louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00639587: Efficacy and Safety of Cetirizine Tablets Versus Ketotifen Dry Syrup in Children With Perennial Allergic Rhinitis
Official title: A Double-blind, Parallel, Active Comparator Controlled, Randomized Trial; Comparison of the Efficacy and Safety in Children With Perennial Allergic Rhinitis of Cetirizine Tablets Versus Ketotifen Dry Syrup
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Keywords: Cetirizine
Zyrtec
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 149
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ketotifen is an established antihistamine drug, widely used in pediatric clinical practice in Japan. The objective of the study was to compare the efficacy and safety of cetirizine hydrochloride versus ketotifen dry syrup on children 7 years and older with perennial allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* had at least one of the 3 symptoms: sneezing, nasal discharge or nasal congestion;
* severity of nasal symptoms was moderate to severe during the observation period;
* criteria for allergic etiology of the disease fulfilled, i.e., positive IgE antibody test and positive eosinophil count in nasal discharge.

Exclusion Criteria:

* history of hypersensitivity to the ingredients of cetirizine or ketotifen formulation or to hydroxyzine;
* history of drug hypersensitivity;
* history of convulsive disorder;
* vasomotor rhinitis or eosinophilic rhinitis;
* asthma requiring treatment with adrenocortical hormones;
* concomitant diseases which could impede the efficacy evaluation of the study drug;
* subjects in the ascending-dose phase of hyposensitization therapy or non-modular therapy and who had not received the maintenance dosage;
* pollen allergy;
* malignant neoplasm.

Primary outcomes:
measure: Total symptom score (TSS) (nasal symptom score [sneezing, nasal discharge, nasal congestion] and rhinoscopy results) Safety: adverse events and laboratory assessments
timeFrame: TSS: 2 weeks - Safety: 3 weeks
Secondary outcomes:
measure: Total 2 symptoms score (T2SS) (sneezing, nasal discharge) Global Improvement Rating
timeFrame: T2SS: 2 weeks - Global Improvement Rating: at the end of the 2-week-treatment period
Other outcomes:
Locations:
Study officials:
affiliation: +1-877-822-9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00685087: A Prospective Study of Natural History of Pancreatitis
Official title: A Prospective Study of Natural History of Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Keywords: To define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (CP).
To identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with CP.
To quantify the behavioral abnormalities associated with CP.
To determine psychological and behavioral correlates of CP disease progression and outcomes.
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2008-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects presenting to the Pancreatitis clinic with diagnosis of pancreatitis

Brief summary: To prospectively define the natural history and the clinical, laboratory and histomorphometric features of chronic pancreatitis (CP) of varying etiology. To identify clinical and laboratory parameters that correlate with the pathophysiologic state in patients with CP. To quantify the behavioral abnormalities associated with CP. To determine psychological and behavioral correlates of CP disease progression and outcomes.


Eligibility criteria: Inclusion Criteria:

* Subjects with pancreatitis

Exclusion Criteria:

* Lack of consent, age \<18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University Medical Center, Richmond VA 23298
name: Bimaljit S Sandhu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandhu B, Vitazka P, Ferreira-Gonzalez A, Pandya A, Vachhani R, Bouhaidar D, Zfass A, Sanyal A. Presence of SPINK-1 variant alters the course of chronic pancreatitis. J Gastroenterol Hepatol. 2011 Jun;26(6):965-9. doi: 10.1111/j.1440-1746.2011.06713.x.
Clinical trial NCT03473587: Promoting Colorectal Cancer Screening in Rural Emergency Departments
Official title: Promoting Colorectal Cancer Screening in Rural Emergency Departments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 191
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial will compare the effects of a culturally targeted intervention designed to assist participants to identify and overcome individual barriers to colorectal cancer (CRC) and to promote CRC screenings using motivational interviewing (Ml) delivered by a lay health advisor (LHA) compared to the current standard-of-care (distribution of a brochure describing CRC screening services offered by the hospital) on CRC screening compliance.

Detailed description: The specific aim of this project is to adapt and pilot a tailored intervention to promote CRC screenings in a rural Appalachian Kentucky emergency department (ED) in order to: (a) evaluate the feasibility of providing a cancer screening promotion intervention in an emergency department (ED) that serves a rural Appalachian community; and (b) assess the effects of the intervention on barriers to CRC screening, stage of readiness to screen and CRC screening engagement. The first phase of the project will involve the adaptation and pretesting of the intervention. This phase will take approximately 6 months. The second phase of the project will involve piloting the intervention and evaluating its efficacy and feasibility and will take place over the following 18 months. We will conduct a randomized controlled trial to examine the efficacy and feasibility of delivering the LHA delivered MI intervention to promote CRC screening in persons waiting in a rural Appalachian emergency department (ED) for non urgent complaints. We will evaluate efficacy by measurement of CRC screening status at baseline and three and six months post intervention.

Eligibility criteria: Inclusion Criteria:

1. 50+ years of age
2. Rural Appalachian resident
3. No personal history of colorectal cancer
4. No cognitive impairment
5. Ability to speak and understand English
6. Has not had one of the following colorectal cancer screening tests--

   1. Fecal Occult Blood Test within the past year
   2. Flexible sigmoidoscopy within the past five years, or
   3. Colonoscopy within the past ten years

Exclusion Criteria:

-

Primary outcomes:
measure: Change in colorectal cancer screening rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Morehead
country: United States
facility: St. Clair Regional Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jennifer Hatcher, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03330587: Living Alone in Old Age With Cognitive Impairment
Official title: Living Alone in Old Age With Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Living Alone
Alzheimer Disease
Mild Cognitive Impairment
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons over 55 years of age living alone and having a medical diagnosis of Alzheimer's disease or mild cognitive impairment

Brief summary: The purpose of this study is to better understand the experience of living alone in older age with cognitive impairment.

We recruit adults 55+ living alone with cognitive impairment such as Alzheimer's disease or mild cognitive impairment.

This study investigates the priorities and concerns of older adults living alone with cognitive impairment. Participants are interviewed 5 times for one hour in their homes within 3 months at a time that works for them.

Detailed description: The purpose of this study is to better understand the experience of living alone in older age with cognitive impairment. This knowledge is important to design programs that are appropriate. Dr. Elena Portacolone, an Assistant Professor from the Institute of Health and Aging is the study researcher.

Study participants are interviewed by Elena at a time and place convenient to them, usually their home. Interviews are audio recorded and last around one hour. Study participants are interviewed five times within 3 months.

After the interview, a transcriptionist will type into a computer the recording and will remove personal names. The sound recording will then be destroyed.

Participants can stop being in the study at any time.

Eligibility criteria: Inclusion Criteria:

* Living alone
* Medical diagnosis of Alzheimer's disease or mild cognitive impairment

Exclusion Criteria:

* Living in nursing homes, assistive living facilities.
* Alcohol abuse

Primary outcomes:
measure: Ethnographic interviews
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Institute for Health & Aging
state: California
Study officials:
affiliation: University of California, San Francisco
name: Elena Portacolone, PhD MPH MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02003287: Comparing FEES to VFSS in Diagnosing Laryngeal Penetration and Aspiration in Infants in the NICU
Official title: Determining the Efficacy of Using FEES Compared to VFSS to Diagnose Laryngeal Penetration and Aspiration in Infants in the Neonatal Intensive Care Unit (NICU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deglutition Disorders
Keywords: Deglutition Disorders
Intensive Care Units, Neonatal
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 25
Sex: ALL
Minimum age (years): 37
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of the study is to determine whether the Fiberoptic Endoscopic Evaluation of Swallowing (FEES) is effective in detecting laryngeal penetration and tracheal aspiration when compared with the Videofluoroscopic Swallowing Study (VFSS) in bottle-feeding infants in the NICU. A secondary objective is to determine whether FEES can be used to detect laryngeal penetration and tracheal aspiration in breastfeeding NICU infants.


Eligibility criteria: Inclusion Criteria:

* 37 weeks or more postmenstrual age
* Diagnosis or suspicion of laryngeal penetration and/or tracheal aspiration by neonatal therapist and/or physician
* Inpatient at Baylor University Medical Center NICU

Exclusion Criteria:

* Not medically stable enough to undergo both FEES and VFSS as determined by neonatal therapist and/or physician
* Bilateral complete cleft lip and palate

Primary outcomes:
measure: High sensitivity and specificity values for FEES
timeFrame: one year
Secondary outcomes:
measure: Evidence of laryngeal penetration or tracheal aspiration during breastfeeding
timeFrame: at time of assessment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: Mustafa S. Suterwala, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: da Silva AP, Lubianca Neto JF, Santoro PP. Comparison between videofluoroscopy and endoscopic evaluation of swallowing for the diagnosis of dysphagia in children. Otolaryngol Head Neck Surg. 2010 Aug;143(2):204-9. doi: 10.1016/j.otohns.2010.03.027.
citation: Leder SB, Karas DE. Fiberoptic endoscopic evaluation of swallowing in the pediatric population. Laryngoscope. 2000 Jul;110(7):1132-6. doi: 10.1097/00005537-200007000-00012.
citation: Suterwala MS, Reynolds J, Carroll S, Sturdivant C, Armstrong ES. Using fiberoptic endoscopic evaluation of swallowing to detect laryngeal penetration and aspiration in infants in the neonatal intensive care unit. J Perinatol. 2017 Apr;37(4):404-408. doi: 10.1038/jp.2016.239. Epub 2017 Jan 5.
Clinical trial NCT01184287: A Study Of Ranpirnase(Onconase®) To Pemetrexed Plus Carboplatin In Patients With Non-Squamous Non-Small Cell Lung Cancer
Official title: A Phase II Trial of Addition of Ranpirnase(ONCONASE®) to Permetrexed Plus Carboplatin in Patientes With Non-Squamous Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer, NSCLC, Lung Cancer
Previously untreated Non-Squamous, Non-Small Cell Lung Cancer
Lead sponsor: Tamir Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2010-08-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to determine the rate of improvement in objective tumor response, following the addition of ranpirnase to ongoing pemetrexed-carboplatin chemotherapy, for patients with SD or PR following 2 cycles of doublet chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* ECOG less than 2
* Estimated survival of greater than 12 weeks

Exclusion Criteria:

* Prior systemic chemotherapy for locally advanced or metastatic NSCLC
* Use of any investigational agent within 28 days prior to registration
* Known hypersensitivity to any of the study drugs
* Brain metastases or leptomeningeal disease
* History of prior malignancy within the past three years

Primary outcomes:
measure: Response
timeFrame: 4 or more months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 2 years
measure: Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Grand Rapids
country: United States
facility: Van Andel Research Institute
state: Michigan
city: Great Falls
country: United States
facility: Sletten Cancer Specialists
state: Montana
city: New York
country: United States
facility: The Cancer Institute at NYU Langone Medical Center
state: New York
city: Canton
country: United States
facility: Tri-county Hematology-Oncology Associates, Inc
state: Ohio
city: Ogden
country: United States
facility: Northern Utah Associates
state: Utah
Study officials:
References:
Clinical trial NCT03300687: First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation
Official title: First in Human Safety Study of FX-322 in Adults Undergoing Cochlear Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hearing Loss
Lead sponsor: Frequency Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-10-03
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a phase 1 safety study performed in male or female adult participants with an established diagnosis of severe to profound sensorineural hearing loss that meets the criteria for cochlear implantation and the participant has already chosen to undergo cochlear implant surgery.

Detailed description: Approximately 12 participants will be enrolled in the study. Assessed will be safety and tolerability of FX-322 administered by intratympanic injection. Also assessed will be the FX-322 concentration in cochlear fluid (perilymph), the pharmacokinetic (PK) profile of FX-322 to determine the systemic exposure to FX-322.

Eligibility criteria: Inclusion Criteria:

1. Male or female adult subjects with an established diagnosis of severe to profound sensorineural hearing loss audiometric threshold of 80 dB HL or poorer at 500 Hz that meets the criteria for cochlear implantation and the subject has already chosen to undergo cochlear implant surgery.
2. Willingness and ability to comply with scheduled visits, ear examination, drug administration plan, auditory and laboratory tests, study restrictions, and all study procedures.

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

1. Persistent perforation of tympanic membrane or other tympanic membrane disorder that would interfere with the delivery and safety assessment of an intra -tympanic medication or reasonably be suspected to affect tympanic membrane healing after injection.
2. Any conductive component defined as air-bone gaps \>10 dB at two or more frequencies.

Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (Safety and Tolerability) of FX-322.
timeFrame: Treatment-emergent adverse events will be assessed over a several hour to two week period
Secondary outcomes:
measure: Plasma Pharmacokinetics
timeFrame: Systemic exposure will be evaluated over a 72 hour period
measure: Plasma Pharmacokinetics
timeFrame: Within a 24 hour period after injection
measure: Cochlear Perilymph Pharmacokinetics
timeFrame: within a 24 hour period after injection
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Royal Victoria Eye and Ear Hospital
state: Victoria
Study officials:
References:
Clinical trial NCT01761487: SDD for Eradicating CRKP Carriage
Official title: SELECTIVE DIGESTIVE DECONTAMINATION USING ORAL GENTAMICIN AND ORAL POLYMYXIN E FOR ERADICATION OF CARBAPENEM-RESISTANT KLEBSIELLA PNEUMONIAE CARRIAGE IN HOSPITALIZED PATIENTS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Carriers of Carbapenem-resistant Klebsiella Pneumonia
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: There is an urgent need to control the current national outbreak of Carbapenem-resistent Klebsiella pneumonia (CRKP). In Israel, the death rate among CRKP carriers is 3.5 times higher than in Carbapenem-sensitive Klebsiella pneumonia carriers (44% vs. 12.5%, respectively).

In the investigators' previous study: A Randomized, Double-Blind, Placebo-Controlled Trial of Selective Digestive Decontamination (SDD) Using Oral Gentamicin and Oral Polymyxin E for Eradication of CRKP Carriage (Infect Control Hosp Epidemiol. 2012;33:14-19) the investigators have shown that the investigators' SDD regimen is effective for decolonization patients colonized with CRKP.

The investigators' assumption is that a higher dose of polymyxin E together with gentamicin (SDD drugs) for a prolonged period is needed to overcome the likelihood of a high rate of drug inactivation in the gut, thereby reaching CRKP carriage eradication.


Eligibility criteria: Inclusion Criteria:

* Provide a sighed and dated written informed consent document indicating that the subject (or a legally accepted representative) has been informed of all pertinent aspects of the study
* Hospitalized men or women at least 18 years of age
* Rectal swab culture positive for CRKP in the last week
* Will be willing to initiate and remain on treatment, except for adverse events occurring

Exclusion Criteria:

* Age less than 18 years.
* Pregnant women, lactating women.
* A know allergy to one of the study drugs.
* Renal failure with creatinine clearance less than 50mL/min.
* Current Treatment with IV gentamicin and/or IV polymyxin E
* Any safety, behavioral, clinical, or administrative reasons that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy

Primary outcomes:
measure: CRKP carriage at end of treatment
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center
state: Negev
Study officials:
References:
Clinical trial NCT04006587: IS Reduces Rib Fracture Complications
Official title: Incentive Spirometer Device Reduces Pulmonary Complications in Patients With Traumatic Rib Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemothorax; Traumatic
Rib Fractures
Rib Trauma
Keywords: incentive spirometer
Hemothorax; Traumatic
trauma
rib Fractures
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 50
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: The incentive spirometer (IS) is a mechanical device that helps lung expansion. It is commonly used to prevent postoperative lung atelectasis and decreased pulmonary complications in patients who received cardiac, lung, or abdomen surgery.This study aimed to explore the effect of the IS on the improvement of lung function and decrease in pulmonary complication rate in rib fractures patients.

Detailed description: Adult patients (\>18 years old) seen at our institution between June, 2014 until May, 2017 with traumatic rib fractures were included. For inclusion, a patient had to have at least one rib fracture as detected by chest X-ray (CXR) or computed tomography scan. We excluded patients with unconsciousness, history of chronic obstructive pulmonary disease, asthma, or an Injury Severity Score (ISS) ≥ 16. Patients were divided into two groups using a randomized envelope technique: in the study group, patients were advised to use the IS and in the control group patients did not received the IS. All patients were managed with the same oral analgesic protocol. A CXR was obtained on the 1st and 5th day of admission and performed by a radiologist. The Pulmonary Function Test (PFT) was administered on the 2nd and 7th day of admission and performed by a pulmonologist. A numeric rating scale (NRS) was used to define the severity of chest pain on the 1st and 5th day of admission.

Eligibility criteria: Inclusion Criteria:

* at least one rib fracture as detected by chest X-ray (CXR) or computed tomography scan

Exclusion Criteria:

* unconsciousness,
* history of chronic obstructive pulmonary disease
* asthma
* Injury Severity Score (ISS) ≥ 16

Primary outcomes:
measure: pulmonary complication rate
timeFrame: 2 weeks after trauma
Secondary outcomes:
measure: 1st lung function test
timeFrame: 2nd day of admission
measure: 2nd lung function test
timeFrame: 7th day of admission
measure: length of hospital stay
timeFrame: total hospital stay days up to 2 months after admission
measure: 1st Pain score
timeFrame: 1st day of admission
measure: 2nd Pain score
timeFrame: 5th day of admission
Other outcomes:
Locations:
Study officials:
References:
citation: Sum SK, Peng YC, Yin SY, Huang PF, Wang YC, Chen TP, Tung HH, Yeh CH. Using an incentive spirometer reduces pulmonary complications in patients with traumatic rib fractures: a randomized controlled trial. Trials. 2019 Dec 30;20(1):797. doi: 10.1186/s13063-019-3943-x.