louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04734340: The Study of EIT-guided Ventilation Strategy on ARDS Patients
Official title: The Study of EIT-guided Ventilation Strategy on ARDS Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ARDS
Pulmonary Perfusion
Keywords: EIT
ARDS
pulmonary perfusion
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a clinical randomized controlled study.The objective of this study is to compare the prognosis of patients with ARDS between eit-v / q-oriented individualized ventilation strategy and traditional lung protection ventilation strategy, and to establish the demonstration application of eit-v / q-oriented ventilation strategy in ARDS


Eligibility criteria: Inclusion Criteria:

1. According to ARDS Berlin standard, ARDS, PaO2 / FiO2 \< 200mmhg, peep \> 5cmh2o;
2. According to clinical judgment, lung recruitment therapy is needed due to hypoxemia;
3. The subjects or their families signed informed consent.
4. Admission to ICU was less than 72 hours;
5. The estimated duration of mechanical ventilation was more than or equal to 48 hours;
6. Age ≥ 18 years old and ≤ 80 years old;

Exclusion Criteria:

1. The patients with heart implants could not be monitored by EIT;
2. Patients or their families refused to participate in the study;
3. Hypernatremia

Primary outcomes:
measure: ventilation free days
timeFrame: 1 Day
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00913640: Prospective Memory in Parkinson's Disease
Official title: Prospective Memory in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Memory
Prospective Memory
Parkinson's Disease
Keywords: Prospective Memory Performance
Prospective Memory Outcome
Parkinson's Disease
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-06-04
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Movement Disorder Clinic at Washington University St. Louis

Brief summary: The investigators tested whether prospective memory is impaired in individuals with Parkinson's Disease compared to controls using reliable and validated experimental measures. Also, the investigators assessed the impact of Parkinson's medication on prospective memory performance in PD to better estimate prospective memory function in PD patients' everyday (chronically treated) life.


Eligibility criteria: Inclusion Criteria:

* PD Group:

  * Clinically definite PD
  * 40-70 years old
  * Hoehn and Yahr stage I,II,III
  * Currently treated with Levodopa/carbidopa
* Control Group:

  * 40-70 years old
  * Spouses of PD Group preferred

Exclusion Criteria:

* PD Group and Control Group:

  * Significant neurological problems
  * Significant current psychiatric diagnoses
  * Mini Mental Status Exam score \< 24 (MMSE)
  * Any significant abnormality on brain imaging
  * MPTP exposure
  * Control Participants met the same exclusion criteria described above as well as a biological family history of PD

Primary outcomes:
measure: Virtual Week
timeFrame: One session at baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Tamara G Hershey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foster ER, Rose NS, McDaniel MA, Rendell PG. Prospective memory in Parkinson disease during a virtual week: effects of both prospective and retrospective demands. Neuropsychology. 2013 Mar;27(2):170-81. doi: 10.1037/a0031946.
Clinical trial NCT04834440: Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)
Official title: Ropivacaine Use in Femoral Nerve Block; What is the Minimal Effective Analgesic Concentration (MEAC 90)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Healthpoint Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the minimal effective ropivacaine concentration required to provide adequate analgesic femoral nerve block in 90% of patients (MEAC90)

Detailed description: * Before induction of GA, all patients will receive sciatic, obturator, lateral femoral cutaneous and femoral nerve blocks.
* The femoral nerve block will be performed using 15ml of ropivacaine which concentration relied on the response of the previous patient.
* Based on biased-coin design up-down sequential method: when a patient has a negative response, the next patient will receive a concentration 0.01% w/v higher. However if he has a positive response, the next patient will be randomized to receive either the same ropivacaine concentration or a concentration 0.01% w/v less.
* Patients with pain free recovery will be considered to have positive response.
* Patients' responses will be analyzed to calculate the MEAC90

Eligibility criteria: Inclusion Criteria:

* Patients, who are scheduled for knee ligament reconstruction

Exclusion Criteria:

* \<18 y,
* ASA physical class greater \>III

  * BMI \>40 has any contraindication for medications or techniques used in the study

Primary outcomes:
measure: effective analgesic femoral nerve block
timeFrame: in recovery unit (one hour after surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Healthpoint Hospital
Study officials:
References:
Clinical trial NCT01167140: Cryo-Touch II for the Treatment of Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Facial Wrinkles
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2010-07-22
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch II device for the treatment of wrinkles.


Eligibility criteria: Inclusion Criteria:

* Age 30-70 years
* Subject has a glabellar and/or forehead wrinkle rating by investigator of at least 1 at rest on the 5-point Wrinkle Scale (5WS)\*
* Subject has signed IRB-approved informed consent form

Exclusion Criteria:

* Subject takes any medication or dietary supplement regularly that affects blood clotting (e.g., Coumadin, aspirin, clopidogrel) or increases the risk of bleeding/bruising
* Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites
* The investigator is unable to substantially lessen facial lines by physical separation
* Subject has undergone another facial cosmetic procedures at or above the level of the cheekbones within the past 6 months
* Subject is participating in another facial cosmetic research study

Patient has any of following conditions:

* History of facial nerve palsy
* Marked facial asymmetry
* Ptosis
* Excessive dermatochalasis
* Deep dermal scarring
* Thick sebaceous skin
* History of neuromuscular disorder
* Chronic dry eye symptoms
* Allergy or intolerance to lidocaine

Primary outcomes:
measure: Number of Participants With Effectiveness and Safety Success
timeFrame: Up to 4 months
Secondary outcomes:
measure: Participants With One Point Improvement in Line Severity
timeFrame: Baseline and up to 4 months
measure: Participants With an Improvement in Global Appearance
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: The Aesthetics Research Center
state: California
Study officials:
References:
Clinical trial NCT01057940: Pilot to Assess DBE as a Rescue Technique for Failed PEJ
Official title: A Pilot Study to Assess the Feasibility of Double Balloon Enteroscopy as a Rescue Technique for Failed Direct Percutaneous Endoscopic Jejunostomy Tube Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Who Have Failed Conventional DPEJ Placement
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have failed conventional DPEJ placement

Brief summary: Is DBE(double balloon enteroscopy)-assisted DPEJ(direct percutaneous endoscopic jejunostomy) a viable option in patients who have failed conventional DPEJ placement and who otherwise would require surgical jejunostomy or parenteral nutrition.

Detailed description: DBE-assisted DPEJ is a viable option in patients who have failed conventional DPEJ placement and who otherwise would require surgical jejunostomy or parenteral nutrition.

Eligibility criteria: Patients:

Patients who have failed conventional DPEJ tube placement will be offered participation in the study. DBE-assisted DPEJ will be performed on a subsequent day following failed DPEJ. Patients who do not wish to undergo an attempt at DBE-assisted DPEJ will follow-up with their primary caregiver for alternative means of feeding tube placement (e.g., surgical jejunostomy).

Inclusion criteria:

1. Age \> 18 years old
2. Appropriate indication for DPEJ tube placement and Nutrition consult approval
3. Absence of bleeding disorder
4. Platelet count \> 50,000 and INR \< 1.5
5. Ability to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Louis Wong kee song, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03683940: Pilot Study of High Risk Lung Cancer Screening
Official title: A Prospective Pilot Study of Lung Cancer Screening in Patients at High Risk for Lung Cancer Who Do Not Meet Current Screening Guidelines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Pilot Study
High Risk
Prospective
Screening
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines.

Detailed description: This study is a prospective trial of 200 individuals at high risk for lung cancer who are not eligible for lung cancer screening under current screening guidelines. Potential subject's 6 yr lung cancer risk must exceed 1.5% by the Tammamagi PLCO2012m calculator. Patients will undergo a non contrast CT chest for lung cancer screening. This cutoff should encompass in excess of 80% of all lung cancer cases (10). However, in patients 78-82 years old we will set the 6 yr lung cancer risk threshold at 4.0% as these patients will typically have other competing risks of death and this may potentially limit screening benefit in these older individuals.

Eligibility criteria: Inclusion Criteria:

1. Adult 40-82 yrs of age.
2. Presenting for lung cancer screening evaluation.
3. Calculated 6 yr lung cancer risk \>1.5% for patients 40-77 years of age or \>4% for patients 78-82 years of age.
4. Able and willing to provide informed consent.

Exclusion Criteria:

1. Eligible for clinically indicated lung cancer screening (55-80 yr old, \>30 pky smoking history, still smoking or quit smoking within the last 15 yr).
2. Chest CT performed within the last year.
3. Life expectancy less than 6 months.
4. Symptoms clinically consistent with lung cancer.
5. Unable or unwilling to undergo treatment for lung cancer.
6. Any individual who does not give oral and written consent for participation.

Primary outcomes:
measure: Lung Cancer Screening
timeFrame: Duration of the study, up to 3 years
measure: Medical Outcomes
timeFrame: Duration of the study, up to 3 years
measure: Medical Outcomes
timeFrame: Duration of the study, up to 3 years
measure: Economic Outcomes
timeFrame: Duration of the study, up to 3 years
measure: Economic Outcomes
timeFrame: Duration of the study, up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Melissa New, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02837640: Studying a Potential Protective Effect of L-Dopa on Retinitis Pigmentosa
Official title: The Effect of L-Dopa on the Progression of Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Retinitis Pigmentosa
Keywords: Retinitis Pigmentosa
Levodopa
Lead sponsor: Beirut Eye Specialist Hospital
Sponsor class: OTHER
First posted: 2016-07-19
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of L-Dopa on the progression of retinitis pigmentosa.

Detailed description: Retinitis pigmentosa is a group of progressive hereditary diseases that diffusely affects the functioning of photoreceptors and the pigment epithelium. It may be speculated that a protective effect on the pigment epithelium, as it is supposed for L-Dopa, can slow the progression of the disease or even lead to an, at least transient, improvement of visual functions. To evaluate the effect of L-Dopa on retinitis pigmentosa progression, visual acuity, electroretinogram and visual field will be preformed regularly.

Eligibility criteria: Inclusion Criteria:

* All confirmed cases of retinitis pigmentosa
* VA of 20/400 or better

Exclusion Criteria:

* Advanced stages of retinitis pigmentosa with poor best corrected visual acuity (less than 20/400)
* co-existing eye morbidities interfering with retinitis pigmentosa (glaucoma, retinal detachment...)
* Flat electroretinogram
* Intolerance or counterindication to drug
* Unability for long-term follow-up

Primary outcomes:
measure: Change in Electroretinogram
timeFrame: Baseline, 1 year, 2 years, 5 years
Secondary outcomes:
measure: Change in Visual Acuity
timeFrame: Baseline, 6 months, 1 year, 2 years, 5 years
measure: Change in Visual Field
timeFrame: Baseline, 1 year, 2 years, 5 years
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Beirut Eye Specialist Hospital
Study officials:
affiliation: Beirut Eye Specialist Hospital
name: Elias F. Jarade, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brilliant MH, Vaziri K, Connor TB Jr, Schwartz SG, Carroll JJ, McCarty CA, Schrodi SJ, Hebbring SJ, Kishor KS, Flynn HW Jr, Moshfeghi AA, Moshfeghi DM, Fini ME, McKay BS. Mining Retrospective Data for Virtual Prospective Drug Repurposing: L-DOPA and Age-related Macular Degeneration. Am J Med. 2016 Mar;129(3):292-8. doi: 10.1016/j.amjmed.2015.10.015. Epub 2015 Oct 30.
Clinical trial NCT00294840: Dynamic PET acquisition-a Quantitative Technique for Grading of Malignant Tumors and Prediction of Response to Treatment
Official title: Dynamic FDG-PET in Aggressive Lymphoma and Pancreas Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 70
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: Patients with pancreatric cancer

Brief summary: To assess a quantitative kinetic model of FDG uptake measurement using PET in patients with aggressive Non-Hodgkin's lymphoma and cancer of the pancreas, malignancies with known variability in disease aggressiveness and prognosis, for optimized tailoring of the therapeutic strategy in the individual patient.


Eligibility criteria: Inclusion Criteria:

* age\>18
* newly diagnosed untreated aggressive NHL
* newly diagnosed untreated cancer of pancreas

Exclusion Criteria:

* none

Primary outcomes:
measure: The impact of the imaging modality on patient management
timeFrame: 5 years
Secondary outcomes:
measure: patient management
timeFrame: 10 years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Ora Israel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03804840: Developing a Mobile Method to Measure THC-induced Impairment
Official title: A Mobile Prototype for a Field Sobriety Test for Cannabis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Measuring THC-induced Cognitive Impairment Using a Mobile Application
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Marijuana use, for both recreational and therapeutic purposes, is becoming increasingly common as states remove restrictions on use. The increased use raises new concern about the safety of this drug, including its ability to impair basic cognitive and psychomotor tasks, and whether the users are aware of their impairment. We propose to design a simple performance test that users can use in the field, using a cell phone, to assess their level of impairment relative to their own drug-free state. In this preliminary study, we will compare participants' simple task performance after a known dose of delta-9-tetrahydrocannabinol (THC), or placebo, administered under double-blind conditions. In our app the participants will be asked to gauge their own perceived level of impairment (as determined by self-ratings and judgments of impairment) as well as their actual impairment (as gauged by the app), providing important feedback and training about their ability to detect impairment.


Eligibility criteria: Inclusion Criteria:

1. 18-35 years old, males and females (N=44; 36 completers; 18 men, 18 women)
2. BMI 19-26
3. High school education, fluent in English
4. Experienced non-daily marijuana users

   Exclusion Criteria:
5. Current drug/alcohol abuse or dependence
6. Past year drug/alcohol dependence
7. Diagnosis with drug treatment for psychosis/bipolar/schizophrenia
8. Past year major depression
9. Panic/anxiety attacks in past 2 months
10. Post Traumatic Stress Disorder
11. Attention Deficit Hyperactivity Disorder
12. Cardiovascular illness, high blood pressure, abnormal EKG
13. Current medications
14. Pregnant or planning to become pregnant

Primary outcomes:
measure: Simple Reaction Time
timeFrame: Assessed two hour post intervention at peak effects
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Elisa Pabon
role: PRINCIPAL_INVESTIGATOR
References:
citation: Broyd SJ, van Hell HH, Beale C, Yucel M, Solowij N. Acute and Chronic Effects of Cannabinoids on Human Cognition-A Systematic Review. Biol Psychiatry. 2016 Apr 1;79(7):557-67. doi: 10.1016/j.biopsych.2015.12.002. Epub 2015 Dec 8.
citation: Hartman RL, Huestis MA. Cannabis effects on driving skills. Clin Chem. 2013 Mar;59(3):478-92. doi: 10.1373/clinchem.2012.194381. Epub 2012 Dec 7.
Clinical trial NCT05147740: Study to Assess Switching to B/F/TAF in Treatment Experienced People With HIV Who Are at Least 65 Years of Age
Official title: Switching to a Fixed Dose Combination of Biktarvy in Treatment Experienced People With HIV Who Are Currently Virologically Suppressed and at Least 65 Years of Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV-1-infection
Keywords: HIV
QOL
Elderly
Lead sponsor: Desert AIDS Project
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2021-12-07
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess patient reported treatment satisfaction and medication tolerability in virologically suppressed HIV-1 infected adults who are at least 65 years of age who switch to a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination regimen.


Eligibility criteria: Key Inclusion Criteria:

1. Be at least 65 years of age at the time of signing the informed consent form.
2. Be currently receiving an antiretroviral regimen for ≥ 3 months prior to the screening visit.
3. Have documented plasma HIV-1 RNA \< 50 copies/mL for a minimum of 3 months on current ART regimen.
4. Have a plasma HIV-1 RNA \< 50 copies/mL at screening visit.

Key Exclusion Criteria:

1. Have resistance to tenofovir (K65R/E/N, ≥3 thymidine analogue mutations or T69-insertions), primary INSTI-resistance, or a history of failure on an INSTI-based regimen.
2. Have been treated with B/F/TAF
3. Participants with CrCl \<30 mL/min
4. Known or suspected severe hepatic impairment (Child-Pugh Class C)

Primary outcomes:
measure: Improvement in treatment satisfaction by a change in total satisfaction scale as measured by the HIVTSQ survey.
timeFrame: 48 weeks
measure: Improvement in overall quality of life as characterized by a change in total satisfaction scale as measured by the HIVDQoL survey.
timeFrame: 48 weeks
Secondary outcomes:
measure: Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at W24
timeFrame: Week 24
measure: Percentage of all participants who have plasma HIV-1 RNA Viral Load < 50 c/mL at end of study
timeFrame: Week 48
measure: Percentage of Participants experiencing Adverse Events (AEs) through End of Study (Week 48)
timeFrame: Week 48
measure: Percentage of patients who reduced their number of total medications from baseline.
timeFrame: Week 48
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: DAP Health
state: California
Study officials:
affiliation: Dap Health
name: Tulika Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: