louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00317668: Role of Antibodies Against Glutamate Receptors and Double Stranded DNA in Epilepsy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-04-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The investigators will check the serum of epilepsy patients for antibodies against glutamate receptors and double stranded DNA. They will characterise the patients (by the kind of epilepsy, autoimmune disease comorbidity, and cognitive profile).


Eligibility criteria: Inclusion Criteria:

* 120 epilepsy patients from the epilepsy clinic and Emergency Room (ER)
* Controls: 100 patients with other neurological diseases and no epilepsy; and 30 healthy volunteers.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Ein-Kerem Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Dana Ekstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00684268: Intravenous Silibinin in Combination With Peg-interferon and Ribavirin in Nonresponders
Official title: Multicenter Study To Evaluate The Efficacy Of Silymarin In Addition To Combination-Therapy With Pegylated Interferon Alfa 2a (Peg-Ifn Alfa 2a) And Ribavirin In Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: silibinin
chronic hepatitis C
peginterferon
ribavirin
nonresponders
efficacy of iv. silibinin
safety
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2008-05-26
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: By chance the investigators found that iv. silibinin has a potent antiviral effect against the hepatitis C virus. Based on the results of the dose finding study (published) te optima dosing schedule is explored.This study will be evaluate whether the highest active dose given for the optimal time combined with standard of care will result in a sustained virologic response (=cure of hepatitis C).

Detailed description: Since the publication of the first data the optimal dosing schedule is investigated

Eligibility criteria: Inclusion Criteria:

* Nonresponders to full dose PEG-IFN/RBV therapy
* Liver biopsy within the last 2 year

Exclusion Criteria:

* Intolerance to one of the study drugs
* Coinfection with HIV/HBV

Primary outcomes:
measure: viral response at week 24
timeFrame: week 24
Secondary outcomes:
measure: sustained virologic response
timeFrame: week 72
measure: Safety
timeFrame: week 72
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Medical University of Vienna
Study officials:
References:
citation: Beinhardt S, Rasoul-Rockenschaub S, Scherzer TM, Ferenci P. Silibinin monotherapy prevents graft infection after orthotopic liver transplantation in a patient with chronic hepatitis C. J Hepatol. 2011 Mar;54(3):591-2; author reply 592-3. doi: 10.1016/j.jhep.2010.09.009. Epub 2010 Oct 14. No abstract available.
citation: Ferenci P, Scherzer TM, Kerschner H, Rutter K, Beinhardt S, Hofer H, Schoniger-Hekele M, Holzmann H, Steindl-Munda P. Silibinin is a potent antiviral agent in patients with chronic hepatitis C not responding to pegylated interferon/ribavirin therapy. Gastroenterology. 2008 Nov;135(5):1561-7. doi: 10.1053/j.gastro.2008.07.072. Epub 2008 Aug 3.
citation: Payer BA, Reiberger T, Rutter K, Beinhardt S, Staettermayer AF, Peck-Radosavljevic M, Ferenci P. Successful HCV eradication and inhibition of HIV replication by intravenous silibinin in an HIV-HCV coinfected patient. J Clin Virol. 2010 Oct;49(2):131-3. doi: 10.1016/j.jcv.2010.07.006. Epub 2010 Aug 14.
citation: Rutter K, Scherzer TM, Beinhardt S, Kerschner H, Stattermayer AF, Hofer H, Popow-Kraupp T, Steindl-Munda P, Ferenci P. Intravenous silibinin as 'rescue treatment' for on-treatment non-responders to pegylated interferon/ribavirin combination therapy. Antivir Ther. 2011;16(8):1327-33. doi: 10.3851/IMP1942.
Clinical trial NCT05737368: Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
Official title: Treatment of Recurrent Glioblastoma With Fractionated Radiotherapy Combined With Cadonilimab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Recurrent Glioblastoma
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: 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 evaluate the safety and effectiveness in the treatment of recurrent glioblastoma with Cadonilimab combined with fractionated radiotherapy.


Eligibility criteria: Inclusion Criteria:

1. . Written and signed informed consent.
2. . Male or female, age≥ 18 and ≤ 75 years old on day of signing informed consent.
3. Epitentorial glioblastoma confirmed by pathology; Diagnosis of recurrence through clinical imaging evidence.
4. The maximum diameter of recurrent tumor is less than 6 cm.
5. Concurrent radiotherapy and chemotherapy with standard STUP treatment scheme in the past.
6. The interval from the last radiotherapy is more than 6 months.
7. KPS (Karnofsky function status score)\>60.

Exclusion Criteria:

1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment.
2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies.
3. Multiple malignant gliomas.
4. Subtentorial glioblastoma or Extracranial metastatic lesions.
5. Active autoimmune diseases.
6. Known history of primary immunodeficiency virus infection or known history of testing positive for human immunodeficiency virus (HIV).

Primary outcomes:
measure: Incidence and severity of adverse events (AEs)
timeFrame: 3 months after treatment
Secondary outcomes:
measure: Local control rate (LC)
timeFrame: from date of enrollment to date of first documented local progression. Assessed up to 6 months
measure: Objective Response Rate (ORR)
timeFrame: from date of enrollment to the date of first documented complete response or partial response. Assessed up to 6 months
measure: Disease control rate (DCR)
timeFrame: from date of enrollment to the date of progress. Assessed up to 6 months
measure: progression-free survival (PFS)
timeFrame: from date of enrollment to the date of first documented progression. Assessed up to 6 months
measure: survival (OS) rate
timeFrame: from date of enrollment to the date of death from any cause. Assessed up to 6months
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang University
name: Qichun Wei, MD/PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04408768: Stress Hyperglycemia and Acute Ischemic Stroke
Official title: Stress Hyperglycemia as a Prognostic Factor in Acute Ischemic Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Hyperglycemia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study included eighty acute ischemic stroke patients who presented within 24 hours of onset of symptoms. They were equally divided into two groups; group A included patients with normal (70-150 mg/dl) RBS on ICU admission and controlled blood sugar within 24 h, while group B included those with high RBS on ICU admission and uncontrolled blood sugar during first 24 h.

Brief summary: Whereas diabetes mellitus is clearly a risk factor for the occurrence of stroke and for its poor prognosis, hyperglycemia per se is also linked to increased morbidity and mortality in stroke patients.Therefore, the objective of this work was to study the glycemic status of acute ischemic stroke patients and to assess its impact on stroke outcome.

Detailed description: Using PASS program, setting alpha error at 5% and power of 80%, the total sample size was estimated to be 80 cases.

The NIHSS was used as a primary outcome; 40 cases were needed in each group. Secondary outcomes were hemorrhagic transformation, hospital stay duration, mechanical ventilation, need for vasopressors, and 30-days mortality.

Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke within 24 hours of onset of symptoms

Exclusion Criteria:

* subdural hematoma
* Transient ischemic attack
* Subarachnoid hemorrhage
* Hemorrhagic stroke
* Major comorbidities Hyperglycemia on admission that was controlled (random blood sugar (RBS) \< 150 mg/dl) within 24 hours with insulin therapy, diabetic
* Ketoacidosis
* RBS less than 70 mg/dl on admission

Primary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: 30 days
Secondary outcomes:
measure: 30-days mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hanaa El Gendy
state: Ain Shams University Specialized Hospital
Study officials:
References:
Clinical trial NCT00493168: Determination of the Prevalence and Prognostic Importance of Unrecognized Non-Q-wave Myocardial Infarction by MRI
Official title: Unrecognized Non-Q-wave Myocardial Infarction: Prevalence, Angiographic Correlation, and Prognostic Significance in Patients With Suspected Coronary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Arteriosclerosis
Myocardial Infarction
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2007-06-28
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The first aim of this study is to determine how often unrecognized myocardial infarction occur in patients using a magnetic resonance imaging (MRI) technique (known as delayed enhancement MRI), as compared to the electrocardiogram. The second aim of this study is to determine the severity of coronary heart disease of the patients with unrecognized myocardial infarction. The final aim is to determine how the presence of unrecognized myocardial infarction detected by the MRI affects lifespan.

Detailed description: Unrecognized myocardial infarction (MI) is known to constitute a substantial portion of lethal coronary heart disease. However, since the diagnosis of unrecognized MI is based on the appearance of incidental Q-waves on 12-lead electrocardiography, the syndrome of unrecognized non-Q-wave MI has not been described. Delayed-enhancement cardiovascular magnetic resonance (DE-CMR) can accurately identify non-Q-wave MI. The aims of this study are three-fold: 1. to determine the prevalence of unrecognized non-Q-wave and Q-wave MI, 2. to define predictors of unrecognized non-Q-wave MI, 3. to determine the prognostic significance of unrecognized non-Q-wave MI.

Eligibility criteria: Inclusion Criteria:

* Patients with suspected coronary artery disease referred for invasive coronary angiography

Exclusion Criteria:

* Clinical history of myocardial infarction
* Percutaneous coronary intervention
* Coronary artery bypass surgery
* Known uncured malignancy
* History of hypertrophic cardiomyopathy, myocarditis, or infiltrative heart disease
* Contraindication of magnetic resonance imaging

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Medical School
state: Illinois
city: Durham
country: United States
facility: Duke Cardiovascular Magnetic Resonance Center
state: North Carolina
Study officials:
affiliation: Duke Cardiovascular Magnetic Resonance Center
name: Han W Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Cardiovascular Magnetic Resonance Center
name: Raymond J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HW, Klem I, Shah DJ, Wu E, Meyers SN, Parker MA, Crowley AL, Bonow RO, Judd RM, Kim RJ. Unrecognized non-Q-wave myocardial infarction: prevalence and prognostic significance in patients with suspected coronary disease. PLoS Med. 2009 Apr 21;6(4):e1000057. doi: 10.1371/journal.pmed.1000057. Epub 2009 Apr 21.
Clinical trial NCT01110668: Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)
Official title: Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST) Previously Treated With Imatinib
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastrointestinal Stromal Tumor
Keywords: Unresectable
metastatic gastrointestinal stromal tumor
disease progression
progression-free survival
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 2
Sex: ALL
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 study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic
* Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose
* At least one measurable site of disease on CT scan at Visit-2
* WHO Performance Status of 0, 1 or 2 at Visit-2
* Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2

Exclusion Criteria:

* Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib.
* Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks
* Prior or concomitant malignancies other than GIST
* Impaired cardiac function at Visit-1 or 2
* Patients with severe and/or uncontrolled concurrent medical disease
* Use of therapeutic coumarin derivatives
* Use of any medications that prolong the QT interval
* Use of CYP3A4 inhibitors
* Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery
* Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks prior to Visit-1 or who have not recovered from side effects of such therapy

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.
timeFrame: every 8 weeks
Secondary outcomes:
measure: To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg.
timeFrame: 6 months
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00924768: A Study of Inhalation of 20,000 EU CCRE and Mucociliary Clearance (MCC) in Otherwise Healthy Individuals Who Are Current Cigarette Smokers
Official title: A Study of Inhalation of 20,000 EU CCRE and MCC in Otherwise Healthy Individuals Who Are Current Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Cigarette Smoking
Keywords: Otherwise healthy current cigarette smokers
current cigarette smokers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in sputum cell samples that the scientists can measure. The investigators are also interested in seeing if the exposure to the endotoxin decreases the body's natural ability to clear mucus from the lungs.

Detailed description: The purpose of this study is to determine the range of neutrophil response (influx of PMNs to the airways as determined in sputum) after inhalation of CCRE (20,000 EU), shown in previous studies of healthy, nonsmoking volunteers as well as in a limited number of otherwise healthy smokers to be well tolerated. This dose induces measurable increases in neutrophil content of induced sputum that can be employed to screen large populations for susceptibility to the inflammatory effect of inhaled endotoxin. Limitations of the understanding of actions of inflammatory stimuli on airway function are likely due to the fact that functional assessments of dynamic airway response /in vivo/ have generally been limited to those based on spirometry and examination of airway samples for assessment of cells and mediator content. Slowing of mucociliary clearance (MCC), a key component of airway defense, can be induced by inflammation and almost certainly contribute to mucus plugging and decreased clearance of inhaled irritants. Measures of mucociliary clearance (MCC), by inhalation of radiolabeled particles to label airway surface liquid, suggest that clearance of secretions is impaired to a mild degree in smokers and more severely in patients hospitalized for acute exacerbations.

Eligibility criteria: Inclusion Criteria:

* Must be current cigarette smokers
* Must be otherwise healthy
* Must be good sputum producers

Exclusion Criteria:

* Any acute illness any chronic illness which would impact results

Primary outcomes:
measure: Increase in sputum neutrophils
timeFrame: 6 hours
Secondary outcomes:
measure: Mucociliary clearance rates
timeFrame: 4 hours
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Environmental Medicine, Asthma and Lung Biology
state: North Carolina
Study officials:
affiliation: University of NC Chapel Hill Hospitals
name: David Peden
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02556268: Interaction With HIV Antiretroviral Agents
Official title: Potential Pharmacokinetic Interaction of Human Immunodeficiency Virus (HIV) Antiretroviral Agents as Fixed-dose Combinations and Riociguat in HIV Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-DDI
Keywords: Single-Dose, Open-Label, Non-Blinded, Non-Placebo-
Controlled, Stratified Design
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-09-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To investigate the pharmacokinetic drug-drug interaction potential of fixed dose antiretroviral therapies, i.e. ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor in combination with (preferably) TRIUMEQ, on the exposure to riociguat in HIV patients on a stable dose of one of these therapies.

• To Assess the safety and tolerability of riociguat treatment in combination with these fixed-dose antiretroviral therapies.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged \>=18 to \<65 years with a confirmed diagnosis of HIV receiving a stable regimen of ATRIPLA, COMPLERA, STRIBILD, TRIUMEQ, or any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir in combination with (preferably) TRIUMEQ consistent with the most recent prescribing information documents for at least 6 weeks before concomitant administration of a single oral dose of 0.5 mg riociguat
* No clinical evidence of pulmonary hypertension
* Written informed consent

Exclusion Criteria:

* Severe diseases for which it can be assumed that the pharmacokinetics or effects of the study drug will not be normal
* History of coronary artery disease
* Symptomatic postural hypotension (e.g. dizziness, lightheadedness)
* History of bronchial asthma or any other airway disease
* Renal impairment with creatinine clearance \<15 mL/min
* Severe hepatic impairment (Child-Pugh class C)
* Systolic blood pressure below 100 mmHg

Primary outcomes:
measure: AUC of riociguat
timeFrame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
measure: Cmax of riociguat
timeFrame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
measure: AUC of riociguat main metabolite M1 (BAY 60-4552)
timeFrame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
measure: Cmax of riociguat main metabolite M1 (BAY 60-4552)
timeFrame: at pre-dose and 0.5, 1, 1.5, 2, 4, 6, 8 24 and 48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
state: Florida
city: Boston
country: United States
state: Massachusetts
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: