louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06616571: Compare the Efficacy and Safety of QL0605 Injections at Different Timepoints
Official title: A Randomized, Open-label, Interventional, Real-world Study to Compare the Efficacy and Safety of QL0605 Administered at Different Timepoints After Chemotherapy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chemotherapy-Induced Febrile Neutropenia
Keywords: Febrile Neutropenia, Breast Cancer, Chemotherapy
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 336
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 goal of this real-world study is to compare the efficacy and safety of QL0605 administered 24 hours and 48 hours after chemotherapy in breast cancer patients.

Detailed description: Patients with stage invasive breast cancer who were scheduled to receive at least 2 cycles of adjuvant or neoadjuvant chemotherapy with TAC/TC/TCbH regimen were eligible for this multicenter, open-label, randomized trial. Patients were randomized (2:1) to receive QL0605 24 hours (24h group) or 48 hours (48h group) after the end of each cycle of chemotherapy. The primary endpoint was the incidence rate of FN for cycle 1. The secondary endpoints included the incidence rates of grade 3/4 neutropenia, chemotherapy dose reduction and chemotherapy delay due to neutropenia, antibiotic administration, the pain (bone, muscle, or joint), ect.

Eligibility criteria: Inclusion Criteria:

* Aged≥18 years；
* The expected survival period is more than 3 months;
* ECOG≤ 2;
* Invasive breast cancer diagnosed by histopathology;
* Plan to receive TAC, TC or TCbH chemotherapy;
* Subjects with good hematology, liver, lung and kidney function ;
* Signed informed consent.

Exclusion Criteria:

* Known hypersensitivity to rhG-CSF or PEG-rhG-CSF;
* Female patients during pregnancy or lactation;
* The previous malignant tumors were not cured;
* Received chemotherapy or radiotherapy within 4 weeks before screening;
* Received PEG-rhG-CSF within 6 weeks before screening;
* Suffering from uncontrollable infectious diseases within 2 weeks before screening.

Primary outcomes:
measure: The incidence of febrile neutropenia for chemotherapy cycle 1.
timeFrame: 21 days (Cycle 1 of chemotherapy treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
Study officials:
References:
Clinical trial NCT03777371: Anti-HIV False Positivity Rate in Pregnant Women; and Investigating the Factors Affecting This Situation
Official title: Anti-HIV False Positivity Rate in Pregnant Women; and Investigating the Factors Affecting This Situation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Seropositivity
Acquired Immunodeficiency Syndrome
Pregnancy, High Risk
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 128
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women between 8 and 40 weeks of gestation

Brief summary: HIV virus is an etiologic agent of ( AIDS ) immunodeficiency syndrome . It is known that the estimated rate of transfer from mother to baby is 25% to 45%, pregnancy rate is 5-10%, pregnancy rate is 15-20% and in lactation period is 5-10%. Risk factors; maternal viral load, breastfeeding, vaginal birth, and prematurity. Although there is a high rate of false positivity in prenatal screening in our country, one of the factors affecting this is the number of pregnancies.


Eligibility criteria: Inclusion Criteria:

* Anti HIV seropositive Pregnant Women

Exclusion Criteria:

* Anti HIV seronegative Pregnant Women

Primary outcomes:
measure: The effect of the number of pregnancies on Anti HIV false positivity rate
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05650671: Measurement of Multiphysical Fields at the Subject-sitting Interface
Official title: Measurement of Multiphysical Fields at the Subject-sitting Interface
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Wheelchair Users
Keywords: Wheelchair
Pressure ulcers
Pressure measurement
Temperature measurement
Humidity measurement
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects

Brief summary: With the population ageing and the increase in disabilities prevalence, demand for wheelchairs is increasing. Padding and shape of seat are important factors for comfort when sitting for long periods of time. Sustained mechanical loads induced by the seated stance can cause pressure ulcers in the ischial prominences. Temperature and humidity have also been shown to be important in the development of pressure ulcers.

Detailed description: The aim of this research is to measure the pressure, temperature and relative humidity fields at the user-seat interface of a wheelchair.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* aged of 18 and more
* agreeing to participate in the study

Exclusion Criteria:

* under 18 years old
* pregnant women

Primary outcomes:
measure: pressure
timeFrame: Day 0
measure: temperature
timeFrame: Day 0
measure: humidity
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06139471: Efficacy of a Virtual Reality-Enhanced Gagne's Instructional Model
Official title: Exploring the Efficacy of a Virtual Reality-Enhanced Gagne's Instructional Model in Promoting Nursing Students' Aging Rejection and Willingness Towards Gerontological Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acceptance Processes
Rejection, Psychology
Keywords: geriatric rejection
willingness towards Gerontological Care
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Gagne's conditions of instructional learning theory, it presumed that several learning levels was exist that require different instruction types, and external and internal environments, commonly referred to as "conditions of learning".

Detailed description: According to Robert Gagne's conditions of instructional learning theory, it presumed that several learning levels was exist that require different instruction types, and external and internal environments, commonly referred to as "conditions of learning", for every learning type. These internal conditions related to the learner's preexisting knowledge and external ones related to the instructions and teaching strategies provided by the instructor. The theory emphasizes the importance of both internal and external factors in creating a conducive learning environment that fosters effective learning outcomes According to this theorist, there are five primary knowledge categories, including verbal information, cognitive strategies, attitudes, and motor and intellectual skills.

Eligibility criteria: Inclusion Criteria:

1. Agreement to participate in this study.
2. Have a Microsoft team's account and able to use it.
3. No previous participation in any gerontological educational course either compulsory or elective.

exclusion Criteria: previous participation in any gerontological educational course either compulsory or elective.

Primary outcomes:
measure: Willingness to Work with Elderly People Scale (WEPS)
timeFrame: three months
Secondary outcomes:
measure: The Fraboni Scale of Ageism (FSA)
timeFrame: 3 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Mohamed Husien
state: Please Select A Country
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
affiliation: Faculty of nursing, Alexandria university, Egypt
name: mohamed H atta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05419271: Controlled Internal Convection in Low Flow Hemodialysis of Dialysate: Removal of Beta-2-microglobulin
Official title: Controlled Internal Convection in Low Flow Hemodialysis of Dialysate: Removal of Beta-2-microglobulin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Daily Home Hemodialysis
Keywords: daily dialysis
home hemodialysis
Middle-molecular weight toxins
Beta2-microglobulin
Push-Pull
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis, intradialytic fall of B2m levels is compared in 16 patients treated by one session of dialysis with 9L internal convection and one usual session with free internal convection.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Since 2013 daily home hemodialysis allows low volumes of convection. This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.

Detailed description: Daily home hemodialysis with low dialysate volume system does not normally allow convection. Middle molecular weight toxins clearance is therefore lower. Beta2-microglobulin is considered representative of these middle molecules and contributes to the uremic toxic state.

Since 2013 daily home hemodialysis allows low volumes of convection ranging from 0 to 9L per session. This technology is called "push pulls" and uses internal convection.

This study is a prospective cross-over trial testing the efficiency of internal convection on Beta2-microglobulin in daily home hemodialysis.

Intradialytic fall of B2m levels is compared in 16 patients treated by one session of dialysis with 9L internal convection and one usual session with free internal convection.

The Kt/V of urea, the phosphorus and sodium removal, the plasma fall of myoglobin, prolactin, kappa and lambda free light chains, intradialytic fall of orosomucoid will be compared between the two session as secondary objectives.

Eligibility criteria: Inclusion Criteria:

* home hemodialysis since at least 2 weeks
* hemodialysis since at least 3 months

Primary outcomes:
measure: Middle molecular weight toxins clearance
timeFrame: during hemodialysis procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen Normandie
Study officials:
References:
Clinical trial NCT02877771: Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus
Type 1 Diabetes
Insulin Pump
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jaeb Center for Health Research
First posted: 2016-08-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected.

Detailed description: This protocol is designed to test the functionality of a predictive low glucose suspend system under supervised conditions where basal insulin rates are manually increased until a system generated suspension occurs. The study will collect data that will be used for planning a pivotal study, and the study data are intended to be used to support a Premarket Approval (PMA) application.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of type 1 diabetes requiring insulin therapy for at least 12 months
* Insulin pump therapy for at least 6 months
* Age ≥18.0 years
* Subject demonstrates stable insulin regimen including basal rates, insulin sensitivity factor and insulin:carbohydrate ratio for at least 3 months

Exclusion Criteria:

* Pregnant (female subjects must have negative urine or serum pregnancy screening test)
* Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
* Diabetic ketoacidosis in the month prior to enrollment
* A current condition that would prevent the use of a CGM sensor or insulin pump, or in the judgment of the investigator is a contraindication to study participation
* Use of acetaminophen during study participation
* Current use of any medication intended to lower glucose other than insulin including naturaceuticals, oral or non-insulin injectable medications

Primary outcomes:
measure: Suspension of Insulin Delivery
timeFrame: 8 hours between 9pm and 5am
measure: Restoration of insulin delivery
timeFrame: 8 hours between 9pm and 5am
measure: Agreement between algorithm-recommended pump action
timeFrame: 8 hours between 9pm and 5am
Secondary outcomes:
Other outcomes:
measure: Duration of insulin suspension
timeFrame: 8 hours between 9pm and 5am
measure: Continuous Glucose Monitoring (CGM) glucose nadir
timeFrame: 8 hours between 9pm and 5am
measure: Reference blood glucose
timeFrame: 8 hours between 9pm and 5am
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
Study officials:
References:
Clinical trial NCT02959671: Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket
Official title: Clinical Performance of a New Esthetic, Self-ligating Orthodontic Bracket
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: 3M Oral Care
First posted: 2016-11-09
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A cohort of 15 patients starting orthodontic treatment with fixed appliances will receive EXD-952 Ceramic Self-ligating brackets on all mandibular incisors and a different type of brackets on the remaining mandibular teeth. Tooth movement will be initiated using 0.014" or 0.016" Nickel-Titanium archwires.

A second cohort of 15 patients will receive EXD-952 Ceramic Self-ligating bracket on all mandibular incisors in a later phase of their ongoing orthodontic treatment. The mandibular incisor brackets will be removed and EXD-952 Ceramic Self-ligating brackets placed instead. Other mandibular brackets will remain in place. Tooth movement will be performed using 0.019x0.025" Stainless Steel archwires.

In both cohorts bracket door stability, the ability of the door to hold the archwire in the bracket slot, the bracket's ability to rotate teeth, clinicians' satisfaction with the bracket, and patient comfort in comparison with other brackets will be assessed.

The evaluation for each patient will last for at least until one archwire change (cohort 1) or one appointment interval (6-8 weeks, cohort 2).

After the evaluation period, EXD-952 Ceramic Self-ligating brackets will remain in place until the orthodontic treatment is completed.


Eligibility criteria: Inclusion Criteria:

* Permanent mandibular dentition including incisors, canines, premolars, and first molars (includes subjects treated with the extraction of premolars)
* Mandibular incisors with sound, non-carious buccal enamel and no pretreatment with chemical agents such as hydrogen peroxide

Exclusion Criteria:

* Mental/emotional/developmental disability
* Inability to give informed consent
* Cleft lip and/or palate, craniofacial anomaly, or syndrome
* Obvious oral hygiene issues such as excessive plaque accumulation, gingivitis, and/or pre-existing white spot lesions
* Prosthodontic or restored substrate extending on the labial surface of mandibular incisors
* Deep bite
* Known allergies to any study materials

Primary outcomes:
measure: Bracket Door Stability
timeFrame: baseline
measure: Ability of Door to Successfully Hold the Archwire in the Bracket Slot
timeFrame: baseline
measure: Bracket's Ability to Rotate Teeth
timeFrame: 6-8 weeks
measure: Clinicians' Satisfaction With the Bracket
timeFrame: 6-8 weeks
measure: Patient Comfort in Comparison With Other Brackets (Questionnaire)
timeFrame: 6-8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT01360671: IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn
Official title: An Open Label Single Arm, Single Centre Study to Investigate the Safety and Efficacy of IV Sildenafil in Neonates With Persistent Pulmonary Hypertension of the Newborn (PPHN)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Persistent Pulmonary Hypertension of the Newborn
Keywords: PPHN
persistent pulmonary hypertension of the newborn
sildenafil
iv
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 0
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of iv sildenafil in term and near term infants with PPHN (persistent pulmonary hypertension of the newborn), by measuring the need for inhaled nitric oxide (iNO) or extracorporeal membrane oxygenation (ECMO) compared to a historical control group not treated with sildenafil.


Eligibility criteria: Inclusion Criteria:

* Babies \< 72 hours old and at least 34 gestational weeks with PPHN or hypoxic respiratory failure associated with idiopathic PPHN, meconium aspiration, sepsis or pneumonia
* Oxygenation index \>15 and \< 60

Exclusion Criteria:

* Congenital anomaly
* Large left to right intracardiac or ductal shunt
* Already on inhaled nitric oxide

Primary outcomes:
measure: Efficacy - incidence of treatment failure
timeFrame: Day 1-14
measure: Need for inhaled nitric oxide or Extracorporeal membrane oxygenation
timeFrame: Day 1-14
Secondary outcomes:
measure: Changes in oxygenation index
timeFrame: 6 & 12 hours
measure: Changes in differential saturation
timeFrame: 6 & 12 hours
measure: Duration of mechanical ventilation
timeFrame: Days 1-14
measure: Time from initiation of sildenafil to inhaled nitric oxide or extracorporeal membrane oxygenation
timeFrame: Days 1-14
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06205771: The Role and Mechanism of GPER-Hippo-CBS/H2S Pathway in Preeclampsia
Official title: The Role and Mechanism of GPER Hippo Pathway in Regulating Uterine Arterial Smooth Muscle CBS/H2S in the Pathogenesis of Preeclampsia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Preeclampsia
Keywords: preeclampsia
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 54
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn about in health conditions. The main questions it aims to answer are:

* The pathological significance of GPER in uterine artery dilation in preeclampsia
* The Mechanism of GPER Hippo Pathway Regulating CBS/H2S in Human Uterine Artery Smooth Muscle Cells (hUASMC) This project intends to use GPER interfering RNA, YAP1 interfering RNA, in vivo perfusion experiments of human uterine artery tissue, and single cell patch clamp technology to study hypotheses under physiological/pathological pregnancy conditions at the tissue, cellular, and molecular levels, revealing a novel signal transduction pathway of estrogen stimulating vasodilation, providing new ideas for studying the mechanism of uterine artery blood flow regulation. This research result will provide new targets for intervention and treatment of diseases such as fetal intrauterine growth retardation and preeclampsia.

Detailed description: 1. Measure the content of H2S in uterine arterial smooth muscle and circulation of normal pregnancy and PE pregnant women, and analyze the relationship between the content of H2S in uterine arterial smooth muscle and circulation of PE pregnant women and PE.
2. Knock down the GPER and overexpression of GPER in HTR-8 cells, and detect the expression of GPER, CBS, and Hippo pathway related proteins using Western blot and qRT-PCR to verify the efficiency of knockdown and overexpression. Use different concentrations of H2S donor (GYY4137) to interfere with HTR-8 cells after treatment, and use RT-PCR and Western blot to detect the mRNA and protein expression of downstream molecules YAP and TAZ in Hippo pathway in cells, respectively.

Eligibility criteria: Inclusion Criteria:

1. Full term pregnancy with clinical diagnosis of preeclampsia and normal pregnancy pregnant woman
2. Pregnant women undergoing lower segment cesarean section for delivery

Exclusion Criteria:

1. Combined with chronic hypertension, kidney disease, intrahepatic cholestasis, etc Other basic diseases;
2. Multiple pregnancy
3. Pregnant women undergoing vaginal delivery
4. Normal pregnant women who are\<37 weeks or\>40 weeks pregnant

Primary outcomes:
measure: H2S content in uterine arterial smooth muscle circulation
timeFrame: 8:00 am
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University &Shandong Provincial Qianfoshan Hospital
state: Please Select
Study officials:
References: