louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00367978: Effects of Amlodipine/Benazepril in the Hypertensive African-American Population With Type 2 Diabetes Mellitus
Official title: A Randomized, Multicenter, Study to Determine the Efficacy and Safety of Amlodipine/Benazepril Hydrochloride Versus Enalapril in the Treatment of Hypertension in an African-American Population With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension, diabetes, African-American, amlodipine/benazepril
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-08-24
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated the efficacy and safety of amlodipine/benazepril compared with that of enalapril in the treatment of hypertension in African-American patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* African-American
* males and females
* current diagnosis of type 2 diabetes documented by medical history;
* mean sitting diastolic blood pressure of ≥ 90 and ≤ 110 mm Hg;
* HbA1C ≤ 9.5%

Exclusion Criteria:

* having unilateral or bilateral renal artery stenosis;
* having clinically significant cardiac dysrhythmias;
* having a significant history of coronary artery disease within the past 6 months;
* having a history or diagnosis of congestive heart failure (CHF);
* having any clinically relevant cardiac valvular disease

Primary outcomes:
measure: Time from baseline to the achievement of first treatment success (defined as achieving a blood pressure (BP) <130/80 mm Hg). The proportion and cumulative proportion of patients who achieved first treatment success were also determined.
Secondary outcomes:
measure: change from baseline in sitting diastolic BP at Week 24
measure: change from baseline in sitting systolic BP at Week 24
measure: change from baseline in urinary protein excretion at Week 24
measure: change from baseline in HbA1c at Week 24
measure: change from baseline in estimated glomerular filtration rate (EGFR) at Week 24
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals Corporation
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals Corporation
role: STUDY_DIRECTOR
References:
Clinical trial NCT02862678: Predictive Value of Diffusion-weighted MRI Performed in Early Post-treatment in the Occurrence of Tumor Recurrence or Progression in Head and Neck Squamous Cell Carcinoma Treated With Chemoradiotherapy: a Pilot Study
Official title: Predictive Value of Diffusion-weighted MRI Performed in Early Post-treatment in the Occurrence of Tumor Recurrence or Progression in Head and Neck Squamous Cell Carcinoma Treated With Chemoradiotherapy: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 59
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: Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI) is a non radiating imaging, not requiring injection of gadolinium, giving informations on tumor activity, based on the brownian motion of water molecules. The differences in motion are expressed by the apparent diffusion coefficient (ADC). The ADC variations reflect changes in water molecules motion and redistribution between the intra- and extracellular compartments. Several studies have shown that malignant lesions have an ADC coefficient lowered as compared to benign lesions.

Detailed description: study the diagnostic performance of diffusion MRI performed in early post treatment, notably changes in the ADC factor, in the onset of tumor recurrence or progression in patients showing no residual tumor at the end a treatment by chemoradiotherapy for squamous cell carcinoma of head and neck seat.

compare the characteristics of diffusion MRI, such as ADC coefficient, between patients with residual tumor and patients with no residual tumor after chemoradiotherapy for squamous cell carcinoma of head and neck location.

Eligibility criteria: Inclusion Criteria:

* patients with head and neck squamous cell carcinoma
* patients with indication of a treatment by chemoradiotherapy (without surgical indication)
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

* patients with contraindications for MRI

Primary outcomes:
measure: tumor recurrence
timeFrame: 12 months
Secondary outcomes:
measure: residual tumors
timeFrame: 6 months
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT03165578: Neural Correlates of Neurofeedback Training
Official title: Neural Correlates of Neurofeedback Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nicotine Dependence
Depression
PTSD
Lead sponsor: Psychiatric University Hospital, Zurich
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the present study is to identify brain networks in patients that contribute to successfully learning self-regulation with real-time fMRI.

Detailed description: Neurofeedback has been established as a promising non-pharmacological therapeutic approach. However, patients differ in their ability to learn control over their own brain activity with neurofeedback. It is thus crucial to understand the brain networks that mediate learned self-regulation with real-time fMRI. The objective of the present study is thus to identify brain networks in patients that contribute to successfully learning self-regulation with real-time fMRI. To achieve this goal, patients suffering from depression, post-traumatic stress disorder, and nicotine addiction will be trained to improve their self-regulation skills using established real-time fMRI neurofeedback protocols.

Eligibility criteria: Inclusion Criteria:

* Magnetic resonance imaging compatibility.
* DSM-V diagnosis of major depressive disorder, post-traumatic stress disorder, or nicotine addiction, respectively.

Exclusion Criteria:

* Other physical or psychiatric disorders.
* Current substance abuse.
* Exclusion criteria applicable to MRI (metallic implants, claustrophobia, epilepsy).

Primary outcomes:
measure: brain patterns that mediate learning self-regulation in patients with fMRI neurofeedback
timeFrame: 12 months
Secondary outcomes:
measure: neurofeedback learning success
timeFrame: 12 months
measure: behavioral consequences of neurofeedback training
timeFrame: 12 months
measure: maintenance of learned self-regulation
timeFrame: 12 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Hospital of Psychiatry, University of Zurich
state: Zürich-
Study officials:
affiliation: Hospital of Psychiatry, University of Zurich
name: Frank Scharnowski, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04643678: Anakinra in the Management of COVID-19 Infection
Official title: Efficacy of Anakinra in the Management of Patients With COVID-19 Infection in Qatar: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Covid19
Pneumonia
Cytokine Release Syndrome
Corona Virus Infection
Viral Infection
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coronavirus Disease 2019 (COVID-19) was first isolated in Wuhan, China in December 2019. It is rapidly spreading worldwide, posing a severe threat to global health. Many therapeutics have been investigated for the treatment of this disease with inconclusive outcomes.

Anakinra - an interleukin (IL)-1 receptor antagonist - had showed survival benefits in patients with macrophage activation syndrome (MAS) and sepsis and was investigated for the use in COVID-19 infection with promising outcomes.


Eligibility criteria: Inclusion criteria:

* Hospitalized adult (age ≥ 18yrs)
* Confirmed COVID-19 diagnosis
* Presence of respiratory distress in addition to signs of cytokine release syndrome
* Radiological evidence of pneumonia
* Signed informed consent

Exclusion Criteria:

* Known allergic reactions to the study medication or any component of the product.
* Active bacterial, viral, TB, fungal infectious diseases
* Received immunosuppressant or immunomodulatory in the past 30 days
* Neutrophil count \< 500 cells/microliter
* Platelets \< 50,000/microliter
* Pregnant or breastfeeding females

Primary outcomes:
measure: Treatment Success at day 14
timeFrame: Day 14
Secondary outcomes:
measure: Change in WHO Clinical Progression Score
timeFrame: Day 7
measure: Time to ICU admission
timeFrame: Day 28
measure: Incidence of Adverse Events
timeFrame: Day 28
measure: Length of hospital stay
timeFrame: Day 28
measure: All-cause Mortality
timeFrame: Day 28
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
References:
Clinical trial NCT02683278: Fibromyalgia: Interventions for Pain and Mood Regulation
Official title: Fibromyalgia: Interventions for Pain and Mood Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Arizona State University
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the impact of cognitive-behavioral therapy for pain (CBT-P), mindful awareness and acceptance treatment (M), and arthritis education as an active control condition (E) on mental and physical health outcomes among adults with chronic pain due to fibromyalgia (FM).

Detailed description: Both cognitive-behavioral and mindful-acceptance based treatments impact pain and disability in people with chronic pain conditions like fibromyalgia. However, these treatments target different mechanisms. The focus of CBT is on helping individuals manage their thoughts and behaviors related to pain. In contrast, the focus of M is on improving individuals' ability be aware of and accept their experiences, and to develop their positive emotional resources.

Eligibility criteria: Inclusion Criteria:

* Pain in at least 11 of 18 tenderpoints
* Able to participate in study assessments and group-based meetings
* Willing to be randomized to treatment condition

Exclusion Criteria:

* Unable to understand written and spoken English
* Involved in pain-related litigation
* Currently involved in psychological treatment for pain and/or mood symptoms

Primary outcomes:
measure: Physical Functioning
timeFrame: Change from baseline, 6-mo followup, and 12-mo followup
measure: Bodily Pain
timeFrame: Change from baseline, 6-mo followup, and 12-mo followup
measure: Vitality
timeFrame: Change from baseline, 6-mo followup, and 12-mo followup
measure: Depressive symptoms
timeFrame: Change from baseline, 6-mo followup, 12-mo followup
measure: Social Functioning
timeFrame: Change from baseline, 6-mo followup, and 12-mo followup
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Arizona State University
name: Mary Davis, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01600378: Prospective Data Collection of Patients With Diffuse Parenchymal Lung Diseases
Official title: Prospective Data Collection of Clinical, Pulmonary Function, Radiological, Bronchoscopic and Fibered Confocal Fluorescence Microscopy Imaging, and Pathological Characteristics in Patients With Diffuse Parenchymal Lung Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diffuse Parenchymal Lung Diseases
Keywords: diffuse parenchymal lung disease
interstitial lung disease
idiopathic pulmonary fibrosis
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2012-05-17
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients evaluated for diffuse parenchymal lung diseases

Brief summary: The purpose of this study is to generate a prospective database of all patients evaluated for diffuse parenchymal lung diseases to provide much needed data on the various disease aetiologies, incidence and prevalence rates, clinical and radiological presentations, pathologic correlations, disease progression and response to treatment, and final outcomes in this group of patients in Singapore.


Eligibility criteria: Inclusion Criteria:

* All patients 21 years old and older diagnosed with suspected diffuse parenchymal lung disease (multi-lobar pulmonary infiltrates)

Exclusion Criteria:

* None

Primary outcomes:
measure: Final diagnoses of patients presenting with diffuse parenchymal lung disease after complete evaluation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Su Ying Low, BMBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: American Thoracic Society; European Respiratory Society. American Thoracic Society/European Respiratory Society International Multidisciplinary Consensus Classification of the Idiopathic Interstitial Pneumonias. This joint statement of the American Thoracic Society (ATS), and the European Respiratory Society (ERS) was adopted by the ATS board of directors, June 2001 and by the ERS Executive Committee, June 2001. Am J Respir Crit Care Med. 2002 Jan 15;165(2):277-304. doi: 10.1164/ajrccm.165.2.ats01. No abstract available.
citation: Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
Clinical trial NCT04963478: Study on Exercise Safety of Patients With Cardiovascular Diseases
Official title: Study on Exercise Safety of Patients With Cardiovascular Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed or suspected cardiovascular disease who completed the trial from January 2008 to September 2019 at Peking University Third Hospital with complete data

Brief summary: To retrospectively observe the cardiovascular safety during exercise in patients with cardiovascular diseases


Eligibility criteria: Inclusion Criteria:

Patients with confirmed or suspected cardiovascular disease who completed the trial

Exclusion Criteria:

Refusing to participate in the study

Primary outcomes:
measure: exercise-related cardiovascular events
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wei Zhao
state: Beijing
Study officials:
References:
Clinical trial NCT04694378: Relationship Between Strain and Stroke Volume in Cardiac Surgery
Official title: Relationship Between Right Ventricular Free Wall Longitudinal Strain and Stroke Volume Index by Thermodilution in Patients Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Right Ventricular Dysfunction
Stroke Volume Index
Longitudinal Heart Strain
Keywords: Echocardiography
Coronary artery bypass graft
Thermodilution
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 30
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: Male and female patients older that 18 years old.

Brief summary: Patients undergoing coronary artery bypass grafting up tp 30% will develop postoperative right ventricle dysfunction. Its imperative for the physician to fully understand the severity of this complication in order to perform an early diagnosis and carry out the appropriate treatment.

Aim:

Investigate the correlation between echocardiographic measurements and hemodynamic changes at different time points in patients undergoing coronary artery bypass graft surgery

Hypothesis:

1. Weak correlation between echocardiographic measurements and hemodynamic changes during coronary artery bypass graft surgery
2. Echocardiographic measurements would change across different time points during surgery independent of hemodynamic values.


Eligibility criteria: Inclusion Criteria:

- Elective coronary artery bypass graft patients who require pulmonary catheter placement for intraoperative monitoring.

Exclusion Criteria:

* Patients with contraindication to Swan-Ganz catheter placement,
* Pre-existing atrial arrhythmias,
* Patients with moderate and/or severe mitral/tricuspid valve stenosis or regurgitation
* Patients with contraindication to transesophageal echocardiogram probe placement (i.e. esophageal stenosis).

Primary outcomes:
measure: Change of right ventricular function during CABG assessed by right heart strain (%)
timeFrame: during CABG surgery
measure: Change of right ventricular function during CABG assessed by stroke volume index (mL/m2)
timeFrame: during CABG surgery
Secondary outcomes:
measure: Change in cardiac output measured with Swan-Ganz during CABG
timeFrame: during CABG surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT01034878: Sunitinib in Metastatic Renal Cancer
Official title: Phase II Study of Sunitinib in Metastatic Renal Cancer With Non-clear Cell Histology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Renal Cell
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2009-12-18
Enrollment: 25
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: Sunitinib is the registered treatment for first-line therapy of metastatic clear-cell carcinoma of the kidney.Data from the Expanded Access Study have shown activity also in non-clear cell renal cancer (NCCRC). The aim of this study is to prospectively evaluate the anti-tumor activity and safety of sunitinib as a first-line therapy in metastatic NCCRC patients.

Detailed description: This is a prospective, open label, multicenter phase II study to evaluate efficacy of Sunitinib (in advanced/metastatic renal cancer with non-clear cell histology (papillary or chromophobe).

Sunitinib will be administered orally at a dose of 50 mg once daily, in six weeks cycles consisting of 4 weeks on treatment followed by 2 weeks off.

Treatment with the study drug will continue until tumor progression or unacceptable toxicity.

The planned total sample size for this study is 55 patients. Approximately 10 study sites will be involved.

Eligibility criteria: Inclusion Criteria:

* Histologically proven diagnosis of metastatic renal cancer with non-clear cell
* No previous treatment

Exclusion Criteria:

* Prior treatment with an antiangiogenetic compound
* Symptomatic and/or unstable pre-existing brain metastases
* Severe or uncontrolled cardiovascular diseases

Primary outcomes:
measure: The antitumor activity in terms of progression free survival
timeFrame: two years
Secondary outcomes:
measure: To evaluate the objective response rate
timeFrame: two years
measure: To evaluate the toxicity and the safety profile
timeFrame: two years
measure: To evaluate the overall survival
timeFrame: two years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinco Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04377178: Tooth Graft of Two Different Particle Sizes in Extraction Sockets
Official title: Comparison of Autogenous Tooth Graft of Two Different Particle Sizes in Extraction Socket Preservation: A Comparative Clinical and Radiographical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Socket Preservation
Lead sponsor: SVS Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the present study is to clinically and radiographically evaluate the efficacy of autogenous tooth graft obtained from bone mill and dental grinder to preserve alveolar ridge dimensions in extraction sockets.

Detailed description: Accordingly, teeth will be used as a test material to allow for comparative tests after processing it in the automated milling system (AMS). The material will be moistened and then placed in toto into the extraction sockets to generate particles at settings 1 (500 RPM for 30s) or 2 (900 RPM for 30s) to generate MS and SS respectively ((SS group; 0.5-0.8 mm) and medium size (MS group; 1.0-1.2 mm)).

Eligibility criteria: Inclusion Criteria:

* Systemically healthy individuals within the age group of 20-50 years with presence of teeth with hopeless prognosis requiring extraction

Exclusion Criteria:

* Medically compromised patients.
* Subjects who underwent radiotherapy or chemotherapy in the past 12 months.
* Patients having uncontrolled periodontal disease or having an active sinus infection.
* Smokers

Primary outcomes:
measure: Bone fill
timeFrame: Baseline to 6months
measure: Bone density
timeFrame: Baseline to 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: R V Chandra
state: Telangana
city: Hyderabad
country: India
facility: Svs Institute of Dental Sciences
state: Telangana
Study officials:
References: