louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04138771: Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients
Official title: Validation of an Artificial Intelligence System for Postoperative Management of Cataract Patients: A Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Postoperative Complications
Artificial Intelligence
Keywords: Conjunctival hyperemia
Pterygium
Intraocular lens dislocation
Posterior capsule opacification
Pupil malformation
Suppurative endophthalmitis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, China
name: Xidian University
First posted: 2019-10-24
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cataract surgery is the current standard of management for cataract patients, which is typically succeeded by a postoperative follow-up schedule. Here, the investigators established and validated an artificial intelligence system to achieve automatic management of postoperative patients based on analyses of visual acuity, intraocular pressure and slit-lamp images. The management strategy can also change according to postoperative time.


Eligibility criteria: Inclusion Criteria:

* Patients who had surgery of cataract extraction combined with introcular lens implantation.
* Patients should be aware of the contents and signed for the informed consent.

Primary outcomes:
measure: The proportion of accurate, mistaken and miss detection of this artificial intelligence diagnostic system.
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05831371: Discard the Curative Causes of Late Onset Epilepsy: the Role of Brain 18F-FDG PET
Official title: Discard the Curative Causes of Late Onset Epilepsy: the Role of Brain 18F-FDG PET
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Late Onset Epilepsy
Alzheimer Disease
Keywords: FDG PET
cognitive prognosis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 87
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non lesional late onset epilepsy

Brief summary: Etiology and cognitive prognosis in late onset epilepsy differ from young adults epilepsy. At the epilepsy onset, this is crucial to detect potential curative/treatable brain disorders. After classical investigation including morphological brain imaging, EEG, clinical assessment, which added value may have brain FDG PET in the diagnosis and prognosis evaluation?


Eligibility criteria: Inclusion Criteria:

* late onset épilepsy patients without lesion
* epilepsy followed at the CHRU Nancy france

Exclusion Criteria:

* epilepsy explained by cortical lesion
* severe psychiatric disorders
* severe addiction (alcool, drugs)
* no FDG TEP performed
* no neuropsychological assessement after 2 years epilepsy onset

Primary outcomes:
measure: diagnostic performances
timeFrame: 2 years after epilepsy onset
Secondary outcomes:
measure: cognitive prognosis performances
timeFrame: 2 years after epilepsy onset
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT02106871: Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer
Official title: Phase I Assessment of NO Mediated Signaling in Cancer Cachexia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Pancreatic Cancer
Cholangiocarcinoma
Keywords: cancer
pancreas
cholangiocarcinoma
fatigue
sildenafil
lean mass
muscle
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Investigation of the effects of daily sildenafil on patients with pancreatic or cholangiocarcinoma cancer undergoing treatment.

Detailed description: This is a double-blinded, placebo-controlled trial in men and women, 40-75 years old, diagnosed with pancreatic or cholangiocarcinoma cancer. Patients will receive placebo or sildenafil daily for 4 weeks during their initial chemotherapy cycle.

Eligibility criteria: Inclusion Criteria:

1. Men and women, aged 40-75 years.
2. Diagnosed with Stage III or IV pancreatic or cholangiocarcinoma receiving the following therapy:

   * Neoadjuvant chemotherapy
   * Surgical resection followed by chemotherapy.
3. Able to comprehend risks and sign a consent form.
4. Performance Status of 0-2.

Exclusion Criteria:

1. Significant renal or heart disease or any acute metabolic disease.
2. Evidence of hepatitis as indicated by a 3-fold increase in of 2 out of 3 liver enzymes.
3. Diabetes mellitus or other untreated endocrine disease.
4. Recent (within 3 months) treatment with anabolic steroids.
5. Ongoing anticoagulant therapy.
6. Androgen secreting tumors of the ovary and adrenal or any ovarian tumor (e.g., Sertoli-Leydig).
7. Polycystic ovary syndrome (PCOS) and/or hyperthecosis.
8. Non-classical adrenal hyperplasia.
9. Cushing's syndrome.
10. Glucocorticoid resistance.
11. Pregnancy.
12. Hyperprolactinoma, hypothyroidism.
13. Use of nitrates.
14. Use of alpha blockers.
15. Use of protease inhibitors.
16. Use of cytochrome p450 inhibitors.
17. Systolic blood pressure \<100 or \>150, diastolic blood pressure \<60 or \>90. This range is smaller than the acceptable range stated in the prescribing information for sildenafil (\>90/50 and \<170/110).
18. Peripheral vascular disease.
19. Use of a phosphodiesterase 5 inhibitor.
20. Any other circumstance deemed exclusionary by the PI or study physician.

Primary outcomes:
measure: Lean Body Mass
timeFrame: 4 weeks
measure: Skeletal Muscle Fatigue
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Galveston
country: United States
facility: The University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Melinda Sheffield-Moore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002271: An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Official title: An Ascending, Single Oral Dose Pharmacokinetic Study of 3'-Deoxy-3'-Fluorothymidine (FLT) in Asymptomatic Human Immunodeficiency Virus (HIV)-Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Thymidine
Nucleosides
Antiviral Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To characterize the pharmacokinetics of orally administered 3'-deoxy-3'-fluorothymidine (FLT), in a liquid formulation, after single doses in asymptomatic HIV-infected patients and to assess the safety and tolerance of the single oral doses of FLT.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Oral candida infection documented by morphology or by response to antifungal therapy within 2 months prior to study entry.
* Temperature \> 37.8 degrees Centigrade.
* Malignancy other than cutaneous basal cell carcinoma or cervical carcinoma in situ.
* Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial.

Concurrent Medication:

Excluded:

-

Patients with the following are excluded:

* Significant chronic underlying medical illnesses which would prevent continuous participation in this clinical trial.
* Unwilling to sign informed consent.
* Intolerant to zidovudine (AZT).
* Oral hairy leukoplakia at any time prior to study entry.

Prior Medication:

Excluded within 7 days of study entry:

* Antiretroviral drugs.
* Immunomodulators.
* Excluded within 30 days of study entry:
* Any investigational drugs.

Patients have the following:

* HIV seropositivity by licensed ELISA test, confirmed by Western Blot analysis.
* No symptoms as defined by:

  1. Normal neurological exam.
  2. Absence of the following:
* Unintentional weight loss of greater than 10 pounds or more than 10 percent of usual body weight within 2 months prior to study entry.
* Unexplained temperature \> 37.8 C on more than 5 consecutive days or on more than 10 days in any 30 day period in the one month prior to expected study entry.
* Unexplained diarrhea defined by = or \> 3 liquid stools per day persisting \> 7 days within 2 months prior to expected study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
Study officials:
References:
Clinical trial NCT04842071: 18F-sodium Fluoride (NaF) PET to Replace Bone Scintigraphy: Safety and Efficacy Assessment
Official title: Open-label Clinical Trial on the Safety and Efficacy of 18F-sodium Fluoride (NaF) PET Imaging in Patients in Need of a Standard 99mTc Bone Scintigraphy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bone Cancer
Articular Disease
Infectious Disease
Keywords: 18F-NaF
Bone scintigraphy
bone diseases
Lead sponsor: Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Université de Sherbrooke
First posted: 2021-04-13
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Every patient in need and/or eligible for a standard 99mTc-biphosphonate bone scintigraphy is eligible to participate to this study. Patient data and examination results will be compiled and monitored. The safety profile of 18F-NaF produced in the primary site will be determined.
Primary purpose: DIAGNOSTIC

Brief summary: 18F-sodium fluoride (18F-NaF) was already investigated numerous times in the last 40 years as a PET alternative to standard 99m-technetium-derived bone scintigraphy. However, lack of universal tracer availability and higher costs contributed to the failure of 18F-NaF to systematically supplant bone scintigraphy as a standard of care.

Recently, an isotope shortage crisis occurred and evidenced the need to have non-reactor-derived alternatives for many nuclear medicine procedures, including bone scintigraphy. Since 18F-NaF is cyclotron-produced, it could become a necessary alternative to bone scintigraphy in case of another worldwide isotope shortage.

The study aims to evaluate the safety profile of 18F-NaF injection. Moreover, a patient registry will be compiled in order to perform sub-studies on 18F-NaF diagnostic performance on diverse bone and articular diseases.


Eligibility criteria: Inclusion Criteria:

* Patients for whom a 99mTc-biphosphonate bone scintigraphy is indicated;
* Pediatric patients for whom a 99mTc-biphosphonate bone scintigraphy is indicated for oncologic or infectious reasons
* Able to tolerate supine position
* Written consent

Exclusion Criteria:

* Healthy subjects
* Pregnancy
* Unable of maintaining supine position for more than 15 minutes
* Refusal to sign the consent form
* Known allergy or hypersensitivity to 18F-NaF or any of its constituants.

Primary outcomes:
measure: Safety profile of 18F-NaF
timeFrame: 17 years
measure: Efficacy profile of 18F-NaF compared to 99mTc-biphosphonate bone scintigraphy
timeFrame: 17 years
measure: Correlate 18F-NaF PET images with pathology reports
timeFrame: 17 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CHUS
state: Quebec
city: Sherbrooke
country: Canada
facility: Université deSherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke, Centre de Recherche du CHUS
name: Éric E Turcotte, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01592071: IgG-mediated Food Test for Weight Loss
Official title: Eliminating IgG-mediated Reactive Foods From the Diet and Its Effect on Body Composition and Quality of Life in Overweight Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: food sensitivity
IgG
obesity
overweight
body composition
reactive foods
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Immuno Laboratories
First posted: 2012-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study assessed the effect of an IgG-mediated food sensitivity test in combination with a food elimination diet on body composition and secondary outcomes in people who were overweight.

Detailed description: This study looked at foods that stimulated IgG food antibody production, which may play a role in certain conditions, such as irritable bowel syndrome, obesity, type I diabetes, and migraine headaches.

Using a proprietary blood test, the Immuno Bloodprint, to determine which foods stimulate IgG food antibodies in each person, this study detailed a personalized list of reactive foods that stimulated such antibodies for each participant. The participant was then advised to eliminate as much as possible the reactive foods for 90 days.

Eligibility criteria: Inclusion Criteria:

* BMI above 20
* Express an interest in losing weight

Exclusion Criteria:

* Less than 18 years of age
* Currently participating in another research trial for weight loss
* Suffering from serious medical complications that might limit their participation, such as recent heart attack, stroke, or chronic kidney disease
* Pregnant

Primary outcomes:
measure: Weight (kg)
timeFrame: 30, 60 and 90 days from baseline
measure: Body Mass Index
timeFrame: 30, 60 and 90 days from baseline
measure: Waist Circumference
timeFrame: 30, 60 and 90 days from baseline
measure: Hip Circumference
timeFrame: 30, 60 or 90 days from baseline
measure: Waist-Hip Ratio (WHR)
timeFrame: 30, 60 or 90 days from baseline
Secondary outcomes:
measure: Blood Pressure
timeFrame: 30, 60 and 90 days from baseline
measure: Heart Rate
timeFrame: 30, 60 and 90 days from baseline
measure: Quality of Life
timeFrame: 30, 60 or 90 days from baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami CRB
state: Florida
Study officials:
affiliation: University of Miami
name: John E Lewis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00535171: Venous Thromboembolism Taskforce Audit Program
Official title: Venous Thromboembolism Taskforce Audit Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thrombosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 8764
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Venous thromboembolism in medical patients bedridden due to acute illness.

Brief summary: To determine the effect of an interventional campaign run by a dedicated "VTE Nurse Educator" over a 6-month period and the effect on prophylaxis rates.

To determine the proportion of medically admitted patients with risk factors for VTE.

To assess and compare the use of venous thromboembolism (VTE) prophylaxis in hospitalized medical patients versus recommendations and current guidelines.

To determine the patient characteristics of those deemed to be at risk of VTE. To determine the proportion of patients receiving appropriate thromboprophylaxis for their risk.

To determine the type and duration (where possible) of prophylaxis used.


Eligibility criteria: Inclusion Criteria:

* Hospital admission for an acute illness with an in-patient hospital stay of 3 days or more.

Exclusion Criteria:

* Patients who have undergone any type of surgery during current admission
* Patients who are admitted to a ward or department that is excluded from this study e.g psychiatric, paediatric, maternity, intensive care unit, coronary care unit.
* Prior enrollment in this protocol during current admission
* Prior enrollment in a VTE study involving pharmaceutical or mechanical treatment within last 90 days.
* Admission for suspected or diagnosed deep vein thrombosis

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: MacQuarie Park
country: Australia
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Fiona Howard
role: STUDY_DIRECTOR
References:
Clinical trial NCT02494271: TIVA, Inhalation Anesthesia, and Surgical Site Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Disorders
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 2046
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013 at SNUBH.

Brief summary: The purpose of this retrospective study was to evaluate the incidence of SSI after colorectal surgery under the general anesthesia by different general anesthetic technique: inhalation versus total intravenous anesthesia.


Eligibility criteria: Inclusion Criteria:

* Adult patients who underwent elective colorectal surgery under general anesthesia from January 2011 to December 2013.

Exclusion Criteria:

* None

Primary outcomes:
measure: Surgical site infection
timeFrame: Postoperative 30 day
Secondary outcomes:
measure: Postoperative C-reactive protein
timeFrame: Postoperative 1 day
measure: Segmented neutrophil count
timeFrame: Preoperaitve 1 day, postoperative 1 day
measure: Transfusion
timeFrame: The day of operation, postoperative 30 day
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT01616771: GlideScope®Video Laryngoscope for Difficult Intubation: Implication of the Size of Blade
Official title: GlideScope®Video Laryngoscope for Difficult Intubation: Implication of the Size of Blade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation; Difficult
Keywords: laryngoscopes
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The investigators evaluated the usefulness of the Glidescope(GVL) compared with direct laryngoscopy in patients whose airway management are anticipated difficult (C\&L grade ≥3) by comparing the laryngoscopic view. Also, the investigators compared the effectiveness of smaller-size blade of GVL (GVLs) with standard blade of GVL selected by patient's weight (GVLw) in the same patients.

Detailed description: We assumed that smaller sized GVL can slide more angulated along the tongue, so the tip of a blade can be placed more anterior and cephalad. The angle of camera would be optimized by inserting the blade further with the blade tip directed toward the larynx. This optimization may be more remarkable with smaller blade because it can be inserted with rotation. Furthermore, the location and the angle of camera are different according to GVL blade size. Considering that patient with difficult airway has hypognathia and more cephalad larynx, it may be helpful with smaller sized GVL (GVLs) rather than GVL selected by weight (GVLw) for improvement of laryngoscopic view in patients with difficult airways. We hypothesized that GVLs can provide better laryngoscopic view than GVLw and DL in patient with difficult airway.

Eligibility criteria: Inclusion Criteria:

* Patients whose C\&L grade were over 3 in previous anesthetic records.

Exclusion Criteria:

* Patients with pulmonary aspiration, increased intracranial pressure, and severe cardiovascular disease

Primary outcomes:
measure: The Differences in the Glottis View (C&L Grade) of Macintosh Laryngoscope and GVL Selected by Weight.
timeFrame: up to 1 day of surgery
Secondary outcomes:
measure: The Differences in the Glottis View (C&L Grade) of GVL Selected by Weight and Smaller Sized GVL
timeFrame: up to 1day of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04254471: This Phase II/III, Multicenter Study is Designed to Evaluate the Safety and Clinical Activity of AL3810 in Patients
Official title: Multicenter, Phase II/III Study of Carboplatin Plus Etoposide With AL3810 in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Extensive-stage Small Cell Lung Cancer
Lead sponsor: Haihe Biopharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Phase II Study is to Evaluate the Safety and tolerability of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.

Phase III Study is to Evaluate the efficacy of AL3810 in combination with carboplatin plus (+) etoposide in untreated participants with ES-SCLC.


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent Form
* Male or female, 18 \~75years of age
* Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
* Histologically or cytologically confirmed ES-SCLC
* No prior treatment for ES-SCLC
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end organ function.
* Serum pregnancy test in screening period for women of childbearing potential should be negative.Except for women who have a history of sterilization or are postmenopausal.Men or woman subjects of reproductive age and their partners must agree to use effective contraception for at least 6 months from the date of signing the Informed Consent Form(ICF) until the last dose of the investigational therapy.

exclusion criteria: main exclusion criteria

* Histologically confirmed mixed small cell lung cancer.
* Symptoms related to central nervous system(CNS) metastasis, unstable CNS metastasis, or CNS diseases needed the increase of steroid dosage to control.
* Uncontrolled hypertension.

Primary outcomes:
measure: Phase II:adverse event(AE)/serious adverse event(SAE)
timeFrame: From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
measure: Phase III:1.PFS
timeFrame: From the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 56 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: