louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06311292: Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis
Official title: Pilot Study of Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.

Participants will use the Volara System during clinic visit in an attempt to produce sputum.

Detailed description: Since the introduction of CFTR modulator therapies, most patients with Cystic Fibrosis (CF) have been unable to produce an adequate sputum sample for clinical monitoring. COVID-19 also presented a safety concern for staff and patients that may become exposed during sputum induction performed in the clinic rooms due to lack of negative pressure rooms and especially for patients who were unvaccinated. These issues led to lack of microbiology data for clinical care.

The purpose of this project is to identify a superior sputum collection method for those patients unable to produce a sputum to guide future antimicrobial management.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. 2. Currently prescribed hypertonic saline treatment as part of routine airway clearance therapy.

2. No sputum culture results in last one year or those who were unable to produce sputum from VPEP method used in QI project 3771

Exclusion Criteria:

1. \< 18 years old
2. Sputum culture results in last one year

Primary outcomes:
measure: Sufficient sputum quantity for a pellet
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: UPMC Children's Hospital of Pittsburgh
name: Daniel Weiner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02139592: Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"
Official title: Brentuximab Vedotin (ADCETRIS) IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma
Keywords: Pharmacological therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2014-05-15
Enrollment: 292
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Relapsed or refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma

Brief summary: The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (IV) infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting, as well as to collect efficacy information for reference.

Detailed description: The present survey was designed to evaluate the safety of brentuximab vedotin (recombinant) for IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting.

The usual adult dosage is 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) infused intravenously once every three weeks. The dose should be adjusted depending on the participant's condition. See the "PRECAUTIONS" section of the package insert.

Eligibility criteria: Inclusion Criteria:

* All patients treated with brentuximab vedotin IV Infusion

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: Up to Week 48 or until discontinuation of treatment
Secondary outcomes:
measure: Percentage of Participants Who Achieve or Maintain Any Best Response
timeFrame: Up to Week 48 or until discontinuation of treatment
measure: Overall Survival (OS)
timeFrame: Up to Week 48 or until discontinuation of treatment
Other outcomes:
Locations:
city: Osaka
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04619992: Consumer Evaluation of Intermittent Catheter Product Modifications
Official title: Consumer Evaluation of Intermittent Catheter Product Modifications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: Intermittent Catheterization
Lead sponsor: Hollister Incorporated
Sponsor class: INDUSTRY
First posted: 2020-11-06
Enrollment: 62
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.


Eligibility criteria: A. Inclusion Criteria for Arm 1

Subject who:

1. is male and at least 18 years of age
2. has been performing unassisted, self-catheterizations, with a Hollister standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month

B. Exclusion Criteria for Arm 1

Subject who:

1. is currently undergoing chemotherapy, radiation or steroid therapy
2. has a symptomatic urinary tract infection (UTI)
3. is currently using a coude intermittent catheter product to perform catheterization
4. performs non-urethral catheterization

C. Inclusion Criteria for Arm 2

Subject who:

1. is male and at least 18 years of age
2. has been performing unassisted, self-catheterizations, with a non-standard with tip Hydrophilic intermittent catheter, 3 or more times a day for at least 1 month

D. Exclusion Criteria for Arm 2

Subject who:

1. is currently undergoing chemotherapy, radiation or steroid therapy
2. has a symptomatic urinary tract infection (UTI)
3. is currently using a coude intermittent catheter product to perform catheterization
4. performs non-urethral catheterization
5. is unable to use a Hollister standard with tip hydrophilic intermittent catheter

Primary outcomes:
measure: Acceptability of Test Hydrophilic Intermittent Catheter
timeFrame: 10 days
measure: Preference of Test Hydrophilic Intermittent Catheter
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Libertyville
country: United States
facility: Hollister Incorporated
state: Illinois
Study officials:
References:
Clinical trial NCT02207192: Postural Changes in Lung Volumes in Obesity
Official title: Effect of Weight Loss on Postural Changes in Pulmonary Function : a Longitudinal Study in Morbidly Obese to Obese Subjects Following Gastroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: obesity, lung volumes, postural changes
Lead sponsor: Association pour la Formation du Personnel à la Medecine d'Urgence
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 12
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twelve morbidly obese adults (BMI over or equal to 40 kg/m2) scheduled for bariatric surgery at the Montpellier university hospital were recruited. They were 3 men and 9 women.

Brief summary: Postural changes are known to affect normal lung volumes. A reduction in sitting to supine functional residual capacity (FRC) is well-described in non-obese subjects adopting a supine position. However, postural changes in lung volumes in the obese require further exploration. We aimed to longitudinally address the effects of weight loss on postural changes in lung volumes and pulmonary function, in obesity. We tested the hypothesis that supine reduction in FRC would be absent in morbid obesity and recovered upon weight loss.


Eligibility criteria: Inclusion Criteria:

* subjects scheduled for bariatric surgery (BMI over or equal to 40 kg/m2)

Exclusion Criteria:

* Subjects with respiratory and cardiac history (asthma, COPD, heart failure) were excluded.

Primary outcomes:
measure: functional residual capacity
timeFrame: baseline and one year after bariatric surgery
Secondary outcomes:
measure: lung volumes and flows
timeFrame: at baseline and after bariatric surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University hospital
Study officials:
affiliation: Montpellier University Hospital
name: Mustapha Sebbane, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sebbane M, El Kamel M, Millot A, Jung B, Lefebvre S, Rubenovitch J, Mercier G, Eledjam JJ, Jaber S, Hayot M. Effect of Weight Loss on Postural Changes in Pulmonary Function in Obese Subjects: A Longitudinal Study. Respir Care. 2015 Jul;60(7):992-9. doi: 10.4187/respcare.03668. Epub 2015 Apr 7.
Clinical trial NCT05891392: Early Results Of Coronary Artery Reconstruction For Extensive Coronary Disease
Official title: Early Results Of Coronary Artery Reconstruction For Extensive Coronary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Reconstruction
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing CABG with extensive coronary artery disease who need reconstruction

Brief summary: Evaluation of early outcome obtained from coronary reconstruction with or without endarterectomy in extensive diseased coronary arteries


Eligibility criteria: Inclusion Criteria:

* Primary elective CABG patients Patch anastomosis more than 2 cm

Exclusion Criteria:

* Patients with combined valvular procedure. Previous open heart surgery Patients with EF \<40%

Primary outcomes:
measure: Free from ischemia
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
References:
Clinical trial NCT00990392: Topical Antibiotics for Prevention of Intensive Care Unit (ICU) Central Line Infections
Official title: Pilot Study: Topical Antibiotics for Prevention of ICU Central Line Infections
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Stream Infections
Skin Diseases, Infectious
Keywords: Blood stream infections
Catheter related infections
Central venous catheter related infections
Line sepsis
Topical antibiotics
Bacitracin
Polymixin
Gramicidin
Polysporin Triple Therapy
Intensive care unit
Lead sponsor: Fraser Health
Sponsor class: OTHER
First posted: 2009-10-06
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine if the overall central venous catheter related infection rate can be reduced by the application of Polysporin Triple Therapy ointment to the insertion site.

Detailed description: Previous studies in the dialysis population have found a reduction in local and system central venous catheter related infections with the application of topical antibiotics to the insertion point. One such study found a mortality benefit with Polysporin Triple Therapy ointment. We intend to determine if this preparation can reduce overall line infection rates in the ICU environment through its application at the time of line insertion and twice more the following week.

Eligibility criteria: Inclusion Criteria:

* all patients admitted to the ICU requiring a central venous catheter

Exclusion Criteria:

* previous line infection during same ICU stay
* CVC for hemodialysis

Primary outcomes:
measure: Overall number of line related infections (local and blood borne)
timeFrame: 6 months
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 7 months
measure: Length of hospital stay
timeFrame: 7 months
measure: Prevalence of methicillin-resistant Staphylococcus Aureus (MRSA)
timeFrame: 12 months
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Fraser Health Authority
name: Steven Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lok CE, Stanley KE, Hux JE, Richardson R, Tobe SW, Conly J. Hemodialysis infection prevention with polysporin ointment. J Am Soc Nephrol. 2003 Jan;14(1):169-79. doi: 10.1097/01.asn.0000038688.76195.a4.
citation: James MT, Conley J, Tonelli M, Manns BJ, MacRae J, Hemmelgarn BR; Alberta Kidney Disease Network. Meta-analysis: antibiotics for prophylaxis against hemodialysis catheter-related infections. Ann Intern Med. 2008 Apr 15;148(8):596-605. doi: 10.7326/0003-4819-148-8-200804150-00004.
Clinical trial NCT01484392: Determinants of Compliance With Glaucoma Therapy
Official title: Determinants of Compliance With Glaucoma Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma
Keywords: open angle glaucoma
compliance
adherence
Lead sponsor: Legacy Health System
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with open angle glaucoma.

Brief summary: The purpose of this study is to determine which medical, demographic, and health belief factors are associated with glaucoma therapy compliance.


Eligibility criteria: Inclusion Criteria:

* open angle glaucoma
* be well controlled on current medical therapy
* be using a prostaglandin analogue

Primary outcomes:
measure: Compliance with glaucoma medication at 1 month
timeFrame: 1 month after enrollment
measure: Compliance with glaucoma medication at 3 months
timeFrame: 3 months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
Study officials:
affiliation: Legacy Health
name: Steven L Mansberger, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01272492: Infant Nutrition: Evaluation of an Educational Touchscreen Computer Program
Official title: Infant Nutrition: Evaluation of an Educational Touchscreen Computer Program for Use in a Spanish-speaking Population of Caregivers of Young Children (APA Phase II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: Academic Pediatric Association
First posted: 2011-01-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are recruiting participants for a randomized controlled trial to evaluate the usability and educational value of a nutrition education touchscreen computer program targeting Spanish-speaking Latina caregivers of children 2 and under.

Participants will be randomized to the intervention group - use the computer program and the control group - do not use the program. They will be asked basic demographic questions, nutrition knowledge questions and computer users will be asked usability questions.

Objectives are

1. Evaluate the subjective and objective usability of the touchscreen computer.
2. Determine whether health knowledge on nutrition topics is enhanced through the use of the computer modules.


Eligibility criteria: Inclusion Criteria:

* 1. Have a child 2 and under in their care 2. Consider themselves Latina 3. Are Spanish-speaking

Exclusion Criteria:

Exclude if child has major medical issues interfering with feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Children's medical Practice
state: Maryland
Study officials:
References:
citation: Thompson DA, Joshi A, Hernandez RG, Bair-Merritt MH, Arora M, Luna R, Ellen JM. Nutrition education via a touchscreen: a randomized controlled trial in Latino immigrant parents of infants and toddlers. Acad Pediatr. 2012 Sep-Oct;12(5):412-9. doi: 10.1016/j.acap.2012.03.020. Epub 2012 Jun 7.
Clinical trial NCT06386692: Community Based Promotion of Physical Activity in Nepal (COBIN-PA)
Official title: Community-based Promotion of Physical Activity in a Semi-urban Area of Pokhara Metropolitan City, Nepal: a Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Exercise
Keywords: Physical activity
Non-communicable disease
Nepal
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Globally, one in four adults does not meet the WHO-recommended level of physical activity. Insufficient physical activity is the fourth leading risk factor, contributing to 9% of global premature mortality. PA is effective in weight management, cardiorespiratory fitness, and increasing quality of life. However, there is lack of evidence on effectiveness on promoting physical activity in community level. The aim of the study is to test the effectiveness of Female Community Health Volunteers (FCHVs)-led community-based educational program on physical activity promotion in community level. This is an open label cluster-randomized controlled trial with 1:1 allocation where FCHVs will deliver a family-based education for the promotion of physical activity at community level in Nepal. The intervention package will be guided by Theory of planned behavior and will contain home-based interactive health education sessions focused on increasing PA in a household setting. FCHVs will use resource materials for health education. The mixed-effect linear regression model will determine the adjusted interaction between time and intervention. The results of this study will show the changes in the mean moderate to vigorous physical activity minutes per day due to time intervention interaction. The evidence generated from this study will help to provide new knowledge on the community-based promotion of Physical Activity and its effectiveness for policymakers and researchers. It will hopefully support the attainment of the national and global target of reducing insufficient physical activity.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 69 years
* without the intention of migrating out of the area for the next 6 months

Exclusion Criteria:

* Those severely ill
* History of mental illness
* Decline to provide consent

Primary outcomes:
measure: Mean moderate to vigorous physical activity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pokhara
country: Nepal
facility: Nepal Development Society
state: Gandaki
Study officials:
References:
Clinical trial NCT00225992: Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
Official title: A Phase II Research Study of Arsenic Trioxide (Trisenox) in Patients With Myelodysplastic Syndrome (MDS)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Myelodysplastic Syndrome (MDS)
Lead sponsor: Oncology Specialties, Alabama
Sponsor class: OTHER
First posted: 2005-09-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: In this phase II study besides evaluating for safety, the primary efficacy parameter is to evaluate the incidence of patients who have had a response to Trisenox by evidence of increased blood counts (red, white, or platelets) and/or by decrease or transfusion dependency. The secondary efficacy parameter is the assessment of the tolerability of the new dosing schedule.

Arsenic trioxide will be administered intravenously over 1 to 2 hours with a loading dose of 0.30mg/kg for days 1-5 of the first week and then twice weekly for 27 weeks for a total of 28 weeks.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Myelodysplastic Syndrome by FAB. Can be made with cytogenetic analysis of Bone Marrow or Hematologist evaluation
* Patient must have had bone marrow biopsy and aspiration to confirm diagnosis within 60 days prior to treatment
* ECOG performance status of 0-2
* An EKG must be performed within 7 days prior to treatment to confirm QT interval \<460msec.
* Serum creatinine less than or equal to 2.5 times the upper limit of normal.
* Serum bilirubin less than or equal to 2.5 times the upper limit of normal.
* Serum potassium greater than or equal to 4.0 mEq/dL and serum magnesium greater than or equal to 1.8 mg/dL. If these serum electrolytes are below the specified limits on the baseline laboratory tests, electrolytes should be administered to bring the serum concentrations to these levels before administering arsenic trioxide.
* Patients must be 18 years of age to participate in this study

Exclusion Criteria:

* Pregnant or nursing women, and men or women of childbearing potential who are unwilling to employ adequate contraception.
* Corrected QT interval of greater than or equal to 460msec in the presence of serum potassium and magnesium values within normal range.
* Significant CHF, coronary is ischemia or serious Arrhythmias including conduction delays.
* Peripheral neuropathy greater than or equal to 2.
* Evidence of active infection
* Concurrent treatment with maintenance therapy, cytotoxic chemotherapy, radiation, or investigational agents.
* Inability or unwillingness to comply with the treatment protocol, follow up, or research tests.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Comprehensive Cancer Institute
state: Alabama
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute
state: Alabama
Study officials:
affiliation: Oncology Specialties, PC
name: John M. Waples, MD
role: PRINCIPAL_INVESTIGATOR
References: