louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05359198: Patient Reported Outcome Study on Long Term LoFric Users
Official title: Patient Reported Outcome Study on Long Term LoFric Users
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Catheters
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2022-05-03
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men and women, aged 18 years or above, practicing urethral intermittent catheterization. The patients should have used LoFric catheters ≥ 6 years for the purpose of urethral intermittent catheterization.

Brief summary: A prospective, observational cohort study evaluating Patient Reported Outcome in subjects with a long term experience from intermittent catheterization using the LoFric catheter. Prescription and use of LoFric catheters fall within current practice and is not dictated within this Non-Interventional Study.


Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent.
2. Female or male aged 18 years or older at time of signing informed consent.
3. Use of LoFric catheters for urethral intermittent catheterization for ≥ 6 years and currently using LoFric.
4. Able to read and write.
5. By investigator judged as able to comprehend and answer study questionnaires.

Exclusion Criteria:

1. Use of other catheter brand(s) than LoFric for \> 8 weeks in total during the past 12 months.
2. Simultaneous participation in any interfering clinical study as judged by the investigator.
3. Involvement in the planning and/or conduct of the NIS (applies to both Wellspect HealthCare staff and staff at the study site).
4. Previous enrolment in the present NIS.

Primary outcomes:
measure: Document urological complications
timeFrame: 5 years
measure: Document urological complications
timeFrame: 5 years
measure: Document urological complications
timeFrame: 5 years
measure: Document urological complications
timeFrame: 5 years
measure: Document urological complications
timeFrame: 5 years
measure: Document urological complications
timeFrame: 5 years
measure: Document urological complications
timeFrame: 5 years
measure: Document urological complications
timeFrame: 5 years
measure: Document urological complications
timeFrame: 5 years
measure: Document urological complications
timeFrame: 5 years
measure: Quality of Life Data
timeFrame: 5 years
measure: Patient perception of therapy
timeFrame: 5 years
measure: Patient perception of LoFric
timeFrame: 5 years
measure: Compliance/non-compliance to LoFric
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05580198: Prognostic Markers of Post-Stroke Depression (PROMoSD)
Official title: Prognostic Markers of Post-Stroke Depression: A Single-center Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who present with an acute ischemic stroke to the emergency department with the onset of symptoms within the past 14 days.

Brief summary: Single-center prospective observational study investigating the association of brainstem raphe hypoechogenicity detected by transcranial sonography and post-stroke depression three months after an acute ischemic stroke.

Detailed description: Post-stroke depression (PSD) is an important complication after a stroke. Despite significant limitations between studies of PSD risk factors, stroke severity or post-stroke disability, prior depressive episodes, and female sex are arguably the most well-known risk factors for developing PSD, although the predictive value of these factors is limited.

A hypoechogenic brainstem raphe (BR) detected by transcranial sonography (TCS) is associated with depressive symptoms in distinct diseases but is also common with approximately 25% of the non-depressed population in Europe. The primary aim of this study is to investigate the association between BR hypoechogenicity and PSD occurrence in a prospective observational study design.

Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke with the onset of symptoms within the past 14 days
* Diagnosis of AIS is confirmed by brain imaging, either computer tomography or magnetic resonance imaging

Exclusion Criteria:

* Insufficient transtemporal bone window for transcranial sonography examination

Primary outcomes:
measure: Post-stroke depression
timeFrame: 3 months
Secondary outcomes:
measure: Severity of depressive symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: St. Josef-Hospital Bochum
state: Nordrhein-Westfalen
Study officials:
affiliation: St. Josef-Hospital Bochum, Ruhr-University Bochum
name: Christos Krogias, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02045498: Effect of Capnography Feedback During Cardiopulmonary Resuscitation (CPR ) on Patient's Outcome
Official title: Effect of Capnography Feedback During Cardiopulmonary Resuscitation on Quality Performance of Rescuers and Outcome of the Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Arrest
Keywords: cpr
feedback
capnography
outcome
quality
resuscitation
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-01-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Compare the quality performance of rescuers and resuscitation outcomes of cardiac arrest patients in both groups with and without capnography feedback

Detailed description: This study has done at Mashhad Ghaem Educational center. Two nurses and an anesthesia resident selected and trained according to the latest guidelines of CPR . In the control sample, with the declare of code 99 and attend the team on the patient's bedside, CPR begins and then every two minutes, return of the patient checks in the usual way. quality performance of rescuers ,Recovery or death of the patient and the result is recording. In the second phase , group members were educated how to use capnography (Comdek's MD-660P Oxi-Capnography) in CPR and guiding restoration efforts by it. with the code 99 and attend the team on the patient's bedside capnography uses and its waveforms will appear on the monitor device which is visible to all rescuers and the quality of performance is renewed based on the its guidance. The two groups patients for age, sex, initial rhythm of arrest, time of arrest until the first action, the time of arrest until the first shocks are comparing to control these factors influence on the outcome. quality performance of rescuers , resuscitation outcomes and CPR duration and relative factors in each of the groups were recorded and compared.

Eligibility criteria: Inclusion Criteria:

* cardiac arrest patient age more than 18

Exclusion Criteria:

* age more than 80 cardiac arrest due to pulmonary embolism

Primary outcomes:
measure: chest compressions and artificial ventilation rate in a minute
timeFrame: By the end of twenty minutes of CPR
Secondary outcomes:
measure: Return of spontaneous circulation or death of patient at the end of resuscitation
timeFrame: about twenty minutes After start of CPR
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Ghaem Educational, Research and Treatment Center
state: Khorasan Razavi
Study officials:
affiliation: MUMS
name: Tayebe PourGhaznein, MSc
role: STUDY_DIRECTOR
References:
citation: Qvigstad E, Kramer-Johansen J, Tomte O, Skalhegg T, Sorensen O, Sunde K, Olasveengen TM. Clinical pilot study of different hand positions during manual chest compressions monitored with capnography. Resuscitation. 2013 Sep;84(9):1203-7. doi: 10.1016/j.resuscitation.2013.03.010. Epub 2013 Mar 15.
Clinical trial NCT00140998: Estrogen Treatment (Oral vs. Patches) in Turner Syndrome
Official title: Estrogen Replacement in Hypogonadal Girls Treated With GH: Differential Effects of Mode of Estrogen Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Turner Syndrome
Hypogonadism
Premature Ovarian Failure
Keywords: Turner syndrome
Hypogonadism
GH
Estrogen
Estrogen Patches
IGF-I
Body Composition
Protein Metabolism
Lipolysis
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2005-09-01
Enrollment: 16
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study attempts to evaluate if the way of administering estrogen, the principal female hormone, via patches or orally, affects the way estrogen works in girls with Turner Syndrome. These are girls who are very short and whose ovaries do not work. We will examine changes bone, protein and fat metabolism under the influence of estrogen delivered by a patch trough the skin vs estrogen taken orally. These studies are conducted while the girls are taking GH therapy.

Detailed description: Girls with Turner Syndrome, between the ages of 10-16 years, were chosen as the study population. The study requires 3 overnight admissions to an in-patient Clinical Research Center(CRC). A baseline study is performed using stable isotope tracers of leucine, glycerol and glucose and serial blood sampling to measure protein and fat metabolism. Indirect calorimetry is used to measure substrate oxidation rates and total energy expenditure. DEXA scan is used to measure bone mineral density and body composition. Once the baseline study is complete subjects are randomly assigned to receive either estrogen orally or through a patch placed onto the skin in increasing doses changed every 2 weeks. After 6 weeks of estrogen treatment a second metabolic study, identical to the first, is performed, followed by a wash out period of 4 weeks. Subsequently, the subjects are switched to the alternate form of estrogen. At the end of 6 weeks a third and final metabolic study is repeated. All subjects continue to be on growth hormone throughout the study procedures.

Eligibility criteria: Inclusion Criteria:Girls with Turner syndrome 10-16 years old who are receiving growth hormone treatment.

-

Exclusion Criteria:Systemic disease or concomitant treatment wtih Oxandrolone. Significant obesity or chronic steroid use.

-

Primary outcomes:
measure: Body Composition
measure: Rates of whole body protein kinetics
measure: Rates of whole body lipolysis
Secondary outcomes:
measure: Changes in IGF-I concentrations
measure: Changes in Plasma Lipids
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Nelly Mauras, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01589198: Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma
Official title: Identification of Molecular Biomarkers to Stratify Patients With Refractory Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Asthma
Lead sponsor: National Jewish Health
Sponsor class: OTHER
Collaborators: name: MedImmune LLC
First posted: 2012-05-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are looking for mild non-smoking asthmatic adults who are well-controlled with their asthma therapy (non-refractory asthmatics).

Brief summary: The purpose of this study is to learn more about asthma in people who are not well-controlled with current asthma medication (refractory asthma). The investigators will compare data from refractory asthmatic patients here at National Jewish Health to mild asthmatics subjects and to people without asthma. Study experiments involve looking at samples from all 3 groups and comparing them at a molecular level. These laboratory experiments may help identify subtypes of refractory asthmatics that require different treatments.


Eligibility criteria: Inclusion Criteria:

* Able to receive Informed Consent
* At least 18 years of age
* ICS \< 880 mcg (FP equivalents)
* PC20\<=16 mg/mL
* No more than 1 oral steroid bursts in previous 12 months
* Less that 3 urgent care visit in previous 12 months
* No deterioration with \<=25% decrease in steroids
* No near fatal asthma event

Exclusion Criteria:

* Pregnancy
* Current smoker, smoking within the past year or pack/year history \>10 years
* Respiratory infection within past 6 weeks
* Antibiotics within the past 6 weeks
* Active lung disease other than asthma
* Cancer within past 5 years (excluding basal cell skin cancer)
* Active or chronic infection
* Hematological or autoimmune disease
* Unable to safely undergo bronchoscopy as determined by doctor or study doctor

Primary outcomes:
measure: Determining phenotypes non-invasively
timeFrame: October, 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
affiliation: National Jewish Health
name: Richard Martin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00157898: A Study to Evaluate Ertapenem Versus It's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults (0826-050)(COMPLETED)
Official title: A Prospective, Multicenter, Open, Randomized, Comparative Study to Evaluate the Safety and Efficacy of Ertapenem Versus it's Comparator in the Treatment of Complicated Intra-abdominal Infections in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Complicated Intra-abdominal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a prospective, randomized, controlled, open, and multi-center trial conducted to compare the clinical efficacy and safety of ertapenem with it's comparator before or following adequate surgical management of complicated intra-abdominal infection.


Eligibility criteria: Inclusion Criteria:

* Males or females between the ages of 18 and 75 who have complicated intra-abdominal infection.

Primary outcomes:
measure: Favorable clinical response at 7-14 days after treatment
Secondary outcomes:
measure: Favorable microbiologic response at 7-14 days after treatment
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02934698: An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations
Official title: An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cystic Fibrosis
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Vertex Pharmaceuticals Incorporated
First posted: 2016-10-17
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This postmarketing N of 2 study is designed to evaluate the efficacy and safety of open-label ivacaftor treatment in two sisters with cystic fibrosis and pancreatic sufficiency.

Detailed description: The two sisters have a splicing mutation that is predicted to respond favorably to ivacaftor therapy. In addition to measurement of usual clinical outcomes (i.e. lung function, nutritional status), there is great interest on the impact on nontuberculous mycobacteria (NTM) airways infection.

Subjects will undergo sputum cultures at baseline and monthly during treatment, initially in the absence of anti-NTM therapy but with the intent to treat with antibiotics if there is persistence of the infection in cultures. Other clinical outcomes will include changes in sweat chloride, lung function and weight. Safety measures will include periodic assessment of liver enzymes. All serious and non-serious adverse events will be collected

Eligibility criteria: Inclusion Criteria:

* Subjects are \>18 years of age and able to provide informed consent.
* Subjects reside in the US and are willing to be treated with ivacaftor.
* Subjects have the splicing mutation of interest.
* Subjects are willing and able to perform requirements of the study.

Exclusion Criteria:

* There are no relevant exclusion criteria for this n-of-2 study.

Primary outcomes:
measure: Forced Expiratory Volume
timeFrame: 24 weeks
Secondary outcomes:
measure: Sputum Results
timeFrame: 24 weeks
measure: Sweat Chloride
timeFrame: 24 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Medical University of South Carolina
name: Patrick A Flume, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04018898: Older Emergency Department Users and Short-term Adverse Events at the Index Visit
Official title: Older Emergency Department Users and Short-term Adverse Events at the Index Visit: Which Clinical Prognostic Tool is Used?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Impairment
Adverse Event
Hospitalization
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 10971
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this study will be enrolled people who are 75 years and over, and who come at Emergency not only for medical reason but also for social.

Brief summary: This study evaluates the difference between PRISMA-7 and ER2 tool. There are some differences between PRISMA-7 and ER2 tool. The differences consist in evaluation criteria that are used to perform the both surveys. We suppose that evaluation criteria of PRISMA-7 is not accurately enough to calculate the length of hospital stay and to predict the short-term outcomes.

Detailed description: The "Program of Research on Integration of Services for the Maintenance of Autonomy" (PRISMA-7) is the Ministry of Health and Social Services' reference tool for the assessment of older ED users in Quebec (Canada). PRISMA-7 has been initially designed to screen disability in community-dwelling older adults and has never been validated for risk for short-term adverse events in older ED users. "Emergency room evaluation and recommendations" (ER2) is another clinical tool which is currently evaluated in Quebec. Compared to PRISMA-7, ER2 has been especially designed for assessing risk for short-term ED adverse events. No study has compared PRISMA-7 and ER2 risk for short-term adverse events. We hypothesised that ER2 could be a better prognostic tool compared to PRISMA-7 for long length of stay in ED and hospital stay, and hospital admission because it was designed and validated for this specific goal. The study aims to 1) examine and compared PRISMA-7 and ER2 risk for long length of ED and hospital stay and hospital admission, and 2) to establish their performance criteria (i.e., sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratios) for these three short-term adverse events in older ED users.

Eligibility criteria: Inclusion Criteria:

* Being 75 years old and over
* Brought at Emergency on medical stretcher

Exclusion Criteria:

* Being less than 75 years old
* Never come at Emergency

Primary outcomes:
measure: Short-term adverse events
timeFrame: Around 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Oliver Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04104698: Cognitive, Psychological and Electrophysiological Attributes to Suicide Among Depressed Patients
Official title: Cognitive, Psychological and Electrophysiological Attributes to Suicide Among Depressed Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suicide
Major Depressive Disorder
Quantitative EEG (qEEG)
Keywords: Suicide
Major Depression
quantitative EEG (qEEG)
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 50 Egyptian patients will be recruited from Mansoura University Hospitals at the outpatient clinics and the inpatient department.

Brief summary: This study will try to provide a better understanding of the psychological, cognitive and electrophysiological factors that contribute to suicide in depressed patients.

Detailed description: Objectives:

1. To investigate the ability of qEEG to suspect suicidal potential in patients diagnosed with major depression.
2. To test the ability of some psychological and cognitive elements in determining the likelihood of suicide in such patients.
3. To give an objective and more reliable method than traditional questionnaires to assess the seriousness of suicidal ideations in patients suffering from depression who usually don't reveal their actual intentions.

Eligibility criteria: Inclusion Criteria:

* Age between 16 and 65 years
* Both males and females will be enrolled
* Patients present with the clinical picture of Major depression according to DSM 5 criteria.

Exclusion Criteria:

* Psychotic features associating depressive episode
* Bipolar depression
* The condition is due to another medical condition
* The condition is substance or medication-induced
* Intellectual disability
* Comorbid epilepsy

Primary outcomes:
measure: Electrophysiological attibutes to suicide among depressed patients
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
References: