louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04199650: Definition of ARDS in Qinghai Province: Verification of Berlin Definition Plateau Criteria
Official title: Definition of Acute Respiratory Distress Syndrome in Plateau of Qinghai in China: Verification of Berlin Definition Plateau Criteria
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS
High Altitude
Lead sponsor: Southeast University, China
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Qinghai University
First posted: 2019-12-16
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2018 to December 2018, patients admitted to the department of critical care, affiliated hospital of qinghai university were diagnosed with acute respiratory distress syndrome according to Berlin Definition.

Brief summary: The severity stratification criteria for acute respiratory distress syndrome (ARDS) in Xi'ning Qinghai province (mean altitude: 2200m) were clarified according to the oxygenation index (PaO2/FiO2).

Detailed description: This study is a single-center retrospective study. According to the Berlin diagnostic standard, ARDS patients admitted to the Department of severe Medicine, affiliated Hospital of Qinghai University from January 2018 to December 2018 were divided into three groups: mild (153mmHg \< PaO2/ FiO2 ≥ 230 mmHg), moderate (76mmHg \< PaO2/ FiO2 ≥ 153 mmHg) and severe (PaO2/ FiO2 ≥ 76 mmHg). The ICU mortality, 28-day mortality, non-ventilator time in ICU, ICU hospitalization time and non-I hospitalization were observed respectively. The difference of CU time and total hospitalization days.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* Meet the diagnostic criteria of ARDS
* Receive invasive mechanical ventilation

Exclusion Criteria:

* Receive a large number of hormone shock therapy in a short period of time
* Death within a short period of time (\< 24 h) after mechanical ventilation
* No chest imaging data
* Data missing

Primary outcomes:
measure: ICU mortality
timeFrame: up to 24 weeks
measure: 28-days mortality rate
timeFrame: 28 days after discharge
Secondary outcomes:
measure: Ventilator Free time
timeFrame: up to 24 weeks
measure: Ventilator time
timeFrame: up to 24 weeks
measure: Hospital length of stay
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: ChunPan
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Qinghai University
name: Liu Xiaoqin, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu X, Pan C, Si L, Tong S, Niu Y, Qiu H, Gan G. Definition of Acute Respiratory Distress Syndrome on the Plateau of Xining, Qinghai: A Verification of the Berlin Definition Altitude-PaO2/FiO2-Corrected Criteria. Front Med (Lausanne). 2022 Feb 23;9:648835. doi: 10.3389/fmed.2022.648835. eCollection 2022.
Clinical trial NCT00141050: Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Official title: Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ADHD
Keywords: ADHD, children
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare the safety and efficacy of two doses of dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD (MPH) and placebo in children ages 6-12 diagnosed with ADHD.


Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of ADHD
* Males and females aged 6-12

Exclusion Criteria:

* Inability to understand or follow instructions
* Is pregnant
* Diagnosis of tic disorder
* History of seizure disorder

Primary outcomes:
measure: Change in attention and deportment measured at 2 hours post-dose
Secondary outcomes:
measure: Onset of effect at 0.5, 1, 2, 3, 4, 6, 8, 10, 11, and 12 hours post-dose
measure: Parent's assessment of patient behavior across all treatment periods as measured by the change from baseline
measure: Safety and tolerability of two doses of dexmethylphenidate compared to two doses of an approved, long-acting, marketed medication for ADHD and placebo in children ages 6-12 diagnosed with ADHD.
Other outcomes:
Locations:
city: Houston
country: United States
facility: Bayou City Research
state: Texas
Study officials:
affiliation: Bayou City Research
name: Matthew Brams, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03141450: Plasma Concentrations of Prophylactic Cefazolin in Pediatric Patients Undergoing Cardiac Surgery With CPB
Official title: Plasma Concentrations of Prophylactic Cefazolin in Pediatric Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 18
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients whose age less than 7 years old, undergo elective cardiac surgery with cardiopulmonary bypass.

Brief summary: Surgical site infection (SSI) is a serious operative complication that may be associated with any surgical procedures. It increases morbidity and mortality after cardiac surgery. Plasma concentration of prophylactic antibiotic, routinely cefazolin, is altered by effects of cardiopulmonary bypass. This study is conducted to measure the plasma concentrations of cefazolin to determine its adequacy in pediatric patients undergoing elective cardiac surgery with cardiopulmonary bypass including its correlation with the incidence of postoperative SSI.


Eligibility criteria: Inclusion Criteria:

1. age \< 7 years old
2. undergoing elective cardiac surgery with cardiopulmonary bypass
3. receive cefazolin as prophylactic antibiotic

Exclusion Criteria:

1. Known or family history of penicillin or cephalosporins allergy
2. Coexisting liver or renal disease
3. Previous infection or received any antibiotics within 4 weeks
4. Previous surgery with median sternotomy
5. Predicted cardiopulmonary bypass time of less than 30 minutes or more than 150 minutes
6. Severe hemodynamic instability during the operation, requiring mechanical circulatory support

Primary outcomes:
measure: plasma concentration of cefazolin in pediatric cardiopulmonary bypass
timeFrame: 12 hours
Secondary outcomes:
measure: incidence of surgical site infection after elective pediatric cardiac surgery
timeFrame: 30 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: Saowaphak Lapmahapaisan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03047850: Comparison of Delta Pulse Pressure and Delta Down Before and After Sternotomy
Official title: Comparison of Delta Pulse Pressure and Delta Down Before and After Sternotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemodynamics
Keywords: Sternotomy
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 200
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: All patients scheduled for open chest surgery.

Brief summary: Delta Pulse Pressure and Delta Down have been validated in surgery upon closed chest. This study aim to evaluate the influence of sternotomy on the value of Delta Pulse Pressure and Delta Down.


Eligibility criteria: Inclusion Criteria:

* All patients scheduled for open chest surgery.

Exclusion Criteria:

* Age \< 18 years
* Patients with arrhythmia

Primary outcomes:
measure: Change of Delta Pulse Pressure Value
timeFrame: 10 minutes
measure: Change of Delta Down Value
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bouge
country: Belgium
facility: Clinique Saint-Luc of Bouge
state: Namur
Study officials:
affiliation: Astes
name: Eric DEFLANDRE, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02461550: Irreversible Electroporation Ablation for Colorectal Metastases to the Lung
Official title: Irreversible Electroporation Ablation for Colorectal Metastases to the Lung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Metastases to the Lung
Keywords: Irreversible Electroporation Ablation
15-001
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 2
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 investigators are investigating the use of a new cancer treatment called Irreversible Electroporation (IRE). This treatment delivers electrical energy between two needles placed in a cancer. The electrical energy causes cells to die. While this has been used in patients for different applications, the investigators are trying to understand how safe and well it works in colon cancer that has spread to the lung. Once the irreversible electroporation procedure is completed during the operation, the surgeon will then remove the cancer according to standard procedure. As part of the study, they will be measuring safety of the electrical energy delivered and will be reviewing the resected specimen under the microscope.


Eligibility criteria: Inclusion Criteria:

* Diagnosed Colorectal cancer with oligometastatic colorectal cancer in the lung
* Lung lesion size is greater than 1 cm
* Patient will undergo surgical resection as per consultation with their thoracic surgeon and medical oncologist
* Patient is cleared to undergo paralytic anesthesia.
* Patients 18 years old and older

Exclusion Criteria:

* Patients with history of cardiac dysrhythmia
* Known heart failure (EF \< 40%)
* Pacemaker/defibrillator
* Patient's with any metallic cardiac implant
* Patient on anti-coagulation therapy and are unable to stop therapy for the perioperative period
* Women who are pregnant and/or nursing

Primary outcomes:
measure: The Frequency of Adverse Events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan-Kettering at Basking Ridge
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Stephen Solomon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03587350: Assessing Cervical Dystonia
Official title: A Single Site, Pilot Study to Assess the Efficacy of a Novel Minimally Invasive Device to Monitor Dystonic Movements in Patients With Cervical Dystonia Receiving Botulinum Toxin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dystonia
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study involves the use of a novel, non-invasive, monitoring device to measure the response to treatment with botulinum toxin injections in 24 (16 Intervention and 8 control) patients with cervical dystonia. A baseline assessment, prior to botulinum treatment,will be structured around validated clinical rating scales for cervical dystonia and questionnaires and the performance of simple neck movements, and will be undertaken while the patient wears a movement sensor attached to the head with an elastic strap. The same assessments will be undertaken at 0, 3, 6, 9 and 12 weeks following treatment to assess response. The patients' treatment will not be affected by their participation in the research. The device readings will then be compared with the clinical ratings to establish whether it might be used as a more sensitive measure of treatment response than clinical assessment alone. This will help clinicians to plan and execute botulinum injections more effectively in future


Eligibility criteria: Inclusion Criteria:

* Male or female participants aged 18 years or older (no upper age limit) and willing and able to provide informed consent.
* Participant is able and willing to comply with the follow-up schedule and protocol.
* Participants diagnosed with cervical dystonia.
* Participant has previously received botulinum toxin therapy for cervical dystonia without adverse side effects OR is naïve to botulinum toxin therapy but is suitable to participate in the investigator's opinion

Exclusion Criteria:

* -Participated in another clinical investigation within 30 days.
* Allergy to device components or botulinum toxin.
* Medical co-morbidities that preclude botulinum toxin therapy.
* Patient is incapable of understanding or responding to the study

Primary outcomes:
measure: Successful monitoring of movement by the shimmer monitor
timeFrame: 3, 6, 9 and 12 weeks post botulinum therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
Study officials:
References:
Clinical trial NCT06612450: Turbinate Volume Reduction Under Local Anesthesia: Randomized Clinical Trial; Our Experience
Official title: Turbinate Volume Reduction Under Local Anesthesia: Randomized Clinical Trial; Our Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Turbinate Surgery
Keywords: Turbinate Hypertrophy
Coblation
Radiofrequency
Nasal obstruction
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to know which method is better in delivering radiofrequency waves for hypertrophied turbinates: coblation or RavoR technique? Researchers will compare both techniques in randomized blinded manner patients will have subjective outcomes like NOSE score, pain Objective outcomes like Turbinate size over long term clinical follow up visits for 1 year


Eligibility criteria: Inclusion Criteria:

All patients with the following criteria were eligible for inclusion:

1. Age group: 18-60 years old.
2. Patients complaining of chronic nasal obstruction because of bilateral (HIT) diagnosed by our former protocol refractory to medical treatment for at least three months.
3. Evident (HIT) on the CT nose and paranasal sinuses with mainly soft tissue component hypertrophy with or without minimal septal deviation without any other cause for the obstruction.
4. Patients who are unfit for general anesthesia

Exclusion Criteria:

* All Patients with:

Marked septal deviation or Concha Bullosa, Nasal polyps, Sinonasal Tumors, Any previous nasal surgeries or radiotherapy, Chronic sinusitis or Cystic Fibrosis, Pregnancy, Patients with severe bleeding tendency, coagulopathy disorder, and Patients who refuse participation in this study were excluded from our study

Primary outcomes:
measure: NOSE score
timeFrame: 1 year
measure: Pain VAS score
timeFrame: 1-3 months postoperative
measure: Turbinate Size grading
timeFrame: 1 year postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr El-sheikh
country: Egypt
facility: Kafr El-Sheikh Universitty
Study officials:
References:
Clinical trial NCT06279338: A Novel Conditioning Regimen for Myelodysplastic Syndrome With Moderate High IPSS-M Score
Official title: A Clinical Study of Azacitidine Combined With BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome With Moderate High IPSS-M Score
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myelodysplastic Syndromes
Keywords: Allogeneic Hematopoietic Stem Cell Transplantation
Molecular International Prognostic Scoring System (IPSS-M)
Azacitidine
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 40
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: Figure out the Efficacy and Safety of Azacitidine Combined with BUCY2 Conditioning Regimen Before Allogeneic Hematopoietic Stem Cell Transplantation for Myelodysplastic Syndrome with Moderate High IPSS-M Score

Detailed description: This study is a prospective, single-center, single-arm clinical study, which plans to enroll 40 patients with high-risk myelodysplastic syndrome (MDS) to be given azacitidine (AZA) combined with busulfan and cyclophosphamide (BUCY2) conditioning regimen to evaluate 18-month progression-free survival (PFS), aiming to evaluate the efficacy and safety of azacitidine plus BUCY2 pretreatment regimen.

Eligibility criteria: Inclusion Criteria:

* Patients fully understand this study, voluntarily participate and sign the informed consent form
* Age equal or more than 18 years old
* Patients with moderate high-risk MDS with an IPSS-M score which is higher than 0
* Patients planning to undergo allogeneic hematopoietic stem cell transplantation, HCT-CI ≤ 3 or KPS ≥ 80%

Exclusion Criteria:

* Patients who refuse to participate in this clinical study
* Patients with central nervous system involvement
* Patients with HIV seropositive
* Patients with other serious medical conditions with a life expectancy of less than six months
* Patients with severe psychiatric or psychological disorders

Primary outcomes:
measure: Progression-free survival (PFS) at 18 months post-transplant, month
timeFrame: 18 months post-transplantation
Secondary outcomes:
measure: Overall survival (OS) at 18 months post-transplant, month
timeFrame: 18 months post-transplantation
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan Union Hospital, China
name: Linghui Xia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01284738: Beta-thalassemia and Microparticles
Official title: Beta-thalassemia and Microparticles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thalassemia Major (TM)
Thalassemia Intermedia (TI)
Microparticles (MP)Originating From Platelets, Endothelial Cells and Monocytes
Keywords: TM
TI
MP
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 33
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The results will allow us to evaluate the role of MP in the thrombo-embolic risk observed in thalassemic patients and to underline a possible difference between TM and TI. The in vitro and in vivo study of MP in erythrocytes concentrates is a new approach to explore the consequence of transfusion in polytransfused patients. Finally, the identification of a possible relationship between the oxidative stress and the production of MP may lead to the development of specific therapeutical approaches

Detailed description: Microparticles (MP) are intact vesicles derived from cell membranes which arise mainly through cell membrane activation processes and from apoptosis. MP originating from platelets, endothelial cells and monocytes have been most extensively studied, though similar particles can arise from red cells and granulocytes. The ability to form microparticles is an essential part of physiological coagulation.However, MP may play an important procoagulant role in several diseases including sickle cell disease, and paroxysmal nocturnal haemoglobinuria (PNH).

Several studies reported the presence of MP in TI and their potential role in the hypercoagulable state. The investigators propose in this study to investigate the presence and origin of MP in TM patients.

Eligibility criteria: Inclusion Criteria:

* Patient recorded in the national register of the patients attained by beta-thalassemia (TI) or (TM)
* Patient monitoring in one of 5 recruiters centers
* Patient more than 15 years
* Patient consented and informed

Exclusion Criteria:

* Blood transfusion dating from less than 3 months for TI
* Composite Heterozygotes HbE /beta-thalassemia
* pregnant women
* other disease

Primary outcomes:
measure: Relationship between TM and TI
timeFrame: 36 months
Secondary outcomes:
measure: Investigate the mechanisms of the elevated production of MP in thalassemias
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
Study officials:
affiliation: APHM
name: Isabelle Thuret, Doctor
role: STUDY_DIRECTOR
References: