louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02690337: Study of DS-1123a in Advanced Solid Tumours
Official title: Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Malignant Tumors
Keywords: Advanced solid malignant tumors
phase 1
oncology
refractory
no standard treatment
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-02-24
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
* Eastern Cooperative Oncology Group performance status (PS) of 0 or 1.

Exclusion Criteria:

* Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:

  • Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia),
* Severe or uncontrolled concomitant disease.
* Clinically active brain metastases defined as symptomatic or requiring treatment.

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: Cycles 1, 2 : Days 1,2, 4, 8, 15
measure: Number and severity of treatment emergent adverse events (TEAEs)
timeFrame: Day 1 to Day 31
measure: Time of maximum concentration (Tmax)
timeFrame: Cycles 1, 2: Days 1,2, 4, 8, 15
measure: Elimination rate constant (Kel)
timeFrame: Cycles 1, 2: Days 1,2, 4, 8, 15
measure: area under the curve AUClast
timeFrame: Cycles 1, 2: Days 1,2, 4, 8, 15
measure: Area under the curve (AUCtau)
timeFrame: Cycles 1, 2: Days 1,2, 4, 8, 15
measure: Area under the curve (AUCinf)
timeFrame: Cycles 1, 2: Days 1,2, 4, 8, 15
measure: Half-life (T1/2)
timeFrame: Cycles 1, 2: Days 1,2, 4, 8, 15
measure: Drug clearance (CL)
timeFrame: Cycles 1, 2: Days 1,2, 4, 8, 15
measure: Volume of distribution (Vz)
timeFrame: Cycles 1, 2: Days 1,2, 4, 8, 15
measure: Mean residence time (MRTinf)
timeFrame: Cycles 1, 2: Days 1,2, 4, 8, 15
Secondary outcomes:
measure: DS-1123a antibody
timeFrame: Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date
measure: Change in Cytokines expression
timeFrame: Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT06474637: Powered Handle Primary Sleeve Gastrectomy Study
Official title: Prospective Clinical Evaluation of the AEON Endoscopic Stapler Powered Handle and Reload in Primary Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleeve Gastrectomy
Keywords: LSG (Laparoscopic Sleeve Gastrectomy)
Lead sponsor: Lexington Medical Inc.
Sponsor class: INDUSTRY
First posted: 2024-06-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this prospective, single arm, single-center study is to evaluate patients who are undergoing primary sleeve gastrectomy procedures and are surgically treated with the AEON Endoscopic Powered Handle Stapler and Stapler Reload. The primary endpoint is to assess the percentage of patients who encountered post-operative staple line complications (bleeding or leak), defined as requiring blood transfusion or revision surgery due to staple line complications.


Eligibility criteria: Inclusion Criteria:

1. Be within the range of 18-65 years of age
2. Patients undergoing primary sleeve gastrectomy procedures
3. Psychosocially, mentally, and physically able to comply with protocol, post-operative management and follow-up schedule.

Exclusion Criteria:

1. Prior bariatric surgery procedure
2. Sleeve gastrectomy procedure that is planned to be performed via open approach
3. Patients receiving anticoagulant medication(s)
4. Severe heart disease or lung problems
5. Known sensitivity to implant materials
6. Evidence of active (systemic or localized) infection at time of surgery
7. Women who are pregnant or planning to get pregnant in the next 12 months
8. Recent history of known alcohol and/or narcotic abuse
9. Investigational drug or device use within 30 days
10. Any other factors that may contribute, based on professional judgement of the treating surgeon, to the subject being a poor candidate for the study

Primary outcomes:
measure: Post Operative Staple Line Complications
timeFrame: 1 week
Secondary outcomes:
measure: Hospital Stay
timeFrame: 1 week
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Gijos Clinic
Study officials:
References:
Clinical trial NCT01996215: Brain Connectivity in Age-Related Macular Degeneration
Official title: Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-11-27
Enrollment: 238
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include 300 participants: 150 subjects with AMD plus 150 age, gender, and education-matched adults without AMD. All participants will receive baseline and 2 year neurocognitive tests and a subset will provide structural and "resting stage"functional magnetic resonance images (MRIs) at each time point.

Brief summary: This study is to determine how cognitive deficits (e.g.,verbal fluency deficit) in patients with Age-Related Macular Degeneration (AMD) relate to specific aspects of brain and function. The study team will assess whether the "brain signatures" associated with specific cognitive deficits differ in older adults with and without AMD.


Eligibility criteria: Inclusion Criteria:

AMD

- Vision loss attributable to AMD

Controls

* Age match (± 5 yrs)
* Gender match
* Education match (± 4yrs)
* Normal macular exam

Exclusion Criteria:

AMD

* Other significant eye pathology
* Mod/severe dementia
* Communication barrier that precludes testing

Controls

* Other significant eye pathology
* Mod/severe dementia
* Communication barrier that precludes testing

MRI subset

* Devices or material incompatible with 3.0 Tesla MRI
* Conditions that may interfere with interpretation of fMRI (e.g. history of stroke, brain tumor or previous brain surgery; psychoactive medications; seizure disorder)
* Claustrophobia
* Left-handed
* Body weight \> 300 lbs
* Pregnant women

Primary outcomes:
measure: Cognitive Changes and Brain Connectivity in Age-Related Macular Degeneration
timeFrame: Baseline, anticipated 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke Medicine
name: Heather Whitson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05004415: Mass Balance Study of AT-527 in Healthy Adult Male Subjects (R07496998)
Official title: An Open-Label, Single-Dose Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of [14C]-AT-527 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2021-08-13
Enrollment: 6
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-Label, Single-Dose pharmacokinetic (PK) study.
Primary purpose: TREATMENT

Brief summary: Mass balance study of AT-527 in Healthy Male Subjects.

Detailed description: This is an open-label, single-dose study assessing the absorption, metabolism, excretion, and mass balance of \[14C\]-AT-527 in healthy adult male subjects.

Eligibility criteria: Inclusion Criteria:

* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* No clinically significant diseases captured in the medical history or clinically significant findings at screening physical examination.
* A non-vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days after dosing. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to dosing. A male who has been vasectomized less than 4 months prior to dosing must follow the same restrictions as a non-vasectomized male).
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: Mass Balance
timeFrame: Day 1 to Day 15
measure: Mass Balance
timeFrame: Day 1 to Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Atea Study Site
state: Nebraska
Study officials:
References:
Clinical trial NCT04165915: Seniors'Health Paths " PAERPA ",
Official title: Seniors'Health Paths " PAERPA ", a Support Being Made Available to General Practionners for Assistance in the Management of Elderly Persons at Risk of Losing Their Independence. Review of the Implementation of the Arrangement on the Est-héraultais Territory.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Loss of Autonomy
Keywords: Aged of 60 years and more
living in the Est-Héraultais territory
seniors'health paths
PAERPA
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 137
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient aged 60 and over with an individual health care plan living in the territory of East Heraultais

Brief summary: •Background: PAERPA experimentation implemented in the East-Herault region since September 2017 aims to identify fragility and prevent the risk of loss of autonomy in elderly persons older than 60 years by facilitating coordination between Professionals taking care of the patient with the personalized health plan " PPS". The main objective of this study was to evaluate the implementation of this device through the achievement or not of the objectives set by the PPS.

•Methods: Descriptive cohort study with retrospective inclusion and prospective follow-up from the East Herault CTA database. All patients over 60 years old living at home and having a PPS written between September 2017 and April 2018 were included. PPS monitoring for 1 year. Description of this population then analysis of PPS.

•Discussion: Our study aims to evaluate the implementation of the device to identify ways to improve the device for the management of subjects at risk of loss of autonomy.


Eligibility criteria: Inclusion Criteria:

An individual must fulfill all of the following criteria in order to be eligible for study enrollment:

* Aged of 60 years and more
* individual health care plan was prepared
* living in the Est-Héraultais territory

Exclusion Criteria:

* Hospitalized patients
* Patients who declined to have an individual heath care planPsychosis

Primary outcomes:
measure: Estimating goals set by the PPS (personalized health plan)
timeFrame: 6 and 12 month follow-up
Secondary outcomes:
measure: correlation between unwillingness and cognitive disorder
timeFrame: 1 day
measure: Correlation between unwillingness and numbers of established goals
timeFrame: 1 day
measure: Correlation between unwillingness and locomotors goals
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Chokri Boubakri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224015: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Facial Rhytides
Crow's Feet Lines
Glabellar Lines
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-10-19
Enrollment: 684
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 safety and efficacy of botulinum toxin type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides) for patients who successfully completed Study 191622-099.


Eligibility criteria: Inclusion Criteria:

* Successfully completed Study 191622-099

Exclusion Criteria:

* Known immunization or hypersensitivity to botulinum toxin of any serotype
* Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment)
* Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
* Anticipated need for surgery or hospitalization during the study

Primary outcomes:
measure: Percentage of Participants Achieving a Grade of None or Mild at Maximum Smile Based on the Investigator Facial Wrinkle Scale Assessment of the Severity of Crow's Feet Lines
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
city: Vancouver
country: Canada
state: British Columbia
city: Antibes
country: France
city: Berlin
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03453515: Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens
Official title: Reducing HIV Risk Among Adolescents: Evaluating HEART for Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Sexually Transmitted Diseases
Lead sponsor: North Carolina State University
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 226
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates an educational web-based intervention designed to increase adolescent boys' and girls' motivation and skills to engage in safer sexual behavior (HEART: Health Education and Relationship Training). Half of participants will receive HEART and half of participants will receive Growing Minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to help youth reduce their risk of HIV and other sexually transmitted diseases and to avoid unplanned pregnancies.

Detailed description: This study evaluates an educational web-based intervention designed to increase adolescent boys' and girls' motivation and skills to engage in safer sexual behavior (HEART: Health Education and Relationship Training). Half of participants will receive HEART and half of participants will receive Growing Minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. The ultimate goal of this work is to help youth reduce their risk of HIV and other sexually transmitted diseases and to avoid unplanned pregnancies.

Primary outcomes for this study include 1) acceptability of the program, 2) safer sex self-efficacy, and 3) safer sex intentions.

Eligibility criteria: Inclusion Criteria:

* 10th or 11th grader
* Able to read English

Exclusion Criteria:

* None

Primary outcomes:
measure: Acceptability
timeFrame: immediate post-test at completion of intervention
Secondary outcomes:
measure: HIV/STD Knowledge
timeFrame: immediate post-test at completion of intervention
measure: Condom Beliefs
timeFrame: immediate post-test at completion of intervention
measure: Sexual Assertiveness
timeFrame: immediate post-test at completion of intervention
measure: Safer Sex Intentions
timeFrame: immediate post-test at completion of intervention
measure: Safer Sex Self-Efficacy
timeFrame: immediate post-test at completion of intervention
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: North Carolina State University
state: North Carolina
Study officials:
affiliation: North Carolina State University
name: Laura Widman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05670015: Ocular Changes With Alpha-2 Receptor Agonist.
Official title: Ocular Changes After Selective Alpha-2 Receptor Agonist.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma, Suspect
Aberration, Corneal Wavefront
Keywords: Glaucoma suspect
Post-lasik
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: selective alpha-2 receptor agonists cause changes in intraocular pressure and pupillary size thus may affect patient quality of life.

Detailed description: In this research, we will analyze the effect of selective alpha-2 receptor agonists on the human eye and investigate ocular changes over 6 months after its topical use.

Eligibility criteria: Inclusion Criteria:

* Glaucoma suspect cases.
* post-refractive surgery cases.

Exclusion Criteria:

* Cases with prostatic hyperplasia or diabetics that may alter the measurements of pupillary diameter.
* Cases with previous history of any retinal intervention or other drugs that may alter intraocular pressure measurements.

Primary outcomes:
measure: Intraocular pressure
timeFrame: Baseline and 6 months after regular use of the topical eyedrops
Secondary outcomes:
measure: Pupillary diameter
timeFrame: Baseline and 6 months after regular use of the topical eyedrops
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy
state: QA
Study officials:
affiliation: Benha University
name: Ahmed A Abdelshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03356015: Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
Official title: Comparison of the Efficacy and Tolerability Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bowel Preparation Scale
Adenoma Detection Rate
Keywords: Polyp detection rate
Adenoma detection rate
Boston Bowel Preparation Scale
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of the dose of Polyethylene Glycol(PEG) on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. 3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. 4L-group received 4bags of PEG and were instructed to drink 2 L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.


Eligibility criteria: Inclusion Criteria:

1. Outpatients aged 18-75 years
2. Referred for routine diagnostic colonoscopy
3. Patients who have signed inform consent form

Exclusion Criteria:

1. pregnancy or breastfeeding
2. allergy to purgatives
3. suspected intestinal obstruction, stricture, or perforation
4. hemodynamic instability
5. impaired swallowing reflex or mental status
6. severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure
7. history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery
8. participation declined.

Primary outcomes:
measure: the Boston Bowel Preparation Scale
timeFrame: 2 days
Secondary outcomes:
measure: Polyp detection rate
timeFrame: 2 days
measure: Adenoma detection rate
timeFrame: 2 days
measure: The mean number of incremental adenomas
timeFrame: 2 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Peng Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheng P, Chen Q, Li J, Pang L, Feng C, Wang N, Bai Y, Li Z, Meng X. 3 liters of polyethylene glycol vs. standard bowel preparation have equal efficacy in a Chinese population: a randomized, controlled trial. Am J Transl Res. 2022 Aug 15;14(8):5641-5650. eCollection 2022.