louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01789593: A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
Official title: A Trial Investigating the Effect of Acute Hypoglycaemia on Cognitive Function and Brain Activation Patterns in Subjects With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-02-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This trial is conducted in Europe. The aim of the trial is to compare cognitive function and associated brain activation patterns during an acute hypoglycaemic episode and during euglycaemia (normal blood glucose concentration). Additionally, the purpose is to assess cognitive function in the recovery phase after hypoglycaemia or euglycaemia, respectively, in subjects with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Right-handed subjects
* Type 1 diabetes mellitus for at least 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for at least 12 months
* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Current tobacco user (any smoking or use of nicotinic products within 3 months prior to screening)
* Visual impairment or auditory impairment

Primary outcomes:
measure: Digit Symbol Substitution Test (DSST) score
timeFrame: Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
Secondary outcomes:
measure: Regional cerebral blood flow (rCBF) score
timeFrame: Average score during hypoglycaemia and/or euglycaemia measured 70-93 minutes after induction of hypoglycaemia and/or euglycaemia
measure: Paced Auditory Serial Addition Task (PASAT) score
timeFrame: During recovery from hypoglycaemia and/or euglycaemia measured 75-90 min after euglycaemia has been restored
Other outcomes:
Locations:
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Gejl M, Gjedde A, Brock B, Moller A, van Duinkerken E, Haahr HL, Hansen CT, Chu PL, Stender-Petersen KL, Rungby J. Effects of hypoglycaemia on working memory and regional cerebral blood flow in type 1 diabetes: a randomised, crossover trial. Diabetologia. 2018 Mar;61(3):551-561. doi: 10.1007/s00125-017-4502-1. Epub 2017 Nov 29.
Clinical trial NCT04672993: Exploratory Study of a New Urine Collection Device for Men
Official title: Exploratory Study of a New Urine Collection Device for Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the investigation is to evaluate the subjects experience of a new collection device for men.

An open-labelled, single arm study design was chosen for this investigation with a duration of 1 week + up to 3 days extra.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Male
3. Be at least 18 years of age and have full le-gal capacity
4. Suffering from urinary incontinence equiva-lent to using up to 6 pads or 2 diapers per day
5. Have had current incontinence issues for at least 3 months
6. Able to understand patient information and able to change the product himself
7. Up to 6 of the subjects can be users who are using an intermittent catheter due to re-tention, but who are also dribble inconti-nent in-between catheterizations, and hence need a product to handle the inconti-nence.
8. Able to fit the test product.

Exclusion Criteria:

1. If experiencing incontinence less than once per week
2. Bedridden, using wheelchair or using a walking aids regularly

Primary outcomes:
measure: Percentage of Participants That Found the Product to be Comfortable to Wear
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Flying Nurses
Study officials:
name: Susan Rasmussen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03903393: Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia
Official title: Serum LncRNAs as Early Potential Biomarkers for the Prediction of Preeclampsia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preeclampsia
Lead sponsor: First Affiliated Hospital of Harbin Medical University
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 260
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preeclamptic women Controls

Brief summary: To identify lncRNAs differentially expressed at early stages of gestation in the serum of pregnant women, who later developed severe preeclampsia (sPE) in the third trimester of pregnancy compared to women with normal pregnancy .

Detailed description: Preeclampsia (PE) is a pregnancy syndrome characterized by hypertension and proteinuria, and a leading cause of maternal and fetal morbidity and mortality, with poorly defined pathophysiological mechanisms remain. Circulating lncRNAs are long, noncoding RNA molecules, which negatively regulate gene expression, and considered as promising biomarkers for PE. The objective of the study is to evaluate circulating lncRNA signatures in women with PE compared to healthy women, and in women sub-grouped per PE severity. This study assessed lncRNA expression profile in the serum at early stages of gestation of women who later developed severe preeclampsia (sPE) in the third trimester of pregnancy compared to women with uncomplicated pregnancies. Circulating lncRNA was extracted from maternal serum. This study also assess lncRNA expression profile in the placenta tissues of PE patients and healthy pregnant women.

Eligibility criteria: Inclusion Criteria:

* new onset hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg on two occasions at least 4 h apart) after 20 weeks of gestation in women who previously had normal blood pressure.
* proteinuria (the excretion of 300 mg or more of protein in a 24-hour urine collection)or other signs/symptoms of preeclampsia after 20 weeks of gestation in women who previously had normal blood pressure.

Exclusion Criteria:

* maternal infections
* smoking
* chemical dependency
* known major foetal or chromosomal anomalies
* intrahepatic cholestasis during pregnancy
* assisted reproductive technology (ART) treatments
* chronic hypertension.

Primary outcomes:
measure: The RNA expression levels of lncRNAs
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: Serum LncRNAs as Potential Biomarkers for the Prediction of Preeclampsia
state: Heilongjiang
Study officials:
affiliation: First Affiliated Hospital of Harbin Medical University
name: Yue Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00679393: Comparative Study of Fixation or Fusion of Calcaneal Fractures
Official title: A Prospective Randomized Multicentre Clinical Trial Comparing Open Reduction Internal Fixation With Primary Subtalar Fusion in Patients With Severely Comminuted (Sanders IV), Displaced, Intra-articular Fractures of the Calcaneus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures, Comminuted
Fracture Fixation, Internal
Keywords: Calcaneus
Intra-articular fracture
open reduction internal fixation
primary subtalar fusion
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
name: AO North America
First posted: 2008-05-16
Enrollment: 26
Sex: ALL
Minimum age (years): 16
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres across Canada. It will compare patients who receive open reduction, internal fixation for Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same type of fracture. Patients will be followed up for a period of two years from the time of operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months.


Eligibility criteria: Inclusion Criteria:

* patients with Sanders IV displaced intra-articular calcaneal fracture
* males and females aged 16-59 inclusive
* ability to provide informed consent
* available for follow-up for at least 2 years after injury

Exclusion Criteria:

* medical contraindications to surgery
* previous calcaneal pathology (infection, tumor, etc)
* co-existent foot or ipsilateral lower limb injury
* open calcaneal fracture
* injury greater than 3 weeks old
* head injured patients
* inability to obtain pre-operative CT scan or accurately classify the fractures according to the Sanders classification system
* inability to comply with advice to diminish smoking after the injury
* metal allergy
* extremely comminuted intra-articular fractures of the calcaneus deemed impossible to reconstruct by the treating surgeon
* any concerns either by the treating surgeon or patient about harvesting autograft needed for fusion

Primary outcomes:
measure: General Health Survey - SF-36
timeFrame: 6 months, 12 months, and 24 months
Secondary outcomes:
measure: Validated Visual Analogue Scale
timeFrame: 6 months, 12 months, and 24 months
measure: Musculoskeletal Function Assessment
timeFrame: 6 months, 12 months, and 24 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Halifax
country: Canada
facility: Halifax Infirmary, QEII Health Sciences Center
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Calgary
name: Richard E Buckley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00299793: Observational Study of Lamotrigine
Official title: Observational Study of Lamotrigine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Quality of life
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to assess efficacy, safety and tolerability of lamotrigine as used in a natural clinical setting, to examine the positive effects of lamotrigine, and the reasons why some patients choose to continue or discontinue lamotrigine.

Detailed description: There have been numerous randomized, double-blind controlled trials demonstrating the value of lamotrigine in the treatment of seizures. However, randomized trials take place in artificial experimental conditions with many restrictions imposed. There hasn't been much focus on positive effects on the patient, such as improvement in mood and level of alertness related to the drug. Other factors related to quality of life that affect the decision to continue or discontinue the drug are also important. Anecdotal experience suggests that lamotrigine is associated with increased alertness, enhanced energy levels and improved general sense of well-being. Observational studies that promote awareness of such distinguishing features and other aspects of efficacy are essential for guiding decision-making when prescribing anti-epileptic drugs.

Eligibility criteria: Inclusion Criteria:

* Patients who are about to be prescribed lamotrigine as an appropriate treatment for their epileptic disorder

Exclusion Criteria:

* Patients with mental retardation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: Northwell Health
name: Alan Ettinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06773793: The Diagnostic Value of Shear Wave Elastography and Viscosity Imaging Techniques in Diabetic Peripheral Neuropathy
Official title: The Diagnostic Value of Shear Wave Elastography and Viscosity Imaging Techniques in Diabetic Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diabetic Peripheral Neuropathy (DPN)
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinically diagnosed type 2 diabetes patients, aged 18 to 75 years, without neuropathy caused by other diseases or factors

Brief summary: The main objective of this observational study is to evaluate the diagnostic value of multimodal ultrasound for diabetic peripheral neuropathy (DPN). The questions it aims to address are: (1) To compare the differences in various parameters between the DPN group, non-DPN group, and healthy control group; (2) To explore the diagnostic efficacy of each parameter for DPN and establish a combined model.


Eligibility criteria: Inclusion Criteria:Individuals aged 18 to 75 years without diabetes -

Exclusion Criteria:Individuals without peripheral neuropathy.

-

Primary outcomes:
measure: Shear Wave Velocity
timeFrame: from 2024-4 to 2029-4
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
state: Jiangsu
Study officials:
References:
Clinical trial NCT06179693: AIMN Multicenter Study: Staging of Lymphomas Using PET/CT
Official title: AIMN Multicenter Study: Staging of Lymphomas Using PET/CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with malignant lymphoma subjected to diagnostic examination by PET/CT with contrast medium in a single session, instead of on two different dates, as occurs in normal clinical practice.

Brief summary: In recent years, the introduction of PET/CT tomographs (which have now almost completely replaced tomographs equipped with PET alone), has allowed a significant increase in diagnostic accuracy in the majority of tumors. However, in order to reduce the radiation doses, administering CT images are acquired for patients at a low dose (generally 60mA 120kV) without the use of contrast agents. This prudential attitude, however, makes it essential to carry out "diagnostic" CT investigations which, at the end of the diagnostic process It leads to an increase in the dose administered for the patient rather than to savings.

This study aims to evaluate the possible advantages in diagnostic, economic and quality of life terms of PET/CT performed with diagnostic CT with intravenous contrast medium, with the aim of benefiting the neoplastic patient in the diagnostic process by optimizing (from a temporal and dosimetric point of view ) the diagnostic procedures to which it is subjected.

It is expected that the integrated PET/CT procedure can facilitate the process of staging the neoplasm and that this procedure can have a positive impact on the patient's quality of life while also reducing the costs incurred in terms of time and money.


Eligibility criteria: Inclusion Criteria:

* Established lymphoma (non-Hodgkin's lymphoma and Hodgkin's disease) being staged;
* Performing the PET/CT examination within two weeks of diagnosis and before treatment;
* Signing of the Informed Consent.

Exclusion Criteria:

* patients \<18 years;
* Patients who have not signed the Informed Consent;
* Execution of previous anti-inflammatory or anti-inflammatory therapies in the 4 weeks preceding the PET exam.

Primary outcomes:
measure: PET/CT with contrast medium in a single session to diagnosis of patients with malignant limphoma.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs San Raffaele
Study officials:
References:
Clinical trial NCT05338593: Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.
Official title: Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extracorporeal Membrane Oxygenation Complication
Outcome, Fatal
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically affected patients treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Based on severe acute respiratory distress syndrome (ARDS) and prolonged therapy for more than 2 weeks.

Brief summary: In the context of the coronavirus (COVID-19) pandemic, healthcare systems worldwide faced an unprecedented shortage of severe ARDS. Critically affected patients were treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO) for complete respiratory failure early in the pandemic. Due to a shortage of resources in the sense of terminal equipment and adequately trained personnel with appropriate expertise in many countries and regions, a strict selection of suitable patients was made. Repeatedly, it was observed that patients under VV-ECMO also needed several weeks to recover sufficiently to generate device sufficient gas exchange. Due to the scarcity of VV-ECMO resources outside of the pandemic, the question arose whether a prolonged therapy still holds a sufficient prospect of success and what the course of treatment of such patients would be like.


Eligibility criteria: Inclusion Criteria:

veno-venous extracorporeal membrane oxygenation

Exclusion Criteria:

veno-arterial extracorporeal membrane oxygenation

Primary outcomes:
measure: Mortality
timeFrame: During intensive care treatment (Usually within 25 weeks)
Secondary outcomes:
measure: Major bleeding
timeFrame: During intensive care treatment (Usually within 25 weeks)
measure: critical device error
timeFrame: During intensive care treatment (Usually within 25 weeks)
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
state: Hessen
Study officials:
affiliation: JWGoethe University
name: Armin N Flinspach, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03570593: Removal of Urinary Catheter After Radical Surgery
Official title: Evaluation of Early Removal of Urinary Catheter After Radical Surgery for Cervical Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Radical Hysterectomy
Bladder Dysfunction
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 95
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Currently, the treatment of cervical cancer in early stages is performed with a radical surgery called Radical Hysterectomy with Pelvic Lymphadenectomy. This surgery, when indicated correctly, in early stages of this disease, has a cure rate of approximately 90% at 5 years, compared to the same Pelvic Radiotherapy. However, it is known that most patients with early stage cervical cancer are young (average age 45) and treating these patients with radiotherapy would have a loss of hormonal function by damage to the ovaries and damage in sexual function by radiotherapy effects in the vagina. Furthermore, if the patient has a pelvic recurrence, the option of radiotherapy treatment could not be offered. Due to the factors listed above, nowadays, in young patients with good clinical conditions and tumors in early stages, radical surgery is a good option. In this radical surgery there is a need for removal of the parametrium, and different degrees of pelvic denervation may occur causing damage of urinary function.Currently, there is no consensus about the correct moment of catheter removal and evaluation of urinary function using the residual urine test. While in some services the urinary catheter is removed on day 1 postoperatively, in others it is removed on the 14th day postoperatively. For these reasons, this study aims to compare the early catheter removal (day 1 postoperatively) versus standard in the investigator's service (7 days postoperatively) withdrawal. If this study detect that the patients may remove the urinary catheter on day 1 postoperatively, much less cost, discomfort, pain and comorbidities associated with the use of indwelling catheter for prolonged periods occur, such as urinary tract infection, use of antibiotics and even hospitalization for this reason.


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria for this study are women with invasive cervical neoplasia treated with hysterectomy or radical trachelectomy

Exclusion Criteria:

* Patients treated at another cancer service.

Primary outcomes:
measure: Urinary retention
timeFrame: up to 7 days after the surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: