louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05385185: Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer
Official title: Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Leptomeningeal Metastasis
Immune Checkpoint Inhibitor
Endostatin
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: immune checkpoint inhibitor combined with recombinant human endostatin can improve the 3-month OS rate of leptomeningeal metastasis of lung cancer, and the combination is safe

Detailed description: We will recruit 20 patients with leptomeningeal metastases from lung cancer.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old, gender unlimited;
2. A clear diagnosis of leptomeningeal metastases derived from lung cancer , including positive cerebrospinal fluid cytology and/or neuroimaging diagnosis;
3. A clear history of lung cancer, including histopathological diagnosis, or a combination of cytopathology and imaging;
4. Proper organ function (neutrophil count ≥1.5× 109 /L, platelet count ≥100× 109 /L, hemoglobin concentration ≥90g/L, serum transaminase concentration ≤2.5 times the limit of normal value, serum creatinine concentration ≤ 1.5 times the upper limit of normal value, proteinuria ≤1+)
5. Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patients requiring long-term use of the hormone
6. Signed the informed consent and was willing to follow the experimental protocol and follow-up

Exclusion Criteria:

1. Patients with positive driver genes and effective treatment, such as patients with positive EGFR gene sensitive mutation
2. Severe infections or serious comorbidities, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, kidney failure, or poorly controlled diabetes;
3. Be allergic to PD-1 inhibitor and recombinant human endostatin
4. The female patient planned to be pregnant, was pregnant and lactating -

Primary outcomes:
measure: 3-month overall survival rate
timeFrame: 3 month
measure: safty
timeFrame: 2 years
Secondary outcomes:
measure: iPFS
timeFrame: 2 years
measure: extracranial PFS
timeFrame: 2 years
measure: DCR
timeFrame: 2 years
Other outcomes:
Locations:
city: Hebei
country: China
facility: The Second Hospital of Hebei Medical University
Study officials:
References:
Clinical trial NCT06029985: Hysteroscopic Follow-up Following Conservative Stepwise Surgical Approach for Management of Placenta Previa Accreta
Official title: Long-term Follow up of the Cases Who Underwent Conservative Surgery for Placenta Previa Accreta: a Prospective Case Series Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Placenta Accreta
Lead sponsor: Ain Shams Maternity Hospital
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with one or more previous cesarean deliveries who were diagnosed with placenta previa accreta and underwent Conservative stepwise surgical approach for management in Ain shams maternity hospital

Brief summary: Conservative management of placenta accreta spectrum can preserve future fertility but should only be done in hospitals with enough experience as it carries a high risk of maternal complications.

Follow up after conservative management is crucial to detect complications early.

Detailed description: Placenta accreta is defined histopathologically as abnormal trophoblast invasion of part or all of the placenta into the myometrium of the uterine wall.1 Depending on the depth of villous tissue invasiveness, placenta accreta was subdivided by pathologists into "creta", "increta", and "percreta", in which the villi adhere superficially to the myometrium without interposing decidua, penetrate deeply into the uterine myometrium, and perforate through the entire uterine wall and may invade the surrounding pelvic organs, respectively.

The term placenta accreta spectrum (PAS) will be used in this manuscript to include both the abnormally adherent and the invasive forms of accreta placentation. Severe and sometimes life-threatening hemorrhage, which often requires blood transfusion, increases maternal morbidity and mortality.

Eligibility criteria: Inclusion Criteria:

1. Pregnant women with one or more previous cesarean deliveries
2. Women diagnosed with placenta previa accreta and underwent Conservative stepwise surgical approach for management.

Exclusion Criteria:

1. women who refused to participate in the study.
2. Associated other medical conditions as pregnancy-induced hypertension, heart diseases, and rheumatological diseases apart from iron deficiency anemia.
3. Presence of uterine anomalies

Primary outcomes:
measure: Easiness of hysteroscopy introduction
timeFrame: 3-6 months
measure: Adequacy of uterine cavity
timeFrame: 3-6 months
measure: intrauterine adhesions
timeFrame: 3-6 months
measure: cesarean scar niche
timeFrame: 3-6 months
measure: Menstrual pattern
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams Maternity Hospital
name: Mohamed Samy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03255785: Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One iStent and One iStent Supra
Official title: A Prospective Evaluation of Mild to Moderate Open-Angle Glaucoma Subjects With Cataract Treated With Cataract Surgery Plus One Trabecular Micro-bypass Stent and One Suprachoroidal Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: iStent and iStent Supra
Primary purpose: TREATMENT

Brief summary: Open Angle Glaucoma Subjects with Cataract treated with Cataract Surgery plus one trabecular micro-bypass stent and one suprachoroidal stent


Eligibility criteria: Inclusion Criteria:

* Clinically significant cataract requiring surgery Primary open-angle or pseudoexfoliative glaucoma Visual field defects no worse than -12dB Subject on two ocular hypotensive medications at screening Medicated IOP at screening between 18 and 30 mm Hg Normal iridocorneal anatomy Absence of peripheral anterior synechiae

Exclusion Criteria:

* Monocular subjects or those with wore than 20/200 vision in fellow eye Prior stent implantation, incision glaucoma surgery, or laser trabeculoplasty in study eye Traumatic, uveitic, or neovascular glaucoma

Primary outcomes:
measure: 20% IOP reduction from baseline
timeFrame: Month 12
Secondary outcomes:
measure: IOP less than or equal to 18 mm Hg
timeFrame: Month 12
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Glaukos Investigator Sites
Study officials:
References:
Clinical trial NCT03973385: Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture
Official title: Evaluation of Efficacy of Cryotherapy for Skin Anesthesia During Arterial Puncture for Blood Gas in Critically Ill Patients. SNOW Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryotherapy Effect
Keywords: cryotherapy
vapocoolant spray
arterial puncture
intensive care unit
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
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 cryotherapy effect by vapocoolant spray to reducing pain during puncture for artérial blood gas

Detailed description: Blood gas analysis by arterial puncture is the Gold Standard in the assessment of a patient's acidbase status and oxygenation. This procedure, which can be repeated depending on the clinical condition of patient, is however associated with a potentially painful experience for patients.

The known anesthetic properties of cold can be an interesting alternative to evaluate in the reduction of pain induced during arterial puncture for gas analysis in critically il patients.

Eligibility criteria: Inclusion Criteria:

* All adult patients (age≥18 years) hospitalized in Intensive Care Unit
* Patient requiering arteriale puncture for ABG
* A négative score of CAM ICU scale
* Patient with a score to visual analog scale \< or equal 30mm
* Securité sociale affiliated
* consentement

Exclusion Criteria:

* patient undergoing mechanical ventilation
* patient with arterial catheter
* patient with arterio veinius fistul
* patient receiving topical anesthesic at least 2 h before the puncture
* patient with cutaneous lesion (zone of puncture)
* Raynaud Syndrom
* cold sensibility
* Allen test negative
* pregnant
* legal guardianship

Primary outcomes:
measure: Pain during arterial puncture
timeFrame: immediately after puncture
Secondary outcomes:
measure: Ease to performing Arterial Blood Gas (ABG) sampling
timeFrame: immediately after puncture
Other outcomes:
Locations:
city: Belfort
country: France
facility: Hopital Nord Franche-Comte
city: Le Chesnay
country: France
facility: Ch Versailles
city: Paris
country: France
facility: CHU Saint LOUIS
city: Paris
country: France
facility: Hopital Européèn Georges Pompidou
Study officials:
affiliation: CH Versailles
name: Gwenaëlle Jacq, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03991585: MCRF Clinical Pilot Study
Official title: Feasibility of the Musical Contour Regulation Facilitation (MCRF) Intervention to Promote Emotion Regulation in At-risk Preschoolers: A Clinical Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Adjustment
Keywords: At-risk preschoolers
Head Start
Emotion regulation
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: American Music Therapy Association
name: University of Kansas
First posted: 2019-06-19
Enrollment: 44
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are six classroom assignments. Classrooms will be randomized to either of the treatment arms.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if music can help children practice how to manage their emotions.


Eligibility criteria: Inclusion Criteria:

* Preschoolers aged 3 to 5 years old enrolled in a Head Start program
* Must be able to speak fluent English
* Must not have previously received music therapy services
* Must regularly attend the Head Start program
* Must have signed parental consent.

Exclusion Criteria:

* Does not meet all inclusion criteria

Primary outcomes:
measure: Change in emotion regulation as measured by Emotion Regulation Checklist (ERC)
timeFrame: Baseline, 12 weeks
measure: Change in emotional lability/negativity as measured by Emotion Regulation Checklist (ERC)
timeFrame: Baseline, 12 weeks
measure: Change in behaviors as measured by the Child Behavior Checklist for Ages 1.5-5 (CBCL/1.5-5)
timeFrame: Baseline, 12 weeks
measure: Change in behaviors as measured by the Caregiver-Teacher Report Form (C-TRF)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in emotion regulation state as self-reported using the Self Assessment Manikin (SAM)
timeFrame: Pre-session, 20-minute post-session
measure: Change in emotion regulation state as observed using the Goal Attainment Scale (GAS)
timeFrame: Pre-session, 20-minute post-session
measure: Percentage of study measures completed
timeFrame: 12 weeks
measure: Percentage of child attendance
timeFrame: 12 weeks
measure: Percentage of intervention components completed by interventionist
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Coconut Grove
country: United States
facility: St. Albans Child Enrichment Center Coconut Grove
state: Florida
Study officials:
affiliation: University of Miami
name: Kimberly Sena Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04605185: Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
Official title: Dose Escalation Study Of Donafenib and Toripalimab Combined With TACE in Patients With Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Unresectable Hepatocellular Carcinoma
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2020-10-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is the single-center, open-label phase I clinical trial to evaluate tolerability, safety and efficacy of Donafenib and JS001 in combination with TCAE in patients with Unresectable Hepatocellular Carcinoma.

Detailed description: The phase I clinical trial is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of Donafenib in this regimen, and select an acceptable safe dose for the phase II clinical trial(RP2D).

Eligibility criteria: Inclusion Criteria:

* Age 18-75 (inclusive), male or female;
* Diagnosis of Unresectable Hepatocellular Carcinoma confirmed clinically or histologically or cytologically according to the "Guidelines for diagnosis and treatment of primary liver cancer" (2019 Edition);
* At least one measurable lesion (according to RECIST v1.1)
* ECOG performance status score of 0 -1;
* Life expectancy ≥ 12 weeks;
* Fully understand this research and voluntarily sign the ICF.

Exclusion Criteria:

* Diffuse liver cancer；
* Refractory hepatic encephalopathy, refractory ascites, or hepatorenal syndrome；
* Pregnancy or lactation；
* Patients with extrahepatic diffusion；
* Spontaneous tumor rupture；
* Expected non-compliance.

Primary outcomes:
measure: Dose limiting toxicity(DLT)
timeFrame: 21 days after the first dose of JS001 and Donafenib, assessed up to 2 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: From the date of randomization until death due to any cause, assessed up to 2 years.
measure: Progression free survival (PFS)
timeFrame: From date of randomization until the date of objective disease progression or death, assessed up to 2 years.
measure: Duration of response (DOR)
timeFrame: From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Shanzhi Gu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01806285: Sample Collection to Evaluate an Investigational Instrument for the Detection of Respiratory Viruses in Nasopharyngeal Swabs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Viral Respiratory Infection
Keywords: Respiratory Virus
Lead sponsor: GenMark Diagnostics
Sponsor class: INDUSTRY
First posted: 2013-03-07
Enrollment: 205
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adults of any age suspected of having respiratory infection with onset of symptoms and fever within 5 days of sample collection.

Brief summary: The purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to establish the clinical performance characteristics of the investigational instrument.


Eligibility criteria: Inclusion Criteria:

* The specimen is a nasopharyngeal swab.
* The specimen is from a pediatric or adult male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long term care facility.
* The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis, and pneumonia.

Exclusion Criteria:

* The specimen is not a nasopharyngeal swab.
* The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.

Primary outcomes:
measure: Sample collection study only
timeFrame: prospective sample collection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00285285: Point of Care Device Use in the Pediatric Emergency Department
Official title: A Randomized Trial to Assess the Efficacy of Point-of-Care Testing in Decreasing Length of Stay in a Pediatric Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dehydration
Seizure
Gastroenteritis
Hyperglycemia
Keywords: Point-of-care Testing
Pediatric Emergency Department
Length of Stay
Efficiency
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Karen A. Santucci
name: M. Douglas Baker
name: i-Stat Corporation
First posted: 2006-02-01
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To compare the effect of "point-of-care" (POC) analysis of blood work with traditional laboratory methods on length of stay in a pediatric emergency department (PED).

Detailed description: This study was a prospective, randomized controlled study of patients requiring blood work that a POC device was capable of performing. Length of time spent at various timepoints were prospectively recorded by a dedicated research assistant after randomization.

Eligibility criteria: Inclusion Criteria:

* Clinically requiring bloodwork capable by the POC device

Exclusion Criteria:

* Requiring other bloodwork such as medication levels, WBC

Primary outcomes:
measure: Total Length of Stay
Secondary outcomes:
measure: Time length for results return, disposition decision, time in ED proper
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: M. Douglas Baker, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05936385: Mobile Integrated Care for Childhood Obesity
Official title: Mobile Integrated Care for Childhood Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Disparities
Stakeholder engagement
Social determinants of health
Healthcare delivery
Lead sponsor: Nemours Children's Health System
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-07-07
Enrollment: 59
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to evaluate a new way of providing healthcare to children with an unhealthy weight.

Families who participate will be assigned by chance to one of two groups. One group will see their child's primary care provider to talk about healthy lifestyles for 6 months.

The other group will be in our Healthy Lifestyle program for 6 months. This will include:

* Check-ins with lifestyle specialists and community health workers,
* A mobile app to help support a healthy lifestyle, and
* Access to community programs and activities.

The main questions the study aims to answer are:

* Do children in the Healthy Lifestyle program have better weight outcomes?
* Do more families in the Healthy Lifestyle program stay in the study?
* Does the Healthy Lifestyle program work better for families from certain communities?


Eligibility criteria: Caregiver and child dyads will be enrolled

Inclusion Criteria:

* Child 4-12 years of age
* Child is a patient of the Nemours Children's Health primary care clinics in Milford, Seaford, and Millsboro
* Child has a BMI ≥ 95% for age and sex
* Child is from a clinic serving rural neighborhoods (RUCA ≥ 4)

Exclusion Criteria:

* Caregiver not child's legal guardian
* Caregiver not proficient in English or Spanish
* Caregiver does not have a device and reliable internet
* Child has a genetic syndrome or endocrine disorder that predisposes to obesity
* Child is on a medication that impacts weight
* Child is already enrolled in a weight management program

Primary outcomes:
measure: Change in child adiposity
timeFrame: 6 months
measure: Visit adherence
timeFrame: 6 months
Secondary outcomes:
measure: Differences in change in child adiposity based on child sociodemographic characteristics
timeFrame: 6 months
measure: Differences in visit adherence based on child sociodemographic characteristics
timeFrame: 6 months
Other outcomes:
Locations:
city: Milford
country: United States
facility: Nemours Children's Health, Milford
state: Delaware
city: Millsboro
country: United States
facility: Nemours Children's Health, Millsboro
state: Delaware
city: Seaford
country: United States
facility: Nemours Children's Health, Seaford
state: Delaware
Study officials:
affiliation: Nemours Children's Health
name: Thao-Ly T Phan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00862485: MCA Doppler Studies in Neborns Following Exchange Transfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exchange Transfusion
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2009-03-17
Enrollment: 50
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: newborns

Brief summary: The purpose of this study is to study MCA Doppler before and after exchange transfusion in newborns.


Eligibility criteria: Inclusion Criteria:

* Newborns who need exchange transfusion by accepted criteria

Primary outcomes:
measure: Doppler measurement
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References: