louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02863939: Quantitation of Cardiac Output Change by Impedance Cardiography in Subjects Undergoing Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to test for an early post-stress cardiac output (CO) change by impedance cardiography and its relation to the severity and extent of myocardial ischemia and angiographic coronary disease in subjects undergoing exercise stress testing using a novel cadmium-zinc-telluride (CZT) SPECT camera.

Detailed description: Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is a well-established noninvasive procedure for the evaluation and risk stratification of patients with coronary artery disease (CAD) (1). However, it has been recognized that in certain patients SPECT MPI is unable to detect the presence of or underestimates the extent of CAD. The fact that moderate to severe perfusion defects are noted in less than half of the patients with significant left main disease (2) has stimulated studies to improve the diagnostic accuracy of SPECT MPI. Such studies have analyzed post-stress parameters such as left ventricular (LV) ejection fraction (EF) (3, 4), wall motion abnormalities (5) and transient LV dilation (6) with images acquired on conventional Anger cameras as long as 60 minutes after the stress tracer injection. Such delayed assessment may miss early ischemic stunning as a result of its transient nature. However, detection of an early post-stress decrease in cardiac output (CO) may serve as a potential marker for the presence of significant or extensive ischemia. The aim of this study is to test for an early post-stress CO change by impedance cardiography and its relation to the severity and extent of myocardial ischemia and angiographic coronary disease in subjects undergoing exercise stress testing using a novel cadmium-zinc-telluride (CZT) SPECT camera.

Eligibility criteria: Inclusion Criteria:

* Patients referred to the Nuclear Cardiology Center for a clinically indicated exercise stress MPI study

Exclusion Criteria:

* known standard contraindications for ergometry
* anemia
* hyperthyroidism
* intra- and extra-cardiac shunts
* significant arrhythmia
* hemodialysis

Primary outcomes:
measure: Ischemia
timeFrame: 15-20 minutes after stress test
measure: Cardiac Output
timeFrame: 15-20 minutes after exercise test
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00540839: A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)
Official title: A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Asthma, Bronchial
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2007-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma.

This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.

Detailed description: This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.

Eligibility criteria: Inclusion Criteria:

* Between 6 months and 5 years, 4 months of age
* Diagnosed with asthma by a doctor
* At least 3 episodes of asthma symptoms within the last 6 months

Exclusion Criteria:

* Active or chronic breathing disease, other than asthma
* Required insertion of a breathing tube for asthma
* Major surgery within the last 4 weeks
* Currently in the hospital
* Allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula

Primary outcomes:
measure: Percentage of days without asthma
timeFrame: 24 weeks
measure: Number of participants who experience at least one adverse event (AE)
timeFrame: Up to 26 weeks
measure: Number of participants who discontinue study drug due to an AE
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Percentage of days without daytime symptoms
timeFrame: 24 weeks
measure: Percentage of days without nighttime cough
timeFrame: 24 weeks
measure: Percentage of days without β-agonist use
timeFrame: 24 weeks
Other outcomes:
measure: Percentage of participants without asthma attacks
timeFrame: 24 weeks
measure: Percentage of participants without corticosteroid rescues
timeFrame: 24 weeks
measure: Caregiver global evaluation
timeFrame: Week 24
measure: Physician global evaluation
timeFrame: Week 24
measure: Percentage of days without individual daytime asthma symptoms (cough, wheeze, trouble breathing, and activity limitation)
timeFrame: 24 weeks
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02879539: Cochlear Implant Low Power Strategy
Official title: Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: cochlear implants, power consumption,
Lead sponsor: The Hearing Cooperative Research Centre
Sponsor class: OTHER
Collaborators: name: Royal Victoria Eye and Ear Hospital
name: Cochlear
First posted: 2016-08-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy. However in order to develop smaller sound processors, further battery life power savings are required. The aim of this study is to evaluate three experimental sets of MP3000 parameter sets, compared against the default ACE program. In the background for each of the four strategies, experimental noise reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the study, low stimulation rate ACE programs will also be evaluated against the default stimulation rate.


Eligibility criteria: Inclusion Criteria:

1. Adult (\>18 years) cochlear implant recipients
2. Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants.
3. User of commercially available Freedom, CP810 or CP900 series sound processor
4. User of the ACE strategy or MP3000 strategy
5. At least 3 months experience with the cochlear implant
6. Native speaker in the language used to assess speech perception performance
7. Willingness to participate in and to comply with all requirements of the protocol

Exclusion Criteria:

1. Additional handicaps that would prevent participation in evaluations
2. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

Primary outcomes:
measure: Word recognition scores in quiet
timeFrame: Testing over 18 weeks
measure: Sentence recognition scores in quiet
timeFrame: Testing over 18 weeks
Secondary outcomes:
measure: Fundamental frequency (F0) discrimination
timeFrame: Testing over 18 weeks
measure: Speech intelligibility and helpfulness subjective ratings
timeFrame: Testing over 18 weeks
measure: Sentence in noise scores
timeFrame: Testing over 18 weeks
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The HEARing CRC
state: Victoria
Study officials:
References:
Clinical trial NCT01093339: To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure
Official title: To Determine if Sleep Deprivation Results in Increased Esophageal Acid Exposure, and if This Effect is Mediated in Gastroesophageal Reflux Disease (GERD)Patients by Altering Appetite Regulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Disease
Keywords: GERD
SLEEP DEPRIVATION
APPETITE REGULATION
GHRELIN
LEPTIN
Lead sponsor: Southern Arizona VA Health Care System
Sponsor class: FED
First posted: 2010-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 subjects w/ GERD 25 subjects w/o GERD

Brief summary: The purpose of this study is to determine if sleep deprivation results in increased esophageal acid exposure in healthy controls and gastroesophageal reflux disease (GERD) patients.

Detailed description: To determine if increased esophageal acid exposure is mediated by altering appetite regulation. To assess if there is any relationship between sleep deprivation and the serum level of TNF-alfa (a protein that can be elevated in inflammation).

Eligibility criteria: Inclusion Criteria:

* Male/Female - 18-80
* 2 or more episodes of heartburn a week for last 3 months

Exclusion Criteria:

* Previous upper GI surgery
* Underlying co-morbidity
* Narcotic medications
* Psychotropic's and Benzodiazapines medications
* Hx of psychological abnormalities
* Hx of ETOH in previous 6 mos.
* Diabetes Mellitus
* Neuropathy
* Seizures
* Sleep Apnea
* Co-morbidity that interfere w/sleep
* Women who are pregnant, or childbearing yrs, not on BC

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: SArizonaVAHCS
state: Arizona
Study officials:
affiliation: SArizona VAHCS
name: Ronnie Fass, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00361439: Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
Official title: Treatment of Olfactory Dysfunction in Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2006-08-08
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: People with allergies frequently complain of a loss or reduction in the sense of smell.

In this study, the investigators propose to perform a randomized, double blind, placebo controlled parallel study of subjects with nasal allergies and decreased smell to determine the effect of a treatment for allergies on the sense of smell.


Eligibility criteria: Inclusion Criteria:

1. Males and females between 18 and 59 years of age.
2. Seasonal allergic rhinitis by clinical history, with symptoms of impaired olfaction.
3. Positive skin or RAST test to allergen.
4. Symptoms of olfactory dysfunction.
5. No significant history of chronic sinusitis.

Exclusion Criteria:

1. Women of childbearing potential not using the contraception method(s) (Birth control pills, depo Provera, double barrier) as well as women who are breastfeeding.
2. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease).
3. Use of any other investigational agent in the last 30 days.
4. Absence of olfactory or nasal symptoms.
5. Use of medications that may affect olfaction.
6. Medical conditions that may affect olfaction.
7. Smoking.
8. URI at the time of screening.

Primary outcomes:
measure: Histological Findings
timeFrame: 2 weeks
Secondary outcomes:
measure: Change From Baseline in Total Nasal Symptom Score at 2 Weeks
timeFrame: baseline and 2 weeks
measure: Change From Baseline in Nasal Peak Inspiratory Flow at 2 Weeks
timeFrame: baseline and 2 weeks
measure: Change From Baseline in Percentage of Eosinophils at 2 Weeks
timeFrame: baseline and 2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jayant M Pinto, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sivam A, Jeswani S, Reder L, Wang J, DeTineo M, Taxy J, Baroody FM, Naclerio RM, Pinto JM. Olfactory cleft inflammation is present in seasonal allergic rhinitis and is reduced with intranasal steroids. Am J Rhinol Allergy. 2010 Jul-Aug;24(4):286-90. doi: 10.2500/ajra.2010.24.3478.
Clinical trial NCT05820139: Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery
Official title: A Randomized Controlled Single-Blinded Study Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Voiding Dysfunction
Keywords: Urinary Tract Infections
overactive bladder
pelvic organ prolapse surgery
urinary incontinence surgery
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be recruited at an Urogynecology office either at the pre-operative visit or on the day of surgery
Primary purpose: TREATMENT

Brief summary: Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events

Detailed description: Postoperative voiding trials (VT) can identify as well as prevent postoperative urinary retention. Voiding trial protocols vary by provider and healthcare facilities/institutions as there is no consensus on how to prevent postoperative urinary retention optimally. Identification of an optimal VT could not only help decrease adverse events associated with urinary retention but also decrease postoperative catheter-associated urinary tract infection (CAUTI) rates, unplanned hospital or clinic visits, and decrease patient discomfort while increasing patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Nonpregnant women \>18yo undergoing pelvic organ prolapse or urinary incontinence surgery

Exclusion Criteria:

* Patients undergoing fistula repair or sacral neuromodulation
* Voiding dysfunction preoperatively that requires intermittent self-catheterization
* Intraoperative bladder injury
* Pregnancy
* Preoperative UTI (culture proven within 7 days prior to surgery)

Primary outcomes:
measure: difference in acute voiding dysfunction between a backfill assisted voiding trial
timeFrame: Week 6
Secondary outcomes:
measure: proportion of patients develops postoperative UTIs
timeFrame: Day 7
measure: proportion of patients developing overactive bladder symptoms
timeFrame: Week 6
measure: proportion of patients developing bladder pain or pressure
timeFrame: Week 6
measure: proportion of patients requiring repeat outpatient voiding trials
timeFrame: Week 6
measure: average number of days postoperatively, that require catheterization
timeFrame: Week 6
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David Lovejoy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06737939: Periprostatic Nerve Block vs. Intravenous Ibuprofen for Pain Management During Transrectal Prostate Biopsy
Official title: Periprostatic Nerve Block vs. Intravenous Ibuprofen for Pain Management During Transrectal Prostate Biopsy: A Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Keywords: Prostate biopsy
ıv ibuprofen
periprostatic nerve block
visual analog scale
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 128
Sex: MALE
Minimum age (years): 45
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the efficacy of intravenous ibuprofen with peri-prostatic nerve block in pain control during prostate biopsy and to investigate factors influencing pain scores.

Detailed description: This study aimed to compare the efficacy of intravenous (IV) ibuprofen with periprostatic nerve block (PPNB) in controlling pain during prostate biopsy, a common procedure used to diagnose prostate cancer. The study also aimed to investigate factors influencing pain perception during the procedure, such as prostate-specific antigen (PSA) levels, prostate volume, and comorbidities.

Eligibility criteria: Inclusion Criteria:

Male gender. Scheduled for a prostate biopsy. Prostate-specific antigen (PSA) levels \> 4 ng/mL.

Exclusion Criteria:

Renal failure. Liver failure. Neurological disorders (e.g., dementia, Alzheimer's disease, epilepsy, paraplegia).

Rectal disorders. Previous negative prostate biopsy. Chronic anticoagulant therapy or bleeding diathesis. Severe comorbidities. Psychiatric conditions interfering with consent or compliance.

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: Before the biopsy, During probe insertion and prostate needle insertion,2 hours and 1 day after the procedure
Secondary outcomes:
measure: Complications
timeFrame: immediately after the intervention/procedure/surgery
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University Hospital
Study officials:
affiliation: University of Gaziantep
name: Elzem Sen, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00906139: Propofol and Fentanyl Versus Midazolam and Fentanyl for Endoscopy Sedation in Cirrhotic Patients
Official title: Propofol and Fentanyl Versus Midazolam and Fentanyl for Sedation During Diagnostic or Therapeutic Gastrointestinal Endoscopy in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cirrhosis
Keywords: Propofol
Midazolam
Cirrhosis
Gastrointestinal endoscopy
Complications
Sedation
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare propofol associated with fentanyl versus midazolam plus fentanyl for sedation during diagnosis or therapeutic upper gastrointestinal endoscopy (UGE) in cirrhotic patients.

Detailed description: UGE is often performed in cirrhotic patients for the diagnosis and treatment of portal hypertension complications. Current data suggests that propofol sedation may have advantages over benzodiazepines. However, there are few reports comparing propofol versus midazolam in patients with liver cirrhosis. The study's objective is to compare propofol associated with fentanyl versus midazolam plus fentanyl for sedation during diagnosis or therapeutic UGE in cirrhotic patients. A prospective randomized study will include cirrhotic patients (Child A, B or C and ASA 2 or 3), referred for diagnostic or therapeutic UGE, randomized for group I: propofol (0,5 mg/kg up to 400 mg) and fentanyl (0,05 mg); or group II: midazolam (0,1 mg/kg) and fentanyl. Sedation was performed by an exclusively dedicated gastroenterologist. Efficacy (completion of procedures), complications (hypoxemia, hypotension, arrhythmias) and recovery time (elapsed from the end of the procedure and discharge) will be studied.

Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis, any etiology
* ASA II or III
* Child A, B or C
* Age between 18 years and 75 years
* Patients that agree in participate of study and signed the contentment term

Exclusion Criteria:

* Schistosomiasis
* Recuse
* Hepatocellular carcinoma
* Contraindications to drugs
* ASA IV or V
* Hepatic encephalopathy, neurologic diseases
* Opioids, narcotics, MAO inhibitors or benzodiazepines use
* Alcohol abuse

Primary outcomes:
measure: To compare propofol and fentanyl versus midazolam and fentanyl regarding safety and efficiency
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
References:
Clinical trial NCT02380339: A Combined Biofeedback-virtual Reality System for Reduction of Fear of Hypoglycemia
Official title: A Combined Biofeedback-virtual Reality System for Reduction of Fear of Hypoglycemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoglycemia
Type One Diabetes
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2015-03-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Uncontrolled diabetes is associated with increased risk for micro-vascular complication. Hypoglycemia is one of the major barriers in achieving good glucose control. Hypoglycemia is associated with a range of unpleasant symptoms including palpitations, tremor, hunger, sweating, confusion, difficulties in thinking as well as other idiosyncratic symptoms. Fear of hypoglycemia (FOH) refers to phobic avoidance reactions associated with hypoglycemia FOH may increase behavioral attempts to avoid hypoglycemia including decreased consumption of insulin and/or increased consumption of carbohydrates, resulting in poor glycemic control and an increased risk of diabetic complication. In this study, the investigators present a novel system, which simultaneously employs BioFeedback and Virtual Reality in order to cope with fear of hypoglycemia.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetic patient, male and females above the age of 18.
* Patients with significant fear of hypoglycemia as indicated in the HFS-W (equals or greater than 3 on at least one of the item on the HFS-W ).

Exclusion Criteria:

Patient with severe hypoglycemia event in the last 6 months will be excluded. Patient with mental illness will be excluded

Primary outcomes:
measure: Reduction of fear of hypoglycemia in type 1 diabetic patients as measured by reduction of 2 point on the HFS-W). pre-treatment and after two months post completion of treatment.
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
References: