louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00772304: Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: rhinitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

1. Must have a history (at least 2 yrs) of allergic rhinitis and be symptomatic at time of enrollment
2. 18 yrs of age or older
3. Read and sign informed consent
4. Females of childbearing potential may participate if: are non-breast feeding, have negative urine pregnancy test at visit 1, agree to take urine pregnancy test upon exiting study, do not intend to become pregnant during the study, are using adequate methods of birth control.

Exclusion Criteria:

1. History of intolerance or hypersensitivity to any component of the study medications, including benzalkonium chloride.
2. Any disease or systemic disorder that may complicate or interfere with investigation or evaluation of the study medications (including but not limited to): Rhinitis medicamentosa, large obstructive nasal polyps, history (w/in last 3 months) of nasal septic ulcers, nasal surgery or nasal trauma, history or evidence of nasolacrimal drainage system malfunction, history (w/in 30 days) or evidence of sinusitis or upper or lower respiratory infection.
3. Impairment of sense of tast or smell (self reported)
4. Asthma, except for mild, intermittent asthma (nat'l Asthma guidelines)
5. Congestion, that in the opinion of the investigator, that would interfere with successful nasal drug administration/absorption
6. Patients w/a severe impairment of nasal breathing
7. Anatomic abnormalities of as identified by nasal examination
8. History of or current severe or uncontrolled cardiovascular, hepatic, renal and/or other disease/illness that could interfere w/study.
9. History of (w/in past 12 months) or ongoing clinically relevant electrolyte abnormalities.

Primary outcomes:
measure: Product Preference Questionnaire for Immediate Taste
timeFrame: 5 min post-dose
Secondary outcomes:
measure: Taste and Aftertaste of Medication
timeFrame: 5 min, 45 min.
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT04429204: Cryoablation for the Promotion of Local Tumor Infiltration in Patients With Mesothelioma
Official title: Evaluation of Cryo-Immune Stimulation in Mesothelioma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mesothelioma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial evaluates if cryoablation will stimulate a local immune response by cluster of differentiation 8 positive (CD8+) cells which are not present in ablation naive regions of the tumors in patients with mesothelioma. Cryoablation uses extreme cold to damage or destroy tumor lesions. Mesothelioma is a rare cancer that grows and spreads quickly, and has low survival rates. The information learned from this study may provide evidence as to whether there is a measurable, local immune response from cryoablation. Studying samples of mesothelioma tissue in the laboratory from patients who have undergone biopsy may help doctors learn more about the effects of cryoablation on cells. It may also help doctors understand how well patients respond to treatment.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the simple hypothesis that cryoablation of mesothelioma will promote local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells that will not be present in ablation naive regions of the tumors.

II. To determine whether there is a preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue.

OUTLINE:

At the time of standard of care pleural biopsy, patients undergo cryoablation over 30 minutes, then a sample of tissue from the ablated region and a non-ablated (tumor negative control) region are collected.

Eligibility criteria: Inclusion Criteria:

* Adults that have been identified at tumor board with high suspicion for mesothelioma and are anticipated to be surgical candidates, as determined/discussed at Mesothelioma Tumor Board

Exclusion Criteria:

* Patients that have a questionable diagnosis of mesothelioma (i.e. there are other potentially more likely considerations in the differential diagnosis) or in patients that would not be expected to be good surgical candidates

Primary outcomes:
measure: Local tumor infiltration by cytotoxic cluster of differentiation 8 positive (CD8+) cells
timeFrame: After cryoablation of mesothelioma up to 1 year
measure: Preponderance of T cells in ablated tumor tissue in comparison to non-cryoablated tissue
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Neema Jamshidi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05298904: Pro-active Genetic Testing in Kidney Transplant Patients
Official title: Pro-active Genetic Testing in Kidney Transplant Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Kidney Transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be identified internally to Mayo Clinic Arizona via the kidney transplant program within one-year post transplant.

Brief summary: The purpose of this study is to determine the prevalence of genetic mutations that increase the risk of cancer and other medically actionable diseases in kidney transplant patients and to assess the impact of genetic testing on subsequent surveillance for cancer.


Eligibility criteria: Inclusion Criteria:

- Post transplant Kidney and Kidney Pancreas recipients.

Exclusion Criteria:

* Simultaneous Liver Kidney Transplant.
* Simultaneous Heart Kidney Transplant.
* Non renal transplant history.

Primary outcomes:
measure: Genetic mutations of cancer
timeFrame: 1 year
Secondary outcomes:
measure: The impact of genetic testing
timeFrame: 1 Year
measure: Develop a Biorepository
timeFrame: 1 year
Other outcomes:
measure: Genetic mutations of cardiomyopathy
timeFrame: 1 year
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Girish Mour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00742001: Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival
Official title: IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: red blood cells
transfusion
recovery
feasibility
white blood cell inactivation
Lead sponsor: Terumo BCTbio
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2008-08-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood

Detailed description: Radiolabeling of red blood cells (RBCs) followed by infusion back to the donor is commonly used to test the quality of RBCs in a person. By measuring the level of radioisotope in a blood sample, these tests evaluate what percentage of the RBCs remain in the bloodstream after 24 hours (recovery) and can predict how long the RBCs will remain in circulation (survival). The IMPROVE trial is a feasibility trial to evaluate these parameters in RBCs obtained from whole blood units that have been treated with the Mirasol System.

Eligibility criteria: Inclusion Criteria:

* healthy adults who meet AABB (formerly known as the American Association of Blood Banks) criteria for whole blood donation
* females incapable of becoming pregnant
* males agreeing to use contraception during trial

Exclusion Criteria:

* pregnancy or nursing
* abnormal medical history (bleeding disorders, anemia, myocardial ischemia, uncontrolled hypertension, heart disease, epilepsy)
* major surgery
* use of drugs affecting coagulation or RBC function
* recent participation in other trials which may confound results

Primary outcomes:
measure: Red Blood Cell (RBC) Recovery
timeFrame: 24-hour post autologous infusion of RBCs
Secondary outcomes:
measure: Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival
timeFrame: 28-days post autologous infusion of RBCs
measure: Count of Participants With Serious Adverse Events (SAE)
timeFrame: 28-days post autologous infusion of RBCs
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati, Hoxworth Blood Center
state: Ohio
Study officials:
affiliation: University of Cincinnati, Hoxworth Blood Center
name: Jose Cancelas-Perez, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05429801: Ozone Therapy in Ankylosing Spondylitis
Official title: Efficacy of Ozone Therapy in Patients With Ankylosing Spondylitis: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankylosing Spondylitis
Keywords: ozone therapy
complementary treatment
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 30
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 aim of this study was to investigate the effects of rectal ozone therapy added to medical treatment on pain severity, disease activity, spinal mobility, functional status, enthesitis, and quality of life (QoL) in patients with ankylosing spondylitis (AS).

Patients and methods: Patients who fulfilled the modified New York criteria for AS were included in this randomized controlled study. Thirty patients selected according to inclusion and exclusion criteria were randomized into two groups. Rectal ozone treatment along with medical treatment was administered to the patients in group 1, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks. The patients in group 2 continued only their current medical treatment. All patients received a comprehensive rheumatologic assessment including pain severity, disease-specific instruments for disease activity, functional status, spinal mobility, enthesitis score, and QoL.


Eligibility criteria: Inclusion Criteria:

* Patients who were diagnosed as AS according to the Modified New York criteria

Exclusion Criteria:

* having other concomitant rheumatic diseases,
* receiving anti-TNF-α therapy within the last 3 months,
* being in clinical remission with standard medical treatment,
* being pregnant,
* having diseases such as favism, asthma, pancreatitis, and uncontrolled hyperthyroidism for which ozone therapy is contraindicated.

Primary outcomes:
measure: visual analogue scale (VAS)
timeFrame: Change from baseline VAS at the 4th week after the treatment
Secondary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: Change from baseline Bath Ankylosing Spondylitis Disease Activity Index at the 4th week after the treatment
measure: Ankylosing Spondylitis Disease Activity Score
timeFrame: Change from baseline Ankylosing Spondylitis Disease Activity Score at the 4th week after the treatment
measure: Bath Ankylosing Spondylitis Functional Index
timeFrame: Change from baseline Bath Ankylosing Spondylitis Functional Index at the 4th week after the treatment
measure: Ankylosing Spondylitis Quality of Life
timeFrame: Change from baseline Ankylosing Spondylitis Quality of Life score at the 4th week after the treatment
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Hakan Alkan
state: None Selected
Study officials:
affiliation: Pamukkale University
name: Füsun Ardıç, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02824601: Photodynamic Therapy in Endodontic Treatment
Official title: Does Supplemental Photodynamic Therapy Optimize the Disinfection of Bacteria and Endotoxins in One-visit and Two-visit Root Canal Therapy? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endodontic Disease
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial evaluated the effectiveness of supplemental photodynamic therapy (PDT) in optimizing the removal of bacteria and endotoxins from primarily infected root canals after one-visit and two-visit treatments.Twenty-four primarily infected root canals with apical periodontitis were selected and randomly divided into one-visit (n=12) and two-visit treatments (n=12). Chemo-mechanical preparation (CMP) was performed by using the single-file reciprocating technique + 2.5% NaOCL and a final rinse with 17% Ethylenediamine tetraacetic acid (EDTA). The photosensitizer agent (methylene blue 10 mg/mL) was applied to root canals for 60 seconds and submitted to laser with a potency of 60 milliwatts (mW) and energy density of 129 J/cm2 for 120 seconds after CMP in the one-visit treatment and after 14-day inter-appointment medication with Ca(OH)2 + saline solution (SSL) in the two-visit treatment. Samples were collected before and after root canal procedures. Endotoxins were quantified by chromogenic limulus amebocyte lysate assay. Culture techniques were used to determine bacterial colony-forming unit counts.


Eligibility criteria: Inclusion Criteria:

* single-rooted maxillary ones with primary endodontic infection and showing presence of one root canal and absence of periodontal pockets deeper than 4 mm.

Exclusion Criteria:

* Those who had received antibiotic treatment during the past three months were excluded.
* The teeth that could not be isolated with rubber dam were also excluded.
* Presence of root canal calcification.

Primary outcomes:
measure: Change in the Determination of Total Cultivable Bacterial Count
timeFrame: At Baseline and after 14-day intracanal medication
Secondary outcomes:
measure: Change in the Quantification of Endotoxin Concentration
timeFrame: At Baseline and after 14-day intracanal medication
Other outcomes:
Locations:
city: São José dos Campos
country: Brazil
facility: Universidade Estadual Paulista Júlio de Mesquita Filho
state: São Paulo
Study officials:
affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
name: Frederico C Martinho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03044301: Performance Thresholds Evaluation by Wet Injection Quantification and Magnetic Resonance Imaging (MRI) of Subcutaneous and Intramuscular Injections (0,65ml) of Several Configurations of Needle-free Devices (ZENEO®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Condition
Lead sponsor: Crossject
Sponsor class: INDUSTRY
First posted: 2017-02-07
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the performance of the ZENEO needle free device in subcutaneous functioning limits (low performance limit and high performance limit) and for intramuscular injections.


Eligibility criteria: Inclusion Criteria:

* male or female healthy volunteers aged between 18 and 60 years,
* affiliated to or covered by the French social security system,
* BMI between ≥20 and ≤30 kg/m²
* Patients without chronic medical or surgical illness
* Patients with normal clinical examination at the screening visit,
* Patients with normal blood pressure at the screening visit: systolic BP \< 140 mmHg and diastolic BP \< 90 mmHg, determined with the patient seated and resting for at least 5 minutes,
* Patients within normal range values for the following laboratory tests (appendix I) unless the investigator considers an abnormality to be clinically irrelevant (to be documented and agreed with the sponsor before inclusion) within 1 month prior to the start of the study (only for MRI sub study volunteers),
* Absence of cannabis, opiate, cocaine, amphetamine history (only for MRI sub study volunteers)

Exclusion Criteria:

* history of drug abuse
* history of hypersensitivity (disease or drug)
* treatment with platelet inhibiting drugs within one week before inclusion
* treatment with anticoagulant within four weeks before inclusion
* subject likely to take any medication during the study
* contra-indication to MRI: metallic intra-corporeal devices, claustrophobia
* prior participation to other interventional clinical research within 3 months
* in custody due to administrative or legal decision or under tutelage or being admitted in a sanitary or social institution.

Primary outcomes:
measure: depth of the injection by MRI
timeFrame: 5 minutes after the injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01706601: Patients With Hemorrhoids Referred to a Surgical Specialist Department
Official title: Patients With Hemorrhoids Referred to a Surgical Specialist Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemorrhoids
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Ersta Hospital, Sweden
First posted: 2012-10-15
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients whith hemorrhoids

Brief summary: Hemorrhoids is the most common disease in rectum with a prevalence of 30 % of population. This means that many patients are referred to surgical specialist reception with diagnosis hemorrhoidal disease. The aim of this study is to describe population of patients with hemorrhoidal disease that are referred to a specialised colorectal unit and to determine what treatment they are given at a general practitioner as well as in colorectal unit.


Eligibility criteria: Inclusion Criteria:

* all patients with diagnosis hemorrhoidal disease that are referred to a surgical specialist department

Exclusion Criteria:

* none

Primary outcomes:
measure: Correct diagnosis?
timeFrame: patients visiting Ersta Hospital between 2007-2009
Secondary outcomes:
measure: treatment of hemorrhoids
timeFrame: patients visiting Ersta Hospital between 2007-2009
Other outcomes:
measure: Examination/treatment
timeFrame: Before visiting Ersta hospital
measure: Operation/complication
timeFrame: postoperatively
measure: genus
timeFrame: between 2007-2009
measure: Treated elsewhere
timeFrame: after compleated treatment at Ersta hospital
Locations:
city: Stockholm
country: Sweden
facility: Ersta hospital
Study officials:
affiliation: Karolinska Institutet
name: Solveig Elmér, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03336801: The Effect of Propofol or Sevoflurane on Renal Function
Official title: The Effect of Propofol and Sevoflurane Anesthesia on Renal Function in Patients Undergoing Back Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Anesthesia
Keywords: sevoflurane
propofol
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2017-11-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients are randomized into one of two treatment groups which during surgery receives one of two different anesthetic agents. The two groups are then compared to each other.
Primary purpose: PREVENTION

Brief summary: This study investigates the role of the anesthetic agents propofol and sevoflurane on renal function in otherwise healthy patients undergoing basic back surgery.

Detailed description: Water-sodium homeostasis is central for anyone undergoing surgery, and can therefore affect surgical outcome, level of postoperative care and the length of hospital stay. Too much or too little fluid during surgery can affect the patients negatively. The kidneys play an imperative role in the regulation of water and sodium homeostasis, however there are lack of knowledge in how the anesthesia per se affects renal function. Previous studies have shown that volatile anesthetic agents such as sevoflurane can cause fluid retention. Why this happens is not completely known.

We are now investigating the different affects of sevoflurane and propofol anesthesia on renal function in patients undergoing basic back surgery to elucidate if there is a difference in the risk of developing acute kidney injury.

Eligibility criteria: Inclusion Criteria:

* Scheduled back surgery

Exclusion Criteria:

* American Association of Anesthesiology class 1-3
* American Heart Association class \>3
* BMI \>37
* Insulin treated diabetes
* Pregnancy or breast feeding
* Sensistivity/allergy against anesthetic agents
* Inadequate understanding about the study
* Depressed kidney function and/or AKI
* Depressed liver function
* Genetic malignant hyperthermia

Primary outcomes:
measure: Change in urine output
timeFrame: 24 hours
measure: Change in serum creatinine levels
timeFrame: 24 hours
measure: Change in creatinine clearance
timeFrame: 24 hours
Secondary outcomes:
measure: Changes in electrolytes
timeFrame: 24 hours
measure: Changes in hormone levels
timeFrame: 24 hours
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Centraloperation
Study officials:
affiliation: Uppsala University, Department of Anesthesiology and Intensive Care
name: Stephanie Franzén, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uppsala University, Department of Anesthesiology and Intensive Care
name: Robert Frithiof, MD PhD
role: STUDY_DIRECTOR
References: