louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02107768: Aerobic Exercise in Early Subacute Stroke
Official title: Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Exercise
Randomized trial
Quality of Life
Lead sponsor: Ostergotland County Council, Sweden
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effects of early intensive aerobic exercise regarding aerobic capacity, gait and balance, Health Related Quality of Life and participation.


Eligibility criteria: Inclusion Criteria:

* Ability to understand Swedish language.
* Ability to walk 5 meters with or without the support of any means or person.
* Be able to get up on a cycle ergometer and cycle in their own chosen pace.
* Approval of medically responsible physician to conduct physical training in groups.

Exclusion Criteria:

* Medical or neurological diseases that may affect the exercise execution.
* Patients for whom transportation to and from hospital can not be arranged during intervention period

Primary outcomes:
measure: Aerobic capacity
timeFrame: Baseline,3month
Secondary outcomes:
measure: Balance
timeFrame: Baseline,3month
measure: Walking capacity
timeFrame: Baseline,3month
Other outcomes:
measure: EQ5-D
timeFrame: Baseline,3month,6month
measure: Stroke Impact Scale
timeFrame: Baseline,3month,6month
Locations:
Study officials:
affiliation: Rehab East, Local Health Care Östergötland County Council
name: Klas Sandberg, Msc,RPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Rehab East, Local Health Care Östergötland County Council
name: Marie Kleist, Bsc,RPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Research and Development Unit, Local Health Care Östergötland County Council, Dept of Dermatology and Venereology, Linköping University Hospital,
name: Lars Falk, PhD,MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research and Development Unit, Local Health Care Östergötland County Council,Dept of Medical and Health Sciences, Linköping University
name: Paul Enthoven, PhD,RPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wijkman MO, Sandberg K, Kleist M, Falk L, Enthoven P. The exaggerated blood pressure response to exercise in the sub-acute phase after stroke is not affected by aerobic exercise. J Clin Hypertens (Greenwich). 2018 Jan;20(1):56-64. doi: 10.1111/jch.13157. Epub 2018 Jan 16.
citation: Sandberg K, Kleist M, Falk L, Enthoven P. Effects of Twice-Weekly Intense Aerobic Exercise in Early Subacute Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1244-53. doi: 10.1016/j.apmr.2016.01.030. Epub 2016 Feb 20.
Clinical trial NCT01807468: Haploidentical Stem Cell Transplantation and NK Cell Therapy in Patients With High-risk Solid Tumors
Official title: Haploidentical Stem Cell Transplantation Followed by NK Cell Infusion in Patients With High-risk Solid Tumors Who Failed Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neuroblastoma
Ewing Sarcoma
Rhabdomyosarcoma
Osteosarcoma
Soft Tissue Sarcoma
Keywords: haploidentical stem cell transplantation
natural killer cell therapy
pediatric solid tumor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 12
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate feasibility and efficacy of haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.

To evaluate feasibility and efficacy of NK cell infusion after haploidentical stem cell transplantation in patients with high-risk solid tumors who failed after tandem high-dose chemotherapy and autologous stem cell transplantation.

Detailed description: HaploSCT following reduced-intensity conditioning (RIC) regimen will be performed in patients with high-risk solid tumors. Both parents will be evaluated for their KIR genotype and phenotype and the one with the greatest degree of KIR-L mismatch with the patient will be selected as the donor. In addition, ex-vivo expanded NK cells derived from the donor will then be administered after haploSCT to increase the GVT effect. Low-dose IL-2 will be given after expanded NK cell infusion to enhance NK cell alloreactivity.

Eligibility criteria: Inclusion Criteria:

* age \< 21 years old
* Patients with high-risk solid tumors who failed prior HDCT/autoSCT
* Patients with a suitable haploidentical donor
* High-risk solid tumors include high-risk neuroblastoma, metastatic or relapsed Ewing sarcoma, relapsed osteosarcoma, high-risk brain tumors, relapsed germ cell tumors, relapsed soft tissue sarcoma, relapsed rhabdomyosarcoma, and etc.
* stable disease with salvage chemotherapy after relapse

Exclusion Criteria:

* organ dysfunction(NCI common toxicity criteria grade \> 2)
* progression of disease despite salvage chemotherapy

Primary outcomes:
measure: Number of study patients with adverse events as a measure of safety of haploidentical stem cell transplantation and NK cell infusion
timeFrame: within 30 days after transplantation
Secondary outcomes:
measure: event-free survival and overall survival
timeFrame: 3 years after transplantation
Other outcomes:
measure: number of patients developing GVHD
timeFrame: up to 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Department of Pediatrics, Samsung Medical Center
name: Ki Woong Sung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00352768: Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents
Official title: SME3110 (Fluvoxamine Maleate) in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents (8 Through 18 Years of Age) -A Double-blind, Randomized, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Obsessive Compulsive Disorder
Keywords: Fluvoxamine Maleate
OCD
Children and Adolescents
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-07-17
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder


Eligibility criteria: Inclusion Criteria Have a minimum total score of 16 on the JCY-BOCS, Weight is within the standard weight ± 2S.D. based on the standard weight for each age in the School Health Statistical Survey Exclusion Criteria Have the following predominant psychiatric diagnosis -Schizophrenia Have previously been treated with fluvoxamine maleate

Primary outcomes:
measure: the time of onset of 25% decrease from baseline in the Japanese Version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item total score
timeFrame: 10 weeks
Secondary outcomes:
measure: The Clinical Global Impression(CGI) improvement at Week 10
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Chiba prefecture
country: Japan
facility: S114.3.118 Kohnodai Hospital, National Center of N
city: Fukuoka prefecture
country: Japan
facility: S114.3.118 Kyushu University Hospital
city: Hiroshima prefecture
country: Japan
facility: S114.3.118 Hiroshima-city Funairi Hospital
city: Hokkaido prefecture
country: Japan
facility: S114.3.118 Goryokai Hospital
city: Hyogo prefecture
country: Japan
facility: S114.3.118 Hyogo Children's Hospital
city: Hyogo prefecture
country: Japan
facility: S114.3.118 Kobe University Hospital
city: Kagawa prefecture
country: Japan
facility: S114.3.118 National Hospital Organization Kagawa C
city: Kumamoto prefecture
country: Japan
facility: S114.3.118 National Hospital Organization Kikuti N
city: Mie prefecuture
country: Japan
facility: S114.3.118 National Hospital Organization Sakakiba
city: Nara prefecture
country: Japan
facility: S114.3.118 Nara Medical University Hospital
city: Tokushima prefecture
country: Japan
facility: S114.3.118 Tokushima University Hospital
Study officials:
affiliation: Solvay Pharmaceuticals
name: Toshiaki Yamaguchi
role: STUDY_DIRECTOR
References:
Clinical trial NCT01574768: LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
Official title: LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Snore
Obstructive Sleep Apnea
Lead sponsor: Hospital do Servidor Publico Estadual
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
First posted: 2012-04-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment of snore and OSAS.


Eligibility criteria: Inclusion Criteria:

* snore
* osas

Exclusion Criteria:

* previous pharynx surgery
* use of medication that modifies the muscular tonus or the perception of sleepiness before or after the surgery
* body mass index (BMI) bigger than 35 kg/m2
* neurological or psychiatric disease.

Primary outcomes:
measure: AHI
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Servidor Público Estadual
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Michel B Cahali, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06755268: Effect of Music on Coronary Angiography
Official title: Effect of Music on Comfort, Anxiety and Hemodynamic Parameters During Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Angiography
Hemodynamic Parameters
Comfort
Anxiety
Music Intervention
Keywords: Anxiety
Comfort
Coronary angiography
Hemodynamic parameters
Nursing
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted in a randomized, controlled experimental design to examine the effect of music on comfort, anxiety and hemodynamic parameters during coronary angiography. The research was conducted with 78 patients (39 intervention and 39 control groups) who were processed in the Coronary Angiography Laboratory of Necmettin Erbakan Training and Research Hospital between February and June 2024. The intervention group listened to nature sounds based music during the angiography procedure, but no intervention was made to the control group. "Introductory Information Form," "State Anxiety Scale," "General Comfort Scale," and "Hemodynamic Parameters Record Form" were used to collect the data.


Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older
* Being at least literate
* Having no mental and cognitive competence
* Understanding and speaking Turkish
* Having a planned coronary angiography
* Performing for diagnostic purposes

Exclusion Criteria:

* Having visual and hearing impairment
* Having a psychiatric diagnosis
* Using psychiatric medication (tranquilizers, etc.)
* Using anxiety medication in the last 6 months
* Having had coronary angiography before
* The coronary angiography procedure is being performed for therapeutic purposes (stent, balloon, etc.)
* An unexpected complication during coronary angiography (arrhythmia, MI, bleeding, etc.)
* coronary angiographyprocedure started for diagnostic purposes and stent and/or balloon procedures were applied during the procedure
* Data collection forms were not filled out by the participant after coronary angiography

Primary outcomes:
measure: General Comfort Scale
timeFrame: before the angiography procedure and after the angiography procedure (average of 15 minutes)
Secondary outcomes:
measure: State Anxiety Scale
timeFrame: before the angiography procedure and after the angiography procedure (average of 15 minutes)
Other outcomes:
measure: Hemodynamic Parameters Record Form
timeFrame: before the angiography procedure and after the angiography procedure (average of 15 minutes)
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
Clinical trial NCT01869868: Neurobiological Changes When Treating Depression With Electroconvulsive Therapy - a Longitudinal Observational Study
Official title: Neurobiological Changes and Clinical Outcome When Treating Depression With Electroconvulsive Therapy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
First posted: 2013-06-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with depression referred for ECT.

Brief summary: The purpose of this study is to determine functional and structural changes in brain following treatment of severe depression with electroconvulsive therapy with correlation to clinical outcome. Our hypothesis is that there are state-dependent changes in functional connectivity within specific neurocircuits systems, as well as structural plasticity changes in hippocampus, when recovering from depression.

Detailed description: The study is a prospective, within-subject, observational follow-up study in individuals with depression who receive electroconvulsive therapy (ECT)at a psychiatric clinic. We will use a consecutive sampling method and patient referred for ECT by their psychiatrist will be screened for inclusion and asked for participation. Both in - and outpatients can be included. At three occasions (before treatment, after four week and after three months) patients will be assessed with clinical ratings, cognitive tests, functional and structural magnetic resonance imaging and biomarkers for cell proliferation.

Eligibility criteria: Inclusion Criteria:

* major depressive disorder
* depressive episode in bipolar disorder
* age 18 - 65 years

Exclusion Criteria:

* alcohol- and/or drug dependence or abuse in the past 3 months
* severe/life-threatening medical disease
* pregnancy
* type I diabetes
* neurodegenerative disorder
* inability to give written informed consent to participation in the study
* contradiction to MRI scanning.

Primary outcomes:
measure: Measures of hippocampal volume assessed by structural MRI
timeFrame: Three months
measure: fMRI BOLD resting state functional connectivity
timeFrame: 3 month
measure: fMRI BOLD responses during execution of emotional and reward processing tasks
timeFrame: 3 months
measure: Biomarkers of cell proliferation
timeFrame: 3 months
Secondary outcomes:
measure: Relation between neurobiological changes and clinical and cognitive outcome
timeFrame: Three months
Other outcomes:
Locations:
city: Linkoeping
country: Sweden
facility: Linkoeping University, Linkoeping University Hospital
state: Ostergotland
Study officials:
References:
Clinical trial NCT04233268: RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study
Official title: RASCALS: Rapid Assay for Sick Children With Acute Lung Infection Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lower Respiratory Tract Infection
Ventilator Associated Pneumonia
COVID19
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 250
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill children with suspected lower respiratory tract infection

Brief summary: Lower Respiratory Tract infections are a common cause of admission to the intensive care unit. Children routinely receive antibiotics until the tests confirm whether the infection is bacterial or viral. The exclusion of bacterial infection may take 48 hours or longer for culture tests on biological samples to be completed. In many cases, the results may be inconclusive or negative if the patient has already received antibiotics prior to the sample being taken.

A rapid assay to detect the most likely cause of infection could improve the speed with which antibiotic therapy is rationalised or curtailed.

This study aims to assess whether a new genetic testing kit which can identify the presence of bacteria and viruses within hours rather than days is a feasible tool in improving antibiotic prescribing and rationalisation of therapy in critically ill children with suspected lower respiratory tract infection.


Eligibility criteria: Inclusion Criteria:

1. Aged \>37 weeks corrected gestation and ≤16 years old
2. Receiving mechanical ventilation
3. Commencing or already receiving antibiotic treatment for lower respiratory tract infection

Exclusion Criteria:

1. Survival not expected/active medical treatment expected to be withdrawn/palliative care only

Primary outcomes:
measure: Performance of the novel pathogen detection assay
timeFrame: 3 years
Secondary outcomes:
measure: Time to results
timeFrame: 3 years
measure: Negative cultures
timeFrame: 3 years
measure: Antibiotic therapy
timeFrame: 3 years
Other outcomes:
measure: Prevalence of COVID19 in children admitted to PICU
timeFrame: 2 years
measure: Prevalence of SARS-CoV-2 antigen in faecal samples following acute admission with COVID-19 related illness
timeFrame: 2 years
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: Cambs
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Nazima Pathan, FRCPCH PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clark JA, Kean IRL, Curran MD, Khokhar F, White D, Daubney E, Conway Morris A, Navapurkar V, Bartholdson Scott J, Maes M, Bousfield R, Gouliouris T, Agrawal S, Inwald D, Zhang Z, Torok ME, Baker S, Pathan N. Rapid Assay for Sick Children with Acute Lung infection Study (RASCALS): diagnostic cohort study protocol. BMJ Open. 2021 Nov 29;11(11):e056197. doi: 10.1136/bmjopen-2021-056197.
Clinical trial NCT02848768: Validation of a Predictive Nomogram of Response or Resistance to Targeted Therapies in Metastatic Clear Cell Renal Cell Carcinoma
Official title: Validation of a Predictive Nomogram of Response or Resistance to Targeted Therapies in Metastatic Clear Cell Renal Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Clear Cell Renal Cell Carcinoma
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 45
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: cohort of 50 patients with metastatic ccRCC who underwent nephrectomy at the University Hospital of Rennes and treated by sunitinib first line treatment.

Brief summary: The purpose of this study is to validate of a predictive nomogram of response or resistance to targeted therapies in metastatic clear cell renal cell carcinoma


Eligibility criteria: Inclusion Criteria:

* patients with metastatic ccRCC
* Underwent nephrectomy at the University Hospital of Rennes
* treated by sunitinib first line treatment

Exclusion Criteria:

* translocation renal cell carcinoma
* other targeted therapies before the sunitinib

Primary outcomes:
measure: Primary refractory patients (Progression Free Survival (PFS)
timeFrame: at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT00663468: Treatment of Sub-capital Fractures of Hip Joint by Using TriboFit™ Acetabular Buffer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hip Fractures
Keywords: determine changes in patient pain level
determine changes in patient functionality
determine changes in patient life quality
Lead sponsor: Active Implants
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 11
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The purpose of this study is to determine the performance and efficacy during 6 and 12 month post operation.

1. determine changes in patient pain level
2. determine changes in patient functionality
3. determine changes in patient life quality


Eligibility criteria: Inclusion Criteria:

* Female or male that is not younger than 60 years old.
* Patient suffers from hip fracture that will need hip arthroplasty.
* Patient that weight less than 150Kg
* Patient femur head diameter between 40mm - 50mm
* Mentally normal
* Patient that could walk before suffering from hip fracture
* Patient that willing to cooperate with the doctor
* Patient that signed on the acceptance form

Exclusion Criteria:

* Patient that does not willing to cooperate with the doctor
* Patient that is legally rejected
* Patient that suffer from cancer
* Patient that had passed amputation in is limbs
* Patient that is paralysis
* Patient that passed CVA or TIA
* Patient that still recovering from hard wounds or surgery
* Patient that suffer from infection in the hip joint

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06751368: The Fate of Aortic Valve After SAS Surgery in Children
Official title: Aortic Valve Regurgitation After Surgical Repair for Subaortic Stenosis in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subaortic Stenosis
Congenital Heart Disease
Aortic Regurgitation
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 232
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients age from 0-18 underwent SAS surgical repair at Fuwai Hospital.

Brief summary: Aortic valve regurgitation (AR) is a common complication following surgery for subaortic stenosis (SAS), yet the long-term outcomes and risk factors for postoperative significant AR (SAR) remain poorly understood. This study aims to investigate the incidence and risk factors of SAR in SAS patients and evaluate the long-term postoperative outcomes.


Eligibility criteria: Inclusion Criteria:

* Age from 0-18
* Clinical diagnosis of subaortic stenosis and underwent surgery

Exclusion Criteria:

* Diagnosed with hypertrophic cardiomyopathy
* Underwent concomitant previous surgical repair for aortic valve or SAS
* Follow-up time less than 1 year or lack of detailed information.

Primary outcomes:
measure: Rate of Postoperative significant AR (SAR)
timeFrame: Through study completion, an average of 4 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
References: