louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06779084: Fasting Durations Before Bronchoscopy And The Discomfort Levels Of Patients
Official title: Association Between Different Fasting Durations Before Bronchoscopy And The Discomfort Levels Of Patients Around The Procedure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bronchoscopy
Fasting ( 6H for Solid ; 2H for Clear Fluid )
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to learn if patients feel more comfortable while being placed on contemporary fasting principle than on conventional fasting time during flexible bronchoscopy. The main questions it aims to answer are:

To compare the thirty levels between patients with conventional fasting time (≥ 8 hours) and those with contemporary fasting principle (clear fluids for up to 2 hours before anesthesia) during flexible bronchoscopy To compare the levels of mucosal dryness between two groups of patients during flexible bronchoscopy To compare the levels of hunger between two groups of patients during flexible bronchoscopy To compare the levels of tiredness between two groups of patients during flexible bronchoscopy To compare the levels of fatigue between two groups of patients during flexible bronchoscopy To compare the levels of nausea/vomiting between two groups of patients during flexible bronchoscopy

Participants will:

Being placed on fasting either using conventional fasting time (≥ 8 hours) or with contemporary fasting principle (clear fluids for up to 2 hours before anesthesia) Being asked to respond to questions regarding thirsty, mucosal dryness, hunger, tiredness, fatigue, and nausea/vomiting in a visual analogue scale of 0 to 10


Eligibility criteria: Inclusion Criteria:

* planned flexible bronchoscopy

Exclusion Criteria:

* tracheostomy or intubated
* known to be pregnant
* significant functional or structural abnormalities of the gastrointestinal tract
* oral intake prohibited and infeasible

Primary outcomes:
measure: patient thirty level
timeFrame: right before the bronchoscopy procedure
Secondary outcomes:
measure: patient mucosal dryness
timeFrame: right before the bronchoscopy procedure
measure: patient hunger
timeFrame: right before the bronchoscopy procedure
measure: patient tiredness
timeFrame: right before the bronchoscopy procedure
measure: patient fatigue
timeFrame: right before the bronchoscopy procedure
measure: patient nausea
timeFrame: right after the bronchoscopy procedure
measure: patient vomiting
timeFrame: right after the bronchoscopy procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02303184: Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Official title: TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Macular Edema
Retinal Vein Occlusion
Keywords: RVO
ME
Central Subfield Thickness
OCT
optical coherence tomography
cystoid macular edema
subretinal fluid
Eylea
aflibercept
anti-VEGF
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 46
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: A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).

Detailed description: A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion

Eligibility criteria: Inclusion Criteria:

* diagnosis of macular edema following RVO
* History of ME ≤ 12 months
* 20-70 letters inclusive BCVA using ETDRS

Exclusion Criteria:

* has had an IVT injection of anti-VEGF for RVO in the study eye
* has had a corticosteroid injection in the past 3 months in the study eye
* any uncontrolled ophthalmic condition in the study eye other than RVO

Primary outcomes:
measure: Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: San Diego
country: United States
state: California
city: Boynton Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Baltimore
country: United States
state: Maryland
city: Saint Louis
country: United States
state: Missouri
city: Winston-Salem
country: United States
state: North Carolina
city: Rapid City
country: United States
state: South Dakota
city: Abilene
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Thomas Ciulla, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01429584: The Effect of Interscalene Peripheral Nerve Block With 0.25% Bupivacaine vs 0.125% Bupivacaine on Lung Function
Official title: Investigation Into the Effect of 0.25% Bupivacaine for Interscalene Peripheral Nerve Block vs 0.125% Bupivacaine on Pulmonary Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaphragm Paralysis
Keywords: bupivacaine concentration
interscalene nerve block
diaphragm function
diaphragm weakness
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2011-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peripheral nerve blocks are used to provide post-operative pain relief. Nerve blocks in the neck, in the interscalene area, provide pain relief after shoulder surgery but can cause temporary weakness or paralysis of the diaphragm. The investigators hypothesized that a lower concentration of bupivacaine would cause less weakness of the diaphragm but still provide good pain relief. Lung function and pain control was studied after interscalene peripheral nerve block with 20 milliliters of 0.25% bupivacaine or 0.125% bupivacaine.

Detailed description: Prior to placement of interscalene brachial plexus peripheral nerve block (ISPNB), diaphragm function was assessed using ultrasound as normal, no movement, or paradoxical. Room air pulse oximetry (SpO2) was recorded. Patients were randomized to receive either 0.25% bupivacaine or 0.125% bupivacaine. ISPNB was performed using a coded syringe of the study drug, so that the anesthesiologists performing the nerve block, the patient, and the nurses assessing the patient were blinded as to the concentration. Patients were given a general endotracheal anesthesia for rotator cuff repair, and opioids were administered at the discretion of the attending anesthesiologist. When patients met criteria for PACU discharge, diaphragm function was again assessed using ultrasound and room air SpO2 was recorded.

Eligibility criteria: Inclusion Criteria:

* patients presenting for outpatient rotator cuff repair
* adults
* English as the primary language

Exclusion Criteria:

* evidence of peripheral nerve damage on affected side
* refusal of peripheral nerve block
* pregnant women
* lung disease, including obstructive sleep apnea
* chronic opioid use
* mental handicap

Primary outcomes:
measure: Abnormal Lung Function
timeFrame: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery
Secondary outcomes:
measure: Pain Relief
timeFrame: At discharge from the post-anesthesia care unit, within 5 hours of the completion of surgery
measure: Satisfaction With Pain Control
timeFrame: Within 30 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopaedics Center
state: Utah
Study officials:
affiliation: University of Utah
name: Elizabeth Thackeray, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Jeffrey Swenson, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05134779: De-convoluting Interactions Between Genes, the Cancer Environment, and the Immune System to Develop Therapies That Work for You
Official title: De-convoluting Interactions Between Genes, the Cancer Environment, and the Immune System to Develop Therapies That Work for You
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 400
Sex: FEMALE
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: breast cancer patients (BC), any stage irrespective of hormonal status will be eligible for this study.

Brief summary: This is a live biobank study for breast cancer (BC) patients where samples will be collected at inflection points in the course of the disease.

Detailed description: To test this hypothesis the investigators will focus on studying BC patients using an innovative approach, the DIGNITY Study (De-convoluting interactions between genes, the cancer environment, and the immune system to develop therapies that work for you) designed to building a live tissue biobank of Patient Derived Tumor Organoids (PDOs) derived from tumor at surgery, preceded or not by neoadjuvant therapy (NAT), and at recurrence/metastasis. BC patients enrolled in this study are consented to enable investigators to generate a biobank of tumor tissue (obtained from surgically removed excess that would otherwise be disposed off ) and matched blood cells ( obtained from an already existing line or a venipuncture ordered per standard of care testing) at key timepoints in their treatment course.

Eligibility criteria: Inclusion Criteria:

* All patients will historically proven BC are eligible to be on the study

Exclusion Criteria:

* Carriers of other cancers other than breast.

Primary outcomes:
measure: establish a live biobank for breast cancer patients
timeFrame: 60 months
Secondary outcomes:
measure: assess immune relevant genes from tumor biopsies
timeFrame: 60 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Brooklyn Methodist Hospital - NewYork Presbyterian
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Queens
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Silvia Formenti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04240379: Metacognition Assessment in Patient With Multiple Sclerosis
Official title: Metacognition Assessment in Patient With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Multiple Sclerosis Functional Composite (MSFC)
Metacognition
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
First posted: 2020-01-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be proposed to subject :

* Male or female with diagnosis of MS,
* admitted in neurological unit for passing the MSFC (Multiple Sclerosis Functionnal Composite) test
* who respect selection criteria.

Brief summary: This study will assessed the level of consciousness of MS patients suffering of cognitive and motor disorders. Understanding the awareness of the disease is crucial to allow better management of these patients. It has been shown, for other neurological pathologies, that a lack of awareness of deficits leads to inefficient rehabilitation and a disorder of understanding the impact of deficits in daily activities. Metacognition could be altered with age, so we will include participants between 18 and 60 years old.

Detailed description: Subject who have to do neurological assessement by the Multiple sclerosis Functional Composite (MSFC) will be enrolled.

The patient will estimate the time to undergo the test. This time will be compared to the time really make by the patient to realise test.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of multiple sclerosis
* Voluntary for participate to study

Exclusion Criteria:

* Neurological disease other than Multiple Sclerosis
* psychiatric disease, other than depressiveness
* illicit substance abuse
* Persons referred to in Articles L1121-5 to 8 of the French Public Health Code

Primary outcomes:
measure: Metacognitive precision
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Chu Grenoble Alpes
Study officials:
References:
citation: Calabrese P. Neuropsychology of multiple sclerosis--an overview. J Neurol. 2006 Feb;253 Suppl 1:I10-5. doi: 10.1007/s00415-006-1103-1.
citation: Chiaravalloti ND, DeLuca J. Cognitive impairment in multiple sclerosis. Lancet Neurol. 2008 Dec;7(12):1139-51. doi: 10.1016/S1474-4422(08)70259-X.
citation: Beatty WW, Monson N. Metamemory in multiple sclerosis. J Clin Exp Neuropsychol. 1991 Mar;13(2):309-27. doi: 10.1080/01688639108401046.
Clinical trial NCT01358279: Transcranial Direct Current Stimulation for Migraine Attack
Official title: Manho Kim, MD, PhD Professor, Neurology Seoul National University Hospital,
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Migraine
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-05-23
Enrollment: 32
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is conducted to investigate the therapeutic efficacy and safety of transcranial direct current stimulation (tDCS) over the primary motor cortex of patients with acute migraine attack.


Eligibility criteria: Inclusion Criteria:

* Aged 17-70 years
* Migraine

  * With or without aura
  * The first attack of migraine was earlier than 50 years of age
  * One to 8 moderate to severe migraine attacks per month in the 2 months preceding the screening
* Willing and able to give written informed consent
* Able to read, comprehend and complete the diary form

Exclusion Criteria:

* Not able to distinguish between migraine and non-migraine headache
* Combined headache, including the tension type headache and medication overuse headache
* Pregnant, actively trying to become pregnant or breast-feeding women
* Uncontrolled and significant medical illness
* Vertebrobasilar or hemiplegic migraine according to the International Headache Society diagnostic criteria
* Having intracranial metal implants or a cardiac pacemaker
* A history of epilepsy or other organic brain disorders
* A history of psychological diseases
* Having changed medications for migraine within 1 month before giving us informed consent
* Drug abuser or alcoholics

Primary outcomes:
measure: Number of participants who experienced pain relief of one level or more
timeFrame: at 2h post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT02248779: Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation
Official title: Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cancer Survivors Treated With Abdominal Radiation
Keywords: Diabetes Risk
14-202
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Childhood cancer survivors followed by the Pediatric Long-Term Follow-Up Program or Adult Long-Term Follow-Up Program will be recruited for the current study.

Brief summary: The purpose of this study is to better understand the risk factors and causes of diabetes in people who received radiation to the abdomen as children. The investigators hope this information will allow them to improve how they screen people at risk for diabetes and how they treat patients in the future.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of childhood cancer between 0-21 years of age
* Prior treatment with abdominal radiation at MSKCC
* Two or more years from completion of therapy
* Records of cancer diagnosis and treatment (including radiation records) available

Exclusion Criteria:

* Known diagnosis of diabetes
* Previous treatment with any radiation impacting the brain (cranial radiation, craniospinal radiation, total body irradiation)
* Neurocognitive deficits that impair ability to give informed consent or assent
* Patients predicted to have difficult intravenous access, who will likely require multiple venipuncture attempts

Primary outcomes:
measure: characterize β cell function
timeFrame: 2 years
measure: insulin sensitivity
timeFrame: 2 years
Secondary outcomes:
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: Danielle N. Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04380779: Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses
Official title: Prevalence of Severe Bleeding in COVID-19 Patients Treated With Higher Than Recommended Thromboprophylaxis Doses (BLEEDING Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Foundation for the study of VTE diseases. (FUENTE)
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 2430
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses and admitted to hospital

Brief summary: The main objectives are:

* To establish the prevalence of major bleeding in patients treated with higher than recommended thromboprophylaxis doses.
* To identify variables associated to higher risk of bleeding.


Eligibility criteria: Inclusion Criteria:

* Patients infected with COVID-19 treated with higher than recommended thromboprophylaxis doses.
* Admission to hospital.

Exclusion Criteria:

* Patients treated with ECMO (Extracorporeal membrane oxygenation).

Primary outcomes:
measure: Bleeding events and complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Manuel Monreal
state: Barcelona
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Manuel Monreal
role: STUDY_CHAIR
References:
Clinical trial NCT01600079: ZOSTAVAX™ (Zoster Vaccine Live) Long-term Effectiveness Study (V211-024)
Official title: Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Herpes Zoster
Shingles
Keywords: Varicella-zoster vaccine
herpes zoster
shingles
Varicella-zoster virus
postherpetic neuralgia
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
First posted: 2012-05-16
Enrollment: 1505647
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of Kaiser Permanente Northern California (KPNC)

Brief summary: This study will describe the impact of vaccination with ZOSTAVAX™ on the epidemiology of herpes zoster (HZ) in a cohort of vaccinated participants 50 years or age or older, compared to a cohort of unvaccinated participants.


Eligibility criteria: Inclusion Criteria:

* Participants with continuous Kaiser Permanente Northern California (KPNC) membership since becoming age-eligible for ZOSTAVAX™ and with 12 months of continuous enrollment in KPNC before their study start date

Exclusion Criteria:

Primary outcomes:
measure: Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79 ≥80) at Vaccination
timeFrame: 10 years
measure: Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination
timeFrame: 10 years
Secondary outcomes:
measure: Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79, ≥80) at Vaccination
timeFrame: 10 years
measure: Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Klein NP, Bartlett J, Fireman B, Marks MA, Hansen J, Lewis E, Aukes L, Saddier P. Long-term effectiveness of zoster vaccine live for postherpetic neuralgia prevention. Vaccine. 2019 Aug 23;37(36):5422-5427. doi: 10.1016/j.vaccine.2019.07.004. Epub 2019 Jul 10.
citation: Baxter R, Bartlett J, Fireman B, Marks M, Hansen J, Lewis E, Aukes L, Chen Y, Klein NP, Saddier P. Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort Study. Am J Epidemiol. 2018 Jan 1;187(1):161-169. doi: 10.1093/aje/kwx245.