louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05312866: Intraoperative Retrolaminar Block as Opioid Free Anesthesia After Posterior Lumber Spine Discectomy
Official title: Intraoperative Retrolaminar Block as Opioid Free Anesthesia and Enhanced Recovery After Posterior Lumber Spine Discectomy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Free Anesthesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2022-04-06
Enrollment: 72
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Opioid-free intraoperative protocols have been successfully used in specific surgical populations with equal or superior results to classic general anesthetic approaches. In instances where opioid-free anesthesia may not be entirely feasible, there exists a continually growing body of evidence that the modern anesthesiologist has a potent pharmacologic and regional anesthetic arsenal that can reduce the amount of opioids required to effectively treat pain.

Retrolaminar block is considered a new, easy and simple technique with decreasing incidence of complications such as hypotension, pleural and nerve injury. Its efficacy had been investigated in trauma patients

Detailed description: * Null hypothesis: Intraoperative retrolaminar block will not produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.
* Alternative hypothesis: Intraoperative retrolaminar block will produce opioid sparing anesthetic effect and enhanced recovery after posterior lumber spine discectomy.

Eligibility criteria: Inclusion Criteria:

* Written informed consent from the patient.
* Age: 21-60 years old.
* Sex: both sex (males and females).
* American Society of Anesthesiologist Physical status: ASA 1\& II.
* Body Mass Index (BMI) = (25-30 kg/m2).
* Type of operation: elective posterior Lumbar discectomy from L3 to L5 disc space.

Exclusion Criteria:

* Altered mental state.
* Patients with known history of allergy to study drugs.
* Advanced hepatic, renal, cardiovascular, and respiratory diseases.
* Patients with chronic pain.
* Patients receiving anticoagulants.
* Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

Primary outcomes:
measure: The recovery time
timeFrame: up to 1 hour postoperative
Secondary outcomes:
measure: pain intensity
timeFrame: up to 24 hours postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Faculty of Human Medicine, Zagazig University
state: Alsharquia
Study officials:
affiliation: Zagazig University
name: Alshaimaa Kamel, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02168166: Short-term Working Memory and Executive Training
Official title: Short-Term Executive Functioning Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Disorders
Keywords: Neurological Disorders
Neuroscience
Neuropsychology
EEG
Cognitive remediation
Cognitive Response
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 40
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: TREATMENT

Brief summary: Cognitive remediation (CR) therapies refer to a number of recent developments to use behavioural strategies to improve neurocognitive abilities and improve everyday functioning in mental disorders such as schizophrenia, bipolar disorder, and depression. In this study, we aim to examine whether we can observe CR effects on measures of neuroplasticity, cognition, and functioning when using a rigorous control comparison group. We hypothesize that the active group will exhibit improvements in executive functioning composite scores, improved EEG theta-gamma frequency modulation, and increased EEG alpha power compared to the placebo group.


Eligibility criteria: Inclusion Criteria:

* diagnosis of a chronic mental disorder (defined herein as bipolar disorder, major depressive disorder, or a schizophrenia-spectrum disorder)
* between the ages of 18 and 65
* speak and read fluent English
* able to use a computer

Exclusion Criteria:

* active substance abuse or dependence diagnosis
* sensory or motor issues that would preclude completion of study procedures
* enrollment in a cognitive remediation program or use of cognitive training programs (e.g. lumosity.com) within the past 6 months

Primary outcomes:
measure: Change from baseline executive functioning composite score at post-treatment assessment
timeFrame: Pre-training assessment (Week 1) and post-training assessment (Week 4)
Secondary outcomes:
measure: Change from baseline EEG theta-gamma frequency modulation at post-treatment assessment
timeFrame: Pre-training assessment (Week 1) and post-training assessment (Week 4)
measure: Change from baseline EEG alpha power at post-treatment assessment
timeFrame: Pre-training assessment (Week 1) and post-training assessment (Week 4)
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Christopher Bowie, PhD, CPsych
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03088566: Implementation of the D-Foot at the Department of Prosthetics and Orthotics
Official title: Implementation of the D-Foot at the Department of Prosthetics and Orthotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled study. One group will be foot screened following the routine described in the web program, the D-Foot. The other group will be foot screened by the use of conventional methods.
Primary purpose: DIAGNOSTIC

Brief summary: Early identification of potential risk factors for the onset of diabetic foot ulcers are recommended. However, in a Swedish context, there has been no standardised routines to be used in the foot screening procedure. In this study a new standardised routine, the D-Foot, will be tested at the Department of Prosthetics and Orthotics. The usability of the web program will be tested.

Detailed description: The primary research questions are"how do patients with diabetes perceive the foot screening?" and "do the perception differ in the group that was foot screened by the use of the D-Foot compared to the group that was foot screened with conventional methods?"

Eligibility criteria: Inclusion Criteria:

* diabetes
* patients referred to the Department of Prosthetics and Orthotics at Sahlgrenska University Hospital with the aim to be provided with assistive devices with the purpose to protect the feet from foot ulcers
* be able to read and understand the Swedish language

Exclusion Criteria:

\*being unable to read and understand the Swedish language

Primary outcomes:
measure: Patients reported experience measure (PREM)
timeFrame: one month
measure: Patients reported experience measure (PREM)
timeFrame: one month
Secondary outcomes:
measure: PREM
timeFrame: one month
measure: Patients reported outcome measure (PROM)
timeFrame: one month
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Department of Prostetics & Orthotics
state: Region Västragötaland
Study officials:
References:
Clinical trial NCT02426866: Risk of CV Events With EFV vs. EFV-free Regimens
Official title: The Risk of Cardiovascular Events Among HIV Patients Initiating Efavirenz-containing Versus Efavirenz-free Antiretroviral Regimens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Truven health
First posted: 2015-04-27
Enrollment: 29612
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Commercial insurance database and Medicaid database

Brief summary: The purpose of this study is to determine whether there is an increased risk of cardiovascular events (CV) with regimens containing efavirenz (EFV) versus other regimens in patients with HIV.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Aged 18 years or older on the index date
* Have at least one pharmacy claim for efavirenz or a drug in the comparison cohort during the period spanning January 1, 2007 through December 31,2013.
* Clinical Modification (ICD-9) diagnosis code for HIV infection including 042 (HIV disease), V08 (asymptomatic HIV infection status), 795.71 (nonspecific serologic evidence of HIV), and 079.53 (HIV, type 2) any time prior to the index claim.
* Have at least 6 months (180 days) of continuous enrollment prior to the index claim

Exclusion Criteria:

* Patients who have been dispensed any antiretroviral medications anytime before the index date including the 180-day baseline period
* Patients with evidence of a cardiovascular outcome of interest during the 180-day baseline period

Primary outcomes:
measure: Cardiovascular events specifically based on incidence rate and compare the hazard between the HIV infected patient initiating efavirenz-containing antiretroviral regimen and efavirenz-free antiretroviral regimen
timeFrame: upto 1 to 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01418066: Ayurvedic Herbs in Diarrhea Predominant Irritable Bowel Syndrome
Official title: Feasibility and Safety of Ayurvedic Herbs in Diarrhoea-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In the present study the investigators are trying to evaluate the effect of Murraya koenigii leaves, Punica granatum and Curcuma which is administered to the patients in a combined form as tea. This study will help to evaluate the effect of these preparations scientifically in improving the IBS symptoms.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* Irritable Bowel Syndrome according to Rom-III
* Subtype Diarrhea or Alternating
* discomfort or pain \> 1 times a week
* discomfort or pain \> 4 on a Visual Analog Scale

Exclusion Criteria:

* Inflammatory bowel diseases (test results necessary)
* Lactose, Fructose Malabsorption (test results necessary)
* Celiac Disease
* Pregnancy or Breastfeeding
* Colectomy or Hemicolectomy \>50cm
* Severe metabolic disorders, hormonal disorders, cardiac or respiratory failure, liver or renal diseases
* severe depression, psychotic or psychiatric disorders, substance abuse
* cancer within the last 5 years
* allergy to caraway
* acute inflammatory diseases

Primary outcomes:
measure: irritable bowel syndrome- symptom severity score
timeFrame: T2 (Day 28)
Secondary outcomes:
measure: Frequency of abdominal discomfort/Pain
timeFrame: last week of treatment (days 21-28)
measure: Intensity of Abdominal Pain/Discomfort
timeFrame: Last week of treatment (days 21-28)
measure: Stool and diarrhea Frequency
timeFrame: last week of treatment (days 21-28)
measure: Quality of life
timeFrame: T2 (Day 28)
measure: IBS Specific Quality of life
timeFrame: T2 (Day 28)
measure: Depression and Anxiety
timeFrame: T2 (day 28)
measure: Adequate Relief Score
timeFrame: at day 7, 14, 21 and 28
measure: Global improvement
timeFrame: at days 7, 14, 21 and 28
measure: adverse events
timeFrame: up to week 15
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Klinik für Naturheilkunde und Integrative Medizin
state: NRW
Study officials:
affiliation: University Duisburg-Essen, Chair of Integrative Gastroenterology
name: Jost Langhorst, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01593566: Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction
Official title: Femoral Nerve Block Using 0.25% Versus 0.5% Bupivacaine for Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia After ACL Reconstruction
Keywords: femoral nerve block
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-05-08
Enrollment: 100
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: Femoral nerve block using 0.25% bupivacaine or 0.5% bupivacaine provides a longer time for analgesia after Anterior Cruciate Ligament (ACL) reconstruction.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for ACL reconstruction
* ASA physical status I-II
* Body weight \> or = 50 kg.

Exclusion Criteria:

* Patients with redo ACL reconstruction
* Contraindication to neuraxial block
* allergy to local anesthetics, sulfa, NSAIDs, morphine, paracetamol
* Patients with communication problem

Primary outcomes:
measure: time to first analgesic requirement
timeFrame: 48 hr
Secondary outcomes:
measure: pain score scale
timeFrame: 48 hr
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
Study officials:
affiliation: Mahidol University
name: arissara iamaroon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06464666: Association Between Renal Resistive Index(RRI) and AKI(Acute Kidney Injury) in Cardiac Surgery Patients With Cardiopulmonary Bypass (CPB)
Official title: Association Between Renal Resistive Index(RRI) and AKI(Acute Kidney Injury) in Cardiac Surgery Patients With Cardiopulmonary Bypass (CPB)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injury
Renal Resistive Index
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 250
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Association between renal resistive index(RRI) and AKI(Acute Kidney Injury) in cardiac surgery patients

Brief summary: AKI(Acute Kidney Injury) is a common complication after cardiac surgery which is associated with increased mortality and morbidity. The conventiional marker for detecting AKI is serum creatinine, however, which has many limits. RRI(Renal Resistive Index) is a non-invasive test measured by ultrasound and could be a useful tool to evaulate renal insult in the early phase. Early detection of renal insult and prevention of progression to AKI can contribute to reduing mortality and morbidity in cardiac surgical patients.


Eligibility criteria: Inclusion Criteria:

* Aged 19 years and older scheduled for cardiac surgery using CPB

Exclusion Criteria:

* Emergency opeartion, pre-operative shock status requiring vasopressor or inotropics, s/p kidney transplant patients, CKD stage 4 and 5 patients, patients who have renal artery stenosis or history of renal artery stent implantation, patients who have ascites with Child-Pugh classification B or C, In case of CPB weaning failure, In case of poor lung function and PaO2 or PaCO2 cannot be maintained within normal range.

Primary outcomes:
measure: post-operative AKI incidence
timeFrame: within first 1 week after surgery
Secondary outcomes:
measure: Major adverse kidney outcome (MAKE) 30
timeFrame: within first 1 month after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02809066: Dietary Calcium Intake in Premenstrual Syndrome
Official title: Effect of Sufficient Dietary Calcium Intake in Women With Premenstrual Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: premenstrual syndrome
calcium
quality of life
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 31
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake.

Detailed description: This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake. Thirty one women, aged between 20-28 years, diagnosed with PMS and suitable for inclusion criteria, were participated in study. Participants were allocated to intervention (n=16) and control (n=15) groups randomly.

Eligibility criteria: Inclusion Criteria:

Women with;

* PMS who have inadequate calcium intake
* Regular menstrual cycle
* Menstrual flow which occurs every 22 to 35 days and last three to eight days

Exclusion Criteria:

* Having any of metabolic diseases
* Use oral contraceptive pill
* user vitamins and minerals supplements
* being smoker

Primary outcomes:
measure: Change in Premenstrual Syndrome Scale (PMSS)
timeFrame: Eight weeks
Secondary outcomes:
measure: Change in Quality of life scale Short Form (SF-36)
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Eastern Mediterranean University
Study officials:
affiliation: Eastern Mediterranean University
name: Merve Yurt, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03460366: Bariatric Surgery and Pharmacokinetics of Enalapril
Official title: Bariatric Surgery and Pharmacokinetics Enalapril: BAR-MEDS Enalapril
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Enalapril
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-03-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on enalapril are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: Enalapril concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03813966: Nasal Swab Home Collection Kit (NSHC Kit) Study
Official title: Self- and Parent/Guardian-Collection of Specimens for Rapid Influenza Nasal Swab Home Collection Kit (NSHC Kit) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Viral Infections
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Quidel Corporation
First posted: 2019-01-23
Enrollment: 1181
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A maximum of 1,000 patients, representing the random ages of the patients presenting at the Urgent Care facilities, will be enrolled.

Brief summary: The purpose of this study is to demonstrate that persons over the age of 13 years can obtain a self-collected nasal swab reliably and safely for subsequent use in the diagnosis of influenza. Similarly, the purpose is to demonstrate that parents or guardians can safely and effectively collect nasal swab specimens from children, ages 0 through 12 years, and others needing assistance in doing so, and that these parent/guardian-collected nasal swabs can also be used in the diagnosis of influenza. Clinical performance of the swabs will be based on the comparison of the performance of the nasal swab that is self- or parent/guardian-collected to one collected from the same specimen donor by a skilled clinical coordinator and used in CLIA (Clinical Laboratory Improvement Amendments)-waived, rapid diagnostic test called Sofia Influenza A+B FIA (fluorescence immunoassay analyzer).


Eligibility criteria: Inclusion Criteria:

* Fever
* Nasal Congestion
* Rhinorrhea
* Sore Throat
* Cough

Exclusion Criteria:

* Unable to read and understand or refusal to sign the appropriate informed consent/assent forms
* Refusal to complete the patient's demographic and medical history
* Treatment with anti-influenza antivirals within the previous 7 days
* Vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.

Primary outcomes:
measure: Diagnostic specificity of self-collected to technician collected nasal swab samples
timeFrame: 1 day (Participant); 17 weeks (Study length)
measure: Diagnostic sensitivity of self-collected to technician collected nasal swab samples
timeFrame: 1 day (Participant); 17 weeks (Study length)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UWHealth Urgent Care Clinics
state: Wisconsin
city: Madison
country: United States
facility: UW Health Urgent Care Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Jonathan Temte, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: