louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02030587: Laparoscopic Adrenalectomy Versus Radiofrequency Ablation
Official title: Laparoscopic Adrenalectomy Versus Radiofrequency Ablation for Aldosterone-producing Adenoma: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperaldosteronism
Conn Syndrome
Adrenocortical Adenoma
Keywords: Hyperaldosteronism
Adrenocortical adenoma
Adrenalectomy
Catheter ablation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized controlled study comparing laparoscopic adrenalectomy (LA) versus image-guided percutaneous radiofrequency ablation (RFA) in treating aldosterone-producing adenoma.

The objectives of this study are to

1. compare the short-term outcomes of LA and RFA in treating aldosterone-producing adenoma.
2. compare the treatment success rates of LA and RFA during follow-up for primary aldosteronism.


Eligibility criteria: Inclusion Criteria:

1. Hypertensive individuals
2. Biochemically confirmed primary aldosteronism
3. Radiologically confirmed unilateral adrenal adenoma ≤3cm

Exclusion Criteria:

1. Bilateral adrenal disease
2. Multiple adrenal tumors
3. Other concomitant adrenal diseases
4. Potentially malignant adrenal tumors as shown on imaging
5. Uncorrected coagulopathy
6. Surgically unfit for general anaesthesia
7. Prior open abdominal surgery

Primary outcomes:
measure: Morbidity rate
timeFrame: 30-day
measure: Resolution of hyperaldosteronism
timeFrame: 1 year
Secondary outcomes:
measure: Operative time
timeFrame: 24 hours
measure: Periprocedural hypertensive crisis
timeFrame: 24 hours
measure: Mortality rate
timeFrame: 30 days
measure: Blood loss
timeFrame: 24 hours
measure: Analgesic requirement
timeFrame: 30 days
measure: Time to resumption of activity
timeFrame: 30 days
measure: Resolution of hypokalaemia
timeFrame: 1 year
measure: Blood pressure control
timeFrame: 1 year
measure: Hospital stay
timeFrame: 30 days
measure: Pain score
timeFrame: 7 days
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Enders KW Ng, MB ChB
role: STUDY_CHAIR
affiliation: Chinese University of Hong Kong
name: Shirley YW Liu, MB ChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu SY, Ng EK, Lee PS, Wong SK, Chiu PW, Mui WL, So WY, Chow FC. Radiofrequency ablation for benign aldosterone-producing adenoma: a scarless technique to an old disease. Ann Surg. 2010 Dec;252(6):1058-64. doi: 10.1097/SLA.0b013e318f66936.
Clinical trial NCT05032287: Medical Expulsive Therapy Post-SWL For Renal Stones
Official title: Medical Expulsive Therapy Post-SWL For Renal Stones. A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urologic Diseases
Urolithiasis
Stone, Kidney
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-09-02
Enrollment: 235
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: To evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-SWL in patients with renal stone less than 20 mm


Eligibility criteria: Inclusion Criteria:

* Renal stone ≤ 20 mm.
* Lower calyceal stone ≤ 15 mm

Exclusion Criteria:

* Women with known or suspected pregnancy or breastfeeding.
* History of alpa-blockers (more than 7 days prior to study participation)
* History of ureteral stricture
* Multiple (that is more than 2) stones
* Stone in solitary kidney (either anatomically or functionally).
* Presence of urinary sepsis.
* Estimated glomerular filtration rate \< 30 ml/min
* Contraindication or allergy to tamsulosin

Primary outcomes:
measure: Stone free rate defined as patient free of any stone residual
timeFrame: at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Urology and Nephrology Center
state: Aldakahlia
Study officials:
References:
Clinical trial NCT02511587: Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
Official title: Comparison of Vaccination Routes: Subcutaneous Versus Intramuscular Application of FSME-Immun®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vaccine Efficacy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: FSME-Immun® is registered for application into the muscle. This study investigates if application under the skin leads to a comparable immune response.

Detailed description: Tick-borne encephalitis (TBE) vaccine (FSME-Immun®) is registered for intra-muscular application. Due to medical reasons (e.g. anticoagulant therapy, adipositas) intra-muscular application is not always possible. The aim of this clinical trial is to investigate whether a comparably good immunogenicity can be achieved via the subcutaneous vaccination route. Thus humoral and cellular immune responses after intramuscular and subcutaneous TBE vaccination in healthy volunteers will be compared.

Eligibility criteria: Inclusion Criteria:

* completed primary TBE immunization + at least one booster immunization
* adults of both sexes between 18 and 60 years of age
* willingness to sign written informed consent form

Exclusion Criteria:

* age \< 18 and \> 60 years
* prior TBE infection
* pregnancy and breast feeding
* acute infection on day of inclusion (day 0), (body temperature \> 37,9°C)
* concomitant medications: systemic cortisone therapy, chemotherapy, immunosuppressive therapy 4 weeks prior to or during study
* administration of other vaccines 4 weeks before/after day 0
* planned surgery within 2 weeks before/after TBE booster vaccination
* specific immunotherapy (Hypo-/Desensibilisation) 14 days before/after vaccination
* any contraindication to administration of FSME-Immun® vaccine according to manufacturer's instructions
* history of malignant disease within the last 5 years
* autoimmune diseases
* drug addictions
* plasma donors
* receipt of blood transfusions or immuno globulins within 3 month before study entry

Primary outcomes:
measure: Humoral Immunity to TBE (Tick-borne Encephalitis) Vaccine
timeFrame: 1 month
Secondary outcomes:
measure: Cellular Immune Responses - Cytokines
timeFrame: before (day 0) and 1 week after booster vaccination
measure: TBE Titer Profile
timeFrame: before (day 0) and 1week, 1 month, 6 months after booster vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Medical University Vienna, ISPTM
name: Ursula Wiedermann, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03746587: Study of Arimoclomol in Patients Diagnosed With Gaucher Disease Type 1 or 3
Official title: Multicentre Double-blinded, Randomized Placebo-controlled Study of Arimoclomol in Patients Diagnosed With Gaucher Disease Type 1 or 3
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gaucher Disease, Type 1
Gaucher Disease, Type 3
Keywords: Gaucher Disease
Lead sponsor: ZevraDenmark
Sponsor class: INDUSTRY
First posted: 2018-11-19
Enrollment: 39
Sex: ALL
Minimum age (years): 4
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized
Primary purpose: TREATMENT

Brief summary: Multicenter, doubleblinded, randomized placebo-controlled study of arimoclomol in patients with Gaucher Disease Type 1 or 3

Detailed description: Evaluating the response of 3 dose levels of arimoclomol on various pharmacodynamic biomarkers in blood and cerebrospinal fluid as indicators of enhanced GBA in Gaucher Disease Type 1 or 3.

Eligibility criteria: Key Inclusion Criteria:

* Be able to understand and voluntarily sign informed consent
* A diagnosis GD, either Type 1 or Type 3
* For GD3 at least 1 neurological symptom
* Age ≥ 4 years and ≤ 60 years at the time of enrolment
* Plasma or serum chitotriosidase activity greater than 3 times the upper limit of normal.

Key Exclusion Criteria:

* Recipient of a liver transplant or planned liver transplantation during the course of the study.
* Splenectomy within 4 months of study entry or planned splenectomy during the course of the study.
* Severe liver damage.
* Severe renal insufficiency.
* Body weight \< 10 kg.

Other inclusion and exclusion criteria may apply

Primary outcomes:
measure: Primary Endpoint
timeFrame: 6 months
Secondary outcomes:
measure: Growth Endpoint
timeFrame: 6 months
measure: Growth Endpoint
timeFrame: 6 months
measure: Maturation Endpoint
timeFrame: 6 months
measure: Maturation Endpoint
timeFrame: 6 - 12 months
measure: Imaging Endpoint
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
city: Mumbai
country: India
facility: King Edward Memorial Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Jaslok Hospital and Reseach Centre
state: Maharashtra
city: Pune
country: India
facility: KEM HOSPITAL Research Centre
state: Maharashtra
city: Vellore
country: India
facility: Christian Medical College and Hospital.
state: Tamilnadu
city: Kolkata
country: India
facility: Institute of Child Health
state: West Bengal
city: New Delhi
country: India
facility: Maulana Azad Medical College
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
Study officials:
affiliation: Jaslok Hospital and Reseach Centre, Mumbai
name: Aabha Nagral, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06597487: The Effect of Prognostic Factors on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis
Official title: Influence of Wolters Classification of Pulpitis and the Radiographic Caries Depth Detected Using Artificial Intelligence on the Success of Full Pulpotomy in Permanent Mature Molars With Irreversible Pulpitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulpitis - Irreversible
Keywords: irreversible pulpitis
full pulpotomy
artificial intelligence
Lead sponsor: Misr International University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of prognostic factors, such as the degree of pulpal inflammation and the radiographic caries depth, on the success of full pulpotomy in mature permanent molars with irreversible pulpitis.

Detailed description: * Patients with mature permanent molars diagnosed with irreversible pulpitis will be enrolled in the study.
* The pre-operative pulpal status will be assessed using the American Association of Endodontists (AAE) classification and Wolters classification.
* Pre-operative radiographs will be taken, and radiographic caries depth will be assessed.
* An Artificial Intelligence software will process the pre-operative X-rays to assess the presence of carious pulp exposure. The diagnostic accuracy of the software will be evaluated by comparing its readings with clinical findings of pulp exposure after caries removal.
* The patients will be randomized to receive either full pulpotomy or conventional root canal treatment.
* The patients will be followed up for 1, 3 and 6 months to assess clinical and radiographic success.

Eligibility criteria: Inclusion Criteria:

* Mature permanent molars with irreversible pulpitis.
* Presence of bleeding pulp tissues from all canals.
* The tooth is not periodontally compromised.

Exclusion Criteria:

* Non-vital teeth.
* Uncontrolled bleeding from any of the canals after ten minutes of application of hemostatic agent.
* Molars with immature roots.

Primary outcomes:
measure: Percentage of Successful Cases
timeFrame: After 1, 3, and 6 months
measure: Diagnostic accuracy (Sensitivity and Specificity) of an artificial intelligence software in detecting carious pulp exposure
timeFrame: On the day of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Misr International University
Study officials:
affiliation: Misr International University
name: Ahmed A Ghobashy, Prof. Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06082687: De-identified Human Tissue Project
Official title: De-identified Human Tissue Project for Use with Translational, Biomedical Research At UCF College of Medicine and Burnett School of Biomedical Sciences
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tissue
Keywords: Tissue
surgery
donate
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 1000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Not applicable. This Project will receive de-identified human tissue from cooperating institutions for unknown/undisclosed donors.

Brief summary: Research scientists of the University of Central Florida College of Medicine (COM) and Burnett School of Biomedical Sciences (BSBS) conduct laboratory studies in biomedical and translational medical research for the purpose of understanding human disease and developing innovative methods for diagnosing, measuring, or treating disease or disease symptoms. The key research divisions are cancer, cardiovascular, immunity and pathogenesis, neuroscience, and molecular microbiology.

Detailed description: The objective of this De-Identified Human Tissue Project is the receipt of de-identified human tissue from medical, surgical, and clinical facilities. The human tissue can be fresh or paraffinized. The human tissue will be picked up by the clinical research team and transferred to research scientists of the University of Central Florida's College of Medicine (COM) or Burnett School of Biomedical Sciences (BSBS) for storage and testing according to their separate IRB-approved or IRB-exempted protocols. These separate protocols cannot be for genetic testing. The Project does not receive human tissue resulting from termination of pregnancy.

Eligibility criteria: Inclusion:

- de-identified human tissue from cooperating institutions for unknown/undisclosed donors.

Primary outcomes:
measure: Receipt of de-identified human tissue for research
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: University of Central Florida
state: Florida
Study officials:
References:
Clinical trial NCT02501187: Risk of Dry Eye Post Different Surgeries for Blepharoptosis Repair
Official title: Comparison Between Three Different Surgeries for Blepharoptosis Repair and Their Impact on Dry Eye Status
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blepharoptosis
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Blepharoptosis, inferodisplacement of the upper eyelid, can be congenital or acquired. Acquired Blepharoptosis is usually aponeurotic, due to stretching or disinsertion of the levator aponeurosis. Treatment is surgical and can be performed by three common procedures - Levator advancement, Müller's muscle-conjunctival resection procedure and White line advancement. A number of reports inspected the possibility that Blepharoptosis repair procedures may cause deterioration in dry eye status. The investigators would like to assess whether there is a difference between the different procedures in their influence on dry eye status.


Eligibility criteria: Inclusion Criteria:

* Ptosis which indicate surgical repair
* The ptosis must be suitable for repair in any of the procedures

Exclusion Criteria:

* Systemic disease which may cause ocular surface disease (eg Sjogren disease)
* Previous orbital or eyelid surgery
* Significantly dry eyes

Primary outcomes:
measure: Diagnosis of objective or subjective deterioration in dry eye status
timeFrame: 6 months
Secondary outcomes:
measure: Ptosis repair procedure success
timeFrame: 6 months
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Ophthalmology clinics, Rabin Medical Center
Study officials:
affiliation: Rabin Medical Center
name: Maya Eiger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03590587: Rapid Structural and Functional Improvements in Following 0.19 mg Fluocinolone Acetonide (FAc) Implant in Diabetic Macular Edema Patients With Poor Visual Acuity: 12-month Audit Results From United Arab Emirates
Official title: Rapid Structural and Functional Improvements in Following 0.19 mg Fluocinolone Acetonide (FAc) Implant in Diabetic Macular Edema Patients With Poor Visual Acuity: 12-month Audit Results From United Arab Emirates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Macular Edema
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Sheikh Khalifa Medical City
First posted: 2018-07-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty patients with pseudophakic lenses, treated with ILUVIEN, were investigated to evaluate functional and anatomical characteristics and outcomes (visual acuity \[VA; ETDRS letters score\], central macular thickness \[CMT\] and intraocular pressure \[IOP\]) at baseline, weeks 2-4 and months 3, 6 and 12 months.

Brief summary: The Health Authority - Abu Dhabi (HAAD) approved the reimbursement of the slow release FAc implant (ILUVIEN) and it is now available for the treatment of diabetic macular edema (DME) in persons who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. We performed a retrospective 12-month audit to assess the efficacy and safety of the FAc implant in our clinical practice.

Detailed description: Twenty patients with pseudophakic lenses, treated with ILUVIEN, were investigated to evaluate functional and anatomical characteristics and outcomes (visual acuity \[VA; ETDRS letters score\], central macular thickness \[CMT\] and intraocular pressure \[IOP\]) at baseline, weeks 2-4 and months 3, 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

* DME
* Pseudophakic

Exclusion Criteria:

* Other causes of macular edema.
* Phakic
* Know case of gaucoma

Primary outcomes:
measure: BCVA
timeFrame: 12 months
Secondary outcomes:
measure: CMT
timeFrame: 12 months
measure: IOP
timeFrame: 12 months
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Shiekh Khalifa medical city
Study officials:
References:
Clinical trial NCT00037687: Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis
Official title: A Phase 3 Study to Demonstrate the Safety and Efficacy of Recombinant Platelet-Activating Factor Acetylhydrolase (rPAF-AH, Pafase®) for Reducing 28 Day All Cause Mortality in Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sepsis
Keywords: Severe sepsis
Platelet-activating factor acetylhydrolase
Lead sponsor: ICOS Corporation
Sponsor class: INDUSTRY
Collaborators: name: Suntory Pharmaceutical
First posted: 2002-05-21
Enrollment: 2500
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 objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis.

Detailed description: This study is a randomized, double-blind, placebo-controlled, multicenter study of rPAF-AH compared to placebo in patients with severe sepsis. Eligible patients from investigative sites located throughout the United States and other countries will be randomized to receive either rPAF-AH or placebo administered daily for five consecutive days by intravenous (IV) infusion. All patients will be evaluated for safety and efficacy endpoints over 28 days. A follow-up evaluation will occur approximately 6 months after Day 28 to assess functional status and quality of life.

Eligibility criteria: Inclusion criteria

* Clinical diagnosis of severe sepsis
* At least 18 years old
* Patient or legally authorized representative able to provide informed consent

Exclusion criteria

* Severe lung injury (acute respiratory distress syndrome)
* Immunocompromised
* Severe liver disease
* Inflammation of the pancreas, organ rejection, or burns to more than 30% of body
* Enrolled in another clinical trial
* Already participated in this or other rPAF-AH study
* There is not a commitment to aggressive treatment
* Has a disease with life expectancy less than 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Mary E. Lonien, M.S.
state: Washington
Study officials:
References:
citation: The Pafase Phase II ARDS Prevention Study Group. Recombinant platelet-activating factor acetylhydrolase (Pafase) decreases the incidence of acute respiriatory distress syndrome (ARDS) and 28 day all cause mortality (Abstract). Intensive Care Med (2000); 26: S321.