louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00922311: Aliskiren for Proteinuric IgAN Despite Angiotensin Blockade
Official title: Aliskiren Combined With Losartan in Immunoglobulin A Nephropathy: an Open-label Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IgA Nephropathy
Keywords: Proteinuria
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: United Christian Hospital
First posted: 2009-06-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study objective: To investigate the potential anti-proteinuric efficacy of aliskiren, a novel direct renin inhibitor (DRI), in addition to angiotensin receptor blocker (ARB) in immunoglobulin A nephropathy (IgAN) patients at risk of developing progressive renal failure.

Detailed description: This will be an open-label pilot study in which IgAN patients with persistent proteinuria despite maximum dose of ARB treatment will be assigned to receive Aliskiren. There is the optional addition of other anti-hypertensive agents to achieve an optimal target blood pressure of \<130/80 mmHg.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 - 70 years of age
* Histologic diagnosis of IgA nephropathy
* Proteinuria \> 1 g/day or UPC \> 1 mg/mg or 113 mg/mmol at least twice
* Receiving treatment with the maximum dose of ARB for at least 3 months
* Patients who are willing to give written, informed consent

Exclusion Criteria:

* eGFR \< 15 ml/min/1.73 sq.m
* UPC \>5000 mg/g or 570 mg/mmol, or \<500 mg/g or 57 mg/mmol
* Serum K+ \> 5.2 mmol/L
* Presence of bilateral renal artery stenosis
* Presence of diabetes mellitus
* Renal histology showing pathologies other than IgAN
* Known allergy to ARB or DRI
* Patients on ARB/ACEi combination within 12 weeks of randomization
* Concurrent treatment with corticosteroids, Nsaid, or immunosuppressant
* Patients with connective tissue disease or obstructive uropathy
* Patients with malignancy or conditions severely limiting life expectancy
* Female who are pregnant or intending to conceive
* Female of child-bearing age unwilling to practice contraception
* Patients who are unable to give informed consent
* Patients simultaneously participating in another study

Primary outcomes:
measure: Change of urine protein excretion rate
timeFrame: 6 months
Secondary outcomes:
measure: Changes in serum creatinine, eGFR, serum potassium and albumin
timeFrame: 6 months
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Medicine, The University of Hong Kong
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Sydney CW Tang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang SC, Lin M, Tam S, Au WS, Ma MK, Yap DY, Ho YW, Lai KN. Aliskiren combined with losartan in immunoglobulin A nephropathy: an open-labeled pilot study. Nephrol Dial Transplant. 2012 Feb;27(2):613-8. doi: 10.1093/ndt/gfr349. Epub 2011 Jun 16.
Clinical trial NCT00631111: Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental Pain
Official title: Ibuprofen 400 mg Effervescent Tablet Dental Pain Study II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: dental pain
analgesic
NSAID
ibuprofen
aspirin
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-07
Enrollment: 270
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of the efficacy and safety of a single dose of an ibuprofen effervescent tablet in the treatment of pain following third molar extraction in comparison to single doses of placebo, standard ibuprofen tablets, and effervescent aspirin plus vitamin C tablets.


Eligibility criteria: Inclusion:

* Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
* In general good health with no contraindications to the study medication or rescue medication (tramadol or acetaminophen + hydrocodone)
* Use of only short-acting local anesthetics with or without vasocontrictor and/or nitrous oxide

Exclusion:

* Presence of a serious medical condition (e.g., poorly controlled hypertension, diabetes, or hyper-/hypo-thyroidism; significantly impaired renal, cardiac, or hepatic function)
* Acute localized dental alveolar infection at the time of surgery that could confound the post-surgical evaluation
* Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years and not using a medically-approved method of contraception

Primary outcomes:
measure: Sum of pain relief and pain intensity difference scores
timeFrame: 8 hours
Secondary outcomes:
measure: Time to meaningful pain relief
timeFrame: 8 hours
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00284011: Effect of the Dietary Supplement SAMe on Blood Homocysteine Levels
Official title: Effect of the Dietary Supplement S-Adenosyl-L-Methionine on Plasma Homocysteine Levels in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Disease
Keywords: SAMe
AdoMet
Methylation
Homocysteine
Dietary Supplement
S-Adenosyl-L-Methionine
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the oral intake of the dietary supplement SAMe increases blood homocysteine levels in healthy human subjects.

Detailed description: S-adenosyl-L-methionine (SAMe or AdoMet) is a commonly used nutritional supplement available in the United States since 1999. SAMe is metabolized to homocysteine, a known cardiovascular risk factor. No study has determined the effect exogenous SAMe administration has on the long-term levels of homocysteine in humans. As a nutritional supplement, SAMe is not regulated by the Food and Drug Administration, despite being used to treat clinical diseases such as depression and osteoarthritis.

Eligibility criteria: Inclusion criteria:

* Women and men age 18 - 65
* Able to understand and sign a consent form

Exclusion criteria:

* Smoking
* Pregnant or lactating
* Women actively trying to conceive
* Diagnosis of panic disorder or bipolar disorder

Primary outcomes:
measure: Homocysteine levels pre- and post- one month of SAMe administration.
timeFrame: 1 Month
Secondary outcomes:
measure: An interim (2 week) homocysteine level, high sensitivity C-reactive protein (hsCRP) level, lipid studies, and liver blood tests.
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Dietland Wahner-Roedler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson MA, Bauer BA, Loehrer LL, Cha SS, Mandrekar JN, Sood A, Wahner-Roedler DL. Dietary supplement S-adenosyl-L-methionine (AdoMet) effects on plasma homocysteine levels in healthy human subjects: a double-blind, placebo-controlled, randomized clinical trial. J Altern Complement Med. 2009 May;15(5):523-9. doi: 10.1089/acm.2008.0402.
Clinical trial NCT04637711: Surgical Intervention for Refractory Granulomatous Lobular Mastitis
Official title: Randomized Controlled Trial for 'Focus Clearing + Whole Breast Exploration and Washing + One-Stage Micro Plastic Surgery' Treatment for Granulomatous Lobular Mastitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Granulomatous Lobular Mastitis
Keywords: granulomatous lobular mastitis ；refractory；surgery
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Granulomatous lobular mastitis (GLM) belongs to a group of benign diseases, which is mainly treated with glucocorticoids and surgical treatment. Nowadays, in China, surgical treatment has gradually become the mainstream, but the timing and the extent of surgery are still controversial, and different literatures report that the recurrence rate after surgery is 20-50%. Empirical lesion resection is generally used. We believe that the main reason for the high recurrence rate is the incomplete removal of the breast lesions. Because GLM is often characterized with microabscesses formation, empirical resection is likely to have residual lesions that are not visible to the naked eye. In order to reduce the postoperative recurrence rate and protect the breast appearance as much as possible, we propose a surgical plan : granulomatous lobular mastitis "lesion removal + whole breast exploration and flushing + one-stage microplastic surgery". The purpose of this study was to compare this surgical scheme of granulomatous lobular mastitis with existing surgical schemes, and to compare the overall benefits of the two for patients with GLM. We aim to protect the breast appearance on the premise of low recurrence, improve the quality of life of GLM patients, and standardize GLM surgical schemes.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older with granulomatous lobular mastitis
* Patients without surgical treatment;
* Extensive lesions involving two or more quadrants of the breast, or accompanied by abscess, sinus fistula formation, skin rupture and other complex lesions;
* Patients volunteered to participate in the study after informed consent.

Exclusion Criteria:

* Patients were diagnosed with mastitis with other definite etiology confirmed by pathology
* Patients who chose conservative treatment and did not receive surgical treatment
* Combined with other basic diseases, unable to tolerate surgery
* Patients in pregnancy.

Primary outcomes:
measure: Recurrence rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Breast appearance and cosmetic effect score
timeFrame: Up to 2 years
measure: Surgical incision healing time
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT00989911: Endothelin Blockade in Patients With Single Ventricle Physiology
Official title: Endothelin Blockade in Patients With Single Ventricle Physiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: Single ventricle congenital heart disease
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Actelion
First posted: 2009-10-06
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar benefit in this patient population.

Detailed description: Patients enrolled in the study will take Bosentan. Baseline and follow up measurements will be collected then analyzed.

Eligibility criteria: Inclusion Criteria:

* At least 12 years of age
* Single ventricle congenital heart disease
* Require cardiac magnetic resonance imaging (MRI) for clinical purposes.

Exclusion Criteria:

* \< 12 years of age
* Pregnancy or women who may become pregnant (sexually active and unwilling to use birth control)
* Patients taking cyclosporin or glyburide
* Patients with baseline liver dysfunction (aspartate aminotransferase or alanine aminotransferase \> 3 times upper limit of normal)
* Contraindications to MRI (including pacemakers)
* Use of Bosentan within one month prior to enrollment

Primary outcomes:
measure: Pulmonary Blood Flow as Determined by MRI Velocity Encoding at 3-6 Months
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Jamil Aboulhosn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giardini A, Balducci A, Specchia S, Gargiulo G, Bonvicini M, Picchio FM. Effect of sildenafil on haemodynamic response to exercise and exercise capacity in Fontan patients. Eur Heart J. 2008 Jul;29(13):1681-7. doi: 10.1093/eurheartj/ehn215. Epub 2008 Jun 4.
citation: Votava-Smith JK, Perens GS, Alejos JC. Bosentan for increased pulmonary vascular resistance in a patient with single ventricle physiology and a bidirectional Glenn shunt. Pediatr Cardiol. 2007 Jul-Aug;28(4):314-6. doi: 10.1007/s00246-007-0037-4. Epub 2007 Jun 11.
Clinical trial NCT01338311: Salbutamol Tolerance Onset
Official title: Salbutamol: Tolerance to Bronchoprotection vs. Methacholine: Time Course of Onset
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2011-04-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Overuse of inhaled bronchodilator beta agonist medication results in a loss of effectiveness (i.e. tolerance). This has been shown for the short acting beta agonist salbutamol and the long acting beta agonist salmeterol. Tolerance to salmeterol is present within 24 hours. The onset of tolerance to salbutamol is not known.


Eligibility criteria: Inclusion Criteria:

* male or female
* 18 to 65 years of age
* non smoker
* beta agonist naive for at least 14 days
* baseline FEV1 at least 70% predicted
* no respiratory tract infection or allergen exposure (if atopic) within 4 weeks of visit 1

Exclusion Criteria:

* poorly controlled asthma
* pregnant or lactating women

Primary outcomes:
measure: Airway responsiveness as a measure of salbutamol bronchoprotection
timeFrame: ten minutes post 200mcg salbutamol on day 1
measure: Airway responsiveness as a measure of salbutamol bronchoprotection
timeFrame: ten minutes post 200mcg salbutamol on day 3
measure: Airway responsiveness as a measure of bronchoprotection. The primary outcome is to determine the onset of this tolerance.
timeFrame: ten minutes post 200mcg salbutamol on day 5
measure: Airway responsiveness as a measure of salbutamol bronchoprotection
timeFrame: ten minutes post 200mcg salbutamol on day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
affiliation: University of Saskatchewan
name: Donald W Cockcroft, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart SL, Martin AL, Davis BE, Cockcroft DW. Salbutamol tolerance to bronchoprotection: course of onset. Ann Allergy Asthma Immunol. 2012 Dec;109(6):454-7. doi: 10.1016/j.anai.2012.08.003. Epub 2012 Aug 22.
Clinical trial NCT02305511: Intraosseous Access During Pediatric Resuscitation
Official title: A Comparison of Four Intraosseous Access Devices With Standard Venous Catheterization During Child Cardiopulmonary Resuscitation Simulation: a Randomized Crossover Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Keywords: Catheterization
Peripheral
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-12-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the Jamshidi, the BIG, the Cook, the EZIO intraosseous devices to standard peripheral venous catheterization during pediatric resuscitation.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* minimum 1 year of work experience in emergency medicine
* experienced emergency medical personnel - EMS-paramedics

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Success rate on first attempt
timeFrame: 1 day
Secondary outcomes:
measure: Ease of use
timeFrame: 1 day
measure: Time to successfully perform
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
References:
Clinical trial NCT02978911: Cranial Nerves Tractography
Official title: Diffusion Tensor Imaging and Tractography for Cranial Nerves. Interest in Skull Base Surgery and Anatomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cranial Nerve Palsy
Keywords: RMI
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Introduction: The skull base tumors surgery remains a challenge since numerous cranial nerves or vessels closely surround them. Recently, diffusion tensor imaging has developed with the tractography following white fibers and visualizing functional tracts. Cranial nerves tractography could allow predicting their displacement by skull base tumors that may help the surgeon to spare them along the surgery.

Methods: Preoperative cerebral MRI was performed on patients who presented with skull base tumors. A 3 tesla MRI machine was used to acquire DTI sequence with specific parameters: 32 directions, slice thickness 2 mm, echo time 86 ms, repetition time 12000 ms, matrix 128x128, b-value 1000 s.mm-1. An anatomic sequence hyperT2 was overlaid as reference. Distortion was corrected by topup and eddy functions from FSL. Cranial nerves fibers were probabilistically tracked with Mrtrix3. Cranial nerves were selected according to their location around the tumor. The "radiological" expected position of the cranial nerve was compared to its "operative" real position.


Eligibility criteria: Inclusion Criteria:

* Patients who present a skull base tumor that requires surgical removal
* Patients adult, informed and agreed

Exclusion Criteria:

* Pregnant women
* Patients under 18 years old, unable to legally consent

Primary outcomes:
measure: Correlation between the expected and the real position of the selected cranial nerve
timeFrame: Date of preoperative MRI (<3 months before the surgery)
measure: Correlation between the expected and the real position of the selected cranial nerve
timeFrame: at 3 months
Secondary outcomes:
measure: postoperative cranial nerve palsy
timeFrame: at 3 months
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Neurologie B, Hôpital Neurologique, HCL
Study officials:
affiliation: Hospices Civils de Lyon
name: Timothée Jacquesson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04581811: Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS)
Official title: Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome (ARDS): A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Covid19
Acute Hypoxemic Respiratory Failure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prone positioning is one of the few therapies known to improve mortality in ARDS. Traditionally, patients are proned for 16 hours per 24 hour period. Some retrospective data suggests improvement may persist beyond 16 hours. We aim to perform a pilot study comparing traditional prone positioning to prolonged prone positioning in patients with COVID-induced ARDS.


Eligibility criteria: Inclusion Criteria:

Positive COVID test Endotracheal Intubation P:F \<150 within 1hours of inclusion on at least 60% FiO2, 10cmH20 PEEP Treating physician plans to implement prone positioning imminently Housed in the UAB MICU.

Exclusion Criteria:

Pre-existing treatment limitation (e.g. DNR order) Prisoner Pregnant Female Children (\<18 years old) Respiratory Failure felt to be caused primarily by something other than COVID-19 Mechanical ventilation for \>48 hours prior to initiation of prone positioning Contraindication to proning Physician discretion

Primary outcomes:
measure: Duration in Prone Position
timeFrame: 96 hours
Secondary outcomes:
measure: Change in P:F Ratio
timeFrame: End of supine session on day 4
measure: Change in Drive Pressure
timeFrame: End of supine session on day 4
measure: Unplanned Extubations
timeFrame: End of supine session on day 4
measure: Pressure Ulcers
timeFrame: End of supine session on day 4
measure: Line Displacement
timeFrame: End of supine session on day 4
measure: Vent Free Days
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
measure: Rescue Interventions
timeFrame: 96 hours
measure: Tracheostomy
timeFrame: 30 days
measure: ICU Free Days
timeFrame: 30 days
measure: S:F Ratio
timeFrame: 96 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
citation: Page DB, Vijaykumar K, Russell DW, Gandotra S, Chiles JW, Whitson MR, Dransfield MT. Prolonged Prone Positioning for COVID-19-induced Acute Respiratory Distress Syndrome: A Randomized Pilot Clinical Trial. Ann Am Thorac Soc. 2022 Apr;19(4):685-687. doi: 10.1513/AnnalsATS.202104-498RL. No abstract available.