louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05831007: Safety and Efficacy Study of LX102-C01 Treatment of Neovascular Age-Related Macular Degeneration (nAMD)
Official title: An Open Label Dose Escalation Clinical Trial to Evaluate the Safety and the Efficacy of LX102-C01 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Innostellar Biotherapeutics
First posted: 2023-04-26
Enrollment: 6
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the safety and efficacy of LX102-C01 treatment of nAMD. This study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (IVT) injection of LX102-C01 to evaluate its safety and efficacy.


Eligibility criteria: Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.

1. Age ≥ 50
2. Diagnosis of active CNV secondary to neovascular AMD
3. The study eye must have a best-corrected E-ETDRS visual acuity letter score of less than or equal to 63.
4. Subjects must have received a minimum of 2 injections within 6 months prior to screening.
5. Demonstrated a meaningful response to anti-VEGF therapy

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to diseases other than nAMD
2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
5. Uncontrolled diabetes defined as HbA1c \>7.5%

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 52 weeks
measure: Incidence of serious adverse events (SAEs)
timeFrame: 52 weeks
Secondary outcomes:
measure: Mean change in BCVA from Baseline
timeFrame: 24 weeks, 52weeks
measure: Mean change in Central Subfield Thickness (CST) from Baseline
timeFrame: 24 weeks, 52 weeks
measure: Mean number of anti-VEGF injections over time
timeFrame: 52 weeks
measure: Change of quality of life scores (VFQ-25) from Baseline
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study officials:
References:
Clinical trial NCT00333307: Evaluation of the Safety of Relaxin in Preeclampsia
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin (rhRlx) in Subjects With Preeclampsia
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Pre-Eclampsia
Keywords: relaxin
preeclampsia
Lead sponsor: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Sponsor class: INDUSTRY
First posted: 2006-06-05
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia

Detailed description: The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of preeclampsia
* Hospital admission for expectant management

Exclusion Criteria:

* Eclampsia or history of seizures
* Vaginal bleeding
* Multifetal gestation
* Requirement for immediate delivery

Primary outcomes:
measure: maternal adverse experiences
measure: fetal adverse experiences
measure: neonatal adverse experiences
Secondary outcomes:
measure: preeclampsia assessments
measure: vital signs
measure: physical examinations
measure: clinical laboratory assessments
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
name: Sam Teichman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00935207: Study of the Impact of a Pain Diary in Pediatric Patients
Official title: The Impact of a Pain Diary on the Communication of Pain in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pain
Keywords: Pain
Pediatric Pain
Pain Diary
Pediatric Pain Measurement
Pain Measurement
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 8
Sex: ALL
Minimum age (years): 3
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen.

Brief summary: The purpose of this study is to show the impact of a pain diary on the communication of pain by pediatric patients. Participants will be given a pain diary after consent and asked to complete the record each time they have pain. A survey about the efficacy of the pain diary will be taken prior to discharge by the nurse, physician, patient and parents. The hypothesis is that the pain diary will improve the communication.


Eligibility criteria: Inclusion Criteria:

* Inpatients at the Blair E. Batson Hospital for Children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen.

Exclusion Criteria:

* Admitted to the Pediatric Intensive Care Unit
* Surgical patients, defined as patients having surgery since admission other than minor procedures
* Patients anticipated to receive pain medication for less than 24 hours
* Patients unable to verbally communicate their pain

Primary outcomes:
measure: Child Survey
timeFrame: Hospital discharge
measure: Parent Survey
timeFrame: Hospital Discharge
measure: Nurse Survey
timeFrame: Hospital Discharge
measure: Physician Survey
timeFrame: Hospital Discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Andrew Ostrenga, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06526507: PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics
Official title: PrEPARE-SCALE: Scaling up Integrated PrEP Delivery in Kenyan Maternal and Child Health Clinics for Pregnant and Postpartum Women
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Hiv
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
First posted: 2024-07-29
Enrollment: 17000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Difference in differences design, also known as a controlled pre-post design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project aims to develop a community of practice; then test a combination of community of practice, quality improvement, and a training toolkit, to enhance implementation and clinical outcomes; and identify patterns attributes associated with successful implementation.

Detailed description: Aim 1: To develop and determine the impact of a Community of Practice (CoP) on stakeholder and healthcare worker engagement and knowledge of integrated pre-exposure prophylaxis (PrEP) delivery.

Aim 2: To determine the impact of a 3-component scale-up package on implementation outcomes and PrEP patient outcomes among pregnant and postpartum populations.

Aim 2a: To determine the impact of the scale-up package on PrEP implementation outcomes, including reach, service penetration, adoption (primary outcomes), and PrEP fidelity and maintenance (secondary outcomes).

Aim 2b: To determine the impact of the scale-up package on PrEP patient outcomes, including PrEP initiation and continuation.

Aim 3: To identify difference-making bundles of facility- and regional-level attributes and implementation processes that influence reach, fidelity implementation, and maintenance.

Eligibility criteria: Inclusion Criteria:

Health Care Workers:

* work at a facility involved in study
* involved in PrEP service delivery
* \>=18 years

Clients:

* female clients seeking health services at study facilities
* pregnant or postpartum
* \>15 years (includes emancipated minors)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Service penetration
timeFrame: 1 year
measure: Reach
timeFrame: 1 year
measure: Adoption (provider)
timeFrame: 1 year
measure: Adoption (facility)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kapsabet
country: Kenya
facility: Kapsabet County Referral Hospital
state: Nandi
city: Kitale
country: Kenya
facility: Kitale County Referral Hospital
state: Trans Nzoia
city: Eldoret
country: Kenya
facility: Uasin Gishu District Hospital
state: Uasin Gishu
city: Busia
country: Kenya
facility: Busia County Referral Hospital
city: Nairobi
country: Kenya
facility: Kenyatta National Hospital
Study officials:
affiliation: University of Washington
name: Anjuli Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03233607: Time of Postpartum Hemoglobin Assessment and Blood Loss During Delivery
Official title: Optimal Time for Postpartum Hemoglobin Assessment and Its Correlation With Estimated Blood Loss (EBL)/Quantitative Blood Loss (QBL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage, Postpartum
Keywords: Postpartum
Hemoglobin
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2017-07-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women who are admitted to the Allen hospital for delivery during the recruitment period.

Brief summary: This is a prospective cohort study of patients delivering at Columbia University Medical Center/ Allen Hospital. For the primary research question, the investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation with estimation of blood loss (EBL) and quantitative blood loss (QBL).

Detailed description: Postpartum hemorrhage is a leading cause of maternal mortality and morbidity worldwide. Early intervention is dependent on care providers ability to accurately estimate ongoing blood loss. Studies in the past have shown that obstetricians and midwives tend to overestimate blood loss when the lost volumes are small while tend to underestimate by as much as 40 to 50 percent when a large volume of blood is lost.

Multiple studies have shown that routine hemoglobin assessment in postpartum patients after uneventful delivery either vaginal or via cesarean section, is not necessary. This leads to increased cost of care without any added benefit and causes inconvenience to the patients. However knowing how imprecise blood loss estimation can be it is reasonable to screen women for anemia prior to discharge.

Eligibility criteria: Inclusion Criteria:

All antepartum patients receiving prenatal care at the Broadway Practice and plan to deliver at Allen Hospital in NYC.

Exclusion Criteria:

Patients who gave consent to participate in the study but did not deliver at Allen hospital.

Primary outcomes:
measure: Change in maternal hemoglobin
timeFrame: Day 1 and Day 2
measure: Correlation of maternal hemoglobin to EBL
timeFrame: Up to 2 days after delivery
measure: Correlation of maternal hemoglobin to QBL
timeFrame: Up to 2 days after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Rachana Gavara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05382507: The Ultrasonographic Measurement of Quadriceps Muscle Thickness and the Shape of the Femoral Nerve in Patients Undergoing Total Knee Arthroplasty: an Observational Study
Official title: The Ultrasonographic Measurement of Quadriceps Muscle Thickness and the Shape of the Femoral Nerve in Patients Undergoing Total Knee Arthroplasty: an Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Total Knee Arthroplasty
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing total knee arthroplasty

Brief summary: For each individual, the femoral nerve shows various shapes and locations. This is because the femoral nerve is located on top of the iliacus muscle, so the shape and location of the femoral nerve seems to be related to the patient's muscle mass. Ultrasound of the quadriceps femoris could represent a widely available, non-invasive, affordable, and reliable tool to evaluate skeletal muscle. We aim to investigate the relationship between muscle mass and the shape of the femoral nerve through this observational study.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 19 years old or older and scheduled for elective total knee arthroplasty

Exclusion Criteria:

1. Pre-existing neurologic or anatomic deficits in the lower extremities

Primary outcomes:
measure: the thickness of rectus femoralis and vastus intermedius, the shape of the femoral nerve
timeFrame: preoperative (about 10 minutes before entering the operating room)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
state: Seodaemun-gu
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
name: Bora Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02097888: Influence of Erythropoietin on Bone Marrow Microenvironment
Official title: Influence of Erythropoietin on Bone Marrow Microenvironment: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Men and Non- Pregnant Women
Lead sponsor: Kantonsspital Baselland Bruderholz
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents living \< 400m over sea level and \>1500m over sea level

Brief summary: This will be a prospective observational study. The investigators will compare Erythropoietin (Epo) levels, erythropoiesis, and regulators of erythropoiesis, bone imaging and bone metabolism in healthy volunteers living at different altitudes.


Eligibility criteria: Inclusion Criteria:

* healthy men and non-pregnant women, ages ≥18-40 years and ≥ 60 years living in the predefined area
* Exclusion Criteria:
* Known bone pathology including osteoporosis, known haematological disease, known renal disease, heart insufficiency, pulmonal disease
* pregnancy

Primary outcomes:
measure: Difference of EPO level between control groups
timeFrame: up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland / Bruderholz
Study officials:
affiliation: Kantonsspital Baselland / Bruderholz, Department of Medicine, Studienabteilung, CH-4101 Bruderholz
name: Sandrine Meyer-Monard, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01515488: Kiosk-Model Self-Triage System in the Pediatric Emergency Department
Official title: Assessing Utility of a "Kiosk Model" Self-Triage System in the Pediatric Emergency Department of A Tertiary Care Teaching Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergencies
Keywords: Triage
Automated
Admitting
Pediatric ED
Lead sponsor: Valleywise Health
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2012-01-24
Enrollment: 400
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: An audio-assisted self-triage kiosk in the Pediatric Emergency Department (ED) is expected to significantly reduce triage times, without any sacrifice of the quality of information that would be obtained by nurse-initiated triage.

Detailed description: With the rapid evolution of consumer based information technology patients have the opportunity to become collaborative partners in their care. In addition, by bridging information gaps and improving workflow efficiency, continuity of care is optimized and the potential risk for error is reduced. Triage time for kiosk self-triage and nurse-initiated triage will be compared in terms of 1) triage time; 2) accuracy of medical history obtained; and 3) patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Between 0 and 18 years of age
* Registered in the Pediatric ED
* Accompanied by parent/guardian 18 years or older
* Version 3 Emergency Severity Index (ESI) of 3 to 5
* Parent or guardian able to communicate in English or Spanish

Exclusion Criteria:

* Deemed medically unstable
* ESI score of 1 or 2
* Incarcerated or in juvenile detention
* Parent/guardian unable to communicate in English or Spanish

Primary outcomes:
measure: Triage Time
timeFrame: From beginning of triage to completion of triage.
Secondary outcomes:
measure: Accuracy of Medical History
timeFrame: Upon completion of triage.
measure: Patient Satisfaction
timeFrame: Upon completion of triage.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Integrated Health System
state: Arizona
Study officials:
affiliation: Valleywise Health
name: Madhumita Sinha, MD, MHSM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morrison-Beedy D, Carey MP, Tu X. Accuracy of audio computer-assisted self-interviewing (ACASI) and self-administered questionnaires for the assessment of sexual behavior. AIDS Behav. 2006 Sep;10(5):541-52. doi: 10.1007/s10461-006-9081-y.
citation: Sinha M, Khor KN, Amresh A, Drachman D, Frechette A. The use of a kiosk-model bilingual self-triage system in the pediatric emergency department. Pediatr Emerg Care. 2014 Jan;30(1):63-8. doi: 10.1097/PEC.0000000000000037.
Clinical trial NCT04227288: A Study Evaluating the Efficacy and Tolerability of Enstilar Foam in Patients With Nail Psoriasis
Official title: An Investigator Initiated Study Evaluating the Efficacy and Tolerability of Enstilar Foam (Calcipotriene and Betamethasone Dipropionate) in Patients With Nail Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nail Psoriasis
Keywords: Enstilar Foam
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: LEO Pharma
First posted: 2020-01-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the efficacy and safety of Enstilar Foam (calcipotriene and betamethasone dipropionate) for the treatment of nail psoriasis.

Detailed description: Eligible subjects will be provided once daily Enstilar Foam (calcipotriene and betamethasone dipropionate). Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The subject will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.

Eligibility criteria: Inclusion Criteria:

* Must have a diagnosis of nail psoriasis in fingernail or toenails
* History of plaque psoriasis or psoriatic arthritis
* Target nail will be KOH negative for dermatophyte fungus
* Must give written informed consent prior to study procedures being conducted, also give consent to the release and use of protected health information (PHI)
* Between the ages of 18 and 85 years old
* Candidate for topical therapy in the opinion of the investigator

Exclusion Criteria:

* Males and Females unable to practice effective contraception throughout the study
* Unable to comply with the protocol
* Nursing mothers, pregnant women, and women planning to become pregnant while in this study
* Patients with erythrodermic or pustular psoriasis
* Sustained treatment to target fingernail within 6 months prior to screening
* History of trauma or surgery to target fingernail
* History of disease known to affect nails such as lichen planus, onychomycosis
* History of systemic psoriasis therapy for less than 6 months

Primary outcomes:
measure: Clinical Improvement in Nail Thickness of Target Nail at Week 24 Compared to Baseline.
timeFrame: 24 Weeks
Secondary outcomes:
measure: Modified mNAPSI (Modified Nail Area Psoriasis Severity Index) Score of Fingernails at Week 24 Compared to Baseline
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham/Dermatology
name: Boni E Elewski, Dr
role: PRINCIPAL_INVESTIGATOR
References: