louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03477578: Freezing of Gait and Cognition
Official title: Freezing of Gait and Cognition: What Can we Learn From Cognition?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gait Disorder, Sensorimotor
Cognition Disorders
Parkinson Disease
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 305
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinsonian patients with and without freezing of gait hospitalized at the Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital.

Brief summary: The study was aimed to investigate the role of cognition n in FoG.

Detailed description: Alteration of cortical circuits in PD leads to cognitive dysfunctions associated with the development of FoG.

The study was aimed to investigate the role of cognition in FoG.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of idiopathic Parkinson's disease according to Gelb et al.

Exclusion Criteria:

* Any other neurological conditions other than PD

Primary outcomes:
measure: UPDRS
timeFrame: 5 years
measure: MMSE
timeFrame: 5 years
measure: FAB
timeFrame: 5 years
measure: WCST
timeFrame: 5 years
measure: TMT A-B
timeFrame: 5 years
measure: Rey Auditory-Verbal Learning Test
timeFrame: 5 years
Secondary outcomes:
measure: 6MWT
timeFrame: 5 years
measure: TUG
timeFrame: 5 years
Other outcomes:
Locations:
city: Gravedona Ed Uniti
country: Italy
facility: "Moriggia-Pelascini" Hospital
state: CO
Study officials:
affiliation: Department of Parkinson's disease, Movement Disorders and Brain Injury Rehabilitation, "Moriggia-Pelascini" Hospital - Via Pelascini, 3, 22015, Gravedona ed Uniti, Como, Italy
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01846078: Accuracy of Holladay 2 Formula in the Absence of Lens Thickness
Official title: Accuracy of Holladay 2 Formula Using IOLMaster Parameters in the Absence of Lens Thickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 143
Sex: ALL
Minimum age (years): 44
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Hypothesis: Holladay 2 formula is still accurate even used without lens thickness data.


Eligibility criteria: Inclusion Criteria:

* patients with cataract

Exclusion Criteria:

* previous ocular diseases
* previous ocular surgery

Primary outcomes:
measure: mean absolute error of Holladay2 formula
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
References:
citation: Narvaez J, Zimmerman G, Stulting RD, Chang DH. Accuracy of intraocular lens power prediction using the Hoffer Q, Holladay 1, Holladay 2, and SRK/T formulas. J Cataract Refract Surg. 2006 Dec;32(12):2050-3. doi: 10.1016/j.jcrs.2006.09.009.
Clinical trial NCT01797978: Methylene Blue in Severe Sepsis and Septic Shock
Official title: Infusion of Methylene Blue in Severe Sepsis and Septic Shock: Randomized, Single Blinded
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Severe Sepsis
Septic Shock
Keywords: Sepsis
Septic shock
Methylene blue
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 354
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 to see whether the intravenous administration of methylene blue improves the outcome in severe sepsis and septic shock.

Detailed description: The mortality of septic shock is still high ranging from 30 to 50%. Vasopressor is the main part in managing septic shock, but the choice of vasopressor is still under-investigated, and area of uncertainty.

The response to vasopressor is sometimes unsatisfactory, and in that case, the outcome of the patients is poor.

Recently, small size clinical trial has investigated the effect of methylene blue (MB), and showed promising results. However, large sized phase III trial has not been performed yet.

Large sized phase III clinical trial is needed to establish the effect of MB in septic shock.

Eligibility criteria: Inclusion Criteria:

* Septic shock meeting the criteria of 2012 surviving sepsis campaign
* Need the norepinephrine of over 0.2microgram/kg/min

Exclusion Criteria:

* Pregnancy
* Less than 18 years old
* Terminal cancer patients
* Declined consents
* glucose-6-phosphate dehydrogenase deficiency
* Medication of Serotonin modulator

Primary outcomes:
measure: 28 day mortality
timeFrame: within 28 days of diagnosis
Secondary outcomes:
measure: Vasopressor dependent period
timeFrame: within 28 days of diagnosis
measure: Vasopressor index
timeFrame: with in 28 days of diagnosis
measure: Change of cardiac output (CO) and systemic vascular resistance (SVR)
timeFrame: with in 28 days of diagnosis
measure: Length of stay in ICU (LOSICU)
timeFrame: with in 28 days of diagnosis
measure: LOS in hospital
timeFrame: with in 28 days of diagnosis
measure: In hospital mortality
timeFrame: with in 28 days of diagnosis
measure: Multiple organ failure (SOFA)
timeFrame: with in 28 days of diagnosis
measure: NO level
timeFrame: before and after infusion of MB, 24hrs, 48hrs later
measure: Cytokine level (IL-6, 10, tumor necrosis factor -alpha)
timeFrame: before and after infusion of MB, 24hrs, 48hrs later
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyeongi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG - SNU Boramae Medical Center
Study officials:
affiliation: Professor, department of emergency medicine
name: Kyuseok Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03101878: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers
Official title: A Blinded, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 757456 Administered Subcutaneously to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers, IONIS AGT-Lrx
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-05
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS AGT-LRx in up to 82 Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements
* Healthy males or females aged 18-60 inclusive and weighing ≥ 50 kg at the time of Informed Consent
* Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* BMI ≤ 35 kg/m
* Agree to conduct at home blood pressure monitoring (in triplicate using study provided device) every morning and every evening throughout study participation for Single-Dose Cohort subjects and every morning for Multiple-Dose Cohort subjects

Exclusion Criteria:

* Treatment with another Study Drug, biological agent, or device within one-month of Screening
* Subject with borderline orthostatic hypotension defined as a fall in systolic blood pressure of ≥ 17 mmHg or diastolic blood pressure of ≥ 7 mmHg when they assume a standing position (within 3 minutes of standing up)
* Use of nicotine-containing products or illicit drugs
* Considered unsuitable for inclusion by the Principal Investigator

Primary outcomes:
measure: Incidence and severity of adverse events that are related to treatment with IONIS AGT-LRx
timeFrame: Up to 127 days
measure: Any observed changes in Blood Pressure measurements, ECGs, or laboratory tests from baseline
timeFrame: Up to 127 days
Secondary outcomes:
measure: Pharmacokinetics after single and multiple doses of IONIS AGT-LRx
timeFrame: Up to 127 days
measure: Pharmacodynamics of IONIS AGT-LRx (Changes in plasma AGT Levels)
timeFrame: Up to 127 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Syneos Health
state: Ontario
Study officials:
References:
citation: Morgan ES, Tami Y, Hu K, Brambatti M, Mullick AE, Geary RS, Bakris GL, Tsimikas S. Antisense Inhibition of Angiotensinogen With IONIS-AGT-LRx: Results of Phase 1 and Phase 2 Studies. JACC Basic Transl Sci. 2021 May 3;6(6):485-496. doi: 10.1016/j.jacbts.2021.04.004. eCollection 2021 Jun.
Clinical trial NCT01062178: Efficacy of Ultrasound Contrast Agent to Assess Renal Masses
Official title: The Comparison of Accuracy of Contrast Enhanced Ultrasound on Diagnosis of Small Renal Masses and Distinguishing Renal Cell Carcinomas From Other Renal Masses, With Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Renal Cell Carcinoma
Keywords: Small renal Mass
Contrast Enhanced Ultrasound
Renal Cell Carcinoma
noninvasive diagnosis of RCC
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Lantheus Medical Imaging
First posted: 2010-02-04
Enrollment: 167
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with an incidentally discovered small renal masses (SRM) \< 4 cm in diameter are included. All patients will undergo biopsy for tissue diagnosis. Most patients will be followed by imaging. Study intervention includes low MI US to be performed following both bolus and infusion injection of Definity contrast. Presence and absence of vascularity, pattern of vascularity, and TIC values will be correlated with the final pathology to find features differentiating benign from malignant masses.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed Renal mass \< 4 cmm, who are going to undergo diagnostic CT, MRI or biopsy.

Primary outcomes:
measure: biopsy
timeFrame: 12 to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT00330278: Timing of Prophylactic Antibiotics for Cesarean Sections
Official title: A Randomized, Double-Blind, Placebo Controlled Trial of Cefazolin Given Either 30 Minutes Prior to Cesarean Section or at Cord Clamping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometritis
Wound Infection
Keywords: Cesarean section
Antibiotic prophylaxis
Cefazolin
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2006-05-26
Enrollment: 350
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, double-blinded placebo controlled trial of cefazolin timing before cesarean section fo infection prophylaxis. Subjects are randomized to cefazolin either 30 minutes prior to skin incision or at time of cord-clamping. Primary outcome is infectious morbidity including wound infections and endometritis.


Eligibility criteria: Inclusion Criteria:

Pregnant 24-43 weeks gestation \> 18 years old Requiring cesarean section -

Exclusion Criteria:

Receiving antibiotics \< 18 years old Allergy to cefazolin

-

Primary outcomes:
measure: Combined infectious morbidity - endometritis + wound infection
Secondary outcomes:
measure: Neonatal sepsis
measure: Allergic reactions
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Scott A Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04527978: Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
Official title: Clinical Comparison of 2 Daily Disposable Contact Lenses - Pilot Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Myopia
Keywords: Daily disposable contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2020-08-27
Enrollment: 56
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 primary objective of this study is to evaluate the overall performance of PRECISION1 contact lenses when compared to Biotrue ONEday contact lenses.

Detailed description: Subjects are expected to attend 3 study visits and wear the PRECISION1 and Biotrue ONEday study lenses in a crossover design for approximately 8 days of exposure to each study lens type. The expected duration of subject participation is up to 22 days.

Eligibility criteria: Key Inclusion Criteria:

* Subject must be able to understand and must sign an Institution Review Board (IRB) approved Informed Consent Form.
* Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
* Willing to wear contact lenses for at least 16 hours per day on one of the days with each lens type.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular condition that contraindicates contact lens wear.
* Previous or current habitual wearer of PRECISION1, Biotrue ONEday, or DAILIES TOTAL1 contact lenses.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Distance Visual Acuity (VA) With Study Lenses
timeFrame: Day 8 (-0/+3 days) after 10 (-2/+6) hours of wear, each study lens type
Secondary outcomes:
Other outcomes:
Locations:
city: Maitland
country: United States
facility: Alcon Investigator 6565
state: Florida
city: Medina
country: United States
facility: Alcon Investigator 6402
state: Minnesota
city: Powell
country: United States
facility: Alcon Investigator 6313
state: Ohio
city: Wichita Falls
country: United States
facility: Alcon Investigator 8028
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: CDMA Project Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT02265978: CopeSmart: Using Mobile Technology to Promote Positive Mental Health in Young People
Official title: CopeSmart: Using Mobile Technology to Promote Positive Mental Health in Young People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Mental Health and Well-Being
Keywords: Emotional Self-Awareness
Positive Coping
Help-Seeking
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: Irish Research Council
First posted: 2014-10-16
Enrollment: 387
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effectiveness of a mental health mobile app (CopeSmart) in promoting positive mental health through emotional self-awareness in adolescents. Participants will be recruited from second-level schools in Ireland. Schools will be randomly assigned to the intervention or control condition. Participants in the intervention condition will use CopeSmart for a four week period. Those in the control condition will not use any mental health app.


Eligibility criteria: Inclusion Criteria:

* Must be between 14 and 19 years
* Must be enrolled in second-level education
* Must have access to an iPhone, iTouch or Android mobile device
* Must obtain signed parental consent to participate

Exclusion Criteria:

- No parental consent

Primary outcomes:
measure: Changes in levels of emotional self-awareness measured by the Emotional Self-Awareness Scale
timeFrame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
Secondary outcomes:
measure: Changes in frequency of use of positive coping strategies measured by the Coping Strategies Inventory
timeFrame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
measure: Changes in levels of well-being measured by the WHO-5 Well-Being Index
timeFrame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
measure: Changes in help-seeking behaviour measured by the General Help-Seeking Questionnaire
timeFrame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
measure: Changes in levels of emotional distress measured by the Depression, Anxiety and Stress Scale
timeFrame: Baseline (pre-test), 4 weeks later (post-test) and 8-10 weeks later (follow up)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University College Dublin
Study officials:
affiliation: University College Dublin
name: Rachel E Kenny, M.Psych.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kenny R, Dooley B, Fitzgerald A. Ecological Momentary Assessment of Adolescent Problems, Coping Efficacy, and Mood States Using a Mobile Phone App: An Exploratory Study. JMIR Ment Health. 2016 Nov 29;3(4):e51. doi: 10.2196/mental.6361.
Clinical trial NCT00852878: The Treatment of Recurrent Abdominal Pain in Children
Official title: The Treatment of Recurrent Abdominal Pain in Children: A Comparison of Biofeedback and Behavioral Intervention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Recurrent Abdominal Pain
Keywords: Recurrent Abdominal Pain
Biofeedback
Heart Rate Variability
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if two treatments, a biofeedback and behavioral protocol, for recurrent abdominal pain are equally effective.

Detailed description: Recurrent abdominal pain (RAP) is a functional disorder that affects approximately 10 to 25% of children in the United States. This population tends to be heavy medical users in a search of a treatment for the chronic pain, but at this time there is no standard treatment protocol. The literature proposes that there are two effective treatments for RAP, a relaxation protocol by Sanders et al. (1994) and a biofeedback protocol currently in use at Kaiser, but neither treatment has been widely accepted as standard treatment. A purpose of this study is to gather more data on both treatments to help move one or both treatments into the standard of care for RAP. The hypothesis of this study is that the biofeedback and the relaxation protocols will have equivalent treatment outcomes.

Eligibility criteria: Inclusion Criteria:

* who speak English
* diagnosis with Recurrent abdominal pain

Exclusion Criteria:

* lactose intolerance, urinary tract infections, or recent head trauma;
* the use of prescribed or over he counter medications, which may interfere with the biofeedback data;
* currently receiving other treatment for recurrent abdominal pain;
* the receipt of a recent and related surgical procedure;
* children who met criteria for depression or anxiety disorder

Primary outcomes:
measure: The measurable primary outcome will use equivalency testing on changes in pain diary ratings, using the average weekly pain intensity and frequency as recorded in the pain dairy
timeFrame: 3 Months
Secondary outcomes:
measure: A measurable secondary outcome will be changes in heart rate variability
timeFrame: 3 Months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Kaiser Permanente Vandever Medical Offices
state: California
Study officials:
affiliation: Kaiser Permanente
name: Warren L Shapiro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01289678: Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Official title: Phase II Trial of Daily Pulse Interleukin-2 With Famotidine in Acute Myelogenous Leukemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Keywords: acute myelogenous leukemia
interleukin-2
Lead sponsor: Leo W. Jenkins Cancer Center
Sponsor class: OTHER
First posted: 2011-02-04
Enrollment: 18
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: Assess the immunotherapy benefit of interleukin-2 in acute myelogenous leukemia treatment during lymphocyte recovery.

Detailed description: Upon lymphocyte recovery after myeloablative induction standard chemotherapy pulse Interleukin-2 administered

Eligibility criteria: Inclusion Criteria:

* Confirmed hematopathology diagnosis of AML receiving marrow suppressive treatment
* Total WBC recovery of 500 mm3 prior to IL-2 treatment
* Platelet count of at least 20,000 mm3 prior to starting IL-2 treatment
* Active infection controlled prior to starting IL-2 treatment
* Stable systolic blood pressure \> 90mm Hg prior to starting IL-2 treatment
* O2 saturation \>90% prior to starting treatment
* Stable cardiopulmonary status prior to starting IL-2 treatment
* Serum creatinine \< or equal to 2.0 mg/dl
* Total bilirubin and AST \<3x upper limits normal

Exclusion Criteria:

* Acute Promyelocytic Leukemia
* Active thrombocytopenic bleeding
* Cardiac ejection fraction below 45%
* Pregnancy and/or lactation

Primary outcomes:
measure: Event-free Survival
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Leo W. Jenkins Cancer Center
state: North Carolina
Study officials:
affiliation: The Brody School of Medicine at East Carolina University
name: Paul Walker, MD
role: PRINCIPAL_INVESTIGATOR
References: