louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00275951: Cetuximab Plus P-HDFL for the First-line Treatment of Advanced Gastric Cancer
Official title: Phase II Study of Cetuximab Plus P-HDFL(Cisplatin and Weekly 24-Hour Infusion of High-dose 5-Fluorouracil and Leucovorin)for the First-line Treatment of Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: Combination
Chemotherapy
Gastric cancer
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: National Health Research Institutes, Taiwan
name: Chang Gung Memorial Hospital
name: Tri-Service General Hospital
First posted: 2006-01-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators have initial evidence that the combination of cetuximab and cisplatin-HDFL may further improve the efficacy of the cisplatin-HDFL combination chemotherapy.

Detailed description: The clinical efficacy (confirmed objective response rates, progression-free survival, overall survival), and treatment-related toxicities of this novel regimen will be examined as the first-line treatment in patients with nonresectable or recurrent/metastatic gastric cancer.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 75 years
2. Histologically proven adenocarcinoma
3. At least one "measurable" lesion (by RECIST)
4. No prior chemotherapy for gastric cancer
5. WHO performance status ≦ 2
6. Adequate baseline organ functions
7. Fasting serum triglyceride level \> 70 mg/dL
8. Written informed consent
9. At least one month from gastrectomy
10. Availability of tumor sample for immunohistochemical or pharmacogenomic testing of EGFR

Exclusion Criteria:

1. Concomitant anti-cancer biological agents, chemotherapy, or radiotherapy
2. CNS metastasis
3. Pregnancy, breast-feeding women and women of child-bearing potential
4. Life expectancy less 3 months
5. Serious concomitant illness
6. Concurrent or prior second malignancy
7. Known hypersensitivity reaction to any of the components of study treatments

Primary outcomes:
measure: Confirmed objective response rates
timeFrame: Confirmed objective response within 4 weeks
Secondary outcomes:
measure: Progression-free survival (PFS), overall survival (OS), treatment-related toxicity
timeFrame: 3 years and 5 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Oncology, National Taiwan University Hospital
Study officials:
affiliation: Department of Oncology, National Taiwan University Hospital
name: Ann-Lii Cheng, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT06899451: Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke
Official title: Impact of Basophobia on Balance and Functional Outcomes in Patients With Stroke.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Balance
Keywords: fear of falling, balance, stroke
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: AlRyada University for Science & Technology
First posted: 2025-03-28
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stroke

Brief summary: Several studies have reported that the physical functions associated with falls, including motor performance, postural balance, flexibility, and muscle strength, are also associated with FoF. Patients with stroke have trouble performing ADLs, including washing their face, eating, bathing, dressing, toileting, and walking, which also affect FoF. Anxiety and depression are common affective disorders in patients with stroke and significantly increase FoF .

Detailed description: People who are afraid of falling because they can't keep their balance can utilize This makes them less susceptible to fall and high tendency to prevent it.

Eligibility criteria: Inclusion Criteria:

an ischemic stroke and having had the disease for longer than three months have frequent falling, having sufficient cognition (as measured by a Montreal Cognitive Assessment score of over 26) and having upper and lower extremity spasticity ranging from (grade 1+: 2) on a modified Ashworth scale

Exclusion Criteria

) Musculoskeletal issues, such as severe arthritis, total hip arthroplasty, knee surgery, lower extremity fractures within the previous six months, or contractures brought on by a fixed deformity and/or disparity in leg length, 2) Instable medical conditions (e.g., unstable angina, recent myocardial infarction, history of congestive heart failure, major heart valve problems, or unstable hypertension);

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 5 months
measure: The 16-item Fall Efficacy Scale-International
timeFrame: 5 months
measure: Timed Up and Go Test (TUG)
timeFrame: 5 months
Secondary outcomes:
measure: fear of falling
timeFrame: 5 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairou
Study officials:
affiliation: ALRyada university for science and technology
name: Heba Gaber, phd
role: STUDY_CHAIR
References:
Clinical trial NCT01880151: Neuroelectrical Biomarkers for Alzheimer's Disease Stages
Official title: NEw approacheS for The dIagnosis of AlzeiMer's diseAse Through neuroElectrical Changes in the Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer's disease
Dementia
Prodromal
EEG
ERP
Biomarkers
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2013-06-18
Enrollment: 87
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Recent diagnostic criteria for Alzheimer's disease (AD) recognize an extended spectrum of AD stages as part of the disease, including a preclinical stage. This underscores the importance of early prognosis of AD when it is still possible to influence the course of the disorder. The investigators propose a comprehensive project which will target the data-driven modeling of the disease development. This goal will be achieved by creating and validating a battery of new sensitive biomarkers for clinical evaluation and prediction of AD in individuals. The AD-related brain changes will be assessed by noninvasive functional EEG measured during an episodic memory task in subjects at different stages of AD, as well as in healthy controls. The novel functional biomarkers will be extracted using a rigorous multistage selection procedure involving advanced methods for feature extraction, as well as statistics and classification for optimal selection. The ESTIMATE project will serve as a first step in an extensive array of research procedures which will enable the early clinical identification of Alzheimer's disease in elderly individuals who could then take advantage of preventive pharmaceutical therapies.


Eligibility criteria: Inclusion Criteria:

* Age: 70-85 years old
* Presence of memory impairment
* Completed educational level: middle school
* Visual and auditory acuity: normal or corrected-to-normal

Exclusion Criteria:

* Monogenic AD
* Presence of a neurological disorder
* Stroke that has occurred in the last three months
* Prohibited medications
* Residence in skilled nursing facility
* Illiteracy, is unable to count or to read
* Claustrophobia

Primary outcomes:
measure: Frequency band charactersitics of the electrophysiological brain response
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital
Study officials:
affiliation: Institute of Memory and Alzheimer's Disease, Pitie-Salpetriere Hospital
name: Bruno Dubois, PhD,MD,Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03165851: Efficacy Analysis of Comparison of CAMS（Chinese Academy of Medical Sciences）-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia
Official title: Efficacy Analysis of Comparison of CAMS-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia, Pediatric
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 320
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to the Department of Pediatrics, Institute of Hematology \& Blood Disease Hospital.

Brief summary: The investigators adopted the CAMS（Chinese Academy of Medical Sciences）-2009 trial for pediatric acute myeloid leukemia (AML) patients between 2009 to 2015, in which a risk-stratified strategy and dose-dense intensive chemotherapy were introduced. The outcomes of CAMS-2009 trial were retrospectively analyzed, and compared to the CAMS-2005 trial.


Eligibility criteria: Inclusion Criteria:

* newly diagnosed AML

Exclusion Criteria:

* children with Down's syndrome and acute promyelocytic leukemia (APL)

Primary outcomes:
measure: overall survival (OS)
timeFrame: From date of diagnosed until the date of death from any cause, assessed up to 60 months
measure: event-free survival (EFS)
timeFrame: From date of diagnosed until the date of first relapse or date of death from any cause, whichever came first, assessed up to 60 months
measure: complete remission (CR)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: InstituteHBDH
state: Tianjin
Study officials:
affiliation: Institute of Hematology & Blood Disease Hospital
name: Zhu Xiaofan
role: STUDY_CHAIR
References:
Clinical trial NCT03082651: Alternate Run Study
Official title: Investigating the Effect of Alternating Training Load and Footwear Singly or in Combination in Runners: The Alternate Run Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overuse Injury
Keywords: Running injuries, footwear, alternating load
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: British Columbia Sports Medicine Research Foundation
First posted: 2017-03-17
Enrollment: 300
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The proposed study will investigate the effect of alternating footwear model and workout-type on the occurrence of running-related pain. To achieve this goal participants will be randomly assigned into one of four different groups who will perform: 1) the same workout throughout a week in the same running shoe model, 2) alternating workout-types throughout the week in the same shoe model, 3) the same workout throughout a week in alternating shoe models, and 4) alternating workouts in alternating shoes. Participants will be characterized based on body alignment, strength, injury and training history. Pain and injury status will be monitored.


Eligibility criteria: Inclusion Criteria:

* Subjects in this study will include adults (men and women) between the ages of 19 and 60, have been running on a regular basis (minimum once per week) over the past 6 months, are able to run for 60 minutes continuously, could tolerate 20-40km per week in training, and have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months. Only neutral and pronated foot postures (Foot Posture Index between -2 and 8) will be recruited

Exclusion Criteria:

* have a history of surgery to their plantar fascia or Achilles tendon,
* have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity,
* take analgesic or anti-inflammatory medication 2 or more times per week over the past 4 weeks,
* take part in high impact activities 2 or more times per week during the study period

Primary outcomes:
measure: Running injuries
timeFrame: 13-weeks
Secondary outcomes:
measure: Running-related pain
timeFrame: 13-weeks
measure: Region specific running-related pain
timeFrame: 13-weeks
measure: Footwear comfort
timeFrame: 13-weeks
measure: Run Quality
timeFrame: 13-weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Division of Sports Medicine
state: British Columbia
Study officials:
References:
Clinical trial NCT02723851: Determining the Optimal Cut-off Point of PEA by Corsens Device for Discriminating Between MI and Non-MI Subjects
Official title: An Open Label Study for Determining the Optimal Cut-off Point of Peak Endocardial Acceleration Measured by Corsens Device for Discriminating Between MI and Non-MI Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Lead sponsor: Corsens Medical LTD
Sponsor class: INDUSTRY
First posted: 2016-03-31
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with ST-elevation acute MI will be recruited to the study. Additional data that was already recorded in previous study from non-MI patients hospitalized for routine elective catheterization will be used.

Brief summary: Acute Myocardial Infarction (MI) is still the leading cause of death in the western world. Early warning (chest pain) signs of an acute MI are often misinterpreted and disregarded. In average it takes between 2-3 hours from the beginning of the chest pain. The damage to the heart in these 2 hours is critical and often irreversible. Thus an early warning test or device is highly warranted.

Corsens has developed a noninvasive device using several sensors applied to the chest and a detection system able to recognize the ischemic origin of chest pain. This clinical study is intended for evaluating the safety and efficacy of the Corsens technology while use for myocardial infarction detection


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the cardiac care unit (CCU) with ST elevation acute MI (STEMI) within 4 hours from beginning of chest pain.
* Male or female subjects aged 18 years or more (with no upper limit), of any race.
* Subjects willing to participate as evidenced by signing the written informed consent.

Exclusion Criteria:

* Obese patients with BMI\>35.
* Subjects with cardiac arrhythmias including atrial fibrillation. Previous MI.
* Patients after coronary artery bypass grafting
* Unstable hemodynamic condition.
* Patient that can't or do not wish to sign the Inform Consent Form

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" to verify safety
timeFrame: 1 day
Secondary outcomes:
measure: To define the optimal cut-off point (in terms of sensitivity and specificity) of the PEA measured by Corsens technology for discriminating between MI and non-MI patient.
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Medical Center, Haifa Israel
name: Eugenia Nikolsky, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00972751: S9304A Study of Protein Expression in Tumor Tissue Samples From Patients With Stage II or Stage III Rectal Cancer Enrolled in Clinical Trial SWOG-9304
Official title: Investigation of Thioredoxin-1 Family Protein Expression in Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: stage II rectal cancer
stage III rectal cancer
adenocarcinoma of the rectum
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-07
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled on SWOG-9304, adenocarcinoma of the recturm Stage II or III

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at protein expression in tumor tissue samples from patients with stage II or stage III rectal cancer enrolled in clinical trial SWOG-9304.

Detailed description: OBJECTIVES:

* Determine expression levels of thioredoxin-1 (Trx-1), thioredoxin-interacting protein (TXNIP), and hypoxia inducible factor-1 alpha (HIF-1α) in paraffin-embedded resected tumor tissue samples from patients with stage II or III rectal cancer enrolled in clinical trial SWOG-9304.
* Determine if there is a correlation between Trx-1 and TXNIP expression and HIF-1α expression.
* Correlate expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence.
* Determine interactions for patient age, performance status, and type of therapy received on clinical trial SWOG-9304.

OUTLINE: This is a multicenter study.

Paraffin-embedded resected tumor tissue samples are analyzed for protein expression levels (thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha) by tissue microarray and immunostaining.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed adenocarcinoma of the rectum

  * Stage II or III disease
  * No metastases
* Enrolled on clinical trial SWOG-9304

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Expression of thioredoxin-1, thioredoxin-interacting protein, and hypoxia inducible factor-1 alpha
timeFrame: upon testing of specimens
measure: Correlation of expression of these proteins with tumor stage, disease-free survival, overall survival, and risk of recurrence
timeFrame: upon provision of expression to Statistical Center
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Arizona
name: Tomislav Dragovich, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05156151: Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis
Official title: Stromal Lenticule Implantation for Management of Herpetic Stromal Keratitis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stromal Keratitis
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is the evaluation of corneal transparency and improvement of visual acuity in patients with herpetic stromal keratitis.

Detailed description: Stromal keratitis is an infectious ocular disease of either necrotizing or non-necrotizing form, due to an HSV infection, and characterized by corneal stromal necrosis, inflammation, ulceration and infiltration by leukocytes.

In our study these early findings suggest that the use of corneal stromal lenticules with stromal stem cells and live keratocytes could be a safe and efficient treatment for stromal scar after herpetic keratitis, and excluding the recurrence of the disease by removing the corneal scar after herpetic infection using Smile and implanting the lenticule equal to the volume of the removed scar tissue.

Stromal lenticule implantation is relatively simple, low-cost and offers advantages over corneal transplantation as a definitive procedure in the treatment of this disease.

Eligibility criteria: Inclusion Criteria:

* low transparenc of cornea
* low visual acuity
* recurrence of herpetic stromal keratitis

Exclusion Criteria:

* previous corneal or anterior segment surgery
* any infection

Primary outcomes:
measure: Corneal transparency
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of visual acuity
timeFrame: 12 months
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References:
Clinical trial NCT05897151: Continuous Spinal Anesthesia Versus General Anesthesia in Sepsis
Official title: Comparative Study Between Continuous Spinal Anesthesia Versus General Anesthesia in Patients With Sepsis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sepsis
Continuous Spinal Anesthesia
General Anesthesia
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 110
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The anesthetic efficacy and safety of continuous spinal anesthesia and comparing it with general anesthesia technique in sepsis diagnosed patient.

Detailed description: Hemodynamic instability due to high block largely limits the use of conventional dose spinal anesthesia in high-risk septic patients. Hypotension is more common, and also more hazardous, in septic patients, as they may have decreased physiological reserve and compromised blood supply to various vital organs. A smaller dose of local anesthetic reduces the severity and incidence of hypotension during spinal anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients over 21 years old
* American Society of Anesthesiologists (III, IV) diagnosed with sepsis (Sequential Organ Failure Assessment (SOFA) score ≥ 7)
* Hemodynamically stable and not on vasopressor due to lower limb pathology candidate for spinal anesthesia to drain source of infection.

Exclusion Criteria:

* Patients with known hypersensitivity to local anesthesia.
* Infection at the site of injection.
* Coagulopathy.
* Septic shock.
* Increase of intracranial pressure.
* Severe deformity of the spinal column.

Primary outcomes:
measure: Mortality rate
timeFrame: 28 Days postoperative
Secondary outcomes:
measure: Changes of Heart Rate
timeFrame: UP to 2 hours postoperative
measure: Changes of Invasive Blood Pressure
timeFrame: UP to 2 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: Elgharbia
Study officials:
References: