louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02850497: 6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Three New Generation Drug Eluting Stent
Official title: 6-month Intracoronary Optical Coherence Tomography (OCT) Evaluation of Endothelization and Malapposition of Three New Generation Drug Eluting Stent: CRE8, Biomatrix and Xience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Angina After Coronary Stent Placement
Keywords: optical coherence tomography
malapposition
endothelization
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Aim of this study is to compare at 6 months follow-up, endothelization and malapposition, evaluated by means of optical coherence tomography, in terms of number of struts not endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience.

Detailed description: This is a randomized study aimed at evaluating in 60 patients with either acute coronary syndromes or stable coronary artery disease submitted with PCI and stenting, endothelization and malapposition at 6 months follow-up (primary endpoint), evaluated by means of optical coherence tomography in terms of number of struts not re-endothelized or malapposed, after the implantation of three new generation stent: Cre8, Biomatrix and Xience. Further clinical follow-up will be performed to evaluate MACE at 12 months follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients with stable angina or acute coronary syndromes submitted to coronary angioplasty on a coronary with a vessel diameter \> 2,5 mm

Exclusion Criteria:

* Known allergy to antithrombotic drugs or to other components of the stent studied Planned surgery 6 months within angioplasty

Primary outcomes:
measure: stent struts coverage assessed by means of intracoronary optical coherence tomography
timeFrame: 6 months
Secondary outcomes:
measure: MACE (cardiovascular death, myocardial infarction, stroke and target vessel revascularization)
timeFrame: 12 months
measure: inducible ischemia at myocardial scintigraphy
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Careggi, Florence, Italy
name: Cristina Giglioli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giglioli C, Formentini C, Romano SM, Cecchi E, Baldereschi GJ, Landi D, Chiostri M, Prati F, Marchionni N. Vulnerable struts with CRE8, Biomatrix and Xience stents assessed with OCT and their correlation with clinical variables at 6-month follow-up: the CREBX-OCT study. Int J Cardiovasc Imaging. 2020 Feb;36(2):217-230. doi: 10.1007/s10554-019-01719-1. Epub 2019 Oct 30.
Clinical trial NCT02252497: Tranexamic Acid in Total Hip Arthroplasty.
Official title: Tranexamic Acid in Total Hip Arthroplasty: Single Preoperative Administration vs Perioperative Administration. A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Arthroplasty
Keywords: hip arthroplasty
Tranexamic acid
randomized control trial
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over height hours on blood loss.

Detailed description: The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over eight hours on blood loss. The efficacy of TXA on blood loss is greatly influenced by the timing of its administration relative to surgery. In total hip arthroplasty, TXA should be started before surgery. However the optimal duration of TXA administration in hip arthroplasty is unknown. Numerous studies have shown that a single preoperative administration of TXA is effective. Yet indirect comparisons indicate a higher efficacy of TXA started before surgery and followed with a continuous infusion or repeated boluses. Our hypothesis is that a single preoperative administration of TXA is not sufficient to maintain therapeutic concentrations of TXA in the postoperative period. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of TXA plasma concentration as a predictor of blood loss.

Eligibility criteria: Inclusion Criteria:

* Patient requiring hip arthroplasty in first line, except recent hip fracture (less than 3 months)
* Consent of the patient or a family member or the support person.

Exclusion Criteria:

* Contraindication to tranexamic acid.
* Contraindication to apixaban.
* Pregnancy.
* Patient receiving a curative anticoagulating treatment in the preoperative period.

Primary outcomes:
measure: Calculated volume of blood losses in the peroperative period.
timeFrame: between the beginning of surgery and the fifth day
Secondary outcomes:
measure: the patients' percentage that will receive the transfusion of at least one allogenic globular sediment
timeFrame: between D1 (day of surgery) and D5 (the fourth postoperative day)
measure: incidence of symptomatic thrombotic events and death
timeFrame: in 6 weeks
measure: tranexamic acid pharmacokinetic analyses
timeFrame: from the beginning of surgery up to 8 hours
Other outcomes:
Locations:
city: SAINT-ETIENNE cedex 2
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Paul ZUFFEREY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00524797: Profonycia - Honey for Improving Quality of Patient's Life Receiving Chemotherapy
Official title: Profonycia - Honey for Improving Quality of Patient's Life Receiving Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myelosuppression
Keywords: Myelosuppression,
chemotherapeutic agents,
leucopenia,
thrombocytopenia,
Profonycia
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2007-09-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Myelosuppression (bone marrow suppression) is the most important toxic side effect of the majority of chemotherapeutic agents and typically is the dose limiting factor. Death occurring after chemotherapy usually results either from infection related to drug induced leucopenia or from bleeding related to thrombocytopenia. Colony stimulating factors (CSFs) are widely used in the treatment of chemotherapy induced neutropenia. The same Erythropoetines are used in the treatment of chemotherapy induced anemia. Both treatments are expensive and have several side effects.

In our previous stud (1) we found a special kind of honey: Life-Mel Honey to reduce the incidence of chemotherapy induced pancytopenia and improving quality of life.

The aim of the recent planed study is to provide prophylactic and protective treatment against neutropenia reducing the need for secondary CSF administration in patients receiving chemotherapy along with a natural and non expensive honey: Profonycia.

This honey which is expressed in Kibutz Shamir in Upper Galliee seems promising and easy for administration: given 5 gr/day per os for 7 days from the administration of chemotherapy.


Eligibility criteria: Inclusion Criteria:

Patients 18 years old or elder receiving chemotherapy 1/2-3 weeks

Exclusion Criteria:

Patients below 18 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Oncology Unit, Ziv MC
city: Safed
country: Israel
facility: Oncology Unit
Study officials:
affiliation: Ziv MC
name: Zidan Jamal, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zidan J, Shetver L, Gershuny A, Abzah A, Tamam S, Stein M, Friedman E. Prevention of chemotherapy-induced neutropenia by special honey intake. Med Oncol. 2006;23(4):549-52. doi: 10.1385/MO:23:4:549.
Clinical trial NCT02430597: Irreversible Electroporation(IRE) For Unresectable Hilus Pulmonis Neoplasms
Official title: Irreversible Electroporation(IRE) For Unresectable Hilus Plumonis Neoplasms: Phase I and Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hilus Pulmonary Neoplasms
Keywords: irreversible electroporation
Hilus Pulmonary Neoplasms
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for Hilus Pumonis Neoplasms.

Detailed description: By enrolling patients with unresectable Head and Hilus Pulmonis adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Hilus Pulmonis Neoplasms.

Eligibility criteria: Inclusion Criteria:

* Hilus Pumonis Neoplasms diagnosed by positive biopsy or non-invasive criteria,
* Not suitable for surgical resection,
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 6 month
Secondary outcomes:
measure: Percentage of lesions that show no sign of recurrence 12 months after IRE
timeFrame: 12 months
measure: A minimum and maximum range of voltage for safe and effective IRE
timeFrame: 3 months
measure: Progress free disease (PFS)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Biological treatment center in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Niu, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06650397: Guatemala Biofortified Maize Study
Official title: Absorption of Zinc and Iron from Nixtamalized Biofortified Maize in School-aged Children in Guatemala
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Zinc Absorption
Iron Absorption
Keywords: biofortification
stable isotope
maize
Guatemala
school-aged children
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Institute of Nutrition of Central America and Panama
name: Semilla Nueva
First posted: 2024-10-21
Enrollment: 56
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Zinc (Zn) and iron (Fe) deficiencies are common in Guatemala, and maize is a staple food throughout the country. The primary aim of this study is to demonstrate if utilizing nixtamalized biofortified maize has the potential to increase dietary Zn and Fe intake and improve the amount of Zn and Fe absorbed when compared to diets incorporating traditional maize (control). This is a randomized, double blinded, comparison study of biofortified vs control maize prepared as tortillas from nixtamalized masa. This study will enroll up to 56 school aged children (10-14 yrs old) living in agricultural communities in the Western Highlands of Guatemala (28/group x 2 groups). Researchers will utilize Zn and Fe stable isotopes to measure total absorbed Zn and Fe. Participants will be active in the study for 27 days. During this time, they will have anthropometric measurements taken and collect 2 blood samples, 1 stool sample, and 9 urine samples.


Eligibility criteria: Inclusion criteria:

* 10-14 years old school children (male and female sex)
* BMI between10-85%tile
* Typically eat homemade tortillas at each meal every day

Exclusion criteria:

* Taking iron or zinc supplements
* Hemoglobin less than 12.9 g/dl for children 10-11 yrs old and less than13.4 g/dl for children 12-14 yrs old (Per the WHO's 2024 publication hemoglobin cut-offs for identifying anemia are 5-11 yrs: less than 11.5 g/dl; 12-14 yrs: less than 12.0 g/dl. To adjust for the elevation of Tecpán at 2254 m, 1.4 g/dl is added to the cut-off point.)
* Girls who are having a menstrual period during the metabolic studies

Primary outcomes:
measure: Total absorbed iron (TAI) (mg)
timeFrame: 2 days
measure: Total absorbed zinc (TAZ) (mg)
timeFrame: 1 day
Secondary outcomes:
measure: Plasma C-reactive protein (CRP) (mg/dL)
timeFrame: 1 day
measure: Plasma zinc concentration (mcg/dL)
timeFrame: 1 day
measure: Plasma Alpha(1)-acid glycoprotein (AGP) (mg/dL)
timeFrame: 1 day
Other outcomes:
Locations:
city: Guatemala City
country: Guatemala
facility: Institute of Nutrition of Central America and Panama
Study officials:
affiliation: University of Colorado, Denver
name: Nancy F Krebs, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04556097: Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management
Official title: Implementation of the Care Ecosystem Training Model for Individuals With Dementia in a High-risk, Integrated Care Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 524
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There is growing need for to provide high quality care for persons living with dementia (PLWD) and provide support for care partners in the primary care setting. The Care Ecosystem model is a telephone-based dementia care program that provides standardized, proactive, personalized, and scalable support and education for care partners. The Care Ecosystem model has demonstrated an improvement in patient quality of life, reduced unnecessary healthcare expenditures, and a decrease in care partner burden and depression.

In this pilot the investigators will assess the feasibility of implementing and measuring outcomes of an adapted Care Ecosystem training model for primary care nurse managers serving a diverse panel of PLWD and their care partners in primary care practices participating in the Mass General Brigham healthcare system's Integrated Care Management Program in Boston, MA. The study team will leverage the Mass General Brigham electronic medical record to determine the feasibility of collecting the primary clinical outcome defined as emergency department visits among the PLWD cared for by the primary care practices. The investigative team will also assess the feasibility of implementation, number of contacts between nurse care managers and care partners, and documented advance care planning.


Eligibility criteria: Inclusion Criteria:

* Medicare beneficiary aligned to the Partners Medicare ACO
* ICD-10 diagnosis code consistent with dementia in Medicare claims between August 1, 2019 and July 31, 2020 (excluding diagnoses for diagnostic testing services)
* Actively engaged in care management services with a nurse care manager enrolled in the study

Exclusion Criteria:

- Permanent resident of long-term care or deceased at the start of the study

Primary outcomes:
measure: Emergency department visits
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Somerville
country: United States
facility: Mass General Brigham
state: Massachusetts
Study officials:
References:
Clinical trial NCT01413997: Connective Tissue Motion Measure
Official title: Feasibility Study of Connective Tissue Motion Measure - a Biomarker for Perimuscular Connective Tissue Pathology.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Stromatec, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2011-08-10
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure (CTMM) -quantifying the functional behavior of perimuscular connective tissues.

Detailed description: The differential motion between specific connective tissue strata will be measured during tissue displacement (linear oscillation) initiated by a computer-controlled needle stimulus tool (NST). The CTMM will be suitable as an outcome measure for mechanistic and clinical studies of CAM interventions. The CTMM also will potentially serve as a clinical diagnostic and treatment-monitoring tool for manual therapists, acupuncturists, and CAM clinicians interested in assessing the functional status of a patient's connective tissue.

Eligibility criteria: Inclusion criteria for LBP subjects:

* history of recurrent or chronic LBP for a minimum of 12 months
* ability to stand and walk without assistance
* ability to understand and read English
* ability to understand and sign a consent form

Inclusion criteria for No-LBP subjects:

* no history of low back pain or any other chronic pain that has limited activities of daily living or work
* a numerical current pain index of less than 0.5.

Exclusion Criteria for all subjects:

* previous severe back or low extremity injury or surgery
* major structural spinal deformity (scoliosis, kyphosis, stenosis)
* ankylosing spondylitis or rheumatoid arthritis
* neurological deficit (weakness and/or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica)
* neurological or major psychiatric disorder
* bleeding disorders
* corticosteroid or anticoagulant medication
* pregnancy
* worker's compensation or disability case
* in litigation for the LBP problem
* acute systemic infection
* BMI less than 21 or greater than 35

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Stromatec, Inc.
state: Vermont
Study officials:
References:
Clinical trial NCT03113097: Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?
Official title: Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Dar El Teb Institute
First posted: 2017-04-13
Enrollment: 627
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women planned to undergo blastocyst-stage embryo transfer after IVF/ICSI were randomized into 2 groups:

* group I: women who had only good-quality embryo transfer.
* group II: women who had both good-quality and poor-quality embryo transfer.

primary outcome was ongoing clinical pregnancy rate


Eligibility criteria: Inclusion Criteria:

* women undergoing primary IVF/ICSI cycles for tubal factor/unexplained infertility and had blastocyst-stage ET

Exclusion Criteria:

* cleavage-stage ET.
* women who had no good-quality embryos to transfer
* women who had known poor endometrial receptivity

Primary outcomes:
measure: Ongoing clinical pregnancy rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Biochemical pregnancy rate
timeFrame: 2 weeks after ET
measure: Clinical pregnancy rate
timeFrame: 4 weeks after ET
measure: Multiple pregnancy rate
timeFrame: 4-6 weeks after ET
measure: Ectopic pregnancy rate
timeFrame: 6 weeks after ET
Other outcomes:
Locations:
Study officials:
affiliation: Dar El Teb IVF and Infertility Center
name: Mohammed Faris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04487197: SARS-CoV2 (COVID-19) Seroepidemiological Transplanted Subjects (Kidney, Kidney-pancreas, Pancreas, Langerhans Islets)
Official title: SARS-CoV2 (COVID-19) Seroepidemiological Investigation in Transplanted Population Subjects of Kidney, Kidney-pancreas, Isolated Pancreas, Langerhans Islets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Pancreatic Transplat
Pancreatic Islets Langerhans
Keywords: COVID-19 infection
Transplanted patients
kidney transplants
pancreas transplants
pancreatic islet transplantation
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Transplanted Kidney, Pancreas or Pancreatic Islet patients

Brief summary: Evaluate SARS-CoV2 infection and the degree of immunity possibly developed in transplanted population using the Luciferase Immuno Precipitation System (LIPS) test.


Eligibility criteria: Inclusion Criteria Cohort 1:

* Adult patients (age ≥ 18 years),
* Kidney or pancreas or pancreatic islets transplantation
* Transplanted patients (period: 01.01.2020 to 30.06.2020)
* Informed Consent signed

Inclusion Criteria Cohort 2:

* Adult patients (age ≥ 18 years),
* Kidney or pancreas or pancreatic islets transplantation
* transplanted patients in follow-up since 01.01.2020 or trasplanted patients after 30.06.2020.
* Informed Consent signed

Exclusion Criteria both Cohort (1\&2):

Symptomatology such as fever\> 37.5, and / or cough and / or respiratory distress and / or diarrhea / vomiting in 14 days prior to collection of blood sample

Primary outcomes:
measure: Serum-prevalence of COVID-19 TX
timeFrame: From 15 July 2020 to 15 January 2021
measure: Serum-prevalence of COVID-19 / Age, Gender, Type of transplantation, comorbities, Italian regions-proviences transplanted patients
timeFrame: From 15 July 2020 to 15 January 2021
Secondary outcomes:
measure: Asymptomatic or subclinical infections in transplanted patients
timeFrame: From 15 July 2020 to 15 January 2021
measure: Risk factors for infection COVID-19 transplanted patients
timeFrame: From 15 July 2020 to 15 January 2021
measure: Hospitalization rate COVID-19 transplanted patients
timeFrame: From 15 July 2020 to 15 January 2021
measure: Mortality rate COVID-19 transplanted patients
timeFrame: From 15 July 2020 to 15 January 2021
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
References: