louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05766722: Feasibility of an Artificial Intelligence Phone Call After Cataract Surgery
Official title: Feasibility of an Artificial Intelligence Phone Call for Post-operative Care Following Cataract Surgery in a Diverse Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: Artificial Intelligence
Lead sponsor: Uptown Eye Specialists
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To analyze the evidence for clinical safety, usability, acceptability, satisfaction, appropriateness, and cost-effectiveness of Dora for recognizing patients who require additional in-person evaluation post cataract surgery. To assess Dora's sensitivity and specificity in cataract surgery management To determine what can be learnt to enhance AI technology in the field of ophthalmology especially when working with culturally diverse patients such as Punjabi and Chinese speaking patients.

Detailed description: Background:

Cataract is defined as the degradation of the optical quality of the crystalline lens that affects vision and is the current leading cause of blindness worldwide. AI is set to revolutionize post-cataract surgery management by enhancing automation, increasing effectiveness, decreasing burdens placed on patients and the health care system. Ultimately, using AI-enabled automation could enhance patient management during and post cataract surgery.Cataract post-operative contact will be delivered by Dora agent, a natural language AI assistant.

Aim and objective:

Dora is a clinically safe, usable, appropriate, satisfactory and cost-effective AI technology for recognizing patients who require additional evaluation post cataract surgery.

Eligibility criteria: Inclusion Criteria:

* Patients who are undergoing uncomplicated cataract surgery at a high volume surgical centre.

Exclusion Criteria:

* clinically significant complications during surgery that require more than the standard postop treatment or follow-up

Primary outcomes:
measure: Dora is clinically safe
timeFrame: through study completion, an average of 4 weeks
measure: Dora is usable
timeFrame: through study completion, an average of 4 weeks
measure: Dora is clinically appropriate
timeFrame: through study completion, an average of 4 weeks
measure: Dora's clinical cost-effectiveness
timeFrame: through study completion, an average of 4 weeks
Secondary outcomes:
measure: Multi-lingual capacity of AI technology
timeFrame: through study completion, an average of 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00696722: Effects of Atazanavir Treatment on Type 2 Diabetes Mellitus Related Endothelial Dysfunction
Official title: Influence of Atazanavir Treatment on Endothelial Dysfunction, Vascular Inflammation and Heme Oxygenase Activity in Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus Related Endothelial Dysfunction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Diabetes Research Foundation
First posted: 2008-06-13
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether atazanavir use is of influence on the endothelial dysfunction associated with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria (most important):

* 18 - 70 years
* type 2 diabetes mellitus treated with diet, oral medication and/or insulin
* BMI of 18 to 35
* determinants of renal and hepatic function within twice the upper limit of normal range, abnormalities in lipid profile permitted

Exclusion Criteria (most important):

* history of smoking within past year
* history of or current abuse of drugs, alcohol or solvents
* current use of antihypertensive, cardiac or other vasoactive medication
* clinical evidence of cardiac or pulmonary disease

Primary outcomes:
measure: Acetylcholine induced vasodilation
timeFrame: following a 4 day treatment with either placebo or atazanavir
Secondary outcomes:
measure: heme oxygenase expression and activity
timeFrame: following a 4 day treatment with either placebo or atazanavir
measure: assessment of vascular inflammation by determination of adhesion molecule levels
timeFrame: following a 4 day treatment with either placebo or atazanavir
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
References:
Clinical trial NCT00188422: Study of Low Dose CT in Sarcoma Patients
Official title: Surveillance Low Dose Computed Tomography of the Thorax in Patients With High Grade Extremity Soft Tissue Sarcoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Soft Tissue Sarcoma
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary outcome of this study is the detection of lung metastases comparing Low dose CT (LDCT) and Minimum dose CT (MnDCT) with CXR.

Hypothesis

1. LDCT and MnDCT have similar sensitivity for the detection of lung nodules (metastases).
2. MnDCT of the thorax detects a larger number of nodules (metastases) than CXR.

Detailed description: A 3-year prospective phase II non-randomized study commenced May 2003 enrolling 60 high-risk patients with Intermediate and High Grade STS. Each patient is kept under radiological surveillance for 3 years unless lung metastases are detected. Conventional thoracic imaging for staging and surveillance of STS patients is shown in Figure 1. In the trial, LDCT and MnDCT are added to each imaging visit (Figure 1). A 2-view CXR (CR) is performed (Direct View, Kodak, Rochester) followed by thoracic CT scans performed on a Siemens 16 row MDCT (Sensation 16, Siemens, Erlangen), CT acquisition; 120kVp, 5/2.5/2.5mm. Images are reconstructed with high and low spatial frequency filters and soft copy viewing is performed on a standalone PACS workstation using standard mediastinal (w 350, l 40) and lung (w 1500, l -600) settings. Examinations are performed with varying mAs; SDCT 120 mAs, LDCT 40 mAs and MnDCT 20 mAs. The examinations are evaluated, blinded to the results of the alternative and previous studies, for the presence of nodules (defined as a non-calcified focal opacity ≥3 mm \< 3 cm). Surveillance imaging is commenced 3 months post surgery.

Eligibility criteria: Inclusion Criteria:

* High Grade Soft tissue sarcoma

Exclusion Criteria:

* None

Primary outcomes:
measure: Detection of metastases
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Narinder Paul, FCPC C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05176522: Motor REHAbilitation TEChnologies for CHIldren With Disability: A Cross-European Survey
Official title: Motor REHAbilitation TEChnologies for CHIldren With Disability
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Children With Disabilities; Motor Rehabilitation; Technologies
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Fondation Ildys
name: BEaCHILD; France
name: Salud de Madrid; Espagne
name: National Clinic Center for Neuro-psychomotor Rehabilitation of Children (CNCRNC); Roumanie
name: KU Leuven; Belgique
name: Hôpital Nestlé CHUV; Suisse
First posted: 2022-01-04
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survey-takers across Europe who will participate in the online survey

Brief summary: The aim of the RehaTech4Child survey led by EACD is to identify the digital technologies (e.g., robotic devices and treadmill systems, virtual reality and gaming systems, telehealth) that are used in clinical practices throughout Europe, and to know more about how rehabilitation professionals use or not use digital technologies in motor rehabilitation practices within the paediatric population. This knowledge would eventually help in designing the future technological developments based on the feedback from rehabilitation professionals.


Eligibility criteria: Inclusion Criteria:

* Rehabilitation professionals who use or not technologies in pediatric motor rehabilitation
* Practice in Europe

Exclusion Criteria:

-

Primary outcomes:
measure: Access, frequency of use and intention to use of digital technologies by paediatric motor rehabilitation professionals A Cross-European Web survey
timeFrame: From Februray till June 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Fondation Ildys
Study officials:
References:
Clinical trial NCT06583122: Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve
Official title: Ultrasound Guided Radiofrequency Ablation of the Occipital Nerve
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nerve Pain
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study an ultrasound guided approach to radiofrequency ablation of the occipital nerve that makes it possible to see the needle during treatment procedure. It is hoped this will reduce the amount of pain after the standard of care procedure.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18-80 with a diagnosis of occipital neuralgia or migraine overlying the occipital region.
* A diagnosis of occipital neuralgia will be based on the International Classification of Headache Disorders (ICHD), whose criteria include: paroxysmal stabbing pain in the distribution of the GON, tenderness over the affected nerve, and relief of pain for at least 3 hours after bupivacaine local anesthetic block of the affected nerve.
* Patients may also be included if they have a diagnosis of migraine based on the ICHD criteria with predominance of pain over the occipital region that responded to occipital nerve block.
* Patients must have failed oral medications including NSAIDs, opioids, and anticonvulsants for the management of their pain.
* Failed treatment will be \<50% pain reduction with oral medication.
* Patients must report headache frequency of at least 10 days per month.

Exclusion Criteria:

* Patients will be excluded from the trial if they have an unstable medical or psychological condition,
* are pregnant,
* have an implanted cardiac pacemaker or defibrillator that could not be disabled,
* have had a craniotomy or scar tissue overlying the site from a previous surgery,
* have a history of cervical spine fusion,
* have evidence of elevated ICP or intracranial tumor,
* or have previous RFA treatment of the greater or lesser occipital nerve.

Primary outcomes:
measure: Reduction pain scores reported using an 11-point numeric rating scale (NRS)
timeFrame: 18 Months
Secondary outcomes:
measure: Frequency of headache days
timeFrame: 18 months
measure: Frequency of moderate-severe headaches
timeFrame: 18 months
measure: Use of acute pain medications
timeFrame: 18 Months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
Clinical trial NCT01150422: The Acceptability and Feasibility of an Alternative to Routine Follow-up Visit After Medical Abortion in Vietnam
Official title: The Acceptability and Feasibility of an Alternative to a Routine Follow-up Visit After Medical Abortion in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Medical Abortion
Keywords: medical abortion
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2010-06-25
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This trial will compare the efficacy and acceptability of post-medical abortion follow-up by assigning women to either 1) alternative follow-up via routine semi-quantitative pregnancy test and a self-administered follow-up questionnaire, or 2) the standard of care: a routine follow-up visit including a bimanual exam and vaginal ultrasound.

The goal of the study is to provide answers to the following questions:

1. Is a follow-up protocol that employs a self-administered questionnaire and at home use of a semi-quantitative pregnancy test effective at identifying women with ongoing pregnancies?
2. Is an innovative follow-up protocol more acceptable to women and providers than the current standard of care?
3. Is an innovative follow-up protocol feasible to implement in abortion services in Vietnam?


Eligibility criteria: Inclusion Criteria:

* Reproductive age women seeking medical abortion services
* Intrauterine pregnancy less than or equal to 63 days gestation on the day of mifepristone administration
* Hold a working, personal phone number
* be willing and able to sign consent forms and agree to comply with study procedures

Exclusion Criteria:

* Pregnancy greater than 63 days gestation on the day of mifepristone administration

Primary outcomes:
measure: Continued, ongoing pregnancy
timeFrame: 9 months
Secondary outcomes:
measure: percentage of women who return for follow-up
timeFrame: 9 months
measure: percentage of women receiving other treatment for ongoing pregnancy
timeFrame: 9 months
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Ob-Gyn Hospital
city: Hanoi
country: Vietnam
facility: National Ob-Gyn Hospital
city: Ho Chi Minh City
country: Vietnam
facility: HocMon District Hospital
city: Ho Chi Minh City
country: Vietnam
facility: Hung Vuong Hospital
Study officials:
affiliation: Center for Research and Consultancy in Reproductive Health
name: Nguyen Thi Nhu Ngoc, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngoc NTN, Bracken H, Blum J, Nga NTB, Minh NH, van Nhang N, Lynd K, Winikoff B, Blumenthal PD. Acceptability and feasibility of phone follow-up after early medical abortion in Vietnam: a randomized controlled trial. Obstet Gynecol. 2014 Jan;123(1):88-95. doi: 10.1097/AOG.0000000000000050.
Clinical trial NCT04055922: Comparison of Solid Organ Transplant
Official title: Comparison of Solid Organ Transplant Specific and Hospital-wide Gram-Negative Antibiograms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gram-Negative Bacterial Infections
Gram-negative Bacteremia
Multidrug-Resistant Organism
Hospital-acquired Pneumonia
Healthcare-associated Pneumonia
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Solid organ transplant (SOT) recipients

Brief summary: Solid organ transplant (SOT) recipients have increased incidence of infections with MDRO pathogens. This difference leads to a disparity in antibiograms between SOT recipients and other hospitalized patients.

Detailed description: There is limited guidance for empiric antimicrobial therapy in this population. Local epidemiology plays a voluble role in managing infections empirically within the hospital setting. Antibiograms can serve as a critical tool in optimizing empiric antimicrobial decisions. Refining antibiogram data to specific populations such as SOT patients may allow for timelier and appropriate empiric use of antimicrobials, and improve clinical outcomes.

Time to appropriate therapy (antimicrobial testing susceptible in vitro to the pathogen identified) is of vital importance in management of serious infections. SOT may have different resistance rates at Methodist Dallas Medical Center making the applicability of the yearly hospital-wide antibiogram unknown for use in this specialized patient population. A SOT-Specific antibiogram may highlight common resistance patterns identified in pathogens seen in this patient population. Additionally, this investigation may further emphasize the importance of antimicrobial stewardship activities such as: appropriate empiric antibacterial decisions, de-escalation, and effective durations of therapy.

Eligibility criteria: Inclusion Criteria:

* 18 years or older

Exclusion Criteria:

* Missing data necessary to determine study outcomes

Primary outcomes:
measure: Creation of a liver transplant specific antibiogram
timeFrame: Jan 1, 2012 - December 31, 2016
measure: Creation of a kidney transplant specific antibiogram
timeFrame: Jan 1, 2012 - December 31, 2016
measure: Comparison of SOT
timeFrame: Jan 1, 2012 - December 31, 2016
Secondary outcomes:
measure: Creation of transplant antibiogram for subgroups
timeFrame: Jan 1, 2012 - December 31, 2016
measure: Identification of risk factors among liver transplant recipients
timeFrame: Jan 1, 2012 - December 31, 2016
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Matt Crotty, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04107922: Nutraceutical on Hyperglycemia
Official title: Metabolic Actions of a Supplement of Ilex Paraguariensis, White Mulberry and Chromium Picolinate in Non-diabetic Subjects With Dysglycemia, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysglycemia
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dysglycemia.

Detailed description: The aim will be to evaluate if Glicoset® 1000, a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate, can be effective in improving glycemic status in subject with dysglycemia.

The investigators will enroll patients with impaired fasting plasma glucose (IFG) or impaired glucose tolerance (IGT), not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents). Patients will be randomized to take placebo or Glicoset® 1000 for 3 months, in a randomized, double-blind, placebo-controlled design. Glicoset® 1000 and placebo will be self-administered once a day, 1 tablet during the breakfast.

Eligibility criteria: Inclusion Criteria:

* Patients with impaired fasting glucose (IFG) or impaired fasting glucose (IGT)
* Patients not taking hypoglycemic agents (both pharmaceuticals or nutraceutical agents)

Exclusion Criteria:

* Patients with type 1 or type 2 diabetes mellitus
* Patients with impaired hepatic function
* Patient with impaired renal function
* Patients with gastrointestinal disorders
* Patients with current or previous evidence of ischemic heart disease, heart failure, or stroke
* Patients with weight change of \> 3 Kg during the preceding 3 months
* Patients with hystory of malignancy, and significant neurological or psychiatric disturbances, including alcohol or drug abuse.
* Patients taking (within the previous 3 months) hypoglycemic agents, laxatives, beta-agonists (other than inhalers), cyproheptadine, anti-depressants, antiserotoninergics, phenothiazines, barbiturates, oral corticosteroids, and antipsychotics
* Women who were pregnant or breastfeeding or of childbearing potential and not taking adequate contraceptive precautions.

Primary outcomes:
measure: Progression of dysglicemia
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
state: Lombardy
Study officials:
References:
Clinical trial NCT03782922: Exercise Training Programm for Physiotherapy Students
Official title: Effect of an Exercise Training Programm on Mental and Anatomical Characteristics of Physiotherapy Students - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Student
Physical Therapy
Keywords: exercise
anatomical
mental
training program
Lead sponsor: THIM - die internationale Hochschule für Physiotherapie
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, i.e. randomized controlled trial, the effect of an exercise training program on mental and anatomical characteristics of physiotherapy students is measured.


Eligibility criteria: Inclusion Criteria:

* age ≥18
* signed consent
* THIM student
* good health status

Exclusion Criteria:

* alcohol
* drugs
* smoking

Primary outcomes:
measure: d2-R-Test
timeFrame: Change from baseline attention and concentration at 4 weeks (objective)
measure: AKA-Questionnaire (attention, concentration, learning ability)
timeFrame: Change from baseline attention and concentration at 4 weeks (subjective)
measure: M360 - physiological parameter of the spine
timeFrame: Change from baseline position and mobility of the spine at 4 weeks
measure: Pain (Visual Analogue Scale)
timeFrame: Change from baseline pain (back) at 4 weeks
measure: FAW-Questionnaire (Actual physical well-being)
timeFrame: Change from baseline physical well-being at 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Landquart
country: Switzerland
facility: THIM University of Applied Sciences
Study officials:
References: