louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00481377: Ablation for ICD Intervention Reduction in Patients With CAD
Official title: Ablation for ICD Intervention Reduction in Patients With CAD - a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ventricular Tachycardia
Coronary Artery Disease
Implantable Cardioverter-Defibrillator
Keywords: Ablation
Ventricular tachycardia
coronary artery disease
Implantable cardioverter defibrillator interventions
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 200
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 is to assess the role of ablation in appropriate ICD interventions reduction in patients with coronary artery disease. The group will consist of 200 patients with implanted ICD and appropriate intervention in the 3 months prior to enrollment. The patients will be randomized into ablation arm and conventional treatment. Number of appropriate ICD interventions is the primary endpoint of this study. All patients will have control follow-up visits every 3 months. The follow-up will be based on ICD memory.


Eligibility criteria: Inclusion Criteria:

* Coronary Artery Disease
* ICD implanted
* Appropriate ICD intervention during the 3 months prior to enrollment
* Coronary angiography during the 6 months prior to enrollment
* Possible revascularization
* Age over 18 years
* Signed informed consent

Exclusion Criteria:

* Age less then 18 years
* Pregnancy
* Active participation in other trial
* Heart failure (NYHA IV)
* Contraindications for ablation procedure: i.e. left ventricular thrombus, artificial aortic or mitral valve, no vascular access.
* Monomorphic, incessant, ventricular tachycardia
* Revascularization or other cardio-surgical procedure scheduled in the next 6 months

Primary outcomes:
measure: Number of appropriate ICD interventions
Secondary outcomes:
measure: Overall mortality
measure: Cardiac mortality
measure: Hospitalization due to arrhythmia or heart failure
measure: Quality of life
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Institute of Cardiology
state: Mazowieckie
Study officials:
affiliation: National Institute of Cardiology, Warsaw, Poland
name: Lukasz J Szumowski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szumowski L, Przybylski A, Maciag A, Derejko P, Bodalski R, Zakrzewska J, Orczykowski M, Szufladowicz E, Szwed H, Walczak F. Outcomes of a single centre registry of patients with ischaemic heart disease, qualified for an RF ablation of ventricular arrhythmia after ICD intervention. Kardiol Pol. 2009 Feb;67(2):123-7; discussion 128-9. English, Polish.
Clinical trial NCT01191177: Investigational Study of Oral Fish Oil in Treating Parenteral Nutrition Associated Liver Disease
Official title: An Initial Trial of Enteral Fish Oil Supplementation in the Treatment of Parenteral Nutrition-associated Liver Disease in Patients With Short Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Liver Disease
Short Bowel Syndrome
Keywords: oral fish oil
Lovaza
Omega-3-acid supplementation
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard University
name: GlaxoSmithKline
First posted: 2010-08-30
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the usefulness of oral fish oil(Lovaza)in normalizing liver function in patients who have parenteral nutrition associated liver disease. The investigators believe that patients who take oral fish oil will normalize liver function faster than those who do not

Detailed description: This is designed as a randomized placebo controlled trial of oral fish oil (Lovaza) in normalizing parenteral nutrition associated liver disease.

Eligibility criteria: Inclusion Criteria:

* History of parenteral nutrition(PN)administration \>4weeks
* PN associated liver disease from intestinal failure
* ability to take full enteral feed
* body weight equal or greater than 3kg
* elevated ALT level twice of that normal(ALT\>84)at the time PN is weaned off

Exclusion Criteria:

* Hemodynamic instability
* renal failure
* suspected congenital obstruction of the hepatobiliary system
* diagnosis hepatitis A, B, or C
* diagnosis of alpha 1-antitrypsin deficiency
* diagnosis of cytomegalovirus infection
* diagnosis of HIV
* children in care

Primary outcomes:
measure: Normalization of ALT
Secondary outcomes:
measure: Normalization other liver function tests and inflammatory status
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Children's Hopsital Boston
name: Tom Jaksic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06410677: Changhai Multimodal Esophageal Cancer Cohort
Official title: Prediction of Immune Infiltration Level and Immunotherapy Efficacy of Esophageal Squamous Cell Carcinoma Based on Multimodal Deep Learning
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: deep learning
Esophageal Squamous Cell Carcinoma
immune infiltration
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-05-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 110 patients with ESCC in the Changhai hospital

Brief summary: The burden of esophageal squamous cell carcinoma (ESCC) in China is substantial, with 85% of the cancers being in the progressive stage. The treatment for advanced ESCC are extremely limited, and immunotherapy, represented by PD-1 inhibitors, has demonstrated a promising application potential. However, the effectiveness of PD-1 inhibitors varies significantly among patients with different types of ESCC, and currently, there is no effective method to predict the response to PD-1 inhibitors. In this study, investigators aim to construct a multimodal deep learning-based model to predict the level of immune infiltration and the efficacy of immunotherapy for ESCC, integrating both pathological image features and clinical information of patients with ESCC, thereby enhancing the level of individualized and precise treatment for ESCC.


Eligibility criteria: Inclusion Criteria:

1. Availability of Hematoxylin and Eosin (H\&E) stained images, molecular data obtained through RNA sequencing (RNA-Seq, DNA-seq), and comprehensive clinical information including patient age, gender, history of alcohol consumption, history of smoking, AJCC Tumor, Node, Metastasis Stage, specific location of oesophageal cancer occurrence, and history of reflux.
2. The sample collection is restricted to cancerous tissue, encompassing both primary tumor samples and those from metastatic sites.

Exclusion Criteria:

1. Patients diagnosed with adenosquamous carcinoma or presenting with a combination of other types of oesophageal cancers;
2. Cases involving combined adenocarcinoma affecting the gastroesophageal junction;
3. Individuals with high-grade tumors that have not penetrated the basement membrane, as confirmed by postoperative pathological examination;
4. Subjects in whom postoperative pathology confirms an absence of residual malignant tissue.

Primary outcomes:
measure: Immunogene signatures with predictive value for immunotherapy of ESCC
timeFrame: After undergoes surgery.
Secondary outcomes:
measure: Prognosis and immunotherapy tolerance in ESCC patients
timeFrame: Follow-up for at least 1 year after undergoing surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
Study officials:
affiliation: Changhai Hospital
name: Luowei Wang
role: STUDY_CHAIR
References:
Clinical trial NCT06197477: Indoor Air Quality Monitoring and Impact on Children's Health
Official title: Development of Novel Assessments for Indoor Air Quality Monitoring and Impact on Children's Health - Cohorts in Schools & Biomarkers of Exposure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognition
Keywords: indoor air pollution
indoor air quality
cognition in children
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 900
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims at understanding the relation between indoor air quality in schools, including both chemical and microbiological determinants, and cognition in children by gathering data across different parts of Europe

Detailed description: The LEARN project, funded by the European Commission, aims to gain an in-depth understanding about indoor air quality in schools and its impact on children's cognitive development. This involves evaluating school cohorts in three different countries (Belgium, Greece and Denmark). In participating schools, we measure and characterise indoor and outdoor air pollutants and evaluate the presence of exposure biomarkers and their effect on children's cognition. Measuring indoor air quality, exposure and creating remedial strategies are crucial steps to improve air quality in the school environment and ensure the well-being of children.

Eligibility criteria: Inclusion Criteria:

* Boys and girls
* Attending school in the 4th -6th grade in elementary schools included in the study
* Signed informed consent form by legal representative

Exclusion Criteria:

* Insufficient knowledge of local language (ie. Dutch, Greek, Danish) by child or parents

Primary outcomes:
measure: Change in Correct Detection of continuous Performance Test
timeFrame: at the end of the intervention and at the end of the sham intervention
measure: Change in the number of correct substitutions of Symbol Digit Modalities Test
timeFrame: at the end of the intervention and at the end of the sham intervention
measure: Change in the Memory Span Task score
timeFrame: at the end of the intervention and at the end of the sham intervention
measure: Change in the Signal Detection Test score
timeFrame: at the end of the intervention and at the end of the sham intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Tim Nawrot, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05022277: Empowering Girls: Health-seeking Behavior, Staying in School, and Preventing Risky Sex
Official title: Empowering Girls: Health-seeking Behavior, Staying in School and Preventing Risky Sex
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pregnancy Related
Behavior, Health
Lead sponsor: Young 1ove
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2021-08-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test the effectiveness of a phone-based big sister/big brother program designed to provide health information and support, reduce school dropouts, and promote safer relationships.

The program's goal is to create a phone-based safe space, to ensure adolescents remained connected with access to support and health information during COVID lockdowns.


Eligibility criteria: Inclusion Criteria:

* Adolescent who provided their phone number to Young 1ove staff when prompted by their school; or their siblings/ other adolescents living in the same household.
* Parents and students consented to participate.

Exclusion Criteria:

-

Primary outcomes:
measure: Share of students that have been or are pregnant and/or have dropped out of school
timeFrame: ~6 months post-program
measure: Share of students with the accurate belief that older partners have the highest risk of HIV compared to younger partners.
timeFrame: ~4 weeks post program
Secondary outcomes:
measure: Share of students reporting that they make the final decision in their life about visiting a Sexual and reproductive health clinic
timeFrame: ~4 weeks post program
measure: Share of students reporting that if they or their partner were pregnant, they would tell the data collector
timeFrame: ~4 weeks post program
Other outcomes:
measure: Share of students disclosing personal information to the data collector in the open-ended question at the end of the survey.
timeFrame: ~4 weeks post program
measure: Share of female students reporting that they agree or strongly agree with the statement 'If I don't want to hold hands with a guy, I can comfortably refuse to do it'
timeFrame: ~4 weeks post program
measure: Share of students listing known support services when asked 'If a friend experienced dating difficulties or violence, do you know any organizations, services or phone numbers you could suggest she contact to get some help if she wanted?'
timeFrame: ~4 weeks post program
Locations:
city: Gaborone
country: Botswana
facility: Young 1ove
Study officials:
affiliation: University of Oxford
name: Noam Angrist, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00832247: Autologous Bone Marrow Mononuclear Cells in Liver Cirrhosis
Official title: Phase 1 Study of Autologous Bone Marrow Mononuclear Cells Infusion in Peripheral Vein in Liver Cirrhosis Due to Hepatitis C Virus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Liver Cirrhosis Due to Virus C Chronic Hepatitis
Keywords: Hepatitis C
Cirrhosis
Stem cell
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ)
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Financiadora de Estudos e Projetos
name: Oswaldo Cruz Foundation
name: University of Edinburgh
First posted: 2009-01-30
Enrollment: 15
Sex: ALL
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 phase I clinical study to evaluate feasibility, safety and kinetics of cellular therapy with autologous bone marrow-derived mononuclear cells (BMMC) in patients with liver cirrhosis due to virus C hepatitis. Another aim is to study liver tissue changes induced by the BMMC presence. All the patients have moderate liver disfunction and will be submitted to a liver biopsy before BMMC injection. The cells will be labeled with 99mTc and infused through a peripheral vein. Scintigraphy will be performed 24 hours after infusion.

Patients will be submitted to frequent clinical, laboratorial and image evaluation during a one-year follow-up. A second liver biopsy will be done in the 3rd month after infusion to check histological, cellular and molecular evolutive changes.


Eligibility criteria: Inclusion Criteria:

* Chronic virus C hepatitis
* Liver cirrhosis
* Moderate liver disfunction

Exclusion Criteria:

* Malignant disease
* Pregnancy
* Significant comorbidity
* Portal vein thrombosis

Primary outcomes:
measure: Liver function worsening
timeFrame: One year
Secondary outcomes:
measure: Liver related mortality
timeFrame: One year
measure: Hepatocellular carcinoma development accessed by ultrasound and CT scan
timeFrame: One year
measure: BMMC kinetics accessed by total body scintigraphy
timeFrame: 24 hours
measure: Liver tissue changes evaluated by histopathology analysis and molecular biology
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
state: RJ
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Guilherme FM Rezende, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02177747: Smartphone-based Ophthalmoscopy
Official title: Comparison of Smartphone-based Ophthalmoscopy Versus Dilated Ophthalmic Examination for Diabetic and Nondiabetic Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy Grading
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
Collaborators: name: Luisa Delcassi
name: Nausica Ghilardi
First posted: 2014-06-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A subset of 120 diabetic patients underwent dilated examination and smartphone ophthalmoscopy. The smartphone was equipped with a compact add-on that filtered and delivered the smartphone's LED light coaxially to the camera, allowing a clear and convenient view of the retina.


Eligibility criteria: Inclusion Criteria:

* type 1 or 2 diabetes
* ability to provide written informed consent

Exclusion Criteria:

* significant optic media opacities

Primary outcomes:
measure: Diabetic retinopathy grading
timeFrame: The same day as dilated ophthalmic examination
Secondary outcomes:
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
state: BS
Study officials:
References:
Clinical trial NCT02008747: Atrial Fibrillation and Neuropathic Pain After Thoracotomy and Continuous Application of Magnesium Sulphate.
Official title: Effects of Prophylactic Administration of Magnesium Sulfate on the Incidence of Atrial Fibrillation and Chronic Neuropathic Pain After Thoracotomy for Lung Resection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Neuropathic Pain
Keywords: Atrial fibrillation
Neuropathic pain
Posterolateral thoracotomy
Lung resection
Lead sponsor: Dr. Horst Schmidt Klinik GmbH
Sponsor class: INDUSTRY
First posted: 2013-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Atrial fibrillation and chronic neuropathic pain are adverse events occurring after posterolateral thoracotomy for lung resection. The continuous application of magnesium sulphate may have a prophylactic effect. The investigators record the incidence of atrial fibrillation during a seven day period after thoracotomy as well as the incidence of chronic neuropathic pain during a three months period, comparing one group with a continuous application of magnesium sulphate against one group without magnesium sulphate.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* posterolateral thoracotomy for lung parenchyma resection
* informed consent

Exclusion Criteria:

* hypersensitivity for magnesium sulphate
* pre-existing atrial fibrillation
* participation in another trial
* pregnancy or breastfeeding

Primary outcomes:
measure: Incidence of atrial fibrillation
timeFrame: Up to 168 hours after operation
Secondary outcomes:
measure: Chronic neuropathic pain
timeFrame: Three months
Other outcomes:
measure: Hypotonia
timeFrame: 24 hours perioperative
Locations:
city: Wiesbaden
country: Germany
facility: HSK
Study officials:
affiliation: HSK Wiesbaden
name: Grietje Beck, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT03463447: Measurement of Handgrip Strength and Pinch of Children and Adolescents Using an Electronic Dynamometer
Official title: Measurement of Handgrip Strength and Pinch of Children and Adolescents Using an Electronic Dynamometer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Strength
Keywords: Dynamometer
Handgrip
children
Lead sponsor: University of Mogi das Cruzes
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study has quantified the hand strength in movements of handgrip and pinch with electronic dynamometer.

Detailed description: The hand is considered the most improved tool and differentiated of the human, with great importance in the accomplishment of numerous actions due to an essential function: The handgrip strength. The handgrip and pinch movements are very important for an accomplishment of daily activities. For an evaluation of the movements, the dynamometry has been used in many fields of health and frequently in the area of rehabilitation. However, if the type of dynamometer used is not suitable for children, a measurement of the handgrip may be compromised. Therefore, the present study verified the effectiveness of an electronic dynamometer to evaluate the handgrip strength and pinch in children and adolescents.

Eligibility criteria: Inclusion Criteria:

* neurological disorder Absence
* Informed Consent signed by the responsible
* with preserved cognitive.
* consent form signed by the volunteer

Exclusion Criteria:

* change Absence of skeletal muscle in the upper limbs

Primary outcomes:
measure: Force
timeFrame: 15 minutes
Secondary outcomes:
measure: Anthropometric variables (weight)
timeFrame: 1 minute
measure: Anthropometric variables (height)
timeFrame: 1 minute
measure: Anthropometric variables (Measurements of the hands)
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Mogi das Cruzes
country: Brazil
facility: Silvia Regina Matos da Silva Boschi
state: São Paulo
Study officials:
affiliation: University of Mogi das Cruzes
name: Silvia R Boschi, PhD
role: PRINCIPAL_INVESTIGATOR
References: