louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04756622: N-acetyl Cysteine for the Prevention of Oral Mucositis After Autologous Hematopoietic Cell Transplantation.
Official title: Efficacy and Safety of N-acetyl Cysteine for the Prevention of Oral Mucositis After High-dose Chemotherapy and Autologous Hematopoietic Cell Transplantation: a Phase III, Randomized, Open Label, Multi-center Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Mucositis
Transplant-Related Disorder
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase III, randomized, open label and multi-center study.
Primary purpose: PREVENTION

Brief summary: Oral mucositis (OM) is a major source of morbidity in patients undergoing hematopoietic cell transplantation (HCT). N-acetyl cysteine (NAC) is an antioxidant, widely used as mucolytic agent or antidote of acetaminophen overdose hepatotoxicity. we intend to explore the safety and efficacy of NAC in the prevention of OM after high-dose chemotherapy and autologous HCT in a phase III, randomized, open label and multi-center study.


Eligibility criteria: Inclusion Criteria:

* Patients with multiple myeloma and lymphoma in partial response and complete remission.
* Undergoing high-dose chemotherapy with autologous transplantation.

Exclusion Criteria:

• Known sensitivity to NAC

Primary outcomes:
measure: Proportion of patients with grade 3-4 OM
timeFrame: day 14
Secondary outcomes:
measure: Proportion of patients with grade 1-4 OM
timeFrame: 14 days
measure: Time from transplantation to first hospital discharge
timeFrame: 30 days
measure: Non-relapse mortality
timeFrame: day 50
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02869022: Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
Official title: A Prospective, Randomized, Single Blind, Multicenter Phase III Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Lead sponsor: Dr. F. Köhler Chemie GmbH
Sponsor class: INDUSTRY
First posted: 2016-08-16
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.


Eligibility criteria: Inclusion Criteria:

Donor criteria:

* deceased donors should fulfil the criteria for organ donation (SCD) Patient criteria
* recipients awaiting their first transplant
* recipients ≥ 18 and \>/= 65 years
* recipient's signed informed consent
* waiting list

Exclusion Criteria:

Donor criteria:

* not applicable

Patient criteria:

* recipients participating in another interventional study
* pregnant or lactating patients
* history/demonstration of HIV antibodies or AIDS
* multiorgan transplantation
* transMedics pump
* the explantation team is affiliated another clinic than transplantation team

Primary outcomes:
measure: Creatine kinase Myocard type "CK-MB" peak value
timeFrame: from 4 to 168 hours after release of the aortic cross clamp
Secondary outcomes:
measure: Catecholamine requirement
timeFrame: from entry to the trial up to day 7
measure: Patient survival
timeFrame: at 7 days and 1, 3 and 12 months
measure: Complications
timeFrame: from the time of the transplantation up to day 7
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Universitätsklinik für Chirurgie-Klin. Abteilung für Herzchirurgie, MUW-AKH Wien
city: Bad Oeynhausen
country: Germany
facility: Klinik für Thorax- und Kardiovaskularchirurgie, Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Klinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin
city: Düsseldorf
country: Germany
facility: Klinik für Kardiovaskuläre Chirurgie, Universitätsklinikum Düsseldorf
city: Freiburg
country: Germany
facility: Klinik für Herz- und Gefäßchirurgie, Universitätszentrum Freiburg Bad Krotzingen
city: Hamburg
country: Germany
facility: Klinik für Gefäßchirurgie, Universitäres Herzzentrum am UKE Hamburg
city: Heidelberg
country: Germany
facility: Abt. Herzchirugie, Universitätsklinikum Heidelberg
city: Jena
country: Germany
facility: Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena
city: Regensburg
country: Germany
facility: Herz- Thorax- und herznahe Gefäßchirurgie, Klinikum der Universität Regensburg
Study officials:
affiliation: Abt. Herzchirugie, Universitätsklinikum Heidelberg
name: Gabor Szabo, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06541522: Impact of Belt Position on the Results of PEEP Titration by EIT During ARDS
Official title: Impact of Belt Position on the Results of PEEP Titration by Electrical Impedance Tomography During Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ARDS
Keywords: ARDS
mechanical ventilation
EIT
Lead sponsor: Centre Hospitalier Saint Joseph Saint Luc de Lyon
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Once the patient is included in the research, two PEEP titrations monitored by EIT will be performed, each with the electrode belt positioned at a different chest height. The order will be drawn at random.
Primary purpose: OTHER

Brief summary: ARDS is a frequent reason for hospitalization in intensive care. In order to improve its management, doctors seek to limit the mechanical ventilation-induced injuries (VILI) that can occur. PEEP is a parameter that plays a role in the appearance of VILI, and its adjustment can be optimized by EIT. The EIT is a non-invasive, non-irradiating, real-time monitoring device, today widely used for the optimization of ventilation in patients intubated for ARDS. The positioning of the EIT belt at different chest heights could influence the result of the PEEP titration.

Detailed description: The aim of this study is to test the hypothesis that the position (2nd intercostal space or 5th intercostal space) of the EIT (Electrical Impedance Tomography) belt significantly influences the result of PEEP (Positive Expiratory Pressure) titration.

Eligibility criteria: Inclusion Criteria:

* Occurrence of moderate to severe ARDS (PaO2/FiO2 ratio ≤ 200 mmHg) within 72 hours following intubation
* Criteria for moderate to severe ARDS for less than 72 hours
* Passive ventilation in controlled assisted ventilation (no spontaneous ventilation)
* Consent of next of kin

Exclusion Criteria:

* Age \< 18 years
* ECMO
* Pneumothorax
* Pacemaker or implantable defibrillator
* Chest trauma in the last 3 months
* Skin peeling (Burned, Lyell)
* Intracranial hypertension
* Uncontrolled shock (noradrenaline \>5 mg/h)
* Pregnant woman
* Adult patient protected within the meaning of the law
* Lack of social security

Primary outcomes:
measure: Impact of the position of the electrode belt on the results of PEEP titration by EIT.
timeFrame: Day 0
Secondary outcomes:
measure: Impact of the existence of intra-tidal recruitment on the discordance between PEPEIT and PEPCRS
timeFrame: Day 0
measure: Factors associated with a discordance between PEPEIT and PEPCRS
timeFrame: Day 0
measure: Discrepancy between compliance measured according to impedance and compliance measured according to exhaled volume
timeFrame: Day 0
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02831322: A Study of Structure and Function of Radial Artery After Transradial Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Transradial
Keywords: Transradial
ﬂow-mediated vasodilation
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2016-07-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Several approaches have been proposed to reduce the risk of RAO, including anticoagulation, immediate postprocedural sheath removal, and a small sheath/radial artery ratio. Doppler ultrasound examination showed that interrupted blood flow in RA tend to occur in the proximal end rather than distal part of the artery,which was ignored by a majority of interventional cardiologists. Different insights into occlusion location may lead to different options of sheath materials, models, catheters and puncture access. Thus, the investigators designed this present study to explore the reason of radial artery endothelial dysfuction and damage and occlusion location by ﬂow-mediated dilation (FMD) to determine the suitable method to reduce occlusion risk during TRI.


Eligibility criteria: Inclusion Criteria:

* admitted for transradial catheterization.

Exclusion Criteria:

* femoral access, arterial circulatory disease, pathological Allen tests, decompensated heart failure, chronic renal failure

Primary outcomes:
measure: radial artery occlusion
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: Qingsheng wang
state: Hebei
Study officials:
References:
Clinical trial NCT00523822: Sacroiliac Orthopedic Blocking and Cervical Spine Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Diseases
Keywords: This study seeks to determine if the correction of a sacroiliac lesion can produce a functional change in cervical spine.
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2007-09-03
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study seeks to determine if the correction of a sacroiliac lesion can produce a functional change in cervical spine. Reduction of a sacroiliac joint lesion may alter cervical spine function.


Eligibility criteria: Inclusion Criteria:

* Young adults currently enrolled at Logan College

Exclusion Criteria:

* Recent cervical spine injuries or surgeries
* Surgical hardware in the cervical spine or pelvis
* Any cervical condition that would make ROM \& strength testing painful.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College
state: Missouri
Study officials:
affiliation: Logan College
name: Kristan Giggey, DC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01851122: The Effect of the Amino Acid L-Theanine on Alertness and Vigilance
Official title: The Effect of the Amino Acid L-Theanine on Alertness and Vigilance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Theanine, (L)-Isomer
Keywords: l-theanine
alertness
well-being
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2013-05-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The amino acid l-theanine (the active ingredient in green tea) is considered to have a calming effect without causing sleepiness. This study evaluates whether l-theanine affects blood pressure, heart rate, alertness, and sense of well-being.


Eligibility criteria: Inclusion Criteria:

* adult
* able to swallow capsule

Exclusion Criteria:

* none

Primary outcomes:
measure: Alertness
timeFrame: 48 hrs
measure: Alertness
timeFrame: 48 hrs
measure: Well-Being
timeFrame: 48 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Sugar Land
country: United States
facility: Physicians at Sugar Creek
state: Texas
Study officials:
References:
Clinical trial NCT01662622: Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram
Official title: Minimal Alveolar Concentration of Sevoflurane Inducing Isoelectric Electroencephalogram
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Middle Aged Patients
Sevoflurane
General Anesthesia
Keywords: anaesthesia
middle aged
minimal alveolar concentration
sevoflurane
isoelectric EEG
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
name: National Natural Science Foundation of China
First posted: 2012-08-10
Enrollment: 31
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sevoflurane can abolish movement or adrenergic response to noxious stimulus. In order to investigate the effect of sevoflurane on cerebral electrical activity, we determined the MAC of sevoflurane inducing isoelectric electroencephalogram (EEG) in 50% of the subjects (MACie) in middle aged subjects.

Detailed description: Patients received sevoflurane for anesthesia induction and maintenance at preselected concentrations according to an 'up and down' design, with 0.2% as a stepsize. General anesthesia was induced and maintained with sevoflurane, tracheal intubation was facilitated with cisatracurium. After a steady-state period of 30min without surgical stimulation, the state of isoelectric EEG was considered as significant when a burst suppression ratio of 100% last for more than 1 min. The haemodynamic responses to skin incision and the vasopressor requirement to maintain cardiovascular system were also analysed according to the EEG state.

Eligibility criteria: Inclusion Criteria:

* 45-65yr
* upper abdominal surgery in general anaesthesia
* ASA physical status classification of I or II

Exclusion Criteria:

* neurological disease
* received central nervous system-active drugs
* cardiac ejection fraction less than 40%
* history of difficult intubation or anticipated difficult intubation
* daily alcohol consumption
* obesity, defined as a body-mass index of more than 30
* without informed consent

Primary outcomes:
measure: MACie
timeFrame: 30min
Secondary outcomes:
measure: MACbs
timeFrame: 30 min
Other outcomes:
measure: Hemodynamic parameters
timeFrame: 3 min
measure: Use of phenylephrine
timeFrame: 30 min
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
name: Yuke Tian, MD.
role: STUDY_CHAIR
References:
Clinical trial NCT05118022: Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE)
Official title: Artificial Intelligence Identified Dyskalemia Using Electrocardiogram (AIDE) Prompts Immediate Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperkalemia
Hypokalemia
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 14989
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of potassium abnormalities.


Eligibility criteria: Inclusion Criteria:

* Patients in emergency department.
* Patients recieved at least 1 ECG examination.

Exclusion Criteria:

* Patients recieved dyskalemia-related treatment before ECG examination.
* The patients recieved ECG at the period of inactive AI-ECG system.

Primary outcomes:
measure: Cumulative proportion of hyperkalemia treatment
timeFrame: Within 3 hours
measure: Cumulative proportion of hypokalemia treatment
timeFrame: Within 3 hours
Secondary outcomes:
measure: Cardiac arrest (sudden death)
timeFrame: Within 3 days
measure: Cumulative proportion of All-cause mortality
timeFrame: Within 365 days
measure: Cumulative proportion of electric shock
timeFrame: Within 6 hours
measure: Cumulative proportion of CPR event
timeFrame: Within 6 hours
measure: Cumulative proportion of Discharge
timeFrame: Within 14 days
measure: Cumulative proportion of Treatment-induced hypokalemia event
timeFrame: Within 24 hours
measure: Cumulative proportion of Treatment-induced hyperkalemia event
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Defense Medical Center
Study officials:
References:
Clinical trial NCT00166322: Dopaminergic Neurotransmission in Schizophrenia, Patients at Risk and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: IBZM-SPECT
Amphetamine Challenge
Schizophrenia
dopaminergic neurotransmission
Persons at risk for the development of schizophrenia
healthy subjects
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is an investigation of the dopaminergic neurotransmission in patients with schizophrenia, patients at risk for the development of schizophrenia, and healthy controls using an iodobenzamide-single photon emission computed tomography (IBZM-SPECT) imaging technique under amphetamine challenge.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of schizophrenia (currently unmedicated)
* Subjects at risk for the development of schizophrenia (prodromal symptoms)
* Healthy subjects
* Written informed consent

Exclusion Criteria:

* Neurological or severe somatic disorders
* Women during pregnancy or lactation
* Occupational exposition to radiation \> 15mSv
* Medication known to interfere with IBZM
* Contraindications for the use of amphetamine challenge

Primary outcomes:
measure: dopamine receptor availability
timeFrame: cross-sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Dept. of Psychiatry
city: Munich
country: Germany
facility: Dept. of Nuclear Medicine
Study officials:
affiliation: Dept. of Psychiatry, University of Munich
name: Oliver Pogarell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Nuclear Medicine, University of Munich
name: Klaus Tatsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03112122: Study for the Treatment of the Bone Marrow Edema:Core Decompression VS Bone Marrow Concentrate (BMC) VS Bone Substitute
Official title: Randomized, Double-blind Study for the Treatment of the Bone Marrow Edema:Core Decompression Versus (VS) Subchondral Injections of Autologous BMC VS Subchondral Injections of Bone Substitute
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Bone Marrow Edema
Keywords: Bone Marrow Edema
Mesenchymal Stem Cells
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, controlled, three-arm, double-blind study
Primary purpose: TREATMENT

Brief summary: Randomized, controlled, three-arm, double-blind study : control group, treated with core decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of autologous BMC.

Detailed description: The clinical trial is a randomized, controlled, three-arm, double-blind study, involving up to 120 patients. Eligible subjects will be randomly allocated to one of the three treatment groups: control group, treated with core decompression technique, study group 1, treated with subchondral plasty by injecting i-FactorTM, and study group 2, treated by injections of autologous BMC.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients between 18 and 75 years;
2. Symptomatic subchondral bone marrow lesions of femoral condyles (grade ≥ 1 according to the WORMS MRI score);
3. Failure after at least two months of a conservative treatment;
4. Single BME areas involving a single compartment of the knee;
5. Availability of the patients to participate actively in the rehabilitation protocol and follow-up clinic and radiology;
6. Signature of informed consent.

Exclusion Criteria:

1. Patients incapable of discernment;
2. History of allergy to calcium phosphates;
3. Patients with malignancies;
4. Patients with rheumatic diseases;
5. Patients with diabetes;
6. Patients suffering of metabolic disorders of the thyroid;
7. Patients with history of abuse of alcohol, drugs or medication;
8. Patients with advanced osteoarthritis (Kellgren-Lawrence grade\> 3);
9. Body Mass Index\> 35;
10. BME that involve more than one compartment;
11. Patients with trauma in the 6 months prior to the intervention. -

Primary outcomes:
measure: change of Visual Analogue Scale (VAS) score
timeFrame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Secondary outcomes:
measure: International Knee Documentation Committee (IKDC) subjective score
timeFrame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
measure: Knee Injury and Osteoarthritis Outcome (KOOS) Score
timeFrame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
measure: Tegner Activity Level Scale
timeFrame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
Study officials:
References: