louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02335294: A Study of TRV130 for the Treatment of Pain After Abdominoplasty
Official title: A Phase 2, Randomized, Double-Blind, Placebo- and Active-controlled Study of TRV130 for the Treatment of Acute Postoperative Pain Following Abdominoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Pain
abdominoplasty
PCA
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
Collaborators: name: Lotus Clinical Research, LLC
First posted: 2015-01-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the analgesic efficacy of IV TRV130 compared with placebo in patients with acute postoperative pain following abdominoplasty.

Detailed description: The primary objective is to evaluate the analgesic efficacy of intravenous (IV) TRV130 administered via patient controlled analgesia device (PCA) compared with placebo administered via PCA in patients with moderate to severe, acute postoperative pain following abdominoplasty.

Eligibility criteria: Inclusion Criteria:

* \>=18 and \<=65 years of age.
* Plans to undergo an abdominoplasty procedure with no additional collateral procedures.
* Is able to understand and comply with the procedures and study requirements, and to provide written informed consent before any study procedure.

Exclusion Criteria:

* ASA Physical Status Classification System classification of P3 or worse.
* Has surgical or post-surgical complications.
* Has clinically significant medical conditions or history of such conditions that may interfere with the interpretation of efficacy, safety, or tolerability data obtained in the trial, or may interfere with the absorption, distribution, metabolism, or excretion of drugs.
* Has previously participated in another TRV130 clinical study.

Primary outcomes:
measure: Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Placebo
timeFrame: 24-hours
Secondary outcomes:
measure: Time Weighted Average (TWA) Change From Baseline in Pain Score Over 24 Hours Between TRV130 and Morphine
timeFrame: 24-hours
Other outcomes:
Locations:
city: Pasadena
country: United States
state: California
city: Houston
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT02356094: Posterior Cornea in Primary Open Angle Glaucoma
Official title: Posterior Cornea in Primary Open Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Keywords: glaucoma
primary open angle glaucoma
cornea
Lead sponsor: Centro Hospitalar do Baixo Vouga
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases from the Glaucoma Outpatient Clinic and controls from the General Ophthalmology Outpatient Clinic from a single ophthalmological center.

Brief summary: Characterization of posterior corneal changes in primary open angle glaucoma patients, using Scheimpflug examination.

Detailed description: A cohort of primary open angle glaucoma (POAG) patients is submitted to Scheimpflug Pentacam examination. The results are compared with a control group of age and central corneal thickness matched healthy subjects

Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma, with the diagnosis supported on structural and functional complementary exams according to the current European Glaucoma Society guidelines
* Healthy subjects from the General Ophthalmology Outpatient Clinic

Exclusion Criteria:

* age inferior to 18 years old
* primary closed angle glaucoma
* secondary open angle glaucoma
* previous intra-ocular surgery
* known or suspected corneal disease
* previous intra-ocular inflammation
* previous ocular trauma

Primary outcomes:
measure: Mean posterior corneal elevation
timeFrame: Single point in time, at baseline at the moment of study enrollment
Secondary outcomes:
measure: Mean anterior corneal elevation
timeFrame: Single point in time, at baseline at the moment of study enrollment
Other outcomes:
Locations:
city: Aveiro
country: Portugal
facility: Centro Hospitalar Baixo Vouga
Study officials:
affiliation: Centro Hospitalar Baixo Vouga
name: Pedro Gil, MSc, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arranz-Marquez E, Bolivar G, Pinero DP, Konstas AG, Mikropoulos DG, Teus MA. Orbscan topography in primary open-angle glaucoma. Optom Vis Sci. 2013 Oct;90(10):1098-103. doi: 10.1097/OPX.0000000000000019.
Clinical trial NCT03563794: Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes
Official title: Efficacy and Safety of Vildagliptin Added to Continuous Subcutaneous Insulin Infusion in Uncontrolled Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: T2DM
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 400
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The randomized, controlled clinical trial investigate the efficacy and safety of vildagliptin added to continuous subcutaneous insulin infusion in uncontrolled type 2 diabetes


Eligibility criteria: Inclusion Criteria:

* T2DM
* 30≤ age≤70 years old
* BMI 18.0-28.0 Kg/m2
* HbA1c ≥8.5%
* Negtive GAD、ICA、IAA
* Patients do not use antihyperglycemia drugs
* Patients use antihyperglycemia drugs for ≥8 weeks(exclusion of DPP-4 inhibitors and GLP-1 receptor agonist)

Exclusion Criteria:

* T1DM,GDM
* Congestive heart failure (New York Heart Association Functional Classification III-IV)
* ALT or AST\> 2 times above normal,GFR \<50ml/min
* Severe infection in the previous 3 months
* Severely acute or chronic diabetic complications
* Patients who were taking medications,known to affect glycaemic control, such as glucocorticoids(aside from antidiabetic medications)
* History of pancreatitis
* Trauma or patients operating at a scheduled time
* Any mental health condition

Primary outcomes:
measure: blood glucose
timeFrame: 7 days
Secondary outcomes:
measure: hypoglycemia
timeFrame: 7 days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The first afilliated hospital of Xiamen university
state: Fujian
Study officials:
References:
Clinical trial NCT00404794: A Study to Compare Mycophenolate Mofetil and Tacrolimus in the Treatment of Membranous Lupus Nephritis
Official title: A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and A Prospective Randomized Open-label Study to Compare Mycophenolate Mofetil and Corticosteroid With Tacrolimus and Corticosteroid as Immunosuppressive Treatment for Lupus Membranous Nephritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lupus Nephritis
Glomerulonephritis, Membranous
Keywords: membranous lupus nephritis
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
Collaborators: name: The University of Hong Kong
First posted: 2006-11-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized open-label pilot study to compare mycophenolate mofetil in combination with corticosteroid treatment and tacrolimus in combination with corticosteroid treatment in membranous lupus nephritis. The change in urine protein excretion will be the primary outcome studied. The study duration will be 24 months for each patient.


Eligibility criteria: Inclusion Criteria:

* abnormal urine protein excretion and biopsy-proven membranous lupus nephritis

Primary outcomes:
measure: Proteinuria
Secondary outcomes:
measure: Adverse effects
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Queen Mary Hospital
Study officials:
affiliation: Department of Medicine, Queen Mary Hospital
name: Daniel TM Chan, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04748094: Quantification of Abdominal Organ Motion Using MRI
Official title: Quantification of Abdominal Organ Motion Using Magnetic Resonance Imaging (MRI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: MRI
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients or staff at The Christie NHS Foundation Trust

Brief summary: The primary aim of the study is to quantify abdominal motion in order to optimise MR imaging. The study will compare three-motion management strategies a) free-breathing, b) using an abdominal compression belt and c) using MRI-compatible visually guided breath-holds.


Eligibility criteria: Inclusion Criteria:

Healthy volunteers

* 18 years or older,
* no MRI contra-indications
* must agree to registration as a non-patient in CWP (the local electronic healthcare records system) and have their MRIs read and reviewed for incidental findings by a clinical radiologist

Patient Volunteers

* undergoing radiotherapy to the abdominal region at the Christie NHS Foundation Trust
* Over 18 years of age

Exclusion Criteria:

* Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form
* Unable to tolerate MRI scan
* Pregnancy
* Colostomy

Primary outcomes:
measure: MRI Motion Management SOP
timeFrame: through study completion, approximately 6 months
Secondary outcomes:
measure: Quantification of motion
timeFrame: through study completion, approximately 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
Study officials:
References:
Clinical trial NCT04948294: Comparison of the Intubation Condition Between Two Different Types of Video Laryngoscope Blades
Official title: Comparison of the Intubation Condition Between Using Two Types of Blade in Patients Receiving Tracheal Intubation Using Videolaryngoscope: Channeled Blade vs. Non-channeled Blade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complication
Lead sponsor: Kyung Hee University Hospital at Gangdong
Sponsor class: OTHER
First posted: 2021-07-01
Enrollment: 118
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients requiring tracheal intubation for general anesthesia
Primary purpose: OTHER

Brief summary: The present study compares two different types of videolaryngoscope blade, which is a channeled and non-channeled blade. The purpose of the study is to investigate the effect of the type of videolaryngoscope blade on the intubation condition.

Detailed description: In tracheal intubation for general anesthesia, one of the two types of the blade during a video laryngoscopy can be used, one is a channeled blade that has a channel for tracheal tube launching, the other is a non-channeled blade. In the present study, the outcomes by using two types of the videolaryngoscope blade such as the intubation condition, intubation time, first-pass rate, and the incidence of intubation-related complications were compared.

Eligibility criteria: Inclusion Criteria:

* Patients receiving tracheal intubation for general anesthesia
* Patients with physical status 1, 2, or 3 by American Society of Anesthesiologists Physical Status.

Exclusion Criteria:

* Body mass index \<18.5 kg/m2 or \>35 kg/m2
* Patients with a history of airway surgery
* Patients with increased risk of aspiration
* Patients who have any pathology (polyp, tumor, or inflammation) in the upper airway and larynx

Primary outcomes:
measure: Intubation time
timeFrame: Immediately after tracheal intubation completed
Secondary outcomes:
measure: First-pass rate
timeFrame: Immediately after tracheal intubation completed
measure: Intubation-related complications
timeFrame: within 24 hours after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Gangdong Hospital
Study officials:
affiliation: Kyung Hee University Hospital at Gangdong
name: Hyungseok Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05169294: The Effect of Fine Motor Skills Training Through Telerehabilitation in Children With Diplegic Cerebral Palsy
Official title: The Effect of Fine Motor Skills Training Through Telerehabilitation on Handwriting, Occupational Performance, Fine Motor Skills and Hand Skills in Children With Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diplegia, Spastic
Keywords: cerebral palsy
handwriting
occupational therapy
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children to be included in the study will be divided into intervention (n: 30) and control (n: 30) groups by randomization. Block randomization will be done using randomizer.org. Children in both groups will be given an occupational therapy home program for intervention goals.

Children in the intervention group will be given telerehabilitation and fine motor skills training for a total of 8 weeks, 45 minutes a day, 3 days a week.
Primary purpose: OTHER

Brief summary: The aim of this study is to compare the effect of occupational therapy intervention through two-way video call, versus occupational therapy home program in written form; on handwriting skills, occupational performance, fine motor and hand skills in children with diplegic cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with diplegic cerebral palsy
* Being between the ages of 7-12
* Being able to read and write
* To be at level I-III in the Manual Ability Classification System (MACS)
* To have the necessary devices (phone, tablet or computer) for video calling
* Not being able to come to the faculty to conduct the first evaluation face to face
* Not receiving occupational therapy in any special education center

Exclusion Criteria:

* Presence of another neurological and/or psychiatric disease
* Not giving consent to the study Individuals included in the study will be randomly assigned to the intervention and control groups. It is planned to keep the number of individuals in the intervention and control groups equal.

Primary outcomes:
measure: Assessment of Children's Hand Skills (ACHS)
timeFrame: 8 weeks
measure: Minnesota Handwriting Assessment
timeFrame: 8 weeks
measure: Shriners Hospital Upper Extremity Evaluation (SHUEE)
timeFrame: 8 weeks
measure: Bruininks-Oseretsky Test of Motor Proficency 2- Short Form (BOT-2 SF)
timeFrame: 8 weeks
measure: Canadian Occupational Performance Measure
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
References:
Clinical trial NCT02093494: Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device When Collected Through Peripheral Intravenous Catheters
Official title: A Randomized, Open Label Study to Evaluate the Effectiveness of the MMT Initial Specimen Diversion Device in Reducing Blood Culture Contamination Compared to Laboratory Standard Procedures When Collected Through Peripheral Intravenous Catheters (PIVC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Septicemia
Keywords: Septicemia
Blood culture
Contamination
Lead sponsor: Magnolia Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-21
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a randomized, open label study to evaluate the Initial Specimen Diversion Device (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. ER, surgical, medical, etc.). Only samples that are collected via PIVC's may be included in this study. The ISDD will be compared to current laboratory practices for the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.


Eligibility criteria: Inclusion Criteria:

* Adults \>19 years old

Exclusion Criteria:

* Not a good candidates for direct-to-media (DTM) technique

Primary outcomes:
measure: Evaluate the rate of blood culture contamination using the Initial Specimen Diversion Device (ISDD) compared to Laboratory Standard Procedures (LSP) when collected through PIVC
timeFrame: Baseline
Secondary outcomes:
measure: Evaluate the occurrence of any adverse device effects
timeFrame: Baseline
Other outcomes:
measure: Evaluate the contamination rates, taking into account the confounding effects of blood draw setting and departure from direct-to-media (DTM) technique
timeFrame: Baseline
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Magnolia Medical Technologies, Inc.
name: Richard Patton, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02231294: The Effect of Sifrol® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease
Official title: The Effect of SIFROL® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 1464
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory patients with idiopathic parkinson's disease requiring therapy with Sifrol®

Brief summary: Documentation of the effect of SIFROL® on tremor and depression as well as its tolerability in ambulatory patients suffering from idiopathic Parkinson's disease under routine conditions


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic Parkinson's disease with tremor and/or depression requiring therapy with Sifrol® or change of therapy to Sifro®l and not under medication with neuroleptics were allowed to be observed during the study

Exclusion Criteria:

* Patients who meet one or more of the general or specific contraindications mentioned in the Summary of Product Characteristics (SPC) for Sifrol®
* Patients under treatment with neuroleptics should not be observed during this study

Primary outcomes:
measure: Change in Parkinson signs and symptoms by means of a 4-point rating scale
timeFrame: up to 6 weeks
measure: Occurrence of tremor (rest and postural) by means of a 4-point rating scale
timeFrame: up to 6 weeks
measure: Change in severity of kinetic tremor assessed by tremor spiral test
timeFrame: up to 6 weeks
measure: Occurrence of depression by means of a 4-point SPES rating scale
timeFrame: up to 6 weeks
measure: Change in severity of depression by means of an 8-point rating scale
timeFrame: up to 6 weeks
measure: Self-Assessment of depression by patient by means of six different visual analogue scales (VAS)
timeFrame: up to 6 weeks
measure: Assessment of efficacy by investigator on a 5-point rating scale
timeFrame: after 6 weeks
Secondary outcomes:
measure: Number of patients with adverse drug reactions
timeFrame: up to 6 weeks
measure: Assessment of tolerability by investigator on a 5-point scale
timeFrame: after 6 weeks
measure: Assessment of tolerability by patient on a 5-point scale
timeFrame: after 6 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03014960: Effects of Leader Sleep Improvement on Leadership
Official title: The Effects of Leader Sleep Improvement on Leadership
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia, Primary
Chronic Insomnia
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to investigate the effects of sleep improvement in leaders on leader outcomes.

Detailed description: The investigators seek to extend the findings of a recent research which demonstrated that treating insomnia has several beneficial effects on employee work outcomes (Barnes, Miller, \& Bostock, in press). In the present study, the investigators propose that the treatment of leader insomnia would beneficially influence leadership, specifically abusive supervision, charismatic leadership, and laissez-faire leadership.

Eligibility criteria: Inclusion criteria:

* Working adults who have at least one direct report (i.e., subordinate).

Exclusion criteria:

* Non-working adults/ adults who do not have at least one direct report (i.e., subordinate).

Primary outcomes:
measure: Self-Control Scale
timeFrame: 2 weeks
measure: Abusive Supervision Scale
timeFrame: 2 weeks
measure: Emotional Labor Scale
timeFrame: 2 weeks
measure: Charismatic Leadership Scale
timeFrame: 2 weeks
measure: Emotional Exhaustion Scale
timeFrame: 2 weeks
measure: Laissez-Faire Leadership Scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Insomnia Scale
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Yu Tse Heng
role: PRINCIPAL_INVESTIGATOR
References: