louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05763069: HOME: Home Monitoring of High-risk Pregnancies
Official title: The HOME Study: Home Monitoring of High-risk Pregnancies
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hypertensive Disorder of Pregnancy
Premature Preterm Rupture of Membranes
Preeclampsia
High Risk Pregnancy
Previous Adverse Obstetric Outcome
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian SIDS and Stillbirth Society
name: University of Oxford
name: Rigshospitalet, Denmark
name: Sykehuspartner
name: Dignio
name: Medexa
First posted: 2023-03-10
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women identified with the at-risk pregnancies described above, attending Oslo University Hospital's Department of Obstetrics (some controls will also be recruited at another South-Eastern Norway Dept of Obstetrics, at Drammen hospital).

Brief summary: High-risk pregnancies often require long-term hospitalization or outpatient maternal and/or fetal monitoring, placing a burden on patients, hospital resources and society. The demand for intensified pregnancy surveillance and interventions is increasing, due to the increased prevalence of risk factors like obesity and advanced maternal age, as well as altered guidelines resulting in increasing labor induction rates.The main aims of the HOME study (Home monitoring of pregnancies at risk) are to assess if home monitoring of selected high-risk pregnancies for maternal and fetal wellbeing is feasible, safe (in a clinical trial), cost-efficient, and simultaneously empowers the users.


Eligibility criteria: Inclusion Criteria:

* Preeclampsia
* Gestational Hypertension
* Premature Preterm Rupture of Membranes
* High Risk Pregnancy
* Previous adverse obstetric outcomes

Exclusion Criteria:

* Multiples (twins, triplets etc)
* Patient or fetus in immediate need for delivery
* Not understanding Norwegian
* Not mastering the technological aspects of home monitoring
* Long travel distance to Obstetric Department

Primary outcomes:
measure: Feasibility of Home monitoring of high-risk pregnancies
timeFrame: 2022-2035
Secondary outcomes:
measure: User acceptability of home monitoring
timeFrame: 2022-2035
measure: Clinical safety of home monitoring
timeFrame: 2022-2035
measure: Health economics of home monitoring
timeFrame: 2022-2035
measure: Placenta-associated biomarkers: improving CTG prediction of adverse outcomes?
timeFrame: 2023-2035
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Anne Cathrine Staff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04277169: A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide
Official title: A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Imaging of Anatomical Structures
Lead sponsor: IntelligentUltrasound Limited
Sponsor class: INDUSTRY
First posted: 2020-02-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers who respond to adverts placed at the University Hospital of Wales (UHW) and related sites in Cardiff.

Brief summary: This is a single-centre, prospective, non-randomised volunteer study to be undertaken in the MediCentre, Heath Park, Cardiff, UK

Detailed description: This is a single-centre, non-randomised, prospective study involving at least 120 participants. The data collected in this study will augment the data collected in IU2019_AG_03 Volunteers will be enrolled sequentially until at least 120 scans have been recorded. Ideally, between 120 and 150 scans will be recorded.

Phase I Data collected from up to the first 80 participants in each of the six peripheral nerve block areas will be used as a training/verification set. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images.

Phase II The remaining 40 videos in each area (total minimum 120 participants) will be used for validation of these models.

The validation videos will be fed into the models created during Phase I of the study and the output anatomy highlighting will be recorded as a separate video, overlaid on the original ultrasound image. The overlay video will then be further split into 30-second segments.

A panel of three independent expert anaesthetists will be convened to review and score the segments for accuracy and performance to the endpoints agreed in Phase I of the study.

Eligibility criteria: Inclusion Criteria:

1. Male or female, at least 18 years of age;
2. Able to comprehend and sign the Informed Consent prior to enrolment in the study.

Exclusion Criteria:

1. Aged \<18 years of age;
2. Unwilling or unable to provide informed consent.

Primary outcomes:
measure: Model development and verification
timeFrame: 4 months
Secondary outcomes:
measure: Model validation
timeFrame: 4 months
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: MediCentre, Heath Park
state: Wales
Study officials:
affiliation: IntelligentUltrasound Limited
name: Steve Margetts
role: STUDY_DIRECTOR
References:
Clinical trial NCT01150669: Lestaurtinib With or Without Chemotherapy Agents in Samples From Young Patients With Leukemia
Official title: SCOR in Targeted Therapies for Infant Leukemia Project 3: Targeting FLT3 in Infant Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Acute Lymphoblastic Leukemia
Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-25
Enrollment: 18
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples from infants with leukemia

Brief summary: This research study is studying lestaurtinib with or with chemotherapy in samples from young patients with leukemia. Studying the effects of lestaurtinib with or without chemotherapy in cell samples from patients with cancer in the laboratory may help doctors learn more about the effects of this treatment on cancer cells. It may also help doctors identify biomarkers related to cancer.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the potential of lestaurtinib with or without chemotherapy agents in treating samples from infants with leukemia.

II. Determine whether FLT3 protein expression level and/or activation and sensitivity to lestaurtinib differ between subgroups of infants with leukemia.

III. Determine whether lestaurtinib activates STAT5, AKT, and RAS-MAPK and other pathways.

IV. Determine whether lestaurtinib can synergize with other chemotherapy agents kill infant leukemia cells.

OUTLINE: This is a multicenter study.

Cryopreserved specimens are studied in vitro with lestaurtinib with or without chemotherapy agents. Samples are analyzed for FLT3 protein expression and/or activation; sensitivity to lestaurtinib with or without chemotherapy agents; and activation of STAT, AKT, and RAS-MAPK and other pathways by western blot. The most effective treatment from this study is then validated in vivo in a NOD/SCID xenograft model.

Eligibility criteria: Inclusion Criteria:

* Cryopreserved samples from infants with leukemia available

Primary outcomes:
measure: Expression level and activation state of FLT3 protein, determined by Western blotting and FACS
timeFrame: Up to 4 months
measure: TKI sensitivity, determined by MTT and annexin V assays
timeFrame: Up to 4 months
measure: Baseline activation and inhibition of STAT5, AKT, and RAS-MAPK and other pathways, examined with Western blotting and phosphospecific antibodies
timeFrame: Baseline
measure: Incidence of cell death in primary infant leukemia samples treated with sequenced combinations of chemotherapy and FLT3 TKI using MTT and annexin V binding assays and median effect analysis
timeFrame: Up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Patrick Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01343069: Safety Improvement and Checklist Application
Official title: Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Complications
Outcome
Keywords: safety
team
team performance
surgery
outcome
Lead sponsor: Regional Hospital of Bolzano
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care center. Study design is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").


Eligibility criteria: Inclusion Criteria:

* elective surgery in general or regional anesthesia lasting \> 15 min

Exclusion Criteria:

* urgent surgery

Primary outcomes:
measure: number of complications after elective surgery
timeFrame: within 30 days
Secondary outcomes:
measure: mortality
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Central Hospital Bolzano Italy
name: Matthias Bock, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06582069: Bleaching Effect of Solo and Combined Kiwi Extract and Ozone and Their Impact on Enamel
Official title: Bleaching Effect of Solo and Combined Kiwi Extract and Ozone and Their Impact on Enamel
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Discoloration, Tooth
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ozone therapy has been extensively used in dentistry to manage wounds healing, dental caries, oral lichen planus, gingivitis and periodontitis, halitosis, osteonecrosis of the jaw, post-surgical pain, plaque and biofilms, root canal treatment, dentin hypersensitivity, tempro-mandibular joint disorders and teeth whitening, And based on the above, in this study kiwi extract and ozone gas will be used individually and combined to evaluate the resultant effects on bleaching, enamel microhardness and micromorphology.


Eligibility criteria: Inclusion Criteria:

* A total of the 40 participants aged between (18-35 years) with no gender prediction.
* The participation will be entirely voluntary, and a signed statement of informed consent will be obtained prior to the start of the study.
* Systemically healthy subject based on medical and drug histories, a subject requiring scaling and polishing with moderate calculus with at least two non-adjacent hypersensitive teeth with Schiff scale scores \&gt;1 with air blast stimulus.
* Access to sound maxillary anterior teeth.
* Vitapan classical shades should be A3 or darker and lighter shades are not included.

Exclusion Criteria:

* Participants with poor oral hygiene.
* Participants with missing anterior teeth.
* Participants with unrealistic expectations.
* Participants with dental caries, those undergoing orthodontic treatment.
* Participants with a history of periodontal treatment, pregnant or lactating women and individuals with a history of asthma.
* Those who are allergic to kiwi or ozone skin therapy were excluded from the study.
* Smokers are excluded from the present study.

Primary outcomes:
measure: Color change assessment
timeFrame: 24 Hours
measure: Color change assessment
timeFrame: one month
measure: Color change assessment
timeFrame: three month
measure: Color change assessment
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03012269: The Neural Substrates for Working Memory Training
Official title: The Study on the Brain Mechanisms for the Rehabilitation of Working Memory Deficits in Patients With Acquired Brain Injury Using Multimodal Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Rehabilitation
Working Memory
Lead sponsor: China Rehabilitation Research Center
Sponsor class: OTHER_GOV
First posted: 2017-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to conduct a contrast study on the characteristics of functional and structural connectivity of neural networks of working memory in patients with acquired brain injury versus normal controls, using resting-state functional connectivity magnetic resonance imaging, task-specific functional magnetic resonance imaging and diffusion tensor imaging, combined with cognitive behavioral examinations. Another purpose is to reveal the characteristics of dynamic change of neural networks of working memory pre- and post-intervention in patients with working memory dysfunction.


Eligibility criteria: Inclusion Criteria:

* Right handedness
* Diagnosis of traumatic brain injury or stroke
* Course of disease within one year
* The score of MoCA test \> 24
* Able to understand instructions

Exclusion Criteria:

* Aphasia, unilateral spatial neglect, agnosia, apraxia
* Hearing impairment or visual impairment
* History of taking psychiatric drugs

Primary outcomes:
measure: Training-induced brain activations during working memory tasks in fMRI
timeFrame: six weeks
Secondary outcomes:
measure: The fluid intelligence measured by Raven's Standard Progressive Matrices (RSPM) test
timeFrame: six weeks
measure: Attention ability assessed by Stroop color-word test
timeFrame: six weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Rehabilitation Evaluation, China Rehabilitation Research Center
state: Beijing
Study officials:
affiliation: Department of Rehabilitation Evaluation, China Rehabilitation Research Center
name: Xiaoping Yun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02917369: Integrative Analysis of Large-cell Lung Cancer
Official title: Integrative Analysis of Large-cell Lung Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: LCLC; Integrative Analysis; Metastasis
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2016-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with large-cell lung cancer

Brief summary: Integrative analysis of LCLC

Detailed description: The investigators will analyzed proteomes of paired normal lung tissues and LCLC with or without liver metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary LCLC carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Eligibility criteria: Inclusion Criteria:

* Age ≤ 75 years with histologically proven LCLC
* No severe major organ dysfunction
* World Health Organization (WHO) performance status of 0 or 1
* No prior cancer chemotherapy

Exclusion Criteria:

* Age ≥ 76
* Severe major organ dysfunction
* WHO performance status of \>1
* Prior cancer chemotherapy

Primary outcomes:
measure: 5 years overall survival
timeFrame: 5 years
Secondary outcomes:
measure: 5 years disease-free survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Ganzhou
country: China
facility: Ganzhou City People's Hospital
state: Jiangxi
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Da Fu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
Clinical trial NCT00980369: The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical
Official title: Incision Type for Lateral Internal Sphincterotomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anal Fissure
Keywords: Lateral internal sphincterotomy
Anal fissure
Surgical technique
Incision
Wound healing
Lead sponsor: SB Istanbul Education and Research Hospital
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of this study is to determine effective incision type for the treatment of chronic anal fissures.

Detailed description: The lateral internal sphincterotomy (LIS) technique is considered the optimal surgical treatment for chronic anal fissures (CAFs); however, questions remain regarding the best technique. The present study investigated whether the type of anoderm incision (vertical or parallel to the anus) affected wound healing, wound-related complications, incontinence and recurrence rates in CAF patients undergoing open LIS.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing open lateral internal sphincterotomy for chronic anal fissure

Exclusion Criteria:

* Younger than 18 and older than 65 years of age, patients who had undergone no previous medical treatment, patients with a history of perianal interventions, patients with inflammatory bowel disease, diabetic patients, patients on steroids and immunosuppressives, patients with collagen tissue diseases, mentally retarded patients and patients with malignant disorders.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: SB Istanbul Education and Research Hospital
Study officials:
affiliation: Istanbul Education and Research Hospital, General surgery clinic
name: Feyzullah Ersoz
role: STUDY_CHAIR
References:
Clinical trial NCT03351569: Intravenous Immunoglobulin for Unverricht-Lundborg Disease.
Official title: Intravenous Immunoglobulin for Unverricht-Lundborg Disease: Single-patient Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Unverricht-Lundborg Disease
Keywords: Unverricht-Lundborg disease
progressive myoclonus epilepsy
pharmacoresistant epilepsy
Lead sponsor: Azienda Socio Sanitaria Territoriale di Mantova
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 1
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: sigle patient trial
Primary purpose: TREATMENT

Brief summary: Single patient randomized double blind trial to assess whether intravenous immunoglobulin can improve the clinical outcome of a case suffering from Unverricht-Lundborg disease.

Detailed description: Single patient randomized double blind trial to assess whether intravenous immunoglobulin can improve the clinical outcome of a case suffering from Unverricht-Lundborg disease (clinical and genetic diagnosis).

The patient was randomized to be treated with intravenous immunoglobulin or placebo 1:1 (crossover) once a month for at least one year.

Main objective: improvement of the action myoclonus. Secondary objectives: Improvement in the overall score and in individual sections of the Unified Myoclonus Rating Scale at one year; patient preferences based on results at the end of the trial.

The first analyst was scheduled at one year from the start of the trial. The program was to discuss the patient's analysis data and to let the patient decide in three possible ways: to continue the trial, to continue treatment with immunoglobulins, to suspend the treatment. Depending on the decision, it was planned to follow the patient throughout the year after the analysis, at least for one year.

Eligibility criteria: Inclusion Criteria:

* Malattia di Unverricht-Lundborg (genetic diagnosis)

Exclusion Criteria:

* Contraindications to intravenous immunoglobulin

Primary outcomes:
measure: Improvement of at least 20% of the action myoclonus at one year, measured with section 4 (Action Myoclonus) of the Unified Myoclonus Rating Scale.
timeFrame: monthly for one year
Secondary outcomes:
measure: Unified Myoclonus Rating Scale (UMRS) overall score improvement.
timeFrame: monthly for one year
measure: Patient's preference
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
citation: Lillie EO, Patay B, Diamant J, Issell B, Topol EJ, Schork NJ. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Per Med. 2011 Mar;8(2):161-173. doi: 10.2217/pme.11.7.
citation: Guatelli JC, Gingeras TR, Richman DD. Alternative splice acceptor utilization during human immunodeficiency virus type 1 infection of cultured cells. J Virol. 1990 Sep;64(9):4093-8. doi: 10.1128/JVI.64.9.4093-4098.1990.