louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01424267: Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry
Official title: Zenith® LP AAA Endovascular Graft Post-Market Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Abdominal Aortic Aneurysm
Aorto-iliac Aneurysm
Keywords: low profile
endovascular graft
endovascular procedure
aortic aneurysm, abdominal aortic aneurysm
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2011-08-26
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with a CE-Marked Zenith® Low Profile AAA Endovascular Graft

Brief summary: A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.


Eligibility criteria: Inclusion Criteria:

* Patient is implanted with Zenith® Low Profile AAA Endovascular Graft

Exclusion Criteria:

* Patients for whom this device would not normally be considered standard of care.

Primary outcomes:
measure: graft patency and aneurysm exclusion
timeFrame: during (day 1) and after implantation through 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH (General Hospital Vienna)
city: Hamburg
country: Germany
facility: UHZ Hamburg GmbH (Eppendorf University Hospital)
city: Munich
country: Germany
facility: Klinikum rechts der Isar (RDI Munich)
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
city: Belfast
country: Ireland
facility: Royal Victoria Hospital
city: Modena
country: Italy
facility: Nuovo Ospendale Civile Sant' Agostino Estense di Baggiovara
city: Rome
country: Italy
facility: Azoemda ospedaliera San Camillo Forlanini
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Trondheim
country: Norway
facility: St. Olav University Hospital
city: London
country: United Kingdom
facility: Guy's and St. Thomas' Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Informary
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Wales
country: United Kingdom
facility: Royal Gwent Hospital
Study officials:
References:
Clinical trial NCT01502267: Desensitization Protocol for Highly Sensitized Patients on the Waiting List for Kidney Transplant
Official title: Phase 2 Study of Desensitization Protocol for Highly Sensitized Wait Listed Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: End Stage Renal Disease
Keywords: Waiting list
Deceased donor kidney transplantation
Desensitization
anti HLA antibody
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2011-12-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether high dose IVIG and B cell depleting agents can be used effectively in highly sensitized wait-listed patients.

Detailed description: HLA sensitization is known to be the most important barrier to deceased donor kidney allocation. Therefore, the investigators need to develop better strategies for managing pre-sensitized patients using desensitization protocol. In this study the investigators will used two kinds of medication for the reduction of circulating antibodies (high dose IVIg, B cell depleting agents) to highly-sensitized patients who are on the waiting list for a deceased donor kidney transplantation. After desensitization, the investigators will check that this treatment can increase their chances of receiving a kidney transplant.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* patients who are on the waiting list more than 4 years
* PRA I or II \> 50%

Exclusion Criteria:

* Recent recipients of any live attenuated vaccine(s) within 4 weeks
* Subjects who have received IVIG or B cell depleting agents previously
* Subjects with positive result for viral hepatitis(B,C) or HIV infection
* Subjects with active infection
* Lactating or pregnant females
* Subjects who have history of malignancy in recent 5years
* Subjects who have experience of treatment for the psychiatric problem in recent 6months
* Subjects who have hematologic abnormality (Hb \< 7g/dL, Platelet \< 100,000/mm3, AST/ALT \> 80IU)

Primary outcomes:
measure: The rates of kidney transplantation
timeFrame: from one to five years
Secondary outcomes:
measure: Reduction in anti-HLA alloantibodies
timeFrame: 1year
measure: Renal allograft survival
timeFrame: from one to five year
measure: The number of serious complication
timeFrame: from one to five year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Curie Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeong JC, Jambaldorj E, Kwon HY, Kim MG, Im HJ, Jeon HJ, In JW, Han M, Koo TY, Chung J, Song EY, Ahn C, Yang J. Desensitization Using Bortezomib and High-dose Immunoglobulin Increases Rate of Deceased Donor Kidney Transplantation. Medicine (Baltimore). 2016 Feb;95(5):e2635. doi: 10.1097/MD.0000000000002635.
Clinical trial NCT03254667: LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis
Official title: Prospective, Observational Study Brodalumab Compared With Other Therapies in the Treatment of Adults With Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Psoriasis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-18
Enrollment: 3500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population consisting of 1500 subjects treated with Brodalumab, and 2000 comparator subjects being treated with a non-biologic IL-17 inhibitor drug.

Brief summary: Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis

Detailed description: Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care

Eligibility criteria: Inclusion Criteria:

1. Diagnosis and main criteria for inclusion: a subject must have moderate to severe psoriasis diagnosed by a dermatologist
2. Must be at least 18 years of age or older
3. Started on or switched to a systemic psoriasis treatment within the previous 12 months. FDA-approved biologic treatments and select non-biologic treatments (eg, methotrexate, cyclosporine, or apremilast only) are permitted.

Exclusion Criteria:

1. The subject is unable or unwilling to provide informed consent to participate in the registry.
2. The subject is participating or planning to participate in a clinical trial with a non-marketed or marketed investigational drug (i.e. Phase I-IV drug trial).
3. The subject is restarting the eligible medication less than 12 months since receiving the last dose.

Primary outcomes:
measure: Assess the incidence of malignancy
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Registry
state: New Jersey
Study officials:
affiliation: Bausch Health
name: Anya Loncaric
role: STUDY_DIRECTOR
References:
Clinical trial NCT03033667: Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients
Official title: Comparative Study Between Conventional Fasting Versus Overnight Infusion of Lipid or Carbohydrate on Free Fatty Acid and Insulin in Obese Patients Undergoing Elective First Time On-pump Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism Disorder
Keywords: perioperative fasting
free fatty acids
coronary bypass grfting
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 63
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: Comparative study between conventional fasting versus overnight infusion of lipid or carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time on-pump coronary artery bypass grafting.

Detailed description: Obese patients scheduled for bypass surgery randomly assigned to three groups:

Group I (Glucose-group): patients received 500 cc of glucose 10% containing 50 g of glucose and providing patients with 200 Kcal with an osmolarity of 556 mosm/L.

Group II (Lipid-group): patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with an osmolarity of 380 mosm/L.

Group III (Control-group): patients fasted overnight from 11 pm till 9 am except for clear fluids which were allowed till 5 am.

Eligibility criteria: Inclusion Criteria:

Adult patients (\> 18 years) with American Society of Anesthesia (ASA) class II-III, BMI 30-40, and New York Heart Association (NYHA) functional capacities I-II, undergoing elective on-pump coronary artery bypass grafting (CABG) using cardiopulmonary bypass (CPB).

All patients were type 1a World Health Organisation (WHO)/Fredrickson classification of primary hyperlipidemias.

Exclusion Criteria:

* Patients with diabetes mellitus
* Patients on fibrates
* Patients type 1,2b,3,4 and 5 WHO/Fredrickson classification of primary hyperperlipidemias
* Patients with history of allergic reactions to fish, egg yolk containing foods peanut or soy products
* Patients with carbohydrate or fat intolerance

Primary outcomes:
measure: The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution
timeFrame: Over an infusion period of 10 hours preoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04563767: Feasibility - Infinitome
Official title: Feasibility of Utilizing the Infinitome Program to Evaluate Abnormal Large Scale Brain Networks in Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 4
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HealthPartners Neurology Clinic in Saint Paul, MN undergoing care for Alzheimer's disease.

Brief summary: The Infinitome Program from Omniscient has the ability to identify abnormal brain networks or connectomes using resting state functional MRI (rs-fMRI). This technology, which visualizes brain networks in three dimensions, was originally developed to ensure neurosurgeons avoid inadvertently lesioning cognitively eloquent brain regions during surgical operations. The potential of Infinitome in identifying connectome dysfunction for neurodegenerative diseases such as Alzheimer's disease has yet to be explored. This diagnostic technique may play a critical role for identifying disease brain networks that may benefit from targeted interventions in clinical trials.


Eligibility criteria: Inclusion Criteria:

1. Patients with a diagnosis of mild, moderate, or severe Alzheimer's disease
2. Age: 40 - 90 Years
3. Patients who are clinically indicated for an MRI

Exclusion Criteria:

1. fMRI contraindicated (eg. Implantable device, pacemaker, metallic implants, etc.)
2. Subject unable to tolerate sitting for a one hour fMRI
3. Other concerns as determined by the investigator

Primary outcomes:
measure: Number of Participants Who Completed Rs-fMRI
timeFrame: 4 months
measure: Number of Subjects Whose Images Completed Analysis
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Neurology
name: Michael H Rosenbloom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05491967: Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome
Official title: Comparison of Vascular Risk in Patients Treated for Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) With Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea/Hypopnea Syndrome
Keywords: cardiovascular risk
Lead sponsor: Centre Hospitalier de Valence
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstructive Sleep Apnea/Hypopnea Syndrome treated with With Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Orthosis

Brief summary: a monocentric,non interventional, prospective study to compare cardiovascular risk in patients with Obstructive Sleep Apnea/Hypopnea Syndrome treated with Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Orthosis.

Detailed description: The first-line treatment of severe Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS) is nocturnal ventilation with Continuous Positive Airway Pressure (CPAP). and The second-line treatment is the mandibular advancement orthosis (MAO)\].

CPAP is the most effective treatment to reduce the apnea-hypopnea index (AHI). However, its tolerance is sometimes difficult, causing many discontinuations.

The purpose of this review is to evaluate a vascular morbimortality criteria:

* Cardiovascular: myocardial infarction, heart failure, rhythm disorder
* Neurological: transient or non transient stroke
* ophthalmologic: anterior ischemic optic neuropathy, occlusion of the central artery or central retinal vein occlusion

Eligibility criteria: Inclusion Criteria:

* Obstructive Sleep Apnea/Hypopnea Syndrome treated with With Continuous Positive Airway Pressure (CPAP) or Mandibular Advancement Orthosis
* Age ≥ 18 years old
* Read, write and understand the French language

Exclusion Criteria:

* Patient under guardianship, deprived of liberty, safeguard of justice
* Refusal to participate in research

Primary outcomes:
measure: morbimortality vascular criteria
timeFrame: up to 6 months
measure: morbimortality vascular criteria
timeFrame: up to 6 months
measure: morbimortality vascular criteria
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valence
country: France
facility: Ch Valence
state: Drome
Study officials:
References:
Clinical trial NCT05423067: Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding
Official title: Interventional Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Other Abnormal Uterine and Vaginal Bleeding
Keywords: permenant occlusion
uterine bleeding
uterine arteries
Lead sponsor: Mansoura Integrated Fertility Center
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 116
Sex: FEMALE
Minimum age (years): 34
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective observational interventional study , The study done in two phases:

1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.

Detailed description: Abstract Objectives: To assess the effectiveness of permanent bilateral occlusion of uterine arteries in treatment of abnormal uterine bleeding.

Design: prospective observational study Setting: Done in Mansoura university hospital, department of Obstetrics and gynecology.

Patients and Methods: The study done in two phases:

1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.

Results: Results are hopeful and courageous in phase one as regards patients satisfaction, Quality of life and improvements of bleeding. Results of phase two will be implemented, analyzed and presented in tables. All data will be statistically analyzed and the results will be presented after completion of eighteen (18) months follow up to rule out any bias and/ or errors in the results.

Conclusion: permanent bilateral uterine arteries occlusion may be a good alternative to radical surgery in abnormal uterine bleeding.

Eligibility criteria: Inclusion Criteria:

* premenopausal with abnormal uterine bleeding and completed their families having normal endometrium (biopsy in preceding 6 months ) and may have uterine intramural myomas not exceeding 150 ml in volume and away from uterine cavity by at least 1cm and /or adenomyosis

Exclusion Criteria:

* patients wishing future fertility
* endometrial sampling not done or more than 6 months or myoma encroaching or distorting cavity or larger than 150 ml in volume

Primary outcomes:
measure: uterine bleeding
timeFrame: October 2011 till January 2016
Secondary outcomes:
measure: patient satisfaction
timeFrame: october 2011 - may 2015
measure: quality of life
timeFrame: october 2011 - may 2015
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Integrated fertility center
state: Dekahlia
Study officials:
affiliation: Mansoura Integrated Fertility Center
name: Adel S Helal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02111967: Study to Identify Adequate Biomarker to Detect Vitamin B12 Deficiency in Type 2 Diabetic Patients Treated With Metformin
Official title: Adequacy of Serum Vitamin B12 Measurement in Type 2 Diabetic Patients Treated With Metformin in Comparison to Holotranscobalamin Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus Type 2
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Solothurner Spitäler AG
First posted: 2014-04-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with diabetes mellitus type 2 treated with and without Metformin.

Brief summary: In this study we compare the vitamin B12 status by measuring serum vitamin B12 and holotranscobalamin in type 2 diabetic patients with and without metformin treatment. Afterwars we investigate which biomarker could be adequate to reflect B12 status in metformin-treated patients.

With the help of a questionnaire we assess clinical, nutritional and demographic factors which are associated with vitamin B12 deficiency.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of T2DM \> 6 months
* Metformin treatment for at least 6 months
* Age \> 18 years
* Ability to give written informed consent
* No metformin treatment in the last 6 months (control group)

Exclusion Criteria:

* Concurrent intake of preparations containing VB12 (within the last 3 months prior to study participation)
* Lack of written and/or oral understanding in German, French, Italian or English languages
* Diagnosis of Transcobolamin transporter defect
* Diagnosis of Chronic or acute liver diseaseliver insufficiency with CHILD-PUGH scores B and C and acute hepatitis
* Diagnosis of Renal disease (Creatinine-Clearance \<60 ml/min)renal insufficiency stadium III, IV and V (KDOQI) and acute renal diseases

Primary outcomes:
measure: Measurements of serum vitamin B12 and serum holotranscobalamin concentrations
timeFrame: day 3
Secondary outcomes:
measure: Questionnaire results
timeFrame: day 8
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Pharmaceutical Care Research Group
Study officials:
affiliation: Pharmaceutical Care Research Group
name: Kurt E Hersberger, Prof.
role: STUDY_CHAIR
affiliation: Pharmaceutical Care Research Group
name: Philipp N Walter, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kantonsspital Olten
name: Gottfried Rudofsky, Prof. Dr.
role: STUDY_DIRECTOR
References: