louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02443467: A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer, Early Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-05-13
Enrollment: 211
Sex: FEMALE
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: Participants with HER2-positive early breast cancer

Brief summary: This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.


Eligibility criteria: Inclusion Criteria:

* Female patients \> or = 18 years of age
* Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression
* Previously treated with adjuvant antracycline containing chemotherapy
* Left Ventricular Ejection Fraction (LVEF) \> 50%
* Eastern Cooperative Oncology Group (ECOG) score \< or = 2
* Life expectancy \> or = 12 weeks

Exclusion Criteria:

* Left Ventricular Ejection Fraction (LVEF) \< 50%
* Advanced pulmonary disease
* Severe dyspnea
* Abnormal laboratory results within 14 days prior to registration
* Peripheral neuropathy
* Presence of Central Nervous System (CNS) metastasis

Primary outcomes:
measure: Percentage of participants with adverse events
timeFrame: Up to 3 years
measure: Percentage of participants with serious adverse events
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sremska Kamenica
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03738267: Study on the Occurrence of Head and Neck Cancers During Pregnancy
Official title: Study on the Occurrence of Head and Neck Cancers During Pregnancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Cancer
Pregnancy Related
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: French scientific group REFCOR
First posted: 2018-11-13
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancers of Head and Neck that occurred during pregnancy

Brief summary: Head and neck cancers that occurred during pregnancy


Eligibility criteria: Inclusion Criteria:

* 18 year old woman or over at the time of participation
* PS 0 -2
* Cancer diagnosed (biopsy date) from 01/01/2010 between the second week of pregnancy and the 12 months postpartum.
* Primitive may concern the following sites:

oral cavity, nasopharynx, oropharynx, hypopharynx, larynx, prevalent lymphadenopathy, nasal cavity, salivary glands, dental tumors, ear tumors, paragangliomas optic pathways, facial sinus / facial mass, nose, ear and other head and neck

* All histologies (epithelial tumors, sarcomas, mucosal melanomas, embryonic tumors, undifferentiated tumors)
* Patient receiving or having received a specific oncological treatment among surgery, radiotherapy, chemotherapy, hormone therapy.
* All stages allowed: localized stages and metastatic stages immediately.
* No opposition of the patient to participate in this study

Exclusion Criteria:

* Any other neoplastic antecedent
* Exclusion of metastases at the level of the VADS of another primitive than a cancer of the VADS
* Exclusion of hematological tumors (lymphoma) and glial tumors
* Person subject to a legal protection measure or unable to express their consent

Primary outcomes:
measure: Serological status of patients
timeFrame: Through study completion, an average of 5 years
measure: Characteristics pregnancy of patients
timeFrame: Through study completion, an average of 5 years
measure: Tumor characteristics of patients
timeFrame: Through study completion, an average of 5 years
measure: Tumor characteristics of patients
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Chu Besancon
city: Bordeaux
country: France
facility: Chu Bordeaux
city: Caen
country: France
facility: Centre François Baclesse
city: Grenoble
country: France
facility: Chu Grenoble Alpes
city: Paris
country: France
facility: Ap-Hp Tenon
city: Poitiers
country: France
facility: Chu Poitiers
city: Toulouse
country: France
facility: Chu Toulouse
city: Villejuif
country: France
facility: Institut Gustave Roussy IGR
Study officials:
References:
Clinical trial NCT00947440: Evaluation of the Bioavailability of Two ABT-072 Tablet Formulations as Compared to ABT-072 Capsule Formulation
Official title: An Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability of Two Candidate Tablet Formulations of ABT-072 With Reference to the Capsule Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C
Keywords: Phase 1
Bioavailability
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-07-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to assess the bioavailability, safety, tolerability and pharmacokinetics of two tablet formulations as compared to the capsule formulation suspended in liquid.

Detailed description: A single-dose, three period, complete cross-over study to evaluate the relative bioavailability, pharmacokinetics, safety and tolerability of two candidate tablet formulations of ABT-072 when compared to that of the original capsule formulation suspended in liquid as a reference.

Eligibility criteria: Inclusion Criteria:

* Overall healthy subjects, non-childbearing females included.

Exclusion Criteria:

* Use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer.
* Pregnant or breast-feeding female.
* Positive test result for hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or HIV antibodies (HIV Ab).
* Positive screen for drugs of abuse, alcohol, or cotinine.
* Clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
* Use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.

Primary outcomes:
measure: To evaluate the relative bioavailability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
timeFrame: 4 days post each dose
Secondary outcomes:
measure: To evaluate safety and tolerability of two candidate tablet formulations of ABT-072 to that of the capsule formulation.
timeFrame: Through 14 days post last dose.
Other outcomes:
Locations:
city: Waukegan
country: United States
facility: Site Reference ID/Investigator# 22384
state: Illinois
Study officials:
affiliation: Abbott
name: Daniel Cohen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04011540: Digital Data in Mental Health Therapy
Official title: The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Anxiety Generalized
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Use of Patient Electronic Communication in Psychiatric Evaluation and Treatment intends to better understand how digital data, social media, and electronic communication can be used in mental health therapy.


Eligibility criteria: Inclusion Criteria:

1. Between 18-65 years of age
2. Primarily English speaking (for language analysis)
3. Willing to share at least one digital data source this includes Facebook, Google searches, YouTube searches, or screen time by downloading a free application (app) on their smartphone.
4. Regular activity viewing and posting on social media sites, defined as once a month posting
5. Has a mental or behavioral health provider and/or has a provider from the Philadelphia Society of Clinical Psychologists and currently enrolled in mental or behavioral therapy
6. Attends therapy at least once a month and intends to remain in therapy for the next three months
7. Willing to share dashboard with their behavioral health provider
8. Able to provide informed consent
9. Owns a smartphone
10. If the patient downloads an app, they are willing to download and keep an app on their phone for 3 months

Exclusion Criteria:

1. Under 18 years of age
2. Non-English speaker
3. Patient is in severe distress, e.g. respiratory, physical, or emotional distress
4. Patient is intoxicated, unconscious, or unable to appropriately respond to questions
5. Not currently enrolled in mental therapy
6. Not expected to remain in mental therapy for the next three months
7. Not a regular social media poster, or does not use Facebook and/or Instagram and/or not willing to share
8. Unwilling to share social media summary dashboard with behavioral health provider
9. Patient with diagnosed psychosis
10. Does not own a smartphone
11. Unwilling to download and keep an app on their phone for 3 months

Primary outcomes:
measure: Health-related Quality of Life (HRQoL), RAND 36-Item Health Survey Changed Value (Baseline to 2 Months)
timeFrame: 2 months
Secondary outcomes:
measure: Depressive Symptoms, Patient Health Questionnaire-8 (PHQ-8) Change Value
timeFrame: 2 months
measure: Anxiety Symptoms, Generalized Anxiety Disorder-7 (GAD-7) Change Value
timeFrame: 2 months
measure: Therapeutic Relationship, Working Alliance Inventory (WAI) Change Value
timeFrame: 2 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine behavioral and mental health clinics
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00428740: Long-Term IOP Fluctuation and VF Progression After Triple Procedure
Official title: Long-Term Intraocular Pressure Fluctuation and Visual Field Progression in Glaucoma Patients With Low Intraocular Pressure After Triple Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Filtering Surgery
Intraocular Pressure
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2007-01-30
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Long-term intraocular pressure (IOP) fluctuation may be significantly associated with the progression of glaucomatous visual field loss, even in patients kept always low IOP after triple procedure, an effective approach for patients with coexisting glaucoma and visually significant cataracts.

Detailed description: Previous studies reported that lowering intraocular pressure (IOP) slowed the advancement of visual field damage in glaucoma patients. However, even if the IOP can been substantially lowered, reduction of mean and peak IOP does not always prevent visual field progression.We believe that the long-term IOP fluctuation may play a significant role in visual field deterioration in those patients.

Eligibility criteria: Inclusion Criteria:

1. Underwent triple procedure
2. At leas 3 years of follow-up after surgery
3. IOP \<18mmHg at each postoperative visit
4. A minimum of 5 visual field examinations
5. A reference visual field defect score of 16 or less
6. Good reliability indices of visual field

Exclusion Criteria:

1. Any other significant ocular diseases or intraocular surgical histories,
2. Diseases that may affect visual field or diabetes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: Yondgong Severance Hospital, Yonsei University College of Medicine
name: Gong Je Seong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hong S, Seong GJ, Hong YJ. Long-term intraocular pressure fluctuation and progressive visual field deterioration in patients with glaucoma and low intraocular pressures after a triple procedure. Arch Ophthalmol. 2007 Aug;125(8):1010-3. doi: 10.1001/archopht.125.8.1010.
Clinical trial NCT00953940: Prevention of Perioperative Acute Renal Failure
Official title: Prevention of Perioperative Acute Renal Failure in Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Abdominal Surgery
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2009-08-06
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to measure the acute renal dysfunction on the first, second, seventh and twentieth days.


Eligibility criteria: Inclusion Criteria:

* All patients who are undergoing elective abdominal surgery after appropriate information of the study, and its possible risks that may arise therefrom and that at any time to refuse their cooperation, give a written consent to participate in the study.
* Patients who at the time of the interview have an ASA between 2 and 4.
* Patients with chronic kidney failure mild moderate (serum creatinine between 1.5 and 3.0 mg / dl) can be included.

Exclusion Criteria:

* Chronic kidney diseases with serum creatinine higher than 3.0 mg /DL
* Laparoscopic abdominal surgery
* ASA 1 and ASA 5 patients.
* Patients with cardiac insufficiency, ascites and respiratory insufficiency
* Diastolic hypertension \> 100 mmHg

Primary outcomes:
measure: Serum creatinine in the first, second, seventh and twenty after surgery in patients undergoing elective abdominal surgery.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
Study officials:
affiliation: Hospital Universitario Ramon y Cajal
name: Dr Fernando Liaño, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Serrano AB, Candela-Toha AM, Zamora J, Vera J, Muriel A, Del Rey JM, Liano F. Preoperative hydration with 0.9% normal saline to prevent acute kidney injury after major elective open abdominal surgery: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jun;33(6):436-43. doi: 10.1097/EJA.0000000000000421.
Clinical trial NCT06978140: Decisions During Drinking
Official title: Decisions During Drinking: Phase 3 Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol
Keywords: alcohol-related consequences
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-05-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Decisions during drinking (D3) is randomized clinical feasibility trial assessing whether health-related materials created for young adults who want to have more positive experiences if they decide to drink alcohol are acceptable and usable. Enrolled participants will be randomized to receive the health-related messages in 5-7 online modules over the 20-30 days or to only receive assessments. Those randomized to receive the intervention will also receive text-messages with health message content during the 20-30 days. After completing the intervention, participants will report on the usability and acceptability of the material, which is the main outcome. For secondary outcomes, participants in both the intervention and control will report on their drinking and drinking-related consequences in the post-intervention questionnaire (or 30 days after initial questionnaire for control participants) and 1 month later.


Eligibility criteria: Inclusion Criteria:

* Aged 18-24
* At least 1 occurrence of heavy drinking in the past month
* At least 2 alcohol related consequences in the past month
* Live in Washington State
* Agree to be randomized to receive intervention to assessment only control
* Ability to receive SMS text-messages
* Complete Identification verification

Exclusion Criteria:

* Not meeting inclusion criteria
* Not being able to verify identification

Primary outcomes:
measure: Usability of intervention
timeFrame: From invitation to the first intervention module to end of modules being available 37 days later
measure: Acceptability of the intervention
timeFrame: From invitation to the first intervention module to end of modules being available 37 days later
measure: Feasibility of intervention
timeFrame: From invitation to the first intervention module to the end of the study 2 months later
Secondary outcomes:
measure: Alcohol consumption
timeFrame: From post-assessment to 1 month follow-up about 30 days
measure: Alcohol related consequences
timeFrame: From post-assessment to 1 month follow-up about 30 days
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Center for the Study of Health and Risk Behavior, University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Brittney Hultgren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03921840: A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints
Official title: A Personalized Behavioral Intervention for Older Adults With Musculoskeletal Pain and Sleep Complaints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Pain
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-04-19
Enrollment: 27
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is well recognized that physical activity/exercise is an effective intervention to improve sleep, reduce pain and improve function in a variety of pain conditions. Traditional interventions to increase physical activity are challenging in older adults due to extensive staffing requirements and low adherence. The investigators plan to conduct a pilot trial in a cohort of older adults (without dementia) with both chronic musculoskeletal pain and nocturnal sleep complaints to test the effectiveness of a 12-week personalized behavioral intervention (compared to a control group) embedded within a smartwatch application in older adults. 27 cognitively intact elders were enrolled and randomly allocated to intervention or control group. Participants in the intervention arm received a 2-hour in person education session, and personalized, circadian-based activity guidelines, with real time physical activity self-monitoring, interactive prompts, biweekly phone consultation with the research team, and financial incentives for achieving weekly physical activity goal. The control group received general education on physical activity in older adults and continue routine daily activity for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Intact cognition
* Poor sleep quality
* Self-reported presence of pain
* Capacity for mild to moderate physical activity.

Exclusion Criteria:

* Non-ambulatory or have severely impaired mobility,
* Visual or hearing impairment that interfered with assessments, and
* An acute or a terminal illness
* Neuropathic pain

Primary outcomes:
measure: Change in Objective Sleep Duration
timeFrame: Week 1, Week 14
measure: Change in Sleep Efficiency as Assessed by Actigraphy
timeFrame: Week 1, Week 14
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Junxin Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05358340: Dual Perfusion Imaging for Characterizing Vascular Architecture of Brain Lesions
Official title: Combined Spin- and Gradient-Echo Perfusion Weighted Imaging for Characterizing Vascular Architecture of Brain Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Tumor
Brain Metastases
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objectives of the study are (1) to evaluate the feasibility of using a combined spin- and gradient- echo (SAGE) sequence in dynamic susceptibility contrast magnetic resonance imaging (DSC MRI) and (2) to determine quantitative estimates of vessel density and size to differentiate between areas of radiation necrosis and tumor recurrence.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with a brain metastasis or primary brain tumour and who will undergo MRI with contrast.

Exclusion Criteria:

* Subject or subject's legally authorized representative is unable or unwilling to consent to the study.
* Subject with documented contrast medium injection contraindication due to severe kidney disease or allergy.

Primary outcomes:
measure: Measurement of perfusion parameter: cerebral blood volume (CBV)
timeFrame: Baseline to end of study (up to 2 years)
measure: Measurement of perfusion parameter: vessel size index (VSI)
timeFrame: Baseline to end of study (up to 2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Paula Alcaide-Leon, MD
role: PRINCIPAL_INVESTIGATOR
References: