louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05847634: Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis
Official title: Depth of Sedation and Its Impact on Cerebrovascular Reactivity in Acute Respiratory Distress Syndrome: a Pilot Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ARDS, Human
Keywords: Near-Infrared Spectroscopy
Depth of Sedation
Intensive Care Unit
Electroencephalography
Acute Respiratory Distress Syndrome
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 40
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: Adults admitted to the ICU with ARDS

Brief summary: Investigation of the feasibility of monitoring processed transcutaneous electroencephalography (EEG), a method of interpreting brain activity, and near-infrared spectroscopy (NIRS), a method of determining levels of tissue oxygenation (StO2) in the brain, for patients with acute respiratory distress syndrome (ARDS) in the ICU.

Detailed description: The aim of this study is to determine the feasibility of using Masimo SedLine processed EEG monitoring and Masimo O3 NIRS to monitor optimal depth of sedation for patients with ARDS in the ICU.

To achieve this, non-invasive devices will be applied to the participant to measure processed EEG signal and StO2. Cerebrovascular reactivity will be determined using the following two values:

1. SEDopt: The optimal depth of sedation that minimizes correlation between StO2 and processed EEG monitoring.
2. MAPopt: The optimal blood pressure that minimizes correlation between StO2 and MAP.

Demographic information (age, sex, height, weight), past medical history, etiology of ARDS, Disease severity, routine bloodwork, and dose of sedation will also be documented.

Eligibility criteria: Inclusion Criteria:

* Adult patient admitted to the ICU
* ARDS confirmed according to the Berlin Definition
* Invasive mechanical ventilation
* Deep sedation and/or neuromuscular blockade required for ARDS treatment at the discretion of the treating medical team
* Application of monitoring devices feasible

Exclusion Criteria:

* More than 24 hours elapsed since ICU admission
* Death is deemed imminent and inevitable during the next 24 hours
* Known allergy to a textile component of the device
* Consent declined from patient or authorized third party
* The treating clinician believes that participation in the study would not be in the best interest of the patient

Primary outcomes:
measure: Recruitment
timeFrame: 20 months
measure: Data Quality
timeFrame: 7 days
Secondary outcomes:
measure: SEDopt
timeFrame: 7 days
measure: MAPopt
timeFrame: 7 days
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre Winnipeg
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Asher Mendelson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02852434: Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation
Official title: Self-administered Lidocaine Gel for Pain-control During Cervical Preparation for Dilation and Evacuation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain Management, Cervical Preparation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study seeks to compare self-administered lidocaine gel for pain control during cervical preparation for dilation and evacuation (D\&E) to paracervical block.


Eligibility criteria: Inclusion Criteria:

* Women 18 and older
* Intrauterine pregnancy ≥16 weeks gestation
* English speaking competency
* Willing and able to sign consent forms
* Agree to comply with study procedures

Exclusion Criteria:

* Women less than 18 years of age
* IV conscious sedation
* Known allergy to study medication (lidocaine)
* Any women not meeting inclusion criteria above will be excluded from participation

Primary outcomes:
measure: Pain Perceived at the Time of Laminaria or Osmotic Dilator Insertion
timeFrame: Intraoperative; Immediately (0-30 seconds) following cervical dilation
Secondary outcomes:
measure: Anticipated Pain Measured by Visual Analogue Scale
timeFrame: Preoperative; 30 minutes prior to procedure
measure: Baseline Pain Measured by Visual Analogue Scale
timeFrame: Immediately prior to procedure
measure: Speculum Placement Measured by Visual Analogue Scale
timeFrame: Intraoperative; Immediately following speculum placement
measure: Overall Pain Measured by Visual Analogue Scale
timeFrame: Postoperative; Assessed once 10 minutes after procedure
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Principal Investigator, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schivone GB, Lerma K, Montgomery C, Wright P, Conti JA, Blumenthal PD, Shaw KA. Self-administered lidocaine gel for local anesthesia prior to osmotic dilator placement: a randomized trial. Contraception. 2019 Mar;99(3):148-151. doi: 10.1016/j.contraception.2018.11.013. Epub 2018 Nov 27.
Clinical trial NCT04303234: Assess Intraoperative Pain for Restorative Treatment of Maxillary 1st Permanent Molars Using Artinibsa Versus Artpharma in Children During Infiltration Technique
Official title: Intraoperative Pain During Restorative Treatment Of Maxillary First Permanent Molars Using Artinibsa Versus Artpharma In Children After Infiltration Technique: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Articaine
Infiltration technique
Restoration primary teeth
Intraoperative pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 46
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess Intraoperative pain for restorative treatment of Maxillary First Permanent Molars using Artinibsa Versus Artpharma in children during infiltration technique.

Detailed description: Local anesthesia is very important during dental procedure because it's a temporary loss of sensation which will lead to decrease the pain. Local anesthesia started with discovery of Cocaine in 1860. Followed by developments of Novocaine 1904 and lignocaine in 1942 by Lofgren. It became the gold standard drug compared to other local anesthetic. Later, several new drugs were discovered such as:Bupivacaine, Articaine, Mepivicaine etc. Articaine Hydrochloride (HCL) was available in Germany since 1976. It's the only amide local anesthesia containing ester group in its molecular structure leading to metabolizing of the drug by both plasma esterases and liver microsomal enzymes, the clinical efficacy and advantages of articaine is the duration of its anesthetic effect and its superior diffusion through the bony tissue.

Eligibility criteria: Inclusion Criteria:

* Children aged 8-10 years old
* Mentally capable of communication
* Cooperative children need restorative treatment

Exclusion Criteria:

* Medically compromised patient
* Primary teeth requiring pulpotomy or pulpectomy
* Parent or guardians who refuse participating in the study

Primary outcomes:
measure: Intraoperative Pain: Wong Baker rating scale
timeFrame: During the procedure.
Secondary outcomes:
measure: Onset of anesthesia
timeFrame: Immediately after the injection.
measure: The sensation after injection
timeFrame: Immediately after the injection.
measure: Time of numbness disappear
timeFrame: 2 hours postoperatively after the procedure.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00095017: Safety and Efficacy of an Investigational Drug Versus Placebo in the Treatment of Cancer Pain (0663-083)
Official title: A 4 Week Randomized, Placebo-Controlled, Parallel Group, Double-Blind Pilot Study to Assess the Safety and Efficacy of Etoricoxib 90 mg Versus Placebo in the Treatment of Cancer Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Bone Neoplasms
Keywords: Arcoxia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-11-01
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 compare the effectiveness of an investigational drug versus placebo in the treatment of metastatic bone cancer pain in patients diagnosed with breast or prostate cancer and a bone neoplasm. Patients in the study will be taking opioids to treat moderate to severe pain for their bone metastases and will remain on their opioids during the entire course of the study.


Eligibility criteria: Inclusion Criteria:

* Patients are required to have a diagnosis of breast or prostate cancer with bone involvement and moderate to severe pain that requires opioid treatment.

Primary outcomes:
measure: Analgesic efficacy over a 4 week treatment period; Safety and tolerability.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01682317: Healthy Eating Patterns During a Lifestyle Intervention
Official title: Healthy Eating Patterns During a Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Weight Loss
Keywords: eating frequency
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to address the gap in knowledge regarding the relationship between eating frequency and weight loss.

Detailed description: Little intervention research has been conducted to examine the influence of eating frequency (EF) on weight loss. It has been hypothesized an increased EF improves appetite control, assisting with better regulation of energy intake, thus decreasing body mass index. Unfortunately, outcomes have not shown greater appetite control with increased EF. Instead, trends favor a lower EF reducing energy intake thereby producing greater weight loss than a higher eating frequency. Thus, a lower eating frequency may lower energy intake via behavioral mechanisms. At thit time no research has examined the behavioral mechanisms that may mediate the relationship between a lower eating frequency and superior adherence to an energy-restricted diet.

Eligibility criteria: Inclusion Criteria:

* age between 18 and 65 years
* healthy overweight and obese men and women
* body mass index (BMI) between 27 and 45 kg/m squared

Exclusion Criteria:

* report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR- Q)
* report being unable to walk for 2 blocks (1/4 mile) without stopping
* are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months
* diagnosed with type 1 or 2 diabetes
* have had bariatric surgery or are planning to have bariatric surgery in the next 4 months
* intend to move outside of the metropolitan area within the time frame of the investigation
* are pregnant, lactating, \< 6 months post-partum, or plan to become pregnant during the investigation

Primary outcomes:
measure: Diet
timeFrame: 0 and 8 weeks
Secondary outcomes:
measure: Ecological Momentary Assessment (EMA)
timeFrame: 0 and 8 weeks
measure: Anthropometrics
timeFrame: 0 and 8 weeks
measure: Binge Eating
timeFrame: 0 and 8 weeks
measure: Physical Activity
timeFrame: 0 and 8 weeks
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Healthy Eating and Activity Laboratory, University of Tennessee
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Hollie A Raynor, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00366717: Cytomegalovirus Reactivation in Cancer Patients Receiving Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Cytomegalovirus
Keywords: Cancer under chemotherapy
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2006-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Cytomegalovirus (CMV) infects most of the world population. This study is to understand if chemotherapy will increase the chance of reactivating CMV. The results may help us in determining when treatment is needed and perhaps Why is it needed.

Detailed description: Despite CMV reactivation has been clearly described in patients underwent transplantation, this phenomenon has not been studied in patients undergoing chemotherapy. Our purpose is to understand if CMV number increases in monocytic leukocytes during chemotherapy and how is the host response to that changes.

Virus load will be studied by quantitative PCR, host response will be studied by measuring patient's anti-CMV IgG, CMV-associated symptoms, serum IFN-r and TNF-a.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of any cancer
* chemotherapy is needed for more than 6 months
* age\>20 years old

Exclusion Criteria:

* those who do not agree to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
Study officials:
affiliation: Mackay Memorial Hospital
name: Yen-Ta Lu, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03874117: Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
Official title: Efficacy of Twice Weekly Hemodialysis in Patients With Residual Kidney Function
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hemodialysis
Kidney Failure, Chronic
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study will determine the efficacy of twice weekly hemodialysis in patients with residual kidney function.

Detailed description: Hemodialysis patients who have residual kidney function will undergo two 4-week study (twice weekly versus thrice weekly hemodialysis). Blood, urine, and dialysate samples will be collected at the end of each study period to determine adequacy of treatment and to assess uremic solute levels. Participants will complete quality of life questionnaires and cognitive paper tests. Food records and medications may be monitored.

Eligibility criteria: Inclusion Criteria:

* Stable dialysis patients able to provide consent

Exclusion Criteria:

* Use of antibiotics for last two months or expected antibiotic use
* Recent hospitalization or other event resulting in instability of food intake
* Residual kidney function \< 2.5 mL/min

Primary outcomes:
measure: QOL: KDQOL36
timeFrame: 4 weeks
Secondary outcomes:
measure: Solute Concentration
timeFrame: 4 weeks
measure: Symptom
timeFrame: 4 weeks
measure: Cognition
timeFrame: 4 weeks
measure: Cognition
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: San Jose
country: United States
facility: Satellite HealthCare
state: California
Study officials:
affiliation: Stanford/VA Palo Alto Health Care System
name: Tammy Sirich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00473317: Sunlight Exposures Effect on Serum Vitamin D Levels
Official title: Sunlight Exposures Effect on Serum Vitamin D Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: sunlight
UVB
Vitamin D
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2007-05-15
Enrollment: 6
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: When people eat a meal, some, but not all of the calcium in that meal is absorbed, that is, moved into the bloodstream. When the skin is exposed to sunlight during summer months, Vitamin D is made there and then modified into more active forms by the liver and kidneys. These more active forms of Vitamin D improve calcium absorption. Many adults living in the U.S. have little or no sun exposure and are low in Vitamin D. We know that specific wavelengths of sunlight called Ultraviolet-B cause Vitamin D to be made in the skin.

Detailed description: At the beginning of the study we will measure your height, weight, skin color, and draw blood to measure your blood levels of Vitamin D and 25-hydroxyvitamin D. Each subject will wear a swimming suit and be exposed to sunlight for 30 minutes total (15 minutes lying on back, 15 minutes lying on stomach).We will draw blood for Vitamin D and 25-hydroxyvitamin D on days 1,2,3,5, and 7 after sunlight exposure. There will be six blood draws for a total of 102 cc of blood drawn (about 3 ½ teaspoons drawn each time).

Eligibility criteria: Inclusion Criteria:

* healthy males or females ages19-50 with "light" skin (self-assessed as Fitzpatrick skin type I-III) with minimal sun exposure and exogenous sources of vitamin D.

Exclusion Criteria:

* less than 16 oz milk per day, less than 10 hours of sun per week, no Vitamin D supplements, no anticonvulsants, no barbiturates, no steroids, no meds that increase photosensitivity, no granulomatous disease, no liver or kidney disease, no history of skin cancer, and BMI less than 30.

Primary outcomes:
measure: The goal of this study is to correlate vitamin D response and 25(OH)D response to sun exposure with most of the body (90 %) exposed to 0.25 hour of July sunlight at 41.2º N latitude and at approximately 1-2 pm in the afternoon.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Laura A Armas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03794817: Immune Monitoring in Sensitized Patients at Risk of Rejection
Official title: Immune Monitoring in Sensitized Patients at Risk of Rejection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Failure
Keywords: Kidney transplant recipient
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 112
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: Patients who have received a kidney transplant and will be taking immunosuppressive medications.

Brief summary: The purpose of this study is to test the effect of anti-rejection medications on your immune system

Detailed description: Recipients of deceased or living donor transplants with calculated percent reactive antibody (cPRA) of 50% or greater at University of California, San Francisco (UCSF) will be enrolled in the trial. Samples for Kidney Solid Organ Response Test (kSORT) will be obtained pre-transplant (and immunosuppression) and post-transplant (see Table 1). Urine will be obtained at the same true intervals including pre-transplant in patients who still produce urine to correlate with graft rejection, inflammation and kSORT. A piece (minimum 1/3 core) of the protocol or for cause biopsy tissue will be saved in Ribonucleic acids (RNA) later for gene expression analysis as a correlate of graft inflammation with the biopsy, kSORT and urine. In addition, samples will be when patients are undergoing cause kidney biopsy, prior to treatment intensification and procedure. Patient's who are treated for rejection, will have additional samples obtained 2-4 weeks after treatment of rejection and at the time of any followup biopsy for monitoring resolution of biopsy confirmed acute rejection.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older able to consent
2. No history of HIV, hepatitis C and active hepatitis B infection
3. cPRA ≥ 50%

Exclusion Criteria:

1. Patients on Coumadin
2. Human Leukocyte antigen (HLA) identical donor recipient patients

Primary outcomes:
measure: Immune monitoring in sensitized patients at risk of rejection
timeFrame: 2 years
Secondary outcomes:
measure: Kidney Solid Organ Response Test (kSORT) with pathological findings
timeFrame: 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Flavio Vincenti, M.D.
role: PRINCIPAL_INVESTIGATOR
References: