louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03308149: Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans
Official title: Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infiltration Facet Joint
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-10-12
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had received inpatient gradual diagnostics in our department

Brief summary: Fifty MRI scans of patients with chronic lumbar back pain were graded radiologically using a wide range of classification and measurement systems. The reported effect of facet joint injections at the site was recorded and a comparative analysis performed.


Eligibility criteria: Inclusion Criteria:

* patients who had received inpatient gradual diagnostics for chronic lumbar back pain
* monosegmental facet joint infiltration on the first day of inpatient gradual diagnostics
* clearly stated pain relief in percentage (%) for that specific infiltration in the medical documentation
* pain level prior to infiltration needed to be clearly documented
* a high-quality MRI available before infiltration.

Exclusion Criteria:

* ositive history of lumbar surgery or the presence of artificial implants in the area of interest

Primary outcomes:
measure: Correlation of radiologic findings and reported pain relief
timeFrame: Improvement in pain level within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen, Department of Orthopaedics
Study officials:
affiliation: Department of Orthpaedic Surgery, University Hospital of Tuebingen
name: Ulf Hofmann, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hofmann UK, Keller RL, Walter C, Mittag F. Predictability of the effects of facet joint infiltration in the degenerate lumbar spine when assessing MRI scans. J Orthop Surg Res. 2017 Nov 21;12(1):180. doi: 10.1186/s13018-017-0685-x.
Clinical trial NCT02168049: Heart and Lung Function Monitoring System
Official title: Heart and Lung Function Monitoring System Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Lung Diseases
Keywords: cardiac, respiratory, monitoring
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The investigator goal is to test a new device to see if it can provide continuous and simultaneous monitoring of heart and lung function.

Detailed description: The purpose of this study is to evaluate and guide progress in the development of a new instrument that may provide continuous, integrated monitoring of heart and lung function.

Eligibility criteria: Inclusion Criteria:

* Adult's ≥ 18 years old

Exclusion Criteria:

* Wounds, surgical incisions at the site of sensor placement

Primary outcomes:
measure: Acoustic heart sound electronic data
timeFrame: 60 minutes during system trial
Secondary outcomes:
measure: Standard echocardiography parameters
timeFrame: 60 minutes during examination simultaneous with system trial
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Kimberly Howard-Quijano, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06909149: Role of Amniotic Membrane Extract Eye Drops as an Adjunctive Therapy in Resistant Corneal Ulcers
Official title: The Role of Amniotic Membrane Extract Eye Drops as an Adjunctive Therapy in Resistant Corneal Ulcers: A Randomized Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amniotic Membrane Extract Eye Drops
Resistant Corneal Ulcers
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to assess the efficacy of amniotic membrane extract eye drops (AMEED) as a supplementary treatment for refractory corneal ulcers.

Detailed description: Corneal ulceration is one of the leading causes of corneal blindness. Multiple causes of corneal ulceration vary in prevalence from country to country according to geographical and economic conditions.

Amniotic membrane (AM) contains pluripotent stem cells, highly organized collagen, immune-modulators, growth factors, anti-fibrotic and anti-inflammatory cytokines, A variety of matrix proteins, in addition to anti-microbial effect. Inspite of the amniotic membrane transplant is still a surgical procedure, it is not indicated in mild to moderate cases of resistant corneal ulceration and persistent epithelial defects and would alter visual function gravely.

Researchers found that amniotic membrane extract eye drops (AMEED) are superior to autologous blood serum in level and variety of growth factors, cytokines, and antimicrobial activity, along with higher success rates and faster healing results; they discarded the amniotic membrane conditioned medium as it failed to provide matching results.

Eligibility criteria: Inclusion Criteria:

* Age from 20 to 80 years.
* Both sexes.
* Patients who were suffering from corneal ulcers that showed no signs of improvement after one week of medical intervention.

Exclusion Criteria:

* Severe corneal melting.
* Perforated corneal ulcer.
* Corneal ulcers with significant thinning with or without descemetocele.
* Patients who were unable to adhere to the treatment plan properly.

Primary outcomes:
measure: Time of improvement of corneal ulcers
timeFrame: 7 weeks after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT02907749: Spironolactone on Fibrosis Progrssion-Portal Hypertension(FP-PH)in Cirrhosis
Official title: Effects of Spironolactone on Fibrosis Progression and Portal Pressure in Patients With Advanced Chronic Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis
Portal Hypertension
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effects of spironolactone on liver fibrosis progression and portal pressure gradient in patients with advanced chronic liver disease. Eligible cirrhosis patients were 2:1 randomized to either combination (carvedilol and spironolactone) or single (carvedilol) therapy group. Changes in virtual portal pressure gradient (vPPG) of portal trunk (calculated based on reconstructed 3D model and measured blood flow velocity), liver stiffness measurement (Fibroscan) and serum markers of liver fibrogenesis were documented at baseline and six months later.


Eligibility criteria: Inclusion Criteria:

-Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings

Exclusion Criteria:

* Treatment with β-blockers or diuretics in the last 3 months
* Severe cardiopulmonary or renal insufficiency
* Chronic alcohol abuse
* Can't tolerate side effects of oral carvedilol or spironolactone
* History of variceal bleeding
* Malignancy
* Portal vein thrombosis
* History of partial splenic embolization or splenectomy
* Moderate or tense ascites

Primary outcomes:
measure: Virtual portal pressure gradient(vPPG)
timeFrame: 6 months
Secondary outcomes:
measure: Liver stiffness measurement (LSM)
timeFrame: 6 months
measure: Occurence of portal hypertension-related complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, Tongji University
state: Shanghai
Study officials:
affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Jing Li, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06811649: Comparison of Echo-assisted ALR Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient
Official title: Comparison of Echo-assisted ALR (Loco-regional Anesthesia) Technique and Traditional ALR Technique for the Placement of an Epidural Catheter in the Obstetric Patient Performed by an Anesthesia Resident
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Keywords: epidural catheter
loco-regional anesthesia
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, open-label, single-center clinical trial. The purpose of the study is to understand whether the aid of ultrasound assessment is useful in improving the competence of resident.

Specifically, to demonstrate how the aid of echo-assistance in the evaluation of the spine increases the atraumatic success rate (primary objective) and reduces the number of complications (particularly, the number of attempts needed and the rate of dura puncture) (secondary objective) in physicians in specialty training.

Pregnant patients requiring peridural analgesia will be assigned to the intervention or control group by simple randomization.

Detailed description: The use of echo-assisted assessment has been studied for about a decade, showing encouraging results as far as experienced medical personnel are concerned, but to date, a systematic study assessing the usefulness of this aid in improving residents' competence (as indicated by the 2019 systematic review) is lacking in the literature.

To date, echo-assisted assessment is not routinely applied to all obstetric patients, as it is a relatively new technique and not yet widely used by all anesthesiologists.

If the results of the study are positive,echo-assisted assessment use could be expanded, reducing the number of complications and increasing the number of atraumatic epidural catheter placements.

Eligibility criteria: Inclusion Criteria:

* Pregnant patients \>18 years of age with no BMI (Body Mass Index) limitation
* Pregnant patients requiring partoanalgesia
* Obtaining informed consent for study participation

Exclusion Criteria:

* Patients with contraindications to epidural catheter placement
* Endocranial hypertension
* Coagulopathies
* Severe thrombocytopenia \< 75,000 per mm\^3.

Primary outcomes:
measure: the rate of FNP (thus atraumatic puncture)
timeFrame: Through study completion,an average of 1 year
Secondary outcomes:
measure: Change the number of complications
timeFrame: Through study completion,an average of 1 year
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Aurora Guglielmetti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01446549: Motor Performance in Parkinson's Disease After High Intensive Exercise or Deep Brain Stimulation
Official title: Quantitative Modeling of Motor Performance in Parkinson's Disease After High Intensive Antigravity Locomotor Exercise or Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
name: Bispebjerg Hospital
name: Danish Parkinson Association
First posted: 2011-10-05
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is (1) to provide quantitative information of the motor manifestations of Parkinson's disease and (2) to quantify the effect of high intensive antigravity locomotor exercise or Deep Brain Stimulation implantations in Parkinson's disease.


Eligibility criteria: Inclusion Criteria (exercise arm):

* Idiopathic Parkinson's disease
* A stable condition the last 6 months
* Hoehn and Yahr 2 - 3

Inclusion Criteria (Deep Brain Stimulation arm):

* Patients referred to Deep Brain Stimulation

Exclusion Criteria:

* Cardiovascular disease
* Conditions that contraindicate physical exercise or the examination

Primary outcomes:
measure: Change in Isometric Tremor Approximate Entropy
timeFrame: Change from baseline up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Department of Exercise and Sport Sciences, University of Copenhagen
name: Martin H Rose, MSci
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Exercise and Sport Sciences, University of Copenhagen
name: Bente R Jensen, MSci, PhD
role: STUDY_CHAIR
affiliation: Department of Orthopedic Surgery, Hvidovre University Hospital
name: Stig Sonne-Holm, MD, DSc
role: STUDY_CHAIR
affiliation: Department of Neurology, Bispebjerg University Hospital
name: Annemette Løkkegaard, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01961349: Phase III Study of ICI35,868 (Diprivan) With and Without EES0000645/A (SDS) on Gastrointestinal Endoscopy
Official title: A Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III Confirmatory Study to Assess Efficacy and Safety of the Moderate Sedation of ICI35,868 With and Without EES0000645/A on Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sedation to be Moderate for a Diagnostic Gastrointestinal Endoscopy and Gastrointestinal Endoscopic Polypectomy
Keywords: sedation, propofol, gastrointestinal endoscopy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson
First posted: 2013-10-11
Enrollment: 279
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed as a multi-centre, randomised, parallel-group, placebo-controlled, phase III confirmatory study. The study will be partially double-blinded: the comparison between Group 1 (placebo group) and Group 2 (ICI35,868 without EES0000645/A) will be carried out in double-blind, but the comparison between Group 1 (placebo group) and Group 3 (ICI35,868 with EES0000645/A) will be carried out in single-blind.

The efficacy and safety of ICI35,868 with and without EES0000645/A for the sedation to be moderate for a diagnostic gastrointestinal endoscopy and gastrointestinal endoscopic polypectomy will be evaluated.


Eligibility criteria: Inclusion Criteria:

1.Provision of written informed consent prior to any study-related procedures/examinations 2.Aged 20 years and older 3.Subjects who are planned to undergo a non-emergent EGD or colonoscopy, including gastrointestinal endoscopic polypectomy that shall be completed within 1 hour (excluding the endoscopic submucosal dissection and ultrasonic endoscope, pernasal endoscope, etc.). Exclusion Criteria:

1. involvement in the planning and/or conduct of the study (applies to both sponsor's employees and/or staffs at the study site)
2. Subjects who underwent a endoscopic procedure under ICI35,868 (propofol) administration within 1 year.
3. Participation in another clinical study with an investigational product within 4 weeks prior to randomisation.
4. Baseline (Visit 1) of blood oxygen saturation (SpO2)\<90% (room air)
5. ASA III, IV, V and VI ; Subject with serious disease of cardiovascular, respiratory, renal, liver, pancreatic or endocrine function.

Primary outcomes:
measure: Achivement of Target Sedation
timeFrame: from scope-in to scope-out
Secondary outcomes:
measure: PSSI Total Score
timeFrame: at 24-48 h after endoscopy
Other outcomes:
Locations:
city: Moriya-shi
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Yokohama-shi
country: Japan
facility: Research Site
Study officials:
References:
Clinical trial NCT04917549: Prevalence of Oral Lesions in COVID-19 Patients
Official title: Prevalence of Oral Lesions in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Lesions
COVID-19
Angiotensin-converting Enzyme 2
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All data was taken for each patient on the admission and during the hospital stay.

Brief summary: Recently, a new coronavirus disease 2019 (COVID-19) has appeared and caused an unprecedented pandemic which is considered as an urgent threat to health authorities worldwide. Several symptoms are observed which are fever, cough, shortness of breath, headache, runny nose, muscle pain, fatigue, arthralgia, sputum production, conjunctivitis, diarrhea. Susceptibility, genetics, systematic diseases, population, gender, and age are crucial considerations for the onset and progression of the viral infection. The patients suffering from asthma or pulmonary deficiency are at high risk of mortality. A metallopeptidase, angiotensin-converting enzyme 2 (ACE2) is considered as the functional receptor for SARS-CoV-2 and it was isolated from a COVID-19 patient. ACE2 was recognized in type I and type II alveolar epithelial cells in both nasal and oral mucosa, in the nasopharynx, in the smooth muscle cells and endothelium of vessels in the stomach and the skin, distinctly in the basal cell layer of the epidermis extending to the basal cell layer of hair follicles, and in the basal layer of the non-keratinizing squamous epithelium. In order to study the possible routes of SARS-CoV-2 infection on the oral mucosa, we investigated whether oral lesions mainly affect the tongue mucosa due to higher ACE2-expressing cell composition and proportion more than that in other oral tissues. Moreover, appearance of oral lesions were as a result of SARS-CoV-2 infection or as a side effect of certain drugs for COVID-19 treatment was evaluated.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years.
* laboratory-confirmed COVID-19 infection (reverse transcription-polymerase chain reaction, RT-PCR).

Exclusion Criteria:

* patients without a laboratory-confirmed diagnosis of COVID-19 infection.
* patients with olfactory or gustatory dysfunctions before the epidemic.
* patients with some malignant neoplasms.
* patients with neurodegenerative disorders.

Primary outcomes:
measure: site of mucosa affected by oral lesions
timeFrame: 1 month
Secondary outcomes:
measure: treatment of the patients
timeFrame: 1 month
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Dalia Rasheed Issa
state: Kafr El-sheikh
Study officials:
affiliation: Kafrelsheikh University
name: Dalia R Issa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05824949: Osseodensification Versus Conventional Drilling Effect on Implant Stability
Official title: The Impact of Osseodensification and Conventional Drilling Protocols on Implants Mechanical and Biological Stability in Posterior Maxilla: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Implant Therapy
Lead sponsor: Arab American University (Palestine)
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of 80 implants were placed in the posterior region of the maxilla in 40 patients in a split-mouth design. Bone quality was classified into type I, II, III, IV, or V as assessed preoperatively on cone-beam computed tomography (CBCT) . Primary implant stability was measured with insertion torque and resonance frequency analysis (ISQ values). Secondary stability was measured by ISQ at abutment installation.


Eligibility criteria: Inclusion Criteria:

* (a) Bilateral edentulism in the maxillary posterior region dating back more than 6 months,
* (b) sufficient bone height (distance between the bone crest and maxillary sinus \>8 mm) and width at the alveolar crest (≥6 mm) that would not necessitate bone augmentation,
* (c) at least 2 mm vestibular keratinized mucosa width and 3 mm mucosa thickness,
* (d) full-mouth plaque and bleeding scores \<20%.

Exclusion Criteria:

* patients with systemic diseases, conditions, or used medications having the potential to impair surgery, bone, and wound healing dynamics (such as diabetes) will be excluded.
* patients who are allergic to antibiotics and non-steroidal anti-inflammatory drugs
* bone height \<8mm
* ridge and soft tissue deficiencies requiring augmentation procedures and
* endodontic or periodontal lesions neighboring the edentulous sites will be also excluded.

Primary outcomes:
measure: Mechanical or primary stability
timeFrame: directly after implant placement
measure: Biological or secondary stability
timeFrame: 4 months after implant installation
Secondary outcomes:
measure: Torque value (N/cm)
timeFrame: directly after implant insertion
Other outcomes:
Locations:
city: Ramallah
country: Palestinian Territory, occupied
facility: Mahmoud Abu-Ta'a
Study officials:
References:
Clinical trial NCT02173249: A Single-Center, Open-Label, Study of the Plasma Pharmacokinetics and Safety of AC-170 0.24%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Aciex Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Plasma Pharmacokinetics and Safety of AC 170 0.24% in Healthy, Adult Subjects when used twice daily for one week.


Eligibility criteria: Inclusion Criteria:

* at least 18 and no older than 55 years of age
* be able to self-administer eye drops or have a parent/legal guardian available for this purpose
* have blood and urine analysis within normal limits
* have ocular health within normal limits

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* have any active systemic or ocular disorder (other than refractive disorder)
* have inability to comply with controlled diet
* have used prescription or non prescription drugs within washout period and throughout study
* have used alcohol or tobacco within the washout period

Primary outcomes:
measure: Cmax values of AC 170 0.24%
timeFrame: 1 week
measure: Tmax values of AC 170 0.24%
timeFrame: 1 week
measure: AUC values of AC 170 0324%
timeFrame: 1 week
measure: T 1/2 values of AC 170 0.24%
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References: