louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00627783: Do You Need to Assess Myocardial Ischemia in Type 2 Diabetes
Official title: Randomized Strategy Trial Comparing Detection of Silent Ischemia With no Detection of Silent Ischemia in Asymptomatic Patients With Type 2 Diabetes Mellitus. Effects on Cardiovascular Events.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2008-03-03
Enrollment: 642
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: DYNAMIT is a prospective, randomized, multicenter, open strategy trial run in 45 French hospitals. Diabetic patients with no evidence of coronary artery disease and at least 2 additional cardiovascular risk factors are randomized to screening for silent ischemia using a bicycle exercise test or Dipyridamole Single Photon Emission Computed Tomography (N=316), or follow-up without screening (N=315). All have access to cardiovascular prevention according current guidelines. The main end point is time to death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention.


Eligibility criteria: Inclusion Criteria:

* Patients 55 to 75 years old had type-2 diabetes and at least two of the following cardiovascular risk factors:

  * urinary albumin excretion \> 30 mg/L or \> 30 mg/24 hours,
  * treated or untreated hypertension,
  * treated or untreated lipid abnormality,
  * peripheral arterial disease,
  * history of transient ischemic accident,
  * tobacco consumption
  * familial history of premature cardiovascular disease.

Exclusion Criteria:

* History of myocardial infarction, coronary artery disease, or stroke,
* Previous positive stress test or myocardial perfusion imaging,
* Negative stress test or myocardial perfusion imaging within the last three years

Primary outcomes:
measure: Death from all causes, non-fatal myocardial infarction, non-fatal stroke, or heart failure requiring hospitalization or emergency service intervention, measured after a minimum follow-up of 2 years
Secondary outcomes:
measure: Unstable angina requiring hospitalization Coronary events Coronary revascularization
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Louis Pradel
Study officials:
References:
citation: Lievre MM, Moulin P, Thivolet C, Rodier M, Rigalleau V, Penfornis A, Pradignac A, Ovize M; DYNAMIT investigators. Detection of silent myocardial ischemia in asymptomatic patients with diabetes: results of a randomized trial and meta-analysis assessing the effectiveness of systematic screening. Trials. 2011 Jan 26;12:23. doi: 10.1186/1745-6215-12-23.
Clinical trial NCT03147183: Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving Thymoglobulin
Official title: Kinetic Study of CD8+ CMV-specific Cellular Immunity in Renal Transplant Patients After Receiving Thymoglobulin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplant Infection
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 150
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: Patients who are candidates for renal transplant and who fulfil the clinical criteria established by the participating institutions to receive induction immunosuppressive therapy. Participating institutions may include centers from the Spanish Network for Research in Infectious Diseases (REIPI, Transplantation Program) as well as other centers outside the network.

Brief summary: Renal transplant candidates who have CMV-specific, CD8+ T-cells, are CMV-seropositive and carry HLA-A1 and/ or HLA- A2 alleles have a high probability to maintain this type of immunity during the three first months after the transplant, despite induction immunosuppressive therapy (thymoglobulin).


Eligibility criteria: Inclusion Criteria:

1. Renal transplant recipients with CMV-positive serology.
2. Patients with pre-transplant, CMV-specific CD8+ T cell-mediated immunity, i.e. IFNγ levels ≥0.2 UI/mL (QF-CMV Reactive).
3. Adults over 18 years of age.
4. Patients receiving induction therapy with thymoglobulin (at least a cumulative dosage of 1mg/kg).
5. Patients receiving prophylaxis with valganciclovir (900 mg/day, adjusted to kidney function) until day 90 after transplant.
6. Patients who signed an informed consent

Exclusion Criteria:

1. Multivisceral transplantation, including pancreas-kidney transplantation.
2. HIV infected patients.
3. Patients who cannot comply with the monitoring protocol.

Primary outcomes:
measure: CMV-specific, CD8+ T-cell immunity
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hosìtal Universitario Reina Sofia
Study officials:
References:
Clinical trial NCT01731483: Coagulation and Fibrinolysis as Virulence Factors for Invasive Staphylococcus Aureus and Streptococcus Infections
Official title: Coagulation and Fibrinolysis as Virulence Factors for Invasive Staphylococcus Aureus and Streptococcus Infections.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infective Endocarditis
Necrotizing Fasciitis
Keywords: virulence factors
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Material will be collected from all patients that undergo surgical treatment for invasive streptococcal or staphylococcal infections, including acute infective endocarditis and necrotizing fasciitis, from the UZ Leuven University Hospital

Brief summary: the aim of this study is to investigate the role of staphylokinase, streptokinase and MMP activation in invasive staphylococcal and streptococcal infections.


Eligibility criteria: Inclusion Criteria:

* all patients that undergo surgical treatment for invasive streptococcal or staphylococcal infections, including acute infective endocarditis and necrotizing fasciitis, from the UZ Leuven University Hospital

Exclusion Criteria:

* none

Primary outcomes:
measure: proteolytic activity
timeFrame: 1 day (on date of surgery (tissue sample))
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven University Hospital
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Peter Verhamme, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00159783: 40 Week Extension Study Of Asenapine and Olanzapine For Bipolar Disorder (A7501007)(COMPLETED)(P05857)
Official title: A Double-Blind, 40-Week Continuation Study Evaluating the Safety of Asenapine and Olanzapine in the Treatment of Subjects With Acute Mania Clinical Trial Protocol A7501007 (Secondary Title: ARES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2005-09-12
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.


Eligibility criteria: Inclusion Criteria:

* Have completed asenapine 3-week and 9 -week studies for the treatment of an acute manic or mixed episode and not had any major protocol violations..

Exclusion Criteria:

* Patients with unstable medical conditions or clinically significant laboratory

abnormalities.

Primary outcomes:
measure: Participants Who Experienced Adverse Event(s)
timeFrame: Up to 40 weeks
measure: Number of Participants With Abnormal Physical Examination Findings
timeFrame: Week 40 or endpoint
measure: Number of Participants With Abnormal Electrocardiogram
timeFrame: Week 40 or endpoint
measure: Body Weight
timeFrame: Baseline to Week 40 or endpoint
measure: Extrapyramidal Symptoms [EPS]
timeFrame: Week 40 or endpoint
measure: Concomitant Medications
timeFrame: Up to 40 weeks
measure: Abdominal Girth
timeFrame: Baseline to Week 40 or endpoint
measure: Number of Participants With Markedly Abnormal Vital Sign Changes
timeFrame: Post-baseline (at Week 4, 12, 20, 28, and 40 or endpoint)
measure: Number of Participants With Laboratory Values Outside Normal Range
timeFrame: Week 40 or endpoint
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: McIntyre RS, Cohen M, Zhao J, Alphs L, Macek TA, Panagides J. Asenapine for long-term treatment of bipolar disorder: a double-blind 40-week extension study. J Affect Disord. 2010 Nov;126(3):358-65. doi: 10.1016/j.jad.2010.04.005.
Clinical trial NCT00485797: Effects of Ritalin on Postural Stability of Hyper Active Children
Official title: Effects of Methylphenidate on Postural Stability of Children Suffer From Attention Deficit Hyperactivity Disorder (ADHD) Under Single and Dual Task Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: attention deficit hyperactivity disorder (ADHD)
Dual tasking
Postural Control
Methylphenidate (Ritalin)
The focus of the study is To explore the effects of Ritalin on postural control in ADHD Children, during single and dual task conditions.
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2007-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Experimental design overview The proposed project is a prospective experimental study design. Children (age \<15) suffer from attention deficit hyperactivity disorder (ADHD) that their Parents willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 1 hour after taking of Methylphenidate (Ritalin) in the movement and Rehabilitation Laboratory at BGU. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). For each of the conditions (before and 1 hour after the use of Ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just Listening to a relaxing music. Participants will be required to stand on the platform 10 times for 30 s. For each trial, they will be instructed to sway as little as possible.


Eligibility criteria: Inclusion Criteria:

* Age 6-12 years old
* Diagnosed as ADHD childrens by a neurologist
* Taking methylphenidate (Ritalin)

Exclusion Criteria:

* Children who suffer from CP, or other neurological disease
* Children who suffer from psychiatric state
* Children who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)

Primary outcomes:
measure: Postural sway measures
timeFrame: Time 1: pre test' and hour later time 2: post testinng proceedure
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: SorokaUMC
Study officials:
affiliation: Ben-gurion University of the Negev, Beer-Sheva, Israel
name: Itshak Melzer, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka Medical Centar
name: Zmir Shorer, Dr
role: STUDY_CHAIR
affiliation: Soroka University Medical Center
name: Press Yossi, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT04387097: Drip-infusion of Remifentanil for RIH
Official title: Postoperative Drip-infusion of Remifentanil for Preventing Remifentanil-induced Hyperalgesia- a Retrospective Observative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperalgesia
Keywords: Remifentanil
Hyperalgesia
Drip-infusion
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 559
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients receiving surgery with age between 20-80 years

Brief summary: The development of remifentanil-induced hyperalgesia (RIH) is an unpleasant experience for surgical patients. An alternative management, gradual withdrawal of remifentanil was effective in prevention of RIH. The investigators designed a simple modality to assess if under withdrawal of remifentanil and further drip-infusion of remifentanil immediately after extubation affected postoperative pain score, the requirement of rescue analgesics, and adverse effects.

Detailed description: In clinical practice, the gradual withdrawal of remifentanil during surgery is unsatisfied. Thus, the investigators conducted a simple modality in a single center retrospective cohort study to assess how under baseline gradual withdrawal of remifentanil and further drip infusion of remifentanil immediately after extubation affected postoperative pain score and use of analgesics.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) score of I-III patients receiving total intravenous anesthesia

Exclusion Criteria:

* The use of inhalation agents or propofol combined with inhalation anesthesia
* Pregnancy
* Previous substance abuse
* Known allergies to opioids, propofol or any drugs used in the study
* History of neuropsychiatric disorder
* Age \< 20 years or \> 80 years

Primary outcomes:
measure: comparison of the numeric rating scale (NRS) between 2 groups
timeFrame: one hour
measure: requirement for rescue analgesics
timeFrame: one hour
Secondary outcomes:
measure: type of surgery
timeFrame: three hours
measure: surgical site
timeFrame: three hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: TriService General Hospital
Study officials:
affiliation: Tri-Service General Hospital and National Defense Medical Center
name: Yi-hsuan Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Comelon M, Raeder J, Stubhaug A, Nielsen CS, Draegni T, Lenz H. Gradual withdrawal of remifentanil infusion may prevent opioid-induced hyperalgesia. Br J Anaesth. 2016 Apr;116(4):524-30. doi: 10.1093/bja/aev547. Epub 2016 Mar 1.
citation: Saxena S, Gonsette K, Terram W, Huybrechts I, Nahrwold DA, Cappello M, Barvais L, Engelman E. Gradual withdrawal of remifentanil delays initial post-operative analgesic demand after thyroid surgery; double-blinded, randomized controlled trial. BMC Anesthesiol. 2019 Apr 25;19(1):60. doi: 10.1186/s12871-019-0731-9.
Clinical trial NCT06088797: Exploration of the Role of Vision on Spatial Cognition
Official title: Exploration of the Role of Vision on Spatial Cognition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Visual Deficiencies
Keywords: spatial cognition
arithmetic
visual deficiency
blind
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participant with Visual Deficiencies monitored in the " Centre Technique Régional pour la Déficience Visuelle" or at the " école spécialisée pour déficients visuels "

Brief summary: Atypical developpement of spatial cognition has been shown in congenital bindness with some consequences on mathematic learning (Cattaneo et al., 2010) as well as on the mental representation of spatial maps (Thinus-Blanc \& Gaunet, 1997). This raises the issue of the role of vision in spatial abilities underlying mathematics and locomotion. These difficulties could also be found in case of partial visual deficiency, like very low visual acuity or large peripheral shrinkage of the visual field.


Eligibility criteria: Inclusion Criteria:

For all :

* Aged 12 to 25
* Participant not opposed to the research and parents do not oppose participation in the protocol for minors

For healthy volunteers (normal sighted):

- with typical visual development with correction if needed

For participant with Visual Deficiencies:

* with congenital blindness
* or low visual acuity (between 1/10 and 3/10)
* or with visual field peripheral shrinkage (angle \<20°).

Exclusion Criteria:

* General knowledge and working memory skills with a standard score of less than 4
* neurological medical history
* Person deprived of liberty by judicial or administrative decision
* Person subject to a legal protection measure (tutorship, curatorship)

Primary outcomes:
measure: percentage of correct responses
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Equipe Trajectoire du CRNL : INSERM U1028, CNRS UMR 5292
Study officials:
affiliation: Equipe Trajectoire du CRNL : INSERM U1028, CNRS UMR 5292)
name: Laure PISELLA, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02099097: Quit IT: Preliminary Testing of a Web-based, 3D Coping Skills Game to Increase Quitting Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
Official title: Quit IT: Preliminary Testing of a Web-based, 3D Coping Skills Game to Increase Quitting Self-Efficacy for Maintaining Smoking Abstinence Following Hospitalization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: 3D Coping Skills Game
Quit smoking
14-062
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: New York University
name: Muzzy Lane Software
First posted: 2014-03-28
Enrollment: 50
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: The purpose of this study is to develop and test a web-based game called Quit It that is designed to help smokers who have quit smoking cope with any smoking urges they may have. The purpose of the game is to help people quit and stop people from smoking again.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* English-speaking
* Cancer (solid tumor) diagnosis or mass suspicious of cancer within past six months as per clinical judgment
* Cancer treatment expected plan to include hospitalization for surgical treatment for at least 2 days at MSKCC as per the patients clinical team
* Referred to MSK's Tobacco Cessation Program
* Patient-reported cigarette use within the past 30 days
* Have sufficient sensory acuity (i.e., auditory, visual) and manual dexterity to use a computer game as per judgment of clinician or consenting professional
* Can be reached by telephone

Exclusion Criteria:

* Distant metastatic disease at the time of enrollment
* Major psychiatric illness or cognitive impairment that in the judgment of the investigator would preclude study participation
* Any patients who are unable to comply with the study procedures as determined by the study investigators

Primary outcomes:
measure: quitting smoking self-efficacy
timeFrame: 1 year
Secondary outcomes:
measure: efficacy of the game
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jamie Ostroff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06402097: TRIP-patch vs Duplex
Official title: 'Transdermal Rigidity Assessment Via Ischemia of the Penis (TRIP). A New Sensor-driven Device to Measure Maximal Rigidity.'
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Keywords: rigiscan
erectile dysfunction
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ED

Brief summary: To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis

Detailed description: To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis

Eligibility criteria: Inclusion Criteria:

* Indication for a penile duplex in our andrology clinic Signed informed consent Male Between 18-60 year

Exclusion Criteria:

* Patients who are unwilling to sign written informed consent
* Patients unable to undergo a duplex of the penis
* Patients with sickle cell anemia because this could affect the accuracy of the measurements

Primary outcomes:
measure: change in sensor-readings
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
Study officials:
References: