louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01549054: A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501
Official title: A Single-center, Randomized, Open-label, Two-part Study to Evaluate Bioavailability of Prototype Third-generation Formulations of E5501 Relative to Second-generation Tablet Formulation in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Thrombocytopenic Purpura
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study in healthy subjects. There are two parts to the study. In the first part of the study each subject will receive a single 10mg dose of each of the four formulations of E550. Based on the results from Part 1, an optimal formulation will be selected for further evaluation in Part 2.


Eligibility criteria: Inclusion Criteria:

* Healthy adult men and women (age ≥ 18 to ≤ 55 years)
* Body mass index ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at the time of screening and baseline of Treatment Period 1
* Platelet count between 120 x 109/L and 300 x 109/L at baseline of each Treatment Period 1, 3, and 5
* Women of child bearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the Treatment Phase of the study.

In addition, other standard criteria for healthy subjects will be used.

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of study drug
* Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of first study drug administration
* Evidence of organ dysfunction or any clinically significant event or illness in the subject's medical history, e.g., history of splenectomy.
* History of arterial or venous thrombosis, including partial or complete thrombosis (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism). Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
* Hemoglobin less than the lower limit of normal levels.

In addition, other standard criteria for healthy subjects will be used.

Primary outcomes:
measure: Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax
timeFrame: 133 days
Secondary outcomes:
measure: Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food
timeFrame: 133 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient
Study officials:
affiliation: Eisai Inc.
name: Bhaskar Rege
role: STUDY_DIRECTOR
References:
Clinical trial NCT06583954: SUBJECTIVE REFRACTION WITH LIGHTFIELD TECHNOLOGY
Official title: PROOF OF CONCEPT OF A NEW DEVICE FOR SUBJECTIVE REFRACTION WITH LIGHTFIELD TECHNOLOGY
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Refractive Error Correction
Keywords: subjective refraction
phoropter
lightfield technology
Lead sponsor: University of Applied Sciences and Arts Northwestern Switzerland
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults with refractive error

Brief summary: The aim of this study is to test whether it is possible in principle to determine defective vision using light field technology. The measurements with this first prototype will be compared with the results of the conventional method for subjective refraction determination and those using a phoropter (Vision R-800 phoropter).


Eligibility criteria: Inclusion Criteria:

* Minimum age of 18 years
* Best corrected visual acuity ≥ 0.8 (logMAR ≤ 0.1).
* Dioptric range for hypermetropia: ≤ +4.50 D.
* Dioptric range for myopia: ≥ -6.50 D.
* Dioptric range for cylinder: ≤ -2.00 D.
* Good general health, i.e.no systemic disease such as diabetes or rheumatism which could influence ocular health
* No ocular pathology or history of (intra)ocular surgery except for cataract surgery

Exclusion Criteria:

* • Contact lens wear during the days of visit

  * Binocular vision problems (e.g. amblyopia, strabismus).
  * Inability to follow the procedures of the investigation, such as language problems, psychological disorders and dementia

Primary outcomes:
measure: precision of determination of refractive error
timeFrame: within one week
Secondary outcomes:
measure: repeatability of all three methods for subjective refraction
timeFrame: within one week
Other outcomes:
Locations:
city: Olten
country: Switzerland
facility: Institute of Optometry, FHNW
state: Solothurn
city: Olten
country: Switzerland
facility: Insititute of Optometry, FHNW University of Applied Sciences and Arts Northwestern Switzerland
Study officials:
References:
citation: Venkataraman AP, Sirak D, Brautaset R, Dominguez-Vicent A. Evaluation of the Performance of Algorithm-Based Methods for Subjective Refraction. J Clin Med. 2020 Sep 29;9(10):3144. doi: 10.3390/jcm9103144.
Clinical trial NCT03535454: Work-Related Fibromyalgia
Official title: Work-Related Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia, Secondary
Keywords: Fibromyalgia
Musculoskeletal Diseases
Work
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2018-05-24
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Working woman

Brief summary: The research is about fibromyalgia prevalency in working population and searching work-related fibromyalgia.

Detailed description: 4 different job population will be included in the study. Totally 200 people wil be included and evaluated. All participants will be women. The investigators will diagnose fibromyalgia with 2016 updated diagnostic criteria and evaluate work related musculoskeletal pain with nordic musculoskeletal questionnaire.

Eligibility criteria: Inclusion Criteria:

* working at least 3 months in same working place

Exclusion Criteria:

* Diagnosed with the other musculoskeletal diseases

Primary outcomes:
measure: work related fibromyalgia
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Taksim Research and Education Hospital
Study officials:
References:
Clinical trial NCT04851054: Postoperative VEGF and Recurrence After Colon Cancer Surgery
Official title: Postoperative Serum VEGF Concentration as an Independent Prognostic Factor for Recurrence After Curative Colon Cancer Surgery. Multicentric Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Angiogenesis
Colon Cancer
Surgery
Recurrence
VEGF Overexpression
Keywords: VEGF
Colon Cancer
Surgery
Recurrence
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
Collaborators: name: Germans Trias i Pujol Hospital
name: Hospital de Granollers
name: Althaia Xarxa Assistencial Universitària de Manresa
name: Hospital Universitari Joan XXIII de Tarragona.
First posted: 2021-04-20
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study, who will undergo elective surgical resection with potentially curative intention.

Brief summary: The purpose of this trial is to study the relationship between the angiogenic response to surgical aggression, determined through the serum levels of vascular endothelial growth factor (VEGF) on postoperative day four, and the tumor recurrence in patients with colon cancer operated with a curative intention.

Detailed description: DESIGN: Prospective multicentric study.

PARTICIPATION: Colorectal Surgery Units of Hospital del Mar, Barcelona; Hospital Universitari Joan XXIII, Tarragona; Hospital Universitari La Fe, Valencia; Hospital Clínico San Carlos, Madrid; Hospital General de Granollers, Granollers; Hospital Germans Trias i Pujol, Badalona; Athalaia, Xarxa Assistencial Universitària de Manresa, Manresa

STUDY SUBJECTS: 280 consecutive patients with non-metastatic colon cancer in whom a curative intent resection is performed.

DETERMINATIONS: Determination of the proangiogenic cytokine VEGF in serum on the postoperative day four to assess its relationship with oncological results on long-term follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with colon cancer admitted to the Colorectal Surgery Unit of the centers participating in the study,
* Patients who will undergo elective surgical resection with potentially curative intention

Exclusion Criteria:

* Patients with metastatic disease
* Patients with synchronous colon neoplasia or in the previous five years
* Patients undergoing emergency surgery
* Patients who do not sign the informed consent.

Primary outcomes:
measure: VEGF in serum on postop day 4
timeFrame: Postoperative day 4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospital del Mar
name: MIGUEL PERA, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01331954: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU)
Official title: Treatment of Breast Fibroadenoma With High Intensity Focused Ultrasound (HIFU): a Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Fibroadenoma
Lead sponsor: Theraclion
Sponsor class: INDUSTRY
First posted: 2011-04-08
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Demonstrate the efficacy of High Intensity Focused Ultrasound in the treatment of the breast fibroadenoma.


Eligibility criteria: Inclusion Criteria:

* One breast fibroadenoma with diagnosis based on:

  * Clinical examination
  * Ultrasound image
  * For women older than 35 years: mammogram with BI-RADS score \< 3
  * Histologic confirmation by two independent readers
* Fibroadenoma size between 1 cm and 3 cm at its largest dimension (measured by ultrasound)

Exclusion Criteria:

* Patient pregnant or lactating
* Bi-RADS score \> 2 at the mammogram, or microcalcifications within the lesion.
* History of breast cancer or history of laser or radiation therapy to the target breast
* Breast implants
* Breast cyst
* Fibroadenoma not clearly visible on the ultrasound images (in B mode)
* Patient participating in other trials using drugs or devices

Primary outcomes:
measure: Reduction of breast fibroadenoma volume at ultrasonography
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
Study officials:
affiliation: University Hospital of Endocrinology (USBALE) "Acad. Ivan Penchev"
name: Roussanka Kovatcheva, M
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kovatcheva R, Zaletel K, Vlahov J, Stoinov J. Long-term efficacy of ultrasound-guided high-intensity focused ultrasound treatment of breast fibroadenoma. J Ther Ultrasound. 2017 Mar 16;5:1. doi: 10.1186/s40349-017-0083-1. eCollection 2017.
Clinical trial NCT02823054: One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery
Official title: One-lung Ventilation During Internal Thoracic Artery Grafting in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Bypass
Keywords: elective surgery
CABG
One-lung ventilation
EZ Blockers
pleural effusion
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 208
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: Coronary artery bypass grafting is a current cardiac surgery. Internal thoracic artery is usually taking to restore coronary revascularization, and its dissection can lead to accidental or voluntary pleural effusions. Respiratory complications are frequent, due to the drainage required. In this study, the investigators propose one-lung ventilation to facilitate artery grafting and surgical procedure. The investigators will include all adult patients with elective coronary artery bypass surgery (CABG) by internal thoracic artery, in a prospective, controlled, randomized and monocentric study. The main objective is to demonstrate that one-lung ventilation using EZ-Blocker can reduce pleural effusion defined by presence of drainage and/or pneumothorax on X-ray chest in the ICU.


Eligibility criteria: Inclusion Criteria:

* elective CABG surgery with internal thoracic artery, with patient consent.
* Patient who have french social security

Exclusion Criteria:

* Cardiac or thoracic past-history
* polyurethane allergy
* guardianship patient
* endotracheal intern diameter too small to allow the EZ-Blocker introduction or the fiberscope
* use of LASER immediately near the EZ-Blocker

Primary outcomes:
measure: Pleural effusions after coronary artery bypass graft surgery
timeFrame: Day 0
measure: absence of pneumothorax
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Mathieu GUILBART, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02483533: Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202
Official title: A Double-Blind Extension Study to Evaluate the Post-Treatment Safety and Duration of Clinical Effect of LIPO-202 in Subjects Who Completed Either the LIPO-202-CL-18 or LIPO-202-CL-19 Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Central Abdominal Bulging
Lead sponsor: Evofem Inc.
Sponsor class: INDUSTRY
Collaborators: name: Neothetics, Inc
First posted: 2015-06-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: LIPO-202-CL-23 is a follow-on study to evaluate the post-treatment safety and duration of clinical effect of LIPO-202 in subjects that completed either the LIPO-202-CL-18 (NCT02397499) or LIPO-202-CL-19 (NCT02398188). No risks related to treatment are anticipated as subjects will not receive additional treatment with LIPO-202 or Placebo for LIPO-202 in this follow-on study.


Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female subjects who completed Study LIPO-202-CL-18 or LIPO-202-CL-19
* Capable of providing written consent
* Willing to comply with the study procedures and schedule

Exclusion Criteria:

* Female subjects who are pregnant or are not using adequate birth control methods
* Plan on starting a weight loss or exercise program during the study
* Plan to enroll in another investigational drug or device study
* Unlikely or unable to adhere to the study visit schedule

Primary outcomes:
measure: Evaluation of the Post-treatment Duration of Clinical Effect of LIPO-202. Photonumeric Score and Global Abdominal Perception Score.
timeFrame: 1 Year
measure: Evaluation of a 12-month Post-treatment, Non-interventional, Observational Period to Evaluate the Safety and Duration of Clinical Effects of LIPO-202.
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Neothetics, Inc
name: Maria Feldman
role: STUDY_DIRECTOR
References:
Clinical trial NCT06146933: System Accuracy of BGM GL22
Official title: Evaluierung Der Systemgenauigkeit Des Blutglucosemonitoring Systems GL22 gemäß DIN EN ISO 15197:2015.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Institut fur Diabetes Karlsburg GmbH
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 113
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: This study assesses the system accuracy of a blood glucose monitoring system pursuant to ISO 15197


Eligibility criteria: Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015

Primary outcomes:
measure: Analysis of system accuracy based on DIN EN ISO 15197
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Karlsburg
country: Germany
facility: Institut für Diabetes Karlsburg GmbH
state: Mecklenburg Vorpommern
Study officials:
affiliation: Institut fur Diabetes Karlsburg GmbH
name: Kerstin Rebrin, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04976933: Post-HSCT Medication Adherence mHealth App
Official title: Design and Feasibility of mHealth App for Pediatric Medication Adherence Post-discharge for Hematopoietic Stem Cell Transplant
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cell Transplantation
Keywords: adherence, mHealth
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-07-26
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary caregivers and health care providers of children discharged during the acute phase (first 100 days) post-hematopoietic stem cell transplant (HSCT).

Brief summary: Through a mixed methods, quasi-experimental design, the study will first focus on developing a mobile health (mHealth) adherence application and evaluating usability and acceptability of the app among caregivers of children in the acute phase post-HSCT. The purpose of this project is to explore the feasibility and acceptability of a mHealth application through user testing and thematic content analysis.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* \>18 years of age

Exclusion Criteria:

* Caregivers with developmental delays or conditions that make processing and responding to verbal questions challenging/frustrating either online or in a group forum

Primary outcomes:
measure: System Usability Scale (SUS)
timeFrame: Baseline to day 100
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Abigail Wexner Research Institute at Nationwide Children's Hospital
name: Micah Skeens, PhD APRN CPNP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Skeens M, Sezgin E, Stevens J, Landier W, Pai A, Gerhardt C. An mHealth App to Promote Adherence to Immunosuppressant Medication and Track Symptoms in Children After Hematopoietic Stem Cell Transplant: Protocol for a Mixed Methods Usability Study. JMIR Res Protoc. 2022 Jul 21;11(7):e39098. doi: 10.2196/39098.
Clinical trial NCT00749333: Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single Doses of AZD8566.
Official title: A Phase I, Randomised, Double Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Single Oral Doses of AZD8566 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
Safety
Tolerability
AZD8566
study
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine how well tolerated and safe AZD8566 is at different dose levels. This study will also determine how AZD8566 is distributed around the body and how it leaves the body.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent.
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG
* Females who are permanently or surgically sterile or postmenopausal.

Exclusion Criteria:

* Intake of medicine (except Hormone Replacement Therapy or occasional paracetamol) within 3 weeks before first administration of study drug
* History of any convulsions or seizures
* History of infection or at risk of infection due to recent surgery or trauma
* History or presence of conditions known to interfere with the absorption, distribution, metabolism and excretion of the study drug

Primary outcomes:
measure: Pharmacokinetic profile: concentration of AZD8566 in blood
timeFrame: Samples taken during Visit 2 (residential period) at up to 16 defined timepoints pre-dose and post- dose
measure: Safety and tolerability of AZD8566 by assessment of vital signs, laboratory variables, ECG and adverse events
timeFrame: Assessments taken at Visit 1 (enrolment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored throughout the study from Visit 1 to Visit 3 for adverse events.
Secondary outcomes:
measure: Pharmacokinetic profile: concentration of AZD8566 in urine
timeFrame: Samples collected over 48 hours from pre-dose to 48 hours post-dose.
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Clinical Pharmacology Unit, Queen's Medical Centre, Nottingham, NG7 2UH
name: William Fahy, MD,MA, MBBS (Hons)
role: PRINCIPAL_INVESTIGATOR
References: