louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01277926: Patterns of Care in Hormone-receptor Positive, Advanced Breast Cancer
Official title: Patterns of Care in Hormone-Receptor Positive, Advanced Breast Cancer in Brazil: A Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: Breast Cancer
Hormone Receptor Positive, Advanced Breast Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of this study is to characterize the current patterns of care for patients with hormone-receptor-positive, advanced breast cancer who have failed one prior endocrine therapy in Brazil. To investigate patient-related, disease-related and physician-related characteristics that correlate with the use of either endocrine treatment or chemotherapy in such patients. And to evaluate patients' understanding of the treatment options and their participation in the choice.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of breast cancer
* Postmenopausal status at the time of enrolment, according to the following definitions:

  * History of bilateral oophorectomy at any age
  * Proven hormonal menopause
* Positive estrogen receptor (ER) and/or progesterone receptor (PR) by immuno
* Failure of one previous endocrine therapy in the adjuvant or metastatic setting
* Use of no more than one previous chemotherapy regimen in the neoadjuvant or adjuvant setting
* Indication to receive chemotherapy or endocrine therapy

Exclusion Criteria:

* Inability to comply with the study protocol
* Use of more than one previous endocrine therapy, regardless of the setting; -- Previous use of chemotherapy for metastatic disease
* Use of neoadjuvant endocrine therapy as the only previous type of endocrine therapy
* Serious medical, surgical or psychiatric comorbidity that, upon investigator's discretion, should preclude participation in the study.

Primary outcomes:
measure: To assess the treatment choice by the medical oncologist for each patient.
timeFrame: 12 months
Secondary outcomes:
measure: To assess determinants of treatment choice
timeFrame: 12 months
measure: To assess the duration of treatment with chemotherapy or endocrine therapy
timeFrame: 12 months
measure: To evaluate the rate of treatment continuation at 6 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Research Site
state: RS
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Belo Horizonte
country: Brazil
facility: Research Site
city: Mogi das Cruzes
country: Brazil
facility: Research Site
city: Ribeirao Preto
country: Brazil
facility: Research Site
Study officials:
affiliation: MC Brazil
name: Paulo André Palhares Miranda, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04551326: Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain
Official title: Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic low back pain
Hamstring flexibility
Hamstring stretching
Immediate stretching effect
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Thigh muscles flexibility deficits contribute to handicap in chronic low back pain patients. The study aims to evaluate the immediate effect of thigh muscles stretching in patients with chronic low back pain. The investigation team suppose that flexibility improvement could be detected by instrumented clinical measurements and such difference could be related to psycho-social factors evaluated by questionnaires.

Detailed description: The primary objective of the study is to evaluate the immediate effect of the hamstring muscle stretching in patients presenting chronic low back pain. The secondary objectives are: (1) to evaluate intra- and interrater reliability, construct validity and responsiveness of the hamstring flexibility measurements (Active Knee Extension \[AKE\], Straight Leg Rise \[SLR\]) realised with digital inclinometer, (2) to evaluate factors that potentially could influence immediate effect of the hamstring stretching, specifically psycho-social factors Fear Avoidance Belief Questionnaire (FABQ), Hospital Anxiety and Depression scale (HAD), neuropathic pain presence (DN4).

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60 years
* Chronic low back pain (\>3 months) with or without pain irradiation to lower limb
* Hamstring flexibility deficit (AKE \<80° and FTF\>5cm)

Exclusion Criteria:

* Pregnancy or breastfeeding,
* Condition of restricted mental/legal autonomy (ex. guardianship) ,
* No social security insurance,

Primary outcomes:
measure: Active Knee Extension test (AKE)
timeFrame: Day 1
Secondary outcomes:
measure: Straight Leg Rise test (SLR)
timeFrame: Day 1 before stretching, Day 1 after stretching
measure: Fingertip-to-floor distance (FTF)
timeFrame: Day 1 before stretching, Day 1 after stretching
measure: Fear Avoidance Belief Questionnaire (FABQ)
timeFrame: Day 1
measure: Ostwestry Disability Index
timeFrame: Day 1
measure: Anxiety and Depression scale
timeFrame: Day 1
measure: Neuropathic pain presence
timeFrame: Day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University Hospital, Clermont Ferrand
city: Nîmes
country: France
facility: CHu de Nîmes
Study officials:
References:
Clinical trial NCT04776226: Post-stroke Depression Treatment Effect on Stroke Recurrence
Official title: Impact of Pots-stroke Depression Treatment on Stroke Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Recurrence
Cardiovascular Events
Depression
Keywords: Depression
Treatment
Stroke
Myocardial infarction
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 1230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-site, prospective, nonrandomized controlled trial.
Primary purpose: PREVENTION

Brief summary: It is not clear whether depresssion can predispose, or precipitate stroke recurrence in patients with stroke. We sought the relationship of post stroke depression with stroke recurrence.

Detailed description: A large body of evidence suggests that depression is associated with a increased risk of many chronic diseases, including hypertension, diabetes, stroke and particularly coronary heart disease. Post stroke depression (PSD) may develop as a result of vascular disease. A previous meta-analysis showed that depression significantly increased the risk of development of stroke, and this increase was probably independent of other risk factors, including hypertension and diabetes.

Clarifying this issue has important implications; if depression increases the risk of development of recurrent stroke, so treating PSD might decrease the occurrence of recurrent stroke. To our knowledge there is no study attempting to clarify the relationship between PSD treatment and stroke recurrence. To fill these gap, we systematically conducted a study to assess whether PSD is associated with recurrent stroke, cardiovascular events or death. Thus, in the current study, three different arms of follow-up of patients with first-ever stroke, were used to predict the outcome over 52 weeks.

Eligibility criteria: Inclusion Criteria:

• Patients who met DSM-IV and V criteria for depression

Exclusion Criteria:

* Severe or unstable medical disorders (eg, myocardial infarction within past 3 months, end-stage cancer, decompensated cardiac failure)
* Known primary neurological disorders including dementia, delirium, Parkinson disease, brain tumors, multiple sclerosis, seizure disorder
* Drugs (eg, systemic steroids)
* Pancreatic cancer, uncorrected hypothyroidism
* Current suicidal risk
* Use of psychotropic prescription or nonprescription drugs, certain hypnotics
* Mini-Mental State Examination (MMSE) score of 21 or lower

Primary outcomes:
measure: Stroke recurrence
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular Event
timeFrame: 12 months
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University Scool of Medicine
name: Huseyin Nezih Özdemir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171626: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Official title: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Knee osteoarthritis, Topical NSAID, Diclofenac sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 480
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Eligibility criteria: Key Inclusion criteria

* Osteoarthritis of the knee Key Exclusion criteria
* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs

Primary outcomes:
measure: WOMAC pain score in target knee at Week 12
measure: WOMAC physical function score in target knee at Week 12
measure: Global rating of disease activity by patient at Week 12
Secondary outcomes:
measure: WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8
measure: WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12
measure: Pain on movement in target knee and use of rescue medication recorded in diary
measure: Global evaluation of treatment at final visit
measure: Treatment responder rate according to OARSI criteria
Other outcomes:
Locations:
city: Parsippany
country: United States
facility: Novartis Consumer Health Inc
state: New Jersey
Study officials:
References:
citation: Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000.
Clinical trial NCT02574026: Tapfinger Psychomotor Target
Official title: MagnetoEncephaloGraphy Study of Cerebral Activations Induced by Psychomotor Tasks for Target Localisation in View of BCI Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Functional Brain Mapping
Keywords: MEG
EEG
MRI
Brain mapping
functional imaging
brain computer interface
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Commissariat A L'energie Atomique
First posted: 2015-10-12
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study aims at mapping the magnetoencephalographic (MEG) activities induced in normal volunteers by tapping the finger .

Detailed description: Normal healthy (20) volunteers and tetraplegic patients(10) will be submitted to the temporo-spatial mapping of their brain activity, both sensory and motor, induced by a simple behavioral task, consisting on tapping with the finger on a detection pad. This will be done in a light and then dark environment, on a rythm spontaneous and then paced by sound bips. Accelerometric recording will provide the three dimensionnal displacements of the finger as well as the time code.

Brain activity is simultaneously recorded using MEG (306 channels) and EEG (64 channels. Data will be processed by an INPLS algorithm to detect the predictors of activity, their location and time-course.

3D mapping data will be matched with the patient's anatomy provided by 1.5T MRI previously performed.

The aim of the study is to prepare the strategy of implantation of multielectrodes ECoG implants to restore motility in tetraplegic patients in a human BCI protocol currently under development.

Eligibility criteria: Inclusion Criteria:

* Male or Female between 18 and 70 years
* Informed consent
* Benefiting from Social Security
* French or english speaking, to understand study procedure
* Tetraplegic patients : traumatic injury of the cervical spine with retained respiratory autonomy and without associated head injury

Exclusion Criteria:

* Contra-indication to MRI
* Claustrophobia
* Mental disorders
* Pregancy
* All categories of protected persons

Primary outcomes:
measure: MEG records for functional brain mapping
timeFrame: one hour study
Secondary outcomes:
measure: MEG measurements during psychomotor tasks
timeFrame: one hour study
measure: EEG measurements during psychomotor tasks
timeFrame: one hour study
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CLINATEC
Study officials:
affiliation: University Hospital, Grenoble
name: Alim L Benabid, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01027026: The Acute Coronary Syndrome Study
Official title: The Acute Coronary Syndrome Study. Organization and Treatment of Patients With Acute Coronary Syndrome, With a Focus on Costs, Organization and Security
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Cost analysis
Safety
Length of stay
Randomized controlled trials
Early discharge
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
First posted: 2009-12-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators will make a prospective study in which they will look at the economics and security of the treatment of patients with acute coronary syndrome.

The investigators want to do a randomized trial. One group will be treated as they have been treated at Ullevål University Hospital (UUS) in recent years, and the other group will be returned to their refering hospital the same day. The objective of this study will be to provide increased knowledge about whether the rapid discharge from the intervention center is associated with differences in costs or security.

Detailed description: The topic of this study is whether patients with Acute coronary syndrome (ACS)may can be transferred to their refering hospital same day that they arrived intervention hospital.

This is to see if one can reduce the hospital stay and costs for the intervention center, and the total hospitalization time.

and this rapid transport not give more medical complications

Our 1 hypothesis is that patients with ACS, who are transported back to the refering hospital the same day, will reduce the length of stay in intervention center without an increase for the stay at the refering hospital.

Our 2 hypothesis is that patients with ACS, who are transported back to the refering hospital the same day as the treatment is performed, have no more complications than those who stay overnight in the intervention hospital.

Eligibility criteria: Inclusion Criteria:

* All patients with acute coronary syndrome who are referred from other hospitals

Exclusion Criteria:

* Patients younger than 18years.
* Known mental retardation, dementia or harmful use of alcohol or drugs.
* Allergy or intolerance to ASA and / or clopidogrel.
* Patients who have previously been involved in this study.
* Acute STEMI infarction for less than 72 hours ago.

Primary outcomes:
measure: Cost effectiveness. Adverse medical events
timeFrame: 30 days and a year's events
Secondary outcomes:
measure: SF-36
timeFrame: One year
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Ullevaal
Study officials:
References:
Clinical trial NCT01225926: A Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation
Official title: A Randomized, Prospective, Multi-Center, Patient-Masked, Bilateral Comparison of Aspheric Toric Intraocular Lens (IOL) Implantation Versus Aspheric Non-Toric Lens Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Intraocular Lens
Toric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-10-21
Enrollment: 24
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 purpose of this study was to evaluate and compare uncorrected distance visual acuity measurement in pseudophakic subjects with bilateral implantation of an AcrySof IQ Toric Intraocular Lens (IOL) versus bilateral implantation of an AcrySof IQ IOL.


Eligibility criteria: Inclusion Criteria:

* Willing and able to understand and sign an informed consent;
* Willing and able to attend post-operative examinations per protocol schedule;
* In good ocular health, with the exception of cataracts;
* Age-related cataracts in both eyes that require extraction followed by implantation of an intraocular lens;
* Pre-operative corneal cylinder of greater than or equal to 0.75 diopter as determined by auto keratometry;
* In good ocular health, with the exception of cataracts;
* Free of diseases/conditions listed in the precautions of the AcrySof® Toric and AcrySof® IQ package inserts;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Previous corneal surgery;
* Corneal abnormality that would prevent stable and reliable visual acuity and refractive measures;
* Planned multiple procedures during cataract/IOL implantation surgery;
* Ocular disease and/or condition that may compromise study results;
* Ocular trauma, infections or nasolacrimal drainage system malfunction within 3 months of enrolment;
* Pregnant or planning pregnancy during course of study;
* Participation in any other investigational study within 30 days prior to enrolment;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Monocular Uncorrected Distance Visual Acuity (Monocular UCDVA) at Month 3
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06996626: Real-time NOMA Evaluation
Official title: Real-time Evaluation of an Outlier-based Alerting System
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Illness
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2025-05-30
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Step wedge RCT
Primary purpose: TREATMENT

Brief summary: Alerts related to outlier clinician behavior are generated in real-time by an intelligent system continuously scraping EHR (electronic health record) data. These alerts are passed to the bedside and their potential impact on bedside clinical behavior is evaluated.

Detailed description: A clinician-informed AI model will generate outlier alerts from real-time review of the EHR (electronic health record) of UPMC Presbyterian/Montefiore ICU patients. These alerts will first be reviewed by an ICU clinician, along with the patients' EHR, for clinical relevance. For those alerts deemed potentially relevant, the ICU clinician will contact the treating ICU clinician (eg, an ICU pharmacist, physician, advanced practice provider) and discuss the alert. The treating ICU clinician will take whatever action, including no action, they deem best.

Eligibility criteria: Inclusion Criteria:

* All patients in the Presbyterian and Montefiore ICUs

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of Clinical Actions Following Revealed vs. Non-Revealed Alerts
timeFrame: From time of ICU admission until ICU discharge
Secondary outcomes:
measure: Rate of Any Clinically Responsive Action Following Alerts
timeFrame: Up to 90 days after ICU admission
measure: True Positive Alert Rate (TPAR) by Study Group and Alert Type
timeFrame: Up to 90 days after ICU admission
measure: Rate of Non-Responsive Actions Following Alerts
timeFrame: Up to 90 days after ICU admission
measure: Overall Alert Rate
timeFrame: Through study completion, an average of 2 years
measure: Alert Rate per Alerting Model
timeFrame: Daily, up to 90 days
measure: Delay Between Alert Generation and First Responsive Action
timeFrame: Measured continuously through study completion, an average of 2 years
measure: ICU Length of Stay
timeFrame: Up to 90 days after ICU admission
measure: Hospital Length of Stay
timeFrame: up to 90 days after hospital admission
measure: In-Hospital Mortality
timeFrame: Up to 90 days after hospital admission
measure: Time Trend of True Positive Alert Rate (TPAR)
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Montefiore
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00930826: Childhood Asthma and Schooling: The Truth Unveiled
Official title: Childhood Asthma and Schooling: The Truth Unveiled
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Keywords: The effect of bronchial asthma on school performance
Lead sponsor: Boushahri Clinic Medical Center
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 450
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents of a certain town

Brief summary: Childhood Asthma and Schooling: The Truth Unveiled.

Detailed description: Children with mild persistent asthma still performed worse than normal healthy children in school. The aim of the study was to evaluate school performance of children with mild persistent asthma in comparison with normal healthy children.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of bronchial asthma
* Must be able to swallow tablets

Exclusion Criteria:

* Steroid inhalation or ingestion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: