louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01860248: Vapocoolant Spray Effectiveness On Arterial Puncture Pain: Randomized Double Blind Placebo-Controlled Trial
Official title: Topical Alkane Vapocoolant Spray Effectiveness On Arterial Puncture Pain Reduction In Emergency Department: Randomized Double Blind Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Puncture Site Pain
Keywords: vapocoolant effectiveness
arterial puncture
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was aimed to compare pain levels from arterial blood gas (ABG) sampling performed with vapocoolant spray in comparison to placebo.

Detailed description: Previous studies of vapocoolant sprays for reducing pain were mainly on venopuncture with inconsistent results. There was only one prospective open labeled controlled study on arterial blood gas sampling with ethyl chloride which did not show effectiveness. This study will assess the efficacy and tolerability of a topical alkane vapocoolant spray for arterial puncture in adults in comparison to control spray.

Eligibility criteria: Inclusion Criteria:

* age of 14 years or older,
* needs ABG as a part of their diagnosis

Exclusion Criteria:

* history of analgesic medication used within 24 hours of enrollment,
* any sign of decreased consciousness,
* history of skin hypersensitivity,
* inability to report a pain score,
* history of a known neurological problem that changes pain perception,
* history of cold related reactions (e.g. Raynaud's phenomenon, cold urticaria),
* abnormal Allen's test

Primary outcomes:
measure: puncture pain
timeFrame: 30 seconds after ABG
Secondary outcomes:
measure: Vapocoolant application pain
timeFrame: 30 seconds affter procedure completion
measure: number of puncture attempts
timeFrame: 30 seconds after procedure
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini hospital complex
Study officials:
affiliation: Tehran University of Medical Sciences
name: Shervin Farahmand, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02310048: Comparative Oral Bioavailability Study of MT-1303
Official title: A Randomised, Open-Label, Single-Dose, Parallel Group Study to Assess the Comparative Oral Bioavailability of Two Capsule Formulations of MT-1303 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsing-remitting Multiple Sclerosis
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-05
Enrollment: 34
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the comparative oral bioavailability of a Formulation B versus the Formulation A of MT-1303.


Eligibility criteria: Inclusion Criteria:

* Caucasian males aged 18 to 55 years at Screening.
* Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory, and other tests at Screening and Day -1.
* A body weight of ≥60 kilograms (kg) and BMI ranging from 18 to 30 kg/m2 at Screening or Day -1.

Exclusion Criteria:

* Presence or history of severe adverse reaction or allergy to any medicinal product or relevant excipient that is of clinical significance.
* Participated in more than three clinical studies of a new chemical entity in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives of the IMP before the administration of the IMP in this clinical study.
* Clinically relevant abnormal medical history, physical findings, or laboratory values at Screening or Day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator.
* Previous medical history of tuberculosis or in the opinion of the Investigator a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections, or fungal infection.
* Subjects who have received any prescribed systemic or topical medication within 14 days prior to administration of the IMP(Day 1) unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety. Slow release medicinal formulations considered to still be active within 14 days prior to the first dose administration will also be excluded unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety.

Primary outcomes:
measure: Area under the concentration-time curve(AUC) .
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Peak drug concentration (Cmax) of MT-1303
timeFrame: up to 6 weeks
measure: Time to reach peak concentration (Tmax) of MT-1303
timeFrame: up to 6 weeks
measure: Half-life(t1/2.) of MT-1303
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Investigational site
Study officials:
affiliation: Covance CRU Ltd.
name: Jim Bush, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05758948: Detection of Germline and Somatic Pathogenic Variants in Patients With de Novo Metastatic Breast Cancer
Official title: Detection of Germline and Somatic Pathogenic Variants in Patients With de Novo Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Breast Cancer
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Hellenic Society of Medical Oncology
First posted: 2023-03-08
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients will be selected from community or academic or private hospitals

Brief summary: To determine somatic and germline pathogenic variants in patients with denovo metastatic breast cancer in order to map the molecular/genetic characteristics of DN- MBC aiming in comprehending the biology and highlighting potential novel treatment options for the disease.

Detailed description: The value of this study is based on the fact that DN-MBC is rare, seems to be different from early and relapsed breast cancer and has not been studied as distinct disease. To achieve the objective of this study blood and tissue sample from patients diagnosed with DN-MBC will be further analyzed using next generation sequencing (NGS), in order to map the molecular/genetic characteristics of DN-MBC and to detect germline and somatic pathogenic variants. All the results will be associated with the clinicopathological characteristics of the patients.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent for the provision of the biological material for research purposes
2. Diagnosis of de novo MBC (histologically confirmed)
3. Age \>18 years
4. Blood samples
5. Tumor tissue block from at least on disease site, primary (preferably) or metastatic

Exclusion Criteria:

Inadequate MBC tissue

Primary outcomes:
measure: Number of participants with somatic pathogenic variants in denovo metastatic breast cancer
timeFrame: up to 12 months
measure: Number of participants with germline pathogenic variants in denovo metastatic breast cancer
timeFrame: up to 12 months
Secondary outcomes:
measure: Definition of the somatic pathogenic variants measured with Next Generation Sequencing
timeFrame: up to 12 months
measure: Collection of clinicopathological characteristics of the included patients from patient's medical file
timeFrame: up to 12 months
measure: Definition of the germline pathogenic variants measured with Next Generation Sequencing
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Evangelia Moirogiorgou
Study officials:
affiliation: YGEIA Hospital
name: EVANGELIA MOIROGIORGOU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00893048: The Use of Oral Steroids in the Treatment of Cellulitis
Official title: Utility of Prednisone in the Treatment of Cellulitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cellulitis
Erysipelas
Keywords: prednisone
cellulitis
erysipelas
steroids
oral
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2009-05-05
Enrollment: 0
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 prevalence of cellulitis in society is very high, as much as 3% of visits to Emergency Departments are for the treatment of this disease. The treatment of cellulitis varies depending on the severity. Low severity cases are treated with pain control and antibiotics by mouth and high severity are treated with antibiotics intravenously and pain control. The investigator's hypothesis is to see if the addition of steroids, which are known to decrease inflammation, will decrease the length of the disease process. If so, it will decrease the length of stay if IV antibiotics are needed, it will decrease duration of days out of work and decrease the overall pain control required and therefore patient satisfaction.

Detailed description: The incidence of cellulitis is about 24.6 cases per 1000 person-years, which is an estimate, since cellulitis is not a reportable disease. In some Emergency Departments up to 3% of visits are for cellulitis. Depending on the severity of the disease, some are treated as outpatients, and others are admitted for IV antibiotics. In some Emergency Departments cases of cellulitis are treated in an observation area for 23 hours with doses of IV antibiotics. My proposed research is to see if the addition of one dose of prednisone the treatment will decrease the inflammatory reaction enough to decrease length of stay and treatment and increase patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* signs/symptoms of cellulitis

Exclusion Criteria:

* steroid use in last 2 weeks
* hx of adrenal insufficiency
* suspicion for dvt or abcess
* systemic signs of sepsis
* ICU admission

Primary outcomes:
measure: Time to cellulitis resolving
timeFrame: 48 hours after initiation of treatment
Secondary outcomes:
measure: Length of stay
timeFrame: after treatment completed
Other outcomes:
Locations:
Study officials:
affiliation: Penn State
name: Scott Goldstein, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05787548: Reducing Emergency Department Utilization With an After Visit Summary Nudge Toward Alternative Care Options
Official title: Reducing Emergency Department Utilization With an After Visit Summary Nudge Toward Alternative Care Options
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Health
Keywords: Emergency Department Use
Urgent Care Use
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 239841
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Decreasing utilization of the Emergency Department (ED) is a priority for the system. Often, ED visits can be avoided if patients contact Geisinger first to get appropriate direction for their concern or are otherwise better informed about reasons to visit the ED vs. urgent care or primary care facilities. The study team is working to reduce ED utilization by including additional information in adult outpatient After Visit Summaries (AVSs). The study will involve will involve A/B testing different AVS versions, including 1) a version that encourages patients to contact Geisinger via different contact methods, 2) a version that includes a map to the patient's closest ConvenientCare location and accompanying information about ConvenientCare, and 3) a version that includes a self-triage guide. A control group will receive the current standard AVS. Analysis results will be assessed to determine which version is most effective at reducing ED use.


Eligibility criteria: Inclusion Criteria:

* Age 18+
* Has a Geisinger Primary Care Physician assigned
* Completes an outpatient office visit or telemedicine appointment at Geisinger

Exclusion Criteria:

* The AVS was not printed according to the EHR, and the patient does not have an active MyGeisinger patient portal account, so they do not have a way to view the AVS

Primary outcomes:
measure: Inappropriate ED visits
timeFrame: In the 30 days following the appointment
Secondary outcomes:
Other outcomes:
measure: Urgent care visits
timeFrame: In the 30 days following the appointment
measure: Calls
timeFrame: In the 30 days following the appointment
measure: Patient portal messages
timeFrame: In the 30 days following the appointment
Locations:
city: Danville
country: United States
facility: Geisinger Clinic
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Amir Goren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00902148: Evaluation of Bioresorbable Sheet to Prevent Intra-Abdominal Adhesions in Colorectal Surgeries
Official title: Evaluation of Intra-Abdominal Adhesions in Ileostomy Procedures When Using a Resorbable Polylactide Film (SurgiWrap) in Colorectal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adhesions
Keywords: Surgery
Colectomy
Proctocolectomy
Adhesions
Lead sponsor: MAST Biosurgery, AG
Sponsor class: INDUSTRY
First posted: 2009-05-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study to investigate and determine the difference between the extent and severity of intra-abdominal adhesions in patients where SurgiWrap film was placed compared to patients with no adhesion barrier inserted.

Hypothesis: Due to the preclinical safety data and clinical case reports in various indications it is anticipated that the surgical sites where the resorbable anti-adhesion barrier SurgiWrap was placed, there will be a reduction of adhesions compared to the control group with no treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with rectal cancer, ulcerative colitis or other pathologies requiring a second surgery for ileostomy closure.
* Age between 18 and 78 years.
* Patient or his/her legal representative has read and signed the approved Informed Consent form before randomization.

Exclusion Criteria:

* Previous abdominal operation through a midline approach
* Use of hernia mesh
* Use of any antiadhesive irrigants or irrigants containing corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs.
* Pregnancy

Primary outcomes:
measure: Assess the extent and severity of new formed adhesions having its source in the target region where the SurgiWrap film initially was placed: between the midline incision/scar and the omentum, and between the midline incision/scar and the small bowel
timeFrame: 6 to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Oslo
Study officials:
affiliation: University Hospital, Akershus
name: Arne Faerden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04534348: Study on the Reduction of Catheter-related Infections by Use of Self-disinfecting Venous and Arterial Access Caps
Official title: Study on the Reduction of Catheter-related Infections by Use of Self-disinfecting Venous and Arterial Access Caps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CLABSI - Central Line Associated Bloodstream Infection
Catheter-Related Blood Stream Infection
Keywords: CLABSI
CRBSI
Blood Stream Infection
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 598
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: All patients treated in the hemato-oncological department at the University Clinic in Cologne, Germany, receiving a central-line catheter during one year previous to the implementation of alcohol-impregnated catheter caps as well as all patients receiving a central-line catheter during the 12 months following the implementation of CUROS were included in this study

Brief summary: Observational study on the reduction of catheter-related Infections by use of self-disinfecting venous and arterial access caps (Curos caps ;3M, Saint Paul, MN, USA)


Eligibility criteria: Inclusion Criteria:

* every patient in the hemato-oncological department who received at least one CVC was included in the study

Exclusion Criteria:

* none

Primary outcomes:
measure: Number of CLABSI
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
References:
Clinical trial NCT03036748: Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients
Official title: Increased Activity of ENaC in Proteinuric Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant; Complications
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Region of Southern Denmark
First posted: 2017-01-30
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental: Kidney transplant recipients with ACR \> 300mg/g receiving standardized sodium diet (150 mmol NaCl/day) for 5 days and amiloride tablet 10 mg two times daily (morning and afternoon) on the last day.

Interventions:◦Dietary Supplement: Standardized salt diet

◦Drug: Amiloride

•Experimental: Kidney transplant recipient with ACR\< 30mg/g (Control) receiving a standardized salt diet (150 mmol NaCl/day) for 5 days, then amiloride tablet 10 mg two times daily (morning and afternoon) for 1 day.

Interventions:◦Dietary Supplement: Standardized salt diet

◦Drug: Amiloride
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to determine if amiloride, a diuretic drug, is capable of increasing renal salt excretion, lowering blood pressure and inhibiting uPA in kidney transplant recipients with proteinuria compared to normoalbuminuric transplant patients.


Eligibility criteria: Inclusion Criteria:

* One Group of kidney transplant recipients with ACR\< 30mg/g
* One Group of kidney transplant recipients with ACR \>300mg/g

Exclusion Criteria:

* Treatment with amiloride, spironolactone, aldosterone- or analogs or tranexamsyre
* Pregnancy
* Clinically relevant organic or systemic disease including malignancy
* eGFR or creatinin-clearance \< 30ml/min
* hyperkalemia (s-potassium \> 5,0mmol/l)

Primary outcomes:
measure: 24-hour urinary sodium excretion induced by amiloride
timeFrame: Change from baseline urinary sodium (after 4 days of standadized sodium diet) excretion at 24 hours after amiloride administration
Secondary outcomes:
measure: Office or 24h blood pressure measurements
timeFrame: Change from baseline office blood pressure at day 4 of salt diet and at 24 hours after amiloride administration
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Cardiovascular and Renal research
name: Gitte Rye Hinrichs, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06091748: Gallium (68Ga) Edotreotide PET/CT for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
Official title: An Open-label, Single Arm Clinical Trial of Gallium (68Ga) Edotreotide PET-CT Scan for Imaging Patients With Gastrointestinal Pancreatic Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Advanced Gastroenteropancreatic Neuroendocrine Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single-arm imaging study using DOTATOC peptide, labelled with the Gallium (68Ga) tracer.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. 18\~75 years old,male or female；
3. ECOG performance status 0 or 1;
4. Confirmed or suspicion of GEP-NET.

Exclusion Criteria:

1. Unable to lie flat for the entire imaging duration (e.g. persistent cough, claustrophobia, severe arthritis, etc.), unable to enter the PET/CT device;
2. Individuals planning to be pregnant, and lactating women;
3. Individuals with concurrent active infections or with unexplained fever \>38.5°C for more than 1 hour during the screening period or prior to administration of investigational medication.

Primary outcomes:
measure: Sensitivity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
timeFrame: 12 months
measure: Specificity of 68Ga-DOTATOC PET-CT Imaging for Detection of Somatostatin Receptor Positive GEP-NET
timeFrame: 12 months
Secondary outcomes:
measure: Incidence and severity of AE and SAE
timeFrame: up to 1 year follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: