louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04077749: Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients
Official title: A Randomized Double Blinded Study of Probiotic Bladder Instillation for Prevention of Catheter Associated UTIs in Chronically Catheterized Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Urinary Tract Infections
Lead sponsor: Lahey Clinic
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study is a randomized, placebo-controlled clinical trial to test the efficacy of an oral Lactobacillus product dissolved in sterile saline and instilled into the urinary bladder in an attempt to colonize the urinary bladder as well as prevent UTIs.

Detailed description: Patients who use a chronic indwelling urinary catheter to drain their bladder will be randomized to receive intravesical instillations of a Lactobacillus solution or sterile saline at the time of a scheduled monthly catheter exchange. Bacterial colonization and frequency of urinary tract infections will be compared between the two groups.

The Lactobacillus solution will be derived from the combination of Lactobacillus rhamnosus (GR-1®) and reuteri (RC-14®) species, which is offered as an over the counter probiotic capsule sold under the brand name of Femdophilus and manufactured by CHR-Hansen of Denmark (phone: +45 45747474; email: info@chr-hansen.com). The contents of the capsules will be dissolved in 50 mL of normal saline at room temperature within one hour prior to administration and left indwelling in the patient's urinary bladder for 30 minutes.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years of age
2. Chronic indwelling urethral catheter or supra-pubic tube for \>6 months
3. Prior symptomatic UTI while catheter in place

Exclusion Criteria:

1. Immunosuppressed (HIV, transplant immunosuppression, uncontrolled diabetes)
2. Active infection (may be considered after treatment of active infection)
3. Prior urosepsis requiring ICU admission
4. Significant gross hematuria resulting from catheter exchanges
5. Supravesical urinary diversion
6. Upper urinary tract anatomical abnormality
7. Obstructing urolithiasis
8. Ongoing antibiotic therapy for non-urological infection
9. Indwelling nephrostomy tube or ureteral stent
10. Radiation cystitis
11. Pregnancy

Primary outcomes:
measure: Bladder colonization with Lactobacillus
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00127049: Trial of Gemcitabine, Cisplatin, and Ifosfamide in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors
Official title: A Prospective Multicenter Phase II Trial of Gemcitabine, Cisplatin, and Ifosfamide (GIP) in Patients With Relapsed Non-Seminomatous Germ-Cell Tumors (NSGCT) and a Predicted Favorable Prognosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Germ Cell Tumor
Keywords: Patients with relapsed non-seminomatous germ-cell tumors (NSGCT)
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-08-05
Enrollment: 37
Sex: MALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective multicenter phase II trial of gemcitabine, cisplatin, and ifosfamide (GIP) in patients with relapsed non-seminomatous germ-cell tumors (NSGCT) and a predicted favorable prognosis.


Eligibility criteria: Inclusion Criteria:

* Patients older than 16 years
* Histologically-proven disseminated (non stage I) NSGCT, or diagnosis of NSGCT based on very elevated serum human chorionic gonadotropin (HCG) and/or alpha fetoprotein (AFP)
* Relapsed disease classified as good prognosis according to the Memorial Sloan-Kettering Cancer Center (MSKCC) classification criteria:

  * Testicular primary site
  * Prior treatment limited to one program (or 6 or fewer cycles of cisplatin)
  * Either a complete response or a partial response with normal serum AFP and HCG
* Relapse documented by rising AFP and/or HCG or by a biopsy
* No previous carcinoma, except basal-cell carcinoma of the skin
* Adequate renal function: measured or calculated creatinine clearance\> 60 ml/min
* Absolute granulocyte count \>= 1,500/mm3, platelets \>= 100,000 mm3, bilirubin \< 1.5 fold the upper normal value
* Signed informed consent.

Exclusion Criteria:

* Patients infected by the human immunodeficiency virus (HIV)
* Patients who do not fit inclusion criteria

Primary outcomes:
measure: Complete response rate
Secondary outcomes:
measure: Toxicity
measure: Progression free survival
measure: Overall survival
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Karim FIZAZI, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fizazi K, Gravis G, Flechon A, Geoffrois L, Chevreau C, Laguerre B, Delva R, Eymard JC, Rolland F, Houede N, Laplanche A, Burcoveanu D, Culine S. Combining gemcitabine, cisplatin, and ifosfamide (GIP) is active in patients with relapsed metastatic germ-cell tumors (GCT): a prospective multicenter GETUG phase II trial. Ann Oncol. 2014 May;25(5):987-91. doi: 10.1093/annonc/mdu099. Epub 2014 Mar 4.
Clinical trial NCT04670549: Improve Osteoarthritis Care
Official title: The Improve Osteoarthritis Care Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Osteoarthritis, Hip
Keywords: Implementation
Treatment guidelines
Lead sponsor: Diakonhjemmet Hospital
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 1541
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-post design
Primary purpose: TREATMENT

Brief summary: The purpose of The Improve Osteoarthritis Care study is to improve the quality of osteoarthritis care in Norwegian primary care, by increasing the use of recommended treatment modalities and improving patient access to recommended treatments. The study will use tailored implementation strategies, targeting primary care physicians and physiotherapists to improve knowledge and addressing individual barriers to providing recommended treatments.

Detailed description: Previous research has shown that current osteoarthritis care for persons with hip or knee osteoarthritis (OA) in Norway has a potential for improvement as the provided care may not necessarily reflect evidence-based guideline recommendations. The overall purpose of the "Improve Osteoarthritis Care" study is that people with symptomatic hip and knee OA should receive care in line with current recommendations. To achieve this goal, tailored implementation strategies will be applied in order to: 1) Improve the quality of care offered to people with symptomatic hip and knee OA, 2) increase knowledge of recommended OA care among people with hip and knee OA, 3) Increase the number of primary care physiotherapists' offering group-based patient-education and structured exercise as part of their routine clinical practice, 4) Increase the number of general practitioners who have received a summary of the OA treatment recommendations.

To evaluate the effect of the tailored implementation strategy a pre-post design will be applied, and members of the Norwegian Rheumatology Association with self-reported hip or knee OA will be asked to evaluate quality of OA care at the two timepoints.

Eligibility criteria: Inclusion Criteria:

* Self-reported hip or knee osteoarthritis

Exclusion Criteria:

* Persons who do not understand the Norwegian language

Primary outcomes:
measure: The OsteoArthritis Quality Indicator questionnaire (OA-QI), version 2
timeFrame: 18 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Diakonhjemmet Hospital
Study officials:
affiliation: Diakonhjemmet Hospital
name: Nina Østerås
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02574806: Normal Values of Brain Natriuretic Peptide in Healthy Newborn
Official title: Normal Values of Brain Natriuretic Peptide in Healthy Newborn
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reference Values of BNP in Healthy Newborn
Keywords: BNP
Reference values
Newborn
Ventricular function
Stress
Pediatrics
Biomarkers
Lead sponsor: Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 167
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy term newborn obtained by vaginal delivery and/or cesarean section.

Brief summary: Brain natriuretic peptide (BNP) is an important tool for diagnosis, risk stratification and prognosis in pediatric patients with heart failure1. In newborn, after delivery, the BNP plays an important role in cardiopulmonary hemodynamics by stimulating vasodilatation and diuresis. The gradual decrease in pulmonary pressure and the initiation of diuresis as expression of renal maturity could explain the subsequent decrease in serum values. This would suggest that, in healthy newborns, BNP values should be found within a given ranges. However, the evidence suggests an important variability in BNP values 2 - 4. In the other hand, in the newborn with respiratory distress BNP could have a high negative predictive value to rule out acute myocardial processes, as responsible for clinical deterioration, from infectious, metabolic or respiratory processes; with a potential of improvement in medical care. Even the increased use of this biomarker in clinical practice, until our knowledge, BNP normal values remain unknown in the healthy newborn. Therefore, the investigators performed a pioneer study to establish normal values in healthy newborn population. Multi-center, prospective and observational study was carried out. Objective: To establish normal BNP values in healthy newborn.


Eligibility criteria: Inclusion Criteria:

* healthy mother with pregnancy at term (38 to 42 gestational weeks) with adequate prenatal care.
* newborns with Apgar score ≥ 7 at 0 and 5 minutes respectively.

Exclusion Criteria:

* newborns of mothers with pregnancy-associated diseases.
* newborns with chromosomopathies detected during the antenatal care and newborns with signs of cardiac and/or respiratory compromise.

Primary outcomes:
measure: BNP values
timeFrame: within the first minute after birth and data will present through study completion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Rodriguez D, Garcia-Rivas G, Laresgoiti-Servitje E, Yanez J, Torre-Amione G, Jerjes-Sanchez C. B-type natriuretic peptide reference interval of newborns from healthy and pre-eclamptic women: a prospective, multicentre, cross-sectional study. BMJ Open. 2018 Oct 17;8(10):e022562. doi: 10.1136/bmjopen-2018-022562.
Clinical trial NCT00652106: Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 432
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: This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ocular hypertension or glaucoma
* Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

* Uncontrolled medical conditions
* Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy

Primary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: El Paso
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06066606: U-LABA/ICS Effects on Exercise Performance, Vilanterol
Official title: Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Vilanterol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Exercise Performance
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist vilanterol + fluticasone furoate


Eligibility criteria: Inclusion Criteria:

* Age 18-39
* Physically active \> 5 h weekly
* Maximal oxygen consumption classified as high or very high

Exclusion Criteria:

* Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
* ECG abnormality
* ACQ score \> 1.5
* Severe bronchial hyperreactivity as determined by mannitol test
* FEV1/FVC ratio \< 0.7 determined with spirometry
* Chronic illness determined to be a potential risk for participant during study
* In chronic treatment with medication that may interfere with study results
* Pregnancy
* Smoker
* Blood donation during the past 3 months

Primary outcomes:
measure: Power output during sprint testing
timeFrame: Through study completion, an average of 3 weeks
Secondary outcomes:
measure: Power output during time trial
timeFrame: Through study completion, an average of 3 weeks
Other outcomes:
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: Through study completion, an average of 3 weeks
measure: Quadriceps strength
timeFrame: Through study completion, an average of 3 weeks
measure: Respiratory muscle function
timeFrame: Through study completion, an average of 3 weeks
Locations:
city: Copenhagen
country: Denmark
facility: August Krogh Building
state: DK
Study officials:
affiliation: University of Copenhagen
name: Morten Hostrup, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02149706: A Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis
Official title: A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Secondary Progress Multiple Sclerosis
SPMS
Multiple Sclerosis
NeuroVax
Lead sponsor: Immune Response BioPharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: cro
First posted: 2014-05-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary Progressive SPMS.

Detailed description: The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.

Eligibility criteria: Inclusion Criteria:

* Ages Eligible for Study: 18 Years to 70 Years
* Genders Eligible for Study: Both
* Accepts Healthy Volunteers: No Criteria
* Subject is between 18 and 70 years of age, inclusive.
* Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course.
* Expanded Disability Status Scale (EDSS) \>=score 3.5 (Appendix B).
* Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening .
* Laboratory values within the following limits:
* Creatinine 1 . 5 x high normal.
* Hemoglobin

Exclusion Criteria:

* Subjects currently prescribed Campath or Lemtrada

Primary outcomes:
measure: The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score
timeFrame: 48 Weeks
Secondary outcomes:
measure: Secondary measurements objectives immunologic evaluations
timeFrame: 48 Weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: CRO
state: California
Study officials:
affiliation: Immune Response BioPharma, Inc.
name: Richard M Bartholomew, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06996106: Outcomes of PRF on Septoplasty in Patient With Nasal Septal Deviation
Official title: Effect of Platelet Rich Fibrin on Septoplasty :A Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nasal Septum; Deviation
Nasal Septal Srur
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 100
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to assess the effectiveness of Platelet-Rich Fibrin (PRF) in improving postoperative healing, reducing complications, and enhancing functional outcomes in patients undergoing septoplasty

Detailed description: Septoplasty is a routine surgical intervention to correct nasal septal deviation, a major cause of nasal obstruction and chronic sinusitis. Despite advancements, postoperative complications-such as mucosal injury, synechiae, septal perforation, and hematoma-continue to impact outcomes and patient satisfaction.

Platelet-rich fibrin (PRF), first described by Choukroun et al., represents an autologous biomaterial rich in growth factors like PDGF, TGF-β, VEGF, and IGF-1, known to accelerate wound healing and tissue regeneration. Unlike platelet-rich plasma (PRP), PRF is easier to prepare, does not require anticoagulants, and forms a fibrin matrix conducive to sustained release of cytokines.

Several studies across disciplines-oral surgery, dermatology, orthopedics-support the regenerative potential of PRF. In nasal surgery, the delicate mucosal environment could benefit significantly from enhanced healing facilitated by PRF.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18-65 years undergoing septoplasty. Presence of cartilage deviated nasal septum requiring repair. No contraindications to PRF therapy.

Exclusion Criteria:

* History of coagulopathy or anticoagulant therapy. Active infection or systemic disease. Known hypersensitivity to PRF components. Previous nasal surgery Autoimmune or systemic inflammatory disease

Primary outcomes:
measure: Effect of submucoperichondrial application of platelet rich fibrin on healing of nasal septum mucosa after septoplasty
timeFrame: postoperative at 1st week , 1st month , 3rd month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01558206: Ultrasonography of Chest Versus Pulmonary Artery CT Angiography in Patients With Symptoms and Signs in Favor of PTE
Official title: Bedside Ultrasonography of Chest Versus Pulmonary Artery CT Angiography in the Patients Who Came to Emergency Department of Alzahra General Hospital With Respiratory Symptoms and Signs in Favor of Pulmonary Thromboemboli.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Thromboembolism
Keywords: PTE
Emergency bedside ultrasonography
pulmonary CT Angiography
Pulmonary Wedge infarction
Pulmonary Thromboembolism
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who come to the Emergency Department of Alzahra General Hospital with signs and symptoms in favor of PTE.

Brief summary: In this study the investigators compare the diagnostic validity of Bedside Ultrasonography of chest and Pulmonary artery CT Angiography in the patients who came to Emergency Department of Alzahra General Hospital from 1 may 2012 to 1 October 2012 with respiratory symptoms and signs in favor of Pulmonary Thromboemboli (PTE).


Eligibility criteria: Inclusion Criteria:

* Patients with signs or symptoms in favor of PTE who come to Emergency department of Alzahra General Hospital.

Exclusion Criteria:

* previous history of Allergy to IV contrast
* Serum creatinin more than 1.8
* patients that will not agree to participate in the study.
* pregnancy
* Body weight more than 120 kg

Primary outcomes:
measure: Emergency Ultrasonography findings in patients with signs and symptoms in favor of PTE.
timeFrame: Within 1 hour of admission
Secondary outcomes:
measure: Pulmonary CT Angiography findings in patients with signs and symptoms in favor of PTE.
timeFrame: Within 24 hours of admission
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Emergency Department of alzahra General Hospital, Isfahan University of Medical Sciences
Study officials:
affiliation: Isfahan University of Medical Sciences
name: Keihan Golshani, M.D.
role: STUDY_CHAIR
References: