louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02962752: Pharmacodynamic Profile of 'Blackadder' Blackcurrant Juice Effects Upon the Monoamine Axis in Humans
Official title: Pharmacodynamic Profile of 'Blackadder' Blackcurrant Juice Effects Upon the Monoamine Axis in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Monoamine Oxidase Inhibitor Activity
Prolactin Levels
Postprandial Blood Glucose
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Plant & food Research Ltd
First posted: 2016-11-11
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The current study uses a double-blind, placebo-controlled, randomised cross- over design to assess the pharmacodynamics of the platelet MAO-B inhibition, plasma prolactin levels and blood glucose levels after consumption of a single serve of 'Blackadder' blackcurrant juice.

Detailed description: There is emerging evidence which supports health benefits of consuming blackcurrant fruit, including improvements to cognitive performance, modulation of blood flow, regulation of blood glucose and inhibition of enzymes underpinning normal cognitive function. Of particular relevance is our previous demonstration of inhibition of MAO-A and B after consumption of a New Zealand 'Blackadder' blackcurrant juice drink in man.

In an attempt to establish a "therapeutic window" on which future nutritional interventions can be based, the current study will assess the pharmacodynamics of MAO-B inhibition, plasma prolactin levels and venous blood glucose profile following consumption of the 'Blackadder' blackcurrant juice. The trial will utilise a 500mg dose of the 'Blackadder' juice (equivalent to \~100g of fresh fruit) which was shown to have MAO inhibitory effects in our previous report and effects will be measured in a cohort of healthy male adults.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Male
* Aged 18-35
* Non- smoker
* No history of metabolic disease

Exclusion Criteria:

* Diagnosis of blood-borne disease
* Diagnosed history of any psychiatric disorder
* Aged under 18 or over 35 years
* BMI above 30 kg/m2 or below 17 kg/m2,
* Diagnosis of diabetes or current use of prescription or over-the-counter drugs

Primary outcomes:
measure: Change from baseline Monoamine Oxidase B - Activity
timeFrame: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.
measure: Change from baseline peripheral prolactin levels
timeFrame: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.
Secondary outcomes:
measure: Change from baseline postprandial blood glucose
timeFrame: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04893252: Vactosertib and Durvalumab in Gastric Cancer
Official title: Vactosertib in Combination With Durvalumab (MEDI4736) in Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomach Neoplasm
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2021-05-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will test the efficacy and safety of durvalumab in combination with vactosertib in patients with metastatic gastric cancers who failed ≥ 2 lines of chemotherapy

Detailed description: Efficacy and safety of durvalumab (anti-PD-L1) via IV infusion Q4W, in combination with vactosertib (TGF-beta inhibitor) PO bid for 5 days a week for up to a maximum of 12 months, will be tested in patients with metastatic hypermutated gastric cancers as ≥ 3rd-line setting until confirmed disease progression, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.

Eligibility criteria: Inclusion Criteria:

* Have histologically- or cytologically-confirmed diagnosis of metastatic gastric adenocarcinoma in the stomach and gastroesophageal junction that are refractory to at least two lines of treatment.
* Have a performance status of 0-1 on the ECOG Performance Scale.
* Have measurable disease at least one investigator-assessed measurable disease per RECIST v1.1
* Have adequate organ functions

Exclusion Criteria:

* Prior ALK5 inhibitor treatment
* Current or prior use of immunosuppressive medication within 14 days before the first dose of study drugs
* Patients weighing \<30kg

Primary outcomes:
measure: Objective response rate
timeFrame: Every 8 weeks from the date of the first dose until the date of progression, assessed up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi
Study officials:
References:
Clinical trial NCT03755752: Safety of Trypan Blue on Endothelium of Diabetic Retinopathy Patients
Official title: Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients With Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Diabetic
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 65
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study examines the use of Trypan Blue staining of the corneal endothelium in patients undergoing phacoemulsification. It is a single-center prospective, randomized individual cohort study. One eye in each patient with diabetic retinopathy will undergo phacoemulsification without Trypan Blue capsule staining (control eye) while the other eye will undergo phacoemulsification with Trypan Blue capsule staining (study eye). Both eyes will undergo intraocular lens implantation. Preoperative and four-week postoperative quantitative and qualitative morphometric endothelial cell analyses of the cornea will be performed using noncontact specular microscopy.


Eligibility criteria: Inclusion Criteria:

* Patients with bilateral cataract and diabetic retinopathy

Exclusion Criteria:

* History of ocular surgery Active
* ocular inflammation Corneal opacities
* Pseudoexfoliation syndrome
* Anterior chamber flare and (or) other signs of possibly altered blood - queous barrier
* Iris neovascularization (rubeosis)
* Uncontrolled glaucoma
* Congenital or traumatic cataracts
* History or present chronic use of topical or systemic steroids
* Poor papillary dilatation (\<6 mm)
* Specular microscopy cell density \< 2000 cell/mm2
* Patients who experienced complications fromphacoemulsification

Primary outcomes:
measure: Endothelial cell density
timeFrame: 4 weeks
Secondary outcomes:
measure: Endothelial cell coefficient of variation
timeFrame: 4 weeks
measure: Percent of hexagonal cells
timeFrame: 4 weeks
measure: Mean corneal thickness
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
citation: Abdelmotaal H, Abdelazeem K, Hussein MS, Omar AF, Ibrahim W. Safety of Trypan Blue Capsule Staining to Corneal Endothelium in Patients with Diabetic Retinopathy. J Ophthalmol. 2019 Mar 27;2019:4018739. doi: 10.1155/2019/4018739. eCollection 2019.
Clinical trial NCT03701152: Comparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers
Official title: Comparison Between Two Different Protocols of Negative Pressure Therapy for Healing of Chronic Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Ulcers
Negative Pressure Therapy
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 30
Sex: ALL
Minimum age (years): 27
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Negative Pressure Wound Therapy (NPWT), is a non invasive wound management tool which develops from negative pressure being applied to the wound. This promotes healing through the removal of infectious materials and enhancing granulation tissue formation. NPWT eases debridement as well as promoting healing of different types of wounds.

Detailed description: Assessment of wound surface area was done by a graded plastic sheet and a metric graph paper, by counting the complete squares of the metric graph paper, while the wound size was done by using a 10 cm syringe filled with dermazin cream and filling the wound with it.

Negative pressure device: VAC system 125mmhg (KCI negative pressure equipment).

Wound surface area tracing tools:

* Sterilized transparent film.
* Fine tipped transparent marker.
* Carbon and a white A4 papers.
* Metric graph paper (1mm²).

Wound volume assessment procedure:

* Using a syringe of ten cubic centimeters filled with dermazin cream.
* The wound is filled with the cream
* The amount of cream injected into the wound was detected in cubic centimeters.

Eligibility criteria: Inclusion Criteria:

* They were free from immune deficiency diseases or collagen diseases.
* All patients were homeostasis.
* All patients were medically stable.
* All cases were chronic and did not heal with other treatment methods

Exclusion Criteria:

* 1. Malignancies or receiving radiotherapy. 2. Dermatological diseases. 3. Deep venous thrombosis. 4. Renal failure. 5. Immunosuppressant or anticonvulsants therapies.

Primary outcomes:
measure: Wound surface area
timeFrame: 8 weeks
measure: Wound size
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha University
Study officials:
References:
citation: Mohammed AH, Hamed SA, Abdelghany AI. Comparison between two different protocols of negative pressure therapy for healing of chronic ulcers. J Tissue Viability. 2020 Feb;29(1):37-41. doi: 10.1016/j.jtv.2019.10.003. Epub 2019 Oct 25.
Clinical trial NCT03506152: Evaluation of Serum Procalcitonin in Critically Ill Patients With Suspected Sepsis
Official title: Prospective Evaluation of Serum Procalcitonin in Critically Ill Patients With Suspected Sepsis- Experience From a Tertiary Care Hospital in Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with suspected sepsis were recruited

Brief summary: Procalcitonin is a promising marker of sepsis in critically ill patients. Procalcitonin have better diagnostic accuracy compared to White blood cell count and C - reactive protein. Investigators propose that adding Procalcitonin to the list of standard laboratory work up of critically ill patients with suspected sepsis could increase diagnostic accuracy leading to better patient care.

Detailed description: Background: Sepsis is the leading cause of mortality in critically ill patients. Procalcitonin (PCT) is a promising marker for identification of bacterial sepsis. The aim of this study was to determine the diagnostic accuracy of serum PCT concentration in patients with suspected sepsis admitted to mixed medical-surgical Intensive care unit (ICU).

Material and Methods: A cross-sectional study conducted at section of Chemical Pathology, Department of Pathology and Laboratory Medicine and ICU. Patients with suspected sepsis were included, serum PCT cut off ≥0.5 ng /ml was taken for diagnosing sepsis. Diagnostic accuracy was measured in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) taking blood culture as gold standard. Furthermore, different cut offs were compared by using receiver operating characteristic curves (ROC). Data analysis was done on SPSS version.

Eligibility criteria: Inclusion Criteria:

1. Both male and female patients less than 70 and greater than 18 years of age
2. Patients full filling the sepsis definition (American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference)
3. Patients were recruited within 24 hour of ICU admission

Exclusion Criteria:

1. Patients discharged before 24 hours
2. Patients who had blood transfusion before ICU stay
3. Patients with organ failure

Primary outcomes:
measure: Diagnostic accuracy of Procalcitonin
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sibtain Ahmed
state: Sindh
Study officials:
References:
Clinical trial NCT03078452: Evaluating Effectiveness of Powered Drill Bone Marrow Biopsy
Official title: Comparison of Quality of Bone Marrow Biopsy and Patient Convenience and Pain Control by a Battery Powered Drill Versus Conventional Methods in Patients With Plasma Cell Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plasma Cell Myeloma
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2017-03-13
Enrollment: 97
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Since the introduction of the Jamshidi needle in 1971, new advances in bone marrow sampling have not been seen. In 2007, a new battery-powered bone marrow biopsy system was developed. This technology, using a battery-powered drill to operate the needle accessing the posterior iliac bone, was approved by the Food and Drug Administration (FDA) and is currently commercially available.

Few randomized controlled trials (RCTs) have compared the use of the battery-powered bone marrow biopsy system to the Jamshidi needle (the traditional manual) method of bone marrow sampling. This research study is designed to evaluate the effectiveness of the Jamshidi needle compared to the battery-powered bone marrow biopsy system.

100 participants will be enrolled in this study at Emory University.

Detailed description: PRIMARY OBJECTIVE:

I. Assessing the quality and quantity of bone marrow core biopsies.

SECONDARY OBJECTIVES:

I. Assessing the nature of pain by established visual analogue scale (VAS) questionnaires.

II. Timing of the actual procedure.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo bone marrow biopsy using the power drill.

ARM II: Patients undergo bone marrow biopsy using the traditional Jamshidi needle.

All patients complete questionnaires at baseline, 30 minutes after biopsy, and on days 1, 3, and 7.

After completion of study treatment, patients are followed up periodically.

Eligibility criteria: Inclusion Criteria:

* All patients with existing plasma cell disorders and no history of psychiatric disorders who can receive conscious sedation are eligible to participate in the trial

Exclusion Criteria:

* Pregnant women are excluded from participating in this study

Primary outcomes:
measure: Bone marrow core biopsy length (in mm) and artifacts assessed by the pathologist
timeFrame: At the time of biopsy
Secondary outcomes:
measure: Intensity of pain measured using visual analogue scale (VAS) pain questionnaire
timeFrame: At the time of, 30 minutes, 1, 3, and 7 days after biopsy
measure: Time taken by the procedure measured in seconds using a stopwatch
timeFrame: At the time of biopsy
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University/Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University/Winship Cancer Institute
name: Ajay Nooka, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06908252: MAPS PrEP Van Study
Official title: Integrating PrEP Into Mobile Addiction Treatment and Primary Care Services
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: HIV Infection
Keywords: People who inject drugs
Mobile Medical Unit
PrEP
Syringe Service Program
HIV prevention
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2025-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: For this study the investigators aim to see if giving participants an oral HIV prevention medication on a medical van, is a good option of care for individuals who inject drugs and/or are sexually active and therefore at a higher risk of contracting HIV.

Detailed description: The purpose of this study is to evaluate a pilot program that provides Pre-Exposure Prophylaxis (PrEP) for people who use drugs (PWUD) and are at risk for contracting HIV. Given the ongoing overdose crisis and the risk of HIV among PWUD, this study aims to assess weather offering oral PrEP on a Medical Mobile Unit (MMU) is a viable strategy for preventing HIV transmission in high-risk populations. The other goal of this study is to assess community perceptions of PrEP and perceived HIV risk among Syringe Service Program (SSP) clients visiting a MMU.

Eligibility criteria: Inclusion Criteria:

* 18 years or older, active drug injection user and/or sexually active, referred from the Syringe Service Program

Exclusion Criteria:

* positive HIV status

Primary outcomes:
measure: Enrollment
timeFrame: Baseline
measure: Negative HIV Status
timeFrame: up to 3 months
measure: PrEP Consultation
timeFrame: up to 6 months
measure: PrEP Initiation
timeFrame: up to 6 months
measure: Retention
timeFrame: up to 6 months
measure: Follow Through
timeFrame: up to 6 months
measure: Negative HIV Status at 6 months
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Department of Population Health Sciences
state: North Carolina
Study officials:
affiliation: Duke Health
name: Mehri McKellar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Health
name: Jacqueline Hodges, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02458352: Ultra Low Dose CT for CACS and AC of SPECT
Official title: Usefulness of Ultra Low Dose Cardiac CT for Coronary Calcium Scoring and for Attenuation Correction of SPECT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2015-06-01
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to compare the CACS obtained from standard dose CT to the CACS obtained from ultra-low-dose scans. Additionally, the usefulness of ultra-low-dose CT for AC of myocardial perfusion SPECT will be assessed.


Eligibility criteria: Inclusion Criteria:

* Patients referred for myocardial perfusion SPECT
* Male and Female subjects ≥18 years of age,
* Written informed consent

Exclusion Criteria:

* Pregnancy or breast-feeding
* CACS of 0 after inclusion of 10 patients with CACS 0
* Stents or implanted cardiac devices (valves, pace makers, ICD)
* Coronary artery bypass grafts

Primary outcomes:
measure: Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT
timeFrame: 1 days
measure: Intra-class Correlation Coefficient Between Segmental Relative Tracer Uptake From SPECT Datasets Reconstructed With AC Maps Based on Ultra-Low-Dose and Standard Dose CT
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Nuclear Medicine, University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Valerie Treyer, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05229952: Assessment of Endogenous Oxalate Synthesis
Official title: Assessment of Endogenous Oxalate Synthesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Kidney Stone
Obesity
Keywords: Oxalate
Kidney stones
Urolithiasis
Nephrolithiasis
Urologic disease
Oxalate metabolism
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to determine the daily rate of endogenous synthesis of oxalate using carbon 13 oxalate isotope tracer technique and a low-oxalate controlled diet.

Detailed description: Urinary oxalate excretion is derived from both dietary sources and endogenous synthesis. This study will use low-oxalate controlled diet and intravenous infusion of the isotope tracer carbon 13 oxalate, timed with blood and urine collections, to determine the daily rate of endogenous oxalate synthesis in non-stone forming volunteers and in subjects with calcium oxalate kidney stones. A DXA scan will be used to assess body composition.

Eligibility criteria: Inclusion Criteria:

* Mentally competent adults, able to read and comprehend the consent form
* Body Mass Index (BMI) between 18.5 and 50 kg/m2
* Acceptable 24 hour urine collections (judged on screening)
* good health as judged from a medical history, reported medications, and a complete blood metabolic profile
* with or without history of calcium oxalate kidney stones

Exclusion Criteria:

* History of any hepatic, bowel, or endocrine disease or other condition that may influence the absorption, transport or urine excretion of ions
* Abnormal urine chemistries or blood metabolic profiles
* Poor 24 hour urine collections completed during screening, judged by 24 hour urine creatinine excretion (indicative of not collecting all urine in the 24 hour period)
* Pregnancy, intention to become pregnant in the near future, or lactation
* Aged lower than 18 or greater than 75 years
* BMI lower than18.5 or greater than 50 kg/m2

Primary outcomes:
measure: Endogenous Oxalate Synthesis Rate
timeFrame: day 5
Secondary outcomes:
measure: Urinary Oxalate Excretion
timeFrame: day 3-4
measure: Urinary Creatinine Excretion
timeFrame: day 3-4
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Sonia Fargue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fargue S, Wood KD, Crivelli JJ, Assimos DG, Oster RA, Knight J. Endogenous Oxalate Synthesis and Urinary Oxalate Excretion. J Am Soc Nephrol. 2023 Sep 1;34(9):1505-1507. doi: 10.1681/ASN.0000000000000176. Epub 2023 Jun 14. No abstract available.