louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06642116: Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
Official title: Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rhinosinusitis Chronic
Wound Healing
Sinus Surgery
Mometasone Furoate
Lead sponsor: Polyganics BV
Sponsor class: INDUSTRY
Collaborators: name: NAMSA
First posted: 2024-10-15
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: DEVICE_FEASIBILITY

Brief summary: The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in patients undergoing nasal/sinus surgery.


Eligibility criteria: Inclusion Criteria:

1. Patient is 18 years or older
2. Patient is scheduled to undergo bilateral endoscopic sinus surgery for Chronic Rhinosinusitis with nasal polyps (CRSwNP) or Chronic Rhinosinusitis without nasal polyps (CRSsNP)
3. Patient is willing and able to comply with all study elements as indicated by their written informed consent
4. Patients with a pre-operative Lund-MacKay score of ≥ 6.

Exclusion Criteria:

1. Patient is pregnant or nursing
2. Patients with a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months
3. Patients with a platelet disorder
4. Patients with a known or suspected allergy to device components
5. Patients with known hemophilia
6. Patients with insulin dependent diabetics
7. Patients with an oral steroid dependent condition
8. Patients with glaucoma, ocular hypertension, posterior subcapsular cataracts
9. Patients with a (previous) diagnosis of Samter's Triad (aspirin-exacerbated respiratory disease (AERD))
10. Patients that require nasal ointments or creams at time of device placement
11. Patients with a neurological, medical, psychiatric condition, or social circumstance that would potentially increase risk, interfere with study participation, or confound interpretation of study data
12. Patients with plans to (or otherwise anticipate the need to) undergo an ear, nose, throat (ENT) procedure within the 90 day study follow up
13. Patients participating in another clinical research study (within 30 days prior to screening up till 90 days post-operative).
14. Patients that used any form of corticosteroid or immunologics within 2 weeks prior to sinus surgery or during follow-up to day 30.

Primary outcomes:
measure: Safety
timeFrame: Up to 25 days after surgery
measure: Performance
timeFrame: Up to 25 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06785324: Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)
Official title: Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With ALL: NEOMA ALL Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Philadelphia Chromosome Negative
B Cell Acute Lymphoblastic Leukemia (B-ALL)
B-ALL
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial aims to assess the effect of nutrition and exercise on muscle and adiposity in adults with Philadelphia Chromosome (Ph) Negative B-ALL undergoing inpatient induction therapy.

Participants will take part in 2 different interventions:

* Nutrition Intervention
* Physical Exercise Intervention

All subjects will be provided with a wearable electronic activity monitor (FitBit®) to assist in recording activity levels in minutes of activity.


Eligibility criteria: Inclusion Criteria:

* New Diagnosis of Philadelphia Chromosome Negative B-ALL
* Receiving intensive pediatric-inspired induction chemotherapy

Exclusion Criteria:

* BMI ≤18.5 kg/m2 at time of diagnosis
* Unable to comply with both the recommended diet and exercise regimen as deemed by the research or treatment team
* Pregnant

Primary outcomes:
measure: Feasibility of nutrition and exercise intervention
timeFrame: End of study recruitment (approximately 1 year)
Secondary outcomes:
measure: Adherence to dietary intervention
timeFrame: 22 days
measure: Adherence to exercise intervention
timeFrame: 22 days
measure: Usability of interventions
timeFrame: 22 days
measure: Body composition changes - Visceral Adiposity
timeFrame: 22 days
measure: Body composition changes - Sarcopenia (SMI)
timeFrame: 22 days
measure: Impact on minimal residual disease (MRD)
timeFrame: 22 days
measure: Impact on Treatment toxicities
timeFrame: 22 days
measure: Changes to the Host Metabolome
timeFrame: 22 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine Comprehensive Cancer Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Wendy Stock
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06219824: Clinical and Radiographic Evaluation of Bioceramic Putty MTA Versus MTA in Pulpotomy of Immature Permanent Molars
Official title: Clinical and Radiographic Evaluation of Bioceramic Putty Mineral Trioxide Aggregate Versus Mineral Trioxide Aggregate in Pulpotomy of Immature Permanent Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Pulpotomy
Deep Caries
Keywords: Immature permanent molars,
young permenent molars
pulpotomy
vital pulp therapy
deep caries
Putty MTA
bioceramic MTA
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to evaluate the clinical and radiographic success of bioceramics putty MTA versus MTA in the pulpotomy of immature permanent molars

The main question it aims to answer is:

Will the biocermaics putty MTA have higher clinical and radiographic success rates than MTA in pulpotomy of immature permanent molars?

Detailed description: limited clinical trials have reported the clinical and radiographic outcomes after pulpotomy with premixed putty bioceramic MTA and conventional MTA in young permanent molars.

MTA has various drawbacks, such as difficulty in handling, long setting time, discoloration of the tooth, and its form as a powder/liquid which raise the responsibility for major material waste. To conquer these issues, bioceramic materials have been developed premixed putty bioceramic MTA is a ready-to-use material for immediate placement with zero waste, saving cost and chair time. Thus, the present study aims to evaluate bioceramic putty MTA's clinical and radiographic success versus MTA in pulpotomy of immature permanent molars.

Eligibility criteria: Inclusion Criteria:

* Patients aged from 6-8 years of both sexes have immature permanent molars
* with deep carious lesions indicated for pulpotomy.
* Restorable young permanent molars with no clinical symptoms of irreversible pulpitis.
* Permanent molars without any clinical sign of pulp necrosis including swelling, fistula, pain on percussion, and pathologic tooth mobility.
* Permanent molars without any adverse radiographic findings including thickening of the periodontal ligament space, radiolucency at the interradicular or periapical regions
* permanent molars without internal and external root resorption, or calcification in pulp tissue.

Exclusion Criteria:

* Medically compromised patients who have systemic disease.
* Uncooperative patients who refuse treatment.
* Permanent molars that were previously restored.

Primary outcomes:
measure: Primary Outcome
timeFrame: 24hrs, 1 week
Secondary outcomes:
measure: Secondary outcome
timeFrame: 6,12 month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT05598424: CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps
Official title: Establishment of CST1 Predictive Model of Oral Glucocorticoid Therapy Sensitivity for Chronic Rhinosinusitis With Polyps
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Glucocorticoids
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. Glucocorticoids sensitivity is significantly correlated with CST1 level in nasal secretions. The goal of this single-arm clinical trial based on a multicenter platform is to test CST1 in patients with chronic rhinosinusitis and nasal polyps before and after oral glucocorticoid therapy. Endoscopic polyp score, Total Nasal Symptom Score(TNSS), SNOT-22 score and other biomarkers are also evaluated before and after the treatment. Researchers will develop a CST1 predictive model of oral glucocorticoid therapy for Chronic Rhinosinusitis with Polyps.


Eligibility criteria: Inclusion Criteria:

1. All meet the diagnostic criteria of CRSwNP in EPOS2020 (Age 18-70 years old);
2. Investigator-assessed endoscopic bilateral Nasal Polyp Size Score (NPSS) was greater than or equal to 4 (minimum score of 2 per nasal cavity);

Exclusion Criteria:

1. Oral glucocorticoid contraindications, such as diabetes, femoral head necrosis, gastric ulcer, etc.
2. Medication history of oral glucocorticoids or immunomodulator within 1 months before enrollment, antibiotics within 2 weeks;
3. fungal sinusitis, allergic fungal sinusitis (AFRS), cystic fibrosis, primary ciliary dyskinesia

Primary outcomes:
measure: The change in endoscopic polyp score
timeFrame: Baseline, week 4, week 6
Secondary outcomes:
measure: The change in Total Nasal Symptom Score
timeFrame: Baseline, week 4, week 6
measure: The change in SNOT-22 score
timeFrame: Baseline, week 4, week 6
measure: The change in asthma ACQ Score
timeFrame: Baseline, week 4, week 6
measure: The change of CST1
timeFrame: Baseline, week 4, week 6
measure: The change of biomarker
timeFrame: Baseline, week 4, week 6
measure: The change in AE / SAE recording
timeFrame: Baseline, week 4, week 6
measure: The change of inflammatory cell
timeFrame: week 4, week 6
measure: The change of serum cortisol
timeFrame: Baseline, week 4, week 6
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Luo Zhang
role: STUDY_CHAIR
References:
Clinical trial NCT03069924: Gain-framed Messages and NRT for Lung Cancer Screening Patients
Official title: Gain-framed Messages and NRT Sampling to Promote Smoking Cessation in Lung Cancer Screening Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer Screening
Smoking Cessation
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-03-03
Enrollment: 367
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs).


Eligibility criteria: Inclusion Criteria:

1. 50 years or older
2. at least a 20-pack year history of smoking
3. current smoker (defined as any smoking in the past 30 days)
4. willing to be randomized
5. English speaking

Exclusion Criteria:

1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
2. known allergy to adhesives
3. being in the immediate (within 2 weeks) post myocardial infarction period
4. serious arrhythmias
5. unstable angina pectoris
6. hemodynamically or electrically unstable.
7. current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)

Primary outcomes:
measure: Smoking Cessation - Available Data
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Cigarettes Smoked Per Day - Average
timeFrame: 6 month follow-up
measure: Smoking Cessation - Imputed
timeFrame: 6 Month Follow up Visit
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Benjamin Toll, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Alana Rojewski, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02924324: Local Injection of Pain Medication to Reduce Pain After Bone Marrow Procedures in Pediatric Neuroblastoma Patients
Official title: RePPAIR -Reducing Procedural Pain and Improving Recovery of Quality of Life in Pediatric Neuroblastoma Patients Undergoing Bone Marrow Procedures: A Prospective Randomized Cross-over Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroblastoma
Keywords: local Injection
pain Medication
propofol
ropivacaine
16-1417
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 56
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to identify whether or not the addition of a numbing medicine that is injected directly into the site of the bone marrow procedure can reduce pain and the use of opioid pain medication after bone marrow procedures. The addition of this medicine, called ropivacaine, is the experimental part of this study. This is the first time ropivacaine will be directly injected into the bone marrow site at MSKCC Pediatrics.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of neuroblastoma as defined by the International Neuroblastoma Risk Group Staging System (INRGSS)22
* 3 - 18 years of age
* Patient has had prior bone marrow procedures
* English speaking

Exclusion Criteria:

* History of allergy to investigational agent: ropivacaine or other amino amide analgesics
* History of allergy to standard agent: propofol
* Chronic daily opioid requirement
* Lansky/Karnofsky Score \< 60
* Inability to comply with protocol requirements including refusal to forego pre-procedural opioid use
* Patient is receiving additional potentially painful interventions (e.g. central line insertion/removal) concurrent with the bone marrow procedure

Primary outcomes:
measure: Number of Participants Requiring Post-procedural Opioid Analgesia Per Study Arm
timeFrame: within 24 hours (+/- 4 hours) post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ellen Basu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zarnegar-Lumley S, Lange KR, Mathias MD, Nakajima-Hatano M, Offer KM, Ogu UO, Ortiz MV, Tan KS, Kellick M, Modak S, Roberts SS, Basu EM, Dingeman RS. Local Anesthesia With General Anesthesia for Pediatric Bone Marrow Procedures. Pediatrics. 2019 Aug;144(2):e20183829. doi: 10.1542/peds.2018-3829.
Clinical trial NCT05338424: Exercise Target Brain Oscillations in Psychosis
Official title: Sprint Interval Training to Target Brain Oscillations in Psychosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Psychosis
Schizophrenia
Schizoaffective Disorder
Keywords: Psychosis
Schizophrenia
Schizoaffective Disorder
Exercise
Cognition
Attention
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals in good health with a psychotic disorder.

Brief summary: Previous studies have shown that cardiorespiratory fitness (how well the heart and lungs are able to function during physical activity) is often reduced in people with psychosis. The goal of this research study is to test the hypothesis that aerobic exercise can lead to small changes in brain functioning that can influence visual perception and attention in psychosis. The type of aerobic exercise used in this study is called Sprint Interval Training, or "SIT". Information from this study will help to develop interventions that enhance cognition and maximize the quality of life for persons living with psychosis.

The exercise procedure used is called SIT, which involves training rigorously on a stationary bike for a short period of time followed by a resting period.


Eligibility criteria: Inclusion Criteria:

* Meet diagnostic criteria for schizophrenia or schizoaffective disorder
* Are age 18-64
* Fluent in written and spoken English
* Have an outpatient status of at least 1 month prior to participation
* Has been on a stable dose of psychiatric medication for at least one month prior to participation (titration to a lower dose of psychotropic medications under supervision of a psychiatrist can be allowed at the discretion of the investigators)

Exclusion Criteria:

* Current or possibility of current pregnancy (self-reported)
* Active suicidal ideation at screening or baseline assessments, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months, as indicated by the C-SSRS
* WTAR standardized score below 70
* American College of Sports Medicine contraindication to exercise

Primary outcomes:
measure: Change in Individual Alpha Frequency
timeFrame: through study completion, on average 2 weeks
measure: Change in Visual Attention
timeFrame: through study completion, on average 2 weeks
measure: Change in Visual Perception
timeFrame: through study completion, on average 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Ian Ramsay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02447224: Pilot Trial of Antibiotics Versus Surgery for Treating Acute Appendicitis
Official title: A Pilot Study for a Randomized Trial of Antibiotics Versus Surgery for Treatment of Patients With Acute Uncomplicated Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acute Uncomplicated Appendicitis
Keywords: appendicitis
non operative management
appendectomy
Lead sponsor: Olive View-UCLA Education & Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The major goal of the project is to demonstrate the feasibility of conducting a multi-center randomized clinical trial of antibiotic therapy versus appendectomy for the treatment of patients with acute uncomplicated appendicitis by conducting a single-site pilot study so as to optimize the chance of a large multi-center clinical trial's future success.

Detailed description: This will be a single-site open clinical trial in which subjects with acute uncomplicated appendicitis are randomized to one of two initial treatment strategies, surgery with peri-operative antibiotics or antibiotics alone, with surgical rescue if necessary.

Eligibility criteria: Inclusion Criteria:

* Adult or child ages ≥5 years;
* Diagnosis of acute uncomplicated appendicitis, confirmed by CT, ultrasound and/or MRI performed within 24 hours of consent, as read by an attending radiologist, and confirmed by consultation of an attending surgeon;
* Ability to provide written informed consent (and for subjects ages 5-17, consent from their parent/guardian and assent if applicable); and
* Negative pregnancy test for subjects who are women of childbearing potential.

Exclusion Criteria:

* instability/severe sepsis, appendiceal perforation by imaging, serious co-morbidities limiting randomization, pregnancy, and inability to complete the treatment protocol.

Primary outcomes:
measure: Major Complications
timeFrame: 30 days
Secondary outcomes:
measure: Recurrent appendicitis
timeFrame: 30 days
measure: QOL outcomes
timeFrame: 30 days
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
Study officials:
References: