louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01411462: VIBE-assisted DEB Registry
Official title: Vascular Imaging Balloon Catheter-assisted Drug-eluting Balloon Angioplasty Prospective Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Lead sponsor: Ospedale Santa Maria Goretti
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic coronary artery disease

Brief summary: VIBER aims at assessing angiographic outcome of drug-eluting balloon angioplasty assisted by the Vascular Imaging Balloon Catheter (VIBE, Volcano, San Diego, CA) device, which integrates a predilation catheter with electronic intravascular ultrasound capabilities.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* De novo native vessel lesion
* RVD 2.5 - 4 mm Limited compliance with \>3 month DAPT

Exclusion Criteria:

* LMCA

Primary outcomes:
measure: Binary restenosis
timeFrame: 6 months
Secondary outcomes:
measure: Procedural success
timeFrame: 1 day
measure: Major adverse cardiac events
timeFrame: 6 months
Other outcomes:
Locations:
city: Latina
country: Italy
facility: S.M. Goretti
Study officials:
References:
Clinical trial NCT04124562: Nitrous Oxide Frequency of Use and Causes in Hospital in Turkey
Official title: Nitrous Oxide Frequency of Use and Causes in Hospital in Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Environmental-Pollution-Related Condition
Keywords: Nitrous oxide
Prevalence
Turkey
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 170
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anesthesiologists working in the operating rooms of hospitals in Turkey

Brief summary: The prevalence of nitrous oxide use in hospitals in Turkey

Detailed description: Nitrous oxide has a long history of use in the healthcare field for over 150 years. However, this gas is slowly being abandoned for various reasons. The decrease in N2O use is probably due to its side effects and negative impact on global warming. Proven side effects include irreversible toxic effects on bone marrow, relative or absolute contraindications related to neuro and cardiac anesthesia, increased incidence of post-operative nausea and vomiting, increased risk of miscarriage in pregnant women (5), the greenhouse effect of nitrous oxide. In 2013, B. Husum et al. investigated the frequency of N2O use in public hospitals in Scandinavian countries and it was confirmed that N2O use was reduced and limited. According to the results of this research, N2O was administered with a volatile anesthetic agent in 21.5% of general anesthesia applications in Scandinavian countries. N2O was used as the second agent in Denmark by 2.4%, Finland by 17%, Iceland by 34.5, Norway by 32.1%, Sweden by 27.5%. In Turkey there are not enough reports of N2O use prevalence. In this study, we will investigate the extent of use and avoidance reasons N2O in Turkey. And we aim creating awareness.

Eligibility criteria: Inclusion Criteria:

Hospitals who accept to participate in Turkey

-

Exclusion Criteria:

Hospitals refusing to participate in the study

Primary outcomes:
measure: The percentage of nitrogen oxide use
timeFrame: A day
Secondary outcomes:
measure: The percentage of nitrogen oxide use
timeFrame: A month
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University, School of Medicine
state: Tusba / Zeve Kampus
Study officials:
affiliation: Study Director
name: Hilmi Demirkıran, 1
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01952262: Ultrasound of the Diaphragm in ICU Patients
Official title: Ultrasound Evaluation of Diaphragmatic Dysfunction in Critically Ill Patients. An Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill
Keywords: ultrasound
diaphragm
intensive care
critical care
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult critically ill patients

Brief summary: Diaphragmatic dysfunction is an important complication of mechanical ventilation. Critically ill patients admitted in a teaching hospital intensive care unit will be evaluated with diaphragm ultrasound to investigate predictors of diaphragmatic dysfunction and the clinical course of these patients.

Vascular surgery patients (aortic abdominal surgery) might also be included and assessed with diaphragm ultrasound before and after surgery irrespectively of the need of intensive care unit. On December 2014 the Etical committee approved an amendment to include the possibility to study elective aortic abdominal surgery patient to assess the relationship between surgery related diaphragmatic dysfunction and postoperative respiratory complications.


Eligibility criteria: Inclusion Criteria:

* adult plus admitted in ICU plus invasive or non-invasive mechanical ventilation or
* adults aortic vascular surgery

Exclusion Criteria:

* \< 18 years

Primary outcomes:
measure: Diaphragmatic dysfunction
timeFrame: participants will be followed for the duration of intensive care unit stay, an expected average of 1 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele di Milano
Study officials:
affiliation: San Raffaele Scientific Institute
name: Massimo Zambon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04120662: Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players
Official title: Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Fracture Metatarsal
Lead sponsor: Fundación Garcia Cugat
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 30
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: Fifth metatarsal stress fracture is a failure of a healthy metatarsal bone subject to repetitive microdamages. It has a high prevalence in soccer players and is classified as a high-risk stress fracture. Based on Torg classification, the treatment options may be conservative or surgical. The recent increase of evidences about Shock Wave Treatment in different bone pathologies, including stress fractures, suggests the possibility to use this conservative intervention option also in patients candidate for surgery. This randomized clinical trial included 18 soccer players diagnosed of proximal fifth metatarsal stress fracture, randomly matched in Surgery group and Shock Wave group. Patients of Surgery group were treated with intramedullary screw fixation; patients of Shock Wave group received 3 weekly sessions of Focused Shock Wave Treatment (F-ESWT), using an electrohydraulic device set to an energy flux density (EFD) of 0.21 mJ/mm2 and 2000 impulses. Patients of both groups were followed monthly until their return to play (RTP) using radiography, Visual Analogue Scale (VAS), Tegner Activity Level Scale and AOFAS score.


Eligibility criteria: Inclusion Criteria:

* Male soccer players, aged over 18 years.
* Diagnosis of proximal fifth metatarsal stress fracture, according to clinical signs and symptoms and to radiologic findings
* Fracture occurred during soccer practice
* Informed consent signed

Exclusion Criteria:

* To be under 18 years old
* Traumatic fracture
* Fracture occurred out of soccer practice
* Patients with metatarsal shaft, neck or head fracture
* Patients with contraindication to receive surgical treatment
* Patients with contraindication to receive shock wave treatment
* Patients that refuse the informed consent

Primary outcomes:
measure: Evaluation of X-Ray
timeFrame: Follow up until recovery (maximum of 6 months)
measure: Period until return to play
timeFrame: Follow up until recovery (maximum of 6 months)
Secondary outcomes:
measure: Evaluation of Visual Analogue Scale
timeFrame: Follow up until recovery (maximum of 6 months)
measure: American Orthopedic Foot and Ankle Score
timeFrame: Follow up until recovery (maximum of 6 months)
measure: Evaluation of Tegner activity scale
timeFrame: Follow up until recovery (maximum of 6 months)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundacion Garcia Cugat
Study officials:
affiliation: Fundación Garcia Cugat
name: Montse Garcia
role: STUDY_CHAIR
References:
Clinical trial NCT00852462: Lung Cancer Symptom Assessment and Management Intervention
Official title: Lung Cancer Symptom Assessment and Management Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Cancer
Keywords: SAMI
Symptom Assessment and Management Intervention Program
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
name: National Cancer Institute (NCI)
First posted: 2009-02-27
Enrollment: 179
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop and test the usability of a computerized symptom assessment and management intervention system in a laboratory setting (phase I) and its feasibility in a clinical setting in a group randomized trial (phase II).


Eligibility criteria: Inclusion Criteria:

* HCPs: attending physician, thoracic medical oncologist, expected to work in the setting for at least 2 years.
* Patients: 21 years of age or older; diagnosis of Stage IIIA, IIIB, IV non-small cell lung cancer OR limited or extensive stage small cell lung cancer; receiving care in the out-patient setting; receiving treatment with chemotherapy +/- additional therapies; English speaking.

Exclusion Criteria:

* Patients: Any patient who needs emergent care, routine visits scheduled less than once a month

Primary outcomes:
measure: % completion of intervention use and adherence to suggested symptom management strategies.
timeFrame: 2 years
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mary E. Cooley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04739462: SMS Maama Project COVID-19
Official title: mHealth for Improvement of Access to Maternal Health Services in the Era of COVID-19 Pandemic (SMS Maama Project)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Complications
Birth Injuries
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Makerere University
First posted: 2021-02-04
Enrollment: 248
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study's purpose is to demonstrate the ability of an mHealth platform as a feasible way of sharing information in a time of restricted movement in order to inform future studies.

Detailed description: The primary objective of this trial is to assess whether an mHealth platform increases maternal health knowledge in the areas of birth preparedness, pregnancy, and birth complications as measured by the pre- and post-surveys in comparison to routine antenatal care.

The secondary objectives of this trial are;

1. To provide knowledge of COVID-19 symptoms, transmission, diagnosis, and treatment, in a time of social distancing and learning.
2. To improve access and linkages to maternal health services and information as well as provide appropriate referrals for pregnant females.
3. Inform the adoption of mHealth into future health delivery plans.

Eligibility criteria: Inclusion Criteria:

* Own a personal mobile phone
* Attend ANC at Kisenyi Health Centre IV, Kawempe Hospital or Rubaga Hospital
* Are at least 24-26 weeks estimated gestational age
* Literate in English or Luganda
* Capable of sending/receiving text messages

Exclusion Criteria:

- Females who plan to travel out of Uganda during the study period

Primary outcomes:
measure: Change in Pre- to Post-Intervention Knowledge
timeFrame: up to 18 weeks
Secondary outcomes:
measure: Change in Knowledge on COVID-19
timeFrame: up to 18 weeks
measure: Rate of COVID Testing
timeFrame: up to 18 weeks
measure: Change in Pregnancy Risk Knowledge
timeFrame: up to 18 weeks
measure: Change in Breastfeeding Knowledge
timeFrame: up to 18 weeks
measure: Antenatal Care Rate
timeFrame: up to 18 weeks
measure: Skilled Birth Attendance Rate
timeFrame: up to 18 weeks
measure: Rate of Negative Pregnancy Outcomes
timeFrame: up to 18 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Kampala
country: Uganda
facility: Makerere University
Study officials:
affiliation: Lubaga Hospital and School of Public Health, Makerere University
name: Betty Nakabuye, MBChB, MMed
role: PRINCIPAL_INVESTIGATOR
affiliation: Mulago Specialised Women's Hospital and School of Medicine, Makerere University
name: Jolly Beyeza
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Katelyn Pastick
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Cheryl Robertson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01138462: Control of MRSA in Nursing Homes: Decolonization vs Standard Precautions
Official title: Universal Screening and Decolonization vs Standard Precautions for Control of Methicillin-resistant Staphylococcus Aureus (MRSA) in Nursing Homes: a Cluster, Randomised Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methicillin-Resistant Staphylococcus Aureus
Keywords: Methicillin-Resistant Staphylococcus aureus
Decolonisation
Nursing homes
Infection Control
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2010-06-07
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the better approach between the currently procedure (i.e. standards precautions) and a reinforced strategy to control MRSA transmission in the institutionalized population of nursing homes in Canton of Vaud, Switzerland.

Detailed description: MRSA carriage among nursing homes residents of Canton Vaud, Switzerland, is increasing, despite use of standard precautions. Recommendation to prevent MRSA transmission in long term care facilities are lacking. We aim to reinforce the current infection control strategy by general MRSA screening of institutionalised residents and decolonisation of MRSA carriers. Because the uncertainties in the impact of this reinforced strategy, we aim to compare this action to the policy actually applied.

Eligibility criteria: Inclusion Criteria:

* all nursing homes of canton Vaud, Switzerland, that give the consent of participation

Exclusion Criteria:

- refusal to participate

Inclusion criteria for decolonisation in intervention nursing homes:

- all MRSA positive residents living in a Nursing Home included in the intervention group

Exclusion Criteria for decolonisation:

* residents that refuse to be screened or refused the decolonisation
* life expectancy shorter of 7 days
* known intolerance of disinfectant/ topical antibiotics used in the protocol
* active MRSA infection
* asymptomatic MRSA bacteriuria
* stage IV wound (according to National Pressure Ulcer Advisory Panel)

Primary outcomes:
measure: To determine the change in prevalence of MRSA carriage among residents of each Nursing homes group at the end of the one study year
timeFrame: 1 year
Secondary outcomes:
measure: To determine the effectiveness of the reinforced strategy to prevent MRSA infection, compared to the standard strategy
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital of Lausanne, Switzerland
name: Giorgio Zanetti, MD
role: STUDY_DIRECTOR
References:
citation: Bellini C, Petignat C, Masserey E, Bula C, Burnand B, Rousson V, Blanc DS, Zanetti G. Universal screening and decolonization for control of MRSA in nursing homes: a cluster randomized controlled study. Infect Control Hosp Epidemiol. 2015 Apr;36(4):401-8. doi: 10.1017/ice.2014.74.
Clinical trial NCT01811862: Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients
Official title: Acupuncture for Symptom Control in Hematopoietic Stem Cell Transplantation Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Keywords: Acupuncture
Hematopoietic stem cell transplantation (HSCT)
13-038
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-03-15
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized controlled trial to obtain preliminary data for the design of a future definitive efficacy study. A randomized controlled trial is needed because comparison to historical data would be biased. The investigators will use sham acupuncture as the control to account for effect from attention from and interaction with the therapist.


Eligibility criteria: Inclusion Criteria:

* Age 21 or above (those age below 21 are usually treated in the Pediatric Transplant Service)
* Diagnosis of multiple myeloma
* Scheduled to receive conditioning chemotherapy followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation

Exclusion Criteria:

* Absolute neutrophil count less than 200/microliter
* Platelet count less than 20,000/microliter
* Acupuncture treatment in the preceding 4 weeks prior to Day 1

Primary outcomes:
measure: whether acupuncture reduces common symptoms
timeFrame: 2 years
Secondary outcomes:
measure: to assess the effect size for each symptom
timeFrame: 2 years
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: Gary Deng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deng G. Acupuncture As a Potential Opioid-Sparing Pain Management Intervention for Patients Undergoing Cancer Treatment. Med Acupunct. 2020 Dec 1;32(6):394-395. doi: 10.1089/acu.2020.1494. Epub 2020 Dec 16.
citation: Deng G, Giralt S, Chung DJ, Landau H, Siman J, Li QS, Lapen K, Mao JJ. Reduction of Opioid Use by Acupuncture in Patients Undergoing Hematopoietic Stem Cell Transplantation: Secondary Analysis of a Randomized, Sham-Controlled Trial. Pain Med. 2020 Mar 1;21(3):636-642. doi: 10.1093/pm/pnz190.
citation: Deng G, Giralt S, Chung DJ, Landau H, Siman J, Search B, Coleton M, Vertosick E, Shapiro N, Chien C, Wang XS, Cassileth B, Mao JJ. Acupuncture for reduction of symptom burden in multiple myeloma patients undergoing autologous hematopoietic stem cell transplantation: a randomized sham-controlled trial. Support Care Cancer. 2018 Feb;26(2):657-665. doi: 10.1007/s00520-017-3881-7. Epub 2017 Sep 17.
Clinical trial NCT00245362: A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer
Official title: A Phase II Trial of CG 8020 and CG 2505 in Patients With Nonresectable or Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Cancer
Nonresectable Pancreatic Cancer
Keywords: cancer vaccine
pancreatic cancer
metastatic pancreatic cancer
unresectable pancreatic cancer
immunotherapy
Lead sponsor: Cell Genesys
Sponsor class: INDUSTRY
First posted: 2005-10-28
Enrollment: 50
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: To evaluate the safety and effectiveness of CG8020 and CG2505.

Detailed description: To evaluate clinical and laboratory safety of CG 8020 and CG 2505 and to evaluate the efficacy of CG 8020 and CG 2505 as measured by clinical benefit response, progression-free survival, survival and CA 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas

Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma
* Chemotherapy naïve or chemotherapy experienced pancreatic cancer

Exclusion Criteria:

* Prior cancer vaccines or gene therapy
* History of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis)
* History of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the Medical Monitor

Primary outcomes:
measure: Safety
measure: Efficacy measured by clinical benefit response
measure: Progression-free survivial
measure: Overall survival
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Dallas
country: United States
facility: US Oncology
state: Texas
Study officials:
References: