louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06747598: Efficacy Evaluation of Using Finger Stick Peripheral Blood for Point of Care Pregnancy Testing
Official title: Efficacy Evaluation of Using Finger Stick Peripheral Blood for Point of Care Pregnancy Testing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Testing
Keywords: POC pregnacy testing serum
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 confirmed pregnant patients who present for their routine care visit to confirm efficacy of finger stick pregnancy test

Brief summary: To evaluate the efficacy of using peripheral blood for POC pregnancy testing in known pregnant participants.

Detailed description: Point of care (POC) pregnancy tests are designed for use with a urine specimen. However, the timely collection of a urine specimen is solely dependent on the patient's need to urinate which can delay the initiation of subsequent care activities. Furthermore, when considering the limitations of urine POC testing in wilderness scenarios, collecting a urine specimen from an injured person may not be a viable option. The literature has demonstrated blood as a viable alternative specimen for use with POC pregnancy testing with a sensitivity of 95.8%. Based on a literature review, these studies used blood specimen that were pre-collected into a serum collection vial. The study postulates the use of peripheral blood via a finger stick has multiple benefits such as 1) eliminating the need to wait for urine, 2) expedite the serum collection process as compared to a venipucture, 3) allow for testing in non-traditional scenarios such as wilderness medicine or mass casualty/gathering scenarios, and 4) minimizing the amount of blood required as compared to a traditional 3-5 ml serum collection vial. Data from this pilot study will provide valuable insight on the potential use of this testing method to inform future studies and treatment protocols for the above mentioned scenarios.

Eligibility criteria: Inclusion Criteria:

* Pregnant female, 19 years or older, being seen at the Nebraska Medicine OB/GYN clinic

Exclusion Criteria:

* Does not meet inclusion criteria

Primary outcomes:
measure: POC serum pregnancy testing
timeFrame: One time test at time of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Thanh T Nguyen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00385645: Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis
Official title: Comparison of 2 Alternative Antiretroviral Combinations in HIV Post-exposure Prophylaxis: AZT-3TC (Combivir®) + Lopinavir-ritonavir (Kaletra®) Versus AZT-3TC (Combivir®)+ Atazanavir (Reyataz®). Multicentre, Prospective, Randomized, Open Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Keywords: HIV seronegativity
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 255
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: The study compares the adherence of 240 HIV-negative subjects randomly assigned to 2 different antiretroviral therapies for 28 days after accidental exposure to HIV.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* HIV exposure requiring prophylaxis under current guidelines

Exclusion Criteria:

* Pregnancy
* Suspected drug resistance in source case
* Contraindications to the study drugs

Primary outcomes:
measure: Proportions of patients completing 28-day antiretroviral treatment (ARVT)
Secondary outcomes:
measure: Proportion of HIV-seropositive at 6 months
measure: Incidence of adverse effects (clinical and laboratory) during ARVT
measure: Adherence to ARVT, time to adherence loss.
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Terrassa
country: Spain
facility: Mutua de Terrassa
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital de Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Felipe Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diaz-Brito V, Leon A, Knobel H, Peraire J, Domingo P, Clotet B, Dalmau D, Cruceta A, Arnaiz JA, Gatell JM, Garcia F; DATEMPEP study group. Post-exposure prophylaxis for HIV infection: a clinical trial comparing lopinavir/ritonavir versus atazanavir each with zidovudine/lamivudine. Antivir Ther. 2012;17(2):337-46. doi: 10.3851/IMP1955. Epub 2011 Nov 25.
Clinical trial NCT00773045: Pain Measurement and Pain Management in the Intensive Care Unit(ICU)
Official title: Pain Measurement and Pain Management in the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill Patients
Keywords: pain scores
critically ill patients
ICU
pain management
pain measurement
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients, 18 years and older

Brief summary: The purpose of this study is to evaluate the effect of a pain training program and systematic measurement of pain scores on actual pain levels and the use of analgesics in critically ill patients.

Detailed description: Systematic evaluation of pain, though still not common practice in all ICUs, is recommended in clinical practice guidelines for optimal pain management. Pain is a frequently experienced problem in patients in the Intensive Care Unit(ICU). In search of literature to support the need for introduction of a pain management system and to train the entire health staff in our department little information was found concerning the effects of pain training and pain management systems in the ICU. The small number of available studies may be explained by the difficulty of systematic pain measurement in ICU patients, mainly due to the inability to communicate effectively with these patients.

Eligibility criteria: Inclusion Criteria:

* All patients admitted to the ICU of the St. Antonius hospital, \>18 years old.

Exclusion Criteria:

* Patients who are suspected to be brain-dead

Primary outcomes:
measure: Pain scores using the numerical rating scale, rated by the attending nurse and by the patient if possible.
timeFrame: 3 times a day
Secondary outcomes:
measure: Dose of all pain medication (morphine, paracetamol) per patient
timeFrame: 24 hr
measure: Length of stay in the ICU
timeFrame: ICU stay
measure: Pneumonia
timeFrame: ICU stay
measure: 30 day Mortality
timeFrame: within 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anaesthesiology, Intensive Care and Pain Management, St Antonius Hospital, Nieuwegein
name: Peter Bruins, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02764398: Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep Anesthesia
Official title: Prospective Analysis of Serious Cardio-respiratory Events During Ophthalmic Artery Chemotherapy for Retinoblastoma Under a Deep and Standardized Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinoblastoma
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-05-06
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children requiring superselective ophthalmic artery chemotherapy for retinoblastoma

Brief summary: Background: Serious adverse cardio-respiratory events (SCRE) occur during super selective ophthalmic artery chemotherapy for retinoblastoma in children. SCRE mechanism remains unclear but may be attributed to an autonomic nervous reflex induced by catheterization of the ophthalmic artery. The investigators hypothesize that inadequacy between depth of anesthesia and catheter stimulation might be a support cause of these SCRE.

Methods: Children requiring super selective ophthalmic artery chemotherapy for retinoblastoma are prospectively included in this observational study. Endovascular procedures are performed under standardized and deep general anesthesia with sevoflurane, sufentanil and rocuronium. SCRE are strictly pre-defined and included arterial hypotension, bradycardia and bronchospasm. SCRE are recorded and the factors influencing their occurrence are investigated.


Eligibility criteria: Inclusion Criteria:

* superselective ophthalmic artery chemotherapy for retinoblastoma required

Exclusion Criteria:

* no

Primary outcomes:
measure: Serious adverse cardio-respiratory events during ophthalmic artery chemotherapy for retinoblastoma.
timeFrame: from the beginning of general anesthesia until the end of injection of chemotherapy in the ophthalmic artery, assessed up to 120 minutes.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03503045: The Rates of Overtreatment and Deintensification in Patients With Diabetes Mellitus
Official title: The Rates of Overtreatment and Deintensification of Antidiabetic and Antihypertensive Medications in Patients With Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Polypharmacy
Overtreatment
Undertreatment
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 1276
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 65 years and older and with type 1 or type 2 diabetes who were under follow-up in the same tertiary endocrine unit for at least a year were enrolled.

Brief summary: This study evaluates the overtreatment and deintensification rates of antidiabetic and antihypertensive medications in patients with diabetes mellitus in Turkey.

Detailed description: Diabetes mellitus is one of the most common chronic diseases which lead to serious public health problems and a significant economic burden worldwide. The prevalence of diabetes in elderly patients is very high and is predicted to increase dramatically.

Prior studies have generally been concerned with the inadequate treatment of diabetes however, over the last few years the overtreatment of diabetes has also come to the fore. Unfortunately, there are very few data worldwide and no data in Turkey about the overtreatment of patients with type 2 diabetes.

This study aimed to assess the rates and predictors of overtreatment and undertreatment of glycemia and blood pressure in older adults with T2DM. Treatment deintensification or intensification by the physicians were also investigated.

Eligibility criteria: Inclusion Criteria:

* Patients with Diabetes Mellitus type I or II
* Age 65 years or older
* To be under follow-up in the same center for at least one year.

Exclusion Criteria:

* Younger than 65 years old
* having decompensated liver disease
* psychiatric disorders interfering cognition or compliance
* having bariatric surgery or on renal replacement therapy

Primary outcomes:
measure: Overtreatment for glycemia
timeFrame: 7 days
Secondary outcomes:
measure: Undertreatment for glycemia
timeFrame: 7 days
measure: Overtreatment for blood pressure
timeFrame: 7 days
measure: Undertreatment for blood pressure
timeFrame: 7 days
measure: Deintensification of treatment
timeFrame: 7 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine
Study officials:
affiliation: Gulhane School of Medicine, Endocrinology and Metabolism
name: Alper Sonmez, Prof.Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06655545: 18F-fluoroestradiol (18F-FES) PET/CT Guided First-line Treatment for HR+/HER2- Metastatic Breast Cancer Patients
Official title: A Single-center, Real-world Study Exploring the Guidance of FES-PET for First-line Treatment of HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: chemotherapy
CDK4/6 inhibitors
18F-fluoroestradiol (18F-FES) PET/CT
HR positive
HER2 negative
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 473
Sex: FEMALE
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: Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between January 2020 to February 2024.

Brief summary: A single-center, real world study to evaluate the role of FES-PET in guiding the first-line treatment of HR+/HER2- MBC patients.


Eligibility criteria: Inclusion Criteria:

1. age \>= 18 years old;
2. Patients who were diagnosed as HR Positive, HER2 Negative recurrent unresectable (local or regional) or stage IV (M1) breast cancer between January 2020 to February 2024;
3. Received CDK4/6 inhibitor plus endocrine treatment or chemotherapy as first-line therapy for at least one cycle;
4. Complete medical history was available.

Exclusion Criteria:

1. Medical history was incomplete.

Primary outcomes:
measure: PFS
timeFrame: 6 weeks
Secondary outcomes:
measure: OS
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Biyun Wang, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06272045: Early Intervention to Promote Cardiovascular Health of Mothers and Children
Official title: Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Health
Keywords: Home visiting
Lead sponsor: JHSPH Center for Clinical Trials
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-02-22
Enrollment: 6618
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Early Intervention to Promote Cardiovascular Health of Mothers and Children (ENRICH) is a cluster randomized clinical trial, funded by the National Heart Lung \& Blood Institute. The study is designed to test the effectiveness of home visiting intervention to promote cardiovascular health and reduce disparities in maternal and early childhood cardiovascular health. Sites, in partnership with evidence-based home visiting programs, are recruiting 6400 participants in total (i.e., 3200 parent-dyads which includes 3200 parents and 3200 children) from diverse community settings with a high burden of cardiovascular disease risk factors.


Eligibility criteria: Inclusion Criteria:

1. Be currently enrolled in an evidence-based home visiting program participating in ENRICH
2. Be pregnant, with a single or multifetal gestation, at or less than 34 weeks 0 days gestation (per self-report at time of consent)
3. Be 18 years of age or older
4. Speak English or Spanish

Exclusion Criteria: There are no exclusion criteria being applied in assessing eligibility for participation in ENRICH.

Primary outcomes:
measure: Parent physical activity
timeFrame: 12 months after birth
measure: Parent diet measured by Mediterranean Eating Pattern for Americans (MEPA) scale
timeFrame: 12 months after birth
measure: Parent body mass index
timeFrame: 12 months after birth
measure: Parent blood pressure
timeFrame: 12 months after birth
Secondary outcomes:
measure: Child body mass index
timeFrame: 24 months old
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Luis Obispo
country: United States
facility: California Polytechnic State University
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: State College
country: United States
facility: Pennsylvania State University
state: Pennsylvania
city: Providence
country: United States
facility: Brown University/Lifespan
state: Rhode Island
Study officials:
References:
Clinical trial NCT05519345: Operant Conditioning After ACL Reconstruction
Official title: Conditioning Brain Responses for Modulating Corticospinal Excitability After ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: ACL
Quadriceps
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-08-29
Enrollment: 22
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine if the changes in corticospinal function that accompany ACL reconstruction can be improved through a form of mental coaching and encouragement, known as operant conditioning.

Detailed description: It is theorized reduced corticospinal excitability contributes to quadriceps dysfunction after knee injury and joint disease. Current rehabilitation does not directly target the alterations in corticospinal excitability, which may limit recovery. Operant conditioning is an emerging approach capable of increasing corticospinal excitability by directly targeting the corticospinal pathways. However, it remains to be determined whether operant conditioning of the corticospinal pathway may improve corticospinal function after knee trauma. Therefore, this study will evaluate the ability of operant up-conditioning of the corticospinal pathway to improve corticospinal function after ACL reconstruction.

Eligibility criteria: Inclusion Criteria:

* aged 14-45 years
* suffered an acute, complete ACL rupture
* have undergone ACL reconstructive surgery
* willingness to participate in testing and follow-up as outlined in the protocol

Exclusion Criteria:

* have suffered a previous ACL injury on the contralateral leg
* have undergone previous major surgery to the contralateral knee
* have a history of recent significant knee injury (other than ACL) or lower-extremity fracture
* have a history of uncontrolled diabetes or hypertension
* be pregnant or plan to become pregnant
* have metal implants in the head
* have electronic devices in their ear or heart (e.g., cochlear implants or cardiac pacemakers)
* have unexplained recurrent headaches
* have a recent history of seizure
* have a history of repeated fainting spells

Primary outcomes:
measure: Changes in corticospinal excitability
timeFrame: Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)
Secondary outcomes:
Other outcomes:
measure: Changes in quadriceps strength
timeFrame: Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)
measure: Changes in quadriceps voluntary activation
timeFrame: Baseline (before the start of the intervention) and post-intervention (approximately 2 weeks after baseline)
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT05831345: Intraoperative Methadone for the Prevention of Postoperative Pain
Official title: Intraoperative Methadone for the Prevention of Postoperative Pain: a Randomized, Double-blind Clinical Study in Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Orthopedic Surgery
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 80
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: SUPPORTIVE_CARE

Brief summary: The pain felt after orthopedic surgery in the absence of adequate locoregional anesthesia is often insufficiently controlled, especially during the first 24 hours postoperatively.

Methadone, due to its long half-life, may provide better pain control after orthopedic surgery when associated locoregional anesthesia cannot be performed.

It may be impossible to perform loco-regional anesthesia in various contexts: patient refusal, pre-existing neurological impairment, infection at the injection site, coagulopathies, inability to cooperate, total language barrier, allergy to anesthetics, unavailability of equipment (ultrasound, etc.) or equipped room, lack of experience of nursing staff in performing the block and in the postoperative management of the patient.

Intraoperative administration of methadone in these settings may be superior to sufentanil for pain control during the 24 hours post orthopedic surgery, and the pain control provided by methadone does not appear to imply a higher likelihood of adverse events related to opioids.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years old
* ASA 1-3 status
* Elective partial or total hip and knee arthroplasty

Exclusion Criteria:

* Patient refusal
* Preoperative renal failure (serum creatinine \> 2 mg/dL or 1.5-fold
* Increase in basal plasma creatinine or GFR \< 90 ml/min/1.73m2)
* Significant hepatic dysfunction (PT \<50% or increase in 3 times basal transaminases)
* Known heart failure
* Preoperative hemodynamic instability (preoperative use of inotropes or vasopressors)
* Known methadone or sufentanil allergy
* Preoperative opioid use or history of opioid abuse
* Pregnancy and breastfeeding.

Primary outcomes:
measure: Total morphine consumption
timeFrame: 72 hours
measure: Standard visual analogue scale (VAS)
timeFrame: 24 hours
Secondary outcomes:
measure: Patient satisfaction
timeFrame: 72 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
References: