louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05890066: Single-port Versus Multi-port Laparoscopic Surgery for Ectopic Pregnancy
Official title: Effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ectopic Pregnancy
Keywords: Laparoscopic surgery
Single-port laparoscope
Multi-port laparoscope
Lead sponsor: Hung Vuong Hospital
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a parallel-group randomized control trial with 2 arms. Arm 1 includes patients who will be treated by traditional multi-port laparoscopic surgery. Aim 2 includes patients who will be treated by single-port laparoscopic surgery. All patients are randomized using computer-generated sequences with allocation ratio 1:1. This is a non-blinded study where all patients and surgical teams know the treatment option.
Primary purpose: TREATMENT

Brief summary: This study aims to compare the effectiveness and Safety of Single-port Versus Multi-port Laparoscopic Surgery in the Treatment of Ectopic Pregnancy

Detailed description: Single-port laparoscopic surgery has become one of the treatment options for ectopic pregnancy with certain advantages such as reduced numbers of incision and scars, and increased patient's satisfaction post-surgery. At Hung Vuong hospital, the investigators do not have data about the application potential of single-port laparoscopic surgery for ectopic pregnancy treatment. Therefore, the investigators carry out this project to compare the effectiveness and safety of single-port versus traditional multi-port laparoscopic surgery in the treatment of ectopic pregnancy.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older pregnant women who are indicated for laparoscopic surgery in the treatment of ectopic pregnancy.
* Agree to participate and give a consent

Exclusion Criteria:

* Allergic reactions to anesthetics
* Hemodynamic instability
* Ruptured ectopic pregnancy

Primary outcomes:
measure: Blood loss
timeFrame: Immediately post surgery
measure: Surgical time
timeFrame: Immediately post surgery
Secondary outcomes:
measure: Pain intensity
timeFrame: Within 4 weeks post surgery
measure: Surgical complications
timeFrame: Within 4 weeks post surgery
measure: Hospital stay
timeFrame: Within 4 weeks post surgery
Other outcomes:
Locations:
Study officials:
affiliation: Hung Vuong Hospital
name: Nghiem X Huynh, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03898466: Effect of Fluticasone Furoate on Methacholine Challenge
Official title: The Effect of Once-daily Fluticasone Furoate on Methacholine-induced Bronchoconstriction in Mild Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will determine the effect of inhaled fluticasone furoate on airway responsiveness to methacholine in mild asthmatics.


Eligibility criteria: Inclusion Criteria:

* forced expiratory volume in one second (FEV1) greater than or equal to 65% predicted
* methacholine PD20 less than or equal to 400mcg
* no allergen exposure (if atopic) or respiratory infection for at least 4 weeks prior to study start

Exclusion Criteria:

* regular use of inhaled corticosteroid within 4 weeks of study start
* poorly controlled asthma
* current smoker or ex smoker with greater than 10 pack year history
* pregnancy or breast-feeding
* health concern/condition that would preclude participation for safety reasons

Primary outcomes:
measure: Methacholine provocation dose causing a 20% fall in FEV1 (PD20)
timeFrame: 24 hours post dose, 72 hours post dose and 168 hours post dose
Secondary outcomes:
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: 168 hours
measure: Sputum eosinophils
timeFrame: Baseline
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall
state: Saskatchewan
Study officials:
References:
citation: Okonkwo CS, Davis BE, Blais CM, Cockcroft DW. Short-term effect of once-daily fluticasone furoate on methacholine-induced bronchoconstriction in mild asthmatics. Respir Med. 2019 Sep;156:53-57. doi: 10.1016/j.rmed.2019.08.007. Epub 2019 Aug 13.
Clinical trial NCT03635866: PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy
Official title: PET/MRI Study of Men With Highly Suspicious MRI Lesions That Showed no Clinically Significant Prostate Cancer Following MRI Fusion Targeted Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The principal aim of this study is to determine if PET/MRI imaging with 18-F fluciclovine (Axumin) identifies those men with false negative MRI fusion targeted biopsy (MRFTB) of PI-RADS 4 and 5 lesions. PI-RADS 4 and 5 MRI lesions are highly suspicious for clinically significant prostate cancer and require future repeat MRI imaging and possible repeat prostate biopsy depending on the results of the repeat MRI. Men, who had negative MRFTB within past 12 months of PI- RADS 4 or 5 MRI lesion will be included in this diagnostic study. The repeat MRI is standard of care at NYU Langone Health. The investigation aspect of the study is to perform an Axumin scan the same day as the MRI. Those men with persistent highly suspicious lesions will under MRFTB. The biopsy results will be compared with intensity of Axumin uptake within the prostate. The urologist will have the discretion to biopsy Axumin avid lesions not detected by MRI.


Eligibility criteria: Inclusion Criteria:

* The participant has undergone MRFTB of an MRI lesion at the Department of Urology or at NYU Langone Health within past 12 months and has signed informed consent to participate in the NYU Urology prostate biopsy database.
* The most recent MRFTB of a PIRADS 4 or 5 lesion did not show clinically significant prostate cancer.

Exclusion Criteria:

* The urologist who performed the initial MRFTB does not feel a repeat MRI is indicated.
* Any contraindication to prostate biopsy including untreated urinary tract infection
* Prior allergic reaction to axumin
* Patient refuses MRI

Primary outcomes:
measure: Number of patients with negative prostate biopsy
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Herbert Lepor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00253266: Venlafaxine Augmentation in Treatment Resistant Depression
Official title: Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Keywords: Treatment resistant depression
Augmentation
Pharmacogenetics
Lead sponsor: Max-Planck-Institute of Psychiatry
Sponsor class: OTHER
First posted: 2005-11-15
Enrollment: 126
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic quetiapine in treatment resistant depression.

Detailed description: We examine the efficacy of Venlafaxine-HCL augmentation with the neuroleptic Quetiapine in treatment resistant depression in a double-blind randomized clinical trial. Secondary objective is the evaluation of pharmacogenetic factors contributing to drug efficacy in treatment resistant depression.

Eligibility criteria: Inclusion Criteria:

* Female and male inpatients with a major depressive disorder without psychotic features or with a depressive episode within a bipolar I or II disorder without psychotic features
* Ages between 20 and 70 years
* Total score greater than 18 on the Hamilton Depression Rating Scale
* Documentation of at least one ineffective antidepressant drug trial under adequate dosage for at least 6 weeks in the current episode

Exclusion Criteria:

* Other psychiatric axis I disorders than those mentioned as Inclusion criteria
* Acute suicidality (Item 3 of the Hamilton Depression Rating Scale greater than 2)
* Drug or alcohol addiction
* Patients with severe hepatic, cardiovascular, neurologic, metabolic or malignant disorders
* Documentation or report of a previous ineffective treatment trial with venlafaxine, lamotrigine or quetiapine
* Functional kidney disorders
* Untreated hypertension
* Acute treatment with thyroid hormone (less than 3 months)
* Pregnant or nursing patients
* Women of childbearing age without effective contraception

Primary outcomes:
measure: Hamilton Depression Rating Scale (HDRS)
timeFrame: after monotherapy and after augmentation
Secondary outcomes:
measure: Self reported psychopathology (Beck Depression Inventory [BDI], State-Trait Anxiety Inventory [STAI])
timeFrame: after monotherapy and after augmentation
measure: Cognitive function
timeFrame: after monotherapy and after augmentation
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Max Planck Institute of Psychiatry
state: Bavaria
Study officials:
affiliation: Max-Planck-Institute of Psychiatry
name: Florian Holsboer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02976766: Gypenosides Treatment for Optic Neuritis
Official title: Gypenosides Treatment for Optic Neuritis: a Randomised, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Optic Neuritis
Keywords: Neuroprotection
Clinical trial
Traditional Chinese medicine
Axonal loss
Jiaogulan
Gynostemma pentaphyllum
Optical coherence tomography
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether gypenosides are neuroprotective in patients with acute optic neuritis.


Eligibility criteria: Inclusion criteria

1. Male and female Chinese patients aged ≥18 to ≤60 years
2. Patients with a first episode of optic neuritis in the eye of interest
3. First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product
4. Best corrected visual acuity in the eye of interest ≤0.8

Exclusion criteria

1. Pre-existing multiple sclerosis MS or NMO
2. Refractive media opacity
3. Hyperopia \>5 diopters, myopia \<-5 diopters, or astigmatism \>3 diopters
4. Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial
5. Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)
6. Existing other retina or optic nerve diseases
7. Pregnant or females who plan to be pregnant during study

Primary outcomes:
measure: Mean retinal nerve fibre layer thickness
timeFrame: 6 months
Secondary outcomes:
measure: Total macular volume
timeFrame: 6 months
measure: Best corrected visual acuity
timeFrame: 6 months
measure: Latency and amplitude of visual evoked potentials
timeFrame: 6 months
measure: Mean visual field defect
timeFrame: 6 months
measure: Number of participants with Adverse events
timeFrame: Screening until end of study
Other outcomes:
Locations:
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: The First Affiliated Hospital of Guangxi Medical University, China
name: Yi Du, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04869566: External Stressors Prior to Traumatic Knee Injury in Youth Athletes.
Official title: External Stressors Prior to Traumatic Knee Injury in Youth Athletes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Knee Injury
Lead sponsor: Linnaeus University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 329
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Coaches of approximately 1400 athletes, aged 16-19 years, involved in sports related to high risk of knee injury (soccer, handball and floorball), at 70 high schools in Sweden, will be contacted and introduced to the study through email. The team coach at each school will distribute a web-based form to the athletes during their first, second or third year of the high-school period by email or through the school's intra-net system.

We estimate that approximately 300 youth athletes (50% women) will be included. From the included participants, ahtletes with traumatic knee injury will be included for furhter analysis.

Brief summary: The aim of this study is to evaluate different aspects of mental stress aspects and its role as a potential risk factor for traumatic knee injury in youth athletes. Approximately 300 athletes (age 16-19) 50% women) who are involved in high risk sports (soccer, handball and floorball) will be included. The athletes will record his/hers traumatic knee injury together with information about training regimes and some details on injury mechanism on a web-based form. The form also includes questions about mental stressors, such as club exchange, changed game system in addition to conflict within and outside the family, etc, prior to injury.

The present study will contribute new knowledge on levels of muscle function and different aspects of mental stress factors that may be related to traumatic knee injury in young athletes.


Eligibility criteria: Inclusion Criteria:

Male and female sport high school athletes Aged 15-19 years Participating and competing in soccer, handball, or floorball

Exclusion Criteria:

Traumatic knee injury prior to sport high school.

-

Primary outcomes:
measure: Number of participants that had occurred an injury during the last year
timeFrame: 12 months
measure: Number of participants with one ore several mental stressors related to environmental and social conditions
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Sofia Ryman Augustsson
Study officials:
affiliation: sofia.rymanaugustsson@lnu.se
name: Sofia Ryman Augustsson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01705366: Clinical Outcomes of Knee Replacement
Official title: Clinical Outcomes of Joint Arthroplasty
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Arthroplasty
Keywords: Osteoarthritis
Joint Disease
Arthritis
Musculoskeletal Disease
Lead sponsor: Northwest Surgical Specialists, Vancouver
Sponsor class: OTHER
Collaborators: name: Stryker MAKO Surgical Corp
First posted: 2012-10-12
Enrollment: 316
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All male and non-pregnant females undergoing knee replacement

Brief summary: The objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.

The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the knee joint has 10 year implant survival and clinical outcomes that are equivalent to other knee replacement systems.


Eligibility criteria: Inclusion Criteria:

* requires either primary or revision knee replacement surgery because of pain and joint stiffness that interferes with performance of normal daily activities
* has failed non-operative management of their joint disease

Exclusion Criteria:

* cognitively unable to complete study health-related quality of life forms
* pregnant women

Primary outcomes:
measure: Survivorship of Components
timeFrame: 10 years
Secondary outcomes:
measure: American Knee Society Knee Score
timeFrame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery
Other outcomes:
measure: Reduced WOMAC
timeFrame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery
measure: EQ-5D
timeFrame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery
measure: Forgotten Joint Score
timeFrame: 1-2 weeks prior to surgery, 1-2 weeks after surgery, 4-6 weeks after surgery, 10-12 weeks after surgery, 6 months after surgery, 1 year, 2 years, 5 years, and 10 years after surgery
Locations:
city: Vancouver
country: United States
facility: Rebound Orthopedics and Neurosurgery
state: Washington
Study officials:
affiliation: Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery
name: Todd Borus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwest Surgical Specialists / Rebound Orthopedics and Neurosurgery
name: Donald Roberts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01880866: (-)-Epicatechin and Pulmonary Arterial Hypertension
Official title: An Open Label Pilot Study of Purified (-)-Epicatechin to Improve Hemodynamics in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2013-06-19
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: Pulmonary arterial hypertension (PAH) is a progressive disease that results in severe activity limitation and death. There are few treatments for PAH and the available medications are expensive, difficult to administer and have significant toxicities.

(-)-Epicatechin is a non-toxic compound that naturally occurs in foods such as tea, wine and chocolate. Clinical intervention studies using dark chocolate in normal volunteers and subjects at risk for or with established cardiovascular disease have demonstrated improvements in peripheral and coronary vascular endothelial function, blood pressure, lipids, glucose tolerance and inflammatory markers.

Our study intends to examine the hemodynamics effects of purified (-)-epicatechin in subjects with pulmonary arterial hypertension. We hypothesize purified (-)-epicatechin will reduce pulmonary vascular resistance in patients with pulmonary arterial hypertension.


Eligibility criteria: Inclusion Criteria:

* Male or female age 18 or older
* NYHA Class II-!V
* 6 minute walk distance \< 450 meters
* Outpatients with suspected WHO group I PAH or and established diagnosis of WHO group I PAH undergoing clinically indicated right heart catheterization
* Written informed consent obtained from subject and ability for subject to comply with the requirements of study

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Systolic blood pressure \<100 or \>160
* History of migraine headaches
* Allergy or intolerance to chocolate, tea or wine
* Subject is considered unsuitable for the study in the opinion of the investigator, nurse practitioner, or study physician for any other reason

Primary outcomes:
measure: Pulmonary Vascular Resistance Index
timeFrame: up to 5 hours after right heart catheterization
Secondary outcomes:
measure: Endothelial function and hemodynamics
timeFrame: up to 5 hours after right heart catheterization
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Christopher Barnett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: