louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03270865: Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging
Official title: Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: AMD Population - Intermediate or Advanced AMD
DR Population- With or Without Diabetic Macular Edema
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-01
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study "Usability and Ergonomic Evaluation of Self-Positioning System for Retinal Imaging" is to enable self-operation of a monitoring device in home-simulated environment

Detailed description: One of the main challenges in developing a retinal imager is to design it to be self-operated by elderly patients in their home setting The study's objective is to explore ergonomic solutions that will allow the user to perform imaging on their own. The study will be done in a home-simulated environment using a dedicated ergonomic system (termed "PAF" - Positioning And Fixation system) that stimulates the retinal imager and enables to record the tested subject using standard cameras. The prototype doesn't include the retinal imager and does not include any imaging capabilities aside from standard means of photography Subjects will be evaluating for positioning accuracy and comfort by comparing different methods. Pupil position will be recorded using commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 65
* Able to understand and sign the informed consent form
* Ability to communicate verbally
* AMD (interim and advanced) or diabetic retinopathy (with and without DME)

Exclusion Criteria:

* Visual acuity \>=20/200 in the better eye

Primary outcomes:
measure: spatial location of the pupil, during an eye examination
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sorasky Medical Center
Study officials:
References:
Clinical trial NCT04144465: Noradrenaline Infusion Versus Phenylephrine Infusion in Improving Serum Lactate Level in HIPEC
Official title: Effect of Noradrenaline Infusuion Versus Phenyephrine Infusion in Improving Tissue Perfusion in HIPEC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ABG PARAMETERS ARE CHANGED DURING HIPEC, WE TRIED TO FIND COMPARISON BETWEEN NORADRENALINE AND PHENYLEPHRINE IN OPTIMIZING ABG PARAMETERS THAT REFLECTS ORGAN PERFUSIONS ESPECIALLY SERUM LACTATE

Detailed description: Arterial blood gas testing is considered one of the most important and widely used test in the detection of acidosis, alkalosis, electrolytes disturbance and tissue perfusion. in regard to tissue perfusion serum lactate above 4 mmol/L indicates poor tissue perfusion. serum lactate could be measured at ABG or separately. in this study we will test the effect of both noradrenaline and phenylephrine on lactate level at ABG during the stage of HIPAC in managing abdominal cancer patients.

Eligibility criteria: Inclusion Criteria:

* CANCER PATIENTS ENROLLED FOR HIPEC

Exclusion Criteria:

* DRUG SENSITIVITY

Primary outcomes:
measure: SERUM LACTATE IN ABG
timeFrame: IMMEDIATELY POSTOPERATIVELY
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
References:
Clinical trial NCT00611065: Imaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging
Official title: Imaging of Prostate Cancer Using Two-dimensional MR Spectroscopy and Diffusion Tensor Imaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Lesions
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 0
Sex: MALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal is to develop MR imaging techniques to improve delineation of cancer extent, and to improve differential diagnosis between prostate cancer and benign prostate hyperplasia or other benign diseases.


Eligibility criteria: Inclusion Criteria:

1. A male older than 21 years of age and under age of 80,
2. Either a normal healthy volunteer; a patient who has confirmed prostate cancer and decided to receive prostatectomy; or a patient who has persistent elevated PSA higher than 4.0 ng/ml, and with a prior benign biopsy scheduled to receive the second biopsy.

Exclusion Criteria:

1. Unwilling to give informed consent,
2. Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants,
3. Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities,
4. Have received orthodontic work involving ferromagnetic materials,
5. Claustrophobic,
6. Unable to lie down still for 60 minutes.

Primary outcomes:
measure: To demonstrate that multi-voxel MR spectroscopy and diffusion tensor imaging can accurately diagnose prostate cancer and benign diseases, also to provide an accurate disease extent.
timeFrame: at completion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Center for Functional Onco-Imaging, University of California
state: California
Study officials:
affiliation: University of California, Irvine
name: Min-Ying Su, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04664465: PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS
Official title: PRediction of DIverse Glucocorticoids ToxIcity OUtcomeS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Rheumatism
Polymyalgia Rheumatica
Giant Cell Arteritis
Idiopathic Inflammatory Myopathies
ANCA Associated Vasculitis
Systemic Autoimmune Disease
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients usually treated with prolonged glucocorticoid therapy in the field of rheumatology.

Brief summary: To date, there is no available tool that allows, at individual level, determination of the probability to develop clinically relevant complications of prolonged glucocorticoid therapy. In patients with inflammatory rheumatic disorders requiring prolonged glucocorticoid therapy, such tool could be useful to adapt first-line treatment decisions (in daily practice and in future clinical trials). The main objective of the study is to identify routine clinical, biological and DXA baseline characteristics predictive of the occurrence of clinically relevant complications of glucocorticoid therapy at 1 year, in order to propose a predictive score.


Eligibility criteria: Inclusion Criteria:

* Life expectancy \> 1 year.
* Indication to initiate prolonged glucocorticoid therapy at a dosage ≥ 15 mg/day for the treatment of an inflammatory rheumatic disease.
* Initial treatment or relapse.
* Previsional treatment duration \> 3 months.

Exclusion Criteria:

* Unable to consent.
* Previous corticosteroid therapy in the last 3 months at a significant dosage (\> 5 mg per day).

Primary outcomes:
measure: Clinically relevant complication of glucocorticoid therapy
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life assessed through SF-36
timeFrame: 1 year
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHRU de Brest
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: Le Mans
country: France
facility: CH Le Mans
city: Morlaix
country: France
facility: CH des Pays de Morlaix
city: Nantes
country: France
facility: CHU de Nantes
city: Orléans
country: France
facility: CHR d'Orléans
city: Poitiers
country: France
facility: <CHU de Poitiers
city: Quimper
country: France
facility: CHIC Quimper
city: Toulouse
country: France
facility: Clinique St Exupéry
city: Tours
country: France
facility: CHU de Tours
Study officials:
References:
Clinical trial NCT02310165: Insertion Technique in Large Volume Paracentesis
Official title: Z-tract Versus Coaxial Insertion Technique in Large Volume Paracentesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Keywords: Paracentesis
Ascites
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 72
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: The purpose of this study is to compare two different methods that are used for inserting the needle during paracentesis. One method is called the "coaxial insertion technique" and the other is called the "z-tract technique". Researchers would like to see which method is better and leads to less problems like oozing from the needle insertion site and pain during the procedure. Both methods are approved and currently used methods for doing a paracentesis at the University of Virginia. Which method is used generally depends on physician preference. There have been no studies done to date that compare these two methods for needle insertion.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Agreement to participate
* Patients with cirrhosis (confirmed by liver biopsy or clinically diagnosed) and ascites
* Patients presenting to UVA Digestive Health Clinic for a scheduled therapeutic paracentesis who do not have any contraindications to the procedure
* Ability to be reliably contacted by phone 24 hours following paracentesis

Exclusion Criteria:

* Prisoners
* Non-english speaking
* Paracentesis with less than 5 liters of ascitic fluid removed. (If this occurs, the specific subject encounter will be removed from the study but the subject may be included if at their next regularly scheduled paracentesis 5 liters or greater of ascitic fluid is removed.)

Primary outcomes:
measure: Post procedural leaking at the needle insertion site
timeFrame: 24 hours
Secondary outcomes:
measure: Patient reported procedural pain
timeFrame: Immediately following paracentesis
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Amy Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01554865: Effects of Diet-induced Weight Loss in Obese Men
Official title: The Effects of Diet-induced Weight Loss on Metabolic and Inflammatory Profile, Endothelial, Sexual and Urinary Function, and Quality of Life in Obese Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sexual Dysfunction
Endothelial Dysfunction
Quality of Life
Inflammation
Keywords: obesity
men
sexual function
urinary tract symptoms
endothelial function
inflammation
quality of life
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
First posted: 2012-03-15
Enrollment: 70
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efficacy of a partial meal replacement diet with a conventional diet, for inducing weight loss and improving metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men.

Detailed description: This study aims to compare the efficacy of a partial meal replacement diet with a conventional diet, for inducing weight loss, and improving metabolic and inflammatory profile, endothelial function, erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in obese men. Men aged 30-65 years, with body mass index (BMI) ≥ 27.5 kg/m2, will be recruited from the community in Singapore. The study will be conducted at Changi General Hospital by trained medical investigators, dieticians and sports trainers. At baseline and 12 weeks, fasting glucose and lipids, insulin, testosterone, sex-hormone binding globulin, serum C-reactive protein and interleukin-6 are measured, endothelial function is measured by the non-invasive EndoPAT method, and validated questionnaires administered to assess changes in erectile function, sexual desire, LUTS and quality of life

Eligibility criteria: Inclusion Criteria:

* Male, aged 30-65 years
* Body Mass Index (BMI) \>/= 27.5 kg/m2
* Waist circumference (WC) \>/= 90 cm

Exclusion Criteria:

* pituitary disease or cranial radiotherapy
* previous or current androgen replacement or deprivation therapy
* current treatment for sexual problems or LUTS
* glomerular filtration rate \< 60 ml/min
* liver disease
* alcohol intake exceeding 500 g/week in the previous 12 months
* use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors

Primary outcomes:
measure: erectile function
timeFrame: 12 weeks
Secondary outcomes:
measure: lower urinary tract symptoms
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: Changi General Hospital
name: Joan Khoo, MBBS,MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00642265: The Treatment of Clavicular Fractures
Official title: The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Displaced, Midshaft Clavicular Fractures
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: AZ Sint-Jan AV
First posted: 2008-03-25
Enrollment: 100
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: Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.

Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 year
* 100% displaced midshaft clavicular fracture
* shortening

  * male: 18mm
  * female: 14mm

Exclusion Criteria:

* pregnancy
* pathological fracture
* open fracture
* history of frozen shoulder
* ipsilateral fracture of shoulder or scapula
* neurovascular injury
* contraindication to anaesthesia

Primary outcomes:
measure: Union
timeFrame: 1 year
measure: Functionality
timeFrame: 1 year
Secondary outcomes:
measure: Complications
timeFrame: 1 year
measure: Time to heal
timeFrame: 1 year
measure: Cost
timeFrame: 1 year
measure: Relation with medication
timeFrame: 1 year
measure: Relation with smoking
timeFrame: 1 year
measure: Relation with job
timeFrame: 1 year
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Stedelijk Ziekenhuis Aalst
city: Brugge
country: Belgium
facility: AZ Sint Jan-Brugge
city: Ghent
country: Belgium
facility: Jan Palfijnziekenhuis
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Roeselare
country: Belgium
facility: Stedelijk Ziekenhuis Roeselare
city: Tielt
country: Belgium
facility: Sint-Andries Ziekenhuis
Study officials:
affiliation: University Hospital, Ghent
name: Lieven De Wilde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ Sint-Jan AV
name: Bart Berghs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sint-Andriesziekenhuis Tielt
name: Pieter-Jan Vandekerckhove, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stedelijk Ziekenhuis Roeselare
name: J. Van Den Daele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stedelijk Ziekenhuis Aalst
name: J. Vanonverschelde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jan Palfijnziekenhuis Ghent
name: G. Vandendriessche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02184065: Observational Study of Meloxicam in Mexican Patients With Rheumatic Diseases
Official title: Clinical and Therapeutic Evaluation of Meloxicam in Mexican Patients With Rheumatic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-09
Enrollment: 22639
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE

Brief summary: Observational study to evaluate the efficacy and safety of meloxicam (Mobicox®) in Mexican population with rheumatic diseases


Eligibility criteria: Inclusion Criteria:

* Age of 12 or older and rheumatologic disease

Exclusion Criteria:

* Hypersensitivity to meloxicam
* Hypersensitivity to other Non-steroidal anti-inflammatory drugs (NSAIDS)
* History of asthma, angioedema or urticaria secondary to NSAIDS
* Pregnancy or lactation
* Recent or current history of peptic ulcer disease, severe renal failure and severe hepatic failure

Primary outcomes:
measure: Intensity of symptoms at rest evaluated with a 4-point scale
timeFrame: 30 and 90 days
measure: Intensity of symptoms during movement evaluated with a 4-point scale
timeFrame: 30 and 90 days
measure: Medical global evaluation on a 4-point scale
timeFrame: 30 and 90 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05348265: High Intensity Interval Training in PCOS
Official title: Effects of High Intensity Interval Training on Psychological Well Being, Anthropometrics, and Quality of Life in Females With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study objective is to determine the effect of High intensity interval training on psychological wellbeing, Anthropometrics and Quality of life in females with Polycystic Ovarian Syndrome


Eligibility criteria: Inclusion Criteria:

* females 18 to 45 years of age
* Diagnosed with PCOS based on Rotterdam criteria
* Ferriman and Gallway score of \>8 for hirsutism

Exclusion Criteria:

* Use of hormonal contraceptives or IUDs for contraception
* Taking metformin \<3 months prior to the inclusion
* Breast feeding mothers
* Type I or II DM
* Hypo/hyperthyroidism
* Regular high-intensity endurance or strength training (defined as ≥ 2 sessions of vigorous exercise per week), Physical ailments/injuries that limited exercise performance.

Primary outcomes:
measure: Mental Well-being
timeFrame: 8th Week
measure: Illness perception
timeFrame: 8th Week
measure: weight
timeFrame: 8th week
measure: BMI
timeFrame: 8th week
measure: waist-to-hip ratio
timeFrame: 8th Week
Secondary outcomes:
measure: Polycystic ovary syndrome health-related Quality of life questionnaire
timeFrame: 8th Week
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Pakistan Railway Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sarah Ehsan, PP-DPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416465: Place of General Medical During Oncology Care Management
Official title: Place of General Medical During Oncology Care Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oncologic Disorders
Keywords: hospitalization
cancer
general practitioner
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient hospitalized in a medical service in an unscheduled way

Brief summary: The Purpose of MGPEC_ONCO is to see if patient consult their general practitioner during the management of their cancer, especially before hospitalization. The study concerns not planned hospitalizations in medicine service.

Before leaving hospital, the patient completes the survey, other data are taken in patient record


Eligibility criteria: Inclusion Criteria:

* Patient undergoing oncology treatment or ≤ 1 year of the latest oncology treatments
* Patient hospitalized in a medical service in an unscheduled way
* Age \> or = 18 years old
* Patient informed and not opposed to the study
* Patient able and agreeing to follow all study procédures
* Patient must be affiliated to a social security system

Exclusion Criteria:

* Patient hospitalized in surgery and continuing care services
* Patient deprived of liberty or under supervision

Primary outcomes:
measure: Patients in unscheduled hospitalization
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: HENRY ALINE
role: PRINCIPAL_INVESTIGATOR
References: