louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04438668: Evaluation of the Safety and Performance of Centaflow
Official title: Evaluation of the Safety and Performance of Centaflow as a Routine Assessment of Placental Vascular Function and Foetal Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Growth Restriction
Lead sponsor: Centaflow
Sponsor class: INDUSTRY
Collaborators: name: Rigshospitalet, Denmark
name: Viborg Regional Hospital
First posted: 2020-06-19
Enrollment: 1704
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Controlled Trial
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the safety and performance of an acoustic approach based on skin-contact microphones as a routine assessment of placental vascular function as predictor of fetal growth restriction.

Detailed description: Evaluation of the safety and performance of Centaflow as routine antenatal assessment of placental vascular function as predictor of fetal growth restriction is performed by randomizing singleton pregnant women with ultrasound-based gestations for either standard care (SC) or SC and Centaflow (CF).

The subjects will be randomized in ratio 1:1 in both groups and examined in pregnancy weeks 27-29, 34-36 and 37-39.

Eligibility criteria: Inclusion Criteria

* Female subjects over the age of 18 years.
* Subejct is pregnant, carries only one fetus and has been pregnancy dated by ultrasound scan (Hadlock reference).

Exclusion Criteria

* Fetal abnormality known to affect growth, diagnosed in-utero or through 12 days postnatally.

Primary outcomes:
measure: Fetal Growth Restriction (FGR)
timeFrame: At birth
measure: Safety: occurrence of device-related adverse events
timeFrame: At gestational week 27-29
measure: Safety: occurrence of device-related adverse events
timeFrame: At gestational week 34-36
measure: Safety: occurrence of device-related adverse events
timeFrame: At gestational week 37-39
Secondary outcomes:
measure: Mode of delivery
timeFrame: At birth
measure: Neonatal Intensive Care Unit
timeFrame: At 12 days postpartum
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Juliane Marie Centeret, Rigshospitalet
city: Viborg
country: Denmark
facility: Obstetrical Department, Regional Hospital Viborg
Study officials:
affiliation: Viborg Regional Hospital
name: Richard Farlie, MD, MI, MHM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01609868: The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU
Official title: The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Problem With Growth of an Infant
Keywords: premature infant feeding protein
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Alegent Health Bergan Mercy Medical Center
First posted: 2012-06-01
Enrollment: 60
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators hypothesis that premature infants receiving a commercially available liquid protein modular will have improved growth when compared with premature infants receiving a commercially available powder protein modular.


Eligibility criteria: Inclusion Criteria:

* Infants less than 2000 gms at birth, receiving maternal breast milk

Exclusion Criteria:

* Infants receiving formula

Primary outcomes:
measure: Growth in premature infants (percentile ranking at 36 weeks CGA)
timeFrame: birth to 36 weeks
Secondary outcomes:
measure: GI tolerance
timeFrame: birth to 36 weeks
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Alegent Bergan Hospital
state: Nebraska
Study officials:
References:
Clinical trial NCT01732068: Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
Official title: Phase II Study for the Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Poor Ovarian Response
Keywords: Poor ovarian response
Poor ovarian responders
Bologna criteria for poor ovarian response
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to examine the level of ovarian response and the pregnancy rates among poor ovarian responders treated with a novel treatment protocol with 150μg corifollitropin alfa followed by 300IU hMG in a short GnRH agonist protocol.

Detailed description: Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after injection , a time interval which is significantly shorter as compared to treatment with rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration may result in a significantly higher exposure of the small antral follicles to constant high levels of FSH during the early follicular phase, securing not only the recruitment of the follicles, but also the continued growth.

In the current study the investigators examine whether administration of corifollitropin followed by 300IU hMG in a short GnRH agonist protocol may result in acceptable pregnancy rates in poor ovarian responders fulfilling the "Bologna criteria"

Eligibility criteria: Inclusion Criteria:

Patients should fulfill the "Bologna criteria" for poor ovarian response

At least two of the following three features must be present:

i. Advanced maternal age (≥40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (≤3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC \<7 follicles or AMH \<1.1 ng/ml).

Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT (ovarian reserve test).

Exclusion Criteria:

-

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 10 to 12 weeks of gestation
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: Day of oocyte retrieval
measure: Cycles with embryo transfer
timeFrame: Day of Embryo transfer
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Centre for Reproductive Medicine UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Nikolaos P Polyzos, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04454268: Intracranial Hydatid Cyst
Official title: Intracranial Hydatid Cyst: Series of 8 Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Neoplasm
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 8
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Central nervous system (CNS) hydatid cysts is a rare presentation of hydatid cyst, although may be the cause of intracranial space-occupying lesions in 4% in endemic countries. It affects mostly children. The diagnosis of CNS hydatid is still problematic in spite of the advancements in imaging techniques (CT or MRI). Extirpation of the intact cyst is the treatment of choice, resulting in most cases to a complete recovery.

Detailed description: Hydatid disease is a parasitic induced disease caused by either Echinococcus granulosus or Echinococcus multilocularis during the larval stage of these tapeworms. Hydatid cysts are endemic in many countries, such as Latin America (Argentina, Brazil, Chile, Peru, and Uruguay); followed by Europe (France, Italy, and Greece), the Middle East (Turkey, Lebanon, Syria, and Jordan), Southeast Asia (China, Iran, and India) and Africa (Tunisia and less commonly, Egypt)

Eligibility criteria: Inclusion Criteria:

* intracranial hydatid cyst

Exclusion Criteria:

* Arachnoid cysts
* conservative treatment

Primary outcomes:
measure: number of patients who haven total removal of intracranial cyst
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03943368: Using Virtual Reality (VR) Models for Robotic Prostatectomy
Official title: Using Virtual Reality (VR) Models for Robotic Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Ceevra, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-09
Enrollment: 92
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care.


Eligibility criteria: Inclusion Criteria:

* Patient is undergoing robotic prostatectomy being performed by participating surgeon
* Patient is willing to be randomized between intervention and control arms

Exclusion Criteria:

* Patients with prior pelvic radiation
* Patients with prior androgen deprivation therapy
* Patients with prior localized ablative therapy
* Patients with prior TURP or other surgical BPH treatment

Primary outcomes:
measure: Postoperative PSA
timeFrame: Up to 24 months
Secondary outcomes:
measure: Surgical Margin Status
timeFrame: Immediately postoperatively
measure: Androgen Deprivation or Radiation Therapy
timeFrame: Up to 24 months postoperatively
measure: Postoperative Erectile Function
timeFrame: Up to 24 months postoperatively
measure: Postoperative Urinary Function
timeFrame: Up to 24 months postoperatively
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Urology
state: California
city: Orange
country: United States
facility: UC Irvine
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: Seattle
country: United States
facility: Swedish Urology Group
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Swedish Medical Center
name: James Porter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Raymond Pak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UC Irvine
name: Thomas Ahlering, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UCLA Urology
name: Robert Reiter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mount Sinai Health System
name: Ketan Badani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shirk JD, Reiter R, Wallen EM, Pak R, Ahlering T, Badani KK, Porter JR. Effect of 3-Dimensional, Virtual Reality Models for Surgical Planning of Robotic Prostatectomy on Trifecta Outcomes: A Randomized Clinical Trial. J Urol. 2022 Sep;208(3):618-625. doi: 10.1097/JU.0000000000002719. Epub 2022 Jul 18.
Clinical trial NCT01118468: Systematic Assessment of Competitive Flow in Coronary Artery Bypass Grafts by Wave Intensity Analysis
Official title: Systematic Assessment of Competitive Flow in Coronary Artery Bypass Grafts by Wave Intensity Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Bypass
Keywords: Competitive Flow
Coronary artery bypass
Wave Intensity Analysis
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2010-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with previous bypass grafts undergoing angiography/ angioplasty who meet stduy criteria

Brief summary: Narrowing of the arteries that supply blood to the heart can lead to heart attacks and death. One way of treating this is to use artery and vein grafts from other parts of the body to bypass the narrowing. However, the blood flow from these grafts "competes" with flow through the natural coronary artery. This may contribute to grafts narrowing with time. This protocol aims to determine the pressure changes responsible for this effect. This could improve our understanding of why some grafts last longer than others.


Eligibility criteria: Inclusion Criteria:

* Patients with previous coronary artery bypass grafts undergoing coronary angiography and graft restudy

Exclusion Criteria:

* Patient's with cardiac pacemakers, valvular heart disease, and chronic renal failure
* Unable to consent
* Contraindications to adenosine
* Contraindications to cardiac MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College NHS Trust
Study officials:
affiliation: Imperial College London
name: Justin E Davies, MRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03134768: Effect of Birth on Immunological Parameters in Cord Blood
Official title: To Investigate the Immediate Effect of Birth on Immunological Parameters in Cord Blood, and Compare With Data of CS Born Infants Collected in the JULIUS SN Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immunologic Activity Alteration
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
First posted: 2017-05-01
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant mothers undergoing normal vaginal delivery

Brief summary: The purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood.

Detailed description: The main purpose of the study is to understand the immediate effect of birth on immunological parameters in vaginally born cord blood and also whether mode and duration of delivery has an influence on immune parameters in cord blood.

Eligibility criteria: Inclusion Criteria:

* Pregnant mothers undergoing normal vaginal delivery

Exclusion Criteria:

* Use of non-steroidal anti-inflammatory drugs (NSAIDs) 2 weeks prior to birth

  * Antenatal antibiotics treatment (2 weeks prior to birth)
  * Diabetes mellitus requiring insulin treatment during pregnancy
  * Uncontrollable Hyperthyroidism during pregnancy

Primary outcomes:
measure: Cytokines Profile in Cord Blood Plasma
timeFrame: 1 year
measure: Cord Blood Immunoglobulin Levels
timeFrame: 1 year
measure: Allergen Stimulated Cytokine Expression in the Supernatants of Cord Blood Mononuclear Cells (CBMC)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Danone Asia Pacific Holdings Ltd
name: Elena Sandalova, PhD
role: STUDY_CHAIR
affiliation: KK Hospital
name: Anne Goh, MD
role: STUDY_CHAIR
affiliation: KK Hospital
name: Mei Chin Chua, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00447668: Effect of Yoga Vs. Stretching on Chronic Back Pain
Official title: Effect of Yoga Vs. Stretching on Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Non-specific Low Back Pain
Keywords: Chronic Low Back Pain
Yoga
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2007-03-15
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effectiveness of yoga classes, exercise classes, and a self-care book in the management of pain and function for people with low back pain.It will also for physical, psychological and physiological factors associated with improvement in back pain.


Eligibility criteria: Inclusion Criteria:

* Group Health Cooperative enrollee
* Uncomplicated low back pain
* At least moderate pain levels

Exclusion Criteria:

* Sciatica persisting 3 or more months after physician visit
* History of cancer (other than nonmelanoma skin cancer)
* Severe disk problems
* Unstable medical conditions
* Back surgery within past 3 years
* Physically unable to do the yoga or exercise classes and homework
* Unable to attend classes
* Currently doing yoga
* Taken yoga or exercise class for back pain within past year
* Currently in litigation for back pain
* Seeking other treatment for back pain

Primary outcomes:
measure: Back-related function
timeFrame: 6 months
measure: Pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Karen J. Sherman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sherman KJ, Cherkin DC, Wellman RD, Cook AJ, Hawkes RJ, Delaney K, Deyo RA. A randomized trial comparing yoga, stretching, and a self-care book for chronic low back pain. Arch Intern Med. 2011 Dec 12;171(22):2019-26. doi: 10.1001/archinternmed.2011.524. Epub 2011 Oct 24.
citation: Sherman KJ, Cherkin DC, Cook AJ, Hawkes RJ, Deyo RA, Wellman R, Khalsa PS. Comparison of yoga versus stretching for chronic low back pain: protocol for the Yoga Exercise Self-care (YES) trial. Trials. 2010 Mar 31;11:36. doi: 10.1186/1745-6215-11-36.
Clinical trial NCT01579968: Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery
Official title: Non-Interventional Study of NovoSeven® Used in Patients With Haemophilia A and B With Inhibitors When Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Bleeding Disorder
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-04-18
Enrollment: 86
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with haemophilia A and B with inhibitors who received NovoSeven® (eptacog alpha) as treatment when undergoing the surgery

Brief summary: This study is conducted in Japan. The aim of this non-interventional study is to investigate the safety and effectiveness of treatment with eptacog alpha (NovoSeven®) when undergoing surgery under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with haemophilia A and B with inhibitors who received eptacog alpha (NovoSeven®) as treatment when undergoing surgery

Exclusion Criteria:

* Patients who was not deemed to be appropriate to the treatment of eptacog alpha (NovoSeven®)

Primary outcomes:
measure: Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed
timeFrame: Year 1
measure: Physician's assessment of the evaluation for efficacy: Amount of blood at surgery, condition of haemostasis after surgery or maintenance of cessation of bleed
timeFrame: Year 10
Secondary outcomes:
measure: Number of adverse events (AEs), including serious adverse events (SAEs)
timeFrame: Year 1, Year 10
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04103268: Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis
Official title: Neutrophil Phenotypic Profiling and Organ Injury Assessment in Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 72
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We will enroll pediatric patients with sepsis in an ICU at Boston Children's Hospital and patients without sepsis presenting for an elective surgical procedure at Boston Children's Hospital.

Brief summary: In this research study we want to learn more about the character of neutrophils that are present in the blood of children with sepsis. Sepsis is a severe type of infection, affecting various parts of the body. Neutrophils are a type of white blood cell that are part of the body's immune system. Even though neutrophils are important in getting rid of germs, they also may be harmful to parts of the body by causing injury in organs in patients with sepsis. Neutrophils can change their character in sepsis. Because of this, it is important for doctors to know what kind of neutrophils are in the blood of children with sepsis so that they can work to develop therapies to prevent these cells from being harmful.


Eligibility criteria: Inclusion criteria Patients will be eligible for enrollment as septic patients if they

* Are \< 18 years old
* Meet the definition of sepsis described in the study design section above. Patients will be eligible for enrollment as control patients if they
* Are \< 18 years old
* Are scheduled for an elective surgical procedure and need preoperative blood draw or will have an intravenous catheter placed for the purpose of their surgical procedure.

Exclusion criteria Patients will be ineligible for enrollment in either control or sepsis group if any of the followings is present or anticipated

* Congenital cardiac disease
* On chronic immunosuppressive drugs such as chronic corticosteroid use, or preexisting immunodeficiency diseases

Primary outcomes:
measure: neutrophil populations
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Koichi Yuki, MD
role: PRINCIPAL_INVESTIGATOR
References: