louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01669148: Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
Official title: Breast Cancer Detection: Comparison of Breast Tomosynthesis and Conventional Mammography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Hologic, Inc.
First posted: 2012-08-20
Enrollment: 496
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary hypothesis to be tested is:

The detection of breast cancer will be increased with tomosynthesis (3D) imaging

Detailed description: The purpose of this study is to determine if: 1 the detection of breast cancer will be increased with conventional (2D) imaging plus tomosynthesis (3D) imaging, or 2. if the the detection of breast cancer will be increased with tomosynthesis (3D) imaging alone.

Eligibility criteria: Inclusion Criteria:

* Female
* Any ethnic origin
* No contraindication for routine bilateral mammography

Exclusion Criteria:

Potential subjects with any of the following will not be enrolled in the study:

* Any contraindications to mammographic screening, including, but not limited to:
* Significant existing breast trauma
* Under the age of 30 at the time of consent
* Breast Implants
* Prior Surgeries

  * Unable to understand and execute written informed consent
  * Pregnant
  * Lactating

Primary outcomes:
measure: Detection of Breast Cancer (Sensitivity)
timeFrame: up to two years follow up for development of breast cancer
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Elizabeth A Rafferty, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03366948: Internet Gaming Disorder and Psychiatric Disorder
Official title: Internet Gaming Disorder Prevalence of Teenager Psychiatric Inpatient of 4 Psychiatric Units of French Region Auvergne-Rhône-Alpes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Disorder
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 102
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged from 12 to 17 of 4 psychiatric units of French region Auvergne-Rhône-Alpes and their parents.

Brief summary: The fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) recently identified Internet gaming disorder as a new potential psychiatric disorder which need further research. Several studies showed the important prevalence of psychiatric disorders among patients suffering from internet gaming disorder. Investigators hypothesize that on an other side the prevalence of internet gaming disorder among patients suffering from psychiatric disorders shall be high but it has never been studied yet.

The main goal of this trial is to examine the prevalence of internet gaming disorder using the Internet Gaming Disorder Test-10 (IGDT-10) among inpatient aged from 12 to 17 of 4 psychiatric units of French region Auvergne-Rhône-Alpes.

Secondary goals will be to assess a parental version of the IGDT-10 (IGDT-10-P) and to compare the two versions.

IGDT-10 will be passed during 6 months to every inpatient and IGDT-10-P to their parents within the 21 first days of the hospitalisation.


Eligibility criteria: Inclusion Criteria:

* Patient aged from 12 to 17
* Parents of the patient, older than 18 years old
* Patients hospitalized in 4 psychiatric units of French region Auvergne-Rhône-Alpes

Exclusion Criteria:

* Patient and/or theirs parents are not fluent in French
* Intellectual deficit (known intelligence quotient below 70)
* Behaviour disorder making impossible to pass the questionnaire

Primary outcomes:
measure: Proportion of patients with a IGDT-10 score above 5
timeFrame: In the first 21 days after the admission in the psychiatric unit.
Secondary outcomes:
Other outcomes:
Locations:
city: Bourgoin-Jallieu
country: France
facility: Service de pédopsychiatrie Centre hospitalier Pierre Oudot
city: Bron
country: France
facility: Psychopathologie du Développement Hôpital Femme Mère Enfant
city: Bron
country: France
facility: Service de psychiatrie adulte Hôpital Pierre Wertheimer-GHE
city: Bron
country: France
facility: Service de pédopsychiatrie - Unité H.Flavigny Centre hospitaliser Le Vinatier
city: Lyon
country: France
facility: Service de pédopsychiatrie - Unité Adolescents ULYSSE - Centre hospitalier St Jean-de-Dieu
Study officials:
References:
Clinical trial NCT04624048: Exercise Influence on COVID-19
Official title: "Influence of Physical Exercise on the Severity of Severe Acute Respiratory Syndrome Coronavirus 2 Infection, COVID-19"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection Viral
Exercise
Coronavirus
Habits
Keywords: Exercise
Universities
Coronavirus
Habits
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 30000
Sex: ALL
Minimum age (years): 17
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University of Salamanca population, which includes:

* Teaching and research staff
* Administration and services staff
* Students

Brief summary: An observational study is carried out in the university population of the University of Salamanca to know the impact of the COVID-19 pandemic and the influence of physical exercise on the severity of symptoms.

Detailed description: * Investigate the relationship between the regular practice of moderate physical exercise and the severity of the COVID-19 disease in the university community of the University of Salamanca.
* Prepare an epidemiological study of the impact of the pandemic at the University of Salamanca.
* Analyze the influence of the pandemic on the sports habits of the university community.
* The study population will be the entire university community (teaching and research staff, administration and services staff, and students) who will be contacted via email.

Eligibility criteria: Inclusion Criteria:

* University of Salamanca population
* Complete the survey

Exclusion Criteria:

* Survey not filled out completely

Primary outcomes:
measure: Impact of COVID-19
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Influence of exercise in COVID-19 infection
timeFrame: Through study completion, an average of 3 months
measure: Change in the practice of physical exercise after home confinement
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Salamanca
name: CARLOS MARTIN-SANCHEZ, DOCTOR
role: PRINCIPAL_INVESTIGATOR
References:
citation: McAuley PA, Keteyian SJ, Brawner CA, Dardari ZA, Al Rifai M, Ehrman JK, Al-Mallah MH, Whelton SP, Blaha MJ. Exercise Capacity and the Obesity Paradox in Heart Failure: The FIT (Henry Ford Exercise Testing) Project. Mayo Clin Proc. 2018 Jun;93(6):701-708. doi: 10.1016/j.mayocp.2018.01.026. Epub 2018 May 3.
Clinical trial NCT00930748: Evaluation of MRI for Prostate Cancer
Official title: Evaluation of the Potential of Endorectal MRI for the Staging and Recurrence of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostatic Neoplasms
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-06-30
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with prostate cancer

Brief summary: The objective of this study is to evaluate imaging quality and correlation with histopathology in prostate cancer.

Detailed description: The objective of this study is to evaluate of the potential of endorectal 3T MRI for the staging of prostate cancer before prostatectomy or recurrence of prostate cancer after prostatectomy

Eligibility criteria: Inclusion Criteria:

* Age of patients: up to 80 years.
* Men scheduled for radical prostatectomy due to prostate cancer or men post radical prostatectomy with suspicion of recurrence.
* Patients who are able and willing to give consent and able to have an MRI examination.

Exclusion Criteria:

* Contraindications to MRI including: claustrophobia, weight over 120 kg, implanted ferromagnetic materials or foreign objects, and known intolerance to the MRI contrast agent (e.g. Gadolinium or Dotarem)
* Individuals who are not able or willing to tolerate the required prolonged stationary supine position during imaging (approximately 1 hr.)
* Any rectal pathology preventing probe insertion, (as active proctitis, active ulcerative colitis, fissure ani)
* Any spinal pathology that prohibits maintaining supine position for an hour
* Patients with documented myocardial infarction within one month of protocol entry, and patients with cardiac pacemakers
* Severe cerebrovascular disease (multiple CVA or CVA within 6 months)

Primary outcomes:
measure: • MRI and pathology correlation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT02683057: Influence of Physical Exercise on Semen Quality
Official title: Influence of Physical Exercise on Semen Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexual Abstinence
Lead sponsor: IVI Bilbao
Sponsor class: OTHER
Collaborators: name: Instituto Valenciano de Infertilidad, IVI VALENCIA
First posted: 2016-02-17
Enrollment: 207
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Candidates for sperm donors in the donation program which aims clinic It is performed in 432 cases. For that, our study addresses a population previously selected either by physical activity or by semen quality

Brief summary: Our study addresses a previously selected population or by physical activity but not for semen quality semen donor candidates donation program within the clinic.

Total physical activity was analyzed according to the universally accepted international physical activity questionnaire (IPAQ) The existence of confounding factors associated She purge age, snuff, weight, BMI, alcohol, drugs, type of sport and associated blood parameters determinations will be made to exercise.

Detailed description: The level of physical activity recommended great unknown and its influence from the therapeutic point of view to improve semen quality.

For it will be held:

* 3 groups of physical activity are established, according to their score in the IPAQ: High, minimum of physical activity between \> 1500 MET week Moderate: minimum of physical activity of between 600- 1500 MET week Low : until \< 600 MET week
* Implementation of a double analysis: Seminal and hormonal
* Standardization of confounding factors associated with the individual

Eligibility criteria: Inclusion Criteria:

* Appear as sperm donor
* Age between 18-35 years
* First sperm donation
* Sexual abstinence 3-5 days
* Having signed informed consent

Exclusion Criteria:

-

Primary outcomes:
measure: Ascertain the influence of physical activity in sperm quality to candidates for sperm donors in the donation program according to the universally accepted questionnaire International physical activity (IPAQ)
timeFrame: 2 years
Secondary outcomes:
measure: Existence of confounding factors associated with physical activity
timeFrame: 2 years
Other outcomes:
Locations:
city: Leioa
country: Spain
facility: IVI Bilbao
state: Vizcaya
Study officials:
affiliation: IVI Bilbao
name: Roberto Matorras
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01276457: Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
Official title: An 18 Month Extension to the Multicenter, Randomized, Open-label Trial (NCT00170885) to Evaluate the Safety, Tolerability, and Efficacy of Two Regimens of Everolimus Plus Cyclosporine Microemulsion, Given According to Different Blood Target Levels, in de Novo Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transplantation Infection
Keywords: immunosuppression
kidney transplantation
everolimus
safety
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-13
Enrollment: 223
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients treated with the upper everolimus target levels plus very low dose cyclosporin in comparison with the standard everolimus target levels plus low dose cyclosporin in patients with renal transplantation.


Eligibility criteria: Inclusion Criteria:

* Patients with functioning graft who had completed the 6-month treatment period of core study
* Patients who were receiving treatment with either everolimus and cyclosporin at the end of the core study
* Patients who signed the informed consent of the present study extension

Exclusion Criteria:

- Women who were pregnant, lactating or who wished to became pregnant.

Other protocol-defined inclusion/exclusion criteria applied to the study.

Primary outcomes:
measure: Number of Participants With Biopsy-proven Acute Rejection
timeFrame: Baseline to end of study (Month 24)
measure: Renal Function Assessed by Creatinine Clearance
timeFrame: Month 12, Month 18, and Month 24
Secondary outcomes:
measure: Number of Participants Who Died, Number of Participants Who Lost Their Graft, and Number of Participants Who Died or Lost Their Graft
timeFrame: Baseline to end of study (Month 24)
measure: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) or Deaths
timeFrame: Baseline to end of study (Month 24)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04960657: The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
Official title: The Hemodynamic Effects of PACAP38 After Glibenclamide Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Headache
Pain
Keywords: Glyburide
Physiological Effects of Drugs
Hypoglycemic Agents
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, cross-over, placebo-controlled design in healthy volunteers.
Primary purpose: OTHER

Brief summary: To investigate the hemodynamic effects of PACAP38 after glibenclamide administration.

Detailed description: 22 healthy participants will randomly be allocated to receive PACAP38 infusion followed by glibenclamide or placebo on two different days.

The aim of the study is to investigate the vascular effect of PACAP38 after glibenclamide administration.

Repeated measurements covering the arteria radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA) before and after PACAP38 infusion and glibenclamide/placebo administration

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers of both sexes.
* 18-60 years.
* 50-100 kg.
* Women of childbearing age must use adequate contraception

Exclusion Criteria:

* A history of serious somatic or psychiatric disease
* Migraine or any other type of headache (except episodic tension-type headache less than 5 days per month)
* Daily intake of any medication except contraceptives

Primary outcomes:
measure: Headache
timeFrame: Time of headache measurements is from before (-20 minutes) and up to 12 hours after PACAP38 infusion
Secondary outcomes:
measure: Changes in the arterial radialis (RA), superficial temporal artery (STA) and middle cerebral artery (MCA).
timeFrame: Time of measurements is baseline and repeatedly every 20 minutes for 260 minutes.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center
state: Capital Region
Study officials:
References:
Clinical trial NCT00233857: Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy
Official title: Auricular Acupuncture Versus Placebo (Sham Acupuncture) for Postoperative Pain Relief After Ambulatory Knee Arthroscopy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Keywords: Acute pain
postoperative pain
auricular acupuncture
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2005-10-06
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim was to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute postoperative pain and in reduction of analgesics consumption on demand and their side effects in patients after ambulatory knee arthroscopy


Eligibility criteria: Inclusion Criteria:

1. Patients with an American Society of Anesthesiologists physical status of I to II scheduled for ambulatory knee arthroscopy under general anesthesia.
2. Surgery time does not exceed 60 minutes.
3. Patients without previous opioid and/or psychiatric medication.
4. Patients ranged 16-65 years old.
5. Patients able to use Visual Analogue Scale-100 for pain intensity measurement.
6. Patients who have given informed consent.

Exclusion Criteria:

1. Pregnant or nursing females.
2. Recidivist alcoholics and/or patients with history of psychiatric disease.
3. Local or systemic infection.
4. Age \< 16 and \> 65 years.
5. Surgery time more than 60 minutes.
6. Inability to use Visual Analogue Scale-100.
7. Patients consumed opioid medication before surgery.
8. Patients with prosthetic or damaged cardiac valves (s. Potential risks)
9. Patients who are unable to understand the consent form.

Primary outcomes:
measure: Postoperative ibuprofen requirement after the surgery
Secondary outcomes:
measure: Pain intensity assessed by patients on VAS-100 ; total piritramide requirement in anesthesia recovery room; incidence of analgesia-related side effects
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
Study officials:
affiliation: Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
name: Taras I. Usichenko, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04965857: Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopy
Official title: Comparison of the Hologic Genius Digital Diagnostics System With the Liquid-based Cytology (LBC) Manual Microscopic Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer Screening
Lead sponsor: Hologic Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2021-07-16
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: As part of the German National Cancer Plan, women over the age of 35 years will be given a co-test comprising a Pap smear and an HPV test, every three years.

Brief summary: Quality assurance of the laboratory examinations. Prospective non-interventional study with ThinPrep slides collected during the German Co-Screening Program and routinely sent to the lab to prospectively evaluate the clinical performance of the Hologic Genius Digital Cytology (DC) system vs. the liquid-based cytology (LBC) manual microscopic approach

Detailed description: The cause of cervical cancer is a persistent infection with high-risk types of human papillomavirus (HPV). Cytology has been the gold standard for cervical screening since the introduction of routine screening with the Pap test in the 1950s due to its effect on mortality in regions with screening programs. Since that time, there have been several technological advances (LBC, Imaging) to improve and automate cervical cytology, resulting in increased disease detection and efficiency. The Hologic's Genius Digital Diagnostics System is a CE-IVD (CE-marked in vitro diagnostic device) marked digital cytology platform. For quality assurance and to prospectively evaluate the Hologic Genius Digital Cytology (DC) system in the lab, selected routinely screened and already archived slides will be additionally reviewed with the liquid-based cytology (LBC) manual microscopic approach. Only anonymized results will be evaluated.

Eligibility criteria: Inclusion Criteria:

* LBC ThinPrep® samples are collected by gynaecologists and sent routinely to cytology laboratory Zotz \& Klimas as part of the German Cervical cancer screening program.

Primary outcomes:
measure: Sensitivity and specificity of detection of pre-cancerous lesions using Hologic Genius Digital Cytology Imaging scanner.
timeFrame: 1 year
Secondary outcomes:
measure: To assess the rate of inadequate slides that cannot be read by the Hologic Genius Digital Cytology system.
timeFrame: 1 year
measure: Change in time needed to screen 80 slides using Hologic Genius Digital Cytology Imaging scanner.
timeFrame: 1 year
measure: Clinical performance of Hologic Genius Digital Cytology Imaging scanner using cells on a ThinPrep® slide.
timeFrame: 1 year
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Zotz Klimas Partner für Diagnostik und Prävention MVZ Düsseldorf-Centrum
Study officials:
References: