louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06486480: Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage
Official title: Effect of Minimally Invasive Surgical Assisted by Robots on Intraventricular Hemorrhage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Clarify the Therapeutic Differences Between Robot Assisted Endoscopic Clearance and Traditional Puncture and External Drainag
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clarify the therapeutic differences between robot assisted endoscopic clearance and traditional puncture and external drainage, and establish a new minimally invasive surgical diagnosis and treatment strategy for intraventricular hemorrhage


Eligibility criteria: Inclusion Criteria:

* Age range from 18 to 80 years old;

  * The time from onset to first CT confirmation of intraventricular hemorrhage is less than 24 hours;

    * Before enrollment, CT confirmed that the intraventricular hemorrhage score (modified Graeb score) was ≥ 8 points, and the total score of bilateral lateral ventricles was ≥ 5 points;

      * If there is concurrent cerebral hemorrhage but the hematoma volume is less than 30ml;

        ⑤ First CT to surgery time\<72 hours;

        ⑥ GCS ≤ 14.

Exclusion Criteria:

* ① Suspected (unless excluded by angiography or CTA/MRA/MRI) or untreated rupture of cerebral aneurysm, Moyamoya disease, intracranial AVM rupture, or tumor;

  * Patients with a GCS score of 3 and/or fixed dilated pupils and/or no spontaneous breathing;

    * Patients with pre-existing neurological disorders that affect neurological function assessment prior to onset;

      * Coagulation dysfunction;

        * Patients who require long-term anticoagulant treatment;

          ⑥ Use dabigatran, apixaban, and/or rivaroxaban (or drugs of the same class) before symptoms appear; ⑦ Platelet count\<100 × 109/L, INR\>1.4;

          ⑧ Pregnancy (positive serum or urine pregnancy test);

          ⑨ Subtentorial hemorrhage or brainstem hemorrhage;

          ⑩ Patients who have previously participated in other interventional clinical studies and participated in observational, natural history, and/or epidemiological studies that do not involve intervention are eligible;

          ⑪ Subjects who are expected to not survive until the 180th day of visit; No written informed consent was given by the subjects or legal representatives.

Primary outcomes:
measure: 6-month mRS score
timeFrame: 180 days
Secondary outcomes:
measure: 30 day mortality rate
timeFrame: 0-30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00225680: In Stent ELUTES Study
Official title: ELUTES II - In Stent ELUTES Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery
stent
drug eluting
patency
restenosis
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-26
Enrollment: 124
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 trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug Eluting coronary stent with conventional treatment for in-stent restenosis for coronary arteries.


Eligibility criteria: Inclusion Criteria:

* Patient has given informed consent
* Patient has target lesion in native coronary artery or coronary bypass graft
* Patient has in-stent restenosis \>60%
* Patient has reference artery diameter 2.7-3.5
* Patient agrees to return for clinical assessment at 1, 6, 9, 12 and 24 months and for a treadmill test at 9 months and an angiogram at 9 months and 24 months.

Exclusion Criteria:

* Patient is less than 18 years of age
* Patient is pregnant or breast feeding
* Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Patient is simultaneously participating in another investigative interventional cardiovascular drug or device study.
* Patient has known hypersensitivity or contraindication to aspirin or stainless steel or a sensitivity to contrast agent.

Primary outcomes:
measure: Angiographic target vessel failure (TVF) at follow up
Secondary outcomes:
measure: Major adverse events
measure: Target lesion revascularization
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Contact Sponsor
state: Indiana
Study officials:
affiliation: University Hospital of Gathuisberg
name: Ivan DeScheerder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02899780: Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
Official title: Treatment of Infected Dialysis Catheters With Fiber Optic Ultraviolet Light
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Catheter-Related Infections
Lead sponsor: Ultraviolet Interventions
Sponsor class: INDUSTRY
Collaborators: name: University of Maryland
First posted: 2016-09-14
Enrollment: 0
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 study is a first-in-man clinical trial using fiber optically delivered ultraviolet light for reducing viable bacteria within indwelling tunneled dialysis catheters.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age
* Have the ability to provide informed consent
* Have an implanted dialysis catheter of one of the following models: Medcomp Titan 15.5F x 24 cm or Medcomp Titan 15.5F x 28 cm
* Positive blood culture drawn from the catheter

Exclusion Criteria:

* Previous inclusion in study
* Pregnant

Primary outcomes:
measure: Quantitative reduction of bacterial counts from blood cultures drawn from the dialysis catheter
timeFrame: Measured immediately after UV treatment
measure: Proportion of patients with any reduction of bacterial counts from blood cultures drawn from the dialysis catheter
timeFrame: Measured at study end, expected at 1 year.
Secondary outcomes:
measure: Number of colony forming units (CFU) per cm2 of surface area on the inner lumen of removed catheters
timeFrame: Measured after UV treatment, with results expected in 5 days.
measure: Procedural complications, including excessive bleeding, infection, vascular injury, and significant catheter damage.
timeFrame: Measured at study end, expected at 1 year.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Nabeel Akhter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06650280: Assessment of Rapid Osseointegration of Dental Implants with Different Coatings
Official title: Assessment of Osseointegration of Dental Implants with Three Different Coatings for Early Loading Purpose and Marginal Bone Loss in the Posterior Maxilla. a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implants
Hyaluronic Acid
Keywords: dental implants
rapid osseointegration
early loading
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2024-10-21
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess early osseointegration of dental implant with three different coating materials through secondary implant stability

Detailed description: Dental implants with sandblasted acid itched coating, nano-hydroxyapatite coating, and hyalouronic acid coating will be placed in the posterior maxilla to restore a missing tooth. Implant stability by the use of Ostell will be measured immediately post-operative, 4, 6, and 12 weeks post-operative.

marginal bone loss around the implants will be compared immediately after final restoration delivery and after one year

Eligibility criteria: Inclusion Criteria:

1. Patients with missing at least one maxillary posterior tooth
2. Patients free from any systemic disease
3. Patients who approve to be included in the trial and sign the informed consent
4. Patients with no intra-bony defect.
5. Adults aged 18 years old and above

Exclusion Criteria:

1. Patients who are allergic to titanium
2. Heavy smoker patient
3. Patients receiving chemotherapy or radiotherapy
4. Patients who refused to be included in the trial

Primary outcomes:
measure: rapid osseintegration
timeFrame: immediately post-operative, 4, 6, and 12 weeks post-operative
Secondary outcomes:
measure: marginal bone loss
timeFrame: immediately after final restoration delivery and one year post-operative
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry, MSA University
Study officials:
affiliation: Faculty of Dentistry, MSA University, Egypt
name: Mohamed Hamdy, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atsumi M, Park SH, Wang HL. Methods used to assess implant stability: current status. Int J Oral Maxillofac Implants. 2007 Sep-Oct;22(5):743-54.
Clinical trial NCT02000180: Colonoscopic Skill Acquisition and Transfer Via Simulated Curriculum of Progressive Training
Official title: Do Progressive Levels of Simulation Fidelity Enhance Colonoscopic Skill Acquisition and Transfer in Novice Endoscopic Trainees?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
First posted: 2013-12-04
Enrollment: 37
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: It is hypothesized that a progressive simulated learning strategy will result in better global clinical performance (e.g., technical, communication) and transfer of endoscopic skill, as compared with a high-fidelity simulation strategy.


Eligibility criteria: Inclusion Criteria:

* novice endoscopists from Adult Gastroenterology, Pediatric Gastroenterology, General Surgery training programs at University of Toronto

Exclusion Criteria:

* Trainees who have performed greater than 25 colonoscopies will be excluded to ensure all participants are novices.

Primary outcomes:
measure: Difference Between Progressive and High-Fidelity Groups on Clinical Colonoscopy Peformance (JAG/DOPS)
timeFrame: 4-6 weeks post-intervention
Secondary outcomes:
measure: Cognitive Knowledge of Endoscopy
timeFrame: Pre-training, immediate post-training
measure: Colonoscopy Specific-performance.
timeFrame: Pre-training, immediate post-training, and 4-6 weeks after training (delayed post-training)
measure: Colonoscopy Specific Performance, Communication Skills, and Global Performance on an Integrated Scenario
timeFrame: Immediate post-training and 4-6 weeks after training (delayed post-training)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Samir C Grover, MD/MEd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grover SC, Scaffidi MA, Khan R, Garg A, Al-Mazroui A, Alomani T, Yu JJ, Plener IS, Al-Awamy M, Yong EL, Cino M, Ravindran NC, Zasowski M, Grantcharov TP, Walsh CM. Progressive learning in endoscopy simulation training improves clinical performance: a blinded randomized trial. Gastrointest Endosc. 2017 Nov;86(5):881-889. doi: 10.1016/j.gie.2017.03.1529. Epub 2017 Mar 31.
Clinical trial NCT04613180: Evaluation of the Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
Official title: Effectiveness of Montelukast in Children With Recurrent Obstructive Bronchitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Bronchiolitis
Keywords: Montelukast sodium
Prevention
Relapse
Obstructive bronchitis
Lead sponsor: Samarkand State Medical Institute
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly divided into 2 groups. I the group (control) included 40 patients who received standard therapy. The second group included 40 patients who received oral montelukast sodium. The therapeutic dosage of the drug was 0.2 mg/kg/day, the daily dose was prescribed once a day for the entire duration of the disease. As a prevention of repeated episodes of bronchial obstructive syndrome, the drug was prescribed at a dose of 0.1 mg/kg/day, the duration of anti-relapse therapy was 30 days.
Primary purpose: TREATMENT

Brief summary: The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups.

Detailed description: The aim of the study was to evaluate the effectiveness of montelukast sodium in the treatment and prevention of recurrent obstructive bronchitis in children. The investigators examined 80 children aged 1 to 7 years with recurrent obstructive bronchitis, who were randomly divided into 2 groups. Group I (control) included 40 patients who received standard therapy and placebo. Group II (main) included 40 patients who received standart therapy and oral montelukast sodium.

Eligibility criteria: Inclusion Criteria:

* RDA score=6 points
* E:I index score \>1.40
* ineffective treatment at home for ≥48 hours
* adverse comorbidities

Exclusion Criteria:

* chronic or congenital diseases of the Central nervous, cardiovascular and bronchopulmonary systems

Primary outcomes:
measure: Evaluation of the effectiveness of oral administration of montelukast sodium in comparison with placebo in children with obstructive bronchitis
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Samarkand
country: Uzbekistan
facility: Samarkand State Medical Institute
Study officials:
References:
Clinical trial NCT00323180: Investigation of Protein Biomarkers of Prostate Cancer
Official title: Investigation of Protein Biomarkers of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-05-09
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prostate cancer

Brief summary: This study is looking at biomarkers in prostate cancer.

Detailed description: 1. To establish primary culture of epithelial cells isolated from prostatectomy samples
2. To study biomarkers in prostate cancer

Eligibility criteria: Inclusion Criteria:

* Patients with prostate cancer.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Marco Bisoffi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02109380: Bed-rest, Muscle Mass and Insulin Sensitivity
Official title: The Impact of Short-term Bed-rest on Skeletal Muscle Mass and Insulin Sensitivity in Healthy, Young Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disuse Atrophy
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: In the present study, the effects of 7 days of bed rest on muscle mass, muscle fiber characteristics and insulin sensitivity will be determined.


Eligibility criteria: Inclusion Criteria:

* Male
* Aged from 18-35 years
* 18.5 \< BMI \< 30 kg/m2

Exclusion Criteria:

* Smoking
* Performing regular resistance training (3+ times per week, carrying out progressive training) in the previous 6 months
* Hypertension (according to WHO criteria) and/or cardiovascular disease
* Any back/leg/knee/neck/postural complaints
* Use of any prescribed medication
* Type 2 diabetes mellitus
* Any family history of thrombosis
* All co-morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthritis, spasticity/rigidity, all neurological disorders and paralysis).
* Myocardial infarction within the last 3 years
* Use of anti-coagulants

Primary outcomes:
measure: Change in quadriceps muscle cross-sectional area
timeFrame: One day before and directly after cessation of bed rest.
Secondary outcomes:
measure: Change in lower back cross-sectional area
timeFrame: One day before and directly after cessation of bed rest.
measure: Change in leg and whole body lean tissue mass
timeFrame: One day before and directly after cessation of bed rest.
measure: Change in muscle fiber size
timeFrame: One day before and directly after cessation of bed rest.
measure: Change in muscle strength
timeFrame: One day before and directly after cessation of bed rest.
measure: Change in insulin sensitivity
timeFrame: One day before and directly after cessation of bed rest.
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Maastricht UMC
name: Luc JC van Loon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dirks ML, Wall BT, van de Valk B, Holloway TM, Holloway GP, Chabowski A, Goossens GH, van Loon LJ. One Week of Bed Rest Leads to Substantial Muscle Atrophy and Induces Whole-Body Insulin Resistance in the Absence of Skeletal Muscle Lipid Accumulation. Diabetes. 2016 Oct;65(10):2862-75. doi: 10.2337/db15-1661. Epub 2016 Jun 29.
citation: Dirks ML, Backx EM, Wall BT, Verdijk LB, van Loon LJ. May bed rest cause greater muscle loss than limb immobilization? Acta Physiol (Oxf). 2016 Sep;218(1):10-2. doi: 10.1111/apha.12699. Epub 2016 May 20. No abstract available.
Clinical trial NCT01103180: Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder
Official title: SSRIs and Self-harm in Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Borderline Personality Disorder
Keywords: Selective Serotonin Reuptake Inhibitor
Escitalopram
Borderline Personality Disorder
Major Depressive Disorder
Self-harm
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Temple University
name: Northwestern University
name: University of Southern Mississippi
First posted: 2010-04-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to examine the effectiveness the selective serotonin reuptake inhibitor (SSRI) escitalopram (also known by the trade name "Lexapro") in reducing desire to self-harm and actual self-harming among young adults with borderline personality disorder who are also currently depressed. Subjects will receive either escitalopram or placebo for eight weeks. During this time subjects will be make weekly visits to see the psychiatrist and record their thoughts and feelings several times each day using an electronic diary.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Borderline Personality Disorder
* Current Major Depression

Exclusion Criteria:

* Past 2 months SSRI use
* Past 6 months non-SSRI antidepressant use
* Past 2 months initiation of psychotherapy
* Lifetime bipolar disorder, organic disorder, psychotic disorder
* Current alcohol or drug dependence
* Current severe suicidal / homicidal ideation necessitating immediate medical intervention
* Currently pregnancy or nursing
* Unable or unwilling to cooperate with study protocol

Primary outcomes:
measure: Self-harm Ideation
timeFrame: pre-treatment (week 0) to post-treatment (end of week 8)
Secondary outcomes:
measure: Depressive Symptoms
timeFrame: baseline (week 0) and post treatment (week 8).
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago Hospitals
state: Illinois
Study officials:
affiliation: Temple University (primary) / University of Chicago
name: Michael S McCloskey, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Emil F Coccaro, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.