louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06870955: Research on the Development and Clinical Evaluation of Biomimetic Abutments
Official title: Research on the Development and Clinical Evaluation of Biomimetic Abutments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Loss
Lead sponsor: Stomatological Hospital Affiliated with Fujian Medical University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the clinical effectiveness of biomimetic abutments in implant restoration.

Detailed description: The biomimetic healing abutments were placed during the second-stage surgery, and the biomimetic prosthetic abutments were used to complete the implant restoration.

To assess soft tissues, digital models were collected in STL files at five time points: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration. These models were analyzed using 3D software for model matching and measurement based on CBCT, focusing on the changes on soft tissue height, width, and volume.

Hard tissue evaluation was conducted through periapical radiographs taken at three time points: immediately after restoration, six months after restoration, and 12 months after restoration.

Additionally, general clinical conditions were assessed at the same three time points, evaluating parameters such as food impaction, plaque index, and gingival index.

Eligibility criteria: Inclusion Criteria:

* aged between 25 and 65 years old
* had one single edentulous site
* implant embedded healed and required secondary surgery to expose
* good treatment compliance and could attend follow-up appointment regularly

Exclusion Criteria:

* soft tissue grafting was needed
* severe acute or chronic periodontitis
* heavy smoking habit (\> 10 cigarettes/day)
* poor oral hygiene

Primary outcomes:
measure: Changes in soft tissue contour
timeFrame: before the second-stage surgery, before the implant impression, immediately after restoration, six months after restoration, and 12 months after restoration
Secondary outcomes:
measure: Changes in hard tissue contour
timeFrame: immediately after restoration, six months after restoration, and 12 months after restoration
measure: Food impaction
timeFrame: immediately after restoration, six months after restoration, and 12 months after restoration
measure: Plaque index
timeFrame: immediately after restoration, six months after restoration, and 12 months after restoration
measure: Gingival index
timeFrame: immediately after restoration, six months after restoration, and 12 months after restoration
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The Affiliated Stomatological Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: Stomatological Hospital Affiliated with Fujian Medical University
name: Hui Cheng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001155: Treatment of Wegener's Granulomatosis With Cyclophosphamide
Official title: Treatment of Wegener's Granulomatosis With Cyclophosphamide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vasculitis
Wegener's Granulomatosis
Keywords: Vasculitis
Prednisone
Granuloma
Wegener's Granulomatosis
Cyclophosphamide
Renal Biopsy
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this protocol is to continue to treat patients with Wegener's granulomatosis who have already entered the study, and to treat new patients. The investigators will attempt to correlate the clinical response with specific immunosuppressive effects of drug administration. The investigators are accumulating data on the optimal duration and side effects of therapy.

Detailed description: The purpose of the protocol is to continue to treat patients with Wegener's granulomatosis who have already entered the study, and to treat new patients. The investigators will attempt to correlate the clinical response with specific immunosuppressive effects of drug administration. The investigators are accumulating data on the optimal duration and side effects of therapy.

Age Range: greater than 1 year

Eligibility criteria: Patients greater than 1 year of age with the clinical and pathological diagnosis of WG whose illness presents a risk of permanent disability or death. Examples of processes that impart risk of permanent disability or death include: peripheral and central nervous system disease, cardiac involvement, glomerulonephritis, and vascular comprise of gastrointestinal organs.

No women who are pregnant or intend to become pregnant.

No patients who have known malignancies.

Patients must be HIV negative.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Allergy and Infectious Diseases (NIAID)
state: Maryland
Study officials:
References:
citation: Talar-Williams C, Hijazi YM, Walther MM, Linehan WM, Hallahan CW, Lubensky I, Kerr GS, Hoffman GS, Fauci AS, Sneller MC. Cyclophosphamide-induced cystitis and bladder cancer in patients with Wegener granulomatosis. Ann Intern Med. 1996 Mar 1;124(5):477-84. doi: 10.7326/0003-4819-124-5-199603010-00003.
citation: Hoffman GS, Kerr GS, Leavitt RY, Hallahan CW, Lebovics RS, Travis WD, Rottem M, Fauci AS. Wegener granulomatosis: an analysis of 158 patients. Ann Intern Med. 1992 Mar 15;116(6):488-98. doi: 10.7326/0003-4819-116-6-488.
Clinical trial NCT01495455: Nottingham Osteoarthritis Biomarker Study 2011
Official title: Nottingham Osteoarthritis Biomarker Study 2011
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 140
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Secondary care clinics

Brief summary: Osteoarthritis is by far the most common joint condition and the single largest cause of disability in the older population. The investigators still have a poor understanding of the nature of osteoarthritis and factors that influence its development and progression. Identification of biochemical markers that relate to cartilage loss, bony overgrowth and other features that occur with osteoarthritis will advance our understanding. Over the last 5 years analytical methods have developed to measure a range of different biomarkers. This pilot study will use these analytical methods to measure biomarker levels in joint fluid, urine and blood of 50 participants with Osteoarthritis (OA) and 50 healthy volunteers.

This study will provide novel pilot data on the changes in the composition of the synovial fluid, urine and blood in patients with OA. Apart from being a key target site for OA, the knee is a suitable joint for study because of its accessibility to clinical assessment, joint aspiration and imaging.


Eligibility criteria: Inclusion Criteria:

All participants:

* Be able to provide written informed consent
* Aged 30 and over

Knee OA patients:

• Radiographic signs of OA - that is definite joint space narrowing plus osteophyte in at least one compartment of the knee

Normal controls:

* No knee pain
* No clinical or radiographic changes of knee OA

Primary outcomes:
measure: Difference in the levels of pro-inflammatory and anti-inflammatory lipids mediators between individuals with knee osteoarthritis and those with normal knees.
timeFrame: within 6 months of recruitment of last participant
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Academic Rheumatology, University of Nottingham
Study officials:
affiliation: University of Nottingham
name: Michael Doherty, MA MB FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01344655: Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients
Official title: A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to Investigate the Effect of Formoterol HFA-pMDI Versus Salmeterol HFA-pMDI on Small Airways Physiological Parameters in COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2011-04-29
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.

Detailed description: A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients.

Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of COPD
* Post bronchodilator FEV1 between 30% and 80% predicted values at screening
* Post-bronchodilator FEV1/FVC \< 0.7

Exclusion Criteria:

* Positive FEV1 reversibility test: FEV1 change greater than 200 mL and 12%
* History of another medical condition contraindicating participation in the study
* Clinical evidence of heart failure

Primary outcomes:
measure: Respiratory Impedance by Impulse oscillometry
timeFrame: from 5 minutes to 8 hours post dose
Secondary outcomes:
measure: Exhaled Nitric Oxide
timeFrame: from 30 minutes to 8 hours post dose
measure: Multiple Breath Nitrogen Washout
timeFrame: from 30 minutes to 8 hours post dose
measure: Forced Expiratory Volume in the 1st second
timeFrame: from 30 minutes to 8 hours post dose
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Airway Disease Section, NHLI, Imperial College London
Study officials:
affiliation: Imperial College London
name: Omar S Usmani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03407755: Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
Official title: Air Versus SF6 for Descemet's Membrane Endothelial Keratoplasty (DMEK)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fuchs' Endothelial Dystrophy
Bullous Keratopathy
Keywords: Intraocular gas
Positioning
DMEK
Endothelial keratoplasty
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients randomized to either air or sulfur hexafluoride (SF6)
Primary purpose: TREATMENT

Brief summary: This blinded, randomized study compares the use of air and sulfur hexaflouride (SF6) tamponade in Descemet Membrane Endothelial Keratoplasty.


Eligibility criteria: Inclusion Criteria:

- Eligible for DMEK surgey

Exclusion Criteria:

Related to ocular health

* Re-DMEK or prior penetrating keratoplasty
* Ocular hypertension resistant to topical medication
* Previous vitrectomy
* Minimally invasive glaucoma devices
* Aphakia
* Anterior chamber or iris claw lens
* Implantable Collamer Lens (ICL)
* Clinically significant corneal scarring
* Central corneal thickness \>750 µm
* BCVA \< 0.1

Related to general health

* Not able to give informed consent
* Inability to position correctly due to organic or psychological condition.

Related to surgical procedure

* Graft diameter \>9 mm or \< 7mm
* Graft central endothelial cell count \< 2000 cells/mm2
* Graft unfolding duration \>1 hour
* Graft morphology grade 4-5
* Significant graft decentration (graft contour not visible in microscope)
* Significant presence of Descemet remnants in the graft-host interface
* Presence of inward folds
* Graft 'stroma-surface' placed facing away from recipient stroma

Primary outcomes:
measure: Graft detachment
timeFrame: Occurence within 3 months postoperative
Secondary outcomes:
measure: Visual acuity
timeFrame: 3 months postoperative
measure: Gas fill
timeFrame: Serial measurements during postoperative week 1.
measure: Positioning
timeFrame: 72 hours postoperative
measure: Complications
timeFrame: Occurence within 3 months postoperative
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup Hospital, University of Copenhagen
Study officials:
affiliation: Rigshospitalet - Glostrup
name: Mark Alberti, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01715155: Management of Metastatic Breast Cancer in Clinical Practice - Retrospective Study
Official title: A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer,
retrospective study,
disease progression,
clinical management
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-10-26
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients newly diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage.

Brief summary: The purpose of this study is to evaluate the incidence rate of progression of disease, to describe the diagnostic and clinical management in patients with Metastatic Breast Cancer in the clinical practice in Bulgaria.

Detailed description: A Retrospective Cohort Study on Therapeutic Management of Metastatic Breast Cancer in Clinical Practice in Bulgaria

Eligibility criteria: Inclusion Criteria:

* New diagnosis of breast cancer according to ICD-10 with confirmed metastasis
* Confirmed diagnosis between 1st July 2010 and 30th June 2011.
* Female patient managed for her disease at the same setting where final diagnosis of MBC was performed.

Exclusion Criteria:

* History of concurrent or other primary malignancies (except curatively resected non-melanoma skin cancer or in situ cervical cancer).

Primary outcomes:
measure: Number of progression events on a per patient-year-basis
timeFrame: Up to 2 years 5 months
Secondary outcomes:
measure: Proportion of patients among study population who have not progressed at 12 and 18 months after they were diagnosed
timeFrame: Up to 2 years 5 months
measure: Median and mean time interval that elapsed between diagnosis and first objective tumor progression (TTP) event and subsequent events
timeFrame: Up to 2 years 5 months
measure: Median and mean time from the date of diagnosis to the date of breast cancer progression or death whichever occurred first
timeFrame: Up to 2 years 5 months
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Ruse
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Reaseach Site
Study officials:
References:
Clinical trial NCT00595855: A Comparison Between Deep Sclerectomy and Trabeculectomy
Official title: Deep Sclerectomy Versus Trabeculectomy. A 7 Year Prospective Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
surgery
non penetrating procedures
cataract
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients affected by medically uncontrolled open angle glaucoma will be randomised to either a non penetrating procedure (deep sclerectomy) or conventional trabeculectomy. The longterm efficacy (i.e. IOP w/out therapy) and safety (i.e. visual acuity, visual field stability and co-morbidities) will be evaluated.

Detailed description: Prospective 7-year randomised investigator -masked clinical trial 79 eyes (79 patients) enrolled randomised to surgery by PEX and previous pilocarpine use Deep sclerectomy n = 41 Trabeculectomy n = 38 Estimated DS : TE success = 1:3 10% attrition ; power = 90%, alpha = 5%

Methods and evaluation of outcomes:

1. IOP: average of the two highest readings of the IOP phasing (6 readings)
2. VA: LogMAR (ETDRS chart)
3. Lens: LOCSII (slit lamp classification), worsening = one step progression confirmed at two visits

study visits: every 4 months

Eligibility criteria: Inclusion Criteria:

* Angle wide open
* Age \> 65 yrs
* IOP \> 23 and \< 30 mmHg (average of the two highest readings of the daily IOP phasing)
* Topical beta blocker in fellow eye
* At least two medications in use + previous ALT
* MD \< 20 dB (HFA 24-2 full threshold)
* LOCSII \< C1-N1-P0

Primary outcomes:
measure: intra ocular pressure without therapy (% of eyes within pre-selected cut-off limits)
timeFrame: 7 years
Secondary outcomes:
measure: (a) LogMAR visual acuity, (b) number of cataract extraction procedures
timeFrame: 7 years
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Sally Williams
Study officials:
affiliation: University of Parma
name: Gandolfi Stefano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00784355: Laparoscopic Cholecystectomy in Idiopathic Pancreatitis
Official title: Does Laparoscopic Cholecystectomy Prevent Recurrence in Idiopathic Pancreatitis? A Prospective Multicentre Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Pancreatitis
Keywords: recurrence of idiopathic pancreatitis
laparoscopic cholecystectomy
etiology of pancreatitis
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2008-11-02
Enrollment: 200
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: The causes of acute pancreatitis in Finland are alcohol overuse (60%), cholecystolithiasis (20%) and idiopathic (i.e. etiology unknown)(20%). Acute pancreatitis may recur in over half of cases and may be fatal in severe cases in 30%. Majority of idiopathic pancreatitis are caused by microlithiasis in gall bladder. The purpose of this randomized study is to prevent recurrence of idiopathic pancreatitis by performing laparoscopic cholecystectomy compared to non-operative group in 2 years follow-up of patients.

Detailed description: Etiologic investigations include serum amylase, lipase, triglyceride and calcium determination, as well as abdominal ultrasound scanning. Alcohol consumption is asked by using WHO audit test. After etiology of acute pancreatitis has been confirmed as idiopathic, 100 patients are randomized to laparoscopic cholecystectomy and 100 patients to follow-up of 2 years. Five to seven Finnish university and main central hospitals are participating the study.

Eligibility criteria: Inclusion Criteria:

* idiopathic pancreatitis

Exclusion Criteria:

* age \< 18 years old
* patients' refusal
* high operative risks
* alcohol overuse

Primary outcomes:
measure: recurrence of acute pancreatitis
timeFrame: 2 years
Secondary outcomes:
measure: etiology of acute pancreatitis in Finland in 2009-10
timeFrame: 2 years
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
References:
citation: Karne S, Gorelick FS. Etiopathogenesis of acute pancreatitis. Surg Clin North Am. 1999 Aug;79(4):699-710. doi: 10.1016/s0039-6109(05)70036-0.
citation: Raty S, Pulkkinen J, Nordback I, Sand J, Victorzon M, Gronroos J, Helminen H, Kuusanmaki P, Nordstrom P, Paajanen H. Can Laparoscopic Cholecystectomy Prevent Recurrent Idiopathic Acute Pancreatitis?: A Prospective Randomized Multicenter Trial. Ann Surg. 2015 Nov;262(5):736-41. doi: 10.1097/SLA.0000000000001469.
Clinical trial NCT03923855: Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
Official title: Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Improvement of Abdomen Appearance
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.


Eligibility criteria: Inclusion Criteria:

* Age above 21 years and below 60 years
* Voluntarily signing of the informed consent form
* Women of child-bearing potential are required to use birth control measures during the whole duration of the study
* Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area
* Subjects willing and able to abstain from partaking in any procedure to promote body contouring during study participation
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation

Exclusion Criteria:

* Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Pulmonary insufficiency
* Metal implants
* Drug pumps
* Malignant tumor
* Hemorrhagic conditions
* Septic conditions and empyema
* Acute inflammations
* Systemic or local infection such as osteomyelitis and tuberculosis
* Contagious skin disease
* Elevated body temperature
* Pregnancy
* Breastfeeding
* Injured or otherwise impaired muscles
* Scars, open lesions and wounds at the treatment area
* Basedow's disease
* Previous liposuction in the treatment area in the last six months
* Abdominal wall diastasis
* Unstable weight within the last 6 months (change in weight ± 3%)
* Previous body contouring treatments in the abdomen area in the last three months
* Any disease or condition contradicting the fat tissue biopsy at the surgeon discretion
* Any disease or condition that may compromise the histologic observation at the pathologist discretion

Primary outcomes:
measure: Histology Examination
timeFrame: 4 months
measure: Evaluation of Satefy: Occurence of adverse events throughout the study
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Dr. Denkova Dermatology
Study officials:
References: