louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04071145: Using Sensors to Measure Drug Concentrations in Exhaled Breath
Official title: Using Sensors to Measure Drug Concentrations in Exhaled Breath
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mental Disorder
Lead sponsor: The Chaim Sheba Medical Center
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Psychiatric patients with traetment plans that require theraputic drug monitoring

Brief summary: The use of blood tests to measure drug concentrations in psychiatric patients is often a crucial part of monitoring and evaluating the course of treatment. Such tests are commonly conducted as part of official protocols, and patients are often tested on a weekly basis.

The current study aims to examine the possibility of using a novel, non-invasive device to measure drug concentrations in exhaled breath as an alternative to blood tests. The device, SniffPhone, uses sensors to detect and measure volatile organic compounds (VOCs) in exhaled breath, and features a small and portable design. Sniff Phone has been previously approved for use in clinical trials and has been used successfully to screen for particular types of cancer and other diseases.


Eligibility criteria: Inclusion Criteria:

* Proper ability to give informed consent
* Psychiatric patients undergoing treatment at Sheba Medical Center
* Patients with treatment plans that require therapeutic drug monitoring

Exclusion Criteria:

* Involuntary psychiatric hospitalization
* Pregnancy

Primary outcomes:
measure: Detection of drug type and concentration in volatile organic compounds (VOCs) profile
timeFrame: Up to 6 months
measure: Correlation between drug concentration and volatile organic compounds VOC concentrations
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01127945: Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
Official title: A Prospective, Single-center, Randomized, Controlled, Open-label, Pilot Study to Evaluate the Effectiveness of High Dose Statin Loading in Acute Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Heart Failure
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, single-center, randomized, controlled, open-label, pilot study to evaluate the effectiveness of high dose statin loading in acute heart failure patients.


Eligibility criteria: Inclusion Criteria:

* Dyspnea at rest or minimal activity
* Tachypnea (respiratory rate \> 20/min) or rales or pulmonary edema on chest X-ray

Exclusion Criteria:

* Acute coronary Syndrome
* Hospitalization plan for PTCA or CABG
* Cardiogenic shock (Systolic Blood Pressure \< 80mmHg)
* Uncontrolled hypertension (Systolic Blood Pressure \> 180mmHg)
* Allergy, adverse drug reaction, hypersensitivity to statin
* Troponin \> 5 times upper limit of normal (ULN)
* Creatinine kinase-MB level \> 3 times ULN
* AST, ALT \> 3 times ULN or acute hepatitis
* Current or past history of muscle disease, rhabdomyolysis
* Life expectancy \< 6 months (e.g. metastatic malignancy, liver cirrhosis)
* Pregnancy or women at age of childbearing potential

Primary outcomes:
measure: hsCRP levels
timeFrame: at hospital day #4
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular hospital, Yonsei University College of Medicine
Study officials:
affiliation: Severance Cardiovascular hospital, Yonsei University College of Medicine
name: Seok-Min Kang
role: STUDY_DIRECTOR
affiliation: Severance Cardiovascular hospital, Yonsei University College of Medicine
name: Hui-Nam Pak
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Cardiovascular hospital, Yonsei University College of Medicine
name: Boyoung Joung
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Cardiovascular hospital, Yonsei University College of Medicine
name: Sungha Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01434745: SLOS: The Effect of Simvastatin in Patients Receiving Cholesterol Supplementation
Official title: Smith-Lemli Opitz Syndrome: A Clinical Investigation of the Effect of Simvastatin in Patients Receiving Cholesterol Supplementation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smith-Lemli-Opitz Syndrome
Keywords: SLOS
Cholesterol Supplementation
Simvastatin
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-09-15
Enrollment: 1
Sex: ALL
Minimum age (years): 1
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if simvastatin improves development and behavior in patients with Smith Lemli-Opitz syndrome (SLOS) receiving dietary cholesterol supplementation.

Detailed description: Patients with SLOS receiving dietary cholesterol supplementation are given simvastatin, a drug that decreases the activity/expression of HMG-CoA reductase, an enzyme that controls the first step of the cholesterol synthesis pathway, reduces the accumulation of toxic 7-dehydrocholesterol (immediate metabolic precursor of cholesterol) and improve neurocognitive and behavioral outcomes.

Eligibility criteria: Inclusion Criteria:

* Male or female over 1 years old
* Subject has confirmed diagnosis of Smith-Lemli-Opitz Syndrome
* Subject is currently receiving cholesterol supplementation

Exclusion Criteria:

* Subjects too ill to travel to the study site
* Subjects who are unable to safely undergo study procedures
* Pregnant women

Primary outcomes:
measure: Development Quotient (DQ)
timeFrame: through study completion, an average of 2 per year
Secondary outcomes:
measure: Whole Body Cholesterol Pool Size, Synthesis & Absorption Using Stable Isotope Testing
timeFrame: end of treatment, an average of 1 per year
measure: Plasma Marker of Sterol Metabolism
timeFrame: through study completion, an average of 2 per year
measure: ADC
timeFrame: end of treatment, an average of 1 per year
measure: MVA
timeFrame: through study completion, an average of 2 per year
measure: MRS Lipids
timeFrame: end of treatment, an average of 1 per year
measure: FA
timeFrame: end of treatment, an average of 1 per year
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Washington State University
name: Jean-Baptiste Roullet, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06186245: Starvation in the Treatment of Diabetic Ketoacidosis
Official title: Starvation in the Treatment of Diabetic Ketoacidosis: Is There Enough Evidence to Support This Practice?
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Ketoacidosis
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are common, but serious metabolic disorders are often encountered in intensive care. In the intensive care setting, it is common to withhold food from patients during treatment of DKA. However, there is no evidence or current literature supporting this practice. The following proposed research investigates the initiation of an early diet versus withholding food during the treatment of diabetic ketoacidosis.


Eligibility criteria: Inclusion Criteria:

* Males and females with the diagnosis of diabetic ketoacidosis (defined as blood glucose greater than 250 mg/dL, arterial pH less than 7.3, serum bicarbonate less than 15 mEq/L, and the presence of ketonemia or ketonuria)
* Age between 18-89
* Admission to the Medical Intensive Care Unit
* Able to provide informed consent

Exclusion Criteria:

* Pregnant and breast-feeding women
* Institutionalized patients or prisoners
* Patients unable to eat by mouth, including intubation, presence of any tube used for enteral feeding (nasogastric tube, orogastric tube, PEG tube, etc.), medical conditions requiring parenteral feeding, and a history of a medical condition that prevented oral intake prior to admission, including achalasia, esophageal cancer, stroke with residual deficits preventing oral intake, amyotrophic lateral sclerosis, or head and neck trauma.

Primary outcomes:
measure: Resolution of DKA
timeFrame: Typically resolution of DKA is 24-72 hours, may be up to 5 days in some patients
measure: Length of stay in the medical intensive care unit (in days).
timeFrame: Days (Typically 3-5 days in the MICU, may be up to 1 week).
Secondary outcomes:
measure: Length of stay in the hospital
timeFrame: 3-7 days, may be up to 1-2 weeks.
measure: mortality
timeFrame: 30 day
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: University Medical Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Science Center
name: Kenneth Kenneth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01276145: Prevalence Of Internal Pudendal Artery Disease In Patients With Erectile Dysfunction Undergoing Diagnostic Coronary Angiography
Official title: Prevalence Of Internal Pudendal Artery Disease In Patients With Erectile Dysfunction Undergoing Diagnostic Coronary Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Assess the Presence of Internal Pudendal Artery Disease in Patients With Erectile Dysfunction Undergoing Coronary Angiography
Keywords: pudendal artery disease
erectile dysfunction
coronary angiography
coronary disease
cardiac
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 1
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only stable patients scheduled to undergo clinically indicated coronary angiography under non-emergent conditions will be approached for participation in the study.

Brief summary: Subjects in this study have recently had or are scheduled for a coronary angiography as part of their normal, routine medical care. This procedure uses x-ray imaging to see the inside of the heart's blood vessels.

This research study will evaluate the possible relationship between erectile dysfunction and vascular disease (diseases of the veins). In order to look at this possible relationship, subjects will complete a questionnaire which will ask questions regarding their sexual activity. Additionally, we will gather information from their medical records and take extra images during the coronary angiography procedure.


Eligibility criteria: Inclusion Criteria:

1. Male
2. Age \>40 years

Exclusion Criteria:

1. Creatinine Clearance \< 60mL/min/1.73m2
2. Age\>85
3. History of penile prosthesis
4. History or pelvic radiation or trauma

Primary outcomes:
measure: To assess the presence of internal pudendal artery disease in patients with erectile dysfunction undergoing coronary angiography
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Atman Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05427045: A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis
Official title: A Pilot Project for Multifidus Muscle Evaluation in Patients With Multiple Sclerosis and Back Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Back Pain
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research study plans to evaluate if multifidus muscle dysfunction is associated with back pain in patients with Multiple Sclerosis (MS).

Detailed description: Since the multifidus muscle helps to stabilize the lumbar spine, the investigators hope to learn if there is dysfunction and/or atrophy of this muscle in MS patients who also have back pain. The main objective is to study if it is possible to do a home-exercise program in patients with MS younger then 50 years old and who do not need any assistance to walk. Another objective is to further characterize the multifidus function in those patients. This will be by by measuring the size of muscle at the beginning and end of the study, and also by physical exam. As an exploratory aim, the investigators would like to evaluate the relation between compliance with the home-exercise program and the change in the size of the multifidus muscle and the change in pain.

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis by an UAMS neuro-immunologist of relapsing-remitting MS or primary progressive MS or secondary progressive MS
* Age between 18 years old and 50 years old on consent
* Complain of low back pain or severe axial back pain
* English-speaking

Exclusion Criteria:

* Patients that also have the diagnosis of thoracic or lumbar radiculopathy or history of prior thoracic or lumbar spinal surgery.

Patients that are currently pregnant EDSS over 5.5 or less than 1.0 Patient younger than 18 years old or older than 50 years old Knee total extension of less than 100 degrees

Primary outcomes:
measure: Study the Compliance of a Home-exercise Program in Patients With MS
timeFrame: 6 months
Secondary outcomes:
measure: Qualify the Multifidus Dysfunction in Patients With MS - Ultrasound
timeFrame: 6 months
measure: Qualify the Multifidus Dysfunction in Patients With MS - Physical Exam
timeFrame: 6 months
measure: Correlation Between Compliance and Plain and Size of Muscle
timeFrame: 6 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Erika Santos Horta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03113045: Seated Time for 90% Incidence of Hypotension
Official title: Seated Time for Hypotension in Cesarean Delivery: A Biased Coin Design Trial for 90% Efficacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Royal Victoria Hospital, Canada
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The study will determine the 90% effective seated time after intrathecal injection of hyperbaric bupivacaine to avoid hypotension in patients undergoing cesarean delivery.

Detailed description: The study will use a Biased Coin Design (BCD), up-and-down sequential method, to determine the ET90 for absence of hypotension during Cesarean delivery. In this methodology, the first patient will be assigned an a priori initial seated time. Any other patient will be assigned a seated time based on the presence or absence of hypotension in the previous patient. If the previous patient developed hypotension, then the new patient will be seated for a longer time, which will be equal to the seated time of the previous patient plus a pre-determined time increment (up to an also pre-determined maximum allowed time). If no hypotension occurred to the previous patient, the new patient will be assigned one seated time from two choices: The same seated time that has been assigned to the previous patient, or a seated time shorter than that of the previous patient by a pre-determined time decrement (the pre-determined time increment and decrement are the same). The choice will be determined from a biased coin result, with a probability of 0.9 for assigning 'the same as previous' seated time and a probability of 0.1 for assigning a 'shorter seated time'.

Eligibility criteria: Inclusion Criteria:

* Patients with singleton pregnancies scheduled for elective cesarean delivery

Exclusion Criteria:

* BMI\>35
* Unable to communicate in study language
* ASA greater than 2
* Hypertensive disease of pregnancy

Primary outcomes:
measure: Hypotension
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Mcgill University Health Center
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Albert Moore
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06608745: CAS vs Standard Technique in TKA: Comparison of Clinical and Functional Results
Official title: CAS vs Tecnica Chirurgica Standard Nella Protesi Totale di Ginocchio: Confronto Dei Risultati Clinico-funzionali
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthroplasty, Total
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 160
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study involves the enrollment of a sample of patients with indication for total knee replacement surgery in order to compare the conventional surgical technique currently used in the reference departments with the surgical technique with the aid of computer-assisted navigation.

The comparison between the two techniques will be performed in terms of clinical-functional results, perioperative bleeding and healthcare costs (surgical time, hospital stay).

The research protocol involves the participation of 160 total patients divided into two groups, of 80 patients each, by type of surgical technique.


Eligibility criteria: Inclusion Criteria:

* Patients with primary or secondary gonarthrosis with indication for knee arthroplasty with primary implant
* Males and females aged ≥ 45
* Willingness to participate in the study
* Acquisition of informed consent to participate

Exclusion Criteria:

* Patients who are not capable of understanding and willing, and therefore unable to express consent to participation in the study
* Patient refusal to participate in the study and to sign the informed consent
* Nickel allergy (suspected or diagnosed)
* Pregnant women or women of childbearing age who cannot exclude pregnancy

Primary outcomes:
measure: Knee Society Score (KSS)
timeFrame: From enrollment to 12 months post-operative followup
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: from enrollment to 12 months post-operative followup
measure: NRS scale
timeFrame: from enrollment to 12 months post-operative followup
Secondary outcomes:
measure: surgical time
timeFrame: the day of surgical procedure
measure: complications
timeFrame: from surgery to 12 month follow-up
measure: delta hemoglobin
timeFrame: from surgery to discharge, up to 4 weeks
measure: Transfusions
timeFrame: from surgery to discharge, up to 4 weeks
measure: hospital stay
timeFrame: from surgery to discharge, up to 4 weeks
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT01114945: Comparative Effectiveness of Intubating Devices in the Morbidly Obese
Official title: A Prospective Study Comparing Video Laryngoscopy Devices to Direct Laryngoscopy for Tracheal Intubation of Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: Direct Laryngoscopy
Video-Mac
GlideScope
McGrath
Laryngoscopy
Bariatrics
Glottic view
Airway intubating devices
Tracheal intubation
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2010-05-03
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This prospective, randomized study will compare the effectiveness of 4 different airway intubating devices which are most commonly used.

The four different devices are as follows: McGrath video laryngoscope, GlideScope video laryngoscope, Video-Mac video laryngoscope, and Macintosh size 4 direct laryngoscope.

Detailed description: Hypothesis: the use of a video laryngoscope will improve the glottic view compared to direct laryngoscopy, and secondarily, use of the video laryngoscope will reduce the time required to achieve successful tracheal intubation in patients undergoing bariatric surgery. (Weight loss surgery). The three types of video laryngoscopy devices include; the Verethon GlideScope, LMA McGrath and Karl-Storz Video-Mac.

Eligibility criteria: Inclusion Criteria:

* Patients with a documented body mass index (BMI) of \>35.
* Patients scheduled to undergo inpatient surgery procedures under general anesthesia.
* Willingness and ability to sign an informed consent document
* 18 - 80 years of age
* American Society of Anesthesiologists (ASA) Class II- III adults of either sex.

Exclusion Criteria:

* Patients who are deemed to be such a significant of an airway risk that they necessitate awake fiberoptic intubation
* Patients with a history facial abnormalities, oral-pharyngeal cancer or reconstructive surgery
* Emergency surgeries
* Pregnancy
* The inability to tolerate 0.2mg of glycopyrrolate based on tachycardia.
* Any other conditions or use of any medication which may interfere with the conduct of the study.

Primary outcomes:
measure: Intubation Time Using a Stop Watch
timeFrame: up to 3 minutes
measure: Time to Obtain Glottis Visualization (Seconds)
timeFrame: up to 1 minute
measure: Percentage of Glottic Opening (POGO) [%]
timeFrame: up to 1 minute
measure: Glottis View Using the Cormack Lehane Score
timeFrame: Up to 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Roya Yumul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: