louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01598116: A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas
Official title: A Prospective Longitudinal Study to Identify Biomarkers in Children With Hemangiomas.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemangioma
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2012-05-15
Enrollment: 68
Sex: ALL
Minimum age (years): 4
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with hemangiomas and children without hemangiomas will be enrolled from Hemangioma and Vascular Malformation Clinic and Ambulatory Pediatric Clinics.

Brief summary: Current treatment options for hemangiomas, such as propranolol, steroids and interferon, all have the potential for significantly harmful side effects. The purpose of this study is to identify potential biomarkers that can be used to design clinical trials and accelerate the delivery of new treatment alternatives to children with hemangiomas.

Detailed description: Urine will be collected from children with hemangiomas and age-matched healthy controls at 2,4,6,9,12,18 and 24 months of age. Children with hemangiomas will also have ultrasound examination performed at each visit.

Eligibility criteria: Inclusion Criteria:

* Children with hemangioma
* Age ≤ 5 months
* Doppler ultrasound confirmed diagnosis of hemangioma to rule out presence of vascular malformation
* Age matched control ≤ 5 months (no hemangioma)

Exclusion Criteria:

* Hemangioma treated prior to or during study period with laser, steroids, interferon, or propranolol, or any other drug or device intended to inhibit the growth of the hemangioma
* Known history of sickle cell anemia, thalassemia, or other hemoglobinopathy
* Hemangioma presented as fully formed at birth consistent with rapidly involuting or non-involuting congenital hemangioma
* PHACES syndrome- posterior fossa malformations, hemangioma, arterial anomalies, cardiac anomalies, eye abnormalities, sternal anomalies
* Parent/guardian unable to speak english to provide informed consent and no interpreter is present

Primary outcomes:
measure: Chemically modified DNA
timeFrame: 6 months
Secondary outcomes:
measure: Blood flow velocity
timeFrame: 6 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Ohio State University
name: Gayle M Gordillo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05496816: Coagulation Disturbances in COVID-19 Septic Patients
Official title: COVID-19 Associated Coagulopathy (CAC) in Septic Critically Ill Patients- a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
COVID 19 Associated Coagulopathy
Sepsis
Septic Shock
Lead sponsor: Cantonal Hospital Zenica
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study was conducted in the COVID-19 Intensive Care Unit in the Department of Anesthesiology, Resuscitation and Intensive Care, Cantonal Hospital Zenica. Electronic data from 100 patients in 2021. were retrospectively analyzed after obtaining approval of the ethics committee of our hospital.

Brief summary: Objective of this study was to determine the relationship between CAC and septic condition in COVID-19 critically ill patients. Data including age, sex, comorbidities, quick Sequential Organ Failure Assessment (qSOFA) score, vasopressors requirement, laboratory findings: platelets, neutrophils, lymphocytes, procalcitonin (PCT), C-reactive protein (CRP), fibrinogen, D-dimer, sepsis-induced coagulopathy (SIC) and disseminated intravascular coagulation (DIC) score were recorded on the day of admission and on the day of starting of invasive mechanical ventilation. Primary outcome was to establish CAC with sepsis; secondary outcome measure was incidence of CAC in sepsis and septic shock in COVID-19 critically ill patients.


Eligibility criteria: Inclusion Criteria:

* all adult critically ill patients tested positive for reverse transcriptase polymerase chain reaction (RT-PCR) of nasopharyngeal swabs to coronavirus 2 (SARS-CoV-2)
* patienets admitted to the ICU and presented with acute hypoxemic respirator failure

Exclusion Criteria:

* patients younger than 18,
* immunodeficient patients,
* patients with a history of malignancies,
* patients who developed septic state before admission,
* patients with a history of previous coagulopathy, liver and platelet disease.

Primary outcomes:
measure: Number of patients with coagulation disorder
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zenica
country: Bosnia and Herzegovina
facility: Cantonal Hospital
Study officials:
References:
Clinical trial NCT00398216: A Study of DU-176b in Preventing Blood Clots After Hip Replacement Surgery
Official title: A Phase IIb, Randomized, Parallel Group, Double-Blind, Double-Dummy, Multi-Center, Multi-National, Multi-Dose, Study of DU-176b Compared to Dalteparin in Patients Undergoing Elective Unilateral Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thrombosis
Hip Replacement
Keywords: Anti-coagulant
hip replacement
hip replacement surgery
unilateral hip replacement surgery
DeepVein Thrombosis
Venous Thromboembolism
pulmonary embolism
Prevention of Blood Clots
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2006-11-10
Enrollment: 903
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: This study is to assess if DU176b is effective in prevention of blood clots following hip replacement surgery. The duration is 7-10 days of treatment and 30 and 60 day follow-up visits.


Eligibility criteria: 1. 18 years of age or older; male or female.
2. Able to provide written informed consent.
3. Must be scheduled for elective unilateral total hip replacement surgery. Only primary surgeries accepted.
4. If female, must be either one year post-menopausal, surgically sterile, or using medically accepted contraceptive measures as judged by the Investigator and in accordance with local regulatory requirements.

Primary outcomes:
measure: Adjudicated Incidence of VTE
timeFrame: end of treatment
Secondary outcomes:
measure: Change in Prothrombin Time (PT) From Baseline
timeFrame: end of treatment
measure: Change in Activated Partial Thromboplastin Time (aPTT) From Baseline
timeFrame: end of treatment
measure: Adjudicated Incidence of Major or Clinically Relevant Non-major Bleeding Events
timeFrame: 10 days after first dose
Other outcomes:
Locations:
city: Hartford
country: United States
state: Connecticut
city: Sarasota
country: United States
state: Florida
city: Austin
country: United States
state: Texas
city: Ajax
country: Canada
state: Ontario
city: Cambridge
country: Canada
state: Ontario
city: Guelph
country: Canada
state: Ontario
city: Kitchner
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Hellerup
country: Denmark
city: Herlev
country: Denmark
city: Horsholm
country: Denmark
city: Gyula
country: Hungary
city: Kecskemet
country: Hungary
city: Szeged
country: Hungary
city: Riga
country: Latvia
city: Krasnoyarsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saratov
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Velikij Novgorod
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Chernivtsy
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkov
country: Ukraine
city: Kiev
country: Ukraine
city: Lutsk
country: Ukraine
city: Lviv
country: Ukraine
city: Odessa
country: Ukraine
Study officials:
References:
Clinical trial NCT05270616: Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
Official title: Robotic Versus Video-assisted Lobectomy/Segmentectomy for Lung Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases
Surgery
Keywords: robotic surgery
VATS
uniport
multiport
Lead sponsor: The Second Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety/efficacy of the robotic-assisted lobectomy/segmentectomy (RAL/S) with the video-assisted lobectomy/segmentectomy (VAL/S) for lung resection.

Video-assisted lobectomy/segmentectomy (VAL/S) for lung resection is divided into uniport group and multiple- port group.


Eligibility criteria: Inclusion Criteria:

1. good cardio- pulmonary function to tolerate surgery;
2. minimaly invasive surgery for lobectomy or segmentectomy or sleeve lobectomy;

Exclusion Criteria:

1. cardio- pulmonary function is not good enough to tolerate surgery;
2. huge tumor or extensive adhesion in thoracic cavity.

Primary outcomes:
measure: mortality
timeFrame: 30 days after surgery
measure: conversion rate to open surgery
timeFrame: during surgery
measure: postoperative complications
timeFrame: within 7 days after surgery
measure: operation time
timeFrame: within 180 minutes
measure: duration of hospitalization
timeFrame: within 7 days after surgery
measure: days to tube removal
timeFrame: within 7 days after surgery
measure: retrieved lymph node
timeFrame: within 1 days after surgery
measure: retrieved lymph node station
timeFrame: within 1 days after surgery
measure: short- term PFS
timeFrame: 3 years
measure: short- term overall survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT02309216: Whole-Body MRI in Suspected Victims of Abusive Head Trauma
Official title: Whole-Body MRI in Suspected Victims of Abusive Head Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shaken Baby Syndrome
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 8
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infant inpatients being evaluated for suspected abusive head trauma who are already getting an MRI of the head and cervical spine.

Brief summary: The purpose: to pilot whole-body MRI scanning in infants who are already getting brain MRI for suspected child abuse

Research design: prospective, blinded reading of Whole-Body MRI (WB-MRI) images during the routine care of the hospitalized infant with comparison to routine radiographic skeletal survey images

Procedures to be used: whole-body MRI images

Risks and potential benefits: no additional risk (the infant will be receiving and MRI of their brain as part of routine care, the additional images will be obtained at the same time without additional sedation); benefits to the infant include the identification of injuries which would have otherwise been missed by routine care importance of knowledge that may reasonably be expected to result: results from this study will potentially influence the use of radiographic skeletal survey and decrease the radiation exposure to infants being evaluated for suspected child abuse.


Eligibility criteria: Inclusion Criteria:

* younger than 12 months
* admitted to the hospital
* getting an MRI for suspected abusive head trauma

Exclusion Criteria:

-

Primary outcomes:
measure: MRI findings of skeletal injuries, soft tissue injuries or visceral injuries
timeFrame: During hospitalization; MRI will typically be obtained on hospitalization day #2
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
References:
Clinical trial NCT00230516: Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects
Official title: A Randomized, Open-Label, Comparative, Two-Treatment, Crossover Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects on Days 1 and 5 of Intravenous Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: N/A this study is being conducted with healthy volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers better intragastric acid suppression than iv lansoprazole (Prevacid ®


Eligibility criteria: Inclusion Criteria:

* Participants must be 18-70 years of age
* Participants can be male or female
* Women that are able to have children must have a negative pregnancy test.

Exclusion Criteria:

* Involvement in or planning of this study
* Participation in another clinical study within 28 days of this one
* For women, pregnancy or attempting to become pregnant.

Primary outcomes:
measure: The primary objective is to compare the pharmacodynamic efficacy in controlling intragastric pH of esomeprazole 40mg and lansoprazole 30mg on Day 5 of once daily IV administration to healthy volunteers.
Secondary outcomes:
measure: Secondary Outcomes will compare additional efficacy and safety parameters.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
Study officials:
affiliation: AstraZeneca
name: Nexium Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02414516: A Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors
Official title: A Phase 1a Dose-Escalation Study of OBP-801 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Solid Tumor
Keywords: HDAC
Epigenetic
Histone
Acetylation
Lead sponsor: Oncolys BioPharma Inc
Sponsor class: INDUSTRY
First posted: 2015-04-10
Enrollment: 17
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: This Phase 1a, single center, open-label, repeat dose study will evaluate the safety, efficacy, and Pharmacokinetics of ascending doses of OBP-801 in patients with advanced solid tumors.


Eligibility criteria: Patient Inclusion Criteria

Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:

* Histologically or cytologically confirmed metastatic or unresectable solid tumor.
* Has failed treatment with all standard therapies for their malignancy.
* Adequate Karnofsky Performance Status.
* An expected survival of at least 3 months.
* Adequate organ and bone marrow function.
* Signed informed consent form for study participation prior to screening.

Patient Exclusion Criteria

Patients presenting with any of the following will be excluded in the study:

* Clinically significant disease as defined by the protocol.
* Surgical therapy or other therapies within period as defined by the protocol.
* Any condition that will interfere with compliance with the protocol as determined by investigator.

Primary outcomes:
measure: Maximum Tolerated Dose
timeFrame: 6 weeks
Secondary outcomes:
measure: Pharmacokinetic (PK) profile; AUC, Cmax, and t1/2
timeFrame: 4 weeks
measure: Objective Response (OR)
timeFrame: 22 weeks
measure: Durability of Objective Response (DOR)
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
References:
citation: Heath EI, Weise A, Vaishampayan U, Danforth D, Ungerleider RS, Urata Y. Phase Ia dose escalation study of OBP-801, a cyclic depsipeptide class I histone deacetylase inhibitor, in patients with advanced solid tumors. Invest New Drugs. 2022 Apr;40(2):300-307. doi: 10.1007/s10637-021-01180-9. Epub 2021 Oct 6.
Clinical trial NCT05530616: Impact of Ultrasound Fetal Weight Estimation on Obstetrical Management and Maternal and Neonatal Outcomes
Official title: Impact of Ultrasound Fetal Weight Estimation on Obstetrical Management and Maternal and Neonatal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Weight
Keywords: Fetal Weight
Ultrasound Fetal Weight
Obstetrical Management
Maternal Outcomes
Neonatal Outcomes
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 70000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major Female (≥18 years of age) with a single pregnancy having had an ultrasound follow-up at HUS between 01/01/2000 and 31/12/2021

Brief summary: The investigators wish to study the obstetrical data of pregnant women who had an ultrasound estimation of fetal weight and who delivered at the University Hospital of Strasbourg over the last 20 years. These retrospectively collected data are a valuable source of scientific information since they are "real life data", currently of growing interest in the scientific community, and have a large volume and quality due to the number of years included and the variety of information collected in the computerized media records.

From this study, the investigators hope not only to better understand the consequences of ultrasound screening for fetal growth, but also to improve its accuracy and to develop useful models in obstetrical decision making in order to decrease maternal and neonatal morbidity.


Eligibility criteria: Inclusion criteria:

* Major subject (≥18 years of age).
* Female and with a single pregnancy
* Subject having had an ultrasound follow-up at HUS between 01/01/2000 and 31/12/2021
* Subject who gave birth at HUS between 01/01/2000 and 12/31/2021
* Subject who does not object to the reuse of her data for scientific research purposes

Exclusion Criteria:

* Subject who has expressed opposition to the reuse of their data for scientific research purposes
* Multiple pregnancies
* Delivery before 24 weeks of amenorrhea
* Diagnosis of a malformative fetal pathology
* Diagnosis of fetal death in utero

Primary outcomes:
measure: Retrospective study of maternal and neonatal clinical and ultrasound data for the development of an algorithm model useful in obstetrical decision making in order to decrease maternal and neonatal morbidity.
timeFrame: Files analysed retrospectively from January 01, 2000 to December 31, 2021 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gynécologie Obstétrique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT06447116: An EFS to Evaluate the CGuard Prime™ Carotid Stent in Acute Ischemic Stroke
Official title: An EFS to Evaluate the Safety and Preliminary Effectiveness of the CGuard Prime™ Carotid Stent Placement in the Procedure Setting of Acute Ischemic Stroke.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Acute Ischemic Stroke
Lead sponsor: Jacobs institute
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Jacobs Institute is conducting a Sponsor Investigator study of patients ≥ 18 years to establish safety and preliminary effectiveness in treating extracranial stenosis with the CGuard Prime™ Carotid Stent in the setting as an acute ischemic stroke.

Detailed description: A prospective, single-arm, open-label, nonblinded EFS to assess the safety and preliminary effectiveness of the CGuard Prime™ Carotid Stent in adults (18 years of age or older) with extracranial stenosis in the setting as an acute ischemic stroke.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18-year-old; Carotid stenosis with at least ≥ 50% stenosis; National Institute of Health Stroke Scale (NIHSS) \>/=6; and evidence of large vessel occlusion (LVO) in the anterior circulation (i.e., intracranial internal carotid artery, M1 and proximal M2) by computed tomography angiography (CTA).

Exclusion Criteria:

* Cannot provide consent or legally authorized representative not available to provide consent. Evidence of intracranial hemorrhage on non-contrast CT or MRI; ASPECTS\<6; and any contraindication to dual antiplatelet therapy.

Primary outcomes:
measure: Proportion of subjects with mRS ≤ 2 at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Rate of TICI 2b or greater; Proportion of subjects with sICH within 24 hours; and New stroke within the same territory within 7 days.
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02754596: Study Comparing Travoprost Intraocular Implants to Timolol Ophthalmic Solution
Official title: Prospective, Randomized Phase II Study Comparing Two Elution Rates of Glaukos Travoprost Intraocular Implants to Timolol Maleate Ophthalmic Solution, USP 0.5%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma Open-angle
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 154
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: This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution.

Detailed description: This is a randomized trial comparing two elution doses of the Travoprost Intraocular implant to timolol ophthalmic solution in patients with open-angle glaucoma. Study assessments will include IOP and medication use as well as safety parameters.

Eligibility criteria: Inclusion Criteria:

* Open angle glaucoma

Exclusion Criteria:

* Uveitic, neovascular, or angle closure glaucoma; or glaucoma associated with vascular disorders.
* Functionally significant visual field loss, including severe nerve fiber bundle defects.
* Prior glaucoma surgery.
* Uncontrolled systemic disease, pregnant females or those planning a pregnancy.
* Other ocular status conditions, etc.

Primary outcomes:
measure: IOP (mmHg) Change From Baseline at Week 12
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
measure: Severe Adverse Events
timeFrame: Post-op through Month 36
Locations:
city: Sioux Falls
country: United States
facility: John Berdahl, MD
state: South Dakota
Study officials:
affiliation: Glaukos Corporation
name: Kerry Stephens, O.D.
role: STUDY_CHAIR
References: