louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03330366: Effects of Allium Hookeri on Blood Glucose
Official title: An 8 Week, Randomized, Double-blind, Placebo-controlled Crossover Clinical Trial of Allium Hookeri Root Extract on Anti-diabetic Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The researchers investigated the anti-diabetic effects of Allium hookeri root extract for Korean prediabetic participants.

Detailed description: Allium hookeri root is widely consumed as a vegetable and herbal medicine in Asia. Although the antidiabetic activities of Allium hookeri have been documented in animal studies, the improved effects of Allium hookeri on human are not clear. Therefore, in this study, the researchers investigated whether Allium hookeri root extract could be effective in reducing the risk of type 2 diabetes in individuals with prediabetes.

Eligibility criteria: Inclusion Criteria:

* Fasting glucose 100\~126 mg/dl

Exclusion Criteria:

* Significant variation in weight (more 10%) in the past 3 months
* Treatment by hypoglycemic and hypolipidemic drug therapy within the past three months
* Type 1 diabetes or HbA1c\>9.0%
* Cardiovascular disease
* Hypoglycemic agent, obesity medicine, and lipid lowering agent within past 6 months or blood sugar, obesity, and lipid improvement functional foods within past 2 monts
* Pregnancy or breast feeding

Primary outcomes:
measure: Changes of blood glucose during OGTT
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes of blood insulin
timeFrame: 8 week
measure: Changes of C-peptide
timeFrame: 8 week
measure: Changes of HbA1c
timeFrame: 8 week
Other outcomes:
Locations:
Study officials:
References:
citation: Park SH, Bae UJ, Choi EK, Jung SJ, Lee SH, Yang JH, Kim YS, Jeong DY, Kim HJ, Park BH, Chae SW. A randomized, double-blind, placebo-controlled crossover clinical trial to evaluate the anti-diabetic effects of Allium hookeri extract in the subjects with prediabetes. BMC Complement Med Ther. 2020 Jul 6;20(1):211. doi: 10.1186/s12906-020-03005-3.
Clinical trial NCT05506566: 68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
Official title: 68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Tumor
Positron-Emission Tomography
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: As an emerging molecule targeting FAP, 68Ga-FAP-CHX is promising as an excellent imaging agent applicable to various cancers. In this study, we observed the safety, biodistribution and radiation dosimetry of 68Ga-FAP-CHX in patients with various types of cancer and compared them with the results of 68Ga-FAPI-04 or 18F-FDG imaging to evaluate the dosimetric characteristics and diagnostic efficacy of 68Ga-FAP-CHX.

Detailed description: Fibroblast activation protein (FAP) is highly expressed in the stroma of a variety of human cancers and is therefore considered promising for guiding targeted therapy. The recent development of quinoline-based PET tracers that act as FAP inhibitors (FAPIs) demonstrated promising results preclinically and already in a few clinical cases. 68Ga-FAP-CHX is a novel FAP-targeted tracers. The present study aimed to evaluate the biodistribution, pharmacokinetics, and dosimetry of 68Ga-FAP-CHX, and performed a head-to-head comparison with 68Ga-FAPI-04 or 18F-FDG PET/CT scans in patients with various cancers.

Eligibility criteria: Inclusion Criteria:

* 18 years \< Age \< 75 years
* Various solid tumors with available histopathological findings, and have not been treated surgically.
* Signed informed consent.

Exclusion Criteria:

* patients with pregnancy
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Human biodistribution
timeFrame: From right after tracer injection to 2-hours post-injection
measure: Human dosimetry
timeFrame: From right after tracer injection to 2-hours post-injection
measure: Standard uptake value (SUV)
timeFrame: Up to 2 weeks
measure: Lesion numbers
timeFrame: Up to 2weeks
measure: the sensitivity of 68Ga-FAP-CHX PET/CT
timeFrame: Up to 2 weeks
measure: the specificity of 68Ga-FAP-CHX PET/CT
timeFrame: Up to 2 weeks
measure: the accuracy of 68Ga-FAP-CHX PET/CT
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Count of participants with treatment emergent adverse events
timeFrame: Up to 3 days
measure: Expression ability of 68Ga-FAP-CHX in different types of tumors
timeFrame: Up to 3 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
affiliation: The First Affiliated Hospital, Fujian Medical University
name: Weibing Miao, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01090726: Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population
Official title: Intubation With Storz Videolaryngoscope® Versus Airtraq® - in an Infant Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Videolaryngoscopy
Infant
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-03-22
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the pilot study is to compare new laryngoscopes for infants by assessing the equipment best suited to assist the intubation, with the best overview, shortest time to intubation and use these numbers to make a sample size calculation for the full protocol. The investigators hypothesis is that the Storz videolaryngoscope® has a better success rate than infants (\<2 years). The patients will be optimally anaesthetized with neuromuscular blockade for the intubation. All patient will be evaluated with af Macintosh blade laryngoscope, with an Airtraq® or a Storz videolaryngoscope®, and finally intubated with the other one of the later, which the patient was randomized to.


Eligibility criteria: Inclusion Criteria:

* Elective surgical patients ASA-class 1-2 below the age of 2 years, with indication for intubation.
* Informed consent from parent.
* The parents must have legal custody of the child.
* The parents must be able to read and understand Danish.

Exclusion Criteria:

* Expected difficult airway.

Primary outcomes:
measure: Success rate
timeFrame: 5 minutes
Secondary outcomes:
measure: Time to Cormack evaluation
timeFrame: 5 minutes
measure: Time to intubation
timeFrame: 5 minutes
measure: Number of intubation attempts
timeFrame: 5 Minutes
measure: Quality of laryngeal overview before intubation
timeFrame: 5 Minutes
measure: Prevalence of post intubation stridor
timeFrame: 12 hours
measure: Intubation conditions
timeFrame: 5 Minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Study officials:
References:
citation: Sorensen MK, Holm-Knudsen R. Endotracheal intubation with airtraq(R) versus storz(R) videolaryngoscope in children younger than two years - a randomized pilot-study. BMC Anesthesiol. 2012 Apr 30;12:7. doi: 10.1186/1471-2253-12-7.
Clinical trial NCT04834726: COVID-19 Vaccine Text Outreach
Official title: Pragmatic Trial of COVID Vaccine Text Outreach Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Vaccination Uptake
Text Messaging
Outreach
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 19554
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project aims to evaluate different approaches to increase COVID-19 vaccine uptake among at-risk patients at Penn Medicine in an equitable and systematic manner through a centralized outreach program. The investigators will evaluate different text-based scheduling and messaging approaches informed by behavioral science to increase uptake among eligible patients, including the use of clinician endorsement, opt-out framing, and scarcity.

Detailed description: This project will evaluate a centralized approach to increasing COVID through direct outreach to eligible patients via text messaging. This pragmatic randomized controlled trial has the following aims:

Aim 1: To conduct systematic large scale text message outreach for vaccine delivery among a defined group of Penn Medicine in a way that advances equity.

Aim 2: To offer different scheduling workflows through text messaging that might increase uptake and reduce disparities.

Aim 3: To compare the equity and efficiency of different messages informed by behavioral science, including PCP endorsement, opt-out framing, and scarcity.

Eligibility criteria: Inclusion Criteria:

* patients of Penn Medicine aged 18+ who reside in Philadelphia and who have had at least 1 visit in the past 5 years with a Penn Medicine primary care provider (PCP)

Exclusion Criteria:

* Patients who have completed any dose of the vaccine at Penn Medicine, are currently scheduled to receive the vaccine, have externally documented vaccination records, or have previously received text-message based vaccine outreach.

Primary outcomes:
measure: Dose 1 Completion
timeFrame: 1 month
Secondary outcomes:
measure: Dose 1 Completion
timeFrame: 2 months
measure: Vaccine Completion
timeFrame: 2 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Shivan Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mehta SJ, Mallozzi C, Shaw PA, Reitz C, McDonald C, Vandertuyn M, Balachandran M, Kopinsky M, Sevinc C, Johnson A, Ward R, Park SH, Snider CK, Rosin R, Asch DA. Effect of Text Messaging and Behavioral Interventions on COVID-19 Vaccination Uptake: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jun 1;5(6):e2216649. doi: 10.1001/jamanetworkopen.2022.16649.
Clinical trial NCT02480426: 3D CT Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation
Official title: Guidance for TIPS Creation: CT-image Versus CO2 Portography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Portal Hypertension
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 15
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: TREATMENT

Brief summary: To prospectively evaluate the efficacy of real-time 3D CT-image guidance and CO2 portography during transjugular intrahepatic portosystemic shunt (TIPS) creation.


Eligibility criteria: Inclusion Criteria:

1. Cirrhosis
2. Scheduled for indicated TIPS procedure

Exclusion Criteria:

1. Presence of portal vein thrombosis
2. Presence of ascites
3. Presence of hepatic vein occlusion or stenosis
4. Proven malignancy including hepatocellular carcinoma 5. End-stage renal disease under renal replacement therapy; 6. Cardiorespiratory failure 7. Pregnancy or patients not giving informed consent for TIPS procedures

Primary outcomes:
measure: Technical success rate
timeFrame: procedure
Secondary outcomes:
measure: Median needle passes for portal vein entry
timeFrame: procedure
measure: Median radiographic fluoroscopy time for portal vein entry
timeFrame: procedure
measure: The median radiation dose for the whole TIPS procedure
timeFrame: procedure
measure: The rate of TIPS complication
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02347826: Evaluation of Satisfaction in Patients Undergoing Non Surgical Lifting by Means of Coned Wires.
Official title: Evaluation of Aesthetic Satisfaction in Patients Undergoing Non Surgical Face and Neck Lift by Means of Coned Wires.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Complications
Keywords: coned wires, wire lift,
patient
discomfort
Lead sponsor: AQ-DE
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 243
Sex: ALL
Minimum age (years): 19
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing non surgical facial and carvical lift from 2013 to 2014

Brief summary: An email questionnaire about subjective satisfaction and discomfort has been sent to 243 patients undergoing non-surgical facial and cervical lift 1 week, 1 month, 6 months and 1 year after treatment.

Detailed description: 243 patients underwent non-surgical coned wires (silhouette soft) facial and cervical lift between October 2013 and November 2014. The procedures has been executed in our aesthetic clinics in Milan, Bologna, Turin, Genoa, Rome, Asti, San Remo and Palermo.

Among the 243 patients, 217 were females and 26 males, with age ranging from 19 to 76 years. 103 patients underwent only facial lift, of which 12 only in the frontal area, 61 only on cheek and malar area, and 30 on both the areas.

39 patients underwent only cervical lift, of those 14 by means of appliance of 1 or 2 wires, 25 by means of appliance of more than 2 wires.

101 patients underwent both facial and cervical non surgical lift. We sent to every patient a email questionnaire1 week, 1 month, 6 months and 1 year after treatment.

In the questionnaire, patients has been asked to enter a value between 1 and 5 about subjective satisfaction regarding the aesthetic improvement (ranging from 1, poor, to 5, excellent), and discomfort related to treatment (ranging from 1, no perceived discomfort, to 5, impossibility to execute working and social activities).

The data has been analyzed and related to other factors such as:

* number of wires applied on each patient
* other aesthetic or regenerative medicine treatments executed on the same patient on the same year
* total expenditure related to aesthetic treatments in the same year

Eligibility criteria: Inclusion Criteria:

* Patients undergoing facial and cervical non surgical lift by means of resorbable coned wires

Exclusion Criteria:

* Patients with asymmetry

Primary outcomes:
measure: Subjective satisfaction questionnaire
timeFrame: up to one year
Secondary outcomes:
measure: Discomfort related to treatment questionnaire
timeFrame: one week, one month, 6 months, one year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: AQCE
state: Lombardia\Milan
Study officials:
affiliation: AQ-DE
name: Mario Goisis, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00419926: Evaluation of the Therapeutic Benefit of an Initial Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Regimen in Renal Transplant Patients
Official title: A Randomized, Multicenter, Parallel-group, Open-label Study to Evaluate the Therapeutic Benefit of an Initially Intensified Dosing Regimen of Mycophenolate Sodium Versus a Standard Dosing Regimen, in Combination With Cyclosporine and Corticosteroids in de Novo Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Renal, Kidney, Intensified, Enteric-coated mycophenolate sodium, Transplant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if an initial intensified enteric-coated mycophenolate sodium (Myfortic) dosing regimen administered during the first six weeks post renal transplantation provides improved efficacy, with a similar safety profile, compared to a standard regimen of Myfortic.


Eligibility criteria: Inclusion Criteria:

* Males or females, 18 to 65 years old
* First or second time kidney transplant patients
* For females capable of becoming pregnant, negative pregnancy test prior to entry into trial and effective birth control during trial and 3 months after stopping trial medication

Exclusion Criteria:

* Previous graft loss due to immunological reasons in the 1st year after the 1st transplant
* Multi-organ recipients or previous transplant of another organ, different from the kidney
* Recipients from a non-heart-beating donor
* Known hypersensitivity to mycophenolic acid or cyclosporine
* HIV positive or Hepatitis B surface antigen positive
* History of malignancy (past 5 years)
* Pregnancy or planned pregnancy, lactating, or unwillingness to use effective contraception.
* Evidence of severe liver disease

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Patients With Treatment Failure 6-months Post Transplant Measured by the Combined Incidence of Biopsy Proven Acute Rejection, Graft Loss, and Death
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of Overall Treatment Failure at Days 21 and 84 Post-transplantation Assessed by Biopsy Proven Acute Rejection (BPAR), GFL, and Death
timeFrame: 21 and 84 days
measure: Renal Function Assessed by Glomerular Filtration Rate (GFR)at Each Visit
timeFrame: at 21 days, 84 days and 180 days
measure: Renal Function Assessed by Serum Creatinine at Each Visits
timeFrame: at 21 days, 84 days and 180 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT00343226: An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.
Official title: An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Keywords: Basiliximab, transplantation, liver, renal function
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of the study are:To compare the renal function of a quadruple immunosuppressive regimen (including basiliximab in combination with an optimized cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard dose, mycophenolate mofetil and corticosteroids)


Eligibility criteria: Inclusion Criteria

* First cadaveric liver transplant
* ABO identical or compatible graft

Exclusion Criteria

* Multiple organ transplant
* renal impairment defined as glomerular filtration rate (GFR) \< 30 ml/min
* Fulminant liver failure

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation
Secondary outcomes:
measure: Frequency and severity of rejection episodes before 6 and 12 months post-transplantation
measure: Frequency of death, graft loss or retransplantation before 6 and 12 months post-transplantation
measure: Adverse events
measure: Duration of initial hospitalization and number or hospital re-admissions.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT03809026: The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes
Official title: The Potential of Sperm Retrieved by Micro-TESE to Fertilize Vitrified/Warmed Oocytes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Azoospermia, Nonobstructive
Keywords: Azoospermia
micro-TESE
Klinefelter's syndrome
Cryptorchidism
Vitrified oocytes
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2019-01-18
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men referred to micro-TESE due to Klinefelter's syndrome, maturation stop in the spermatogenesis, or failed sperm retrieval using conventional needles or TruCut.

Brief summary: Couples referred for microdissection-TESE (m-TESE) due to Klinefelter's syndrome, maturation stop in the spermatogenesis, or failed retrieval of testicular spermatozoa by conventional techniques with needle or TruCut are included. The women are stimulated with FSH in IVF protocols and the aspirated oocytes vitrified with usual applied techniques. Fresh sperm retrieved by micro-TESE are used for fertilization of the warmed oocytes. when it is not possible to obtain testicular sperm, the couples are offered fertilization with warmed oocytes.

Fertilization, cleavage, implantation and pregnancy rates using sperm from the patients versus from sperm donors will be compared.


Eligibility criteria: Inclusion Criteria:

Couples referred for micro-TESE

Exclusion Criteria:

None

Primary outcomes:
measure: Cleavage rate
timeFrame: six years
measure: Pregnancy rate
timeFrame: six years
measure: Fertilization rate
timeFrame: six years
Secondary outcomes:
measure: Implantation rate
timeFrame: six years
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
city: Odense
country: Denmark
facility: Centre of Andrology & Fertility Clinic, Odense University Hospital
Study officials:
References: