louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04912050: EXtension of Tablo TrEatmeNt Duration Registry
Official title: EXtension of Tablo TrEatmeNt Duration Registry (XTEND)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Renal Disease (ESRD)
End Stage Renal Disease on Dialysis
Acute Kidney Injury
Keywords: Tablo
Outset Medical
Hemodialysis
AKI
ESKD
Lead sponsor: Outset Medical
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \> 12 hours.

Brief summary: Observational, retrospective and prospective, multicenter, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Kidney Disease or Acute Kidney Injury who are prescribed renal replacement therapy \> 12 hours.


Eligibility criteria: Inclusion Criteria:

* Participant weighs ≥ 34kg.
* Participant is hospitalized and has dialysis dependent End-Stage Kidney Disease or Acute Kidney Injury and is prescribed renal replacement therapy \> 12 hours.

Exclusion Criteria:

* Any documented condition that the Physician feels would prevent the participant from successful inclusion in the study.

Primary outcomes:
measure: Treatment Success
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Tablo Cartridge Life
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: St. Mark's Hospital
state: Utah
Study officials:
References:
Clinical trial NCT04087850: Encouraging Social Inclusiveness as a Means to Improving Academic Performance
Official title: Encouraging Social Inclusiveness as a Means to Improving Academic Performance for Children at Risk Attention-Deficit/Hyperactivity Disorder (ADHD) and Typical Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: peer relationships
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 558
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children's peer relationships in elementary school are important to promote their academic learning and their social-emotional development. Many children with or at risk for Attention-Deficit/Hyperactivity Disorder (ADHD) have difficulty being accepted and getting along with their classroom peers. This study tested a classroom intervention that aimed to help improve the peer relationships of elementary school age children, with a particular focus on children with or at risk for ADHD.


Eligibility criteria: Inclusion Criteria:

-General education teachers of grades K-5 or children in these teachers' classrooms

Exclusion Criteria:

-None

Primary outcomes:
measure: Children's Peer Relationships - Peer Report
timeFrame: Change from baseline to post-test (approximately 7 months after baseline)
measure: Children's Peer Relationships - Child Self-Report
timeFrame: Change from baseline to post-test (approximately 7 months after baseline)
measure: Children's Peer Relationships - Teacher Report
timeFrame: Change from baseline to post-test (approximately 7 months after baseline)
Secondary outcomes:
measure: Children's Academic Functioning - Teacher Report
timeFrame: Change from baseline to post-test (approximately 7 months after baseline)
measure: Children's Academic Functioning - Teacher Report
timeFrame: Change from baseline to post-test (approximately 7 months after baseline)
measure: Children's Academic Functioning - Grades
timeFrame: Change from baseline to post-test (approximately 7 months after baseline)
measure: Children's Social Behaviors - Observations
timeFrame: Change from baseline to post-test (approximately 7 months after baseline)
measure: Children's Social Behaviors - Observations
timeFrame: Change from baseline to post-test (approximately 7 months after baseline)
measure: Children's Problem Behaviors - Teacher Report
timeFrame: Change from baseline to post-test (approximately 7 months after baseline)
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Amori Mikami, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio University
name: Julie Owens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06650150: Respiratory Muscle Strength and Exercise Capacity in Smokers
Official title: Comparative Study on Respiratory Muscle Strength and Exercise Capacity in Smokers With COPD, PRISm and Pre-COPD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD - Chronic Obstructive Pulmonary Disease
Keywords: PRISm
Pre-COPD
COPD
MIP
6mwt
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of symptomatic smokers admitted to the pulmonary outpatient clinic of Muğla Training and Research Hospital between July 2024 and December 2024.

Brief summary: This cross-sectional study aims to evaluate the respiratory muscle strength and physical capacity of symptomatic adult smokers in Muğla. The study population will be the patients who were admitted to the pulmonary outpatient clinic of Muğla Training and Research Hospital between July 2024 and December 2024. The primary outcome is the proportion of individuals with Maximum Inspiratory Pressure (MIP) below 80%. Secondary outcomes include the 6-Minute Walk Test (6MWT) distance, Maximum Expiratory Pressure (MEP), and COPD Assessment Test (CAT) scores. Smokers will be categorized into COPD, PRISm, and Pre-COPD groups. The study will adjust for BMI as a key confounder and assess the modifying effects of gender, smoking habits, and age. Ethical approval and informed consent will be obtained, with data analysis focusing on descriptive statistics, comparative analysis, and regression models to understand the impact of smoking on respiratory health.


Eligibility criteria: Inclusion Criteria:

* At least 5 packages of cigarette smokers who have an appropriate PFT done at our lab. (pulmonary function test must be performed at evaluable standards according to ERS/ATS guidelines)

Exclusion Criteria:

* Respiratory infection at the time of measurement (upper or lower resp. tract, viral or bacterial infections)
* Presence of chronic respiratory diseases (Asthma, IPF, Bronchiectasis, \[except COPD\])
* Exacerbation due to chronic respiratory diseases (except mild COPD exacerbation)
* Neuromuscular disease (ALS, Guillain-Bare syndrome, Muscular dystrophies, Myasthenia gravis)
* Restrictive pulmonary disease (IPF, Sarcoidozis, Progresif Pulmonary Fibrosis)

Primary outcomes:
measure: MIP
timeFrame: day 1
Secondary outcomes:
measure: MEP
timeFrame: day 1
Other outcomes:
measure: 6MWT
timeFrame: day 1
Locations:
city: Muğla
country: Turkey
facility: Muğla Training and Research Hospital
Study officials:
References:
Clinical trial NCT05725850: The Effect of an Experimental Gel Based on Acmella Oleracea Extract in Reducing Post-bleaching Tooth Sensitivity
Official title: Evaluation of the Effect of an Experimental Gel Based on Jambu Extract ( Acmella Oleracea) in Reducing Post-bleaching Tooth Sensitivity : a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Bleaching
Pain
Dentin Desensitizing Agents
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind clinical trial aimed to evaluate the effect of an experimental gel containing 10% jambu extract (Acmella Oleracea) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. The volunteers of this study were randomized into two different groups - GE (A. Oleracea extract at 10%) and GP (placebo). The dental elements of the GE received application of the experimental desensitizing gel on the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active way, for 10 minutes. The GP group also received the application of a placebo gel (without active ingredient), under the same conditions described for the experimental gel. Subsequently, all groups underwent in-office bleaching treatment with 35% hydrogen peroxide.Post-bleaching sensitivity was collected through a form composed of the visual analogue scale (VAS). Color measurement was performed at two times: baseline (Ti) and one week after the 3rd bleaching session (Tf).


Eligibility criteria: Inclusion Criteria:

* good oral hygiene
* absence of active caries lesions
* never having undergone previous whitening therapy
* not present dental hypersensitivity
* don't be a smoker
* not be pregnant
* present at least 28 teeth in the oral cavity.

Exclusion Criteria:

* volunteers who were under orthodontic treatment,
* presence of periodontal disease
* dental cracks or fractures
* restorations and prostheses on anterior teeth
* extensive molar restorations
* gastroesophageal disorders
* severe internal dental darkening
* presence of dentinal exposure in anterior and / or posterior teeth.

Primary outcomes:
measure: Assessment of post bleaching sensitivity
timeFrame: 21 days
Secondary outcomes:
measure: Color evaluation
timeFrame: Baseline (Ti) and one week after the 3rd whitening session (Tf).
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Federal University of Para
state: PA
Study officials:
References:
Clinical trial NCT06024850: Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)
Official title: Predictive Factors of Good Results After Multiligamentar Knee Reconstruction (MLKR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Ligament Injury
Keywords: Multiligamentar
injury
knee
magnetic resonance imaging (MRI)
knee reconstruction
knee dislocation
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 80
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: Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne will be included.

Brief summary: Multiligamentar knee injury has consequences on knee function (instability, arthritis, life disagreement). Surgical reconstructions have known recent evolutions. The goal of this study is to evaluate functional and clinical results at one year of those new surgical technics. A clinical and functional follow up will be performed before the surgery, then at 6 months and one year.

Detailed description: Patients will also benefit of a Magnetic Resonance Imaging (MRI) and isokinetic evaluations at one year.

Eligibility criteria: Inclusion Criteria:

* Any patient who benefits of a multiligamentar knee reconstruction at hospital of Saint-Etienne

Exclusion Criteria:

* Refusal

Primary outcomes:
measure: Functional score : International Knee Documentation Committee (IKDC)
timeFrame: Months : 0, 6 and 12
Secondary outcomes:
measure: Functional score : Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Months : 0, 6 and 12
measure: Visual Analogue Scale (VAS) scale
timeFrame: Months: 0, 6 and 12
measure: Laxity
timeFrame: Month : 12
measure: Joint amplitudes
timeFrame: Months: 0, 6 and 12
measure: Clinical data
timeFrame: Month : 0
measure: Recovery of muscle function
timeFrame: Month : 12
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Thomas NERI, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01477450: Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Official title: Comparison of Oxygen Delivery Devices for Reversal of Altitude-Induced Hypoxemia in Normal Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxemia
Hypobaric Hypoxemia
Keywords: Hypobaric hypoxemia
Altitude
Oxygen
oxygen concentrator
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: United States Air Force
First posted: 2011-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the ability of pulsed-dose oxygen from a concentrator to reverse altitude-induced hypoxemia compared to compressed gas from a standard oxygen cylinder.

Detailed description: Subjects will be monitored non-invasively with pulse oximetry, end-tidal carbon dioxide, tissue oxygenation and ECG. The mean seal level oxygen saturation will be recorded.Subjects exposed to an altitude of 14,000 feet will experience moderate hypobaric hypoxia. The mean oxygen saturation at this altitude is 83%. Subjects will receive oxygen from both an oxygen concentrator or a cylinder of oxygen following exposure to hypobarism. Oxygen from each source will be increased in 1 liter per minute increments until the oxygen saturation returns to the baseline sea level oxygen saturation.

The oxygen requirement to return oxygen saturation to baseline values will be recorded. The flow from the concentrator and the cylinder will be compared.

Eligibility criteria: Inclusion Criteria:

* Current altitude chamber certification
* Age 18 years - 60 years

Exclusion Criteria:

* Current upper respiratory infection
* Current symptoms of lower respiratory infection -- productive cough

Primary outcomes:
measure: Return of Oxygen Saturation to Baseline (Sea Level) Values
timeFrame: 50 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Brooks City Base
state: Texas
Study officials:
affiliation: University of Cincinnati
name: Richard Branson, MSc RRT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03787550: PK/PD of the Sedatives, Analgesics and Antibiotics in Patients Receiving ECMO
Official title: Pharmacokinetics/Pharmacodynamics of the Sedatives, Analgesics and Antibiotics in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Drug Effect
Keywords: ECMO
Sedatives
Analgesics
Antibiotics
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients undergoing ECMO will be invited to participate. At least 2-12 subjects will be enrolled to build a pharmacokineic model for each drug, and 1-4 subjects for external validation for each drug. The investigators plan to study the sedatives, analgesics and antibiotics with the initial sample size at 36 in total.

Brief summary: It is a multi-center, open-label, observational study aimed to understand the pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by measuring the plasma concentrations and the clinical effect of dexmedetomidine, midazolam, butorphanol, remifentanil, sufentanil, propofol, linezolid, tigecycline, teicoplanin, caspofungin, voriconazole and meropenem.


Eligibility criteria: Inclusion Criteria:

* Patient given the sedatives, analgesics and antibiotics of interest during ECMO.
* Age from 18 to 85 years old.
* Multiple blood sampling is acceptable.

Exclusion Criteria:

* Patients who are allergic to the investigated drugs.
* Patients who are pregnant.

Primary outcomes:
measure: Minimum Plasma Concentration [Cmin]
timeFrame: Up to 24 hours.
measure: Area Under the Curve [AUC]
timeFrame: Up to 24 hours.
measure: Maximum Plasma Concentration [Cmax]
timeFrame: Up to 24 hours.
Secondary outcomes:
measure: ICU mortality
timeFrame: Up to 60 days.
measure: Hospital mortality
timeFrame: Up to 60 days.
measure: Mechanical ventilation duration
timeFrame: Up to 60 days.
measure: ICU length of stay (LOS)
timeFrame: Up to 60 days.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Guandong General Hospital
name: Chunbo Chen, Ph. D.
role: STUDY_CHAIR
References:
Clinical trial NCT06249750: Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer
Official title: Clinical Application of Near-infrared Whole Body Heat Shock Multimodal Technique in Treatment of Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Castration-resistant Prostate Cancer (CRPC)
Keywords: hyperthermia, immune checkpoint inhibitor, RTK inhibitor, CRPC
Lead sponsor: Zhejiang Hospital
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, we propose to use the combination of ET-SPACE NIR irradiation whole-body thermal stimulation, ICI (Tislelizumab), and RTK inhibitor (Anlotinib) in the multimodal treatment of CRPC.

Detailed description: The initial efficacy and safety of the multimodal therapy will be evaluated at the animal level to fully validate the potential feasibility of the therapy. Subsequently, the efficacy of the multimodal therapy will be verified at the organoid level, and based on which a translational randomized controlled clinical trial will be conducted to evaluate the efficacy and safety of the multimodal therapy at the human level, and the patients will be followed up for a long period of time, so as to collect detailed data on improvement of the quality of life. Finally, the synergistic effect of the multimodal therapy will be analyzed at the molecular and cellular levels.

Eligibility criteria: Inclusion Criteria:

* Histopathologically confirmed diagnosis of PC and clinically confirmed diagnosis of CRPC;
* Complete and reliable medical history and medical records;
* No other primary tumors except CRPC;
* Blood tests, liver function, renal function and electrocardiogram are basically normal;
* Patients with ECOG score 0\~3, aged ≥18 years and \<90 years old;
* Patients with good compliance, able to accept regular follow-up.

Exclusion Criteria:

* History of malignant tumor other than PC within the past 5 years;
* Severe abnormalities in the patient's laboratory indices may jeopardize patient safety or compromise this study;
* Accompanied by severe underlying diseases that cannot tolerate this therapy;
* With acute diseases, such as acute infection, active bleeding;
* Those who have recently participated in other clinical trials and have not passed the washout period;
* Those who cannot tolerate systemic heat stress, such as claustrophobic patients;
* Those who have a history of allergy to the drugs used in the trial;
* Patients with other reasons for not being able to be enrolled in the study, according to the study doctor.

Primary outcomes:
measure: Biochemical objective response rate (BORR)
timeFrame: 3 weeks
Secondary outcomes:
measure: Bio-Disease Control Rate （BDCR）
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT04219150: Cardiometry Versus Fluid and Catheter Treatment Trial (FACTT Lite) on Fluid Management in Acute Respiratory Distress Syndrome Patients
Official title: Comparative Study Between Cardiometry Versus Fluid and Catheter Treatment Trial (FACTT Lite) on Fluid Management in Acute Respiratory Distress Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Fluid Management
Cardiometry
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study will be to compare the fluid management in acute respiratory distress syndrome ARDS guided by electrical cardiometry (EC) versus the guidance with simplified conservative fluid protocol, Fluid and Catheter Treatment Trial "FACTT Lite". Group (A) consists of 35 patients: Fluid management in this group will follow a simplified conservative fluid protocol, "FACTT Lite" The FACTT Lite provided three possible instructions determined by the CVP and urine output: furosemide administration, fluid bolus, or no intervention. Group (B) consists of 35 patients: Fluid will be allowed according to an FTc-based fluids algorithm protocol and the type of bolus fluids will be determined according to Transthoracic fluid content (TFC), vasopressors and inotropes will be given according to reading of EC reading of systemic vascular resistance (SVR) and index of contractility (I CON).


Eligibility criteria: Inclusion Criteria:

* Acute onset within one week
* Mild to moderate ARDS (FiO2/PaO2) less than 300 mmHg and more than 100 mmHg with a minimum PEEP of 5 cmH2O
* Bilateral lung opacities consistent with pulmonary edema on chest radiogram or lung ultrasound, cardiac failure, and fluid overload should be excluded in the absence of a definite cause of ARDS
* ARDS due to pulmonary cause.

Exclusion Criteria:

* Hemodynamic instability, patients on vasopressor,
* Barotrauma
* organ/s dysfunction at presentation.
* Pregnant

Primary outcomes:
measure: Percentage of mortality at 28th day
timeFrame: 28 day
Secondary outcomes:
measure: Oxygenation index
timeFrame: 28 day
measure: Lung injury score
timeFrame: 28 day
measure: Duration of mechanical ventilation
timeFrame: 28 day
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbiaa
Study officials:
References: