louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06910072: Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer
Official title: Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Triple-Negative Breast Cancer (TNBC)
Neoadjuvant Therapy
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-arm, multicenter study to observe and evaluate the efficacy and safety of paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab in neoadjuvant therapy for triple-negative breast cancer. The main endpoint of the study is pCR, 32 patients are scheduled to be enrolled.


Eligibility criteria: Inclusion Criteria:

* Triple-negative breast cancer
* The diameter of the primary tumor must be greater than 2cm, and the clinical stage should be II-III
* There is sufficient primary organ function
* The ECOG (PS) score is 0 or 1
* Expected survival ≥ 6 months
* The serum pregnancy test was negative. Use highly effective methods of contraception during the study period and for 180 days after the last dose of the study drug, and do not breastfeed

Exclusion Criteria:

* Bilateral breast cancer
* There is a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
* A history of invasive or metastatic breast cancer
* Any malignancy diagnosed within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma
* There is an immune deficiency disease
* The presence of any autoimmune disease that still requires treatment or a history of prior autoimmune disease

Primary outcomes:
measure: Primary endpoint
timeFrame: After surgery（within 1 month）
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: During neoadjuvant therapy before surgery（within 6 months）
measure: The rate of event-free Survival (EFS)
timeFrame: 2-year
measure: The incidence of treatment-related adverse event
timeFrame: 2-year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
Study officials:
References:
Clinical trial NCT02022072: Evaluation of Vital Capacity
Official title: Measurement of Assisted Vital Capacity to Appreciate the Level of Recruitment in Neuromuscular Diseases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Respiration Disorders
Neuromuscular Disease
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Respiratory failure is the most common cause of death in neuromuscular diseases. The aim of this research is to evaluate the thoracopulmonary recruitment by comparison of inspiratory vital capacity (VC ins)and inspiratory/expiratory vital capacity (VC ins-ex) with the vital capacity (VC) according to pathology and severity of pulmonary damage of patients with neuromuscular diseases. The methodology consists in realize VC by support of inspiratory/expiratory pressures, while the patient is passive and realizing a maximal inspiratory/expiratory effort simultaneously, with the aid of mechanical insufflation/exsufflation device (Cough Assist®). The evaluation will last for 30 minutes and the non-inclusion criteria are those for an insufflation. The study hypothesis is that long term insufflation/exsufflation device use could improve thoracopulmonary mobility.


Eligibility criteria: Inclusion Criteria:

* consent form signature
* Men and women aged over or equal to 18 years old
* Medical examination before the research
* Negative results of tests of pregnancy for the women at age to procreate or taking an effective contraceptive
* Patients with neuromuscular pathologies without tracheostmy - Vital Capacity \< 80% of theoretical value

Exclusion Criteria:

* Refuse to participate at the research
* Patient under guardianship or under trusteeship
* pregnant Women
* Patients unable to cooperate
* Patients without a security social scheme (as beneficiary or bearer of rights)
* Usual contra-indications for an insufflation (haemoptise, recent pneumothorax, pulmonary emphysema, pleuresy, nausea, chronic obstructive pulmonary diseasee or asthma, recent lobectomy, intracranial hypertension, troubles of consciousness, unable to talk)

Primary outcomes:
measure: Difference between spontaneous vital capacity and supported vital capacity at the inspiration and at inspiration/expiration at the same manoeuver.
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital R Poincare
Study officials:
References:
Clinical trial NCT00624572: Efficacy of Chlorexidine as Intracanal Medicament in Primary Teeth
Official title: Efficacy of 1% Chlorexidine Gel as Intracanal Medicament in Primary Molar Teeth - a Clinical and Microbiological Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dental Pulp Necrosis
Keywords: primary teeth
chlorexidine
root canal therapy
Pulpectomy
Lead sponsor: Universidade Federal do Ceara
Sponsor class: OTHER
First posted: 2008-02-27
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the action of the chlorexidine as intracanal medicament in the reduction of the levels of bacteria inside root canals of primary molar teeth with pulpal necrosis.


Eligibility criteria: Inclusion Criteria:

* Healthy children of both gender;
* Without history of reactions or alergical diseases;
* With situated age between 04 and 08 years of age
* With normal standard of growth and development
* Patients with necessity of radical endodontic treatment (pulpectomy) in, at least, two primary molar teeth in different hemi-arches.

Exclusion Criteria:

* Patients with history of alergical diseases
* Patients with allergy to any type of medicine and/or foods
* Patients with comprometimento of its general state of health
* Healthy patients with risk to develop bacterial endocardite or patients that their general state of health can be aggravated had the transitory bacteremies, as for example children with congenital cardiac illnesses
* Patients who are making use of sistemis antibiotics, or that they have made use of sistemic antibiotic in the period of 3 (three) months before the beginning of the endodontic treatment
* With periapical x-ray evidencing less than 2/3 of remaining root of the primary tooth to be treated
* Patients whose tooth with endodontic necessity to meet in advanced state of root pathological reabsortion
* Patients whose legal responsible or parents to refuse to sign the term of free and clarified assent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Ramille Araújo Lima
state: Ceará
Study officials:
References:
Clinical trial NCT00215072: Death Following Congenital Heart Surgery
Official title: Death Following Congenital Heart Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Heart Surgery
Congenital Heart Defects
Keywords: Death after heart surgery
surgical mortality
post-operative mortality
pediatric health
cardiac
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the congenital surgery database

Brief summary: The purpose of this study is to elucidate the patterns of death following congenital heart surgery.

Detailed description: With the improvements in instrumentation, surgical technique, and critical care, the overall mortality following congenital heart surgery has become extremely low. Also, with the introduction of extracorporeal support (ECMO), especially in the emergency setting, acute deaths are extremely rare. The majority of post-operative deaths seem to be the result of a prolonged hospitalization with a progressive decline to multi-system organ failure.

The primary aim of the study is to elucidate the patterns of death following congenital heart surgery. The secondary aims of the study are to discover patterns and consistencies among the deaths and to discover points of potential intervention to reduce surgical mortality. The study will be conducted through a retrospective chart review of approximately 40 patients.

Eligibility criteria: Inclusion Criteria:

* Patients in the congenital surgery database
* Post-operative surgical mortality
* Deaths within 30 days of surgery
* Deaths prior to ever leaving the hospital

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Kogon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00694772: Coblation-Tonsillotomy vs Electrocautery-Tonsillectomy for the Treatment of Obstructive Sleep Apnea (OSA) in Children
Official title: Coblation-Tonsillotomy Versus Electrocautery-Tonsillectomy for Treatment of Moderate and Severe Obstructive Sleep Apnea in Children: A Randomized, Prospective, Single-Blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive sleep apnea
OSA
Apnea hypopnea index
AHI
Coblation
Electrocautery
Tonsillectomy
Tonsillotomy
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: ArthroCare Corporation
name: Calgary Health Region
First posted: 2008-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most frequently performed surgical procedures in North America. The two most prevalent indications for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep apnea (OSA). OSA is a common childhood condition that is characterized by upper airway obstruction, disturbed sleep and disrupted normal respiratory gas exchange. In the majority of children with OSA, overgrowth of the adenoid and tonsils is the primary underlying aetiology, making tissue removal via AT the standard of care. The purpose of this study is to evaluate the effectiveness of two different surgical techniques, electrocautery-tonsillectomy and coblation-tonsillotomy, in the treatment of obstructive sleep apnea (OSA) in children.


Eligibility criteria: Inclusion Criteria:

* Moderate or severe OSA on PSG (AHI ≥ 5.0)
* Pronounced tonsillar hyperplasia on physical exam
* No previous tonsil or adenoid surgery
* No history of recurrent tonsillitis
* Participants and their families must be willing to comply with follow-up
* Parents/caregivers fluent in English

Exclusion Criteria:

* Severe co-morbidities, including, but not limited to, poorly controlled asthma, chromosomal abnormalities, and developmental delay

Primary outcomes:
measure: Compare coblation-tonsillotomy to electrocautery-tonsillectomy as a treatment of obstructive sleep apnea (OSA), as assessed by apnea-hypopnea index (AHI) measured on polysomnography (PSG)
timeFrame: 6 months and 2 years post-op
Secondary outcomes:
measure: Evaluate post-operative pain and analgesic use associated with electrocautery-tonsillectomy and coblation-tonsillotomy
timeFrame: 1 week post-op
measure: Evaluate quality of life following coblation-tonsillotomy and electrocautery-tonsillectomy for the treatment of OSA
timeFrame: 6-8 weeks post-op
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: University of Calgary
name: Derek S Drummond, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05291572: Comparative Study Between Three Different Methods for Stuttering Therapy in Children
Official title: Comparative Study Between Three Different Methods for Stuttering Therapy in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stuttering, Childhood
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of work is comparing between three different methods for treatment of stuttering in children in order to reach to the best method for treatment


Eligibility criteria: Inclusion Criteria:

* Children from 5 to 15 years old with IQ above 80

Exclusion Criteria:

* 1 - mental disability. 2- psychiatric problem as autism or attention deficit hyperactive disease. 3. secondary stuttering. 4. Children with sever anxiety. 5. Children with history suggested epileptic fits.

Primary outcomes:
measure: Stuttering severity instrument (SSI-3)
timeFrame: before therapy
Secondary outcomes:
measure: Stuttering severity instrument (SSI-3)
timeFrame: post therapy by 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04087772: Enhancing School-Based Violence Prevention
Official title: Enhancing School-Based Violence Prevention Through Multilevel Racial/Ethnic Discrimination Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aggressive Childhood Behavior
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2019-09-12
Enrollment: 4840
Sex: ALL
Minimum age (years): 10
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare two versions of Mental Health Enhanced Positive Behavioral Interventions and Supports in reducing aggression in middle school students.


Eligibility criteria: Inclusion Criteria:

* for student participants: in 6th and 7th grades in a study school at study entry
* for teacher participants: teacher at a study school

Exclusion Criteria:

* .for student participants: intellectual disabilities, very limited reading abilities, or in foster care

Primary outcomes:
measure: Mean change from baseline in student report on aggression as measured by the Reactive and Proactive Aggression Survey
timeFrame: Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
measure: Mean change from baseline in teacher report on students' aggression as measured by the Teacher Report of Aggression
timeFrame: Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
measure: Mean change from baseline in student aggression as measured by the number of Office Discipline Referrals per month
timeFrame: From first day of school in year 1 to last day of school in year 2
Secondary outcomes:
measure: Change from baseline in student report on discrimination from teachers as measured by the Adolescent Discrimination Index - Educational Discrimination Distress Subscale
timeFrame: Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
measure: Change from baseline in student report on discrimination from peers as measured by the Adolescent Discrimination Index - Peer Discrimination Distress Subscale
timeFrame: Fall of year 1 (average of October), spring of years 1 and 2 (average of May)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Name and state withheld to protect anonyminty of study site
state: South Carolina
Study officials:
References:
Clinical trial NCT06295172: A Study Comparing Lafullen15 and Lafullen for Temporary Nasolabial Fold Improvement
Official title: A Randomized, Evaluator-blind, Matched Pairs, Prospective, Non Inferiority, Confirmatory Study to Compare the Safety and Efficacy Between Lafullen15 and Lafullen in the Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nasolabial Folds
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2024-03-06
Enrollment: 73
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Evaluator-blind, Matched pairs, Prospective, Non inferiority, Confirmatory Study
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to verify the safety and efficacy of Lafullen15 in the temporary improvement of nasolabial Folds


Eligibility criteria: Inclusion Criteria:

1. Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS)
2. Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study

Exclusion Criteria:

1. Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening
2. Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study
3. History of bleeding disorder in past or present
4. Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening
5. Administered an hyaluronic acid filler within 24 weeks of the date of the screening

Primary outcomes:
measure: Changes in WSRS at 12 months after the last application of the clinical trial medical device compared to the baseline evaluated by an independent evaluator
timeFrame: 12months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jongho KIM, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02080572: Parkinstep: Automated PD Gait and Balance Assessment for Optimizing DBS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease With Deep Brain Stimulation
Lead sponsor: Great Lakes NeuroTechnologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: University Hospitals Cleveland Medical Center
name: University of Cincinnati
name: National Institute on Aging (NIA)
First posted: 2014-03-06
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with Parkinson's disease, gait impairment, and deep brain stimulation will be recruited.

Brief summary: Changes in deep brain stimulation (DBS) settings can have a delayed effect on gait function, which makes it impractical to optimize DBS for gait parameters in the clinic. Wearable movement sensors could be used to assess gait impairment in the patient's home hours after treatment adjustments are made in the clinic. This study aims to quantitatively evaluate the effects of turning off deep brain stimulation on lower extremity and gait function over three hours. This study will provide vital information about our patient worn system's ability to detect changes in lower impairment over time, which could be used to assist with DBS tuning for the lower extremities and gait in the future.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease
* Age \> 21
* Underwent DBS surgery targeting the subthalamic nucleus (STN)
* Bilateral or midline involvement when "off" DBS/medication state
* Clinical history of gait impairment or freezing of gait

Exclusion Criteria:

* "Parkinson's plus" syndrome, secondary, or atypical Parkinson's disease
* Underwent DBS surgery targeting the ventral intermediate (VIM)
* Unable to walk independent of a wheelchair (use of assistive devices, like a cane, is okay for this study)
* Dementia (determined by a neuropsychological assessment).

Primary outcomes:
measure: Effect of DBS cessation on motor function over time
timeFrame: All data will be collected within a single session not to exceed 4 hours. All data will be analyzed within one month of study completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Case Western
state: Ohio
Study officials:
affiliation: Great Lakes NeuroTechnologies
name: Joseph P Giuffrida, PhD
role: PRINCIPAL_INVESTIGATOR
References: