louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03740776: The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in STEMI Patients After PCI
Official title: The Eosinophils Percentage Predicts In-hospital Major Adverse Cardiac Events in Patients With ST-elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST Elevation Myocardial Infarction
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 2
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: STEMI Patients

Brief summary: Eosinophils (EOS) in peripheral blood are significantly decreased in ST-segment elevation myocardial infarction (STEMI) and the reduced EOS indicates severe myocardial damage. Whether EOS is a good predictor for in-hospital major adverse cardiac events (MACEs) of patients with ST-segment elevation myocardial infarction remains unknown. The aims of this study was to evaluate prognostic role of EOS for in-hospital MACEs in STEMI patients who have undergone primary percutaneous coronary intervention (PCI)

Detailed description: The investigators retrospectively analyzed the clinical data of 518 patients with STEMI after PCI. MACEs were defined as cardiac arrest, cardiac rapture, malignant arrhythmia and cardiac death. The receiver operating characteristic (ROC) curves were used to demonstrate the prognostic value of EOS% in in-hospital MACEs. All patients were divided into 2 groups according to the best cut-off EOS% value, including reduced EOS% group and control group. Cox regression analyses and KM survival curve were used to calculate the correlated between EOS with in-hospital MACEs.

Eligibility criteria: Inclusion Criteria:

1. Patients with STEMI who underwent PCI within 12 hours from symptom onset
2. Patients from whom informed consent has been properly obtained in writing prior to start of the trial.

Exclusion Criteria:

1. Patients with previous myocardial infarction, congenital heart disease
2. Patients with liver disease, and renal failure
3. Patients with immunologic disease, malignant tumors, pregnancy, infection caused by various pathogens, chronic inflammatory disease, trauma.

Primary outcomes:
measure: major adverse cardiac events
timeFrame: The median time of 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00727376: Evaluation of Polyflex Stenting in Esophageal Cancer Patients
Official title: Clinical Evaluation of Polyflex Stenting in Esophageal Cancer Patients Undergoing Chemotherapy and/or Radiation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: esophageal
stenting
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2008-08-04
Enrollment: 26
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: Esophageal cancer patients who have elected to have a stent placed.

Brief summary: To evaluate the effectiveness of an esophageal stent as a way to maintain nutrition during radiation and/or chemotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Willing and able to provide informed consent
* Willing to comply with follow-up requirements
* Biopsy-confirmed esophageal cancer (adenocarcinoma or squamous cell carcinoma) in mid or distal esophagus (clinical stage 3 or less)
* Indicated for chemotherapy and/or radiation therapy
* Ability to dilate stricture to 15mm diameter at extent of disease evaluation
* Placement of at least 18 x 23mm diameter and 120mm length PolyFlex stent

Exclusion Criteria:

* Patients contraindicated for endoscopy
* Patients with prior esophageal stent placements
* Advance stage of disease, greater than T3 tumor or M1 disease

Primary outcomes:
measure: Clinical benefit of the Polyflex Esophageal Stent as a means to maintain oral nutrition during chemotherapy and/or radiation
timeFrame: 8 - 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Robert Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin RC 2nd, Cannon RM, Brown RE, Ellis SF, Williams S, Scoggins CR, Abbas AE. Evaluation of quality of life following placement of self-expanding plastic stents as a bridge to surgery in patients receiving neoadjuvant therapy for esophageal cancer. Oncologist. 2014 Mar;19(3):259-65. doi: 10.1634/theoncologist.2013-0344. Epub 2014 Feb 24.
citation: Brown RE, Abbas AE, Ellis S, Williams S, Scoggins CR, McMasters KM, Martin RC 2nd. A prospective phase II evaluation of esophageal stenting for neoadjuvant therapy for esophageal cancer: optimal performance and surgical safety. J Am Coll Surg. 2011 Apr;212(4):582-8; discussion 588-9. doi: 10.1016/j.jamcollsurg.2010.12.026.
Clinical trial NCT03713476: Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation
Official title: Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation for Upper Extremity Function of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation, Tenodesis, Stroke
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the proposed study, the investigators assumed that using robot assisted tenodesis-grip training providing high does assisted grip movement may do the effects on motor shaping and greater brain priming for hand paresis of the stroke patients. The specific aim of this study is to examine the difference in the treatment effects between the combination of robot assisted tenodesis-grip training with task-oriented training and combination of traditional occupational therapy with task-oriented training on the motor, sensation, hand performance of the stroke patients. The expected outcomes of this research are to help the clinicians understand the training mechanism and effects of robot assisted tenodesis-grip training on functional performance of upper extremity for unilateral stroke patients.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of stroke with unilateral side involved;
2. Stroke at least 7 days before the start of the first assessment session;
3. A score of Mini-mental state examination greater than 24 for proving higher mental function;
4. Premorbid right-handedness.

Exclusion Criteria:

1. Uncontrolled hypertension;
2. Major cognitive-perceptual deficit;
3. Other brain disease.

Primary outcomes:
measure: Change in the result of Fugl-Meyer assessment for UE motor function
timeFrame: baseline, 6 weeks and 18 weeks
measure: Change in the result of Modified Ashworth scale (MAS)
timeFrame: baseline, 6 weeks and 18 weeks
measure: Change in the result of Box and blocks test
timeFrame: baseline, 6 weeks and 18 weeks
measure: Change in the result of Semmes-Weinstein monofilament (SWM) test
timeFrame: baseline, 6 weeks and 18 weeks
measure: Change in the result of Motor Activity Log
timeFrame: baseline, 6 weeks and 18 weeks
Secondary outcomes:
measure: Clinical global impression scale
timeFrame: post-intervention (week 6)
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References:
citation: Hsu HY, Yang KC, Yeh CH, Lin YC, Lin KR, Su FC, Kuo LC. A Tenodesis-Induced-Grip exoskeleton robot (TIGER) for assisting upper extremity functions in stroke patients: a randomized control study. Disabil Rehabil. 2022 Nov;44(23):7078-7086. doi: 10.1080/09638288.2021.1980915. Epub 2021 Sep 29.
Clinical trial NCT03293927: Polypharmacy-related Adverse Events in Critically Ill Children
Official title: Investigating Polypharmacy-related Adverse Events in Critically Ill Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Delirium
Keywords: children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.


Eligibility criteria: Inclusion Criteria:

* Ages 2-\<18 at the time of enrollment
* Admitted to the Duke PICU or PCICU
* Planned or anticipated mechanically ventilation for ≥2 days
* Require sedation to maintain mechanical ventilation
* No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment
* Availability and willingness of the parent/legal guardian to provide written informed consent

Exclusion Criteria:

* Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
* Previous participation in this study
* Planned receipt of sedatives other than fentanyl or dexmedetomidine
* Participants with any of the following diagnoses: traumatic brain injury, intracranial hemorrhage, baseline neurodevelopmental delay, status epilepticus, or requiring inotropic support for hemodynamic stability.
* Renal failure requiring renal replacement therapy
* Hepatic failure
* Support with extracorporeal membrane oxygenation

Primary outcomes:
measure: Change in delirium scores as measured by CAPD score
timeFrame: up to 10 days
Secondary outcomes:
measure: Drug level associated with CAPD score
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke
name: Kanecia Zimmerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02977676: Ventilator-Associated Events: Prevalence, Outcome and Preventability
Official title: Ventilator-Associated Events: Prevalence, Outcome and Preventability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator-Associated Lung Injury
Lead sponsor: Hospital Sao Domingos
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days.

Brief summary: The aim of this study is to determine the prevalence of ventilator-associated events (VAE). To analyze the patients profile, morbidity and mortality compared to patients who did not develope VAE. The preventability of VAE will be assessed by comparing the percentage of adherence to the bundle of preventive measures among patients who developed and did not develope VAE.

Detailed description: This is a retrospective analysis of prospectively collected data, approved by the Research Ethics Committee of Hospital Sao Domingos. The need for informed consent was waived.

Included were all patients admitted to a surgical (13 beds) and medical (32 beds) of a tertiary hospital over a 3-year period (February 2013 to January 2016), aged above 18 years and submitted to mechanical ventilation for at least 4 days.

At admission and daily the following data were collected: head of bed elevation, daily interruption of sedation, gastric ulcer prevention, Thromboembolism prophylaxis, aspiration of subglottic secretions, oral care with chlorhexidine gluconate and monitoring of endotracheal tube cuff pressure.

Identification of VAE, Ventilator-associated condition (VAC), Infectious condition associated to mechanical ventilation (IVAC) and ventilator-associated pneumonia possible and probable followed definition criteria of the National Healthcare Safety Network / Center for Disease Control and Prevention.

The percentage of adherence to the bundle of preventive measures of VAE prevention was registered.

Eligibility criteria: Inclusion Criteria:

* Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days.

Exclusion Criteria:

* Patients aged bellow 18 years and those that remained under mechanical ventilation less than 4 days.

Primary outcomes:
measure: Number of patients who developed ventilator-associated events
timeFrame: 1 year
measure: All cause Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 1 year
measure: Percentage of adherence to the package of VAE preventive measures
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Sao Domingos
name: JOSE R AZEVEDO, MA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06985576: Long-term Study to Evaluate Safety and Persistence of GF-CART01
Official title: A Long-term Follow-up Study of GF-01-01 to Evaluate the Safety and Persistence of GF-CART01 (CD20/19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: DLBCL - Diffuse Large B Cell Lymphoma
Follicular Lymphoma (FL)
Primary Mediastinal Large B-Cell Lymphoma
High Grade B Cell Lymphoma
Lead sponsor: GenomeFrontier Therapeutics TW Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-22
Enrollment: 18
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: Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are eligible to participate in this follow-up study. The study may allow for a maximum enrollment of 18 subjects.

Brief summary: The goal of this observational study is to learn about the long-term safety of GF-CART01 after cell infusion up to 15 years.

Detailed description: This comprehensive long-term follow-up study is meticulously designed to assess the safety and persistence of GF-CART01. Subjects who participated in the initial study of GF-01-01 and received treatment with GF-CART01, irrespective of their completion status, are eligible to participate in this follow-up study. The study may allow for a maximum enrollment of 18 subjects.

Eligibility criteria: Inclusion Criteria:

1. Subjects previously enrolled in the study of GF-CART01 (Protocol No.: GF-01-01) and received GF-CART01 infusion
2. Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent
3. Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement

Exclusion Criteria: None

Primary outcomes:
measure: Long-Term Safety of GF-CART01 after infusion
timeFrame: up to 15 years after GF-CART01 infusion
Secondary outcomes:
measure: GF-CART01 persistence
timeFrame: up to 15 years after GF-CART01 infusion
measure: Efficacy of GF-CART01
timeFrame: up to 15 years after GF-CART01 infusion
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT06176027: Azacytidine Plus CAOLD Regimen in Relapsed/Refractory Peripheral T-Cell Lymphomas
Official title: Therapeutic Effect of Chemotherapy Azacytidine Plus CAOLD Regimen on Patients With Relapsed/Refractory Peripheral T-Cell Lymphomas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsed Peripheral T-Cell Lymphomas
Refractory Peripheral T-Cell Lymphomas
Lead sponsor: Navy General Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: Chinese PLA General Hospital
First posted: 2023-12-19
Enrollment: 52
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: This is a multicenter prospective single arm phase II study. The purpose of this study is to evaluate the safety and efficiency of azacytidine combined with CAOLD Regimen in the treatment of relapsed/refractory peripheral t-cell lymphomas.

Detailed description: The investigators will evaluate response rate, progression free survival (PFS), overall survival (OS), and toxicity of azacytidine combined with CAOLD Regimen in relapsed/refractory peripheral t-cell lymphomas.

Eligibility criteria: Inclusion Criteria:

Patients must satisfy all following criteria to be enrolled in the study:

* Pathologically confirmed angioimmunoblastic T-cell lymphoma according World Health Organization (WHO) classification;
* Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
* Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
* Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
* Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy (there is no mandatory resting period after the previous treatment as long as the biochemistry and hematology labs meet the inclusion criteria as below.)
* Meet the following lab criteria:

  * Absolute Neutrophil Count (ANC) ≥ 1,5 x 10\^9/L (≥ 1 x 10\^9/L if bone marrow (BM) involvement by lymphoma)
  * Platelet ≥ 75 x 10\^9/L (≥ 50 x 10\^9/L if BM involvement by lymphoma)
  * Hemoglobin ≥ 8 g/dL.
* Anticipated life expectancy at least 3 months

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy;
* Pregnant or lactating women

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 1 year
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: through study completion, an average of 2 year
measure: Progression Free Survival (PFS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Navy General Hospital
state: Beijing
Study officials:
affiliation: Navy General Hospital, Beijing
name: Liren Qian, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01385527: Pediatric Atopic Dermatitis (AD) Internet Survey
Official title: Using an Internet Survey to Improve Adherence in Pediatric Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate whether participation in an Internet-based intervention helps improve atopic dermatitis treatment outcomes.


Eligibility criteria: Inclusion Criteria:

* Any child age 2 to 8 with a diagnosis of atopic dermatitis confirmed by a dermatologist, together with the child's parent/guardian. Written consent must be given by parent/guardian.

Exclusion Criteria:

* Child is less than 2 or greater than 8 years of age.
* Known allergy or sensitivity to topical triamcinolone in the child.
* Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
* Introduction of any other prescription medication, topical or systemic, for atopic dermatitis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for atopic dermatitis must be on a stable dose for at least 3 months prior to enrollment.

Primary outcomes:
measure: Adherence to topical triamcinolone
timeFrame: 12 weeks
Secondary outcomes:
measure: Eczema Area Severity Index
timeFrame: 12 weeks
measure: Investigator's Global Assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04609527: Management of Placenta Accreta Spectrum
Official title: Management of Placenta Accreta Spectrum
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Placenta Previa
Placenta Accreta
Keywords: placenta
accreta
praevia
hyterectomy
PPH
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All women with placenta praevia and previous scar in the uterus. Surgical management and follow up will be defined
Primary purpose: OTHER

Brief summary: placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.

Detailed description: placenta accreta spectrum is group of disorders which have a depate about the best way of management. this is a descriptive study about the best techniques to reduce morbidity and mortalities related to it.

1. surgical management of placenta accreta
2. short term follow up to the outcomes
3. long term follow up

Eligibility criteria: Inclusion Criteria:

* All placenta accreta e high possibility of placenta accrete
* consent
* easy follow up visits

Exclusion Criteria:

* bleeding tendency
* associated medical disorder hypertension, diabetes, preeclapsia..

Primary outcomes:
measure: Failure of the novel conservative management
timeFrame: 3 hours
measure: Estimated amount of blood loss
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Osama Abdalmageed
state: Non-US/Non-Canadian
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References: