louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00926939: Technological Innovations in Behavioral Treatments for Cigarette Smoking
Official title: Technological Innovations in Behavioral Treatments for Cigarette Smoking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Cigarette
Nicotine
Smoking
Contingency Management
Voucher reinforcement
Smoking Abstinence
Internet-based treatment
Lead sponsor: National Development and Research Institutes, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2009-06-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate a sustainable and broadly accessible treatment delivery model (Motiv8) for smoking cessation based on abstinence-reinforcement.

Detailed description: Smokers are randomly assigned to one of two groups: an Abstinence Contingent (AC) group and a Submission Contingent (SC) group. The AC group receives vouchers for abstaining from smoking (measured by a carbon monoxide monitor and confirmed through video-submission), and the SC group receives vouchers for submitting videos of their carbon monoxide breath tests. Both groups take videos of their CO-monitoring on a secure website designed for the study, as well as receive standard care counseling and education related to smoking cessation. The main intervention lasts four weeks, and a three-week maintenance phase will follow. Assessments will be conducted at intake, week four (end of the main treatment phase), and at three and six months after the intervention period is completed

Eligibility criteria: Inclusion Criteria:

* Self-reported smoker
* Permission to contact applicant by phone
* Ability to use the internet

Exclusion Criteria:

* Self-report of a history of or current severe or unstable medical or psychiatric illness that would interfere with the study

Primary outcomes:
measure: CO sample of ≤ 4ppm
timeFrame: 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention
measure: Participant reporting not smoking, not even a puff in the last 7 days.
timeFrame: 4 weeks, 7 weeks during intervention; 3 months and 6 months after intervention
Secondary outcomes:
measure: Twice-daily breath CO samples obtained during treatment period.
timeFrame: First 4 weeks of treatment
measure: The longest duration of sustained abstinence based on the twice-daily breath samples during the treatment period.
timeFrame: First 4 weeks of treatment
Other outcomes:
Locations:
city: New York City
country: United States
facility: National Development and Research Institutes
state: New York
Study officials:
affiliation: National Development and Research Institutes, Inc.
name: Jesse Dallery, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05110339: Efficacy of Dexmedetomidine on Postoperative Analgesia
Official title: Efficacy of Dexmedetomidine on Postoperative Analgesia After Radical Mastectomy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Universidad Autónoma de Tamaulipas
Sponsor class: OTHER
Collaborators: name: Universidad Nacional Autonoma de Mexico
First posted: 2021-11-05
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized double-blinded study
Primary purpose: TREATMENT

Brief summary: This prospective, randomized, double-blind study is designed to evaluate the postoperative analgesic efficacy of dexmedetomidine as an adjunct to ropivacaine in erector spinae block in patients undergoing radical mastectomy. The investigators hypothesis is that the administration of ropivacaine 0.5% associated with dexmedetomidine in the blockade via the plane in the erector spinae is less effective in controlling acute postoperative pain in radical mastectomy than the administration of ropivacaine 0.5% without dexmedetomidine.

Detailed description: Patients undergoing radical mastectomy are randomly assigned to receive, in addition to standard general anesthesia, a block of the erector spinae plane with ropivacaine at a dose of 0.5% for the control group (n = 13) and ropivacaine at a dose of 0.5% more dexmedetomidine at 0.3 mcg kg (n = 15) for the intervention group. General anesthesia was induced using anxiolysis with midazolam at 30 mcg / kg corrected weight, as induction, propofol at a dose of 1.5 - 2 mg kg, opioid analgesia with fentanyl at a dose of 3 mcg / kg weight corrected with 30% according to ideal weight initial bolus dose, and dose as required, neuromuscular relaxation with cisatracurium at a dose of 0.1 mg / kg.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing radical mastectomy for pathology "breast cancer"
* Patient undergoing anesthetic technique due to erector spinae plane block
* Informed consent to perform the anesthesia technique.
* Karnofsky\> 80 points

Exclusion Criteria:

* Emergency surgery
* Patient with mental pathology that prevents pain assessment.
* Rejection of anesthetic technique.
* Patient with allergy to local anesthetics
* Patient with local infection of the puncture site for application of the erector spinae block

Primary outcomes:
measure: Postoperative Pain score
timeFrame: 0 hours
measure: Postoperative Pain score
timeFrame: 6 hours
measure: Postoperative Pain score
timeFrame: 12 hours
measure: Postoperative Pain score
timeFrame: 24 hours
Secondary outcomes:
measure: Additional opioid-type drugs
timeFrame: 24 hours
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Matamoros
country: Mexico
facility: Jose Camilo Muñoz Chaves
state: Tamaulipas
Study officials:
References:
Clinical trial NCT06297239: Argentine Registry of Lp(a)
Official title: Argentine Registry for the Study of Lipoprotein a
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lp(A)
Hypercholesterolemia
Cardiovascular Diseases
Diabete Type 2
Hypertension
Keywords: LP(a)
Cardiovascular risk
Lead sponsor: School of Medicine. National University of Cuyo
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients residing in Argentina

Brief summary: The Argentine Registry on Lipoprotein(a) (LP(a)), orchestrated by the Argentine Group for LP(a) Study, stands as a pioneering and extensive prospective initiative. This registry systematically collects geolocation data, including patient postal codes, demographic information, and a multifaceted array of health parameters to unravel the intricate associations surrounding LP(a) levels.

The dataset encompasses diverse patient characteristics, ranging from standard metrics like blood pressure, weight, and race to broader factors such as diabetes, smoking habits, menopausal status, and hypothyroidism. This holistic approach enables a nuanced exploration of the interplay between LP(a) levels and various risk factors, providing invaluable insights for both clinical and public health considerations.

One distinctive feature of this registry lies in its focus on medication history, shedding light on the impact of routine pharmaceutical interventions on LP(a) profiles. Additionally, it delves into the intricate web of inflammatory diseases, recognizing their potential role in LP(a) modulation.

Genetic predispositions are meticulously examined, with a specific emphasis on identifying homozygous and heterozygous variants associated with hypercholesterolemia. This genetic dimension adds a layer of complexity to the understanding of LP(a) dynamics, contributing significantly to the ongoing discourse on cardiovascular risk.

The prospective nature of this registry allows for dynamic analyses, fostering a continuous exploration of emerging patterns and trends. By amalgamating geographical, clinical, and genetic data, the Argentine LP(a) Registry emerges as a comprehensive platform poised to unlock novel facets of LP(a) biology and its implications for cardiovascular health. As the dataset matures, it holds the promise of guiding personalized interventions and refining risk stratification strategies, thereby advancing the landscape of preventive cardiovascular care.


Eligibility criteria: Inclusion Criteria: Adult patients with validated Lp(a) values -

Exclusion Criteria: Associated pathologies that can increase the Lp(a) value in a non-specific manner

-

Primary outcomes:
measure: prevalence of high level of Lp(a)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Mendoza
country: Argentina
facility: Universidad Nacional de Cuyo
Study officials:
affiliation: FASTA University
name: Pablo Corral, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06765239: Breathe-Easy: Hayfever Care for Patients With Seasonal Allergic Rhinitis
Official title: Evaluation of Breathe-Easy Hayfever Care for Managing Symptoms in Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hayfever
Allergy Pollen
Allergic Rhinitis
Keywords: Breathe-Easy
Hayfever Care
Lead sponsor: Innowage Limited
Sponsor class: INDUSTRY
Collaborators: name: Mettle Networks
First posted: 2025-01-09
Enrollment: 63
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: SUPPORTIVE_CARE

Brief summary: This waitlist-controlled trial aims to evaluate the therapeutic effectiveness of Hayfever Care by assessing disease-specific symptoms over a 4-week period. Additionally, the study examines the tolerability and safety of the solution.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate symptoms during the hayfever season
* Generally healthy individuals without chronic illnesses
* Willingness to comply with study requirements, including completing symptom diaries.

Exclusion Criteria:

* History of anaphylaxis or severe hayfever symptoms requiring emergency treatment.
* Pregnant or breastfeeding
* History of substance abuse or excessive alcohol consumption.
* Use of systemic corticosteroids, immunotherapy

Primary outcomes:
measure: Well-being Numerical Rating Scales
timeFrame: Change from Baseline to 4 weeks after baseline
Secondary outcomes:
measure: Change of Symptom Dry Eyes
timeFrame: Change in symptom scores from baseline to 4 weeks.
measure: Change of Symptom Itching Eyes
timeFrame: Change in symptom scores from baseline to 4 weeks.
measure: Change of Symptom Burning Eyes
timeFrame: Change in symptom scores from baseline to 4 weeks.
measure: Change of Symptom Respiratory Complaints
timeFrame: Change in symptom scores from baseline to 4 weeks.
measure: Change of Symptom Sneezing
timeFrame: Change in symptom scores from baseline to 4 weeks.
measure: Change of Symptom Rhinitis
timeFrame: Change in symptom scores from baseline to 4 weeks.
measure: Change of Symptom Fatigue
timeFrame: Change in symptom scores from baseline to 4 weeks.
measure: Change of Symptom Headache
timeFrame: Change in symptom scores from baseline to 4 weeks.
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Gyansanjeevani India
state: Rajasthan
Study officials:
affiliation: Mettle Networks
name: Sandeep Shinde
role: STUDY_CHAIR
affiliation: Innowage, India
name: Dr. Pradyuman S Rathore
role: STUDY_DIRECTOR
affiliation: Gyansanjeevani India
name: Dr Mridu Sharma
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06669039: Comparison of the Computer Controlled and Conventional Local Anesthesia Techniques in Primary Molar Extraction in Children Aged 5 to 9 Years Old
Official title: Comparison of Computer Controlled Intra-ligamentary Local Anesthesia and Conventional Inferior Alveolar Nerve Block in Primary Molars Extractions - Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Computer-controlled Intraligamentary Anaesthesia
Inferior Alveolar Nerve Block
Pain Perception
Anesthesia Effectiveness
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to assess pain perception, child stress level and compare the effectiveness between periodontal ligament anesthesia using Computer-controlled Local Anesthetic delivery system and the Conventional Inferior Alveolar Nerve Block during extraction of the primary molars.

The main questions it aims to answer are:

Is there a difference in pain perception, child stress level and anesthesia effectiveness between the CC-ILA system and the traditional syringe when administering IANB in pediatric patients undergoing primary molar extractions.

Researchers will compare CC-ILA system to traditional syringe when administering IANB to see if there a difference in pain perception, child stress level and anesthesia effectiveness.

Participants will:

Have their lower first primary molar extracted by receiving either periodontal ligament anesthesia using computer-controlled local anesthetic delivery system or the conventional inferior alveolar nerve bock.

Pain perception during the anesthesia process was measured using both objective criteria through the Sound-Eye-Motor scale and subjective assessment using Wong-Baker Faces Pain Rating Scale. Salivary cortisol level will be used to determine child stress level. The efficacy of anesthesia at various stages of the extraction procedure was evaluated using the Sound-Eye-Motor scale.


Eligibility criteria: Inclusion Criteria:

* Healthy children (ASA I).
* Ranging in age from 5-9.
* Cooperative (Frankle ++).
* With mandibular first primary molars earmarked for removal owing to factors such as: extensive caries, crown damage, periapical lesions and unsuccessful pulp treatment.

Exclusion Criteria:

* Mobile teeth (Grade III).
* Ankylosed teeth.
* Teeth with root resorption (more than 1\\3).
* Patients with facial cellulitis and when there is a need for supplemental anesthesia

Primary outcomes:
measure: Pain
timeFrame: Immediately after receiving anesthesia
measure: Pain
timeFrame: Immediately after receiving anesthesia
measure: Stress level
timeFrame: Before and after local anesthesia delivery
measure: Effectiveness
timeFrame: Through dental procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King AbdulAziz University
Study officials:
References:
Clinical trial NCT02156739: Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions
Official title: Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma
Liver and Intrahepatic Bile Duct Disorder
Metastatic Malignant Neoplasm in the Liver
Primary Malignant Liver Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.

Detailed description: PRIMARY OBJECTIVES:

I. To compare the specificity of contrast enhanced MRI using a liver specific agent Eovist (gadoxetate disodium) versus the combined use of Eovist and an intravascular-extracellular agent Gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging.

OUTLINE:

Patients receive gadoxetate disodium intravenously (IV) over 1 minute and undergo MRI. Patients then receive gadobutrol IV over 1 minute at the 20 minute mark during MRI.

Eligibility criteria: Inclusion Criteria:

* Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week
* Patients with renal function (estimated glomerular filtration rate \[eGFR\] \>= 30)
* Any disease type

Exclusion Criteria:

* Pregnant women
* Patients with impaired renal function (eGFR \< 30)
* Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
* Patients with contraindications to the use of intravenous contrast such as allergic type reactions

Primary outcomes:
measure: Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Janio Szklaruk, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01531439: Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
Official title: Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Postoperative Nausea and Vomiting
Scoliosis
Keywords: Narcotic Antagonists
Naloxone infusion
Postoperative pruritis
Patient controlled analgesia
Pediatric
Children
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2012-02-13
Enrollment: 84
Sex: ALL
Minimum age (years): 10
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose. The trial is designed to determine if a higher dose of naloxone infusion will reduce side effects from opioid therapy in patients who have undergone spine fusion for scoliosis.

Detailed description: Currently, patients undergoing spinal fusion for scoliosis are routinely given patient controlled analgesia (PCA) for pain control postoperatively. PCA therapy is typically combined with an ultra low dose naloxone infusion because of the established benefit of reduced pruritis and nausea. The investigators hypothesize that using a higher dose naloxone infusion may lead to further improvement in pruritis and nausea and may improve GI function. Improvement in bowel function could lead to faster initiation of oral intake as well as transition to oral pain medication and even decreased length of stay.

Eligibility criteria: Inclusion Criteria:

* Idiopathic scoliosis requiring spine fusion surgery
* Age 10-21 years

Exclusion Criteria:

* Inability to understand PCA instructions
* Allergy to: morphine, hydromorphone, fentanyl, naloxone, or diphenhydramine
* Chronic opioid therapy \> 2 months
* Non-English speaking

Primary outcomes:
measure: Number of Hours Until Tolerating Oral Intake
timeFrame: Assessed daily in hospital while in hospital until taking orals, average 4 days.
Secondary outcomes:
measure: Severity of Itching
timeFrame: Assessed daily while in hospital requiring PCA
measure: Severity of Nausea
timeFrame: Assessed daily while in hospital requiring PCA.
measure: Severity of Pain
timeFrame: Assessed by bedside nurse 3 times daily while requiring PCA
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Benjamin J. Pieters, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01123239: Understanding and Improving Diabetes Care for Ethnic Minorities
Official title: Reducing Racial Disparities in Diabetes Care - The Coached Care Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Healthcare Disparities
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-05-14
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, we are testing the effectiveness of an intervention known as "Coached Care" to improve health outcomes and quality of care of patients being treated for type 2 diabetes, particularly patients in underserved populations. The intervention involves training members of minority communities who have diabetes to be "coaches", teaching minority patients the skills needed to participate effectively in care during office visits, as they present for those visits. Coaches follow patients for 9 routine consecutive visits, reinforcing participation skills before and between their routine office visits.


Eligibility criteria: Inclusion Criteria:

* diagnosis of type 2 diabetes
* At least one Hemoglobin A1c value greater than 7.5% in the year prior to recruitment.

Exclusion Criteria:

* Age above 80 years
* patients with dementia or other serious mental health problems that would prevent them from participating in the intervention.
* patients with other serious medical problems that would prevent them from participating in the intervention.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 1 year and 2 year follow-up
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 1 year and 2 year follow-up
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Mary and Dick Allen Diabetes Center at Hoag Hospital
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center
state: California
city: Westminster
country: United States
facility: Westminster Medical Center
state: California
Study officials:
References:
citation: Malik S, Billimek J, Greenfield S, Sorkin DH, Ngo-Metzger Q, Kaplan SH. Patient complexity and risk factor control among multimorbid patients with type 2 diabetes: results from the R2D2C2 study. Med Care. 2013 Feb;51(2):180-5. doi: 10.1097/MLR.0b013e318273119b.
citation: Sorkin DH, Ngo-Metzger Q, Billimek J, August KJ, Greenfield S, Kaplan SH. Underdiagnosed and undertreated depression among racially/ethnically diverse patients with type 2 diabetes. Diabetes Care. 2011 Mar;34(3):598-600. doi: 10.2337/dc10-1825. Epub 2011 Jan 27.