louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05927246: Radiotherapy-Associated Atrial Fibrillation
Official title: Radiotherapy-associated Atrial Fibrillation: Onset Time and Frequency
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation New Onset
Keywords: Atrial fibrillation
breast cancer
lung cancer
thoracic malignancies
cardiotoxicity
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with breast and thoracic cancers will be evaluated for incidence and onset time of AFib.

Brief summary: Radiotherapy associated Atrial Fibrillation (RADAF) is an observational study to evaluate onset time and frequency of atrial fibrillation in patients with thoracic malignancies and breast cancer.

Each patient will have 12 lead ECG prior, and daily during radiotherapy.

Detailed description: Collected data will be truly anonymised and individuals will no longer identifiable, and than evaluated for occurrence of atrial fibrillation.

Inclusing Criteria:

1. Patients with radiotherapy for thoracic malignancy or breast cancer
2. Between 18-99 years-old

Exclusion Criteria:

1. Patients with history of radiotherapy
2. Patients with history of atrial fibrillation
3. Patients with pacemaker implantation

Eligibility criteria: Inclusion Criteria:

* Patients with radiotherapy for thoracic malignancy or breast cancer
* Between 18-99 years-old

Exclusion Criteria:

* Patients with history of radiotherapy
* Patients with history of atrial fibrillation
* Patients with pacemaker implantation

Primary outcomes:
measure: Occurrence of atrial fibrillation
timeFrame: 1 day During radiotherapy
measure: Onset time of atrial fibrillation
timeFrame: 1 day During radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Fatih
country: Turkey
facility: Istanbul Faculty of Medicine
state: Istanbul
Study officials:
affiliation: Faculty member
name: Cafer Zorkun, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02279446: Development of a Validated Chart for Intermediate Vision Assessment
Official title: Development of a Validated Chart for Intermediate Vision Assessment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Hyperopia
Presbyopia
Astigmatism
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Random

Brief summary: Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity.

Detailed description: Development of a validated computer-based instrument (software program) for the assessment of intermediate visual acuity (IVA). It is known that no validated method for the evaluation of IVA exists.

Primary objective of the study is to validate a specific computer-based chart (optotype) that will enable: a) comparative studies among different groups of presbyopic patients with refractive errors (ie. myopia, hyperopia, and/or astigmatism), and, b) assessment of the efficacy of surgical refractive procedures (ie. LASIK) on presbyopic patients.

Intermediate Visual acuity chart is similar to the prevalent Jaeger chart. It consists of short blocks of text in various type sizes.The computer screen is set at a specific reading distance (1 meter) and the patient is asked to read the passage with the smallest type he/she can see. According to the smallest text he/she can read, IVA is classified from IVA1 (which is considered the equivalent of 20/20 distance visual acuity) to IVA5

Validation of the computer-based IVA chart will be done by correlating the results of the IVA chart to the corresponding ones from the validated 20/20 distant and Jaeger near visual acuity charts, in a random sample of study participants with different refractive errors and different near and distant visual acuities.

Eligibility criteria: Inclusion Criteria:

* native Greek participants or foreigners with perfect knowledge (verbal and written) of Greek language

Exclusion Criteria:

* glaucoma or suspicion for glaucoma,
* corneal disease or suspicion for corneal disease
* fundus disease or suspicion for fundus disease
* pregnancy or nursing,
* underlying autoimmune disease
* mental or neurologic disease

Primary outcomes:
measure: Intermediate Visual Acuity (IVA)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Eye Institute Of thrace
state: Evros
Study officials:
affiliation: Assistant Professor
name: Georgios Labiris, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03431246: Immunogenicity of One Dose of Gardasil and One Dose of Gardasil-9
Official title: Persistance of Anti-HPV After a Single Dose of Gardasil and the Effect of a Dose of Gardasil-9 When Administered 3-8 Years Later
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Papillomavirus Vaccines
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2018-02-13
Enrollment: 32
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group exploratory study
Primary purpose: PREVENTION

Brief summary: This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9

Detailed description: This is a one group exploratory study.

The main objective of this study is to assess the persistance of anti-HPV after a single dose Gardasil and the effect of one dose of Gardasil-9 when administered 3-8 years later.

Eligibility criteria: Inclusion Criteria: Have received a single dose of Gardasil 3-8 years before recruitement.

-

Exclusion Criteria: Immunossupressed or blood coagulation problems

-

Primary outcomes:
measure: Anti-HPV seropositivity
timeFrame: One month post vaccine administration.
Secondary outcomes:
measure: HPV antibody titers
timeFrame: One month post vaccine administration
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Laval University Research Hospital Center
Study officials:
affiliation: Quebec Public Health Institute
name: Gaston DeSerres, MD, PhD
role: STUDY_CHAIR
References:
citation: Gilca V, Sauvageau C, Panicker G, De Serres G, Schiller J, Ouakki M, Unger ER. Long intervals between two doses of HPV vaccines and magnitude of the immune response: a post hoc analysis of two clinical trials. Hum Vaccin Immunother. 2019;15(7-8):1980-1985. doi: 10.1080/21645515.2019.1605278. Epub 2019 Jun 3.
Clinical trial NCT02131246: A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Official title: A Randomised Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-05-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of faster-acting insulin aspart in subjects with Type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female 18-64 years (both inclusive) at the time of signing informed consent
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking at least one cigarette, cigar or pipe daily)

Primary outcomes:
measure: Mean plasma glucose concentration
timeFrame: From 0-6 hours after start of a standardised meal
Secondary outcomes:
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: From 0 to 12 hours after trial product administration
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. Faster Onset and Greater Early Exposure and Glucose-Lowering Effect with Faster-Acting Insulin Aspart vs. Insulin Aspart: A Pooled Analysis in Subjects with Type 1 Diabetes. Diabetes. 2016; Suppl. 1: A239. doi:10.2337/db16-861-1374 http://dx.doi.org/10.2337/db16-861-1374
citation: Heise T, Pieber TR, Danne T, Erichsen L, Haahr H. A Pooled Analysis of Clinical Pharmacology Trials Investigating the Pharmacokinetic and Pharmacodynamic Characteristics of Fast-Acting Insulin Aspart in Adults with Type 1 Diabetes. Clin Pharmacokinet. 2017 May;56(5):551-559. doi: 10.1007/s40262-017-0514-8.
Clinical trial NCT02948946: Clinical Utility Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors
Official title: The Clinical Utility of a Blood-Based Multitranscriptome Assay as a Biomarker for Gastroenteropancreatic and Lung Neuroendocrine Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteropancreatic Neuroendocrine Tumor
Lung Neuroendocrine Neoplasm
Keywords: lung cancer
pancreatic cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants to be enrolled in the study will be recruited within the Gastrointestinal (GI) Clinic of Moffitt Cancer Center.

Brief summary: The purpose of this study is to evaluate how well an investigational blood test performs. The study will look at the sensitivity and specificity of a blood-based multitranscriptome assay (NETest).


Eligibility criteria: Inclusion Criteria:

NET Cohort-

* Patients with histologically or cytologically proven diagnosis of any grade, any stage NET of GEP or lung origin; In the first stage of the study (initial 50 patients) only patients with stage IV, well-differentiated tumors (G1/G2) will be enrolled.
* Patients with stable or progressive disease, as documented on a scan (CT, MRI); Progression status will be documented on case report form (CRF).
* Allowed prior therapies include: a.) Surgery (tumor surgery at least four weeks prior to study entry); b.) Locoregional therapy such as: chemoembolization, radio-embolization, radiofrequency ablation, radiotherapy at least six weeks prior to study entry; c.) Any number of previous lines of systemic therapy, providing that cytotoxic therapies (chemotherapy, PRRT) have been discontinued at least 4 weeks prior to study entry.

Non-NET Cohort -

* Healthy participants
* Patients with histologically or cytologically proven diagnosis of any grade, any stage GI malignancies.

Exclusion Criteria:

NET Cohort -

* Patients on treatment with cytotoxic agents (chemotherapy, PRRT).
* Patients with renal insufficiency or congestive heart failure.
* No other active malignancy within 3 years of enrolment except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission.

Non-NET Cohort

* Patients with GI malignancies with neuroendocrine differentiation.

Primary outcomes:
measure: Rate of Successful Test Results Per Cohort
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Jonathan Strosberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01325246: Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair
Official title: Correlation Between Reoperation and Clinical Palpable Recurrence 3 Years After Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral Hernia
Keywords: ventral hernia
repair
clinical
reoperation
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 945
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1200 patients who had a ventral hernia repair in 2007

Brief summary: The risk for recurrence after ventral hernia repair is often based on reoperation rates with short follow-up rather than recurrences identified by clinical examinations.

The purpose of current study is find the real incidence of recurrences 3 years after ventral hernia repair and to compare with the reoperation rate.

Detailed description: all patients in a restricted area (all patients in the part of Denmark called Zealand) who had a ventral hernia repair in 2007 (appr. 1200 patients). The patients will be sorted by a questionnaire and if the patients are suspicious for recurrence they will be offered a clinical examination.

Eligibility criteria: Inclusion Criteria:

* Primary ventral hernia repair performed in the region of Zealand in Denmark

Exclusion Criteria:

* Patients who died and patients not resident in region Zealand

Primary outcomes:
measure: Clinical recurrence after ventral hernia repair
timeFrame: up to 4 years
Secondary outcomes:
measure: explanations for not having a recurrence repair
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Dept. of surgery, Køge Hospital
Study officials:
affiliation: dept. of surgery, Køge Hospital
name: Frederik Helgstrand, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helgstrand F, Rosenberg J, Kehlet H, Strandfelt P, Bisgaard T. Reoperation versus clinical recurrence rate after ventral hernia repair. Ann Surg. 2012 Dec;256(6):955-8. doi: 10.1097/SLA.0b013e318254f5b9.
Clinical trial NCT02324946: Comparison of STOP-BANG and DES-OSA as Predictive Score for Difficult Intubation.
Official title: Comparison of STOP-BANG and DES-OSA as Predictive Score for Difficult Intubation Among Patients Scheduled for Bariatric Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Keywords: Sleep Apnea Syndromes
Perioperative Period
Mass Screening
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2014-12-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for bariatric surgery

Brief summary: The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea.

This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult intubation.

Detailed description: The DES-OSA Score and the STOP-BANG score were predictive scores for Obstructive Sleep Apnea.

This study will compare, among patients scheduled for bariatric surgery, these two scores as predictive scores for a difficult mask ventilation of tracheal intubation.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30 kg m-2
* Preoperative Polysomnography

Exclusion Criteria:

* Pregnant women
* ENT Cancer

Primary outcomes:
measure: Predictive value of STOP-BANG and DES-OSA scores for difficult mask ventilation or intubation.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bouge
country: Belgium
facility: Clinique Saint-Luc de Bouge
state: Namur
Study officials:
affiliation: Astes
name: Eric P DEFLANDRE, MD, FCCP
role: STUDY_CHAIR
References:
Clinical trial NCT03419546: Clinical Validation Trial of a Single-use Bronchoscope (Ambu® aScope ™ 4)
Official title: Clinical Validation Trial of the Single-use Bronchoscope Ambu® aScope ™ 4
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchoscopy
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Ambu A/S
First posted: 2018-02-05
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Patients that require a low complexity bronchoscopy that accept the informed consent

Brief summary: The aim of this study is to evaluate the usefulness of the new Ambu® aScope ™ 4 bronchoscope, in the usual practice of low complexity diagnostic bronchoscopy managed by bronchoscopists who meet the minimum training requirements (having performed 100 supervised procedures \[ 10\]) and maintenance of competition (with more than 25 bronchoscopies per year \[10\]).

Detailed description: Muticentric trial to evaluate three outcomes

1. Describe the experience of bronchoscopists performing low complexity bronchoscopic procedures with the Ambu® aScope ™ 4.
2. Collect the opinion of bronchoscopists about the technical characteristics of the device subject to study through a standardized questionnaire.
3. Analyze the quality of both microbiological and cytological samples obtained through the disposable bronchoscope.

Eligibility criteria: Inclusion Criteria:

* Low complexity bronchoscopies in patients that need to undergo a low complexity bronchoscopy in the sites of the study

Exclusion Criteria:

* No acceptance of the informed consent
* Any procedure out of a low complexity bronchoscopy in the sites of the study

Primary outcomes:
measure: Bronchoscope Quality questionnaire evaluation
timeFrame: Feb 2018- july 2018
Secondary outcomes:
measure: -Opinion of the operator -Quality of the sample
timeFrame: Feb 2018 -july 2018
measure: - Sample quality
timeFrame: Feb 2018- july 2018
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
Study officials:
affiliation: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Javier Flandes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04941846: The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage
Official title: The Role of Deep Cerebral Vein Variation in Patients With Angiographic Negative Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This project plans to include 296 patients who meet the admission and discharge criteria

Brief summary: The incidence of Rosenthal basilar vein (BVR) variants (deep venous drainage variants) was relatively increased in patients with AN-SAH compared with patients with aneurysms. However, the inclusion criteria for AN-SAH patients in these studies were different. Some studies have investigated both PAN-SAH and NPAN-SAH, while some studies have only investigated PAN-SAH patients. However, we believe that NPAN-SAH may be the bleeding caused by non-BVR variation. Although previous studies did not find any association between NPAN-SAH and BVR variants, the results in their study were different, which may be due to the limited number of cases.


Eligibility criteria: Inclusion Criteria:

Patients with negative subarachnoid hemorrhage diagnosed by DSA

Exclusion Criteria:

1. In patients with aneurysms, external ventricular drainage (EVD) alone or decompression craniotomy alone or conservative treatment was performed
2. Have a history of trauma or prior brain injury (stroke, cerebral hemorrhage, etc., with associated chronic changes on CT)
3. Patients with loss of imaging data and severe comorditions prior to onset of SAH

Primary outcomes:
measure: favorable or poor outcome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2ndAffiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
name: Yuanjian Fang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04870346: Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia
Official title: Long Term Follow-up Observational Study After Clinical Trials of AMG531 (Romiplostim) in Patients With Untreated Aplastic Anemia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Aplastic Anemia
Keywords: aplastic anemia
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled in Study 531-003/531-004

Brief summary: To evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation \[up to 5 years\] of patients who were registered for Study 531-003/531-004 in immunosuppressive therapy-naïve patients with aplastic anemia.


Eligibility criteria: Inclusion Criteria:

* Patients whose written consent to participate in this research was obtained among patients registered for Study 531-003/531-004
* Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients whose legally authorized representatives such as their family had given the consent or patients whose legally authorized representatives had not refused in the disclosure of information by opt-out
* Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients, patients for whom the consent process exemption was approved by the Ethics Review Committee, etc. of the participating medical institutions at the participating medical institutions in the countries without the opt-out system

Exclusion Criteria:

* Patients who are judged by the investigator or sub-investigator to be unfavorable for participation in this research

Primary outcomes:
measure: Hematological response at 2 years after the start of romiplostim treatment in Study 531-003/531-004
timeFrame: 2 years
measure: Hematological response at up to 5 years after the start of romiplostim treatment in Study 531-003/531-004
timeFrame: 5 years
Secondary outcomes:
measure: The duration of hematological response, and the presence or absence of occurrence of new chromosomal abnormality or transformation to AML/MDS.
timeFrame: 52, 78, 104, 130, 156, 182, 208, 234, 260 weeks
Other outcomes:
Locations:
city: Kanazawa
country: Japan
facility: Kanazawa University, College of Medical Pharmaceutical and Health Sciences, School of Medicine, Department of Hematology
state: Ishikawa Prefecture
Study officials:
affiliation: Kanazawa University Hospital, Blood Transfusion Department
name: Hirohito Yamazaki
role: PRINCIPAL_INVESTIGATOR
References: