louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00632450: EnSite Real-Time Cardiac Performance Measurements (RT CPM) Study
Official title: EnSite Real-Time Cardiac Performance Measurements Study, a Non-significant Risk Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients indicated for implantation of a CRT pulse generator

Brief summary: The EnSite Real-Time Cardiac Performance Measurements Study (EnSite RT CPM) is a multicenter, international, acute, non-significant risk study, designed to enroll a maximum of 40 patient. The goal of the study is to collect 3-D systolic/diastolic data with the EnSite NavX Mapping system during a CRT implant.

Patients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite NavX Mapping system during the implantation of a cardiac resynchronization therapy device.


Eligibility criteria: Inclusion Criteria:

* Be undergoing a new St. Jude Medical CRT-D or CRT-P device implantation
* Have the ability to provide informed consent for study participation and be willing to comply with the prescribed perioperative evaluations

Exclusion Criteria:

* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures
* Be less than 18 years of age
* Be pregnant women
* Be currently participating in a clinical study that includes an active treatment arm

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: St. Jude Medical
state: California
Study officials:
affiliation: Kerckhoff Klinik GmbH
name: Johannes Sperzel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Andre d'Avila, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arrhythmia Center of Southern Wisconsin, Ltd
name: Imran Niazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sperzel J, Brandt R, Hou W, Doelger A, Zdarek J, Rosenberg SP, Ryu K, Koh S, Yang M. Intraoperative characterization of interventricular mechanical dyssynchrony using electroanatomic mapping system--a feasibility study. J Interv Card Electrophysiol. 2012 Nov;35(2):189-96. doi: 10.1007/s10840-012-9695-0. Epub 2012 Jun 14.
Clinical trial NCT00895050: Study Evaluating Impact of the Use of a Computer-based Tool on the Clinical Management of RA Patients
Official title: Impact of the Use of a Computer-based Tools on the Clinical Management and Evolution of Patients With Rheumatoid Arthritis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 321
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 with RA treated in rheumatology offices

Brief summary: The primary purpose of this study is to evaluate a computer-based tool on the clinical management of patients with rheumatoid arthritis in Spain.


Eligibility criteria: Inclusion Criteria:

Main Inclusion Criteria:

* Patients, male or female, over 18 years old.
* Patients diagnosed with RA according to investigator criteria
* Patients with a disease evolution \>= 1 year
* Patients with \> = 5 affected joints

Exclusion Criteria:

Exclusion Criteria:

* Patients with other muscle skeletal, rheumatic and/or degenerative diseases different from RA.
* Patients who are taking part or have taken part in a clinical trial or in a study with drugs within the last 12 months. Any condition that, in the investigator's judgment would interfere with the subject's ability to comply with protocol requirements or give informed consent.

Primary outcomes:
measure: Global mean DAS28 at 6 and at 12 months of follow-up. Differences between global mean DAS28 at 6 and at 12 months compared to baseline
timeFrame: 12 months
Secondary outcomes:
measure: Disease activity (DAS28; number affected joints; CRP; ESR; PGA).-Number of variables used in patient's follow-up; number of treatment adjustments. -Investigator's satisfaction with the computer-based tool (specific questionnaire)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06059950: Feasibility of the Mindfulness Flow Program (MFP) on Archers
Official title: Examining the Feasibility of the Mindfulness Flow Program (MFP) on Archers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletes
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 12
Sex: ALL
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mindfulness-based interventions have gained popularity among elite athletes, but their effectiveness for enhancing archery performance remains inconsistent. This study examined the feasibility of a 12-week mindfulness flow program (MFP) specifically designed for archers, and assessed the effect of the MFP on shooting performance. The intervention aims to enhance shooting performance, mindfulness, and the flow state, while reducing post-intervention anxiety.

Detailed description: The primary goal of the present study was to test the feasibility of a prototype mindfulness flow program (MFP), with 11 sessions conducted via Zoom video meeting and one in-person session of sport-specific session. Additionally, the program seeks to examine the psychological outcomes associated with the intervention specifically among archery athletes. It is anticipated that the experimental group will show reduced anxiety levels and increased levels of mindfulness and flow when comparing their baseline and post-intervention assessments. This study explores the potential of delivering mindfulness programs conveniently to sport populations via the internet, supplemented by one face-to-face sport-specific session to enhance mindfulness and improve sports performance among athletes.

Eligibility criteria: Inclusion Criteria:

* at least one year of archery training experience and training for at least two hours per week

Exclusion Criteria:

* Participants who had previously participated in a mindfulness session were excluded

Primary outcomes:
measure: Feasibility of the Mindfulness Flow Program (MFP)
timeFrame: up to two weeks
Secondary outcomes:
measure: Shooting scores
timeFrame: up to 20 weeks
measure: Cognitive State Anxiety
timeFrame: up to 20 weeks
measure: Somatic State Anxiety
timeFrame: up to 20 weeks
measure: Self-confidence
timeFrame: up to 20 weeks
measure: Mindfulness
timeFrame: up to 20 weeks
measure: Flow state
timeFrame: up to 20 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Lion Rock Archery Venue
Study officials:
affiliation: Hong Kong Metropolitan University
name: Mum Yee Tse, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01612650: Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
Official title: Assessment of Substitution of Focused Cliches and Ultrasound for Tomosynthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
2D Mammography
3D Mammography
Keywords: breast cancer
surveillance
diagnosis
2D mammography
3D mammography
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
First posted: 2012-06-06
Enrollment: 1069
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study aims to assess if using tomosynthesis for breast cancer surveillance will allow a significant decrease of ultrasound cliches (and radiation exposure)


Eligibility criteria: Inclusion Criteria:

* woman with breast cancer histologically proven (group 1), on surveillance of a treated breast cancer (group 2) or diagnosis of an detected anomaly
* age ≥ 40 years (group 1, group 2); age ≥ 50 years (group 3)
* breast size suitable for detector size
* possible prior mastectomy
* security social covered
* signed informed consent

Exclusion Criteria:

* breast implant
* high genetic risk (mutation)
* under justice measures
* breast feeding or pregnant woman

Primary outcomes:
measure: determine the benefit of tomosynthesis for diagnosis
timeFrame: 30 months
Secondary outcomes:
measure: determine best incidence of realization
timeFrame: 30 months
measure: measurement of breast irradiation
timeFrame: 30 months
measure: evaluate non focused ultrasound residual place for 2 - 3 - 4 density breast
timeFrame: 30 months
measure: number of additional cancer detected by tomosynthesis
timeFrame: 30 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Oscar Lambret Center
city: Roubaix
country: France
facility: Centre Hospitalier - Pavillon Paul Gelé
city: Valenciennes
country: France
facility: Centre Hospitalier
city: Valenciennes
country: France
facility: Clinique des Dentellières
Study officials:
affiliation: Oscar Lambret Center
name: Sophie TAIEB, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05493150: Antalgic Effects of Well-being Treatments in Cancer Care
Official title: Antalgic Effects of Well-being Treatments in Cancer Care; Foot Reflexology, Socio-aesthetics, Sophrology, Singing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Cancer Pain
Lead sponsor: Centre Hospitalier de Valence
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 180
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 treated for a cancer in CH Valence, agree to participate on one of the 4 Well being treatments: foot reflexology, socio-aesthetics, sophrology and singing

Brief summary: observational , Monocentric, study to assess antalgic effects of well-being treatment in cancer care.

Detailed description: Contrary to supportive care, well-being care is imperfectly assessed. Well being care (WBC) consist on complementary programs, with no real consensus. Very few studies have rigorously evaluated its benefits

The objective of this study was to evaluate the impact of four well-being treatments (foot reflexology, socio-aesthetics, Sophrology and singing) provided in a healthcare facility

Eligibility criteria: Inclusion Criteria:

* all type of cancer treated at the general Hospital of Valence
* patient agree to participate on Well being session: foot reflexology, socio-aesthetics, Sophrology and singing
* Age ≥ 18 years
* Affiliation to a Social security system
* Patient who has given written consent signed before any specific procedure of the protocol

Exclusion Criteria:

* Patient under guardianship, deprived of liberty, safeguard of justice
* Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the scale (at the discretion of the investigator)
* Refusal to participate in research

Primary outcomes:
measure: Pain assesment
timeFrame: 1 immediately before well being treatment
measure: Pain assesment
timeFrame: 1 immediately after well being treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Valence
country: France
facility: Ch Valence
state: Drome
Study officials:
References:
Clinical trial NCT01430650: Endometrial Priming for Embryo Transfer
Official title: A Randomised Control Trial to Evaluate Efficacy and Safety of Two Different Protocols of Endometrial Priming for Embryo Transfer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sterility
Keywords: Oral estrogens
transdermal estrogens
endometrial priming
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is compare two different endometrial priming protocols

* women that receive oral estrogens
* women that receive transdermal estrogens


Eligibility criteria: Inclusion Criteria:

* Women between 18-50 years old with desire of children and needs of embryo transfer.
* Plasma prolactin less than 30.
* Uterine cavity that allow pregnancy, body mass index between 20-30.
* And signed consent inform.

Exclusion Criteria:

* History of estrogen dependent cancer, unknown origin vaginal bleeding.
* Ovarian cyst.
* Contraindications to be pregnant.
* Estrogen allergy.

Primary outcomes:
measure: Difference between day means in endometrial priming to achieve 7 mm.
timeFrame: 11-16 days
Secondary outcomes:
measure: Biochemical Pregnancy rate
timeFrame: 26-30 days
measure: The patient's adherence to the recommended treatment.
timeFrame: 1-16 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
References:
Clinical trial NCT00566150: Levetiracetam in the Management of Bipolar Depression
Official title: Levetiracetam in the Management of Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Depression
Keywords: Keppra
Levetiracetam
Anticonvulsant
Depression
Bipolar Disorder
Affective Disorders
Mood Disorders
Double Blind
Acute Antidepressant Effects
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2007-12-03
Enrollment: 35
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: A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the effects of levetiracetam on depressive symptoms in bipolar depressed patients.


Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis of bipolar disorder
* Presence of a current major depressive episode on the SCID
* Score of 17 or great on the HDRS
* Capable of giving voluntary written consent

Exclusion Criteria:

* Significant current substance dependence/abuse within 3 months preceding the trial
* Active suicidal ideation
* Pregnant/lactating mothers
* Significant medical history

Primary outcomes:
measure: Change in Hamilton Depression Rating Scale (HDRS-21) Total Score From Baseline at Week 6.
timeFrame: Baseline to week 6
Secondary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From Baseline at Week 6.
timeFrame: Baseline to week 6
measure: Number of Subjects Who Achieve Remission.
timeFrame: Week 6
measure: Change in Clinical Global Impressions Scale for Bipolar Disorder (CGI-BP) Depression Severity Rating From Baseline at Week 6.
timeFrame: Baseline to week 6
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Zubin Bhagwagar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muralidharan A, Bhagwagar Z. Potential of levetiracetam in mood disorders: a preliminary review. CNS Drugs. 2006;20(12):969-79. doi: 10.2165/00023210-200620120-00002.
citation: Saricicek A, Maloney K, Muralidharan A, Ruf B, Blumberg HP, Sanacora G, Lorberg B, Pittman B, Bhagwagar Z. Levetiracetam in the management of bipolar depression: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):744-50. doi: 10.4088/JCP.09m05659gre. Epub 2010 Oct 19.
Clinical trial NCT01690650: Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter
Official title: Oxygenation of the Neonatal Brain - a Study Using the INVOS Oximeter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Response to Hyperoxia
Keywords: Preterm
Newborn
Neonate
Cerebral oxygenation
Oxygen
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: The Ludvig & Sara Elsass Foundation
First posted: 2012-09-24
Enrollment: 33
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: * Due to the increased risk of brain damage, continuous monitoring of the cerebral oxygenation is interesting. The investigators will evaluate the capability of the INVOS Oximeter to detect induced changes in the cerebral regional saturation.
* The purpose of the study is to investigate our hypothesis that cerebral vasoconstriction after oxygen exposure is prolonged in preterm infants compared to term infants.

Detailed description: Preterm infants are at increased risk of brain damage compared with term infants, and cerebral hypoxia is considered to have an important role. The preterm infants are at increased risk of respiratory distress, episodes with low oxygenation, mechanical ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of interest, since high levels of oxygen can cause vasoconstriction.

The investigators will examine the normal physiological cerebral response to exposure of oxygen in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group of term infants.

The investigators will do dynamic research with continuously monitoring of the cerebral oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)). Reproducibility is examined by repeated measurements.

There will be no follow-up.

Eligibility criteria: Inclusion Criteria:

* Newborns with a gestational age of 32-40 weeks
* Clinically stable
* +/- CPAP with a oxygen limit below 30%
* Parental consent

Exclusion Criteria:

* Severe birth asphyxia
* Prohibition of oxygen exposure

Primary outcomes:
measure: Changes from baseline of cerebral oxygen saturation after oxygen exposure.
timeFrame: Measurements will take between 30 minutes and 3 hours depending of situation. Measurements within the first 4 weeks of life. No follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Department of Paediatrics, Copenhagen University Hospital; Hvidovre
Study officials:
affiliation: Department of Paediatrics, Copenhagen University Hospital, Hvidovre
name: Ole Pryds, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00281450: An Intervention to Reduce Inappropriate Prescriptions for Elderly Patients in General Practice
Official title: A Cluster Randomized Educational Intervention to Reduce Inappropriate Prescription Patterns for Elderly Patients in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Aged
Family Practice
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2006-01-24
Enrollment: 85836
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will explore the possible effect of a tailored educational intervention towards general practitioners, in order to reduce inappropriate prescription patterns for elderly patients \> 70 years.


Eligibility criteria: Inclusion Criteria:

* General practitioner
* Specialist in general practice

Primary outcomes:
measure: Changes in a set of predefined quality indicators measuring appropriateness of prescriptions for elderly out-patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Oslo
name: Sture Rognstad, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Straand J, Fetveit A, Rognstad S, Gjelstad S, Brekke M, Dalen I. A cluster-randomized educational intervention to reduce inappropriate prescription patterns for elderly patients in general practice--The Prescription Peer Academic Detailing (Rx-PAD) study [NCT00281450]. BMC Health Serv Res. 2006 Jun 11;6:72. doi: 10.1186/1472-6963-6-72.
Clinical trial NCT01568450: A Open-label, Single-dose Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
Official title: A Randomized, Open-label, Single-dose, Crossover Study to Investigate The Pharmacokinetics Between a GL2907 XL and Oxycontin CR Tab. 10mg in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Oxycodone, controlled release formulation
Lead sponsor: GL Pharm Tech Corporation
Sponsor class: INDUSTRY
First posted: 2012-04-02
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this clinical trial is to compare the pharmacokinetic characteristics of GL2907 XL 20mg tablet and Oxycontin CR 10mg tablet.

GL2907 XL 20mg tablet is controlled released formulation which is made by GL Pharm Tech.


Eligibility criteria: Inclusion Criteria:

* 20\~45 years old, Healthy Adult Male Subject
* ≥ 50kg(Body Weight) and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

* ALT or AST \> 1.25(Upper Normal Range)
* Total Bilirubin \> 1.5 (Upper Normal Range)
* BUN or Creatinine \> Normal Range
* Systolic BP \> 160mmHg or \< 80mmHg, Diastolic BP \> 100mmHg or \< 50mmHg

Primary outcomes:
measure: Cmax
timeFrame: 48hr
measure: AUC(0-24h)
timeFrame: 24 hr
Secondary outcomes:
measure: Tmax
timeFrame: 48 hr
measure: t1/2
timeFrame: 48 hr
measure: Vz/F
timeFrame: 48 hr
measure: CL/F
timeFrame: 48 hr
measure: Safety Monitoring
timeFrame: 27 days
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: AJOU University Hospital
state: Gyeonggido
Study officials:
affiliation: Ajou University School of Medicine
name: Doo-Yeoun Cho, MD
role: PRINCIPAL_INVESTIGATOR
References: