louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03029520: Post-Obturation Pain Following the Use of the AH Plus and iRoot SP Sealers
Official title: Termoplastik Kor tekniğini Iki farklı Kanal patı Ile kullanıp Tedavi sonrası Hassasiyet ve kök Ucundan taşma miktarının değerlendirilmesi: Randomize kontrollü Klinik çalışma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontically-Treated Teeth
Keywords: Endodontic Postoperative Pain
iRoot SP Sealer
Randomized Clinical Trial
Herofill carrier-based obturation
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2017-01-24
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate and compare postoperative pain and overextension of root canal filling after root canal treatment using a carrier-based obturation system and two different sealers.

In this prospective randomized clinical trial, 160 mandibular premolars and molars in 160 patients were treated. Patients with vital and devital teeth were assigned to four groups using a randomized block design with block sizes of 10 patients each. The groups were composed of devital teeth with periapical lesions treated with iRoot SP sealer, vital teeth treated with iRoot SP sealer, devital teeth with periapical lesions treated with AH Plus sealer, and vital teeth treated with AH Plus sealer. In single visits, a single operator prepared root canals and filled them with sealer using the carrier-based obturation technique. Radiographs were taken and obturation length was recorded. Patients recorded pain scores use of Visual Analogue Scale and frequency of analgesic intake at baseline and 0-6, 6-12, 12-24, and 24-72 h..

Detailed description: This randomized controlled clinical study was conducted to compare the incidence and intensity of post-obturation pain, evaluate the overextension of filling material radiographically, and assess the relationship between pain and analgesic intake in patients with vital and devital teeth undergoing carrier-based obturation with two different sealers (iRoot SP, AH Plus)

Eligibility criteria: Inclusion Criteria:

* no systemic diseases
* women were not pregnant or breastfeeding status
* no history of taking analgesics in the previous seven days or other drugs prior to presenting for treatment.
* all selected teeth were mandibular molar or mandibular premolar.

Exclusion Criteria:

* systemic and/or periodontal disease;
* allergy to local anesthetic agents and/or history of intolerance to nonsteroidal anti-inflammatory drugs;
* requirement for antibiotic prophylaxis
* open tooth apex
* pacemaker use

Primary outcomes:
measure: The incidence of postoperative pain by using VAS scale after obturation with different sealers.
timeFrame: 72 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: vice dean
name: oguz yoldas, professor
role: STUDY_CHAIR
References:
Clinical trial NCT05550220: A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients
Official title: A Modified Cuff Leak Test and Reintubation in Mechanically Ventilated Patients: a Multicenter Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Ventilation Complication
Weaning Failure
Airway Obstruction
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.

Detailed description: The cuff leak test is an effective method for predicting the occurrence of upper airway obstruction in patients with endotracheal intubation after extubation, with high specificity and moderate sensitivity. However, there is still no clear and unified cuff leak test operation specification. A cohort study has proposed a modified method. When the patient is placed in a semi-recumbent position of 60 degrees and the ventilator is set to a low-flow square wave, it is more predictive than conventional methods. We hypothesized that the accuracy of the modified cuff leak test in predicting re-intubation in tracheal intubated patients is better than that of the conventional balloon leak test, thereby further reducing the re-intubation rate.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Oral endotracheal intubation and mechanical ventilation \> 36 hours
* Fulfilled the weaning criteria

Exclusion Criteria:

* The patient has a chest drainage tube and there is persistent air leak
* Abnormalities of the larynx: such as tumors or vocal cord paralysis
* The patient cannot maintain the semi-recumbent position
* Unconventional weaning, such as awake ECMO, etc
* Participated in the study during the hospitalization
* Patients or their relatives refused written informed consent

Primary outcomes:
measure: fulfilled predefined criteria indicating the need for reintubation within 48 hours following extubation
timeFrame: 48 hours
Secondary outcomes:
measure: Reintubation within 48 hours after extubation
timeFrame: 48 hours
measure: Post-extubation stridor
timeFrame: 24 hours
measure: Invasive mechanical ventilation time before first extubation
timeFrame: 28 days
measure: length of ICU
timeFrame: 90 days
measure: length of hospital
timeFrame: 90 days
measure: required reintubation within 48 hours following extubation
timeFrame: 48 hours
Other outcomes:
measure: mortality of 90 days
timeFrame: 90 days
Locations:
city: Beijing
country: China
facility: Bing Sun
state: Beijing
Study officials:
References:
Clinical trial NCT01420120: Remedy, Biodegradable Peripheral Stent Registry
Official title: A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Arterial Disease
Keywords: Biodegradable stent, PAD
Lead sponsor: be Medical
Sponsor class: INDUSTRY
First posted: 2011-08-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with documented symptomatic occlusion and/or \> 70% stenosis of SFA.

Brief summary: This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters:

  * 1 cm from the femoral bifurcation in the SFA
  * 3 cm from the proximal margin of the intercondylar fossa
* Rutherford-Becker Category 2-5. In patients with bilateral lesions, the highest Rutherford Category limb should be treated. Only 1 leg can be included.
* Single lesion which can be covered by one stent.
* Target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate)
* A patent popliteal artery free from significant stenosis (\>50%) with at least one patent vessel runoff as confirmed by baseline angiography
* Signed informed consent.

Exclusion Criteria:

* Pregnancy
* Previous stenting of target lesion
* Acute ischemia
* Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). Inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis.
* Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
* Known intolerance to study medications or contrast agents.

Primary outcomes:
measure: Absence of clinically driven target lesion revascularization at 12 months.
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: During procedure
measure: Clinical success
timeFrame: During procedure
measure: Primary and secondary patency rate
timeFrame: 12 months
measure: Ankle-Brachial Index improvement of ≥ 0.1
timeFrame: 1, 6 and 12 months
measure: Clinically driven target vessel revascularization
timeFrame: 6 and 12 months
measure: Major complications at 6 and 12 months, including amputation of a part of the foot, the leg below and above the knee.
timeFrame: 6 and 12 months
measure: Rutherford-Becker classification of chronic limb ischemia
timeFrame: 1, 6 and 12 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
References:
Clinical trial NCT02903420: A Clinical Trial of Transcatheter Aortic Valves in Dialysis Patients (Japan)
Official title: A Clinical Trial for Transcatheter Aortic Valve Implantation in Chronic Dialysis Patients With Aortic Valve Stenosis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2016-09-16
Enrollment: 38
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: A single arm, prospective, open, non-randomized, Japanese multicenter trial to evaluate the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve System (Model: 9600TFX) in the treatment of symptomatic severe aortic stenosis patients on chronic dialysis, who are determined by the heart team to be unable to undergo safe open surgical therapy and have the benefits of the study valve implantation. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Detailed description: 1-year mortality after the study valve implantation will be compared to the performance goal based on the literature review of clinical outcomes for dialysis patients who underwent surgical aortic valve replacement. Data will be collected from all patients for up to five years following the index valve replacement procedure.

Eligibility criteria: Inclusion Criteria:

* Patient is determined by the heart team to be unable to undergo open surgical therapy and have the benefits of the study valve implantation.
* Patient has senile degenerative aortic valve stenosis
* Patient has been on dialysis (hemodialysis or peritoneal dialysis) in stable condition for ≥ 3 months.
* Patient has appropriate aortic valve annulus size measured by TEE or 3D-CT.

Exclusion Criteria:

* Patient has evidence of an acute myocardial infarction (MI) within 30 days prior to the index procedure.
* Patient has a congenital unicuspid or bicuspid aortic valve, or non-calcified aortic valve.
* Patient has severe aortic valve regurgitation.
* Patient has severe mitral valve regurgitation.
* Patient has an experience of any therapeutic invasive cardiac procedures within 30 days prior to the index procedure. Implantation of a permanent pacemaker or balloon valvuloplasty for bridging to procedure after a qualifying echo are not considered exclusionary.
* Patient with planned concomitant surgical or transcatheter ablation for atrial fibrillation.

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Device Success
timeFrame: 30 days
measure: Hospitalization Length of Stay
timeFrame: 7 days
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
Study officials:
affiliation: Osaka University Hospital
name: Yoshiki Sawa
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03539120: Post-amputation Survival Following Rehabilitation Medium and Long-term Follow up Study, a Retrospective Analysis.
Official title: Prognosticating Outcomes in Stroke, Acquired Brain Injury, Amputee and Other Neurological Impairments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 73
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study aimed to analyse survival outcome in patients with dysvascular lower limb amputation and identify relationship with existing comorbidities, i.e. diabetes mellitus (DM), peripheral vascular disease (PVD), ischaemic heart disease (IHD), estimated glomerular filtration rate (e-GFR), and chronic kidney disease (CKD). We also analysed the length of hospital stay, linear relationship with duration of DM, and vascular interventions.

Brief summary: This is a retrospective data analysis of patients who underwent lower limb amputation and rehabilitation and follow up.

Investigators analysed their survival outcomes in relation to various comorbidities i. e ischaemic heart disease, renal impairment, vascular interventions.

Detailed description: Inclusion criteria: Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.

Exclusion criteria: Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records.

Eligibility criteria: Inclusion Criteria:

Patients admitted for major dysvascular lower limb amputation, with complete follow-up record available.

Exclusion criteria:

Exclusion Criteria:

Traumatic amputations, minor amputations, i.e. ray and toe amputation, and incomplete follow-up records

Primary outcomes:
measure: survival in relation to time
timeFrame: 6 months to 6 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04952220: Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee
Official title: Exploratory Study of Ultrasound Signs of Native Septic Arthritis of the Knee
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ultrasound Therapy; Complications
Septic Arthritis
Knee Arthritis
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with native septic arthritis of the knee

Brief summary: Primary objective: Description of ultrasound abnormalities seen in native septic arthritis of the knee during each visit.

Primary endpoint: Describe the ultrasound abnormalities observed on Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee.

Detailed description: Secondary Objectives:

1. Search for poor prognostic factors in native septic arthritis of the knee.
2. To look for an association between initial sonographic factors and the use of joint lavage.
3. Look for associations between sonographic signs and clinico-radio-biologic factors at each visit (D10, 6 weeks, 3 months and 6 months)

Eligibility criteria: Inclusion Criteria:

* Male or female of legal age
* Bacteriologically proven native septic arthritis
* Meets the definition of septic arthritis: Bacteriological documentation of joint puncture fluid-Native articulation
* Free subject, without guardianship or trusteeship, or subordination
* Non-opposition of the patient after clear and fair information about the study

Exclusion Criteria:

* Presence of material in the affected joint
* Arthritis with Mycobacterium Tuberculosis.
* Patients benefiting from a reinforced protection, namely: minors, pregnant and/or breast-feeding women, persons deprived of liberty by a judicial or administrative decision, adults under legal protection

Primary outcomes:
measure: description of the ultrasound abnormalities seen in native septic arthritis of the knee
timeFrame: Day0, Day 10 or before surgery, 6week, 3months, 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes
state: Pays De La Loire
city: Angoulême
country: France
facility: CH D'Angouleme
city: La Roche-sur-Yon
country: France
facility: CH de La roche-sur-yon
city: La Rochelle
country: France
facility: CH De La Rochelle
city: Niort
country: France
facility: CH de Niort
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Poitiers University Hospital
name: GERVAIS Elisabeth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00312520: Pulse Steroids Versus Oral Steroids in Problematic Hemangiomas of Infancy
Official title: The Efficacy and Safety of Intravenous Pulse Steroids Compared to Standard Oral Steroids in the Treatment of Problematic Hemangiomas in Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hemangiomas
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Society for Pediatric Dermatology
First posted: 2006-04-10
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if pulse steroids are more efficacious and safer than the standard treatment with oral corticosteroids.

Detailed description: Currently there is no prospective study in hemangioma patients answering critical questions such as: which type of steroid should be used,how much should we use and for how long. This study is an investigator blinded study with two arms:one arm is receiving standard treatment with daily oral corticosteroids and the other is receiving intravenous pulse corticosteroids daily for 3 days, monthly for 3 months. The main outcome of the study is assess the efficacy of each treament modality as the percentage improvement in the hemangioma's appearance. The secondary outcomes are the safety profiles of the two drugs and the changes in the angiogenesis markers as a result of treatment intervention.

Eligibility criteria: Inclusion Criteria:

* problematic facial hemangiomas (periorbital/facial hemangiomas with potential visual obstruction, large/dysfiguring hemangiomas)
* 1-4 months of age
* signed consent form

Exclusion Criteria:

* refusal to participate
* age \> 4 months
* complicated nonvisible hemangiomas
* congenital heart disease

Primary outcomes:
measure: Percent improvement in the appearance of hemangioma
Secondary outcomes:
measure: Frequency of side-effects experienced by the patients
measure: Changes in the angiogenesis markers
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Elena Pope, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02098720: An Open, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration (wAMD)
Official title: An Open, Non-randomize, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Very Low Vision Secondary to Wet Age-related Macular Degeneration
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the effect of Conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration.


Eligibility criteria: Inclusion Criteria:

1. Patients give fully informed consent and are willing and able to comply with all study procedures.
2. In the study eye:

   There are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.

   The criterion of active CNV should meet at least one of following three conditions :
   * fresh bleeding;
   * neurosensory detachment showed on optical coherence tomography(OCT);
   * leakage showed on fundus fluorescein angiography (FFA).
3. BCVA in study eye \< 19 letters (approximately 20/400 Snellen equivalent).

Exclusion Criteria:

1. Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision;
2. Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas;
3. History of vitreous hemorrhage within last month;
4. The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye;
5. Photodynamic therapy (PDT) or drug treatment of CNV within last 6 months in study eye, or anti-vascular endothelial growth factor (VEGF) therapy in fellow eye within last month;
6. History of glaucoma in study eye;
7. Aphakia (excluding artificial lens) in the study eye.

Primary outcomes:
measure: percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain
timeFrame: 6-month
Secondary outcomes:
measure: mean change in BCVA from baseline
timeFrame: 6-month
measure: change from baseline of macular area thickness and other anatomy results
timeFrame: 6-month
measure: safety of Conbercept therapy
timeFrame: 6-month
Other outcomes:
Locations:
city: Guangzhou city
country: China
facility: Zhongshan Ophthalmic Center,Sun yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT02679820: PostPlacental IUD Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Lead sponsor: Woman's Health University Hospital, Egypt
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 500
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The immediate post cesarean section IUD insertion is a further step towards spreading more compliance to females in developing countries, with rapid increase in population size


Eligibility criteria: Inclusion Criteria:

* Females desiring contraception by using intrauterine device following their vaginal delivery or cesarean section

Exclusion Criteria:

* refusal to participate in the study
* desiring other methods of contraception
* will not use any method of contraception
* has a contraindication for the use of IUD as bicornuate or septate uterus, sub mucous myomas, etc.

Primary outcomes:
measure: Expulsion rate
timeFrame: 6 months
measure: The percentage of females seeking contraception
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr el aini hospital
Study officials:
affiliation: Cairo University
name: Dina MR Dakhly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bayoumi YA, Dakhly DMR, Bassiouny YA, Gouda HM, Hassan MA, Hassan AA. Post-placental intrauterine device insertion vs puerperal insertion in women undergoing caesarean delivery in Egypt: a 1 year randomised controlled trial. Eur J Contracept Reprod Health Care. 2020 Dec;25(6):439-444. doi: 10.1080/13625187.2020.1823366. Epub 2020 Oct 2.