louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04807101: Sedation Regimens in GI Endoscopy
Official title: A Randomized Study of Midazolam and Fentanyl Versus Midazolam Alone for Sedation in Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Anesthesia
Endoscopy
Colonoscopy
Conscious Sedation
Lead sponsor: Greg S Cohen MD LLC
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a noninferiority study designed to examine whether conscious sedation with midazolam alone results in efficacy and safety that is not inferior to the combination of midazolam and fentanyl. English-speaking patients ≥18 years old and ≤75 years old presenting for GI endoscopy planned with conscious sedation using midazolam and fentanyl, will be randomized 1:1 to single agent sedation with midazolam or combination sedation with midazolam and fentanyl. Participants will be blinded to the choice of sedation. Sedation quality and adverse events will be measured with a validated patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS) \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. Endoscopic quality measures in the 2 study groups will be collected by retrospective chart review, as an additional metric to ensure the quality of the procedure is not compromised by the choice of sedation.


Eligibility criteria: Inclusion Criteria:

* English-speaking patients
* Patients ≥18 years old and ≤75 years old
* Outpatients presenting for EGD and/or colonoscopy planned with conscious sedation using midazolam and fentanyl
* Patients presenting for endoscopic procedures with no GI fellow or trainee involvement in the procedure

Exclusion Criteria:

* Patients with an allergy or prior adverse event to either fentanyl or midazolam
* Patients who have previously not tolerated endoscopy with conscious sedation and require monitored anesthesia care (MAC)
* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Vulnerable populations, including cognitively impaired adults and adults who are otherwise unable to consent

Primary outcomes:
measure: Pain Felt During the Procedure
timeFrame: 1 day
measure: Adequacy of Sedation
timeFrame: 1 day
Secondary outcomes:
measure: Patient Reported Nausea
timeFrame: 1 day
measure: Adverse Events
timeFrame: 1 day
measure: Cecal Intubation Rate
timeFrame: through study completion, an average of 1 year
measure: Cecal Intubation Time
timeFrame: through study completion, an average of 1 year
measure: Colonoscopy Withdrawal Time
timeFrame: through study completion, an average of 1 year
measure: Adenoma Detection Rate
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT01516801: A Pragmatic Trial of the Effect of a Mailed Patient Flyer About Prostate Specific Antigen (PSA) Testing Prior to an Annual Exam
Official title: A Pragmatic Randomized Trial of the Effect of a Mailed Patient Flyer About PSA Testing Prior to an Annual Exam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer Screening
Keywords: Prostate Cancer Screening
Pragmatic Trial
Health Literacy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2012-01-25
Enrollment: 303
Sex: MALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 1. Does a one-page American College of Physicians educational flyer about the pros and cons of prostate cancer screening sent to men within two weeks of their scheduled annual health examinations in a general medicine clinic result in a different rate of prostate cancer screening than among men who were not sent the flyer?
2. Do patients find the flyer useful and understandable?

Context: The use of prostate specific antigen (PSA) screening for prostate cancer is controversial because of a lack of evidence that such screening saves lives when applied within a population and because such testing can lead to invasive downstream biopsies and aggressive treatment that is associated with a high risk of permanent side effects (e.g. impotence, incontinence). Almost all professional societies (American Cancer Society, American Urologic Association, American College of Physicians, United States Preventive Services Task Force) advocate that patients receive education and complete an informed decision-making discussion with their medical providers about the pros and cons of the PSA test, as well as their personal preferences, before proceeding with this test. Unfortunately, despite these recommendations, there is seldom sufficient time during clinic visits to achieve this goal.


Eligibility criteria: Inclusion Criteria:

* Men age 50-74 who were cared for in a general internal medicine clinic
* had scheduled an annual health exam
* had not had a PSA test within the previous year

Exclusion Criteria:

* active cancer diagnosis
* history of prostate cancer
* need for PSA surveillance

Primary outcomes:
measure: Rate of PSA testing
timeFrame: At the time of the annual exam (within two weeks of their annual physical)
measure: Rate of documented PSA discussions
timeFrame: At the time of the annual exam (within two weeks of their annual physical)
Secondary outcomes:
measure: Flyer acceptability
timeFrame: Within two weeks of the annual exam
measure: Perceived participation
timeFrame: Within two weeks
measure: Prostate Cancer Screening knowledge
timeFrame: Within two weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
References:
Clinical trial NCT03657901: Sleep, Stress and Learning: an Experimental Pilot Study
Official title: Sleep, Stress and Learning: an Experimental Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Sleep
Lead sponsor: University of Helsinki
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized control trial with a cross-over design.
Primary purpose: BASIC_SCIENCE

Brief summary: To investigate the efficiency and effect of a programmed slow-breathing exercise in the evening to the heart rate variability, sleep quality and memory performance over night.

Detailed description: Background Stress and increased alertness in the evening are major reasons for sleep onset problems, poor sleep and insomnia symptoms. For instance, increased amount of REM, and decreased amount of slow wave sleep may result. Also, the function of sleep in memory consolidation may suffer. They also affect the sleep structure and continuity during the night. They are highly prevalent phenomena among the entire population, including healthy adults and children. However, at the physiological level, the concept of evening alertness is still understudied and often neglected.

Recent advances show that breathing exercise is an efficient tool to reduce stress. However, its use specifically prior to sleep onset and with measurement sleep stages and their microstructures with sleep EEG has been little been studied before. The overall objective of this study is to explore interrelations of stress, learning and sleep quality.

Eligibility criteria: Inclusion Criteria:

* age 20-45

Exclusion Criteria:

* chronic disease requiring daily medication, acute sickness (e.g. a flu), jet lag from a recent travel, current diagnosed sleep disorder (such as snoring or insomnia) and any use of medication affecting autonomic nervous system function or sleep.

Primary outcomes:
measure: Sleep structure
timeFrame: Change from night 1 to night 2
Secondary outcomes:
measure: Sleep spindle duration
timeFrame: Change from night 1 to night 2
measure: Sleep spindle power
timeFrame: Change from night 1 to night 2
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: University of Helsinki
Study officials:
affiliation: University of Helsinki
name: Anu-Katriina Pesonen, prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05808881: Clinical Outcomes From Nalmefene
Official title: Clinical Outcomes From Injectable Nalmefene in the Emergency Department (COINED)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Opioid Overdose
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2023-04-12
Enrollment: 0
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 assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.


Eligibility criteria: Inclusion Criteria:

1. Presumed or known opioid overdose in community settings.
2. Experiencing clinically significant respiratory depression based on appropriate medical judgement.
3. Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.)
4. Pre-hospital naloxone administration is allowed.

Exclusion Criteria:

1. Patient age known or estimated to be less than 18 years.
2. Patient has one or more additional documented acute medical, traumatic, toxicologic, or psychiatric conditions that would extend length of treatment or adversely alter the clinical outcome.
3. Cardiac arrest, secondary to opioid intoxication.
4. Arrested, jailed, or imprisoned patients.
5. Inappropriate for the study per judgement of research team.

Primary outcomes:
measure: Reversal of Respiratory Depression
timeFrame: Up to 3 hours
Secondary outcomes:
measure: Time to Reversal from administration of opioid antagonist
timeFrame: Up to 3 hours
measure: Recurrence of Respiratory Depression
timeFrame: Up to 3 hours
measure: ED Disposition
timeFrame: Up to 3 hours
measure: Drug Dosing
timeFrame: Up to 3 hours
measure: Richmond-Agitation Sedation Scale (RASS) Score
timeFrame: Up to 3 hours
measure: Clinical Opioid Withdrawal Scale (COWS) Score
timeFrame: Up to 3 hours
measure: Oxygen saturation level
timeFrame: Up to 3 hours
measure: Length of time during ED encounter
timeFrame: Up to 3 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01170481: Assessment of Retinal Nerve Fibre Layer by Optical Coherence Tomography in Uveitis Patients With Papilloedema
Official title: Retinal Nerve Fibre Layer in Uveitic Secondary Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Glaucoma
Keywords: anterior and intermediate uveitis
papilloedema
Lead sponsor: St. Franziskus Hospital
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients with anterior or intermediate uveitis and papillooedema in fluoreszein angiography.

Brief summary: Assessment of optic disc morphology can be difficult in patients with uveitis and papilloedema. Therefore different optical coherence tomography (OCT) and laser scanning techniques may help to detect damage to the retinal nerve fibre layer.


Eligibility criteria: Inclusion Criteria:

* anterior or intermediate uveitis
* papilloedema
* glaucoma

Exclusion Criteria:

* dense cataract
* dense vitreous opacification
* circular posterior synechiae

Primary outcomes:
measure: Alterations of retinal nerve fibre layer by optical coherence tomography
timeFrame: once at study entry
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Ophthalmology at St.-Franziskus Hospital
Study officials:
affiliation: Department at St. Franziskus Hospital
name: Arnd Heiligenhaus, MD
role: STUDY_CHAIR
References:
citation: Heinz C, Kogelboom K, Heiligenhaus A. Influence of optic disc leakage on objective optic nerve head assessment in patients with uveitis. Graefes Arch Clin Exp Ophthalmol. 2016 Feb;254(2):361-4. doi: 10.1007/s00417-015-3218-5. Epub 2015 Nov 18.
Clinical trial NCT06789081: GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient with Alveolar Soft Part Sarcoma (CLIC-YYC-GPNMB-02)
Official title: GPNMB-targeting Chimeric Antigen Receptor T-Cell Therapy (GCAR1) for a Patient with Alveolar Soft Part Sarcoma (CLIC-YYC-GPNMB-02)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Alveolar Soft Part Sarcoma
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Patient Study (SPS)
Primary purpose: TREATMENT

Brief summary: CLIC-YYC-GPNMB-02 is a Single Patient Study (SPS) developed according to the Health Canada template and guidelines released in 2019 for studies to access therapies not otherwise available to patients, in the situation where there are no options of treatment or cure remaining. The patient under consideration for CLIC-YYC-GPNMB-02 has progressive metastatic alveolar soft part sarcoma (ASPS). We propose to treat the patient with GCAR1, a patient-specific cell therapy product containing a mixture of autologous lymphocytes transduced with a lentiviral vector containing a chimeric antigen receptor (CAR) that enables the specific targeting towards tumor cells expressing the cell surface protein glycoprotein non-metastatic B (GPNMB).


Eligibility criteria: Inclusion Criteria:

* Completion of Informed Consent Form
* Adequate organ function, defined as creatinine clearance \>30 ml/min and LVEF \>45%.

Exclusion Criteria:

* Any active uncontrolled infection, pregnancy or nursing.

Primary outcomes:
measure: Assess for anti-tumor activity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04209881: Ovarian Reserve and Ankylosing Spondylitis
Official title: Evaluation of Ovarian Reserve Using Anti-müllerian Hormone and Antral Follicle Count in Ankylosing Spondylitis: Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Diseases
Ankylosing Spondylitis
Anti-Mullerian Hormone Deficiency
Keywords: Ankylosing spondylitis
fertility
anti-müllerian hormone
ovarian reserve
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women who are diagnosed with ankylosing spondylitis will form the study group.

Brief summary: The aim of this study was to determine the status of ovarian reserve in patients with ankylosing spondylitis (AS) using anti-mullerian hormone (AMH) level and antral follicle count (AFC). Women with AS and women controls diagnosed according to the classification criteria proposed by the American-European Consensus Group will be included in the study. Ovarian reserve will be evaluated in terms of clinical findings, AFC and serum AMH and reproductive hormone levels.

Researchers predict that the ovarian reserve may be reduced in patients with AS due to the autoimmune process and the pathophysiology of the disease. Serum AMH and ovarian AFC may be useful for assessing ovarian reserve. It is aimed to determine the course of ovarian reserve abnormalities and the best possible biomarkers of reduced ovarian reserve in patients with AS.


Eligibility criteria: Inclusion Criteria:

* regular menstruation with intervals of 21-35 days;
* cycle length variations \<4 days;
* both ovaries still present

Exclusion Criteria:

* history of liver failure;
* diagnosed malignancy;
* cigarette smoking;
* chronic renal failure;
* known infertility;
* presence of gynecological abnormalities such as abnormal uterine bleeding or menorrhagia;
* history of ovarian surgery;
* history of hormone preparation (including corticosteroids) use or use of herbal products within 3 months;
* diagnosis of polycystic ovary syndrome.

Primary outcomes:
measure: anti-müllerian hormone (AMH)
timeFrame: 3 days
measure: antral follicle count (AFC)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
citation: Yalcin Bahat P, Kadirogullari P, Topbas Selcuki NF, Yucel B, Cakmak K, Ureyen Ozdemir E. Ovarian reserve in patients with ankylosing spondylitis. Arch Gynecol Obstet. 2021 Jan;303(1):189-193. doi: 10.1007/s00404-020-05824-8. Epub 2020 Oct 8.
Clinical trial NCT01989481: Predicting the Outcome of Total Knee Arthroplasty and Spinal Surgeon
Official title: Prospective Study of Risk Factors and Outcomes Following Total Knee Arthroplasty and Spinal Surgeon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis;
Intervertebral Disc Degeneration
Lead sponsor: Beijing Jishuitan Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Peking University Third Hospital
name: Chinese PLA General Hospital
name: Beijing Hospital
First posted: 2013-11-21
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients; Patients have been diagnosed with osteoarthritis or disc degeneration disease.

Brief summary: The purpose of this observational study is to investigate the preoperative and operative factor of pain and functional outcome at one years following total knee arthroplasty and spinal surgeon.


Eligibility criteria: Inclusion Criteria:

1. The patients have been waiting for surgery for treatment of osteoarthritis or disc degeneration disease.
2. Must be between 18 and 65 years of age, of either sex.
3. Must demonstrate willingness to participate in the study by signing the written informed consent.

Exclusion Criteria:

1. Patients with Mandatory spondylitis, infections, neoplasms, inflammation, deformities, or previous surgery of spine or knee.
2. The patient is participating in an interventional clinical trial or has in an interventional clinical trial within 30 days prior to enrollment.

Primary outcomes:
measure: Change of functional score over time in the patients after operation
timeFrame: 3, 6, 12 months after surgery
Secondary outcomes:
measure: Change of quality of life score over time in the patients after operation
timeFrame: 3, 6, 12 monthes after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
Study officials:
affiliation: Beijing Jishuitan Hospital
name: Wei Tian, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02825381: One-Stage Exchange for Chronically Infected Total Hip Arthroplasty
Official title: Evaluation of Routine One-Stage Exchange Procedure for Chronically Infected Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Keywords: Arthroplasty
Hip
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
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: All cases operated on at the investigators institution between January 1, 2007 and November 30, 2010

Brief summary: The primary goal of the study is to evaluate the success rate of routine one-stage exchange for treatment of chronically infected total hip arthroplasty performed at the investigators institution, and to compare it to the current literature reporting success rate of selected one-stage exchange procedure or two-stage procedure.

The secondary goal is to detect the potential prognostic factors and potential selection criteria which may influence the success rate. The tested hypothesis is following: the success rate of routine one-stage exchange is lower than that of selected one-stage or two-stage procedure


Eligibility criteria: Inclusion Criteria:

* Chronically infected total hip Arthroplasty
* One-stage exchange procedure operated on at the investigators institution between January 1, 2007 and November 30, 2010

Exclusion Criteria:

* Patient refused to participate

Primary outcomes:
measure: infection of the prosthesis
timeFrame: For the duration of hospital stay, up to 1 year]
Secondary outcomes:
Other outcomes:
Locations:
city: Illkirch
country: France
facility: CCOM, Hôpitaux Universitaires de Strasbourg
state: Bas Rhin
Study officials:
References: