louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06964295: Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope
Official title: Comparison of First Attempt Success in Nasotracheal Intubation Using Macintosh Videolaryngoscope vs. Flexible Bronchoscope: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intubation Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 74
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Participants are randomly assigned to two groups: one group undergoes nasotracheal intubation using a videolaryngoscope, while the other group undergoes nasotracheal intubation using a flexible bronchoscope. The primary outcome is the first-attempt success rate, assessed at the time of tracheal tube placement. Additional outcomes include the degree of subglottic injury upon extubation, and the incidence and severity of sore throat and hoarseness at 1 hour and 24 hours postoperatively, as well as overall intubation success rates.


Eligibility criteria: Inclusion Criteria:

* Adults aged 19 years or older
* Undergoing ear, nose, and throat (ENT) surgery requiring nasotracheal intubation

Exclusion Criteria:

* Refusal to participate in the study
* History of gastroesophageal reflux disease
* History of surgery or radiation therapy involving the upper airway
* Presence of severely loose teeth

Primary outcomes:
measure: First-attempt success rate of nasotracheal intubation
timeFrame: At the time of tracheal intubation
Secondary outcomes:
measure: Degree of subglottic injury
timeFrame: At the time of extubation
measure: Postoperative sore throat severity
timeFrame: 1 hour and 24 hours postoperatively
measure: Incidence of postoperative hoarseness
timeFrame: 1 hour and 24 hours postoperatively
measure: Cormack-Lehane grade
timeFrame: At the time of tracheal intubation
measure: Changes in blood pressure
timeFrame: Within 5 minutes before and after intubation
measure: POGO score
timeFrame: At the time of tracheal intubation
measure: Changes in heart rate
timeFrame: Within 5 minutes before and after intubation
measure: Changes in saturation
timeFrame: Within 5 minutes before and after intubation
measure: Changes in bispectral value
timeFrame: Within 5 minutes before and after intubation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01684995: Motivation and Nicotine Patch Treatment for Under-served Smokers
Official title: Motivation and Nicotine Patch Treatment for Under-served Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-09-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to test, in combination with the nicotine patch, the incremental efficacy of a motivationally tailored behavioral intervention over a minimal intervention. The interventions will be delivered through primary care medical clinics. The defined population comprises low income, less educated smokers who will vary in their level of motivation to quit smoking. Patients will be randomly assigned within clinics to one of two interventions (a) Nicotine patch prescription plus brief physician advice (minimal care); and (b) Nicotine patch prescription plus brief physician advice, with the addition of a tailored motivational intervention, a behavioral skills counseling session for smoking cessation.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Currently smoking at least 10 cigarettes/day for past 3 months
* Speak English or Spanish
* Have a telephone or live close to a relative or neighbor with a telephone
* Agree to participate in the study and be available over the next 6 months.

Exclusion Criteria:

* Unable to use nicotine patch due to medical status
* Active skin condition or history of skin allergy
* Currently using smokeless tobacco, nicotine replacement or other smoking cessation treatment
* Pregnant or nursing

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
References:
citation: Bock B, Lopes CE, van den Berg JJ, Roberts MB, Stein LA, Martin RA, Martin SA, Clarke JG. Social support and smoking abstinence among incarcerated adults in the United States: a longitudinal study. BMC Public Health. 2013 Sep 17;13:859. doi: 10.1186/1471-2458-13-859.
Clinical trial NCT00544895: Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants
Official title: Neonatal Estimation Of Brain Damage Risk And Identification of Neuroprotectants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Damage, Chronic
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: European Commission
First posted: 2007-10-16
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm newborns with a gestational age \< 28wks

Brief summary: NEOBRAIN brings together small and medium sized enterprises (SMEs), industry and academic groups devoted to the diagnosis, management, and neuroprotection in newborns with perinatal brain damage. The focus of NEOBRAIN is to identify strategies prevention of brain damage mainly observed in preterm newborns. (Copy from www.neobrain.eu)


Eligibility criteria: Inclusion Criteria:

* Gestational age \< 28 weeks

Primary outcomes:
measure: Brain white matter damage (WMD, defined by MRI ,US, EEG)
timeFrame: during stay in NICU and until discharge
Secondary outcomes:
measure: Developmental assessment
timeFrame: at 2 years of age
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Paris
country: France
facility: Hôpital Robert Debré
city: Berlin
country: Germany
facility: Charité, Campus Virchow Klinikum
city: Essen
country: Germany
facility: Universität Duisburg-Essen
city: Hannover
country: Germany
facility: Hannover Medical School
city: Milano
country: Italy
facility: Fondazione I.R.C.C.S Ospedale Maggiore Policlinico MA.RE.
city: Siena
country: Italy
facility: Azienda Ospedaliera Universitaria Senese
city: Utrecht
country: Netherlands
facility: Wilhelmina Children's Hospital
city: Gothenburg
country: Sweden
facility: Perinatal Center
city: Lund
country: Sweden
facility: University Hospital
city: Uppsala
country: Sweden
facility: Academic Children's Hospital
city: Geneva
country: Switzerland
facility: Hôpital des Enfants
Study officials:
affiliation: Medical School Hannover
name: Olaf Dammann
role: STUDY_DIRECTOR
References:
citation: Dammann O, Cesario A, Hallen M. NEOBRAIN--an EU-funded project committed to protect the newborn brain. Neonatology. 2007;92(4):217-8. doi: 10.1159/000102967. Epub 2007 May 21. No abstract available.
Clinical trial NCT02013895: Accuracy and Reliability of GSA for Remnant Liver Function
Official title: Accuracy and Reliability of GSA for Remnant Liver Function in Scheduled Hepatectomized Patients
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Both Benign and Malignant Liver Mass
Keywords: liver
surgery
liver function
GSA
ICG
Lead sponsor: Kochi University
Sponsor class: OTHER
First posted: 2013-12-17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Preoperative evaluation of future remnant liver function is critical for patients undergoing hepatic surgery. Overestimation of the remnant liver function can lead to life-threatening postoperative hepatic failure, and its underestimation can lead to a lost opportunity for potentially curative surgery. Conventionally, post-hepatectomy remnant liver function has been estimated preoperatively using computed tomography (CT) volumetry. CT can provide precise anatomical information, and the remnant liver volume, measured by CT volumetry, has been reported to be an effective predictor of hepatic dysfunction after hepatectomy. However, the indirect estimation of liver function by CT volumetry is reliable only when the function is assumed to be homogenous over the whole liver.

Detailed description: 99mTc-galactosyl human serum albumin (99mTc-GSA) single-photon emission CT (SPECT) was developed to facilitate investigations of regional hepatic function. A disadvantage of conventional 99mTc-GSA SPECT was poor anatomical resolution, and this newly developed SPECT has a tremendously improved anatomical resolution owing to the fusion of CT and 99mTc-GSA SPECT. Recent reports have indicated that accurate regional function, based on precise anatomical information, could be evaluated using this technique.

Eligibility criteria: Inclusion Criteria:

* All eligible patients were those surgically treated for hepato-biliary diseases.

Exclusion Criteria:

* Patient exclusion criteria included a body weight loss greater than 10% during the six months prior to surgery, the presence of distant metastases, or seriously impaired function of vital organs due to respiratory, renal or heart disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kochi
country: Japan
facility: Kochi Health Sciences Center
Study officials:
affiliation: Kochi Health Sciences Center
name: Yasuo Shima, MD PhD
role: STUDY_CHAIR
References:
citation: Okabayashi T, Shima Y, Morita S, Shimada Y, Sumiyoshi T, Sui K, Iwata J, Iiyama T. Liver Function Assessment Using Technetium 99m-Galactosyl Single-Photon Emission Computed Tomography/CT Fusion Imaging: A Prospective Trial. J Am Coll Surg. 2017 Dec;225(6):789-797. doi: 10.1016/j.jamcollsurg.2017.08.021. Epub 2017 Sep 11.
Clinical trial NCT03664895: Density Lowering Effect of "OFS Add on to TMX"(DELFINO Trial)
Official title: Density Lowering Effect of Ovarian Function Suppression in Premenopausal Breast Cancer Patients Who Had no Density Change With One Year of Tamoxifen Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer Invasive
Keywords: premenopausal women, MMG density, Ovary function suppression
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 224
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: DELFINO tial is designed to investigate the role of "OFS add on to TMX ", based on MMG density as a surrogate marker in premenopausal women

* Premise - MMG density as a surrogate marker of hormone therapy
* Assumption - "Add on OFS to TMX" would have further decrease of density

  * 3-arm(Observation arm + Randomised 2-arm), phase III, RCT with 1:1 allocation

Detailed description: Enroll : Sep03,2018\~(Planned N= 224)

1. Inclusion criteria

   * Premenopausal
   * ER+
   * Planned tamoxifen(TMX)
   * No planned ovary function suppression(OFS)
   * Regardless of ChemoTx
   * Mammography(MMG) density check via Volpara\*(=Baseline MMG density, BaMD) (\*Volpara= software to check MMG density)
2. Check MMG Density via Volpara After 1yr TMX (At1yrMD) Check menopausal status after 1yr TMX(Menstruation episode or FSH \<30)
3. MMG Density Reduction(MDR =BaMD-AtMD ) at 1yr
4. MDR ≥5% -\> Keep go on TMX MDR \<5% -\> 1:1 randomization -\> Keep go on TMX vs OFS add on to TMX
5. Analysis : 5yr MDR (1'endpoint), 5yr DFS(2'endpoint), 5yr OS
6. Calculation of patients' number In previous study(\<Kim et al. Breast Can Res 2012\>) MDR (Mammography Density Reduction) was found in about 50% of all patients who received endocrine therapy.

Expected

* MDR in "TMX only" cohort -\> 6 ± 7%
* MDR in "OFS add on to TMX" -\> 10 ± 7%

  * after 1yr, Significance level 5%, average MDR 4% difference, 80% power, 10% dropout rate =\> 1:1 randomization Number = 112(56:56) Total number = 224

Eligibility criteria: Inclusion Criteria:

* Premenopausal women, ER+ breast cancer, stage I\~III, underwent standard treatment including surgery, Planned TMX
* available MMG density check via Volpara

Exclusion Criteria:

* Bilateral breast cancer
* Prior endocrine therapy
* Postmenopausal status
* unavailable MMG density check via volpara before and after TMX

Primary outcomes:
measure: MMG density Reduction
timeFrame: 5 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 5 years
Other outcomes:
measure: overall survival
timeFrame: 5 years
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University College of Medicine/Seoul National University Hospital
name: Wonshik Han
role: STUDY_CHAIR
References:
Clinical trial NCT01359995: Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis
Official title: Topical Ganciclovir in Patients Receiving Penetrating Keratoplasty With Cytomegalovirus Endotheliitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cytomegalovirus Endotheliitis
Keywords: cytomegalovirus endotheliitis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-05-25
Enrollment: 7
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4 men, 3 women, aged 40-90 years old

Brief summary: The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.

Detailed description: In this study, we recruit 7 immunocompetent patients with unexplained graft failures, which mimicked herpetic anterior uveitis and graft rejection initially, were diagnosed as CMV endotheliitis after aqueous tapping for CMV polymerase chain reaction (PCR). Topical ganciclovir was used to control and prevent the reactivation of CMV without systemic application and their clinical courses were presented after this treatment modality.

The purpose of this study was to evaluate the outcomes of topical ganciclovir in patients with cytomegalovirus endotheliitis receiving penetrating keratoplasty at National Taiwan University hospital.

Eligibility criteria: Inclusion Criteria:

* immunocompetent patients with positive results of the CMV PCR (polymerase chain reaction) from aqueous humor tapping receiving penetrating keratoplasty

Exclusion Criteria:

* patients receiving systemic or intravitreal ganciclovir before topical ganciclovir use

Primary outcomes:
measure: clinical courses before and after topical ganciclovir in patients with CMV endotheliitis
timeFrame: participants will be monitored after receiving topical ganciclovir,an expected average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: I-Jong Wang, M.D. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koizumi N, Suzuki T, Uno T, Chihara H, Shiraishi A, Hara Y, Inatomi T, Sotozono C, Kawasaki S, Yamasaki K, Mochida C, Ohashi Y, Kinoshita S. Cytomegalovirus as an etiologic factor in corneal endotheliitis. Ophthalmology. 2008 Feb;115(2):292-297.e3. doi: 10.1016/j.ophtha.2007.04.053. Epub 2007 Jul 31.
citation: Chee SP, Bacsal K, Jap A, Se-Thoe SY, Cheng CL, Tan BH. Clinical features of cytomegalovirus anterior uveitis in immunocompetent patients. Am J Ophthalmol. 2008 May;145(5):834-40. doi: 10.1016/j.ajo.2007.12.015. Epub 2008 Feb 6.
citation: Anshu A, Chee SP, Mehta JS, Tan DT. Cytomegalovirus endotheliitis in Descemet's stripping endothelial keratoplasty. Ophthalmology. 2009 Apr;116(4):624-30. doi: 10.1016/j.ophtha.2008.10.031. Epub 2009 Feb 4.
Clinical trial NCT00581295: Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients
Official title: Use of Diffuse Optical Spectroscopy for Evaluation of the Trauma/Critically Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: internal bleeding
changes in tissue perfusion
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-12-27
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma/Critically Care Patients

Brief summary: Trauma remains the leading cause of death and disability for Americans age 1-44. Trauma can cause internal bleeding, and this bleeding is often hard to detect without sophisticate tests that take time to complete and analyze.

In addition, internal bleeding, including bleeding into the lung and chest cavity, as well as other blood loss, happens in many critically ill patients. For example, for hemorrhage, it is very difficult to detect active hemorrhage and to determine optimal rates of fluid and blood resuscitation.

Diffuse optical spectroscopy has the potential to accurately assess adequacy of tissue perfusion, oxygenation, tissue oxygen extraction, and cytochrome oxidation states that may be critical to optimal treatment, end- organ preservation, and survival.

Detailed description: The research' want to monitor tissue perfusion and indicators of tissue damage and viability in critically ill patients by using DOS.

Non-invasive Optical Techniques DOS,near-infrared diffuse optical spectroscopy (NIR-DOS.

NIR-DOS provides functional physiologic tissue/organ information without ionizing radiation and without withdrawing any blood, in a cost-effective and rapid manner. The application of frequency-domain photon migration analysis (FDPM) to NIRS allows independent measurements of tissue absorption and scattering properties at depths of 1 cm or more below the skin surface.

Such capabilities will improve early diagnosis, detection, optimization of therapy, assessment of adequacy of resuscitation, and alteration in management plans for all of these critical conditions.

Eligibility criteria: Inclusion Criteria:

* Adult age 18 years or older, male or female
* Trauma/Critical Care patient

Exclusion Criteria:

* Subject is not Trauma/Critical Care patient

Primary outcomes:
measure: The ability to noninvasively diagnose conditions in the intensive care unit, or in battlefield conditions.
timeFrame: 5 to 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute,University of California, Irvine
state: California
city: Orange
country: United States
facility: Trauma/Critical Care Units, UCI Medical Center
state: California
Study officials:
affiliation: Beckman Laser Institute
name: Michael E Lekawa, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03498495: Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program for Kids With Mild Traumatic Brain Injury
Official title: Kids With mTBI Get SMART: Development and Pilot Trial of a Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury Traumatic Mild
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Cincinnati
First posted: 2018-04-13
Enrollment: 74
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: SMART is an interactive web-based program that will allow youth with mild traumatic brain injuries (mTBI) to monitor their symptoms and receive education on problem-solving and coping strategies. This study will evaluate the effectiveness of SMART as a means of improving symptom-management, coping skills, and general well-being during recovery from mTBI. Half of participants will receive the SMART intervention, while half will receive usual care.


Eligibility criteria: Inclusion Criteria:

* 11-18 years old
* Sustained mTBI within the past week

Exclusion Criteria:

* Patient and/or family do not speak and read English
* Patient and/or family do not have Internet access
* Patient experiencing more severe brain injury (Glasgow coma score \<13)
* Patient with more than one moderate extracranial injury
* Patients with non-mTBI reasons for altered mental status
* Patients with severe pre-existing neurologic or cognitive disorders or other disorders that may impair ability to participate in the intervention.

Primary outcomes:
measure: Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)
timeFrame: From baseline to 4 weeks post-injury
Secondary outcomes:
measure: Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form)
timeFrame: From baseline to 4 weeks post-injury
measure: Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS)
timeFrame: From baseline to 4 weeks post-injury
measure: Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: From baseline to 4 weeks post-injury
measure: Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI)
timeFrame: From baseline to 4 weeks post-injury
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lynn Babcock, M.D.
role: PRINCIPAL_INVESTIGATOR
References: