louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00801827: PET Imaging and Bariatric Surgery
Official title: PET Imaging and Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity, Morbid
Keywords: Obesity
Addiction
PET imaging
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-12-04
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors' (DRD2/3) and other studies have shown that obese people have less of these. We propose that low DRD2/3 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.

Detailed description: The purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors' (DRD2/3) and other studies have shown that obese people have less of these. We propose that low DRD2/3 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.

Eligibility criteria: Inclusion Criteria:

* Ages 18-60 years
* BMI equal to or greater than 40, or equal to or greater than 35 if there are 2 or more co-morbidities
* Weight less than 350 pounds

Exclusion Criteria:

* History of substance abuse,including but not limited to alcohol, cocaine, marijuana, heroin, nicotine
* History of psychiatric disorders
* Use of any antidepressants or psychotropics in the past 12 months
* Diabetes Mellitis
* Positive pregnancy test
* Any condition felt by the PI or co-investigators to interfere with the individual's ability to complete the study
* Subjects on medications for the last 3 months, such as sibutramine, which could affect the quality of the study, as determined by the PI
* Inability to travel to Nashville, TN four times

Primary outcomes:
measure: Regional DRD2/3 Binding Percent Changes After Bariatric Surgery
timeFrame: ~7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Julia P Dunn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Robert M Kessler, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05702827: Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
Official title: Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stress Urinary Incontinence
Surgical Incision
Pain Vulva
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2023-01-27
Enrollment: 148
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.


Eligibility criteria: Inclusion Criteria:

* undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair)
* English as first language

Exclusion Criteria:

* patients undergoing concomitant posterior repair, vaginal vault suspension, or any other intra-peritoneal surgeries including hysterectomy
* NSAID use within 7 days of surgery
* steroid use within 10 days
* daily opioid use in the last 3 months
* long acting opioids within 3 days
* any opioids within 24h
* patients unable to consent for themselves
* patients allergic to meloxicam or bupivacaine
* pregnant or lactating patients

Primary outcomes:
measure: To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery
timeFrame: 72 hours post surgery
Secondary outcomes:
measure: Compare average pain on each day post operatively
timeFrame: 72 hours post surgery
measure: Compare worst pain on each day post operatively
timeFrame: 72 hours post surgery
measure: Compare satisfaction with pain control post operatively
timeFrame: 72 hours post surgery
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
city: Cincinnati
country: United States
facility: Trihealth (Good Samaritan Hospital, Bethesda North Hospital)
state: Ohio
Study officials:
References:
Clinical trial NCT03069027: Efficacy of External Nasal Nerve Block in Prevention of Postoperative Agitation Following Nasal Surgeries
Official title: Efficacy of External Nasal Nerve Block on Postoperative Agitation Following Nasal Surgeries Under General Anesthesia. Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Agitation States as Acute Reaction to Gross Stress
Keywords: Nasal surgery
external nasal nerve block
postoperative agitation
Lead sponsor: Al Jedaani Hospital
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emergence agitation following general anaesthesia may lead to serious complications like self-extubation or removal of catheters, which can lead to hypoxia, aspiration pneumonia, bleeding or reoperation. Nose surgery is associated with a higher incidence of emergence agitation. The investigators planned to evaluate the efficacy of external nasal nerve block in prevention of postoperative agitation following external nasal surgeries under general anesthesia(GA).


Eligibility criteria: Inclusion Criteria:

* 110 adult patients of ASA physical status I and II,
* Age 20-60 years,
* Scheduled for elective external nasal surgeries in which nasal packing on each side was used postoperatively for 24 hours.

Exclusion Criteria:

1. History of uncontrolled hypertension,
2. Ischemic or valvular heart disease,
3. Use of MAO inhibitors or adrenergic blocking drugs,
4. Cognitive impairment,
5. Patients taking antipsychotics,
6. Renal insufficiency or liver dysfunction

Primary outcomes:
measure: postoperative agitation
timeFrame: Emergence is defined as the time interval from discontinuation of anesthesia to 5 min after extubation.
measure: Quality of recovery
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: dose of fentanyl
timeFrame: intraoperative period in minutes
measure: morphine dose in PACU
timeFrame: one hour in PACU
measure: Nausea and vomiting in PACU
timeFrame: one hour in PACU
measure: Extubation time
timeFrame: Up to 15 after discontinuation of anesthesia
measure: Surgical time
timeFrame: duration of surgery in minutes up to 3 hours
measure: first verbal response time
timeFrame: up to 15 minutes
measure: complication of nasal block
timeFrame: From injection to 24 hours postoperative
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Al Jedaani group of hospitals
state: Meccah
Study officials:
References:
Clinical trial NCT00970827: Remote Ischemic Postconditioning During Percutaneous Coronary Interventions
Official title: Remote Ischemic Postconditioning During Percutaneous Coronary Interventions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
PCI
Postconditioning
Elective or urgent PCI
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2009-09-03
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Angioplasty is a commonly performed procedure for treating blockage of the blood vessels in the heart. Although this procedure is usually successful, it is often accompanied by a small degree of damage to the heart (i.e., small heart attack).

The purpose of this study is to find out if inflating a blood pressure cuff on the arm or the leg at the time of angioplasty for several minutes has a beneficial effect.

Patients will be assigned to one of three treatment groups: inflating blood pressure cuff on the arm, inflating blood pressure cuff on the leg and a control group.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for PCI

Exclusion Criteria:

* Acute myocardial infarction
* Myocardial infarction or coronary bypass surgery during the last 4 weeks before PCI
* Use of Glyburide
* Heart failure (NYHA III/IV)
* Chronic inflammatory disease
* Severe renal impairment
* Significant peripheral vascular disease
* Unsuitable for use of an embolic protection device for PCI to SVG

Primary outcomes:
measure: Myocardial injury after PCI.
timeFrame: 24 hours
Secondary outcomes:
measure: To study the effects of different degrees of remote ischemic postconditioning on myocardial necrosis and inflammation following PCI.
timeFrame: 24 hours
measure: Platelet function
timeFrame: 24 hours
measure: Cardiac events
timeFrame: One year
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sceinces Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Shahar Lavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lavi S, Abu-Romeh N, Wall S, Alemayehu M, Lavi R. Long-term outcome following remote ischemic postconditioning during percutaneous coronary interventions-the RIP-PCI trial long-term follow-up. Clin Cardiol. 2017 May;40(5):268-274. doi: 10.1002/clc.22668. Epub 2017 Jan 11.
citation: Lavi S, D'Alfonso S, Diamantouros P, Camuglia A, Garg P, Teefy P, Jablonsky G, Sridhar K, Lavi R. Remote ischemic postconditioning during percutaneous coronary interventions: remote ischemic postconditioning-percutaneous coronary intervention randomized trial. Circ Cardiovasc Interv. 2014 Apr;7(2):225-32. doi: 10.1161/CIRCINTERVENTIONS.113.000948. Epub 2014 Apr 1.
Clinical trial NCT01100827: A Retrospective Molecular Epidemiology Study in Singapore Patients With Advanced Non Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Histology to Assess Epidermal Growth Factor Receptor (EGFR) Mutation Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NSCLC
Keywords: EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC
The association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients.
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2010-04-09
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In order to determine the EGFR mutation status, data analysis will be performed on demographic data and medical records (i.e. case notes and pathology reports) from patient with advanced stage adenocarcinoma NSCLC

Brief summary: To determine EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC.

To determine the association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients.


Eligibility criteria: Inclusion Criteria:

Nil

Exclusion Criteria:

Nil

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital Singapore
Study officials:
References:
citation: Shigematsu H, Lin L, Takahashi T, Nomura M, Suzuki M, Wistuba II, Fong KM, Lee H, Toyooka S, Shimizu N, Fujisawa T, Feng Z, Roth JA, Herz J, Minna JD, Gazdar AF. Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers. J Natl Cancer Inst. 2005 Mar 2;97(5):339-46. doi: 10.1093/jnci/dji055.
citation: Miller VA, Kris MG, Shah N, Patel J, Azzoli C, Gomez J, Krug LM, Pao W, Rizvi N, Pizzo B, Tyson L, Venkatraman E, Ben-Porat L, Memoli N, Zakowski M, Rusch V, Heelan RT. Bronchioloalveolar pathologic subtype and smoking history predict sensitivity to gefitinib in advanced non-small-cell lung cancer. J Clin Oncol. 2004 Mar 15;22(6):1103-9. doi: 10.1200/JCO.2004.08.158.
Clinical trial NCT06631027: Dietary Adherence and Cognitive Function in Older Adults
Official title: The Relationship Between Adherence to Mediterranean, DASH and MIND Diets and Cognitive Function in Older Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Function
Mediterranean Diet
Dietary Approaches to Stop Hypertension
Elderly Population
Keywords: Cognitive Function
Mediterranean Diet
Elderly Health
DASH Diet
MIND Diet
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 1027
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample in Ankara, Turkey

Brief summary: This study aimed to evaluate the relationship between adherence to the Mediterranean, DASH, and MIND diets and cognitive function in elderly individuals. Data were collected from 1,027 participants aged 65 and older, using dietary assessment tools and the Standardized Mini Mental Test (SMMT), and were analyzed with SPSS 26.

Detailed description: A total of 1027 elderly individuals aged 65 years and over were included in the study. Demographic questionnaire and Mediterranean diet adherence scale were administered to the individuals. Adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet was scored and food consumption was recorded for adherence to the Dietary Approaches to Stop Hypertension (DASH) diet. Standardised mini mental test (SMMT) was used to assess mental status. Data were analysed with SPSS 26 software.

Eligibility criteria: Inclusion Criteria:

1. Individuals aged 65 years and older.

Exclusion Criteria:

1. Individuals diagnosed with psychiatric or neurological diseases (e.g., dementia, Alzheimer\&#39;s disease).

3. Individuals with alcohol or drug addiction. 4. Illiterate individuals.

Primary outcomes:
measure: Cognitive Function Assessment
timeFrame: Basaline
Secondary outcomes:
measure: Sociodemographic characteristics
timeFrame: basaline
measure: Mediterranean Diet Adherence Scale
timeFrame: Basaline
measure: Compliance with the Dietary Approaches to Stop Hypertension diet
timeFrame: Basaline
measure: Compliance with the Mediterranean-DASH Intervention for Neurodegenerative Delay diet
timeFrame: Basaline
measure: Body Mass Index (BMI)
timeFrame: Basaline
measure: Body weight
timeFrame: Basaline
measure: Height
timeFrame: Basaline
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University
Study officials:
References:
Clinical trial NCT01550627: Effect of Intravenous Fluid Supplementation on Serum Bilirubin and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
Official title: Study of Possible Effects of Intravenous Fluid Supplementation on Serum Bilirubin Levels and Cardiorespiratory Parameters in Preterm Infants During Phototherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hyperbilirubinemia
Keywords: preterm infants < 32 weeks of gestation
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate the influence of a systematic extra intravenous fluid supplementation during phototherapy in comparison to a fluid supplementation due to short term demand in preterm infants.

Detailed description: 60 preterm infants (GA ≤ 32 week) were assigned randomly to either receive a fluid supplementation due to short term demand (control group, n=30;) or a 20% extra fluid supplementation (study group, n=30) during intermediate phototherapy.

Collected data:

* cardiorespiratory parameters(heart rate, blood pressure, SaO2 and capillary refill time, breathing rate, temperature) and a pain score was completed at the first day of phototherapy
* The maximum total serum bilirubin levels (TSB) within one week after onset of phototherapy

Eligibility criteria: Inclusion Criteria:

* Hyperbilirubinemia

Exclusion Criteria:

* Preterm infants \> 33 weeks of gestation

Primary outcomes:
measure: The maximum total serum bilirubin levels
timeFrame: within one week after onset of phototherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: University Hospital of Jena
Study officials:
References:
Clinical trial NCT02614027: Prevalence of Lipodystrophy Syndrome and Its Role as Cause of Metabolic Disturbances
Official title: Prevalence of Lipodystrophy Syndrome and Secondary Metabolic Syndrome in HIV-infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lipodystrophy
Metabolic Syndrome
Lead sponsor: Asociacion para el Estudio de las Enfermedades Infecciosas
Sponsor class: NETWORK
First posted: 2015-11-25
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected patients on antiretroviral therapy with current drugs (excluding drugs previously associated with fat disturbance), and HIV-infected patients with previous evaluation of lipodystrophy syndrome in different severity, as determined by DXA and questionnaire.

Brief summary: To evaluate the prevalence of lipodystrophy syndrome in patients receiving currently available antiretroviral drugs, and the prevalence of associated metabolic syndrome in HIV-infected patients with a previous diagnosis of lipodystrophy syndrome, according to the severity of fat accumulation and antiretroviral drug use.

Detailed description: Cross-sectional evaluation of two groups of patients:

* patients receiving currently available drugs, in order to determine the changes in fat accumulation by successive dual X-ray absorptiometry (DXA) determinations
* patients with previous lipodystrophy syndrome, as evaluated by questionnaire (HOPS) and total body dual X-ray absorptiometry (DXA), in order to determine the prevalence of hypertension, low high density lipoprotein (HDL)-cholesterol, glucose disturbance (insulin resistance or diabetes), fat accumulation (waist circumference) and hypertriglyceridemia.

The prevalence of Metabolic syndrome will be evaluated according to the different definitions (IDF, NCEP-ATP III, WHO).

Eligibility criteria: Inclusion Criteria:

* HIV infection
* Older than 18 years
* Receiving first or second antiretroviral regimen or
* Previous evaluation and classification of lipodystrophy syndrome

Exclusion Criteria:

* Pregnancy
* Diagnosis of hypothyroidism, Cushing's syndrome or prolonged intake of corticosteroids or hormones before inclusion
* Patients who had received antiretroviral drugs known to produce fat disturbances (for lipodystrophy prevalence objective)

Primary outcomes:
measure: Prevalence of metabolic syndrome as defined by the NCEP-ATP III (National Cholesterol Education Programme-Adult Treatment Panel III)
timeFrame: 3 months
measure: Prevalence of lipodystrophy syndrome as defined by changes in fat by DXA
timeFrame: 6 meses
Secondary outcomes:
measure: Value of dual X-ray absorptiometry (DXA) in predicting the development of lipodystrophy and metabolic syndrome
timeFrame: 3 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramon y Cajal Hospital
Study officials:
affiliation: Ramon y Cajal Hospital
name: Jose L Casado, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03056027: Testicular Vascular Evaluation in Patients Undergoing Inguinal Hernia Repair
Official title: Evaluation of the Impact of Open or Laparoscopic Preperitoneal Inguinal Hernia Repair on Arterial and Venous Testicular Vascularization by Means of Ecocolordoppler Ultrasound Examination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia
Testicular Diseases
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by inguinal hernia, scheduled to undergo either open or laparoscopic extraperitoneal inguinal hernia repair

Brief summary: Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before and after surgery in order to rule out the potential impact of the surgical procedure on testicular arterial and venous blood flow

Detailed description: Patients scheduled to undergo laparoscopic preperitoneal or open inguinal hernia repair will be evaluated by means of scrotal/testicular ecocolordoppler ultrasound investigation before and after surgery in order to rule out the potential impact of the surgical procedure on testicular arterial and venous blood flow

Ecocolordoppler will evaluate:

1. testicular arterial flow (Peak Systolic Velocity Testicular Artery - End-Diastolic Velocity Testicular Artery - Resistive Index testicular Artery)
2. venous impaired outflow using varicocele classifications (DUBIN - scale 1-3; HIRSCH scale 1-5)
3. testicular volume

Eligibility criteria: Inclusion Criteria:

* Inguinal hernia with surgical indication for surgical repair

Exclusion Criteria:

* History of urologic surgery and/or radiotherapy
* Recurrence of inguinal hernia

Primary outcomes:
measure: Changes in arterial and venous testicular vascularization before and after inguinal hernia repair
timeFrame: Preoperatively - 1 and 4 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Andrea Cestari
Study officials:
affiliation: Istituto Auxologico Italiano
name: Andrea Cestari, MD
role: PRINCIPAL_INVESTIGATOR
References: