louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01301638: Retrospective Evaluation of Safety and Efficacy of Daptomycin Used in Patients With Serious Gram-positive Infections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bacteremia
Endocarditis
Serious Gram-positive Infections
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Before Daptomycin (Cubicin ®) approved by the U.S. FDA in 2003, There were large-scale clinical trials conducted that include more than 1,000 subjects and than Daptomycin got complicated skin and soft tissue infections (CSSSI) indication. After 2004, Daptomycin got new indications about bacteremia and endocarditis due to success outcomes in the clinical trial which included infected in blood flow and endocardial infected patients.

All subjects in Daptomycin clinical trials are European and American race. It is necessary that collecting safety and efficacy data of Daptomycin in Taiwan race. I will intent to evaluate the safety and efficacy of Daptomycin which were used in patients with serious gram-positive infections retrospectively. And the outcome could be a reference for Daptomycin future using

Brief summary: Before Daptomycin (Cubicin ®) approved by the U.S. FDA in 2003, There were large-scale clinical trials conducted that included more than 1,000 subjects and than Daptomycin got complicated skin and soft tissue infections (CSSSI) indication. After 2004, Daptomycin got new indications about bacteremia and endocarditis due to success outcomes in the clinical trial which included infected in blood flow and endocardial infected patients.

All subjects in Daptomycin clinical trials are European and American race. It is necessary that collecting safety and efficacy data of Daptomycin in Taiwan race. I will intent to evaluate the safety and efficacy of Daptomycin which were used in patients with serious gram-positive infections retrospectively. And the outcome could be a reference for Daptomycin future using.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients who were prescribed daptomycin from 1st January 2009 to 31st December 2010 for gram positive infections as deemed necessary by his/her treating physician. And patients received Daptomycin therapy for at least 3 days.

Exclusion Criteria:

* Patients received Daptomycin therapy for over 3 days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Men_Shan Hsu, medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00837538: Screening of Instability of the Spinal Column With Spinal Mouse® and X-ray
Official title: A Comparison of Spinal Mouse® and X-ray Film to Measure a Instability of Lumbar Spine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Instability of Lumbar Spine
Keywords: Spinal sagittal range of motion
Intersegmental range of motion
Spinal Mouse
Lead sponsor: Jyväskylä Central Hospital
Sponsor class: OTHER
First posted: 2009-02-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: persons of Central finland Health Care District

Brief summary: The SpinalMouse is a computer-assisted medical device that measures and graphically reports on posture and range of motion of the axial spine. The data has shown to be highly valid and reproducible while compared to x-ray film. The aim of the study is to evaluate if the Spinal Mouse is a reliable clinical diagnostic device to screen those patients having instability in the lumbar area.


Eligibility criteria: Inclusion Criteria:

* supposed instability of lumbar spine

Exclusion Criteria:

* not willing to participate to study

Primary outcomes:
measure: Sagittal spinal range of motion
timeFrame: One measurement before or after x-ray film
Secondary outcomes:
measure: Pain; pain drawing, VAS
timeFrame: Once in the same day with range of motion measurements
measure: Oswestry Disability Questionnaire
timeFrame: Once in the same day with range of motion measurements
measure: Questionnaire; socio-demographic variables, back/leg trouble history
timeFrame: Once in the same day with range of motion measurements
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Health Care District
Study officials:
affiliation: Central Finland Health Care District
name: Jari Ylinen, MD, Phd
role: STUDY_DIRECTOR
affiliation: Central Finland Heallth Care District
name: Mirja Vuorenmaa, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Finland Care District
name: Kirsi Piitulainen, M. Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Central Finland Heallth Care District, University of Jyväskylä
name: Arja Häkkinen
role: STUDY_CHAIR
References:
Clinical trial NCT01833338: Non-invasive and Invasive Plaque Characterisation
Official title: Coronary Artery Plaque Characterisation With Non-invasive Multi-Slice Computed Tomography and Invasive Intravascular Ultrasound and Optical Coherence Tomography in Patients With Acute Coronary Syndromes Without ST-segment Elevation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non ST Elevation Myocardial Infarction
Keywords: Non ST elevation myocardial infarction
optical coherence tomography
intravascular ultrasound
multi-slice computed tomography
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 30
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 accuracy of coronary plaque characterization with Multi-slice computed tomography as compared to intravascular ultrasound and optical coherence tomography will be investigated in patients presenting with acute coronary syndrome without ST-elevation.


Eligibility criteria: Inclusion Criteria:

* Chest pain suggestive for myocardial ischemia for at least 30 minutes; - Electrocardiogram (ECG) with ST-segment shifts (ST-segment depression \>1 mm in at least two contiguous leads or transient ST-segment elevation \> 1mm with duration of \< 30 min in at least two contiguous leads) and/or T-wave changes (T-wave inversion \> 1.5 mm in at least three contiguous leads); - Positive hs Troponin T \> 14 ng/L or positive Troponin T \<0.01 µg/L - Clinical indication for invasive coronary angiography followed by PCI of the ischemia-related target lesion; - Informed consent.

Exclusion Criteria:

* Persistent ST-elevation of \>1 mm in 2 or more leads; - Need for emergency invasive coronary angiography and percutaneous coronary intervention (PCI); - Need for emergency coronary artery bypass grafting; - Presence of cardiogenic shock; - Estimated glomerular filtration rate (eGFR) \< 50 ml/min; - Known allergy to iodine contrast agents; - Cardiac rhythms other than sinus rhythm; - Inability to lay supine; - Inability tot sustain a breath-hold for 15 seconds; - Inability to provide informed consent.

Primary outcomes:
measure: Accuracy of detection of thrombus with MSCT as compared to IVUS and OCT will be investigated.
timeFrame: 24 hours
Secondary outcomes:
measure: Accuracy of atherosclerotic plaque characterisation with MSCT as compared to IVUS and OCT will be investigated.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen, Departments of Cardiology and Radiology
Study officials:
affiliation: Department of Cardiology
name: Gabija Pundziute, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Radiology
name: Tineke Willems, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00407238: Corneal Barrier Function With Multi-Purpose Solutions
Official title: Comparison of Human Corneal Barrier Function With Three Marketed Multi-Purpose Solutions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Care
Keywords: barrier function, multi-purpose solutions, silicone hydrogel contact lenses
Lead sponsor: Southern California College of Optometry at Marshall B. Ketchum University
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2006-12-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Detailed description: The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Eligibility criteria: Inclusion Criteria:

* Adapted daily soft contact lens wearers, at least 18 years of age, vision correctable to 20/40

Exclusion Criteria:

* Ocular or systemic allergies, abnormalities of the cornea, active ocular infection, prior keratorefractive surgery, use of ocular medications

Primary outcomes:
measure: Ratio of fluorescein dye penetration rate of test eye vs. control
Secondary outcomes:
measure: Corneal fluorescein staining
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
Study officials:
affiliation: Southern California College of Optometry at Marshall B. Ketchum University
name: Jerry R Paugh, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06259838: Oral Cavity Squamous Cell Carcinoma and Readmission: Rates, Causes, and Risk Factors.
Official title: Oral Cavity Squamous Cell Carcinoma and Readmission: Rates, Causes, and Risk Factors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Cavity Squamous Cell Carcinoma; Readmission
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 93
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient underwent oral cancer surgery in king Abdulaziz University hospital

Brief summary: We sought to comprehend the rates and causes of unplanned hospital readmission within 60 days following oral cancer surgery


Eligibility criteria: Inclusion Criteria:

* all patient underwent oral cancer surgery in king Abdulaziz University hospital

Exclusion Criteria:

* significant missing data

Primary outcomes:
measure: rate of readmission
timeFrame: 60 days after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University Hospital
Study officials:
References:
Clinical trial NCT04498338: Neural Mobilization and Conventional Physical Therapy After Laminectomy
Official title: Effects of Neural Mobilization Augmented by Traditional Physical Therapy on Pain, Functional Disability and H-reflex in Patients After Lumbar Laminectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laminectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to evaluate the effect of addition of neural mobilization to a standard post-operative physical therapy program in patients with lumbar laminectomy.

Detailed description: After Laminectomy, patients are suffering from many problems as pain, weakness. This study was conducted on two groups of patients who underwent lumbar Laminectomy as a surgical treatment for lumbar canal stenosis. The control group received TENS and strengthening exercises, while the study group received neural mobilization in addition to the program that was given to the control group. The outcome measures include pain intensity, nerve root compression and functional level which were measured pre-treatment and post-treatment through using visual analogue scale, H-reflex latency and Oswestry Disability Index (ODI) respectively.

Eligibility criteria: Inclusion Criteria:

* Aged from 35-50 years.
* Underwent lumbar laminectomy of one or two levels.

Exclusion Criteria:

* Patients who had arthritis in the joints of the lower limbs (which would limit walking).
* Patients who had tumors, fractures or infections of the spine.
* Patients who had diabetes mellitus.
* Patients who had polyneuropathy.
* Patients who had evidence of spinal cord compression.
* Patients who had previous spinal surgery.
* Patients who had spinal stability problems (e.g. spondilo-listhesis, spondilolysis).
* Patients who had sensory loss.

Primary outcomes:
measure: Pain intensity
timeFrame: Up to 6 weeks
measure: Nerve root compression
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Functional ability
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University, Egypt
name: Moussa A Sharaf, Assist Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University, Egypt
name: Khalid Z Fouda, Assist Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT01513538: Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
Official title: TherapyGuide : Analysis of the Acceptance and Changes to Parameters Programming Suggested by the TherapyGuide Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradyarrhythmia
Keywords: Pacemaker programming
Bradyarrhythmia
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2012-01-20
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with a dual chamber pacemaker featuring the TherapyGuide function

Brief summary: The technological progress allowed the development of more and more sophisticated pacemakers, widening the therapeutic indications but also meeting the physiological needs of the patient. This progress led to a more and more complex programming for the physicians. To help them set optimally the pacing parameters, physicians refer to the existing recommendations of learned societies as well as to his expertise. Manufacturers developed also algorithms integrated into pacemakers with the aim of assisting physicians in their programming.

TherapyGuide is a function which proposes a programming adapted to the psychopathological state of the patient, with a justification based on experts' consensus, clinical studies as well as on published articles.

Physicians have the choice to accept or reject the programming proposed by TherapyGuide. When rejected, there is no means to analyze the modifications brought to the proposed set of parameters. The nature, the frequency and the reasons of these modifications are not thus known.

The purpose of this study is to assess the acceptance of the TherapyGuide proposals by physicians and to identify the most frequent type of programming changes they make and their rationale.


Eligibility criteria: Inclusion Criteria:

* Patient implanted with a pacemaker featuring the TherapyGuide function
* Patient more than 18 years of age.
* Patient able to sign a data release authorization form

Exclusion Criteria:

- Unwillingness or inability to provide written consent

Primary outcomes:
measure: Acceptance of TherapyGuide Proposals and Typology of Programming Changes
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Clinique Bouchard
Study officials:
References:
Clinical trial NCT06406738: Simulator Use in Newborn First Care
Official title: The Effect of High Reality Simulator Use in Newborn First Care Training on the Knowledge, Skills, Satisfaction and Self-Confidence of Midwifery Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn; Vitality
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the effects of using high-fidelity simulators in newborn first care training on the knowledge, skills, satisfaction and self-confidence of midwifery students.

Detailed description: Hypotheses H01: There will no difference between the students' knowledge skills, satisfaction, and self-confidence of the simulation-based newborn first care training group and the knowledge skills, satisfaction, and self-confidence score of control group.

The study will be carried out in two different groups. The practice will start with meeting the students who apply to the study. After the students are evaluated in terms of eligibility criteria for the research, the students who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. The random distribution of women to the study groups will be carried out using the Block Randomization method. The following applications will be made to the groups.

Newborn first care training will be given by the responsible investigator, and then one of the groups separated by randomization will perform newborn first care on the second group model using High Reality Simulator. These trainings will first be in the form of the instructor responsible for the groups demonstrating the application, and then the students will apply it one by one.

Eligibility criteria: Inclusion Criteria:

* Agreeing to participate in the research and obtaining written permission,

Exclusion Criteria:

-

Primary outcomes:
measure: First Care of the Newborn Information Form
timeFrame: immediately before simulation and immediately after the training and 6 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Ilkadim
country: Turkey
facility: Sumeyye
state: Samsun
Study officials:
affiliation: Ondokuz Mayıs University
name: Sumeyye BAL, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05738538: Expanded Access to Ziftomenib
Official title: Expanded Access to Ziftomenib
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Acute Lymphoblastic Leukemia, With Appropriate Mutations
Acute Myeloid Leukemia, With NPM1 Mutations
Lead sponsor: Kura Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Requests for single patient expanded access to ziftomenib monotherapy may be considered for eligible adult patients with Acute Lymphoblastic Leukemia (ALL) with KMT2A rearrangements, or Acute Myeloid Leukemia (AML), with NPM1 mutations or KMT2A rearrangements.

To request access, use Responsible Party contact information provided in this record.

Expanded access for ziftomenib is only available in the United States.

Detailed description: • Subsection Condition:

* NPM1 mutation in AML patients
* KMT2A rearrangement in AML patients
* KMT2A rearrangement in ALL patients

Eligibility criteria: Inclusion/Exclusion Criteria:

* Diagnosed with Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL).
* Adult, ages 18+.
* Has exhausted appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available or exists to treat the disease or condition. For newly diagnosed AML patients with either NPM1-mutant, or KMT2A-rearranged AML, ziftomenib therapy will be considered for patients not eligible for ongoing clinical trials. In the case of patients with KMT2A-rearranged AML, Expanded Access to ziftomenib will only be provided for use in combination with FDA-approved therapies currently under clinical investigation at Kura Oncology (e.g., venetoclax + azacitidine, cytarabine + daunorubicin).
* Is ineligible for participation in any ongoing clinical study of the investigational drug, which includes lack of access due to geographic limitations.
* Meets any other pertinent medical criteria for access to the investigational drug, as established by Kura Oncology.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01777438: Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy
Official title: Evaluating Symptom Control in in Allergic Rhinitis at Three Years After Starting Immunotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 434
Sex: ALL
Minimum age (years): 19
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who started immunotherapy

Brief summary: Allergic rhinitis (AR) is defined as inflammation of the nasal mucosa after exposition to an allergen in sensitized patients. AR causes not only nasal symptoms such as sneezing, itchy nose, rhinorrhea and nasal obstruction, but also has a significant impact on quality of life. Symptom control and overall satisfaction in patients undergoing subcutaneous immunotherapy (SCIT) or sublingual immunotherapy (SLIT) on the long term has not yet been investigated so far.


Eligibility criteria: Inclusion Criteria:

1. Patients with at least 2 AR symptoms and a positive skin prick test for the 20 most prevalent inhalant allergens (house dust mites, grass pollen, tree pollen, animal dander, Alternaria, Penicillium and Cladosporium) in Belgium.
2. Moderate/severe and/or persistent AR according to ARIA guidelines
3. Age \> 18 and \< 60 years.
4. Written informed consent
5. Dutch, French or English speaking patients

Exclusion Criteria:

Exclusion criteria

1. Age \< 18 and \> 60 years
2. Patients with mild AR
3. Patients not being able to give an informed consent
4. Patients being enrolled in other clinical trials
5. No knowledge of Dutch, French or English

Primary outcomes:
measure: Current Medication Use Three Years After Diagnosis of AR
timeFrame: 3 years after starting SCIT
measure: Degree of Symptom Control 3 Years After IT or 3 Years After Medical Treatment With VAS of Total Nasal Symptom < 5/10 Defined as a Controlled Situation.
timeFrame: 3 years after diagnosis
Secondary outcomes:
measure: Percentage of Patients Having Controlled Allergic Rhinosinusitis (AR) Symptoms 3 Years After Starting Treatment
timeFrame: 3 years after starting SCIT
measure: Percentage of Patients That Met ARIA Criteria for Mild AR Symtoms at a Mean Interval of 3 Years After Diagnosis
timeFrame: 3 years after diagnosis
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: ORL
state: Vlaams-Brabant
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams-brabant
Study officials:
affiliation: UZ Leuven
name: Peter Hellings, MD
role: PRINCIPAL_INVESTIGATOR
References: