louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01491191: Palmitoylethanolamide for Post-operative Pain Prevention
Official title: Perioperative Use of Palmitoylethanolamide for Prevention of Chronic Postsurgical Pain in Patients Undergoing Elective Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Post-operative Pain
Keywords: surgical pain
chronic pain
prevention
palmitoylethanolamide
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postsurgical pain becomes chronic when it lasts more then two months after surgery. A neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high rates after urologic and gynecologic surgeries.

Palmitoylethanolamide (PEA) binds to mast cells and regulates pro-inflammatory factors release, without adverse events.

The investigators assume that perioperative administration of PEA can reduce chronic postsurgical pain incidence of patients undergoing to urologic and gynecologic elective surgery.


Eligibility criteria: Inclusion Criteria:

* patients undergoing elective gynecological or urological surgical procedures

Exclusion Criteria:

* age \< 18
* pregnancy or nursing
* pre-existing chronic pain
* severe hepatic or renal failure
* post-operative progression of local cancer disease
* post-operative infection or inflammation of surgical wound

Primary outcomes:
measure: Reduction of chronic post-surgical pain
timeFrame: 2 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico di Modena
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Policlinico di Modena
name: Laura Rinaldi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Azienda Ospedaliero-Universitaria Policlinico di Modena
name: Alberto Pasetto, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02562391: Effect of Left Atrial Appendage Excision on Procedure Outcome in Patients With Persistent and Long-standing Persistent Atrial Fibrillation Undergoing Surgical Ablation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
ablation
thoracoscopy
left atrial appendage
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2015-09-29
Enrollment: 180
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: The aim of this study is to assess the effect of left atrial appendage excision on atrial fibrillation recurrence and incidence of stroke in patients with persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.


Eligibility criteria: Key Inclusion Criteria:

* Patients with persistent and long-standing persistent atrial fibrillation eligible for thoracoscopy surgical ablation
* Signed inform consent

Key Exclusion Criteria:

* Paroxysmal atrial fibrillation
* Contraindications for surgical ablation
* Unwilling to participate

Primary outcomes:
measure: Atrial fibrillation recurrences
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Krasnoyarsk
country: Russian Federation
facility: Federal Center of Cardiovascular surgery
city: Moscow
country: Russian Federation
facility: Federal State Institution Clinical Hospital of the Presidental Administration of the RF
city: Moscow
country: Russian Federation
facility: Scientific center of the cardiovascular surgery named by A.N. Bakulev
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of CIrculation Pathology
Study officials:
References:
citation: Romanov A, Pokushalov E, Elesin D, Bogachev-Prokophiev A, Ponomarev D, Losik D, Bayramova S, Strelnikov A, Shabanov V, Pidanov O, Kropotkin E, Ivanickii E, Karaskov A, Steinberg JS. Effect of left atrial appendage excision on procedure outcome in patients with persistent atrial fibrillation undergoing surgical ablation. Heart Rhythm. 2016 Sep;13(9):1803-9. doi: 10.1016/j.hrthm.2016.05.012. Epub 2016 May 12.
Clinical trial NCT05523791: Whey Protein Supplementation in Patients With Parkinson's Disease
Official title: Can we Add Whey Protein Supplementation in Patients With Parkinson's Disease Without Interfering With Levodopa Response?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: levodopa
whey protein supplementation
aerobic rehabilitation
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 51
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many dietary supplementations are available to help people in balancing the protein intake and overcoming muscle mass loss. However, most of the products contain protein and could potentially affect levodopa action in people with Parkinson's disease (PWPD). The study aims at verify if whey protein supplementation interferes with dopamine replacement therapy efficacy in PWPD admitted at the clinic for a four weeks intensive multidisciplinary rehabilitation training.

Detailed description: Authors performed a randomised single blind monocentric study on PWPD admitted in the rehabilitative unit of the Moriggia Pelascini Hospital for a 4-week multidisciplinary intensive aerobic rehabilitation treatment. All patients received a standard protein redistribution dietary regimen plus a whey protein-based oral formula (N=26) or Magnesium (N=25) twice daily for 28 days.

Neurological assessment and physical evaluation were conducted before (T0) and after (T1) rehabilitative treatment; dopamine replacement therapy was recorded T0 and T1 as well. The delta of changes within groups in neurological (UPDRS III) and physical (TUG, 6MW) evaluation scales was compared between groups.

Eligibility criteria: Inclusion Criteria:

* diagnosis of Parkinson's disease (UKBB criteria Hughes et al., 1992),
* H\&Y stage 2 or 3
* presence of motor fluctuations (by means of UPDRS III item 4.3≥1)

Exclusion Criteria:

* cognitive decline

Primary outcomes:
measure: Assessment of maintained efficacy of dopaminergic therapy in WPS group
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gravedona
country: Italy
facility: Ospedale Generale di Zona Moriggia Pelascini
state: Como
Study officials:
References:
Clinical trial NCT01916291: Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38
Official title: Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Induction of Labor
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 189
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has intact membrane after 38weeks of gestational age. The investigators study safety and efficacy of dinoprostone in the pregnant women with premature rupture of membrane or GA\<38weeks


Eligibility criteria: Inclusion Criteria:

* Pregnant women who admitted for induction of labor
* Bishop score \<= 6

Exclusion Criteria:

* Contraindication to induction of labor
* Active labor
* Vaginal bleeding, unknown origin
* Hypersensitive to Prostaglandin E
* History of asthma, glaucoma
* Infection (birth canal)
* Placental abruption
* Multiparity(\>5)
* Pelvic inflammatory disease
* Heart, lung, kidney disease
* Multiple pregnancy
* Major anomaly
* Fetal distress before induction of labor

Primary outcomes:
measure: Induction success rate after propess insertion
timeFrame: Day 1 after propess insertion
Secondary outcomes:
measure: Concentration of prostaglandinE
timeFrame: at delivery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Goverment Seoul National University Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Joong Shin Park, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04343391: Brief Psychotherapies for Emotional Disorders in Primary and Secondary Care
Official title: Brief Psychotherapies for Emotional Disorders in Primary and Secondary Care: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Disorder
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
First posted: 2020-04-13
Enrollment: 150
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 present work aims to develop a randomized clinical trial with a sample of 150 patients diagnosed with at least one of the following emotional disorder: somatoform disorder, panic disorder, generalized anxiety disorder and depression disorder. Participants are tested by several self-reports related to the emocional disorders mentioned in a repeated measures design, pre and post treatment. The investigators think this study will demonstrate that brief psychological treatments should be prioritized over pharmacological treatment for such pathologies in the Primary or Secondary Care context to improve the patient´s quality of life.

Detailed description: Nowadays, the heavy demands placed on health systems exceed the resources in many developed countries. So-called "emotional disorders" and their mostly pharmacological treatment are, in no small part, responsible for this situation. However, research indicates that psychological treatment should be the first step when caring for these types of problems. The investigators expect that the results show that brief psychological therapies are more effective than pharmacological interventions. Moreover, it is expected that brief individual psychotherpay approach delivered in secondary care is more effective than brief group psychotherapy delivered in primary care.

Eligibility criteria: Inclusion Criteria:

* Emotional Disorder

Exclusion Criteria:

* Severe mental disorder
* Substance use disorder
* Severe depression

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-15)
timeFrame: 10 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 10 weeks
measure: Beck Depression Inventory (BDI-II)
timeFrame: 10 weeks
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 10 weeks
measure: Patient Health Questionnaire (PHQ-PD)
timeFrame: 10 weeks
measure: Generalized Anxiety Disorder score (GAD-7)
timeFrame: 10 weeks
measure: Brief Symptom Inventory (BSI-18)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: Universidad de Córdoba
state: Córdoba
Study officials:
References:
Clinical trial NCT05300191: In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
Official title: In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Peritoneal Dialysis-associated Peritonitis
End Stage Renal Disease
Lead sponsor: CloudCath
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 500
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: Patients currently using peritoneal dialysis and at elevated risk for developing peritonitis.

Brief summary: A proof-of-concept study of a prototype CloudCath device designed to detect peritonitis using the effluent dialysate from patients undergoing peritoneal dialysis.


Eligibility criteria: Inclusion Criteria:

* Males or females with end-stage renal disease on peritoneal dialysis for a minimum of 10 days prior to obtaining the specimen.
* Specimens shall be leftover (or remnant) from a specimen that has been drained as part of the routine care for the patient.
* Specimens shall not contain any individually identifiable information from the patient it was obtained from.

Exclusion Criteria:

* Patients providing specimens should not be under the administration of any antibiotics other than those utilized for the treatment of peritonitis.
* Patients providing specimens should not suffer from a known liver disease or from ovarian or liver cancer.
* Patients providing specimens should not be under the administration of calcium channel blockers or amlodipine for less than 30 days prior to providing a specimen.

Primary outcomes:
measure: Spectral measurements of effluent dialysate solutions
timeFrame: immediately post dialysis
measure: Conductivity measurements of effluent dialysate solutions.
timeFrame: immediately post dialysis
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: CloudCath Investigational Site
state: Jalisco
Study officials:
affiliation: University of California, San Francisco
name: Ben Briggs, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01834391: Diagnosis of Subclinical Urinary Tract Infections Using Advanced Microbiome Survey Techniques in High Risk Trauma Patients
Official title: Diagnosis of Subclinical Urinary Tract Infections Using Advanced Microbiome Survey Techniques in High Risk Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: J. Craig Venter Institute
First posted: 2013-04-17
Enrollment: 129
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Geriatric traumatic injury patients that were admitted to Saint Marys Hospital.

Brief summary: The purpose of this study is to see if the investigators can identify early those patients who are admitted to the hospital and have a urinary tract infection (UTI) or those patients that develop a UTI during their hospitalization.


Eligibility criteria: Inclusion Criteria:

* 65 years old or older admitted as a result of trauma to Saint Marys Hospital at Mayo Clinic

Exclusion Criteria:

* Prisoners
* Pregnancy
* Active urinary tract stones
* Less than 65 years of age

Primary outcomes:
measure: Identify of bacteria, genes and proteins that are highly predictive of UTI development
timeFrame: Nine months
Secondary outcomes:
measure: Biomarker candidates for UTIs recalcitrant to antibiotic treatment.
timeFrame: Nine months
measure: Morbidity
timeFrame: 9 months
measure: Mortality
timeFrame: 9 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Martin Zielinski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02096991: Associations of Exposure to Bisphenol A With Blood Pressure and Epigenetic Change
Official title: Associations of Exposure to Bisphenol A With Blood Pressure and Epigenetic Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: * Bisphenol A(BPA) is an endocrine disrupting chemical, which mimics the action of estrogen.
* Previous studies reported that BPA exposure is associated with increased risk of cardiovascular diseases.
* Exposure to BPA occur mainly through oral route, and epoxy coating of canned food is one of the well established source.
* The investigators hypothesis is that increased BPA exposure from canned beverage would disrupt normal physiology in a short term.
* In the present trial the investigators are to investigate whether increased BPA exposure by consuming canned beverage actually affect cardiovascular indices and epigenetic feature.
* For this aim, the investigators will conduct a cross-over trial.


Eligibility criteria: Inclusion Criteria:

* Reside in Seoul
* Who provided Informed consent

Exclusion Criteria:

* Who has cancer
* Who has disease or disorder of liver, nervous system, endocrine system, cardiovascular system
* Who does not provieded informed consent

Primary outcomes:
measure: Blood Pressure
timeFrame: 2 hours after consuming beverage
Secondary outcomes:
measure: Percent DNA methylation
timeFrame: 2 hours after consuming the beverage
measure: Heart Rate Variablility
timeFrame: 2 hours after consuming the beverage
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Preventive Medicine, College of Medicine, Seoul National University
Study officials:
affiliation: Department of Preventive Medicine, College of Medicine, Seoul National University
name: Yun-Chul Hong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bae S, Hong YC. Exposure to bisphenol A from drinking canned beverages increases blood pressure: randomized crossover trial. Hypertension. 2015 Feb;65(2):313-9. doi: 10.1161/HYPERTENSIONAHA.114.04261. Epub 2014 Dec 8.
Clinical trial NCT02854891: Ambient Light Levels in the Kindergarten and Schools and the Relation to Refractive Development
Official title: Ambient Light Levels in the Kindergarten and Schools and the Relation to Refractive Development
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Keywords: Effects
Heat
Light
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-08-04
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Two hundred children at ages range from kindergarten to junior year of high-school (4-17), enrolled in the formal education system in hadera and it surrounding.

Brief summary: Myopia, the most common human eye disorder, is a phenomenon characterized by an unconstrained elongation of the eye globe There are number of theories concerning the environmental effect on the emmetropization process, most are related to childhood exposure to outdoor activity, near work and sleep with night light. Studies in lab animals found an association between intensity of ambient lighting and myopia development.

In this study, the investigators will examine the ambient light in kindergarten and schools and their relation to refractive error. Diurnal luminance in kindergarten and school class room will be measured and correlated to biometric measures such as refraction, axial length and keratometry.


Eligibility criteria: Inclusion criteria

* Every child that have been studying in the same class for the last 6-12 months (kindergarten and school respectively).

Exclusion criteria

* Noncooperative child or parents.
* Ocular surgery.
* Ocular genetic disease.

Primary outcomes:
measure: the relation between the level of myopia and light intensity
timeFrame: change from baseline at the start point of the study, after 6 months and after 12 months
Secondary outcomes:
measure: levels of ambient light intensity
timeFrame: natural light- start of study and once a month until completion, average of 1 year. artificial light- once at the start point of the study
measure: measurement of axial length
timeFrame: change from baseline at the start point of the study, after 6 months and after 12 months
measure: measurement of Visual acuity
timeFrame: change from baseline at the start point of the study, after 6 months and after 12 months.
measure: measurement of refraction
timeFrame: change from baseline at the start point of the study, after 6 months and after 12 months.
measure: measurement of cornea curvature
timeFrame: change from baseline at the start point of the study, after 6 months and after 12 months.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02700191: Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial
Official title: Cardiovascular Diagnosis Using µ-Cor - an Interventional Pilot Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Congestive Heart Failure
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2016-03-07
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Subjects that are being treated at the Congestive Heart Failure clinic in Nazareth will be given the µ-Cor system to be added to their standard care, and randomized 1:1 to an interventional arm or a control arm.


Eligibility criteria: Inclusion Criteria:

* Men or women 20-90 years old.
* New York Heart Association (NYHA) class III-IV heart failure
* Followed by the Congestive Heart Failure (CHF) clinic in Nazareth
* Left ventricular ejection fraction \<35%
* Requiring treatment with \>40mg/day of furosemide\* orally or with repeated bolus or intravenous infusion of furosemide\* (\*or equivalent bumetanide or torasemide).

Exclusion Criteria:

* Pregnancy
* Subjects who have received a heart transplant.
* Subjects who are unable or unwilling to follow the study requirements.
* Patients with allergies or skin sensitivities to electrode hydrogel and/or acrylic based adhesive.
* Patients with skin breakdown in areas on the chest where device and electrode placement is required

Primary outcomes:
measure: composite of all-cause death or hospitalizations due to heart failure in the Interventional arm compared to the Control arm.
timeFrame: 30 days to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: