louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01267825: CT Guided Injection for Low Back Radiculopathy: A Randomized Clinical Trial
Official title: A Randomized Trial of CT-guided Perineural Injection With a Corticosteroid Plus a Long Acting Local Anesthetic Versus Standard Medical Management in Patients With Acute Lumbar Radiculopathy and a Corresponding Disc Herniation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Disc Herniation
Lumbosacral Radiculopathy
Keywords: Disc herniation
Lumbosacral radiculopathy
Corticosteroids
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2010-12-29
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe that it is functionally disabling. The purpose of this randomized clinical trial is to determine if corticosteroid medication, delivered directly to the area near the herniated disc, can improve the pain and functional disability associated with a herniated disc.


Eligibility criteria: Inclusion Criteria:

* Adults \<60y
* \< 1m of symptoms
* Symptoms consistent with herniated disc
* MRI demonstrates corresponding disc
* Back pain resulting in functional disability

Exclusion Criteria:

* Chronic pain
* Daily pain medication
* Frequent back pain
* On the job injury

Primary outcomes:
measure: Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
timeFrame: Baseline and one week after emergency department discharge
Secondary outcomes:
measure: Functional Disability Assessed Using Roland-Morris Scale
timeFrame: 1 month
measure: Adverse Events
timeFrame: 1 week after discharge from emergency department
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Todd Miller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Benjamin W. Friedman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01343225: Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection
Official title: Pilot Study of the Effect of a Non-tenofovir, Non-efavirenz-based HIV Regimen on Bone Density and Vitamin D Levels in African-American Patients With HIV Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV
Keywords: African american vitamin d bone density
African American male or female treatment naive
Lead sponsor: East Carolina University
Sponsor class: OTHER
First posted: 2011-04-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 2. Objectives

1. To determine the vitamin D status of African-American HIV patients who are HIV-treatment naïve.
2. To compare the effects of an efavirenz-containing regimen to a protease inhibitor regimen on 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3 levels.
3. To compare the effect on bone density of a tenofovir- and efavirenz-containing regimen to a regimen that does not contain these drugs.
4. To compare the efficacy of an alternative regimen (raltegravir, darunavir, ritonavir) to a standard once-daily regimen (tenofovir-emtricitabine-efavirenz).

Hypothesis

The investigators hypothesize that patients receiving efavirenz will be more likely to have lower 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3levels based on the fact that efavirenz is an inducer of CYP3A4 and CYP24 enzymes that degrade 25-hydroxyvitamin D and 1,25 dihydroxyvitamin D3, respectively, to inactive metabolites. The investigators speculate that patients on a tenofovir-containing regimen will be more likely to have progression of bone density loss compared to those in the non-tenofovir-containing regimen.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 50 years old
* HIV infection and HIV RNA \> 4000 copies/ml of plasma

Exclusion Criteria:

* known risks for osteoporosis, including low body mass index (BMI \< 20)
* chronic alcohol use
* chronic steroid use
* use of phenytoin or phenobarbital
* chronic renal insufficiency (calculated glomerular filtration rate \< 50 ml/min)
* males with testosterone deficiency, and post-menopausal females will be excluded

Primary outcomes:
measure: Vitamin D levels and bone density
timeFrame: 48 weeks
Secondary outcomes:
measure: viral load and CD 4 count
timeFrame: 48 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00355225: Community-Effectiveness of the Distribution of Insecticide-Treated Bed Nets Through Social Marketing Antenatal Care Services in Malaria Control in Rural Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Keywords: insecticide-treated bednets
malaria
africa
social marketing
ante-natal care
ITN coverage
ITn use
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2006-07-21
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

Brief summary: The study aims at assessing which of two distribution channels for insecticide treated bendnets (ITNs), social marketing vs. social marketing coupled with free distribution through ante-natal care, is most effective in reaching groups at high risk of malaria, i.e. pregnant women and children under 5.

Detailed description: The hypothesis that insecticide-treated bed net (ITN) effects may not be long-lasting in young children living in areas of intense malaria transmission due to interactions with the immunologi-cal development has now been refuted in a number of studies including the D4 study. The highly controversial question remains how African programmes can best reach a sustainable high coverage with ITNs in young children and pregnant women. Against this background it is planned to implement a cluster randomised controlled trial in Nouna Health District in Burkina Faso. Twenty-two peripheral health centres and their catchment areas will be randomised to (1) ITN provision to the general population through social marketing and (2) ITN provision to the general population through social marketing plus free provision to all pregnant women through antenatal services. The primary outcomes are ITN coverage in households and ITN use during pregnancy and infancy.

Eligibility criteria: Inclusion Criteria:

* Being one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso

Exclusion Criteria:

* Being outside one of 25 primary health facility catchment areas in the Nouna Health District, Burkina Faso

Primary outcomes:
measure: ITN coverage in households 12 and 24 months after the start of the interventions
measure: ITN use during pregnancy and infancy
Secondary outcomes:
measure: Costs per malaria case and per DALY prevented
measure: Self-reported information on ANC visits
measure: Insecticide content on ITN and mortality of vector mosquitoes over time
measure: Acceptance of health staff and population
Other outcomes:
Locations:
Study officials:
affiliation: Heidelberg University
name: Olaf Mueller, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01227122: NGAL Predictive Value of Acute Kidney Failure After Cardiac Surgery in Patients With Preoperative Chronic Kidney Failure
Official title: Plasmatic Level of Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a Predictive Marker of Acute Kidney Failure in Patients With Preoperative Chronic Kidney Failure Undergoing Cardiac Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preoperative KIDNEY FAILURE, CHRONIC
Postoperative KIDNEY FAILURE, ACUTE
Cardiac Surgical Procedures
Keywords: NGAL plasmatic level
Preoperative KIDNEY FAILURE, CHRONIC
Postoperative KIDNEY FAILURE, ACUTE
Cardiac Surgery Procedures
Lead sponsor: Hopital Jean Minjoz
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a chronic kidney failure, undergoing cardiac surgery.

Brief summary: Primary endpoint: To evaluate predictive value of plasmatic levels of Neutrophil Gelatinase Associated Lipocalin (NGAL) to reveal acute kidney failure after cardiac surgery in patients with preoperative chronic kidney failure Secondary endpoint is to obtain threshold values of NGAL.

Detailed description: (N/A)

Eligibility criteria: Inclusion Criteria:

* Renal clearance less than 60 mL/min
* Able to give written consent
* Elective valve surgery
* Elective CABG surgery

Exclusion Criteria:

* Less than 18 years old
* Iodine injection within 3 days before surgery
* Iodine injection within 24 first postoperative hours
* preoperative infection
* evolutive cancer disease
* Refusal
* Pregnancy
* Unable to give written consent

Primary outcomes:
measure: Neutrophil Gelatinase Associated Lipocalin (NGAL) level
timeFrame: From surgery to discharge from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre hospitalier Universitaire (CHU) Jean Minjoz
state: Franche-Comté
Study officials:
affiliation: Centre Hospitalier Universitaire (CHU) Jean Minjoz, Besançon, France
name: Chocron Sidney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04552522: Immunological Response After Shrimp Oral Immunotherapy Treatment
Official title: Immunological Response After Shrimp Oral Immunotherapy Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy to Shrimp
Immunotherapy
Keywords: Shrimp allergy
Oral immunotherapy
Specific Immunoglobulin E
Skin sensitization
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral immunotherapy is effective in desensitized food allergy. Shrimp allergy is increasing in Thailand. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to shrimp, Immunoglobulin G4 and immunoblot analysis in shrimp allergy patients after shrimp oral immunotherapy.

Detailed description: All subject in this study were sensitized to shrimp. All patient was clinically evaluated, with focus on shrimp allergy by medical history, medical examination and gold standard oral food challenge test. Compare oral immunotherapy to shrimp and shrimp avoidance. Blood sample was taken for baseline determination of immunoglobulin E antibodies to shrimp. The primary outcome was the specific immunoglobulin E antibodies to shrimp,Immunoglobulin G4 and immunoblot analysis in case that oral immunotherapy.

Eligibility criteria: Inclusion Criteria:

* Age 12 - 40 years old
* History of Immunoglobulin E-mediated shrimp allergy \> 3 episode/year or disturb quality of life
* Positive oral food challenge test for shrimp

Exclusion Criteria:

* History of shrimp anaphylaxis (include cardiovascular or neurological symptoms)
* Shellfish dependent exercise induced anaphylaxis
* History of cardiovascular disease, uncontrolled asthma, severe atopic dermatitis
* History of Beta-blocker, Angiotensin-converting enzyme inhibitor, Angiotensin receptor blocker, Calcium channel blocker

Primary outcomes:
measure: specific Immunoglobulin E, Immunoglobulin G4, immunoblot analysis from Desensitized to shrimp allergen
timeFrame: 1 year
Secondary outcomes:
measure: Adverse event from Shrimp oral immunotherapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Punchama Pacharn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pajno GB, Fernandez-Rivas M, Arasi S, Roberts G, Akdis CA, Alvaro-Lozano M, Beyer K, Bindslev-Jensen C, Burks W, Ebisawa M, Eigenmann P, Knol E, Nadeau KC, Poulsen LK, van Ree R, Santos AF, du Toit G, Dhami S, Nurmatov U, Boloh Y, Makela M, O'Mahony L, Papadopoulos N, Sackesen C, Agache I, Angier E, Halken S, Jutel M, Lau S, Pfaar O, Ryan D, Sturm G, Varga EM, van Wijk RG, Sheikh A, Muraro A; EAACI Allergen Immunotherapy Guidelines Group. EAACI Guidelines on allergen immunotherapy: IgE-mediated food allergy. Allergy. 2018 Apr;73(4):799-815. doi: 10.1111/all.13319. Epub 2017 Dec 5.
Clinical trial NCT05887622: The Potassium Supplementation Study
Official title: The Role of Potassium Supplementation on Endothelial Function, BP Regulation, and Oxidative Stress Under High Sodium Conditions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Health
Cardiovascular Risk Factor
Lead sponsor: University of Delaware
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will complete all arms in a randomized, crossover design.
Primary purpose: PREVENTION

Brief summary: This study will test whether potassium supplementation can reduce the deleterious effect of a high sodium diet on blood vessel function, blood pressure reactivity and autonomic nervous system function in apparently healthy adults.

Detailed description: Excess sodium intake is linked to poor blood pressure (BP) regulation and endothelial dysfunction, both of which are implicated in the pathogenesis of atherosclerosis and high BP. Evidence suggests potassium may offset the damaging effects of sodium; however, studies in healthy adults are lacking. This is important as these pre-clinical risk factors have been observed in this population, suggesting early intervention may be critical for cardiovascular disease prevention. High potassium diets have been effective at attenuating a sodium-induced decline in endothelial function. However, potassium intake was increased using whole foods; thus, the vascular benefits cannot be attributed solely to potassium. Furthermore, whether potassium can reduce sodium-induced oxidative stress is unknown. The central hypothesis of this study is that endothelial function will be greater and BP reactivity and oxidative stress will be lower with a high potassium intake compared to a low potassium intake, in the context of a high sodium diet. The investigators will assess macrovascular function using flow-mediated dilation, BP reactivity using the cold pressor test and isometric handgrip grip test, and oxidative stress using electron paramagnetic resonance.

Eligibility criteria: Inclusion Criteria:

* men and women
* 18-45 years of age
* all races/ethnicities
* BMI \< 30 kg/m2
* BP \< 130/80 mmHg

Exclusion Criteria:

* presence of hypertension
* known heart disease
* diabetes
* kidney disease
* cancer
* inflammatory conditions
* blood clotting disorders
* pregnancy
* adrenal gland disorder
* history of stomach or intestinal bleeding
* history of kidney stones
* serum potassium outside of the normal range

Primary outcomes:
measure: Conduit artery endothelial dependent dilation
timeFrame: on day 10 of each diet
measure: Blood pressure reactivity
timeFrame: on day 10 of each diet
measure: Superoxide levels
timeFrame: on day 10 of each diet
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Tower at STAR
state: Delaware
Study officials:
References:
Clinical trial NCT02646722: Relation Between Withdrawal Movement for Rocuronium and Emergence Agitation
Official title: Relation Between Withdrawal Movement on Rocuronium Injection and Emergence Agitation and Pain in Preschool Ages: Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for inguinal hernioplasty in university hospital

Brief summary: Rocuronium results in burning pain on injection site. It can be reduced by local anesthetics or opioid, but still some patients, especially in children, show withdrawal movement for pain. This might resulted from individual pain sensitivity.

Emergence agitation (EA) in children is quite frequent postoperatively and is known to be associated with postoperative pain. If a patient is susceptible to postoperative pain, he or she would have high probability of EA postoperatively. Therefore, the investigators explore the relation of withdrawal movement of rocuronium and EA.


Eligibility criteria: Inclusion Criteria:

* ASA class I, II

Exclusion Criteria:

* Intravenous cannulation other than a hand or an upper arm with 24 gauge catheter

Primary outcomes:
measure: emergence agitation (Watcha scale)
timeFrame: 1 min after postanesthesia care unit (PACU) admission
Secondary outcomes:
measure: Pain (FLACC scale)
timeFrame: 1. 1 min after postanesthesia care unit (PACU) admission 2. 10 min after PACU admission 3. 20 min after PACU admission 4. 30 min after PACU admission 5. 40 min after PACU admission
measure: emergence agitation (Watcha scale)
timeFrame: 2. 10 min after PACU admission 3. 20 min after PACU admission 4. 30 min after PACU admission 5. 40 min after PACU admission
Other outcomes:
Locations:
Study officials:
affiliation: Ajou University School of Medicine
name: Go Un Roh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00291122: An Examination of Predictors of Indicators of Response to Celecoxib in Women Who Have a Diagnosis of Early Breast Cancer
Official title: Quantitative Real Time PCR in Formalin Fixed Breast Tissue From Biopsy and Re-Excision Specimens: An Ancillary Protocol to a Chemoprevention Trial of Celecoxib
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast atypia
breast epithelial hyperplasia
ki-67
RTPCR
microdissection
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2006-02-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To assess the quantitative real time PCR results results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors of indicators of response to celecoxib.

Detailed description: To assess the quantitative real time PCR results of oligonucleotide probes for a number of gene transcription products that may be useful as predictors or indicators of response to celecoxib, the feasibility of performing six different molecular assays by qRTPCR on formalin fixed paraffin embedded tissue obtained from breast cancer core biopsies and breast cancer reexcision patients, to assess change in Ki-67, PCNA, and several other markers by qRTPCR, correlate change in expression of Ki-67, PCNA, CAX-2, and bcl-2, measured by immunohistochemistry to change measured by qRTPCR, and to determine the reliability of the qRTPCR and immunohistochemical assays by performed selected assays on the same tissue in two different institutions

Eligibility criteria: Inclusion Criteria:

* women with a recent diagnosis of T1 or T2 noninvasive breast cancer by large core needle or excisional biopsy
* confirmation that tissue was processed in methods acceptable to protocol and sufficient tissue remains post diagnostic analyses to perform research assessments
* reexcision planned within 10 days to 6 weeks from study start

Exclusion Criteria:

* no hormone replacement therapy within 90 days prior to biopsy
* no history of asthma, allergy ASA, NSAIDS, celecoxib of other COX-2 inhibitors for a chronic non-oncological condition with the excision of low dose ASA (160 mg daily) during 4 weeks prior to biopsy and for the duration of the study
* no celecoxib or rofecoxib use within one month of biopsy
* no history of gastrointestinal ulcer or ulcerative colitis requiring treatment
* no current anticoagulants
* no neoadjuvant antihormone or chemotherapy as treatment following biopsy prior to study entry or concurrently with participation on study
* no aromatase inhibitor in the six months prior to participation
* no concomitant lithium
* no known significant bleeding disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol J Fabian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913822: To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets
Official title: Bioavailability of Desipramine Hydrochloride Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Antidepressant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Desipramine Hydrochloride tablets.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 22 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Jules Kann, M.D.
role: PRINCIPAL_INVESTIGATOR
References: