louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00935142: Non-invasive Imaging With [18F]VM4-037
Official title: Non Invasive Imaging of [18F]VM4-037 With Positron-Emission-Tomography (PET): A Phase I Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Stage 4 Cancer
Keywords: stage IV cancer with no treatment options
non-curative
Lead sponsor: Maastricht Radiation Oncology
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
First posted: 2009-07-08
Enrollment: 0
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 purpose of this study is to determine the toxicity of the hypoxia PET-tracer \[18F\]-VM4-037 in cancer patients in two dose-steps:

* Step 1 (3-6 patients): a single dose of maximum 8 mCi (296 MBq) dose of \[18F\]VM4-037 via a bolus IV injection.
* Step 2 (3-6 patients): a single dose of maximum 12 mCi (444 MBq) dose of \[18F\]VM4-037 via a bolus IV injection


Eligibility criteria: Inclusion Criteria:

* Histological or cytological confirmed solid tumour, primary or secondary stage IV and/ or tumours with no curative treatment options
* WHO performance status 0 to 1
* Normal white blood cell count and formula
* Normal platelet count
* No anaemia requiring blood transfusion or erythropoietin
* Adequate hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for the institution; ALT, AST, and alkaline phosphatase ≤ 2.5 x ULN for the institution)
* Calculated Creatinin clearance at least 60 ml/min
* No administration of Fluor-18 in the previous 24 hours
* The patient is capable of complying with study procedures
* 18 years or older

Exclusion Criteria:

* Only visible tumor sites in the upper abdomen (because the uptake of VM4-037 in the liver, stomach and the kidneys would interfere with image quality of the tumor)
* Known hypersensitivity for sulfonamides
* Recent (\< 3 months) myocardial infarction
* Uncontrolled infectious disease
* Less than 18 years old
* Pregnancy
* No concurrent anti-cancer agents or radiotherapy allowed

Primary outcomes:
measure: Toxicity (CTCAE 3.0)
timeFrame: 1 week
Secondary outcomes:
measure: Image Quality
timeFrame: 1 week
measure: Correlation with circulating biomarkers of hypoxia
timeFrame: 1 week
measure: Correlation with [18F]-FDG on PET scans
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Maastro Clinic, The Netherlands
name: Philippe Lambin, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02385942: KT(KT Corporation)-SNUBH(Seoul National University Bundang Hospital) U-health Cooperative Research
Official title: KT-SNUBH U-health Cooperative Research: Target Selection and Consumers' Intention Research for Commercialization of the Pressure Ulcer Management u-Health Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: u-health
chronic wound management
pressure ulcer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: KT Corporation
First posted: 2015-03-11
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to analyse utility and compatibility of U-health solution service based on mobile for chronic wound management.

Detailed description: In this study, 'the management of pressure ulcer' defined as procedures comprising wound assessment, wound dressing and infection control, visually evaluated the outcomes of 'the management of pressure ulcer' through the tele-consultation.

This study designed to draw service targets based on utility and compatibility of U-health solution service and to analyse whether health providers use U-health solution service.

Eligibility criteria: Inclusion Criteria:

* Subject who has pressure ulcer or Health care provider for wound management

Exclusion Criteria:

* Subject who have Osteomyelitis
* Subject who have suppuration
* Subject who participated in other clinical trial within 30 days from screening date

Primary outcomes:
measure: concordance rate of wound size between live assessed wound size and transmitted wound size
timeFrame: a week from post treatment
Secondary outcomes:
measure: concordance rate of wound size between live assessed wound size and transmitted wound size
timeFrame: 2 weeks from post treatment
measure: concordance rate of wound size between live assessed wound size and transmitted wound size
timeFrame: 3 weeks from post treatment
measure: concordance rate of wound size between live assessed wound size and transmitted wound size
timeFrame: 4 weeks from post treatment
Other outcomes:
measure: Satisfaction degree of the tele-consultation as measured by questionnaire.
timeFrame: 4 weeks from post treatment
measure: Usability survey
timeFrame: 4 weeks from post treatment
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chanyeong Heo, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05694442: The Effect of Lipmatte K
Official title: The Effect of Lipmatte K on Lip Hydration and Brightening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aesthetic
Cosmetic
Healthy
Lead sponsor: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
Sponsor class: INDUSTRY
First posted: 2023-01-23
Enrollment: 34
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is conducted to evaluate the safety and the effectiveness of Lipmatte K on lip hydration and brightening. The study duration is 4 weeks and the lip assessment will be carried out at baseline, week 2 and week 4.The main questions this study aims to answer are:

1. The hydration effect of the product on lip.
2. The brightening effect of the product on lip.
3. To observe any adverse effect occurrence with the usage of the product.


Eligibility criteria: Inclusion Criteria:

* Malaysia citizen
* Female (age 30-55 years old)
* Lip with mild-to-moderate dryness

Exclusion Criteria:

* Subjects who have history of performing lips-related treatments such as lip augmentation (filler, botox, laser)
* Heavy lips desquamation or chapped lip conditions

Primary outcomes:
measure: Change in lip roughness from baseline and at week 2 and 4 after using Lipmatte K
timeFrame: Baseline, Week 2, Week 4
measure: Change in lip wrinkles from baseline and at week 2 and 4 after using Lipmatte K
timeFrame: Baseline, Week 2, Week 4
measure: Visual assessment of the lip from baseline and at week 2 and 4 after using Lipmatte K
timeFrame: Baseline, Week 2, Week 4
measure: Adverse effect after using Lipmatte K
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: Ungku Shahrin Medical Aesthetic Research & Innovation (USMARI) Centre
state: Selangor
Study officials:
References:
Clinical trial NCT05161442: Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic
Official title: Minimally Invasive Surgery in Crohn's Disease: Laparoscopic vs Robotic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Surgery
Keywords: crohn disease
minimally invasive surgery
ileocolic resection
outcomes
complication
enhanced recovery after surgery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 249
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retrospective cohort of patients with Crohn underwent ileocolic resection.

Brief summary: Retrospective observational cohort study including patients with Crohn's Disease undergoing minimally invasive ileocolic resection.

Detailed description: All consecutive patients with Crohn's disease (CD) who underwent minimally invasive ileocolic resection from 2014 at Mayo Clinic were retrospectively identified using a prospectively maintained institutional database.

Eligibility criteria: Inclusion Criteria:

* Crohn's disease
* Ileocolic resection

Exclusion Criteria:

- N/A

Primary outcomes:
measure: conversion
timeFrame: 30-day after surgery
measure: postoperative complications
timeFrame: 30-day after surgery
measure: postoperative complications grade
timeFrame: 30-day after surgery
measure: length of hospital stay
timeFrame: 30-day after surgery
measure: hospital readmission
timeFrame: 30-day after surgery
Secondary outcomes:
measure: Recurrence date
timeFrame: 5 years
measure: Recurrence grade
timeFrame: 5 years
measure: Recurrence clinical
timeFrame: 5 years
measure: Gastrointestinal Quality of Life Index
timeFrame: 7 years
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic, Rochester, MN
name: David W Larson, MD,MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00515242: Therapeutic Massage for Generalized Anxiety Disorder
Official title: Therapeutic Massage for Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Generalized Anxiety Disorder
Keywords: massage therapy
relaxation treatments
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2007-08-13
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the relative effectiveness of three relaxation treatments (therapeutic massage, thermotherapy, and time in a relaxing environment) in reducing anxiety in persons with Generalized Anxiety Disorder.

Detailed description: Anxiety and stress are costly problems that afflict millions of American adults. Together, they are among the most common reasons for which adults use complementary and alternative medical (CAM) therapies as well as more conventional relaxation therapies. Although massage is one of the most popular CAM treatments for anxiety, its effectiveness for this problem has never been rigorously evaluated. This study is designed to evaluate the effectiveness of massage as a treatment for a diagnosed anxiety disorder. Massage will be compared with two other relaxing treatments: thermotherapy and time in a relaxing environment, which reflect the types of activities that persons with anxiety might try to relieve their symptoms.

Eligibility criteria: Inclusion Criteria:

* Member of Group Health, Seattle metropolitan area
* Generalized Anxiety Disorder confirmed by SCID
* At least moderate anxiety

Exclusion Criteria:

* Serious mental health co-morbidity
* Any life threatening condition
* Currently receiving psychotherapy
* Substantial alcohol use
* Contraindications for massage

Primary outcomes:
measure: anxiety
timeFrame: 6 months
Secondary outcomes:
measure: worry, depression, disability
timeFrame: 6 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Group Health
name: Karen J. Sherman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06165042: Silver Diamine Fluoride in Molar-Incisor Hypomineralisation
Official title: Evaluation of Silver Diamine Fluoride Application in Molar-Incisor Hypomineralisation-Affected Molars
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Molar-Incisor Hypomineralisation
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 120
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the efficacy of silver diamine fluoride application in molars affected by molar-incisor hypomineralization. Additionally, the study aims to evaluate the effectiveness of the combined application of silver diamine fluoride, commonly used for dentin hypersensitivity, with a glass hybrid restorative system. The goal is to mitigate sensitivity and improve chewing functions in teeth affected by molar-incisor hypomineralization.

Detailed description: In a research study focusing on 120 children aged 8-13 with molar incisor hypomineralization (MIH), a comprehensive examination of 240 teeth will be conducted. Study will employ selective caries removal to eliminate decay and subsequently apply restorations. The two intervention groups are delineated as follows:

Group 1: Glass hybrid restorative system (Equia Forte, GC Europe, Leuven, Belgium)

Group 2 : Restoration involving fluoride varnish (SDI Riva Star) + glass hybrid restorative system (Equia Forte, GC Europe, Leuven, Belgium)

Eligibility criteria: Inclusion Criteria:

* Children aged between 8 and 13 who are cooperative, having at least 2 teeth with a BAKH-TII score of 4a or 4b.
* Complete occlusion of teeth with MIH.
* Presence of signs of pulpal pathology with symptoms in the teeth included in the study during the pre-treatment clinical examination (absence of spontaneous and prolonged pain, no percussion and palpation sensitivity, no swelling or fistula in soft tissue, presence of periapical radiolucency in radiographs, and absence of internal or external resorption).
* Additionally, no parafunctional habits (e.g., bruxism) and no malocclusion (posterior crossbite).
* Good general health condition, without systemic illnesses.
* Absence of silver allergy.

Exclusion Criteria:

* Non-cooperative individuals.
* Having MIH severity outside the specified scoring.
* Presence of systemic diseases.
* Lack of complete occlusion in the molars.
* Presence of parafunctional habits.
* Presence of pulpal pathology.
* Individuals with a silver allergy.

Primary outcomes:
measure: United States Public Health Service (USPHS): Retention, marginal compliance and gingival health criteria
timeFrame: 1.5 -2 year
measure: The Schiff Cold Air Sensitivity Score
timeFrame: 1.5-2 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01197742: Sweetheart-Register: Risk Management of Diabetics with Acute Myocardial Infarction
Official title: Sweetheart: Risiko-Management Von Diabetikern Mit Akutem Myokardinfarkt
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
STEMI
NSTEMI
Myocardial Infarction
Keywords: Diabetes
STEMI
NSTEMI
Myocardial infarction
Lead sponsor: Stiftung Institut fuer Herzinfarktforschung
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2010-09-09
Enrollment: 2772
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients with acute (no older than 24 h) ST-Elevation Myocardial infarction or acute (no older than 24 h) Non-ST-Elevation Myocardial infarction.

Brief summary: The Sweetheart register (Risk management of Diabetics with acute myocardial infarction) documents both the prevalence of pathologic glucose metabolism in consecutive high-risk patients with STEMI and NSTEMI in daily hospital routine as well as the anti-diabetic acute and long-term therapy. Furthermore the register will provide data about the implementation of new guidelines for the interventional and adjuvant medical therapy of STEMI and NSTEMI.


Eligibility criteria: Inclusion Criteria:

* consecutive patients with acute (no older than 24 h) ST-Elevation Myocardial infarction
* consecutive patients with acute (no older than 24 h) Non-ST-Elevation Myocardial infarction

Exclusion Criteria:

* missing informed consent

Primary outcomes:
measure: Documentation of the characteristics consecutive patients with acute STEMI or NSTEMI in daily hospital routine in Germany
timeFrame: 04/01/2007-09/30/2009
Secondary outcomes:
measure: Documentation of the fraction of patients with (I) a previous know Diabetes Mellitus (DM) type I and II, (II) a newly diagnosed DM, (III) diagnosed with IFG or IGT for the first time
timeFrame: 04/01/2007-09/30/2009
measure: Documentation of acute invasive and adjuvant medicamentous therapy of STEMI and NSREMI in hospital daily routine in Germany
timeFrame: 04/01/2007-09/30/2009
measure: Documentation of diabetic therapy during the acute phase of a myocardial infarction
timeFrame: 04/01/2007-09/30/2009
measure: Documentation of the hospital mortality, the serious but non-fatal complications (stroke, re-myocardial infarction) and other bleeding complications
timeFrame: 04/01/2007-09/30/2009
measure: Verification of the implementation of a therapy according to the guidelines for STEMI / NSTEMI in daily hospital routine
timeFrame: 04/01/2007-09/30/2009
Other outcomes:
Locations:
city: München
country: Germany
facility: Städ Krankenhaus münchen Schwabing
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd /Cardiology
Study officials:
affiliation: Stiftung Institut für Herzinfarktforschung
name: Anselm K Gitt, MD
role: STUDY_CHAIR
affiliation: Stiftung Institut für Herzinfarktforschung
name: Jochen Senges, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06729242: Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes
Official title: Influence of Menstrual Cycle Phases on the Glycemic Control of Aerobic or HIIT Exercise in Adult Women With Type 1 Diabetes (DIABETEXX/2)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type I
Menstruation
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
First posted: 2024-12-11
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Six interventions will be carried out in a single group, being three aerobic sessions, two in two luteal phases and another in follicular phase, and other three session of high intensity interval exercise (HIIT).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Continuous glucose monitors, as a technology that aims to improve glycaemic control in patients with type 1 diabetes, must always adjust to changes in blood glucose levels in these patients, e.g. during sporting activities. In women, in particular, menstruation and its different phases can affect blood glucose levels in different ways. Therefore, this study aims to determine whether there is a different behaviour of blood glucose levels during aerobic or high-intensity exercise in different phases of menstruation. If so, we will try to model this behaviour and create specific guidelines in this regard in terms of physical exercise programming in women. In addition, the information derived from this study will be used to design better artificial pancreas systems that take into account the effects of the menstrual cycle in women.


Eligibility criteria: Inclusion Criteria:

Age between 18-45 years T1D with a diabetes duration for more than 2 years Glycated hemoglobin (HbA1c) \< 8.5% (\<69 mmol mol-1) Stable insulin regimen in the past 6 months with less than 20% change in total insulin daily dose Multiple daily injections or insulin pump Weekly physical activity of 90 min or more, but no practicing any sport as amateur or professional.

Exclusion Criteria:

Clinical conditions or use of medications (other than insulin) known to affect glycemic control (e.g., oral/parenteral steroids or metformin, among others).

Primary outcomes:
measure: Mean interstitial glucose
timeFrame: 24 hours pre-intervention and 24 hours post-intervention
measure: Glycemic variability
timeFrame: 24 hours pre-intervention and 24 hours post-intervention
measure: Time spent at each glucose range
timeFrame: 24 hours pre-intervention and 24 hours post-intervention
Secondary outcomes:
measure: Oestrogens
timeFrame: pre-intervention
measure: Progesterone
timeFrame: Pre-intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01323842: Emergency Department Ultrasound in Renal Colic
Official title: Hydro II: Emergency Department Ultrasound in Renal Colic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Colic
Hydronephrosis
Abdominal Aortic Aneurysm
Keywords: renal colic
hydronephrosis
abdominal aortic aneurysm
ultrasound
emergency medicine
urolithiasis
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2011-03-28
Enrollment: 414
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ED patients with suspected renal colic being imaged while in the ED

Brief summary: Renal colic is a common (1300 visits per year at our institution) and painful condition caused by stones in the kidney and ureter, and can be mimicked by life threatening conditions such as a ruptured abdominal aortic aneurysm (AAA). This can create clinical uncertainty. Emergency department targeted ultrasound (EDTU) is performed by an emergency physician at the patient's bedside, and has been shown to be accurate, safe, and efficient. We have shown that EDTU can accurately identify hydronephrosis, which is a predictor of complications of kidney stones. A normal formal ultrasound (US) predicts an uncomplicated clinical course. We will assess the accuracy of EDTU for the diagnosis of hydronephrosis, and when normal, whether patients can be safely discharged.


Eligibility criteria: Inclusion Criteria:

* Age 16 - 65 years
* Symptoms suggestive of renal colic
* EDTU performed within one hour (before or after) of formal imaging
* Imaging study arranged during this ED visit (includes next morning)

Exclusion Criteria:

* Hemodynamic instability (Pulse \> 120 or SBP \< 90 or requiring vasopressors)
* Fever (\>38 degrees C)
* Leukocytes and nitrites on dipstick urinalysis (evidence of urinary tract infection)
* Pregnancy
* Inmate
* Renal transplant or single functioning kidney

Primary outcomes:
measure: complications post-ED visit in patients with and without negative EDTU.
timeFrame: 30 days
measure: diagnostic accuracy for hydronephrosis
timeFrame: 1 hours
Secondary outcomes:
measure: ED length of stay
timeFrame: 1 day
measure: radiation dose
timeFrame: 1 hour
measure: accuracy in ruling out AAA
timeFrame: 1 hour
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: Eric Bruder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sibley S, Roth N, Scott C, Rang L, White H, Sivilotti MLA, Bruder E. Point-of-care ultrasound for the detection of hydronephrosis in emergency department patients with suspected renal colic. Ultrasound J. 2020 Jun 8;12(1):31. doi: 10.1186/s13089-020-00178-3.