louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05442970: Cohort Study for Atrial Fibrillation Risk Stratification
Official title: An Epidemiologic, Prospective, Single Center Cohort Study for the Improvement of Atrial Fibrillation Risk Stratification in High Risk Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient cardiology sample at risk for AF. Recruitment in a single center design, at the Department of Cardiology, University Medical Center Hamburg-Eppendorf.

Brief summary: AFHRI is planned as a prospective, single-center cohort study in patients at high risk of AF.

Detailed description: The primary aim of the study is to evaluate and improve atrial fibrillation risk prediction, which takes into account clinical, psycho-social, environmental and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint, AF (paroxysmal or permanent).

Eligibility criteria: Inclusion Criteria:

* Age 18 to 85 years;
* Personally signed informed consent

Exclusion Criteria:

* Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation;
* Physical or psychological incapability to cooperate in the investigations

Primary outcomes:
measure: Incident atrial fibrillation
timeFrame: up to 4 years
Secondary outcomes:
measure: Myocardial infarction
timeFrame: up to 4 years
measure: Cardiovascular death
timeFrame: up to 4 years
measure: Heart failure
timeFrame: up to 4 years
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Cardiology, University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Department of Cardiology, University Medical Center Hamburg-Eppendorf
name: Renate B Schnabel, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Assum I, Krause J, Scheinhardt MO, Muller C, Hammer E, Borschel CS, Volker U, Conradi L, Geelhoed B, Zeller T, Schnabel RB, Heinig M. Tissue-specific multi-omics analysis of atrial fibrillation. Nat Commun. 2022 Jan 21;13(1):441. doi: 10.1038/s41467-022-27953-1.
Clinical trial NCT00293670: FINNPROSTATE Study VII: Intermittent Versus Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
Official title: Intermittent Vs Continuous Androgen Deprivation in Patients With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Patients With T1-4 Advanced Prostate Cancer
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: Finnish Prostate Cancer Group
First posted: 2006-02-17
Enrollment: 573
Sex: MALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare intermittent androgen deprivation (LHRHa treatment) with continuous androgen deprivation (LHRHa treatment or orchidectomy)


Eligibility criteria: • Inclusion Criteria (run-in period): T1-T4, metastatic (M1) prostate cancer T1-T4, non-metastatic (M0) prostate cancer with PSA \> 60 ng/mL T3-T4, non-metastatic (M0) prostate cancer with PSA \> 20ng/mL T1-T4, N+ prostate cancer WHO performance status 0-2 Written informed consent

• Inclusion criteria to the randomised period: Patients who fulfilled all entry criteria of the run-in period Patients who completed the 24-week run-in period Patients who responded to the 24-week run-in period with a decrease of PSA to \< 10 ng/mL. If the baseline was \< 20ng/mL, at least 50% decrease from the baseline measurement is required

Exclusion Criteria (run-in period):

Any previous or concurrent treatment of prostate cancer, except TURP, 5-alpha reductase inhibitor, radical prostatectomy or radiotherapy Any medication/treatment affecting sex hormone status

-

Primary outcomes:
measure: Time To Progression (TTP)
Secondary outcomes:
measure: Overall and prostate cancer-specific survival, time to treatment failure, quality of life
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: TUCH (Tampere University Central Hospital)
Study officials:
affiliation: Tampere University Central Hospital, Finland
name: Teuvo L Tammela, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salonen AJ, Taari K, Ala-Opas M, Viitanen J, Lundstedt S, Tammela TL; FinnProstate Group. Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects. Eur Urol. 2013 Jan;63(1):111-20. doi: 10.1016/j.eururo.2012.07.040. Epub 2012 Jul 27.
citation: Salonen AJ, Taari K, Ala-Opas M, Viitanen J, Lundstedt S, Tammela TL; FinnProstate Group. The FinnProstate Study VII: intermittent versus continuous androgen deprivation in patients with advanced prostate cancer. J Urol. 2012 Jun;187(6):2074-81. doi: 10.1016/j.juro.2012.01.122. Epub 2012 Apr 11.
Clinical trial NCT01029470: To Describe the Effect of rhLH Supplementation in Women With Hyporesponse to rhFSH After Pituitary Downregulation
Official title: A Multicentre, Prospective, Open Study to Describe the Effects of rhLH Supplement in Women With Hyporesponse to rFSH After Pituitary Downregulation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infertility
Keywords: Luveris
hyporesponse
pituitary downregulation
IVF
Infertility women
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Chongqing Medical Center for Women and Children
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Reproductive & Genetic Hospital of CITIC-Xiangya
First posted: 2009-12-10
Enrollment: 150
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective:

To evaluate the efficacy in terms of oocyte retrieval number of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation.

Secondary objective:

To further explore the efficacy of rLH supplement in women with hyporesponse to rFSH after pituitary downregulation To evaluate the safety of rLH supplementation in hyporesponse women

Detailed description: Primary endpoint:

Number of oocyte retrieved

Secondary endpoints:

1. Oestrodial on hCG day (pg/ml)
2. Number of embryos
3. Implantation rate (%)
4. Clinical pregnancy rate (%)
5. Ongoing PR per IVF cycle (%)
6. Abortion rate (%)
7. Ampoules of rFSH
8. FertiQoL score Safety endpoint: adverse events

Eligibility criteria: Inclusion Criteria:

1. 20-40 years old women
2. With menstrual cycles ranged 24-35 days, intraindividual variability±3 days
3. Basal FSH \<10 IU/L at cycle D2-D5
4. 18 \< BMI \< 30
5. Presence of two ovaries
6. No ovarian stimulation over the past 3 months
7. Signed inform consent form.

Exclusion Criteria:

1. Polycystic ovarian syndrome
2. rAFS stage Ⅲ-Ⅳ endometriosis
3. Chromosomal abnormalities, endocrinological and/or autoimmune disorders.
4. More than two previously unsuccessful IVF.

Primary outcomes:
measure: Number of oocyte retrieved
timeFrame: 2009Dec-2010Oct
Secondary outcomes:
measure: 1. Oestrodial on hCG day (pg/ml) Safety: adverse events
timeFrame: 2009 Dec-2010 Oct
measure: 2. Number of embryos
timeFrame: 2009 Dec-2010 Oct
measure: 3. Implantation rate (%)
timeFrame: 2009 Dec-2010 Oct
measure: 4. Clinical pregnancy rate (%)
timeFrame: 2009 Dec-2010 Oct
measure: 5. Ongoing PR per IVF cycle (%)
timeFrame: 2009 Dec-2010 Oct
measure: 6. Abortion rate (%)
timeFrame: 2009 Dec-2010 Oct
measure: 7. Ampoules of rFSH
timeFrame: 2009 Dec-2010 Oct
measure: 8. FertiQoL score Safety: adverse events
timeFrame: 2009 Dec-2010 Oct
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jie Qiao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04349670: Safety and Efficacy of GPOEM in the Treatment of Gastroparesis
Official title: Safety and Efficacy of GPOEM in the Treatment of Gastroparesis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroparesis
Gastroparesis Postoperative
Gastroparesis With Diabetes Mellitus
Keywords: GPOEM
gastroparesis
pyloromyotomy
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected with clinical or scintigrafic severe gastroparesis or patients with moderate symptoms/gastric scintigraphic delayed emptying with good response to botulinum.

Brief summary: The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis.

Detailed description: After being informed about the data collected, all the patients affected with gastroparesis undergoing Gastric Per-Oral Endoscopic Myotomy (GPOEM) will be included in the observational protocol.

Data concerning pre-operative symptoms and results of the imaging studies will be recorded together with operative time and operative complications.

Patients will undergo periodical clinical consults and gastric emptying scintigraphy to assess the improvement in the symptoms and gastric motility.

Eligibility criteria: Inclusion Criteria:

* Gastroparesis (GCSI \> 2 OR Gastric emptying half-time \> 180 min OR gastric retention at 120 min \> 60% OR good response to botulinum if former criteria not met)

Exclusion Criteria:

* Age \< 18 years
* Inability to understand protocol

Primary outcomes:
measure: Clinical efficacy
timeFrame: 1, 3, 6, 12, 24 months
measure: Functional efficacy
timeFrame: 3, 12, 24 months
measure: Complications
timeFrame: peri-operative time (48 hours)
Secondary outcomes:
measure: Correlation of symptoms
timeFrame: 3, 12, 24 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Pier Alberto Testoni
Study officials:
References:
Clinical trial NCT06033170: Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage
Official title: Prospective, Single-Arm Confirmatory Clinical Investigation to Demonstrate the Effectiveness, Performance, and Safety of the Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postpartum Hemorrhage
Lead sponsor: Medtrade
Sponsor class: INDUSTRY
Collaborators: name: Charite University, Berlin, Germany
First posted: 2023-09-13
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage (PPH).


Eligibility criteria: Inclusion Criteria:

* Subject or her legally authorized representative is able to understand and provide consent to participate in the clinical investigation
* Female Adult subjects (\>18 years of age).
* Diagnosis of PPH with suspected uterine atony placental bed bleeding, placenta accreta or previa within 24 hours after vaginal delivery.
* Subjects with coagulation disorders can be included
* Minimal Estimated Blood Loss (EBL), to be determined when investigator is ready to have the Celox™ PPH package opened. 500 ml of EBL for vaginal delivery or 1000 ml for caesarean section.
* Failed first-line intervention of uterotonics and uterine massage/bimanual compression to stop bleeding. Note: Uterotonic administration may continue concomitant with and post the Celox™ PPH use.
* Subjects with PPH of cervical or vaginal origin.

Exclusion Criteria:

Subjects who present with, uterine rupture or for any other conditions outside of atonic post-partum haemorrhage needing other interventional methods or surgery including uterine artery embolization (UAE).

* Pregnancy or incomplete multiple pregnancy
* Unresolved uterine inversion.
* Current cervical cancer.
* Current purulent infection of the vagina, cervix, uterus.
* Planned c-section with closed cervix.
* Patients requiring trans-abdominal insertion of Celox™ PPH.

Primary outcomes:
measure: Celox™ PPH in controlling uterine bleeding in postpartum hemorrhage (PPH).
timeFrame: Successful haemostasis is defined as absence of additional surgical or non-surgical interventions after application of Celox PPH. It is expected that within 2-5 minutes of application, the bleeding will be controlled.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Charite University, Berlin, Germany
name: Anna Maria Dückelmann, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Raja Perempuan Zainab II - Malaysia
name: NIK Abdullah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00694070: Evaluation of a Diabetes Data Management System
Official title: Evaluation of a Diabetes Data Management System In a Clinical Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Lay users males or females and health care professionals.

Brief summary: The purpose of this study is to evaluate a diabetes data management program in the hands of potential users, both health care professionals and lay users.

Detailed description: Diabetes data management programs analyze blood glucose results downloaded from glucose meters to assist health care professionals or lay users manage their diabetes. During the study, subjects download meters, generate and print reports, evaluate the program's ease of use, and verify that they understand the program output.

Eligibility criteria: Inclusion Criteria:

* Health Care Professionals:

  1. Must have experience using diabetes data management software in the medical office such as downloading meters, reviewing reports (computer screen or printouts), or assisting in patients' diabetes disease management using software.
  2. May include: endocrinologists, primary care physicians, nurse educators, or other medical staff involved in downloading meters or interpreting the data output.
* Lay users must:

  1. Be at least 18 years of age.
  2. Have diabetes (or be the parent or legal guardian of a child with diabetes) and have been testing blood sugar at home at least twice daily for one month or more.
  3. Be able to speak, read and understand English.
  4. Currently using diabetes management software at home or be familiar with diabetes management software. At least 75% of subjects must have been using software for at least one month.
  5. Have experience using PC programs or browsing the internet.

Exclusion Criteria:

* Persons working for a competitive medical device company.

Primary outcomes:
measure: Number of Participants That Rated 80% of Tasks as Very Simple, Simple, or Neither Simple Nor Difficult (Ease of Use of the Software Program)
timeFrame: 1-2 hours
measure: Number of Participants Rated as <= 3 (Success in Using the Program)
timeFrame: 1-2 hours
measure: Number of Participants That Could Answer at Least 85% of the Comprehension Questions Correctly (Comprehension of the Program Reports)
timeFrame: 1-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
Study officials:
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00291070: Effects of L-Theanine in Boys With ADHD
Official title: A Double Blind, Randomized Placebo Controlled Clinical Trial Examining the Effects of L-Theanine (Suntheanine®) in Male Child Subjects With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
attention
insomnia
hyperactivity
anxiety
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2006-02-13
Enrollment: 100
Sex: MALE
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effects of L-theanine (an amino acid found in green tea) on the behavior, cognitive performance and sleep quality of boys with ADHD.


Eligibility criteria: Inclusion Criteria:

Diagnosis of attention deficit hyperactivity disorder (ADHD)

Exclusion Criteria:

-

Primary outcomes:
measure: Cognitive performance
Secondary outcomes:
measure: Sleep quality, hyperactive behaviors, anxiety
Other outcomes:
Locations:
city: Coquitlam
country: Canada
facility: Canadian Center for Functional Medicine
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Dr. Michael Lyon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03834870: Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)
Official title: Virtual cOaching in Making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Elder Abuse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-02-08
Enrollment: 1012
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To develop an interactive tool to screen for Elder Mistreatment (EM) in the Emergency Department (ED) to promote self-disclosure.

Detailed description: To develop and refine the interactive VOICES tool, which will promote self-identification and self-disclosure to increase reporting of EM at point-of-care in the Emergency Department (ED) setting. Prior to conducting a feasibility study, focus groups will be conducted to inform the process and to develop a tool to evaluate the use of VOICES.

Feasibility Study: To conduct a feasibility study (N= 800) examining the use of VOICES in a busy ED.

Exploratory Aim: To perform a preliminary evaluation of the accuracy of VOICES as a screening tool in correctly classifying EM cases that were referred to Adult Protective Services (APS).

Eligibility criteria: Inclusion Criteria:

* Age 60 years or older
* Non-full trauma track
* Alert and oriented to person and place
* AMT-4 score of 4
* Able to consent and communicate in English
* Agrees and able to use the iPad
* Not in police custody

Exclusion Criteria:

* subjects who live in nursing homes or other long-term care sitting and do not reside in community setting
* patients will be excluded if they cannot safely undergo the studies required for participation
* subjects with clear signs of EM
* Patient or clinician refusal to participate
* severe hearing and vision impairment
* presenting with active psychotic symptoms
* presenting with acute intoxication
* COVID-19 positive

Primary outcomes:
measure: Implementation in Terms of Participation
timeFrame: up to 16 months
measure: Implementation in Terms of Usage
timeFrame: up to 16 months
Secondary outcomes:
Other outcomes:
measure: Acceptability
timeFrame: up to 16 months
measure: Demand
timeFrame: up to 16 months
measure: Practicality
timeFrame: up to 16 months
measure: Efficacy of the Educational Material
timeFrame: up to 16 months
measure: Efficacy of the Brief Negotiation Interview
timeFrame: up to 16 months
measure: Efficacy of Self-Identification on Self-Disclosure
timeFrame: up to 16 months
measure: Accuracy
timeFrame: up to 16 months
Locations:
city: New Haven
country: United States
facility: St. Raphael Emergency Department
state: Connecticut
Study officials:
affiliation: Yale University
name: Fuad Abujarad, PhD,MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06290570: A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's
Official title: Prospective Evaluation of Artificial Intelligence ECG With Consumer-Facing ECG Devices for Detection of Hypertrophic Cardiomyopathy and Distinction From Athlete's
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 300
Sex: ALL
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: Outpatients scheduled for appointments in the sports cardiology or HCM clinic at Mayo Clinic in Rochester, MN will be approached to participate in the study.

Brief summary: The purpose of this study is to evaluate the AI-ECG algorithm for HCM in detecting HCM and in differentiating it from athlete's using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices.


Eligibility criteria: Inclusion Criteria:

* Patients with clinically validated diagnoses of HCM (n=150) and athlete's (n=150) will be identified by pre-screening of the clinic appointments for each of the specialty HCM and Sports Cardiology clinics or in the CV fellows' clinic (in patients with an established diagnosis and no pending testing). All diagnoses will need to be supported by unequivocal imaging and other ancillary data per our standard of care and at the determination of clinic experts.

Exclusion Criteria:

* Any exception to the above criteria.

Primary outcomes:
measure: Distribution of AI-ECG probabilities in HCM
timeFrame: Baseline
measure: Comparative diagnostic performance between tracings obtained from different devices
timeFrame: Baseline
Secondary outcomes:
measure: Distribution of AI-ECG probabilities in Athlete's
timeFrame: Baseline
measure: Correlation with false negative AI ECG result
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Konstantinos Siontis, MD
role: PRINCIPAL_INVESTIGATOR
References: