louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00867295: Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device
Official title: A Randomized, Double-blind, Placebo-controlled Trial to Determine Effectiveness of Antibiotic Prophylaxis for Totally Implantable Venous Access Device.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Solid Tumor
Keywords: implantable catheters
Indwelling Catheters
infection
cefazolin sodium
prophylactic
antibiotic
totally implantable venous access device
cancer patients
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2009-03-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized trial is determining the role of antibiotic prophylaxis in the prevention of the infectious complications in patients carrying out totally implantable venous access device.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years of age
* Have solid tumor
* White cells \>4000
* Platelets \>100.000
* Prothrombin time in normal range

Exclusion Criteria:

* Drug allergy
* Diabetes mellitus

Primary outcomes:
measure: infectious complication
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Institute of Oncology
state: Capa
Study officials:
affiliation: Istanbul University Institute of Oncology Department of Surgery
name: Hasan Karanlik, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karanlik H, Kurul S, Saip P, Unal ES, Sen F, Disci R, Topuz E. The role of antibiotic prophylaxis in totally implantable venous access device placement: results of a single-center prospective randomized trial. Am J Surg. 2011 Jul;202(1):10-5. doi: 10.1016/j.amjsurg.2010.05.005. Epub 2011 May 23.
Clinical trial NCT03933995: Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived MSCs in Erectile Dysfunction
Official title: Follow up Study(Phase 1) to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erectile Dysfunction
Lead sponsor: Pharmicell Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-01
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).

Brief summary: This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849).

Detailed description: This is a 5year (+-30 days) long term follow up study to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in erectile dysfunction subject who participated in and completed the Phase 1 trials (refer to ClinicalTrials.gov.Identifier: NCT02344849).

This trial is planned to evaluate the safety of autologous bone marrow derived mesenchymal stem cell in patients with erectile dysfunction subject. Subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, Serious Adverse Events, cancer incidence, recurrence of prostate cancer and vital sign).

Eligibility criteria: Inclusion Criteria:

1. Subjects who treated with Mesenchymal stem cell and enrolled the phase 1 study(NCT02344849).
2. Subjects who can agree to participate in the long term observation study by oneself.

Exclusion Criteria:

* Not Applicable

Primary outcomes:
measure: Safety Evaluation assessed by Tumor Marker Test.
timeFrame: 5 year(+-30 days)
measure: Safety Evaluation assessed by Serious Adverse Events, cancer incidence and recurrence of prostate cancer.
timeFrame: 5 year(+-30 days)
measure: Safety Evaluation assessed by Vital Signs.
timeFrame: 5 year(+-30 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
affiliation: Asan Medical Center
name: Chungsu Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01135095: Low Dose One-Day Tc99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera For Detection of Coronary Disease
Official title: Validation of a Low-Dose One-Day TC99m Protocol With a High-Efficiency Cardiac Dedicated Gamma Camera for Detection of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Pain
Keywords: Myocardial perfusion
Low radiation dose
Single photon emission computed tomography
Lead sponsor: Spectrum Dynamics
Sponsor class: INDUSTRY
Collaborators: name: PeaceHealth Medical Group
name: Brigham and Women's Hospital
name: Cedars-Sinai Medical Center
First posted: 2010-06-02
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective single clinical trial to validate the use of a low-dose (\~5mSv) Tc-99m protocol with a high-efficiency cardiac dedicated camera (Dynamic Single Photon Emission Computed Tomography; D-SPECT) to detect myocardial perfusion abnormalities during myocardial perfusion imaging.

Detailed description: as above

Eligibility criteria: Inclusion Criteria:

1. Patient is referred to myocardial perfusion D-SPECT for clinical indications.
2. Written informed consent is obtained by a study investigator.

Exclusion Criteria:

1. Patient is diagnosed as having uncontrolled congestive cardiac failure or cardiogenic shock.
2. Patient is diagnosed as having uncontrolled hypertension with resting blood pressure \> 220 mm Hg systolic or 110 mm Hg diastolic.
3. Patient pregnancy (known or suspected).
4. Lack of written informed consent
5. Prisoner status
6. Minors under the age of 18 as coronary artery disease is generally an adult disease

Primary outcomes:
measure: Summed Rest Score (SRS) Using American Heart Association 17 Segment Polar Map Model
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Springfield
country: United States
facility: Oregon Heart and Vascular Institute
state: Oregon
Study officials:
affiliation: Columbia University Medical Center, Department of Medicine, Division of Cardiology
name: Andrew Einstein, MD,PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars-Sinai Medical Center
name: Dan Berman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02671695: Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
Official title: Effect of Spirulina Compared to Amlodipine on Cardiac Iron Overload in Children With Beta Thalassemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Beta Thalassemia Major
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload and cardiac functions in multi-transfused children with beta thalassemia major

Detailed description: the aim of this study is to evaluate the effect of Spirulina compared to Amlodipine on cardiac iron overload using magnetic resonance imaging and cardiac functions in multi-transfused children with beta thalassemia major

Eligibility criteria: Inclusion Criteria:

* patients on regular blood transfusions.
* iron overload with no perspective of changing the chelation therapy in the following three months

Exclusion Criteria:

* formal contraindication to magnetic resonance examinations
* implantable cardiac device
* advanced cardiomyopathy or conduction block
* other types of hemolytic anemias

Primary outcomes:
measure: cardiac iron concentration by magnetic resonance imaging
timeFrame: 3 months
Secondary outcomes:
measure: cardiac troponin 1
timeFrame: 3 months
measure: N-terminal pro-brain natriuretic peptide
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Medicine- Tanta University
state: Gharbia
Study officials:
affiliation: assisstant professor of clinical pharmacy- Faculty of Pharmacy- Tanta University
name: Sahar M El-Haggar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01995955: Evaluation of Coronary Microvascular Dysfunction (EVACORY)
Official title: The Proposed Study is to Validate a New Non-invasive Imaging Technique for Evaluation of Cardiac Microciculation in Coronary Artery Disease With a Comparison With Validated Technique Invasive, Which is Measure of Index of Myocardial Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Microvascular Dysfunction
coronary artery disease
index of myocardial resistance
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 45
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 proposed study is to validate a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease with a comparison with validated technique invasive, which is measure of index of myocardial resistance.

Detailed description: Coronary microvascular dysfunction is closely associated with coronary artery disease, it is an independent risk factor and predicts future coronary events or clinically manifest disease up to 10 years later.

Index of microcirculatory resistance (IMR) is a validated method to Assessment of the Coronary Microcirculation but this is an invasive technique.

In this study, we use a new mathematic technique from homogeneity analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with new camera CZT SPECT. We compare the results with those of the measurement of IMR.

Eligibility criteria: Inclusion Criteria:

* Stable angina
* Cadmium-zinc-telluride gamma camera SPECT
* Coronarography

Exclusion Criteria:

* Pregnant woman
* Patient with terminal illness,
* Terminal Renal failure
* Allergy to iodine
* Contraindications for adenosine: Asthmatic patients, Second- or third-degree AV block without a pacemaker or sick sinus syndrome, Systolic blood pressure less than 90mm Hg, Recent use of dipyridamole or dipyridamole-containing medications, Methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test, Known hypersensitivity to adenosine, Unstable acute myocardial infarction or acute coronary syndrome

Primary outcomes:
measure: coronary microcirculation
timeFrame: day 0 (inclusion)
Secondary outcomes:
measure: scintigraphy
timeFrame: day 0 (inclusion)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
state: Isère
Study officials:
affiliation: University Hospital, Grenoble
name: BARONE ROCHETTE MD Gilles
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00710255: Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm
Official title: Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm Determined by Dynamic Analysis of Exhaled Breath Condensate.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma, Exercise Induced
Keywords: Asthma
Exercise induced bronchospasm
Hyperpnea induced bronchospasm
leukotrienes
adenosine
exhaled breath condensate
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2008-07-04
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthmatics with exercise induced bronchospasm

Brief summary: This research is being conducted to help us better understand what causes exercise induced asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and adenosine, play an important role. The investigators will be measuring these chemicals in the exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic exercise induced asthma. The investigators will determine how the levels of these chemicals change in association with how lung function changes before, during and after an episode of exercise induced asthma.


Eligibility criteria: Inclusion Criteria:

* Physician diagnosed asthma
* Age 12-75 yrs
* FEV1 \> 70% predicted
* HIB response \> 10 %
* No smoking last 6 mo and \< 10 pack yrs
* No URI last 4 weeks
* No asthma exacerbation last 4 weks
* Able to withhold SABA \> 8 hrs and LABA \> 24 hrs

Exclusion Criteria:

* Other lung disease
* Cardiac disease or other condition that would preclude safe participation, on theophylline or leukotriene modifiers

Primary outcomes:
measure: Change in level of cystLTs and adenosine
timeFrame: Before and after hyperpnea challenge
Secondary outcomes:
measure: Change in pH of EBC and change in pulmonary function
timeFrame: Before and after hyperpnea challenge
Other outcomes:
Locations:
city: Colchester
country: United States
facility: Vermont Lung Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: David A. Kaminsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00170755: A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
Official title: A Long-Term Safety, Tolerability and Efficacy Study of Darifenacin in Adult Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder Syndrome
Keywords: Overactive Bladder, incontinence, antimuscarinic, darifenacin, long-term treatment
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 718
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.


Eligibility criteria: Inclusion Criteria:

* Adult patients with overactive bladder who completed a previous darifenacin short-term trial.
* Patients capable of independent toileting and able of independently completing the patient diary.

Exclusion Criteria:

* Patients in whom the use of anticholinergic drugs was contraindicated
* Evidence of severe liver disease
* Patients with other clinically significant urinary or gynecological conditions

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Long term safety and tolerability. Safety assessments consisted of monitoring and recording all adverse events (AEs), serious adverse events (SAEs), hematology, blood chemistry, and urinalysis, vital signs, physical condition and body weight.
Secondary outcomes:
measure: Long term efficacy on the symptoms of overactive bladder
measure: King's Health questionnaire and EQ-D(at month 3, 6, 12, 24), Patient satisfaction questionnaire, patient valuation questionnaire,bowel questionnaire (at month 6, 12 and 24) and patients' willingness to reuse(at month 12, 24),
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: East Hanover NJ
name: Novartis
role: STUDY_CHAIR
References:
citation: Dwyer P, Kelleher C, Young J, Haab F, Lheritier K, Ariely R, Ebinger U. Long-term benefits of darifenacin treatment for patient quality of life: results from a 2-year extension study. Neurourol Urodyn. 2008;27(6):540-7. doi: 10.1002/nau.20620.
Clinical trial NCT05504655: N-Acetylcysteine as an Adjuvant Therapy in Critically Ill COVID-19 Patients:
Official title: Safety and Efficacy of N-Acetylcysteine as an Adjuvant Therapy in Critically Ill COVID-19 Patients: A Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pneumonia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older of both genders diagnosed with confirmed critically ill COVID-19

Brief summary: In this study, we retrospectively will investigate safety and efficacy of NAC dose given in paracetamol toxicity as an adjuvant therapy in critically ill COVID-19 patients with acute respiratory distress and determine whether NAC in high doses can avoid respiratory failure in patients with COVID-19.

Detailed description: Type of Study:Retrospective Observational Cohort Study. Study Setting: Ain shams university hospitals . Study Period: from December 2020 to February 2022 Study Population:Patients aged 18 years or older of both genders diagnosed with confirmed critically ill COVID-19 .

This is a retrospective observational study in which all cases will be collected from ICU of Ain shams university hospitals during COVID-19 outbreak. All data will be extracted from clinical records. All patients initially admitted to ICU with SPO2 less than 94 % will be included between December 2020 to February 2022. Infection with COVID-19 was confirmed by PCR. All patients received standard care, according to the institutional protocol.

Laboratory and Radiological Investigations Demographic, clinical, laboratory, management, and outcome data will be obtained from the medical records. Routine laboratory tests were done for all patients, including CBC, C-reactive protein, renal profile, coagulation profile, liver profile, lactate, electrolytes, procalcitonin, ferritin and D-dimer.Infection with COVID-19 was confirmed by reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasopharyngeal swab. Chest computed tomography (CT) was also done for all patients.

Eligibility criteria: Inclusion Criteria:

* Oxyhemoglobin saturation (SaO2) of less than 94% while breathing ambient air

Exclusion Criteria:

* Need for immediate mechanical ventilation on admission, known allergy or hypersensitivity to NAC, end stage renal and liver diseases, heart failure and pregnancy.

Primary outcomes:
measure: The necessity for invasive mechanical ventilation
timeFrame: 3 to 4 months
Secondary outcomes:
measure: The onset and duration of invasive mechanical ventilation, length of ICU stay, length of hospital stay and 28 days mortality
timeFrame: 3 to 4 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa El Gendy
state: Ain Shams University Specialized Hospital
Study officials:
References:
Clinical trial NCT04260555: Clinical Trial to Evaluate the Efficacy and Safety of 'DW1601' in Acute Bronchitis
Official title: A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Bronchitis
Lead sponsor: Daewon Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-07
Enrollment: 204
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multicenter, Randomized, Double-Blind, Parallel, Active-controlled, Superiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1601 Compared to DW16011 and DW16012 for Acute Bronchitis


Eligibility criteria: Inclusion Criteria:

* Both gender, 19 years ≤ age ≤ 80 years
* Bronchitis Severity Score\* ≥ 5point at Visit 2 (Randomized Visit)
* Acute bronchitis within 48hr based on Visit 2 (Randomized Visit)
* Those who can comply with the requirements of clinical trials
* Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

* Patients who investigators determines to severe respiratory disease that would interfere with study assessment
* Patients with systemic infections requiring systemic antibiotic therapy
* patient with hemostatic disorder

Primary outcomes:
measure: Bronchitis Severity Score(BSS)
timeFrame: Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
Clinical trial NCT01456455: Gastric Cancer Metastasized to the Central Nervous System (CNS)
Official title: Registry of Gastric Cancer and Brain Metastases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
Keywords: Central nervous system
pathological markers
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: international

Brief summary: Descriptive registry to investigate frequency of HER-2 positive gastric cancer involving CNS.

Exploration of additional prognostic factors for brain involvement from gastric cancer.

Detailed description: HER2 Status E-Cadherin Status

Eligibility criteria: Inclusion criteria:

* in order to be eligible for the study, the diagnosis of gastric cancer and/or lower esophageal cancer must be confirmed histologically. CNS involvement must be confirmed either via independent neuroradiological and/or positive CSF cytology.

Exclusion criteria:

* Patients whose diagnosis is not confirmed upon pathological review or where the CNS involvement cannot be confirmed after neuroradiological review will be excluded from this study.

Primary outcomes:
measure: HER2 Status
timeFrame: 2 years
Secondary outcomes:
measure: Outcome according to HER2 Status
timeFrame: 2 years
Other outcomes:
measure: Outcome according to ethnicity of patients
timeFrame: 2 years
Locations:
city: Zurich
country: Switzerland
facility: Dept Oncology, University Hospital Zürich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Division of Oncology
name: Silvia Hofer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feilchenfeldt J, Varga Z, Siano M, Grabsch HI, Held U, Schuknecht B, Trip A, Hamaguchi T, Gut P, Balague O, Khanfir K, Diebold J, Jochum W, Shoji H, Kushima R, Wagner D, Shimada Y, Cats A, Knuth A, Moch H, Aebi S, Hofer S. Brain metastases in gastro-oesophageal adenocarcinoma: insights into the role of the human epidermal growth factor receptor 2 (HER2). Br J Cancer. 2015 Sep 1;113(5):716-21. doi: 10.1038/bjc.2015.279. Epub 2015 Aug 27.