louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03875469: Study to Test the Usability of a New Injector to Administer Contrast Media Into Humans for Diagnostic Purposes
Official title: Performance of Centargo - A Novel Piston-based Injection System for High Throughput in Contrast-enhanced Computed Tomography (CE CT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Computed Tomography
Keywords: Contrast-enhanced computed tomography (CECT)
Injector
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-03-14
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates if a new medical device, which injects contrast media and flushing solution into humans to increase the visibility of images taken of the human body for diagnostic purposes, is easier to handle, quicker and cheaper than an older injector.

Detailed description: The study compares an investigational injection system (Centargo) for computed tomography (CT) to a currently marketed injection system (Stellant MP) in terms of efficiency, cost, performance and user satisfaction (Part 1). In addition, the reliability of the new injection system Centargo is tested (Part 2).

Eligibility criteria: Inclusion Criteria:

* Adult subjects referred for contrast-enhanced computer tomography using a power injector

Exclusion Criteria:

* Pregnant and lactating women
* Subjects with know hypersensitivity to iodinated contrast media
* Subjects with unacceptable renal function per local guidelines

Primary outcomes:
measure: Setup time of CT systems
timeFrame: 1 day
measure: Change time for bottle/ bag containing contrast medium
timeFrame: 1 day
measure: Patient setup time for the multi-patient set per day
timeFrame: 1 day
measure: Teardown time of CT-system
timeFrame: 1 day
measure: Number of multi-patient sets per day
timeFrame: 1 day
Secondary outcomes:
measure: Total cost for multi-patients set and disposables per patient and day
timeFrame: 1 day
measure: Reason for change of multi-patient syringe set for the injection of contrast media prior to expiration at 24 hours
timeFrame: 1 day
measure: Volume of unused contrast agent at teardown time
timeFrame: 1 day
measure: Volume of unused saline at teardown time
timeFrame: 1 day
measure: Flow rate of contrast agent through the injector
timeFrame: 1 day
measure: Volume of contrast agent delivered through injector
timeFrame: 1 day
measure: Injector-generated pressure
timeFrame: 1 day
measure: Number of automated system alerts
timeFrame: 1 day
measure: Radiographer satisfaction with contrast-media injector by study-related questionnaire
timeFrame: Up to 4.5 months
measure: Number of errors requiring a CT-system reboot
timeFrame: 1 day
Other outcomes:
Locations:
city: Merrylands
country: Australia
facility: Medscan
state: New South Wales
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
References:
Clinical trial NCT01166269: Study to Asses Efficacy of Intralymphatic Immunotherapy
Official title: Intralymphatic Specific Immunotherapy - as a New Treatment Form for Grass-pollen Allergic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergy
Keywords: grass-pollen allergy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: TRYG Foundation
First posted: 2010-07-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to try a new route for specific immunotherapy (SIT). The current treatment form for SIT is subcutaneously (SCIT), which is a long treatment with up to 50 injections subcutaneously in the upper arm.

The investigators believe that there is additional effect if the allergen is injected directly into the lymph node, since it is here, the allergen presentation is happening. The trial has been performed in Switzerland with significant effect of only three injections of grass-allergen into a lymph node (Clinicaltrials.gov; NCT00470457).

The investigators would like to see what happens if the the dose is doubled, so the patients will receive 6 injections all in all, with the same amount of allergen as the earlier study (1000 SQ-U). Also the outcome measurements is slightly different as the patients will note their symptoms in a diary.

The patients will be divided into three groups using allocation:

1 group with 6 injections of allergen

1 group with 3 injections of allergen and 3 injections of placebo

1 group with 6 injections of placebo. The trial will be double blinded.


Eligibility criteria: Inclusion Criteria:

* grass pollen allergy through at least 2 seasons
* positive skin prick test
* positive Specific IgE of at least 2. (CAP)
* Signed informed consent
* for females a negative pregnancy test.

Exclusion Criteria:

* out of age limits
* rhinoconjunctivitis all year round.
* uncontrolled seasonal asthma
* patients treated with steroids continuously or beta-blockers.
* pregnancy and breastfeeding
* HIV, Hepatitis B+c, and other immunological diseases.
* psychiatric disease
* treatment with SCIT or SLIT within the last 5 years
* participation in other clinical trials within the last 3 months.

Primary outcomes:
measure: symptom improvement
timeFrame: 2 seasons. (2 years)
Secondary outcomes:
measure: Improvement of reactivity of skin prick test and Specific IgE
timeFrame: 2 years
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Dermato-allergological dept. K
state: Hellerup
Study officials:
affiliation: Copenhagen University Hospital, Gentofte, Denmark
name: Hans-Joergen Malling, Prof. Dr. Med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06348069: Pharmacy-based PrEP for Young Women Who Sell Sex in Zimbabwe
Official title: Pharmacy-based PrEP for Young Women Who Sell Sex in Zimbabwe
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adherence, Medication
HIV Prevention
Keywords: HIV
PrEP
People who engage in sex work
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
Collaborators: name: Centre for Sexual Health and HIV/AIDS Research Zimbabwe (CeSHHAR Zimbabwe)
name: University of California, San Francisco
name: Liverpool School of Tropical Medicine
First posted: 2024-04-04
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Groups (sites/clusters) are randomized to either the intervention (pharmacy-based PrEP refills plus gift card incentives) or the control (standard of care) and are followed and compared over time.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Pharmacy-based PrEP for Young Women who Sell Sex in Zimbabwe is a cluster-randomized control trial and pilot study co-led by Dr. Euphemia Sibanda, Reader (Associate Professor) of Global Health and Epidemiology at Liverpool School of Tropical Medicine, UK and Research Director at the Centre for Sexual Health and HIV Research (CeSHHAR Zimbabwe) and Dr. Sandra McCoy, Professor of Epidemiology and Biostatistics at the University of California, Berkeley. The goal of the proposed study is to optimize, refine and pilot a pharmacy-based PrEP intervention for female sex workers (FSW) in Zimbabwe. Despite efforts to reach the most impacted and vulnerable populations with PrEP, retention rates, particularly among FSW in Africa, are very low. Relatively high levels of uptake indicate that FSW are interested in PrEP and ready to initiate it, but in most cases fewer than 50% of those who initiate return for medication refills by month 4. Pharmacy-based PrEP has the potential to address known barriers to PrEP retention among FSW such as stigma and access, and coupled with a small escalating incentive in the form of a gift card incentive, could also boost motivation for effective use of PrEP.


Eligibility criteria: Inclusion Criteria:

* 1) Exchanged sexual intercourse for money or gifts in past 6 months
* 2) Age 16 or older
* 3) HIV negative (via rapid test per national guidelines) at enrollment and no signs/symptoms of acute HIV infection

Primary outcomes:
measure: PrEP retention at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
measure: PrEP retention at 6 months among FSW who are 18-24 years of age
timeFrame: 6 months
measure: : PrEP retention at 6 months among participants who have remained active in sex work
timeFrame: 6 months
measure: FSW (overall) and FSW (18-24 years) patronage for PrEP services at pharmacies
timeFrame: 9 months
measure: HIV tests
timeFrame: 9 months
measure: HIV care referrals
timeFrame: 9 months
Locations:
city: Harare
country: Zimbabwe
facility: CESHHAR Zimbabwe
Study officials:
References:
Clinical trial NCT04229069: Acid-Base Balance, Metabolism and Minerals
Official title: Randomized, Double-blind, Placebo-controlled Intervention Study on Effects of Basica® on Acid-base Balance, Metabolism and Quality of Life in Elderly Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acid-Base Balance Disorder
Metabolic Acidosis
Keywords: acid-base balance
energy metabolism
protein-rich diet
alkaline supplementation
calorimetry
microdialysis
randomized placebo-controlled trial
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Metabolism is controlled by macro- and micronutrients. Protein-rich diets should lead to latent acidosis at tissue level with further negative implications. Food supplements with alkaline salts are available and popular pretending to prevent these changes.

Within a randomized double-blind placebo-controlled trial, the investigators tested the hypotheses 1) that a 4-week protein-rich diet induces a latent tissue acidosis and 2) an alkaline supplement can compensate this. Acid-base balance and important metabolic parameters were determined before and after 4 weeks of supplementation by peripheral blood samples, indirect calorimetry and muscle microdialysis before and after a protein-rich test meal.


Eligibility criteria: Inclusion Criteria:

* slightly reduced kidney function (GFR 60-89 ml/min)
* Body mass index 20.0 - 29.9 kg/m2
* normal daily diet composition: 45-50, 35-40, and 15 E% from carbs, fats and proteins, respectively

Exclusion Criteria:

* sorbitol-/fructose-intolerance
* intake of antacidic drugs
* vegetarians, vegans
* intake of any nutritional supplements
* any cardiovascular, pulmonary, endocrine or metabolic diseases
* any drug abuse
* intake of any anticoagulant drugs

Primary outcomes:
measure: Change in muscle dialysate lactate-pyruvate ratio
timeFrame: before and after 4-weeks of supplementation at baseline (after a 12 hours overnight fast) and 60, 120, and 180 minutes after a protein-enriched test meal
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00595569: Flexible, Intensive Insulin Therapy in Patients With Type 1 Diabetes
Official title: Flexible, Intensive Insulin Management in Patients With Type 1 Diabetes and Changes in Metabolic Control, Quality of Life, Locus of Control and Diabetes Knowledge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: flexible insulin therapy
diabetes education
diabetes
insulin
Weekly ambulatory sessions
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Diabetes Association Basel
name: University Hospital, Basel, Switzerland
First posted: 2008-01-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with type 1 diabetes followed at the Division of Endocrinology and Diabetology, University of Basel are strongly encouraged to attend the course 6 to 12 months after having been diagnosed. The population that participates in those FIT courses includes patients from the University of Basel Hospital, but also patients that are referred from out of hospital physicians/diabetologists.

Brief summary: To prospectively evaluate the long term metabolic and psychological effects of flexible intensive insulin therapy (FIT) courses in an unselected population of type 1 diabetic patients at the University of Basel Hospital. We hypothesize that both metabolic control and psychological parameters will improve.


Eligibility criteria: Inclusion Criteria:

* All patients participating in 5 consecutive FIT courses that began between April 2002 to April 2004

Exclusion Criteria:

* None

Primary outcomes:
measure: Metabolic control (HbA1c, severe hypoglycemic events), psychological effects, diabetes knowledge
timeFrame: Over 18 months
Secondary outcomes:
measure: Changes in insulin doses, changes in weight
timeFrame: Over 18 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel Hospital
Study officials:
affiliation: University of Lausanne, University of Basel
name: Jardena J Puder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00358969: Guanfacine to Treat Borderline Personality Disorder
Official title: Guanfacine in the Treatment of Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: borderline personality disorder
guanfacine
impulsivity
aggression
affective instability
Lead sponsor: Bronx VA Medical Center
Sponsor class: FED
First posted: 2006-08-01
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate whether guanfacine (Tenex) is an effective treatment for borderline personality disorder (BPD), an illness often characterized by unstable mood and impulsive aggression. Guanfacine stimulates activity in the front portion of the brain, a region associated with attention and the control of behavior. We believe that guanfacine may improve symptoms of BPD by improving attention and aiding regulation of behavior.

Detailed description: This is an 8-week treatment study designed to test whether guanfacine is an effective treatment for borderline personality disorder (BPD). Prior to taking the study medication, subjects will have medical and psychiatric evaluations, complete self-report questionnaires, do a functional MRI scan, and complete a set of cognitive tests. While taking the study medication, participants will meet weekly with a study doctor and be administered interviews and questionnaires. At the end of the 8-week trial, participants will be asked to repeat the MRI scan and cognitive tests.

Eligibility criteria: Inclusion Criteria: This study includes men and women between the ages of 18 and 55 who meet criteria for borderline personality disorder with impulsive aggression.

Exclusion Criteria: Subjects must not currently be taking any psychiatric medications. Subjects must not meet criteria for current substance dependence, current major depression, bipolar disorder, or schizophrenia-spectrum disorders.

Primary outcomes:
measure: measures of impulsive aggression
measure: measures of affective disturbance
measure: measures of social and occupational functioning
measure: measures of overall clinical status
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital - Mood & Personality Research Group
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Antonia S. New, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06189469: Reliability and Validity of Urdu Version of the King's Health Questionnaire
Official title: Is Urdu Version of the King's Health Questionnaire a Reliable and Valid Tool
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: Urinary Incontinence
King's Health Questionnaire
Reliability
Validity
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Females presenting with Urinary Incontinence

Brief summary: This study is aimed to translate King's Health Questionnaire into Urdu language and to test its reliability and validity among Pakistani women with urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Having symptoms of Urinary Incontinence
* Age 21 or more than years
* Sufficient literacy to complete questionnaire

Exclusion Criteria:

* Being unable to complete questionnaires due to language and cognitive limitations
* Pelvic organ prolapse
* Concomitant neurological disorders

Primary outcomes:
measure: King's Health Questionnaire
timeFrame: 7th day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT00206869: Does Exercise and Heat Increase the Lightsensibility in Patients With Erythropoietic Protoporphyria
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erythropoietic Protoporphyria
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to evaluate the effect of exercise and heat on the light sensibility of patients with erythropoietic protoporphyria


Eligibility criteria: Inclusion Criteria: erythropoietic protoporphyria, age 14 to 70.

-

Exclusion Criteria:

* Not able to exercise

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
state: Copenhagen NV
Study officials:
affiliation: Bispebjerg Hospital
name: Hans C Wulf, MD, Sci
role: STUDY_DIRECTOR
References:
Clinical trial NCT03147469: The Influence of Head and Neck Position on Performance of Ambu AuraGain™
Official title: The Influence of Head and Neck Position on Performance of Ambu AuraGain™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.

Fiberoptic bronchoscopic view will be also assessed for each head and neck positions.
Primary purpose: OTHER

Brief summary: The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated.

This study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway.

AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.

The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.

Fiberoptic bronchoscopic view will be also assessed for each head and neck positions.


Eligibility criteria: Inclusion Criteria:

* Adults who were to undergo elective surgery under general anaesthesia using supraglottic airway device

Exclusion Criteria:

* Patients who had risk factor for difficult intubation
* BMI \> 30kg/m2
* Emergency operation without NPO
* History of cervical spine surgery or disease
* History of esophageal operation or gastroesophageal reflux disease

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: 30 seconds after positioning of head and neck
Secondary outcomes:
measure: Peak inspiratory pressure
timeFrame: 30 seconds after positioning of head and neck
measure: Expiratory tidal volume
timeFrame: 30 seconds after positioning of head and neck
measure: Ventilation score
timeFrame: 30 seconds after positioning of head and neck
measure: Fiberoptic score
timeFrame: 30 seconds after positioning of head and neck
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00057369: Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections
Official title: Phase II, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections With Suspected or Confirmed Gram-Positive Bacterial Pathogens
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bacteremia
Lead sponsor: Vicuron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2003-04-02
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (CR-BSI). The primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI relative to a standard of care treatment, vancomycin.


Eligibility criteria: * The patient or his/her legally authorized representative has given informed consent by means approved by the investigator's IRB/EC;
* \> 18 years of age;
* Had one or more central venous catheters at the time initial signs of infection were evident;
* Creatinine clearance \<50 mL/min;
* Bilirubin \> 2x the upper limit of normal;
* Treatment with an antibiotic effective against Gram-positive bacterial infections for more than 24 hours within 48 hours of study medication initiation,
* Prolonged antibiotic therapy for CR-BSI anticipated (i.e., \>2 weeks)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Wellstar/Kennestone Hospital
state: Georgia
Study officials:
References:
citation: Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):423-434. doi: 10.1007/s40121-021-00568-7. Epub 2021 Dec 14.