louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01561417: Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects
Official title: A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acquired Bleeding Disorder
Acquired Haemophilia
Congenital Bleeding Disorder
Congenital FVII Deficiency
Glanzmann's Disease
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).


Eligibility criteria: Inclusion Criteria:

* Caucasian
* Body Mass Index (BMI) between 18 and 27 kg/m\^2, both inclusive
* Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results
* Smoke less than 10 cigarettes (or equivalent) per day
* Capable of giving written Informed Consent (IC)

Exclusion Criteria:

* Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator
* Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I
* Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation
* Overt bleeding, including from gastrointestinal tract
* Hepatitis (B or C) infection
* HIV (human immunodeficiency virus) infection

Primary outcomes:
measure: Area under the plasma concentration versus time curve for FVIIa clot activity
Secondary outcomes:
measure: The maximum plasma concentration (Cmax)
measure: Terminal half-life (t½)
Other outcomes:
Locations:
city: Paris
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Bysted BV, Scharling B, Moller T, Hansen BL. A randomized, double-blind trial demonstrating bioequivalence of the current recombinant activated factor VII formulation and a new robust 25 degrees C stable formulation. Haemophilia. 2007 Sep;13(5):527-32. doi: 10.1111/j.1365-2516.2007.01516.x.
Clinical trial NCT04002817: Giant Cell Tumor of the Bone in Young Patients
Official title: Giant Cell Tumor of the Bone in Patients Under 15 Years Old: a Single Institution Case-series
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Tumor of Bone
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 18
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young patients with giant cell tumor of bone

Brief summary: single institution cases series review of histological and clinical data of young patient with Giant Cell Tumors


Eligibility criteria: Inclusion Criteria:

1. Male and female patients under 15 years old treated at Rizzoli Institute from 01 January 1982 to 31 December 2018.
2. Diagnosis of giant cell tumor of bone, aneurysmatic bone cysts with solid features and giant cell reparative granuloma.
3. Histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis
4. Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

1. Patients with histological diagnosis different from diagnosis of giant cell tumor, aneurysmatic bone cysts with solid features, and giant cell reparative granuloma.
2. Patients with no available material for additional immunohistochemical and molecular analysis

Primary outcomes:
measure: selection and review of 50 cases of young patients with Giant Cell Tumor of bone.
timeFrame: at baseline (Day0)
Secondary outcomes:
measure: analysis of H3F3A mutation expression on tissue tumor material
timeFrame: at baseline (Day0)
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Campanacci M, Baldini N, Boriani S, Sudanese A. Giant-cell tumor of bone. J Bone Joint Surg Am. 1987 Jan;69(1):106-14.
citation: Al-Ibraheemi A, Inwards CY, Zreik RT, Wenger DE, Jenkins SM, Carter JM, Boland JM, Rose PS, Jin L, Oliveira AM, Fritchie KJ. Histologic Spectrum of Giant Cell Tumor (GCT) of Bone in Patients 18 Years of Age and Below: A Study of 63 Patients. Am J Surg Pathol. 2016 Dec;40(12):1702-1712. doi: 10.1097/PAS.0000000000000715.
citation: Dahlin DC, Cupps RE, Johnson EW Jr. Giant-cell tumor: a study of 195 cases. Cancer. 1970 May;25(5):1061-70. doi: 10.1002/1097-0142(197005)25:53.0.co;2-e. No abstract available.
Clinical trial NCT06385717: Multicenter Cohort Study of ESD and Chemo-radiotherapy for High-risk Early-stage Esophageal Cancer
Official title: Multicenter Cohort Study of Chemo-radiotherapy After Endoscopic Submucosal Dissection for High-risk Early-stage Esophageal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophagus Cancer
Keywords: esophagus cancer; radio-chemotherapy; ESD
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Esophageal cancer patients, and pathologic-comfirmed pT1a-MM stage or pT1b stage

Brief summary: This multicenter, prospective observational cohort study has the potential to optimize individualized chemoradiotherapy regimen for early-stage esophageal cancer patients who have received endoscopic submucosal dissection.

Detailed description: Our study can further improve the local-regional lymph nodes control rate and alleviate the toxicity of chemoradiotherapy.

Eligibility criteria: Inclusion Criteria:

* 1. Esophageal cancer patients who are pathologically confirmed as pT1a-MM stage or pT1b stage after endoscopic submucosal dissection； 2. No definite contraindications for chemo-radiotherapy； 3. Informed consent has been signed； 4. Refused surgery after endoscopic submucosal dissection.

Exclusion Criteria:

* 1. Severe heart, brain, lung disease or renal dysfunction; 2. Previous history of other malignancies; 3. Prior radiation or chemotherapy 4. Researchers consider it inappropriate to participate in this experiment

Primary outcomes:
measure: Incidence of toxic events
timeFrame: 2026.2
Secondary outcomes:
measure: 3-year overall survival
timeFrame: 2029.1
measure: 3-year local-regional recurrence free survival
timeFrame: 2029.1
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University, School of Medicine
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jing Xu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00587717: The Acute Effect of Statins on Inflammatory Markers of Athersclerotic Tissue
Official title: The Acute Effect of Inflammatory Markers of Atherosclerotic Plaque in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carotid Artery Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-01-07
Enrollment: 35
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 study is being done to determine if the acute administration of the drug Simvastatin reduces plaque tissue inflammation and plaque instability in patients undergoing carotid endarectomy


Eligibility criteria: Inclusion Criteria:

* Patients undergoing carotid endarterectomy
* No previously known side effects of statins
* Patients who will sign an informed consent
* Age \> 18 years old
* No signs of current infection

Exclusion Criteria:

* Patient hypersensitive to any component of this medication
* Patients with acute liver disease (AST\> normal value)
* Patients with chronic liver disease (history of Hepatitis B or C)
* Patients with renal failure (creatinine \> 3.0)
* Patients with unexplained muscle pains and aches
* Patients with rheumatoid arthritis
* Patients with Lupus
* Current cancer treatment
* Patients on cyclosporin, digoxin, Itraconazole, Ketoconazole and other antifungal azoles, the macrolide antibiotics and antidepressant nefazodone
* Pregnant females

Primary outcomes:
measure: This study is being done to see if giving the study drug, Simvastatin, quickly lessens the swelling of plaque tissue (tissue around your heart) and plaque movement in patients undergoing cqrotid endarterectomy procedure.
timeFrame: 24 prior to surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04797117: Analytical Validation of the abioSCOPE Device With a PSP Test: Point-of-Care Precision, Sample Type Comparison and Sample Stability
Official title: Analytical Validation of the abioSCOPE Device With a PSP Test: Point-of-Care Precision, Sample Type Comparison and Sample Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: In Vitro Diagnostic Device
Sepsis
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Abionic SA
First posted: 2021-03-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Abionic SA has developed a novel point-of-care (POC) platform, the abioSCOPE, and an in vitro diagnostic kit for the quantification of the pancreatic stone protein (PSP) to be analyzed specifically with the abioSCOPE® device. This test is intended to be used to aid in the early recognition of sepsis. The test is extremely easy to use and has a total turnaround time of approximately 8 minutes. This test uses only 30 microliters of K2/K3-EDTA anticoagulated whole blood or plasma. Results are quantitative (ng/ml). The product is for Investigational Use Only in the US and bears CE-marking. It is commercially available in selected European and non-European countries. The test has also been clinically validated in a multicentric, prospective, observational study performed (AB-PSP-001, clinicaltrials.gov identifier NCT03474809).

The main goals of this study are to evaluate certain analytical performances components of this product in a point-of-care environment, in particular the precision, sample type comparability and specimen stability of the product. Such data will support regulatory filing of a US FDA 510(k) premarket notification file and of a European IVD Regulation technical file to continue product commercialization in 2022, when this novel regulation will be effective.


Eligibility criteria: Inclusion Criteria:

* Provide signed and dated written informed consent by patient or close / family / trusted person prior to any mandatory study-specific procedures, sample collection, or analysis
* Male or female, 18 years of age or older;
* Hospitalized patient;
* Covered by a social security scheme.

Exclusion Criteria:

* Subject suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure;
* Subject under juridical protection.

Primary outcomes:
measure: Precision variance components
timeFrame: Day 1
measure: Sample type comparison
timeFrame: Day 1
measure: Sample stability
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
References:
Clinical trial NCT05729217: Long COVID Symptoms in SARS-CoV-2-positive Children in China
Official title: Long COVID Symptoms in SARS-CoV-2-positive Children Aged 6-18 Years in China: a Consequential Observation Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Symptoms and Signs
Lead sponsor: GlobalMD Organization Network Corp
Sponsor class: OTHER
Collaborators: name: Capital Institute of Pediatrics, China
First posted: 2023-02-15
Enrollment: 5000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any children (aged from 6 to 18 years) who had infected with SARS-CoV-2 in Dec. 1st, 2022 to Jan 15th, 2023.

Brief summary: The goal of this observational study is to learn about in children aged 6-18 years, after the acute phase of SARS-CoV-2 infection, the COVID symptoms or Long COVID symptoms to impact their daily activities. We aimed to investigate the prevalence of long-lasting symptoms, the duration and intensity of symptoms, quality of life, number of sick days or absences from school, and psychological and social outcomes. The participants will be asked to fill in Long COVID symptom burden questionnaires who had been infected with SARS-CoV-2 as self-reported PRC test or antigen test positive.

Detailed description: The goal of this observational study is to learn about in children aged 6-18 years, after the acute phase of SARS-CoV-2 infection, the COVID symptoms or Long COVID symptoms to impact their daily activities. We aimed to investigate the prevalence of long-lasting symptoms, the duration and intensity of symptoms, quality of life, number of sick days or absences from school, and psychological and social outcomes.

The participants will be asked to fill in SBQ-Long COVID symptom burden survey questionnaires who had been infected with SARS-CoV-2 as self-reported PRC test or antigen test positive.

The survey questionnaires will be filled every two weeks after the participants have been tested SARS-CoV-2 positive.

Eligibility criteria: Inclusion Criteria:

infected with SARS-CoV-2 as self-reported PRC test or antigen test positive or have symptoms, but without Covid-19 test.

Exclusion Criteria:

aged below 6 years or above 18 years

Primary outcomes:
measure: long symptoms of SARS-CoV-2
timeFrame: 6 to 12 weeks
measure: absences from school
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Institute of Pediatrics
Study officials:
affiliation: Capital Institute of Pediatrics, China
name: Jun Ting Liu, MD
role: STUDY_DIRECTOR
affiliation: GlobalMD Organization
name: Tim Shi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03441217: Hyoscine Butylbromide Effect on Duration of Labor
Official title: Hyoscine Butylbromide Effect on Duration of Labor in Nulliparous Women: A Randomized, Double Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor
Keywords: Duration of labor
Hyoscine butylbromide
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
Collaborators: name: Sistema Nacional de Investigadores de Panamá
First posted: 2018-02-22
Enrollment: 218
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the duration of labour (active phase of labour) in nulliparous women with gestations between 37 and 41 6/7 weeks when 20 mg of Hyoscine butylbromide was applied intravenously and compared with similar patients that received a placebo.


Eligibility criteria: Inclusion Criteria:

* Low risk gestation between 37 and 41 6/7 weeks.
* Cephalic (vertex) presentation.
* Spontaneous labor in active phase (4 cms)

Exclusion Criteria:

* Premature rupture of membranes upon arrival at the Labor and Delivery Unit \> 4 hours.
* Multiple order pregnancy.
* Stillbirth.
* Any fetal condition that could interfere in the mode of delivery (macrosomia, fetal growth restriction, oligohydramnios).

Primary outcomes:
measure: Duration of first stage of labor
timeFrame: 24 hours
measure: Rate of cervical dilation
timeFrame: 24 hours
Secondary outcomes:
measure: Duration of labor
timeFrame: 24 hours
measure: Fetal and neonatal complications
timeFrame: 72 hours
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Maternity Hospital
Study officials:
affiliation: Maternidad del Hospital Santo Tomás
name: Osvaldo Reyes, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04827017: Acute and Chronic Pulmonary and Renal Complications Following Contracting Severe Respiratory Distress Syndrome Coronavirus-19
Official title: Acute and Chronic Pulmonary and Renal Complications Following Contractiong Coronavirus Severe Respiratory Distress Syndrome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary and Renal State
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All COVID positive population

Brief summary: Tracking post- corona virus infection pulmonary and renal complications

Detailed description: Mortality from pulmonary and renal system is highly noticable with COVID-19 pandemic . We trying to monitor compliction

Eligibility criteria: Inclusion Criteria:

* All COVID 19 patients admitted to ICU

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: renal function
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06851117: Compare The Effectiveness of SCT and PNF In Children With Cerebral Palsy
Official title: Compare The Effectiveness of Spider Cage Therapy and Proprioceptive Neuromuscular Facilitation (PNF) In Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will evaluate the comparative effectiveness of Spider Cage Therapy (SCT) and Proprioceptive Neuromuscular Facilitation (PNF) in managing motor impairments in children with cerebral palsy (CP). Cerebral palsy often leads to motor deficits that limit movement and impair functionality.

Detailed description: SCT and PNF are therapeutic interventions that target these motor challenges but use distinct approaches. Spider Cage Therapy will involve the use of elastic cords within a supportive frame (the "spider cage") to stabilize the child, enhancing postural control and enabling dynamic movement training. This approach is expected to improve balance and alignment, promoting functional mobility. In contrast, PNF will focus on neuromuscular reeducation through specific movement patterns intended to enhance strength, coordination, and flexibility. By comparing SCT and PNF, this study aims to identify their respective impacts on motor function improvements, particularly in gross motor skills, balance, and postural stability, potentially guiding future rehabilitation protocols for children with CP.

Eligibility criteria: Inclusion Criteria:

* Children aged 4-12 years.
* Clinical diagnosis of cerebral palsy.
* Classified within Gross Motor Function Classification System (GMFCS) levels I to III.
* Ability to follow instructions and participate in therapy sessions.

Exclusion Criteria:

* Severe cognitive impairments hindering participation.
* Severe musculoskeletal deformities or recent surgeries.
* Other medical conditions contraindicating participation in physical therapy.

Primary outcomes:
measure: Gross Motor Function Measure (GMFM-66
timeFrame: 12 Months
measure: Paedetric balance scale
timeFrame: 12 months
measure: Functional Independence Measure for Children (WeeFIM)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References:
Clinical trial NCT00494117: Investigation of Heart Failure Status Over Time Using Respiratory Parameters
Official title: Investigation of Heart Failure Status Over Time Using Respiratory Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure, Congestive
Sleep Apnea Syndromes
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2007-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population under investigation is moderate to severe heart failure who are outpatients of a major Sydney hospital.

Brief summary: The purpose of the study is to investigate respiratory indicators for clinically important changes in Heart Failure status over time.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe Heart Failure (as determined by Echocardiogram or by treating physician)

Exclusion Criteria:

* Malignant disease affecting gas exchange or respiratory parameters
* Medications compromising breathing with no adverse affects on heart failure
* Clinically significant (moderate to severe) asthma requiring therapy
* Chronic parenchymal lung disease (FEV1/FVC ratio = 65% or as determined by the treating physician)
* Severe pulmonary hypertension
* Heart failure due to alcohol abuse or chemotherapy
* Narcotic abuse/intravenous drug use (including HIV+ and hepatitis C)
* Alcohol consumption \> 80g/day
* Patients receiving home Oxygen
* Methicillin- resistant Staphylococcus aureus infection
* Narcolepsy
* Cataplexy
* Enrolled in any concurrent study, that may confound the results of this study.
* Inability or refusal to sign the Patient Consent Form
* Inability or refusal to adhere to protocol requirements

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
Study officials:
affiliation: ResMed/The University of New South Wales
name: Rachel A Coxon, BE/MBiomedE
role: STUDY_DIRECTOR
affiliation: ResMed/The University of New South Wales
name: Klaus Schindhelm, PhD
role: STUDY_DIRECTOR
affiliation: Royal Prince Alfred Hospital, Sydney, Australia
name: Jodie Lattimore, PhD
role: STUDY_DIRECTOR
affiliation: Royal Prince Alfred Hospital/The University of Sydney
name: Ian Wilcox, PhD
role: PRINCIPAL_INVESTIGATOR
References: