louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01343914: An Observational Study on Patients With Non-Squamous NSCLC Who Reached A Long PFS After Avastin (Bevacizumab)-Based First-Line Therapy
Official title: Retrospective Study to Determinate the Clinical Phenotype of Patients With Non Squamous NSCLC Treated With First Line Bevacizumab-based Therapy That Reached a Long PFS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-28
Enrollment: 118
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: Non squamous NSCLC patients treated with bevacizumab-based first line therapy and PFS \>/= 9 months

Brief summary: This retrospective observational study will analyse demographic, clinical and treatment-related data of patients with non-squamous non-small cell lung cancer (NSCLC) who had reached \>/= 9 months of progression-free survival after Avastin (bevacizumab)-based first-line therapy. Data will be collected for approximately 9 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Non-squamous non-small cell lung cancer (NSCLC) treated with first-line Avastin-based therapy
* Progression-free survival of \>/= 9 months reached

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Progression-free survival (>9 months) according to clinical phenotype
timeFrame: approximately 9 months
Secondary outcomes:
measure: Overall survival
timeFrame: approximately 9 months
measure: Safety: Incidence of adverse events
timeFrame: approximately 9 months
Other outcomes:
Locations:
city: Alcoy
country: Spain
state: Alicante
city: Elche
country: Spain
state: Alicante
city: Elda
country: Spain
state: Alicante
city: Almería
country: Spain
state: Almeria
city: San Sebastian de Los Reyes
country: Spain
state: Guipuzcoa
city: Manacor
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Vigo
country: Spain
state: Pontevedra
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Caceres
country: Spain
city: Jaen
country: Spain
city: Leon
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Murcia
country: Spain
city: Navarra
country: Spain
city: Pontevedra
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02370914: Concussion Testing: A Novel Non-invasive Concussion Detection Device
Official title: Concussion Testing: A Novel Non-invasive Concussion Detection Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concussion
Keywords: Concussion
Lead sponsor: Jan Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-25
Enrollment: 84
Sex: MALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Varsity high school football players at a local High School.

Brief summary: The purpose of this study is to establish and evaluate a distinctive signal for concussion.

Detailed description: The purpose of this study is to establish a non-invasive objective measurement for the detection of concussions with the Jan Medical Device (JMD). The study will assess the ability of this device to demonstrate unique signals that correlate with concussions. The study will also test the athletes at baseline at rest and during exertion to determine if there is a difference in the signal from exertion alone. The JMD is a non-invasive band that is placed around the participants head. The JMD detects a unique pattern of signals based on displacement of the skull from changes in blood flow during individual heartbeats. The athletes will be tested longitudinally to assess to changes over time, in addition to changes after impact

Eligibility criteria: Inclusion Criteria:

* Junior Varsity and Varsity Players a local High School.

Exclusion Criteria:

* None

Primary outcomes:
measure: A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data
timeFrame: Individual assessments were made within 2 days of recording
Secondary outcomes:
Other outcomes:
Locations:
city: Los Altos
country: United States
facility: Los Altos High School
state: California
Study officials:
affiliation: Stanford University
name: Paul S Auerbach
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00075114: Prevent Inability To Control Urination
Official title: Promoting Self -Care to Prevent Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence
Keywords: Self Care
Behavior Modification
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2004-01-05
Enrollment: 417
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the capacity of self-efficacy to predict maintaining a behavior change at four years post urinary control intervention.

Detailed description: This is a study that will monitor and compare attitudes and strategies that women use to maintain behavior changes that prevent urination problems. Women will complete questionnaires, do muscle strength exercises, and bladder training at 3 months, one year, and 4 years post intervention.

Eligibility criteria: Inclusion and exclusion criteria

1. Female 55 through 80 years old
2. Post-menopausal-no menstrual cycle for the past 12 months except for women who are on hormone replacement therapy.
3. Continent of urine (using the MESA definition of continence) defined as:

   1. No previous incontinence episode except during pregnancy and/or postpartum period.
   2. Urine loss less than 6 days during the last 365 days
   3. No previous or present incontinence treatment with pharmacological agents, behavioral programs or surgical therapy.
4. No history of bladder cancer, stroke, multiple sclerosis, parkinsonism, epilepsy, spinal cord tumor or trauma.
5. No reported difficulty with activities of daily living, i.e. walking about the house, dressing, getting in/out of bed, getting to/using the toilet, bathing/showering, or eating.

Additional criteria are applied at a physical examination:

1. Mini Mental Status of at least 24
2. Negative for objective urine loss during coughing.

Primary outcomes:
measure: Mean number of incontinence episodes
timeFrame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Secondary outcomes:
measure: Pelvic floor muscle strength
timeFrame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
measure: Length of voiding interval
timeFrame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
measure: Self-efficacy
timeFrame: Baseline, 6-, 12-, 18-, 24-, 32-, 42-, 48-months post baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan, School of Nursing, MICHIN Center
name: Carolyn M Sampselle, PhD, APH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04764214: SRT for Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
Official title: An Open-label, Single-Arm, Phase 2 Trial of Stereotactic Radiotherapy for Patients With Residual Oligometastases of NSCLC After 3rd Generation EGFR-TKIs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NSCLC Stage IV
EGFR Activating Mutation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, single-arm phase 2 trial to evaluate the efficacy and safety of stereotactic radiotherapy (SRT) for patients with oligo-residual NSCLC after 3rd generation EGFR-TKIs.


Eligibility criteria: Inclusion Criteria:

* The patient has a diagnosis of pathologically confirmed NSCLC by tumor biopsy and/or fine-needle aspiration.
* The patient has a diagnosis of American Joint Committee on Cancer (AJCC) 8th Edition stage IV NSCLC.
* The patient receives 3rd generation EGFR-TKI in the first line setting.
* The patient is ≥18 years of age and ≤75 years of age at the time of screening.
* The patient's Karnofsky performance score (KPS) is ≥70 at study entry.
* The patient has adequate baseline tumor assessment before initiation of 3rd generation EGFR-TKI.
* The patient has at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
* The patient presents with a residual "oligometastatic" state after 3rd generation EGFR-TKI therapy that would be amenable to consolidative SRT in the opinion of the investigator.
* The patient has signed informed consent.
* EGFR Exon19 deletion or Exon21 L858R mutation

Exclusion Criteria:

* History of another malignancy or concurrent malignancy. Patients with cervical carcinoma in situ or adequately treated basal cell carcinoma who have been disease free for \> 5 years are eligible.
* The patient is pregnant (confirmed by serum b-HCG if applicable) or is breastfeeding.
* Patients with uncontrolled epilepsy, mental disorders, drug abuse, or social condition that may affect compliance or ability to sign a written informed consent in the opinion of the investigator.
* Patients with residual metastatic disease after 3rd generation EGFR-TKI therapy that is deemed not amenable to consolidative SRT.

Primary outcomes:
measure: Progression Free Survival
timeFrame: Two years
Secondary outcomes:
measure: Percentage of Participants With Adverse Events
timeFrame: Two years
measure: Overall Survival
timeFrame: Two years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Zhengfei Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05197114: Assessing the Feasibility and Acceptability of a Virtual Food Skills Program for Children With Type 1 Diabetes During COVID-19
Official title: Assessing the Feasibility and Acceptability of a Virtual Food Skills Program for Children With Type 1 Diabetes During COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
First posted: 2022-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Food forms an integral part of diabetes management. As children mature into young adults, they must learn to adopt lifestyle behaviours critical for optimal diabetes care. The development of food preparation and cooking skills at a young age may help to facilitate healthy food choices in children and provide a solid foundation for young adulthood. Food skills workshops are effective interventions that have been shown to improve food literacy and healthy eating in the general pediatric population. However, food skills programs have not been adequately evaluated in children with type 1 diabetes. Further, virtual programs are not well assessed, which can increase the accessibility of food education during the pandemic and in the future.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for over one year

Exclusion Criteria:

* Type 1 diabetes for less than one year, non-English speaking, do not have access to a computer or internet

Primary outcomes:
measure: Feasibility and acceptability of the virtual summerlunch+At Home program
timeFrame: Two months
measure: Feasibility and acceptability of the virtual summerlunch+At Home program
timeFrame: Three months
measure: Feasibility and acceptability of the virtual summerlunch+At Home program
timeFrame: Six months
Secondary outcomes:
measure: The impact of the program on food literacy skills children's attitude towards cooking, cooking confidence, food knowledge and food preferences -
timeFrame: Two months, three months and six months
measure: Changes in glycemic control as measured through HbA1C levels
timeFrame: Two months, three months and six months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Vanita Pais
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06400914: Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere
Official title: Clinical Evaluation of Biomedics Monthly Sphere and Avaira Vitality Sphere
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the short-term clinical performance of two sphere contact lenses.

Detailed description: The aim of this study is to evaluate the short-term clinical performance of two different sphere contact lenses after 15 minutes of daily wear each.

Eligibility criteria: Inclusion Criteria:

1. Is at least 18 years of age and has full legal capacity to volunteer.
2. Has read and signed an information consent letter.
3. Self-reports having a full eye examination in the previous two years.
4. Anticipates being able to wear the study lenses for the required time of the study.
5. Is willing and able to follow instructions and maintain the appointment schedule.
6. Has refractive astigmatism no higher than -0.75 DC.
7. Can be fit with the available lens parameters (sphere +6.00 to -10.00D).
8. Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study.
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear.
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study.
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
7. Has undergone refractive error surgery or intraocular surgery.

Primary outcomes:
measure: Lens Fit Acceptance Ratings
timeFrame: 15 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Consultorio Optométrico Queretaro
Study officials:
affiliation: National Autonomous University
name: Ruben Guerrero, MSc, FIACLE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00946114: To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks
Official title: A Local, Multi-Centre, Open Label Access Study, To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For One Hundred Twelve Weeks / Prior To Reimbursement And Availability For Patients In Poland.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Expanded access

Brief summary: The purpose of this study is to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study for the treatment of PAH in Poland. Only safety and tolerability data will be collected in these patients.


Eligibility criteria: Inclusion Criteria:

1. Subjects aged 18 and over who have any of the following conditions:

   * Idiopathic pulmonary arterial hypertension.
   * PAH associated with connective tissue disease (CTD).
   * PAH with surgical repair, at least 5yrs previously, of atrial septal defect (ASD), ventricular septal defect (VSD) patent ductus arteriosis (PDA) or aorta-pulmonary window.
2. Subjects with a mean pulmonary artery pressure (mPAP) \> 25mmHg and a pulmonary artery wedge pressure (PAWP) \< 15mmHg at rest, assessed via right heart catheterization.
3. Subjects whose baseline 6-min walk test distance was \> 100m and \< 450m.

Exclusion Criteria:

1. PAH secondary to any etiology other than those specified in the inclusion criteria.
2. Subjects with congenital heart disease (other than those specified in the inclusion criteria), PAH due to thrombo-embolism, HIV, chronic obstructive airways disease, congestive heart failure.
3. Subjects whose 6-Minute Walk test might have been limited by conditions other than PAH, associated dyspnea or fatigue.

Primary outcomes:
measure: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 116 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Zabrze
country: Poland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00692614: A Study of MK0140 in Diabetic Patients With Macular Edema (0140-001)
Official title: A Phase IIb, Randomized, Masked, Sham-Controlled, Clinical Trial to Study the Efficacy and Safety of the Helical Triamcinolone Acetonide Implant (MK0140) in Diabetic Patients With Clinically Significant Macular Edema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Macular Edema
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the treatment effect of three doses of the I-vation TA implant (MK0140) in diabetic patients with clinically significant macular edema.


Eligibility criteria: Inclusion Criteria:

* Patient has clinically significant macular edema as a result of their diabetes (Type I or Type 2)
* Patient has in the study eye, 20/40 - 20/160 vision
* Patient has Type 1 or Type 2 diabetes
* Patient agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control

Exclusion Criteria:

* Patient has had any active ocular infection in either eye
* Patient has intraocular pressure \> 22 mmHg or a diagnosis of glaucoma
* Patient has cystoid macular edema in the study eye
* Patient has a history of elevated IOP in response to ocular steroid therapy in either eye
* Patient has had intraocular surgery in the study eye within 6 months prior to Visit 1
* Patient has an HbAIc value \> 10% at Visit 1
* Patient has within the last 4 months initiated intensive insulin treatment or plan to do so in the next 4 months
* Patient has a history of cancer within 5 years prior to signing informed consent
* Patient has clinically-relevant chronic renal failure
* Patient has high blood pressure
* Patient has coronary heart disease
* Patient has known allergies to steroids

Primary outcomes:
measure: Change from baseline in OCT retinal thickness; evaluate the safety and tolerability of doses.
timeFrame: After 12 months of therapy.
Secondary outcomes:
measure: Evaluation of visual acuity; change from baseline in OCT center-point retinal thickness; the need for focal/grid laser photocoagulation during the study; the progression of diabetic retinopathy
timeFrame: After 12 months of therapy.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: