louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01846936: Disconnection Technique With a Bronchial Blocker for Improving Lung Deflation
Official title: A Randomized, Prospective Trial Comparing Double-lumen Tube and Bronchial Blocker With or Without Modified Disconnection Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumothorax
Keywords: one lung ventilation
efficacy
bronchial blocker
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 54
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One lung ventilation (OLV) is accomplished with a double lumen tube (DLT) or a bronchial blocker (BB). In this study, the investigators compared the effectiveness of lung collapse using DLT, BB with spontaneous collapse, and BB with disconnection technique.

Detailed description: In selecting this maneuver of OLV, lung collapse is a major concern because it permits adequate surgical exposure. Although once lung deflation was achieved, the overall clinical performance appears to be similar, BB takes longer to deflate the operative lung and there is some conflict reports as to BB provides a similar degree of lung deflation compared to that of DLT.

The aim of this study was to compare the efficacy of BB and DLT for achieving lung collapse, and to evaluate the efficacy of disconnection technique with monitoring the carbon dioxide trace on a capnograph in BB. The investigators further evaluated the disconnection time, which is the time to loss of carbon dioxide trace on the capnograph, needed to facilitate lung collapse.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing thoracic surgery for which OLV is required

Exclusion Criteria:

* Patients with an anticipated difficult intubation with infectious or bleeding lung lesions are excluded.

Primary outcomes:
measure: Effectiveness of three lung isolation methods
timeFrame: Five min from the start of one lung ventilation
measure: Effectiveness of three lung isolation methods
timeFrame: Ten min from the start of one lung ventilation
Secondary outcomes:
measure: The disconnection time
timeFrame: The time to loss the carbon dioxide trace on the capnograph (30 seconds)
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyung Gi
Study officials:
affiliation: Ajou University
name: Sung Yong Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04080336: Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women
Official title: Comparison of Vaginal Misoprostol and Dinoprostone Prior to Copper Intrauterine Device Insertion in Nulliparous Women:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: IUD Insertion Complication
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD inertion pain and the difficulty in inserting the IUD in nulliparous women.

Detailed description: Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.

Eligibility criteria: Inclusion Criteria:

* nulliparous women requesting copper IUD insertion

Exclusion Criteria:

* pregnancy, Parous women, contraindications or allergy to dinoprostone or misoprostol,contraindication to IUD insertion, untreated active cervicitis or vaginitis, undiagnosed abnormal uterine bleeding

Primary outcomes:
measure: The difference in pain scores during intrauterine device insertion
timeFrame: 10 minutes
Secondary outcomes:
measure: the difference in pain scores during tenaculum application
timeFrame: 10 minutes
measure: the difference in pain scores during sound insertion
timeFrame: 10 minutes
measure: the ease of IUD insertion
timeFrame: 10 minutes
measure: women's satisfaction level
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Ahmed Samy
Study officials:
affiliation: Cairo University
name: AHMED SAMY
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Mohamed El Sharkawy
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Mohamed El Mahy
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004336: Pilot Study of Familial Nonsyndromal Mondini Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mondini Dysplasia
Keywords: Mondini dysplasia
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Michigan
First posted: 1999-10-19
Enrollment: 2
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES:

I. Determine the mode of inheritance of nonsyndromal Mondini inner ear dysplasia, an inner ear malformation causing deafness, vestibular dysfunction, and recurrent meningitis.

Detailed description: PROTOCOL OUTLINE:

The parents of 1 family with known Mondini dysplasia are screened for the disorder using temporal bone computerized tomography without contrast. This information is used to determine the mode of inheritance.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Parents of a study family with nonsyndromal Mondini dysplasia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
Study officials:
affiliation: University of Michigan
name: Andrew J. Griffith
role: STUDY_CHAIR
References:
Clinical trial NCT05562336: Optical Coherence Tomography Angiography Criteria Of The Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia (Comparative Study).
Official title: Optical Coherence Tomography Angiography Criteria Of The Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia (Comparative Study).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-09-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Cnv in age related macular degeneration and in pathological myopia

Brief summary: This study aims to compare choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia.

Detailed description: All patients will be examined by optical coherence tomography (OCT) and optical coherence tomography angiography (OCT-angio) .

The size, the location, the criteria of the choriodal neovascular membrane will be examined and imaged.

Study include 50 cases of CNV in age related macular degeneration and 50 cases of CNV in pathological myopia.

Eligibility criteria: Inclusion Criteria:

* Patients with age related macular degeneration should be at least 50 years of age with CNV with no other causes.

Patients with pathological myopia where axial length more than 26 mm or refractive power more than -6 diopter with CNV in OCT with clear media and OCT-angio can be used.

Exclusion Criteria:

* Exclude other pathological causes of CNV .

Primary outcomes:
measure: choroidal neo-vascular membrane criteria in cases of age-related macular degeneration and cases of pathological myopia
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Hee MR, Baumal CR, Puliafito CA, Duker JS, Reichel E, Wilkins JR, Coker JG, Schuman JS, Swanson EA, Fujimoto JG. Optical coherence tomography of age-related macular degeneration and choroidal neovascularization. Ophthalmology. 1996 Aug;103(8):1260-70. doi: 10.1016/s0161-6420(96)30512-5.
citation: Secretan M, Kuhn D, Soubrane G, Coscas G. Long-term visual outcome of choroidal neovascularization in pathologic myopia: natural history and laser treatment. Eur J Ophthalmol. 1997 Oct-Dec;7(4):307-16. doi: 10.1177/112067219700700401.
citation: Miller DG, Singerman LJ. Vision loss in younger patients: a review of choroidal neovascularization. Optom Vis Sci. 2006 May;83(5):316-25. doi: 10.1097/01.opx.0000216019.88256.eb.
citation: Kovach JL, Schwartz SG, Flynn HW Jr, Scott IU. Anti-VEGF Treatment Strategies for Wet AMD. J Ophthalmol. 2012;2012:786870. doi: 10.1155/2012/786870. Epub 2012 Feb 28.
Clinical trial NCT03923036: Anticancer Vigilance Of Cardiac Events (AVOCETTE) in Metastatic Colorectal Cancer
Official title: Anticancer Drug-induced Cardiac Adverse Events in Metastatic Colorectal Cancer: Insights From the French County Calvados Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer Metastatic
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Exhaustive population of metastatic colorectal cancers in the French county Calvados registry diagnosed between 2004 and 2014 (synchrone and metachrone diagnosis).

Brief summary: This study is a retrospective observational study that evaluates the rate of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer in the French county Calvados by drug exposure.

Detailed description: This study investigates the characteristics of cardiovascular adverse events leading to hospitalization in metastatic colorectal cancer. Descriptive analysis will include incidence, type of cardiovascular adverse events.

We will explore the incidence of cardiovascular adverse events with regard of the antineoplastic drug exposures. This will provide information about the individual drug safety profiles.

Eligibility criteria: Inclusion Criteria:

* Patients with a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados

Exclusion Criteria:

* Minors \< 18 year old
* Patients without a metastatic colorectal cancer diagnosed between 2004 and 2014 in the French county Calvados

Primary outcomes:
measure: Difference in rates of cardiovascular adverse events leading to hospitalization between chemotherapy treated patients and chemotherapy-free patients.
timeFrame: Between 2004 and 2017
Secondary outcomes:
measure: Risk of cardiovascular adverse events (any) for each individual anticancer drug.
timeFrame: Between 2004 and 2017
measure: Risk of cardiovascular adverse events (any) for each anticancer drugs combination/protocol
timeFrame: Between 2004 and 2017
measure: Risk of individual cardiovascular adverse events of chemotherapy treated patients versus chemotherapy-free patients
timeFrame: Between 2004 and 2017
measure: Dose-effect relation ship between individual anticancer drugs and cardiovascular adverse events
timeFrame: Between 2004 and 2017
measure: Dose-effect relation ship between individual anticancer drugs combination/protocol and cardiovascular adverse events
timeFrame: Between 2004 and 2017
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
state: Normandy
Study officials:
affiliation: CHU CAEN
name: Joachim Alexandre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02811536: Investigation of Vascular Pathology in Eye Diseases Using Using Optical Coherence Tomography Angiography (OCT-A)
Official title: Investigation of Vascular Pathology in Eye Diseases Using Using Optical Coherence Tomography Angiography (OCT-A)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Disease
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a history of clinically diagnosed retinal diseases, including but not limited to age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, macular macroaneurysma, and diabetic macular edema and healthy individuals undergoing ophthalmic Imaging in Routine clinical practice will be included

Brief summary: Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases

Detailed description: Optical coherence tomography angiography (OCTA) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information. OCTA compares the decorrelation signal between sequential OCT b-scans taken at precisely the same cross-section in order to construct a map of blood flow. At present, level 1 evidence of the technology's clinical applications doesn't exist. The investigators plan to compare OCTA as an imaging modality to conventional imaging modalities used in clinical routine.

Eligibility criteria: Inclusion criteria:

Patients from the Department of Ophthalmology, University Hospital Bern requiring conventional imaging for eye disease and willing to sign informed consent Patients of 18 years or older

Exclusion criteria:

Patients not willing or able to sign informed consent Patients younger than 18 years Patients with epilepsy Patients having had photodynamic therapy within the last 48 hours prior to imaging with OCTA

Primary outcomes:
measure: Evaluation of the sensitivity and specificity of OCTA
timeFrame: 2 years
Secondary outcomes:
measure: Evaluation of the intra-and inter-reader reproducibility of the diagnosis of vascular abnormalities using OCTA
timeFrame: 2 years
measure: OCTA and Fundus color photographs
timeFrame: 2 years
measure: Subgroup analysis
timeFrame: 2 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital Bern, Department of Ophthalmology
Study officials:
affiliation: Inselspital, University Clinic for Ophthalmology
name: Martin Zinkernagel, Prof.MD PhD
role: STUDY_CHAIR
References:
citation: Tian M, Tappeiner C, Zinkernagel MS, Huf W, Wolf S, Munk MR. Evaluation of vascular changes in intermediate uveitis and retinal vasculitis using swept-source wide-field optical coherence tomography angiography. Br J Ophthalmol. 2019 Sep;103(9):1289-1295. doi: 10.1136/bjophthalmol-2018-313078. Epub 2018 Dec 11.
Clinical trial NCT03191136: Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Volunteers
Official title: A Open-label, Randomized, Single Dose, Crossover Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Neuropathic Pain
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2017-06-19
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, open-label, single dose, cross-over clincial trial
Primary purpose: TREATMENT

Brief summary: This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.

Hypothesis: "YHD1119" is showing equal equal pharmacokinetics in fasted and fed state.

Detailed description: This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.

Group 1: 12 subjects will be assigned and they will be administered YHD1119 in fasted state at Day 1 and in fed state at Day 8.

Group 2: 12 subjects will be assigned and they will be administered YHD1119 in fed state at Day 1 and in fasted state at Day 8.

Eligibility criteria: Inclusion Criteria:

* Healthy male with body mass index(BMI) between 18.5 and 30 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing
* Volunteers considered not eligible for the clinical trial by the investigator due to reasons including laboratory test results, ECGs, or vital signs

Primary outcomes:
measure: YHD1119 Cmax
timeFrame: 0 - 36hrs
measure: YHD1119 AUC last
timeFrame: 0 - 36hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
Study officials:
affiliation: Chonbuk National University Hospital
name: Mingul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moon SJ, Jeon JY, Lim Y, An T, Jang SB, Kim S, Na WS, Lee SY, Kim MG. Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. Clin Ther. 2021 Aug;43(8):1381-1391.e1. doi: 10.1016/j.clinthera.2021.06.010. Epub 2021 Jul 11.
Clinical trial NCT00004436: Randomized Study of Hormonal Regulation of Infantile Hemangioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemangioma
Keywords: cardiovascular and respiratory diseases
hemangioma
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: Boston Children's Hospital
First posted: 1999-10-19
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the clinical efficacy of leuprolide, a gonadotropin-releasing hormone agonist (GnRHa), in treating infants with vision-endangering or large, disfiguring hemangiomas.

II. Assess the impact of GnRHa on growth and development during infancy. III. Assess the safety of GnHRa in these patients.

Detailed description: PROTOCOL OUTLINE: This is a randomized, placebo-controlled study. Patients are stratified according to gender and by position of the lesion (periorbital vs nonperiorbital).

All patients receive oral prednisone daily for 3 weeks. Patients are then randomized to receive either placebo or leuprolide IM every 3 weeks, while continuing oral prednisone. Tumors are assessed at 1, 3, and 6 weeks. If the tumor is not responding, the leuprolide will be administered every 2 weeks. Tumors are reassessed at 3 and 6 months, at which point the treatment is stopped. Responding patients are observed every 3 weeks for 3 months. If the tumor begins to grow again, leuprolide may be administered for another 3 months. Patients whose tumors grow rapidly during treatment may crossover to the alternate therapy, repeat the leuprolide or prednisone therapy, or undergo surgical excision.

Eligibility criteria: * Presence of hemangioma meeting at least one of the following criteria: Vision-threatening because of induced astigmatism or occlusion of the visual axis or proptosis Severe anatomic distortion compromising function of an organ or creating an unacceptable cosmetic outcome Other complications, e.g., Kasabach-Merritt consumptive coagulopathy, high-output heart failure, etc.
* No lesions that are clearly regressing before therapy
* No vascular malformations other than juvenile hemangiomas

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: Lois Hodgson Smith
role: STUDY_CHAIR
References:
Clinical trial NCT05541536: Facilitating Learning Health Care (LHC) and Neonatal Research: Effects of a Brief Introductory Discussion Between a Neonatologist and the Parents of Eligible Infants
Official title: Facilitating Learning Health Care (LHC) and Neonatal Research: Effects of a Brief Introductory Discussion Between a Neonatologist and the Parents of Eligible Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Understanding of Consent in Clinical Research
Implementation of Consent in Clinical Research
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary purpose of this pilot quality improvement study is to assess the impact of a brief introductory discussion about Learning Health Care (LHC) and clinical research between a neonatologist and the mothers (and the fathers, if present) of infants eligible for trials of the Neonatal Research Network (NRN) before they are approached for consent by clinical research coordinator (CRC) approach for NRN trial). Mothers will also be given a general information pamphlet addressing the same topic.


Eligibility criteria: Inclusion Criteria:

* Mothers of infants eligible for Neonatal Research Network (NRN) trial (antenatal or postnatal)
* English or Spanish speaking
* Available for in-person (preference) or phone consultation meeting
* Mother not already approached for NRN trial

Exclusion Criteria:

* Mother already approached by clinical research coordinator (CRC) for NRN trial

Primary outcomes:
measure: Neonatal Research Network (NRN) trial consent rate
timeFrame: Within 1 week of the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: McGovern Medical School at UTHealth Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Susan Wootton, MD
role: PRINCIPAL_INVESTIGATOR
References: