louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01384903: An Open-label Study of KW-3357
Official title: An Open-label Study of KW-3357 Compared to Plasma-derived Antithrombin for Disseminated Intravascular Coagulation (DIC) Associated With Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Disseminated Intravascular Coagulation (DIC)
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-29
Enrollment: 221
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of KW-3357 compared to plasma-derived antithrombin using multi-center, open-label, parallel-group, comparative method in patients with Disseminated Intravascular Coagulation (DIC) associated with infection.


Eligibility criteria: Inclusion Criteria:

* Meet the ACCP/SCCM-defined sepsis criteria
* Japanese Association for Acute Medicine-defined DIC criteria score \>= 4
* Antithrombin activity \<= 70%
* Written informed consent from patient or guardian

Exclusion Criteria:

* Anamnesis or complication of serious drug allergy
* Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis
* Pregnant, nursing, or possibly pregnant woman

Primary outcomes:
measure: DIC resolution
timeFrame: 6 days (or discontinuation)
Secondary outcomes:
measure: DIC score
timeFrame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
measure: Mortality
timeFrame: 28 days
measure: Organ symptoms
timeFrame: Screening, 4, 6 days (or discontinuation)
measure: Severity
timeFrame: Screening, 4, 6 days (or discontinuation)
measure: Plasma antithrombin activity
timeFrame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
measure: Number of patients with adverse events
timeFrame: up to 6 days (or discontinuation)
Other outcomes:
Locations:
city: Saga
country: Japan
Study officials:
References:
citation: Endo S, Shimazaki R; Antithrombin Gamma Study Group. An open-label, randomized, phase 3 study of the efficacy and safety of antithrombin gamma in patients with sepsis-induced disseminated intravascular coagulation syndrome. J Intensive Care. 2018 Nov 16;6:75. doi: 10.1186/s40560-018-0339-z. eCollection 2018.
Clinical trial NCT01483703: Noninvasive Optical Measurement of Critical Care Neonates
Official title: Noninvasive Optical Measurement of Critical Care Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Signs and Symptoms
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2011-12-01
Enrollment: 6
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children

Brief summary: The purpose of this study is to determine whether reflections of light can be used to provide real-time pictures of blood vessel formation around infants' heads. This study device is called laser speckle imaging.

Detailed description: The researchers can use the laser speckle imaging device to image superficial cerebral blood flow in the infant's head. The researchers can quantify blood flow and measured vessel diameter, versus actual diameter assessed with conventional digital camera imaging.

Eligibility criteria: Inclusion Criteria:

* New born or infant

Exclusion Criteria:

* non- new born or infant

Primary outcomes:
measure: Medical tool
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: CHOC
state: California
Study officials:
affiliation: Beckman Laser Institute, UCI
name: Bernard Choi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05271903: Simulation Training for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania
Official title: A Simulation and Experiential Learning Intervention for Labor and Delivery Providers to Address HIV Stigma During Childbirth in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiv
Stigmatization
Pregnancy Related
Keywords: HIV
stigma
childbirth
simulation training
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Fogarty International Center of the National Institute of Health
First posted: 2022-03-09
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: MAMA intervention: a simulation training for labor and delivery providers
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will work in Tanzania to develop and pilot test a simulation and experiential learning intervention for labor and delivery providers, in order to address HIV stigma during childbirth. The primary endpoint will be patient-rated changes in respectful maternity care, comparing women who deliver in the pre-intervention time period and women who deliver in the post-intervention period.

Detailed description: The study will pilot test the MAMA intervention in six clinics in the Kilimanjaro Region. 60 L\&D providers will be enrolled across the sites. Patient level outcomes will be assessed using an interrupted time series design. Approximately 206 participants will be enrolled (103 in the pre-intervention period and 103 in the post-intervention period). The primary outcome will be patients' reported experiences of respectful maternity care (RMC). Secondary outcomes will be internalized HIV stigma, trust in health care, birth outcomes, HIV care engagements at 3 months, anticipated HIV stigma, and attitudes to long-term antiretroviral therapy. Our enrollment targets (103 per condition) will allow for detection of a medium effect of 0.4 in the change of RMC overall scores with 80% power and α=0.05. Pre- and post- surveys will be conducted for providers enrolled in the intervention, assessing outcomes related to practices of RMC, stigma toward WLHIV, self efficacy and clinical knowledge.

Eligibility criteria: Inclusion Criteria:

For labor and delivery providers:

* Over age 18
* Employed by a study clinic
* Work in the labor and delivery ward

For birthing women:

* Over age 18
* Gave birth in a study clinic
* Diagnosed with HIV

Exclusion Criteria:

For labor and delivery providers:

* Has not provided clinical care in the labor and delivery ward in past 6 months

For birthing women:

* Under age 18
* Unconfirmed HIV status

Primary outcomes:
measure: Change in respectful maternity care
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moshi
country: Tanzania
facility: Kilimanjaro Christian Medical Centre
Study officials:
References:
Clinical trial NCT01245803: Acute Rosuvastatin for Preventing Myocardial Damage in Patients With ACS
Official title: Acute Rosuvastatin for Preventing Myocardial Damage in Patients With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Angioplasty
Keywords: rosuvastatin
angioplasty
acute coronary syndrome
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2010-11-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rosuvastatin reload may prevent myocardial damage in ACS patients undergoing PCI


Eligibility criteria: Inclusion Criteria:

* 18-75 year old
* diagnosed as acute coronary syndrome
* Plan to PCI

Exclusion Criteria:

* STEMI patient
* emergency PCI(\<2h) for NSTE-ACS
* History of liver disease and myopathy (ALT/AST\>3 x upper limit of normal,CK\>5 x upper limit of normal)
* TG\>500mg/dl,CCr\<30ml/min
* inflammatory disease
* allergic to rosuvastatin
* nephrotic syndrome,hypothyroidism,systemic lupus erythematosus,myeloma,et.al.

Primary outcomes:
measure: peri-procedural myocardial damage
timeFrame: 48 hours after PCI
Secondary outcomes:
measure: MACE
timeFrame: 30 days after PCI
Other outcomes:
Locations:
city: Beijing
country: China
facility: the 28th division, Beijing Anzhen Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01449903: Survival of Different Core Build-up Materials
Official title: Core Build-up Materials: a Randomized Clinical Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Prosthesis Failure
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of the department of porsthodontics, university of heidelberg

Brief summary: The purpose of this study is to compare three different core build-up materials for dental use. The study hypothesis is that there is no differences in survival rate of the different core build-ups.

Detailed description: Core build-ups replace dental structures which are decayed through caries or tooth fractures. Often there are necessary before insertion of dental restorations. In clinical practice, there are two main material groups: glass ionomer cements and composites. Because of there good physical properties the composite materials claimed to fulfill the expected criteria of core build-ups. However, some of these composite core build-ups get lost before insertion of definite prosthetic restorations. The current prospective, randomized controlled study should investigate the survival rate of three different composite materials: "Rebilda DC", "Clearfil Core DC / Plus" and "Multicore Flow". The statistical analysis will performed with logistic regression performed by the institute of institute of Medical Biometry and Informatics, university of heidelberg. The study hypothesis is that there is no differences in the survival rate.

Eligibility criteria: Inclusion Criteria:

* patients need a single crown or fixed dental prostheses
* patients are able to signed inform consent form, more than 18 years,

Exclusion Criteria:

* no pregnant women
* insufficient oral hygiene

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of prosthodontics, university of heidelberg
Study officials:
affiliation: Heidelberg University
name: Peter Rammelsberg, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04345003: MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
Official title: MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroid
Keywords: HIFU
Fibroid treatment
MR elastography
Perfusion
Diffusion weighted imaging
ARFI
Fibroid stiffness
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to exclude in advance patients who would not benefit from this treatment. For that purpose this study assesses the influence of fibroid elasticity and diffusion on ablation efficiency during treatment by MR-HIFU

Detailed description: Pre-procedural predictors of treatment efficacy will be useful for excluding in advance patients who would not get benefit of this treatment. It seems that elastography, cellular density and perfusion could be considered as predictors. Fibroid elastography will be quantified by MRE Resoundant® system and pelvic ultrasound. Perfusion and cellular density will be quantified by MR diffusion.

Eligibility criteria: Inclusion Criteria:

* Woman
* Aged more than 18 years
* Not postmenopausal
* Having one or two symptomatic fibroid with size \< 15cm.
* Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI
* Normal cervicovaginal smear performed within 2 years prior to inclusion
* Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI
* SSS score on UFS-Qol ≥ 10
* Signed informed consent prior to any study related procedure
* With a medical insurance

Exclusion Criteria:

* Contraindicated to MR examination, gadolinium contrast injection (pregnancy etc..).
* Presence or suspicious of pelvic malignant tumor
* Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb \<10g/dl)
* Pregnant or lactating woman
* Small submucous myoma accessible for hysteroscopic treatment.
* Active pelvic infection
* Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.

Primary outcomes:
measure: Composite criteria
timeFrame: Baseline
Secondary outcomes:
measure: leiomyoma stiffness measured by Resoundant system
timeFrame: Baseline
measure: leiomyoma stiffness measured by ARFI-US
timeFrame: Baseline
measure: clinical efficiency
timeFrame: month 6
measure: inter-observer reproducibility
timeFrame: Baseline
measure: leiomyoma perfusion
timeFrame: Month 6
measure: leiomyoma T2 signal
timeFrame: Month 6
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
Study officials:
References:
Clinical trial NCT03285503: PK Study of Aripiprazole IM Depot for Chinese Patients With Schizophrenia
Official title: A Single-center, Uncontrolled, Open-label Clinical Trial Evaluating the Pharmacokinetic Characteristics and Safety of Aripiprazole IM Depot in Chinese Patients With Schizophrenia After Multi-dose Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Otsuka Beijing Research Institute
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study assess pharmacokinetics and safety of multi-administration of Aripiprazole IM Depot formulation at doses of 400mg in patients with schizophrenia.

Detailed description: To evaluate the pharmacokinetics and safety of aripiprazole prolonged IM depot 400mg administered to Chinese adult subjects with schizophrenia every four weeks for 20 consecutive weeks

Eligibility criteria: Inclusion Criteria:

1. Subjects, and their legal representatives(or their guardian ), who have signed the informed consent form(ICF);
2. Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR (295.30, 295.10, 295.20,295.90 , 295.60);
3. subjects, both male and female, who are at age between 18 and 64 (also including 18 and 64 years of age) at time of informed consent.

Exclusion Criteria:

1. Presence of other mental disorders than schizophrenia confirmed through diagnostic criteria of DSM-IV-TR;
2. Subjects who are alcoholomania or independent of drug, or have drug abuse history;
3. Positive for any of HIV antibody, HBsAg, HCV antibody and syphilis serology testing;

Other protocol-defined inclusion and exclusion criteria may apply.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: up to 24 weeks
measure: time of maximum observed plasma concentration (tmax)
timeFrame: up to 24 week
measure: AUC672h
timeFrame: up to 24 weeks
measure: Apparent clearance after extravascular administration
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: up to 24 weeks
measure: Vital Signs
timeFrame: up to 24 weeks
measure: Laboratory Examination
timeFrame: up to 24 weeks
Other outcomes:
measure: Positive and Negative Symptoms Scale (PANSS)
timeFrame: up to 24 weeks
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital of Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Anding Hospital of Capital Medical University
name: Tao Jiang, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06985303: Cell-Based Therapy for White Matter Repair in Periventricular Leukomalacia
Official title: Phase 1 Study Evaluating the Safety and Preliminary Efficacy of a Novel Cell-Based and Small Molecule Combination Therapy for White Matter Injury in Patients With Periventricular Leukomalacia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Periventricular Leukomalacia
White Matter Disease
Hypoxic-Ischemic Encephalopathy
Demyelinating Diseases
Neonatal Encephalopathy
Keywords: Periventricular Leukomalacia
Myelin Repair
White Matter Injury
Demyelination
Neonatal Brain Injury
Neuroregeneration
CNS Regeneration
Brain Repair
Neonatal Hypoxia
Lead sponsor: MGAM LLC
Sponsor class: INDUSTRY
First posted: 2025-05-22
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will receive a cell-based therapy using outer radial glia (oRG) combined with molecular agents including 20α-Hydroxycholesterol, ESI1, and Chondroitinase ABC. The goal is to assess white matter repair mechanisms and functional recovery in PVL.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to explore a new treatment that may help repair brain damage in individuals with periventricular leukomalacia (PVL), a condition that affects white matter in the brain. Researchers are testing whether a combination of outer radial glia (oRG) cells and specific molecules can support brain repair.

The main questions the study aims to answer are:

Can the treatment help regrow white matter and improve myelin repair?

Does the treatment reduce scarring in the brain?

Is the treatment safe and well-tolerated?

The study uses several components, including:

20α-Hydroxycholesterol to support cell function

ESI1 to help repair the myelin sheath

Chondroitinase ABC to break down scar tissue in the brain

Researchers will study how these work together to protect and repair the brain by influencing specific pathways involved in damage and recovery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of periventricular leukomalacia (PVL) confirmed by MRI
* Clinically stable at time of intervention
* Parental or legal guardian consent if participant is a minor

Exclusion Criteria:

* Severe congenital brain malformations unrelated to PVL
* Active CNS infection or systemic inflammatory disease
* History of severe intraventricular hemorrhage (Grade III/IV)
* Known allergy to any therapeutic components (e.g., Chondroitinase ABC)
* Participation in another interventional study within the past 30 days

Primary outcomes:
measure: Improvement in White Matter Integrity
timeFrame: At baseline and 12 weeks post-intervention
Secondary outcomes:
measure: Functional Motor Outcome
timeFrame: Baseline, 6 weeks, and 12 weeks post-intervention
measure: Reduction in Glial Scar Density
timeFrame: 12 weeks post-intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05087303: Telemedicine for Children With Sickle Cell Disease
Official title: Telemedicine for Pediatric Sickle Cell Patients in Medically Underserved Areas
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anemia, Sickle Cell
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-10-21
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to learn more about how the use of two different types of telemedicine (distance medical care) can address barriers to receiving comprehensive sickle cell care, and whether care can be improved. Aim 1: Adapt two telemedicine models (i.e., hub-and-spoke; direct-to-consumer) for use with children with SCD using caregiver input from our preliminary K12 work. Aim 2: Demonstrate the feasibility of the telemedicine models developed in Aim 1 as the models undergo successive stakeholder refinement during use in actual clinical care. Aim 3: Evaluate the effectiveness of the refined models from Aim 2 in a pre/post study by assessing (a) process of care measures, (b) provider satisfaction, (c) caregiver/patient-centered outcomes, and (d) clinical outcomes and healthcare utilization.


Eligibility criteria: Inclusion Criteria:

* Caregivers must be 18 years or older, who have children between 0 to 21 years old with a diagnosis of Sickle Cell Disease and receive care at the Riley Hospital for Children Comprehensive Sickle Cell Disease clinic.
* Adolescent patients 16 years and older are also able to participate in interviews/surveys.
* The family must be willing to receive their care using the telemedicine model available to them based on the location of their primary residence.
* TeleSCD model participants must live within 1 hour of the pre-identified telemedicine sites, while VirtualSCD model participants must live within the city limits of the pre-identified area.

Exclusion Criteria:

* If a patient receives chronic transfusion therapy, they will not be eligible to participate, as our telemedicine models will not support this.

Primary outcomes:
measure: Measuring adherence to appointment in sickle cell care.
timeFrame: 1 year
measure: Measuring adherence to lab draws in sickle cell care.
timeFrame: 6 months
measure: Measuring healthcare utilization pre and post telemedicine participation.
timeFrame: 1 year
measure: Measuring collaboration of primary care provider and subspecialty care provider.
timeFrame: 1 year
measure: Provider Feedback
timeFrame: 1 year
measure: Caregiver feedback
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Seethal Jacob, MD
role: PRINCIPAL_INVESTIGATOR
References: