louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05593068: Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic (ERDFP)
Official title: Retrospective Study of Iron Deposits in the Pancreas by MRI Method of Dialysis Patients With Hemosiderosis Iatrogenic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Iron Deposition
Dialysis
Iatrogenic Hemosiderosis
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: European Clinical Trial Experts Network
First posted: 2022-10-25
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient on hemodialysis or peritoneal dialysis at Claude Galien Private Hospital. They had to perform an MRI for iron quantification

Brief summary: Recently, a multidisciplinary scientific conference proposed to consider iron overload in dialysis patients as pathological only in the event of demonstration of radiological (in MRI), pancreatic or cardiac ferric deposits.

In this context, the aim of the proposed scientific study is to demonstrate the presence of ferric deposits in the pancreas by T2\* MRI in dialysis patients with radiological hepatic iron overload, particularly in cases of moderate and severe iron overload.


Eligibility criteria: Inclusion Criteria:

* Male, female, over 18 years old
* Patient on hemodialysis or peritoneal dialysis at the Claude Galien Private Hospital
* Patient on dialysis who has undergone one (or more) abdominal MRI for iron quantification
* Patient who has signed a non-objection form for the retrospective use of their MRI, medical and biological data for the purpose of scientific study

Exclusion Criteria:

* Patient who has signed a form to object to the use of their health data
* Pregnant woman
* Poor adherence to the dialytic technique
* Severe cognitive impairment
* Hepatic cirrhosis
* Frank inflammatory syndrome or an active infectious disease
* Genetic hemochromatosis and transfusion hemosiderosis of hemoglobinopathies and hematological diseases
* Recent major bleeding (\< 3 months)
* Recent major surgery (\< 3 months)
* Transfusion dependence
* Progressive malignant disease
* Pacemakers incompatible with an MRI and metal heart valves

Primary outcomes:
measure: Presence of pancreatic iron deposit
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
References:
Clinical trial NCT00919568: Monitoring Arrhythmia Patients (IMPACT)
Official title: Arrhythmia Detection With Adherent Patient Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias
Lead sponsor: Corventis, Inc.
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Remote cardiac monitoring

Brief summary: Prospective, multicenter, non-randomized study to determine the performance of NUVANT Mobile Cardiac Telemetry system in arrhythmia detection.

Detailed description: Arrhythmia patients will be externally monitored. The collected information will be used to evaluate the NUVANT MCT system.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patients undergoing remote ambulatory electrocardiographic monitoring

Exclusion Criteria:

* Is participating in another clinical study that may confound the results of this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Steubenville
country: United States
facility: Dr. Bedi
state: Ohio
Study officials:
affiliation: Corventis, Inc.
name: Imad Libbus, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01075568: The Satiety Effect After Okara Compared to Porridge Eating
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy People
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Nutrigal LTD
First posted: 2010-02-25
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To examine the satiety effect after eating of Okara.

Detailed description: This will be a single blind, cross-over design. Study population will include 10 subjects. The patients will be randomly assigned to receive one of two meals, 48 gram Okara or 40 gram (similar caloric value) semolina in two occasions (two visits). After the eating, the subject will stay in a closed room, without watch or any irritation. After three hours, the patient will fill a VAS questionnaire, and will get a standard meal. The meal will be weighed before and after.

Okara is a natural water extracted food grade soy product, contains approximately 35% protein (mfb), and about 43% of dietary fibers.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* Age 20-65 years old
* Written Informed Consent

Exclusion Criteria:

* History of gastro-intestinal surgery
* On medication that may influence gastric emptying, or medication for weight loss
* Patient on PPI treatment, H2 Blockers or medication for weight loss
* Known allergies to soy
* Pregnancy or breast-feeding
* Smoking
* Athletes
* Metabolic syndrome or diabetes mellitus
* Family history of metabolic syndrome or diabetes mellitus
* Weight loss \> 2 kg during two months before the study

Primary outcomes:
measure: To examine the satiety effect after 48 gram Okara compared to 40 gram of porridge eating.
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
References:
Clinical trial NCT06475768: The Influence of Menopausal Status on Myocardial Stiffness and Exercise Capacity Among Female Masters Endurance Athletes.
Official title: The Influence of Menopausal Status on Myocardial Stiffness and Exercise Capacity Among Female Masters Endurance Athletes.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Stiffness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Masters athletes (40-70 yrs of age) with a longstanding history of competitive endurance athletic performance defined as \>15 years of continuous athletic training for at least 7 hours per week, and ongoing engagement in competitive events, will be recruited from Mayo registry and from the local athletic community via brochures within the Dan Abraham Healthy Living Center and the Mayo Clinic Classifieds.

Brief summary: The purpose of this research is to study postmenopausal female masters athletes to see if they will show greater myocardial stiffness and reduced exercise capacity than premenopausal females and similarly aged male masters athletes.


Eligibility criteria: Inclusion Criteria:

* Longstanding history of competitive endurance athletic performance defined as \>15 years of continuous athletic training for at least 7 hours per week and ongoing engagement in competitive events.

Exclusion Criteria:

* A current or prior diagnosis of cardiovascular disease as defined by the presence of structural heart disease, heart failure, symptomatic coronary artery disease, more than moderate valve disease or prior valve surgery,
* Current or recent pregnancy within 1 year
* Positive pregnancy test (study visit 1)
* Concurrent or use within 1 year of oral contraceptives or hormone replacement therapy,
* Unable to undergo a cMRI (Please refer standard clinical contraindications for MRI)

Primary outcomes:
measure: Myocardial stiffness
timeFrame: Day 14
Secondary outcomes:
measure: Left ventricular filling pressures with exercise
timeFrame: Baseline
measure: Exercise capacity
timeFrame: Baseline
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kathryn Larson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00755768: More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time in Dialysis Patients
Official title: More Time Better Outcome - a Randomised Trial to Investigate the Effect of More Dietetic Time on Phosphate Levels in End Stage Renal Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: hemodialysis
phosphate
calcium phosphate product
dietician
dietetic advice
Lead sponsor: Royal Free Hampstead NHS Trust
Sponsor class: OTHER
First posted: 2008-09-19
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether spending more time with a dietitian will improve dietary compliance in a group of hemodialysis patients, with particular respect to phosphate control.

Detailed description: * randomised prospective controlled trial
* stable haemodialysis patients on thrice weekly haemodialysis (URR \> 66%)
* either had standard dietetic review - 6 monthly or intensive review - monthly
* all patients had to have a serum phosphate \> 1.8 mmol/l over the previous three months to be recruited
* study period 6 months, and then patients followed for a further 3 months

Eligibility criteria: Inclusion Criteria:

* stable chronic hemodialysis patients
* serum phosphate \> 1.8 mmol/l sustained over 3 months prior to trial entry adequate dialysis treatment as assessed by urea reduction

Exclusion Criteria:

* pregnancy
* unable to give consent
* phosphate \< 1.8 mmol/l
* inadequate dialysis
* aged \< 18 or \> 80
* poor nutritional state
* weight loss in proceeding three months

Primary outcomes:
measure: phosphate control
measure: calcium phosphate product
Secondary outcomes:
measure: parathyroid hormone
measure: number and type of phosphate binders prescribed
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: UCL Center for Nephrology
Study officials:
affiliation: UCL Center for nephrology
name: andrew davenport, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01355068: A Study to Assess if Epanutin Infatabs 50 mg From Germany Are Similar to Dilantin Infatabs 50 mg From Australia
Official title: An Open Label, Randomized, Single Dose, Crossover Pivotal Bioequivalence Study of Epanutin Infatabs 50 mg (Sourced From Germany) Verses Dilantin Infatabs 50 mg (Sourced From Australia) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: phenytoin
chewable tablets
dilantin
epanutin
infatabs
bioequivalence
Partial seizure
Tonic-clonic seizure
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-17
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the bioequivalence of Epanutin Infatabs® 50 mg (sourced from Germany) and Dilantin Infatabs® 50 mg (sourced from Australia) will be assessed. This is intended to be a pivotal bioequivalence study.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities.
* Any condition possibly affecting drug absorption (e.g. gastrectomy).

Primary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, and 72 hours (hrs) post-dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞])
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
measure: Extrapolated Area Under the Curve (AUC Percent [%] Extrap)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
measure: Plasma Decay Half Life (t1/2)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hrs post-dose
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00710268: Study to Assess Safety & Tolerability of AZD2281 in Combination With Bevacizumab in Patients With Advanced Solid Tumours
Official title: A Phase I, Open Label, Dual Centre Study To Assess The Safety And Tolerability Of AZD2281 In Combination With Bevacizumab (Avastin®) In Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm Metastasis
Keywords: Bevacizumab
Poly(ADP ribose) polymerases
Metastatic Solid Tumours
PARP inhibitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase I, open label, dual centre, dose finding study to evaluate the safety and tolerability of continuous twice daily oral dosing with AZD2281 when administered in combination with Bevacizumab 10mg/kg given every 2 weeks to patients with advanced solid tumours.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed metastatic cancer, not amenable to surgery or radiation therapy with curative intent
* Adequate bone marrow, kidney and liver function in accordance with laboratory parameters set out in the protocol
* Estimated life expectancy of at least 12 weeks

Exclusion Criteria:

* Disorders that may put the patient at risk of bleeding, including gastrointestinal perforation, intra-abdominal abcess, major surgery of the chest or abdomen, previous haemorrhage, coughing up blood or thrombotic event
* Hypertension (high blood pressure) or significant cardiovascular disease
* Hypersensitivity to Chinese hamster ovary cell products or other recombinant or humanised antibodies

Primary outcomes:
measure: safety and tolerability of twice daily oral doses of AZD2281 when administered in combination with Bevacizumab to patients with advanced solid tumours by assessment of adverse events, vital signs, ECG, clinical chem, haematology, urinalysis and phys exam
timeFrame: various timepoints.
Secondary outcomes:
measure: To compare exposure to AZD2281 when given alone and in combination with Bevacizumab, by assessment of appropriate derived PK parameters
timeFrame: various timepoints.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: KuDOS Pharmaceuticals Ltd
name: James Carmichael, BSc MBChB MD FRCP
role: STUDY_DIRECTOR
affiliation: Christie Hospital, Manchester, UK
name: Malcolm Ranson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04212572: Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome According to the Duration of the Disease
Official title: Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary sjögren's Syndrome
Keywords: Primary sjögren's syndrome
ultrasonography
salivary glands
auto-immune disease
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-12-27
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Primary sjögren syndrome

Brief summary: Salivary gland ultrasonography is identified as a valuable diagnostic tool and potential criteria item for disease classification of sjögren's syndrome and evaluate evolution of parenchyma.

The investigators have to include 242 patients. The objective is to evaluate the modification of ultrasonographic abnormalities according to disease in primary Sjögren syndrome.


Eligibility criteria: Inclusion Criteria:

* Male or female patient ≥ 18 years
* Primary sjögren syndrome according of age to 2002 or 2016 classification criteria

Exclusion Criteria:

* Secondary sjögren syndrome

Primary outcomes:
measure: Presence or absence of parenchymal abdnormalities.
timeFrame: inclusion
Secondary outcomes:
measure: Parenchymal abnormalities according to disease activity
timeFrame: inclusion
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
city: Lille
country: France
facility: CHU de LILLE
city: Montpellier
country: France
facility: CHU de MONTEPELLIER
Study officials:
References:
Clinical trial NCT04489472: The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.
Official title: The Effect of a Dietary Supplement Rich in Nitric Oxide in Patients Diagnosed With Primary Ciliary Dyskinesia.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Ciliary Dyskinesia
Keywords: Nitric oxide
Intranasal nitric oxide
Beet juice
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of a dietary supplement rich in nitric oxide (NO) on nasal nitric oxide and fractional exhaled nitric oxide (FeNO),on ciliary beat frequency assessed by high-speed digital video microscopy and on lung function assessed by spirometry in normal patients and patients with Primary ciliary dyskinesia (PCD).


Eligibility criteria: Inclusion Criteria:

Experimental group:

* PCD patients

Control Group:

* patients with no known chronic lung disease
* 18 years to 99 years

Exclusion Criteria(both PCD patients and control group):

* any other pulmonary co-morbidities and diseases entities like cystic fibrosis, nasal sinus surgery, nasal sinus hypoplasia/aplasia, deviated nasal septum, nasal polyps and with upper respiratory tract infection
* patients allergic to beet
* a known prolonged bleeding disorder.

Primary outcomes:
measure: Change in nasal NO as measured by a chemiluminescence analyzer
timeFrame: Baseline,after beet juice consumption(1 hour after consumption)
measure: Change in nasal NO as measured by a chemiluminescence analyzer
timeFrame: Baseline,after beet juice consumption( 2 hours after consumption)
measure: Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor
timeFrame: Baseline,after beet juice consumption(1 hour after consumption)
measure: Change in nasal FeNO as measured by using the NIOX MINO® Airway Inflammation Monitor
timeFrame: Baseline,after beet juice consumption(2 hours after consumption)
Secondary outcomes:
measure: Change in ciliary beat frequency as measured using high-speed video-microscopy (HSVM)
timeFrame: after beet juice consumption(2 hours after consumption)
measure: Change in lung function as measured by spirometry
timeFrame: Baseline,after beet juice consumption(2 hours after consumption)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Ricardo A Mosquera, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05470972: Relation Between Ethanol Sclerotherapy for Endometrioma Systemic Immune Milieu
Official title: Endometrioma Cystic Fluid Aspiration and Retained Ethanol Sclerotherapy Might Improve the Systemic Immune Milieu
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Endometriosis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 69
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Design: Prospective interventional study. 69 women with OE were evaluated clinically and by transvaginal ultrasonography (TUV). AEST procedure was performed and the collected aspirate and pre-procedural blood samples were collected for estimation of cytokines' levels. At 6-m post-procedure, clinical evaluation and TUV were repeated and serum cytokines' levels were re-estimated.


Eligibility criteria: Inclusion Criteria:

* Women with OE of a mean diameter of \>3 cm

Exclusion Criteria:

* Women with recurrent OE
* a cyst that was suspicious of being malignant
* diabetes mellitus
* polycystic ovary syndrome
* body mass index (BMI) of \>30 kg/m2
* previous surgical interference that resulted in pelvic adhesions

Primary outcomes:
measure: The effect of AEST procedures on patients' cytokines levels.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
state: El-Gharbyia
Study officials:
References: