louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00172484: North Taiwan Stroke Center for Prevention and Treatment
Official title: North Taiwan Stroke Center for Prevention and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebrovascular Accident
Keywords: cerebrovascular accident
stroke center
stroke team
intensive care of stroke
rehabilitation of stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The Northern Taiwan Stroke Center for Prevention and Treatment Project is a single medical center, 3-year, multipurpose study. The aims of this study are (1) to set up a multidisciplinary stroke team in a well-designed stroke center for stroke care; (2) to establish a systemic stroke prevention / education protocol based on people's awareness of stroke; and (3) to create a better stroke rehabilitation protocol and pathway.there are three components in rehabilitation projects. First, we want to identify potential factors related to functional outcome in patients with stroke before and after stroke center. Second, we want to compare the functional outcome in patients who admit to the stroke center as to those admitted to the general ward. Third, we want to investigate the effect of electrical stimulation on upper limb function in patient with acute stroke.


Eligibility criteria: Inclusion Criteria:

* acute stroke
* age \> 18 y/o
* consult rehabilitation
* client or agent can sign a letter of consent

Exclusion Criteria(for rehabilitation protocol):

* contraindication of electrical stimulation(pacemaker implant, severe arrhythmia, malignant cancer, wound on stimulation site)

Primary outcomes:
measure: Bureau Of Health Promotion,Department of Health , R.O.C.
timeFrame: 2003/08/29；2004/02/02；2004/08/26；2004/12/03；2005/06/12；2005/11/22
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Stroke Intensive Care Unit
Study officials:
affiliation: Department of Neurology, National Taiwan Univisity Hospital
name: Ping-Keung Yip
role: STUDY_CHAIR
References:
Clinical trial NCT05278884: Can VAST Improve ACLS in Rwanda
Official title: Can the VAST Course Enhance Resuscitation Skills in a Resource-limited Setting?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Global Health
Education
Resuscitation
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University of Rwanda
name: ANZCA Health Equity Project
First posted: 2022-03-14
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: For each hospital, the intervention will be to pair a 2-day technical resuscitation skills training adapted from the ACLS/AHA and a 3-day VAST course for a multidisciplinary team of 20 participants (i.e., nurses, doctors, non-physician anesthesia providers). Participants' resuscitation skills will be tested at 4 time points: immediately before the ACLS course, immediately after the ACLS course, immediately after the VAST Course, and at 4 months post training.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Aim The purpose of this study is to determine if the addition of the VAST Course to technical resuscitation skills training enhances healthcare providers' resuscitation performance in a resource-limited setting.

Objectives

The aims of this research will be achieved by meeting the following objectives:

1. Quantitative evaluation of study participants' resuscitation performance during a simulation scenario before ACLS course, immediately following ACLS course, immediately following VAST course, and at 4 months post training.
2. Qualitative exploration of the barriers and supports identified by course participants to implementing resuscitation in the workplace after resuscitation skills training through focus groups.

New knowledge Lessons learned from this study will help inform the design and the implementation of resuscitation training programs in resource-limited settings. This has potential to improve resuscitation capacity in resource-limited settings leading to higher quality of care for patients.


Eligibility criteria: Inclusion Criteria:

* Full course participation
* Available for focus group interviews

Exclusion Criteria:

* Refusal to provide informed consent
* Participated in VAST or ACLS training in the four months prior to study

Primary outcomes:
measure: Time to initiation of CPR
timeFrame: From start of simulation scenario to time of first chest compressions, assessment up to 2 minutes of simulation
Secondary outcomes:
measure: Time to epinephrine administration
timeFrame: From start of simulation scenario to time of first epinephrine administration, assessment up to 5 minutes of simulation
measure: Time to defibrillation
timeFrame: From start of simulation scenario to time of first defibrillation, assessment up to 5 minutes of simulation
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: University of Rwanda
Study officials:
affiliation: University of Toronto
name: Teresa Skelton, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07002684: Metabolic Profiling of Esketamine Treatment in Depressive Disorder
Official title: Metabolic Profiling of Esketamine Treatment in Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Major Depressive Disorder
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical Hospital Centre patients

Brief summary: Major depressive disorder (MDD) is one of the most common psychiatric disorders, characterized by extremely high prevalence, relapse rate and therapeutic resistance. Treatment with ketamine and its enantiomer esketamine is the next step towards the successful treatment and understanding of depression that is resistant to treatment with standard antidepressants. The proposed study will include approximately 50 patients with MDD and 50 healthy control subjects of both sexes. Using untargeted metabolomic approach, we plan to detect changes in biochemical pathways related to the diagnosis of treatment-resistant MDD and changes related to the mechanism of action of esketamine. The proposed research will contribute to further understanding of the mechanism of action of esketamine in patients with MDD. Metabolic changes will be associated with improvements in specific domains of depressive symptoms and symptom severity in subjects with treatment-resistant major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* for healthy control participants: 18-70 years, both sexes, without psychiatric drugs
* for patients: from 18- 70 years, both sexes, failed treatment attempts with at least two antidepressants of the appropriate dose and duration.

Exclusion Criteria:

* for patients: treatment with tryptophan, St. John's wort, and/or opioid analgesics in the last month, daily intake of benzodiazepines;
* for all participants: presence of psychotic symptoms, alcohol and/or drug addiction, disorder seizures, eating disorder, dementia and other neurodegenerative diseases, epilepsy, intellectual disabilities, severe somatic diseases (including insufficiently controlled arterial hypertension, diabetes and thyroid diseases), active psychotherapeutic treatment (except supportive psychotherapy, which is an integral part of every psychiatric treatment and will be the same in all groups of respondents).

Participants will be excluded if they follow a weight loss diet or take weight loss medication, are pregnant or breastfeeding.

Primary outcomes:
measure: changed metabolomics
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Tea Fabijanić
Study officials:
affiliation: University of Zagreb School of Medicine
name: Tea Fabijanić, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05809284: Determining the Mechanisms of Loss of CAR T Cell Persistence
Official title: Determining the Mechanisms of Loss of CAR T Cell Persistence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Lymphoblastic Leukemia With Failed Remission
Acute Lymphoblastic Leukemia Not Having Achieved Remission
Acute Lymphoblastic Leukemia, Pediatric
Acute Lymphoblastic Leukemia, Adult
Acute Lymphoblastic Leukemia, in Relapse
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 50
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is paediatric and young adult patients aged 25 or younger who have relapsed/refractory B-cell acute lymphoblastic leukaemia.

Brief summary: A prospective observational study of pediatric and young adult acute lymphoblastic leukaemia (ALL) patients treated with CD19 chimeric antigen receptor T-cells (CAR-T cells). The study will examine changes in CAR-T persistence over time and causal factors.


Eligibility criteria: Inclusion Criteria:

1. Children and young adults (age 25 years or younger) with relapsed/refractory ALL who are planned to receive licensed CD19-targeted CAR-T cell treatment (Tisagenlecleucel)
2. Written informed consent

Exclusion Criteria:

1. Patients receiving an alternate CD19-directed CAR T-cell product on a clinical trial
2. Any reason that in the opinion of the investigator, patients won't be able to adhere to the protocol

Primary outcomes:
measure: Time to circulating CAR-T cell loss
timeFrame: Through study completion, until the last patient reaches 1 year post-infusion
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
Study officials:
affiliation: UCL Institute of Child Health
name: Persis Amrolia, BSc,MBBS,PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03089684: Correspondence of Folate Dietary Intake and Biomarker Data
Official title: Correspondence of Dietary Intake and Biomarker Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Folate Deficiency
Keywords: NHANES
Folate
Folic Acid
Lead sponsor: National Institute of Health and Nutrition
Sponsor class: OTHER_GOV
First posted: 2017-03-24
Enrollment: 4878
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: NHANES is a nationally-representative, cross-sectional study of nutrition and health for individuals residing in the U.S.

Brief summary: This NHANES analysis compares self-reported dietary folate with serum and red blood cell folate status in U.S. adults.

Detailed description: Background: Public health concerns of both low and high folate status exist in the U.S. Recent publications have questioned the utility of self-reported dietary intake data in research and monitoring.

Objective: The purpose of this analysis was to examine the relationship between self-reported folate intakes and folate status biomarkers, and to evaluate their usefulness for several types of applications.

Design: Usual dietary intakes of folate were examined using the National Cancer Institute (NCI) method to adjust 2, 24-hour dietary recalls (including dietary supplements) for within-person variation and compared these intakes with serum and red blood cell (RBC) folate among 4,878 non-pregnant, non-lactating participants ≥19y in NHANES 2011-2012, a nationally representative, cross-sectional survey, with respect to consistency across prevalence estimates and rank order comparisons.

Eligibility criteria: Inclusion Criteria:

* adults, ages 19+ years

Exclusion Criteria:

* missing data
* non-pregnant
* non-lactating

Primary outcomes:
measure: Folate status
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02642484: Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Official title: Gabapentin in Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Liver Cirrhosis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Muscle cramps markedly affect the quality of life in cirrhotic patients with no highly effective drug.
* Quinine was suggested for treatment of patients with muscle cramps in patients with liver cirrhosis. However, thrombocytopenia, cardiac arrhythmias and cinchonism are serious side effects.

Detailed description: • The aim of the study was to assess the efficacy and safety of Gabapentin in the treatment of muscle cramps in patients with liver cirrhosis.

Eligibility criteria: Inclusion Criteria:

* liver cirrhosis patients

Exclusion Criteria:

* allergy to gapabentin.
* pregnancy and lactation. Renal failure.

Primary outcomes:
measure: Number of muscle cramps
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university - faculty of medicine
state: Elgharbia
Study officials:
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Sherief M. Abd-Elsalam, Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Gastroenterology and Hepatology, UAB, Birmingham, AL, USA
name: A. K. Singal, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Walaa A. Elkhalawany, Lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT05200884: Local Anesthesia With Lidocaine or Articaine for Molars Affected by MIH
Official title: A Comparison the Effectiveness of Anesthesia With Lidocaine 2% or Articaine 4% in Children With Molar Incisor Hypomineralisation (MIH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Molar Incisor Hypomineralisation
Keywords: the local anesthesia
Lidocaine 2%
Articaine 4%
children
MIH molars.
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, controlled, crossover, double-blind clinical study, Comparison of articaine 4% and lidocaine 2%
Primary purpose: TREATMENT

Brief summary: Aims: Comparison of injection pain with lidocaine and articaine in children with MIH .

Comparison of the efficacy of lidocaine and articaine during treatment of MIH molars.

Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children, aged 6-12years old

Detailed description: Background and Aims: Effectively achieving anesthesia is one of the difficulties a dentist faces when treating MIH molar There are no studies comparing the effectiveness of lidocaine and articaine in MIH molar Design: A randomized, controlled, crossover, double-blind clinical study including twenty cooperative children , aged 6-12 years old Each child will receive either lidocaine or articaine at their ﬁrst or second visit.

Eligibility criteria: Inclusion Criteria:

* Absolute positive or positive behavior according to the Frankel Scale.
* Healthy, both physically and mentally.
* Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment.
* A child with a MIH-affected mandibular permanent first molar on the right and left sides .

Exclusion Criteria:

* Teeth with non-response pulpitis Inflammation at the injection site.
* Allergy to the substances used in anesthesia.
* Presence of general or developmental medical conditions.

Primary outcomes:
measure: dental pain
timeFrame: during the injection of local anesthesia
measure: dental pain
timeFrame: Immediately after the injection of local anesthesia
measure: dental pain
timeFrame: during treatment
measure: dental pain
timeFrame: Immediately after the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University
Study officials:
affiliation: Tishreen University
name: Nabih Raslan, Dr
role: STUDY_CHAIR
affiliation: Tishreen University
name: Mai Haidar, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01183884: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma
Official title: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma: A Phase II Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Neuroblastoma
Keywords: GM-CSF
MAB 3F8
RETINOIC ACID (CIS-9 & 13)
09-160
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-08-18
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out what effects, good and/or bad, the combination of 3F8 and GM-CSF has on the patient and the cancer.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine levels.
* High-risk NB as defined by risk-related treatment guidelines1 and the International NB Staging System,89 i.e., stage 4 with (any age) or without (\> or = to 18 months of age) MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified stage 4S.
* The patients are in \>2nd CR/VGPR, including no measurable MIBG-avid soft tissue tumor assessable for response.
* Signed informed consent indicating awareness of the investigational nature of this program.

Exclusion Criteria:

* Creatinine \> 3.0 mg/dL
* ALT, AST and Alkaline Phosphatase \> 5.0 times the upper limit of normal
* Bilirubin \> 3.0 mg/dL
* Patients with grade 3 or higher toxicities (using the CTCAE v34.0) related to cardiac, neurological, pulmonary or gastrointestinal function as determined by physical exam. Patients must have normal blood pressure for age.
* Progressive disease
* History of allergy to mouse proteins
* Active life-threatening infection.
* Human anti-mouse antibody (HAMA) titer \>1000 Elisa units/ml.
* Inability to comply with protocol requirements.

Primary outcomes:
measure: Assess the Impact of High-dose 3F8/GM-CSF on Relapse-free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Apply Real-time Quantitative RT-PCR to Test the Hypothesis That the Minimal Residual Disease Content of Bone Marrow
timeFrame: 2 years
measure: Monitor Safety of the High-dose Antibody Treatment
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Brian Kushner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kushner BH, Modak S, Basu EM, Roberts SS, Kramer K, Cheung NK. Posterior reversible encephalopathy syndrome in neuroblastoma patients receiving anti-GD2 3F8 monoclonal antibody. Cancer. 2013 Aug 1;119(15):2789-95. doi: 10.1002/cncr.28137. Epub 2013 Apr 30.
Clinical trial NCT01044784: Acute Evaluation of the Safety of Left Ventricular-left Ventricular (LV-LV) Delays and Its Effects on Mechanical Dyssynchrony
Official title: Acute Evaluation of the Safety of LV-LV Delays and Its Effects on Mechanical Dyssynchrony
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Resynchronization Therapy
Keywords: CRT
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-01-08
Enrollment: 73
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: Patients indicated for standard CRT-D indications.

Brief summary: The purpose of this study is to evaluate the effects of various LV-LV delays during multi-site left ventricular (MSLV) pacing on mechanical dyssynchrony in cardiac resynchronization therapy (CRT) patients post-implant.


Eligibility criteria: Inclusion Criteria:

1. Have an approved indication for a CRT implant
2. Undergoing or previously received the implant of a St. Jude Medical Promote Q 3221-36 CRT-D with a Quartet Model 1458Q LV lead at participating clinical study site
3. Ability to provide informed consent for study participation and be willing and able to comply with the prescribed evaluations

Exclusion Criteria:

1. Have persistent or permanent atrial fibrillation
2. Have an intrinsic heart rate of \<50 beats per minute
3. Have Cheyne-Stokes breathing
4. Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
5. Have had a recent CVA or TIA within 3 months prior to enrollment
6. Be less than 18 years of age
7. Be pregnant

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Rothenfelde
country: Germany
facility: Schuchtermannklinik
Study officials:
References:
citation: Rinaldi CA, Leclercq C, Kranig W, Kacet S, Betts T, Bordachar P, Gutleben KJ, Shetty A, Donal E, Keel A, Ryu K, Farazi TG, Simon M, Naqvi TZ. Improvement in acute contractility and hemodynamics with multipoint pacing via a left ventricular quadripolar pacing lead. J Interv Card Electrophysiol. 2014 Jun;40(1):75-80. doi: 10.1007/s10840-014-9891-1. Epub 2014 Mar 14.
citation: Rinaldi CA, Kranig W, Leclercq C, Kacet S, Betts T, Bordachar P, Gutleben KJ, Shetty A, Keel A, Ryu K, Farazi TG, Simon M, Naqvi TZ. Acute effects of multisite left ventricular pacing on mechanical dyssynchrony in patients receiving cardiac resynchronization therapy. J Card Fail. 2013 Nov;19(11):731-8. doi: 10.1016/j.cardfail.2013.10.003. Epub 2013 Oct 10.