louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00758446: Efficacy and Safety Study of BLX-028914 in Subjects With Allergic Rhinitis
Official title: A Double-blind, Randomized, Placebo-controlled, Cross-over, Allergen Challenge Study to Evaluate the Efficacy, Safety and Tolerability of BLX-028914 in Subjects With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Dart NeuroScience, LLC
Sponsor class: INDUSTRY
Collaborators: name: Orexo AB
First posted: 2008-09-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.

The aim of this study is to compare the effect, safety and tolerability of 14 days treatment with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.


Eligibility criteria: Inclusion Criteria:

* 18 to 50 years of age (inclusive), male or female
* Body Mass Index (BMI) between 18 and 28 kg/m2 (inclusive)
* History of pollen-induced seasonal allergic rhinitis but otherwise healthy
* Positive skin prick test for timothy and/or birch allergen
* Sufficient reaction to nasally administered allergen at screening
* Signed informed consent obtained

Exclusion Criteria:

* Expected symptoms of seasonal allergic rhinitis during the study period
* Asthma
* Nasal anatomical deviations, ongoing nasal symptoms, ongoing upper respiratory tract infection
* Anti-allergy immunotherapy in the previous two years
* Extensive use of nasal sprays
* Any medication except for contraceptives, during their last five half- lives prior to the first treatment period except for occasional OTC analgesics
* Ingestion of grapefruit or grapefruit juice or herbal remedies (e.g. St John's-wort) that may effect the enzyme CYP3A4
* Smoking within 3 months of first treatment period
* Clinically significant laboratory findings
* Pregnant or breast feeding woman or woman of childbearing potential not using adequate birth control
* Known hypersensitivity to any constituent of the study medication or placebo
* Participation in any other investigational study in the last three months
* Subject anticipated not being able to adhere to study plan according to investigator judgement

Primary outcomes:
measure: Post allergen challenge; Total Nasal Symptom Score(TNSS)
timeFrame: 10 minutes after allergen challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Department of otorhinolaryngology
Study officials:
affiliation: Department of otorhinolaryngology
name: Lennart Greiff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03550846: Clinical and Radiological Investigation of a New Spinal Fixateur Interne (Ennovate®)
Official title: Total Indications Ennovate® Non-Interventional Study on Clinical and Radiological Results With Pedicle Screw Fixation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Fusion
Keywords: Spinal Fusion
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 188
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: adult patients

Brief summary: This study is planned and conducted to document all patients in the participating Centers, who are treated with the CE-marked product, the Fixateur Ennovate®, regardless of the diagnosis or indication. Data on performance and safety of the product, validated patient based questionnaires (Oswestry Disability Index, ODI) as well as the satisfaction of the patients in general are captured.

Detailed description: The list of spinal treatments is growing, and healthcare authorities today are at times limiting their access due to a lack of evidence of safety and efficiency.

The study enables a quick, but detailed implant documentation, which is of great interest for the current and future users of the internal fixation system targeted in this study. It includes the relevant outcomes to evaluate safety and efficacy of the implant system for various indications in trauma and degenerative disorders.

Eligibility criteria: Inclusion Criteria:

- Consent in the documentation of clinical and radiological results

Exclusion Criteria:

- If it is clear that the patient cannot participate in a follow-up examination, he will be excluded from the study documentation.

Primary outcomes:
measure: Change of Clinical Results from Preoperative Status to Follow-Up at 12 Months
timeFrame: preoperative, 12 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: APEX Spine Wirbelsäulenpraxis
state: Bayern
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Göttingen
country: Germany
facility: Klinik und Poliklinik für Neurochirurgie
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz
city: Köln
country: Germany
facility: Carolin Meyer
city: Nürtingen
country: Germany
facility: medius Klinik
city: Tuttlingen
country: Germany
facility: Praxis für Neurochirurgie am Klinikum
Study officials:
affiliation: Klinik für Orthopädie und Unfallchirurgie der Universitätsklinik Köln
name: Carolin Meyer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03800446: Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
Official title: Validation of a Point-of-care Device Measuring Ferritin With Capillary Blood
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anemia, Iron Deficiency
Iron Overload
Iron-deficiency
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective cohort diagnostic study design
Primary purpose: DIAGNOSTIC

Brief summary: Measurement of iron is important for identifying both low and high iron levels in the body. Measuring a protein in the blood called ferritin is currently the easiest way to determine a patient's iron status. However, the test requires a blood sample that is be sent to the laboratory for measurement, which can cause delays in obtaining the result. The investigators are testing whether a point of care device that measures ferritin levels using a capillary blood sample is accurate compared to current methods of testing. This could allow measurement of ferritin immediately in the clinic with only a drop of blood, and enable treatment decisions based on these results.


Eligibility criteria: Inclusion Criteria:

* able to read and understand English (the consent form is in English)
* attending ambulatory hematology clinic and/or outpatient medical care

Exclusion Criteria:

-

Primary outcomes:
measure: Point of care ferritin detection accuracy
timeFrame: Within 12 hours of standard testing
Secondary outcomes:
measure: Distribution of the differences between ferritin level as measured by the standard test and POC test
timeFrame: Within 12 hours of standard testing
measure: Comparison of the differences between ferritin levels as measured by the standard test and POC test in a Repeated Measures Design
timeFrame: Within 12 hours of standard testing
measure: Agreement between testing methods in patients who have been assessed at least twice
timeFrame: Within 12 hours of standard testing
measure: Diagnostic accuracy of the new measurement method
timeFrame: Within 12 hours of standard testing
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03999346: Opportunities and Limitations of Swiss Polytrauma Registry Data for Scientific Purposes- Registry Data for Scientific Purposes
Official title: Opportunities and Limitations of Swiss Polytrauma Registry Data for Scientific Purposes- Registry Data for Scientific Purposes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: Swiss Polytrauma Registry
quality control
standardized identification procedures
data capture
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The data source for this project is the Swiss Trauma Registry with approx. 65 patients per year. Data will be extracted from the databank and transferred for analysis in anonymized form.

Brief summary: The aim of the analysis is an evaluation of the current performance of the Swiss Trauma Registry (STR) with respect to providing a reliable basis for (scientific) investigations on the management of trauma patients in Switzerland. The current project tries to address this question by considering central aspects of completeness and by exemplifying the use of the registry for research questions. The aim is to identify potential shortcomings of the registry.


Eligibility criteria: Inclusion Criteria:

* documentation in the STR
* Injury Severity Score (ISS) ≥ 16

Exclusion Criteria:

* none

Primary outcomes:
measure: analysis of data completeness
timeFrame: single time point assessment at baseline
measure: rate of 28 day survival
timeFrame: single time point assessment at baseline
measure: length of hospital stay
timeFrame: single time point assessment at baseline
measure: rate of patients receiving intensive care treatment
timeFrame: single time point assessment at baseline
measure: rate of patients returning to the previous living situation
timeFrame: single time point assessment at baseline
Secondary outcomes:
measure: cost of maintenance of the register
timeFrame: single time point assessment at baseline
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Orthopaedics and Trauma Surgery (DOTS).
Study officials:
affiliation: Department Orthopedic and Trauma Surgery, University Hospital Basel
name: Nicolas Bless, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02220946: Effect of Vaginal Electrical Stimulation on Female Sexual Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Female Sexual Dysfunction
Keywords: Vaginal Electrical Stimulation
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Bezmialem Vakif University
First posted: 2014-08-20
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: vaginal electrical stimulation improves female sexual dysfunction


Eligibility criteria: Inclusion Criteria:

* women with complaint of sexual dysfunction at any part of sexual cycle

Exclusion Criteria:

* pregnancy previous gynecologic surgery pelvic organ prolapsus greater than stage 1 women with neurological disease and anatomical defect women with anatomical defect

Primary outcomes:
measure: Change from baseline in on domains and total score of Female Sexual Function Index (FSFI) at week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change from baseline in power, endurance, dynamic endurance and fast contractions on the PERFECT scheme at week 8
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Department of Obstetric and Gynecology, Bezmialem Vakif University
Study officials:
References:
Clinical trial NCT01007812: Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US
Official title: Clinical Comparison of Two Silicone Hydrogel Toric Lenses in the US
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-11-04
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to compare the performance of two different contact lenses for contact lens wearers with astigmatism.


Eligibility criteria: Inclusion Criteria:

* Have a current spectacle prescription, preferably within 6-9 months.
* Currently wearing toric soft contact lenses in both eyes with at least 1 month experience wearing current brand for daily wear.
* Be correctable to at least 20/40 distance visual acuity in each eye while wearing trial lenses in the parameters available for this trial.
* Have acceptable or optimal fit for each eye at the dispense of each pair of study lenses.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
* Currently enrolled in any Clinical Trial.
* Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of their accessory solutions as determined by the investigator.
* Any use of medications for which contact lens wear could be contraindicated as determined by the investigator.
* Currently wearing soft toric contact lenses as extended wear.
* Currently wearing either of the products to be worn in the study.
* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall Vision
timeFrame: After 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00749112: Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias
Official title: Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Idiopathic Thrombocytopenic Purpura
Anemia, Hemolytic, Autoimmune
Keywords: Idiopathic Thrombocytopenic Purpura
Anemia
Hemolytic
Autoimmune
Alemtuzumab
Rituximab
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2008-09-09
Enrollment: 19
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the combination of low doses of alemtuzumab and rituximab are effective in the treatment of patients with autoimmune cytopenias who has failed on steroids, relapsed after steroids withdrawal or required continuous steroids treatment.

Detailed description: Autoimmune cytopenias are a common entities with good responses to steroids therapies as first line, but there is a considerable percentage of patients who relapse, become refractory or dependant on steroids to maintain an acceptable level of hemoglobin or platelets, and the treatment becomes more difficult increasing the secondary effects. The current study evaluates the safety and efficacy of the combination of low doses of alemtuzumab (anti CD52) and Rituximab (anti CD 20) as a second line treatment option for this subset of patients improving the cytopenias without increasing the adverse effects.

Eligibility criteria: Inclusion Criteria:

* Age: \> or = 16 years
* Weight: more than 40 Kg
* Autoimmune Hemolytic anemia with clinical and biochemical evidence of hemolysis refractory to treatment, in relapse or steroids dependant
* Idiopathic thrombocytopenic purpura with platelet counts \< 50,000, refractory to treatment, in relapse or steroids dependant

Exclusion Criteria:

* Current viral or bacterial infection.
* Positive serology for HIV, HCV, HBV.

Primary outcomes:
measure: Objective response rate (CR: complete remission, PR: partial remission, relapse rate.
timeFrame: 1, 2, 4 and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hopsital Universitario Dr. Jose E. Gonzalez, Centro Universitario contra el Cancer
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: David Gomez-Almaguer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gomez-Almaguer D, Solano-Genesta M, Tarin-Arzaga L, Herrera-Garza JL, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Jaime-Perez JC. Low-dose rituximab and alemtuzumab combination therapy for patients with steroid-refractory autoimmune cytopenias. Blood. 2010 Dec 2;116(23):4783-5. doi: 10.1182/blood-2010-06-291831. Epub 2010 Sep 14.
Clinical trial NCT06678412: Turkish Version of the Cognitive Functioning Self-Assessment Scale
Official title: The Validity and Reliability of the Turkish Version of the Cognitive Functioning Self-Assessment Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Keywords: cognitive function
self-assessment
psychometrics
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy individuals over 18 years old

Brief summary: Self-report scales used in the assessment of cognitive functions can serve as an initial screening tool for the general population, aside from specific neuropsychiatric tests, which are more costly and time-consuming. This study is designed to examine the validity and reliability of the Turkish version of the Cognitive Functioning Self-Assessment Scale (CFSS). Permission for the study has been obtained from the developer of the scale, Dr. Maria Antonietta Annunziata. The Turkish translation of the scale will be made, and approval will be obtained from the original author for the final version. Subsequently, the Turkish version of the CFSS, the Hospital Anxiety and Depression Scale, and the Cognitive Failures Questionnaire will be administered to participants. Surveys will be completed either online via Google Forms or in written form. To assess the reliability of the scale, the Turkish version of the CFSS will be re-administered to the same participants 7-14 days later.


Eligibility criteria: Inclusion Criteria:

* Individuals over 18 years old

Exclusion Criteria:

* Taking antidepressants
* Having a neurological or psychiatric disease

Primary outcomes:
measure: Cognitive Functioning Self-Assessment Scale (Turkish Vesion)
timeFrame: Baseline and 7-14 days after
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline
measure: Cognitive Failures Questionnaire (CFQ)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
References:
Clinical trial NCT03492112: A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams
Official title: A Non-randomized Trial to Evaluate a TEst and Treat Intervention Integrating Novel Point-of-care Hepatitis C RNA Testing, Linkage to Nursing Care, and Peer-supported Delivery of HCV Testing and Treatment aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2018-04-10
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: TEMPO is an interventional cohort study recruiting injecting drug users attending needle and syringe programs (NSP) in Australia. Three hundred participants will be invited to on-site HCV testing with NSP integrated care for HCV treatment.

Participants will be screened for HCV using point-of-care testing and HCV positive participants will be offered treatment with Sofosbuvir/Velpatasvir. Of those who initiate treatment, participants will receive weekly peer-based support on-treatment and return at End of Treatment (ETR) and 12 weeks following end of treatment (SVR12) for clinical follow-up.


Eligibility criteria: Inclusion criteria

Participants must meet all the following inclusion criteria to be eligible to participate in this study:

1. Participants have voluntarily signed the informed consent form;
2. 18 years of age or older;
3. Current injecting drug use (previous month);
4. HCV RNA positive participants commencing treatment must be eligible to initiate therapy with Sofosbuvir/Velpatasvir; and
5. In the opinion of the Investigator, the participant is suitable for NSP-based HCV treatment delivery.

Exclusion criteria

1) For HCV RNA positive participants commencing treatment:

1. Any clinically significant condition or history known to contraindicate the use of Sofosbuvir/Velpatasvir or would not be suitable for management within a NSP-based treatment setting;
2. Any contraindicated medication in the Sofosbuvir/Velpatasvir product information;
3. Has previous HCV DAA treatment experience
4. Has a fibroscan score \> 12.5 Kpa
5. HIV co-infection
6. HBV co-infection
7. Is female and is pregnant or breastfeeding
8. Is unable or unwilling to provide informed consent or abide by the requirements of the study.

Primary outcomes:
measure: Uptake of HCV DAA therapy among current PWID
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: NUAA NSP
state: New South Wales
Study officials:
References: