This study will evaluate the amount of movement based on the method of being secured at the time of placement

Eligibility criteria: Inclusion Criteria:

* age greater than 18
* having a spinal cord stimulator trial lead placement done
* lead placement to be done in the thoracic spine area

Exclusion Criteria:

* dermabond allergy
* inability to place 2 leads in subject
* lead placement not in thoracic spine

Primary outcomes:
measure: Lead migration between groups
timeFrame: From Baseline through Day 8
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Baseline, Day 8
measure: Affect of length of trial on migration
timeFrame: Baseline, Day 8
measure: Prone fluoroscopy
timeFrame: Baseline, Day 8
measure: Number of patients who received pain relief from the SCS trial
timeFrame: Baseline, Day 8
measure: Upright x-ray
timeFrame: Baseline, Day 8
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Carlyle Hamsher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03112811: Influence of Techniques of Chest Physiotherapy in the Pediatric Intensive Care
Official title: Influence of Techniques of Chest Physiotherapy on the Respiratory Status and the Hemodynamic Impact in the Pediatric Intensive Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atelectasis
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 80
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of the autogenic drainage and the intrapulmonary percussive ventilation on the levying of the lung atelectasis, by means of the thoracic imaging (thoracic ultrasound and radiography), at the intubated or extubated child with the ventilatory support.


Eligibility criteria: Inclusion Criteria:

* Child \< 10 kg
* Hospitalization in the pediatric intensive care
* Presence of an atelectasis to the radiography and/or to the lung ultrasound
* Presence of an invasive ventilation or a non-invasive ventilation
* Criteria of cardio-respiratory stability met

Exclusion Criteria:

* Absence of the physiotherapist and the radiologist referents (by ex: at night)
* Prematurity
* Neuromuscular disease
* Ventilation by high-frequency oscillation
* Extraphysical Assistance
* Patient cardiac post-surgery with closure postponed from the thorax. In the closure of the thorax, the patient becomes eligible
* Intracranial pressure \> 20 mmHg or clinical signs of intracranial high blood pressure

Primary outcomes:
measure: Change from baseline Atelectasis scores at 20 min
timeFrame: Baseline and at 20 min
measure: Change from baseline cardiac frequency at 20 min, 30 min, 50 min, 80 min
timeFrame: Baseline and at 20 min, 30 min, 50 min, 80 min
measure: Change from baseline respiratory frequency at 20 min, 30 min, 50 min, 80 min
timeFrame: Baseline and at 20 min, 30 min, 50 min, 80 min
measure: Change from baseline systolic blood pressure at 20 min, 30 min, 50 min, 80 min
timeFrame: Baseline and at 20 min, 30 min, 50 min, 80 min
measure: Change from baseline diastolic blood pressure at 20 min, 30 min, 50 min, 80 min
timeFrame: Baseline and at 20 min, 30 min, 50 min, 80 min
measure: Change from baseline oxygen saturation at 20 min, 30 min, 50 min, 80 min
timeFrame: Baseline and at 20 min, 30 min, 50 min, 80 min
measure: Change from baseline expiratory CO2 at 20 min, 30 min, 50 min, 80 min
timeFrame: Baseline and at 20 min, 30 min, 50 min, 80 min
measure: Compare the atelectasis scores
timeFrame: Baseline between thoracic ultrasound and chest x-ray
Secondary outcomes:
measure: Number of unexpected events
timeFrame: At 20 min
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
Study officials:
References: