louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01234922: Benazepril Hydrochloride, Lisinopril, Ramipril, or Losartan Potassium in Treating Hypertension in Patients With Solid Tumors
Official title: A Phase II Study of the Effect of ACE Inhibitors on Pro-Angiogenic Hormones in Cancer Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension
Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2010-11-04
Enrollment: 6
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: RATIONALE: Benazepril hydrochloride, lisinopril, ramipril, and losartan potassium may help lower blood pressure.

PURPOSE: This phase II trial is studying how well benazepril hydrochloride, lisinopril, ramipril, or losartan potassium works in treating hypertension in patients with solid tumors.

Detailed description: PRIMARY OBJECTIVES:

I. To determine which drug has the greatest effect on Ang-(1-7) levels in cancer patients with hypertension.

SECONDARY OBJECTIVES:

I. To determine the effect of these drugs on levels of Ang II, VEGF, PlGF, and ACE in the same patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

* ARM I: Patients receive oral benazepril hydrochloride once daily on days 1-7.
* ARM II: Patients receive oral lisinopril once daily on days 1-7.
* ARM III: Patients receive oral ramipril twice daily on days 1-7.
* ARM IV: Patients receive oral losartan potassium once daily on days 1-7. In all arms, treatment continues in the absence of unacceptable toxicity.

Eligibility criteria: Inclusion Criteria:

* Patients must have histologically or cytologically confirmed solid tumor malignancy AND hypertension, defined as a systolic pressure \> 130 OR a diastolic pressure \> 80
* Patients cannot be on active chemotherapy or radiation therapy; start of treatment with ACE-I or ARB must occur at least four weeks after the last dose of chemotherapy or radiation therapy
* Creatinine \< 2.5
* Potassium \< ULN
* Ability to understand and the willingness to sign a written informed consent document
* HIV positive patients are eligible to participate in this study

Exclusion Criteria:

* Patients who are pregnant or nursing due to significant risk to the fetus/infant
* Patients who are unable to take oral medications
* Patients who are currently taking an ACE-Inhibitor or ARB

Primary outcomes:
measure: Changes in Ang1-7 Levels Among Patients After ACE-I/ARB Treatment Measured in Picogram/Milliliter
timeFrame: 7 days post-baseline
Secondary outcomes:
measure: Change in Ang II, VEGF, PlGF, and ACE Levels
timeFrame: 1 week
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: William Petty
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00257322: Cellular Immune Augmentation in Colon and Rectal Cancer
Official title: A Pilot Study of Cellular Immune Augmentation in Colon and Rectal Cancer Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Cancer
Rectal Cancer
Keywords: Metastatic colon cancer
Metastatic rectal cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2005-11-22
Enrollment: 20
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: While new treatments for metastatic and recurrent colorectal cancer have become available over the past several years, this disease remains incurable with a limited life expectancy from the time of diagnosis. New strategies for treatment of disseminated colorectal cancer are needed. Under this proposal, patients with advanced colorectal cancer will receive Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) to stimulate endogenous dendritic cells and enhance anti-tumor immune mechanisms. This will be combined with standard chemotherapy and patients will be followed for response and overall survival. Detailed correlative laboratory analysis will also be performed to define the extent of dendritic cell and cellular immune system stimulation.


Eligibility criteria: Inclusion Criteria:

* Patient must have: metastatic, disseminated or recurrent colon or rectal cancer
* Patient to receive weekly or biweekly chemotherapy for at least 4 cycles (4 weeks) Examples include: 5FU or 5FU/leucovorin given once weekly Irinotecan (single agent) given once weekly 5FU/leucovorin/irinotecan given once weekly
* Patient must be able to be taught to administer GM-CSF subcutaneously

Exclusion criteria:

* Known allergic or other adverse reaction to GM-CSF
* Chemotherapy administration more frequently than bi-weekly
* Pregnant or lactating women

Primary outcomes:
measure: Participants Exhibiting Immune Response
timeFrame: 24 Months
Secondary outcomes:
measure: Response Rates and Overall Survival.
timeFrame: 24 Months
Other outcomes:
Locations:
city: Orange
country: United States
facility: Chao Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: Chao Family Comprehensive Cancer Center
name: Randall Holcombe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez M, Ono N, Planutiene M, Planutis K, Nelson EL, Holcombe RF. Granulocyte-macrophage stimulating factor (GM-CSF) increases circulating dendritic cells but does not abrogate suppression of adaptive cellular immunity in patients with metastatic colorectal cancer receiving chemotherapy. Cancer Cell Int. 2012 Jan 23;12(1):2. doi: 10.1186/1475-2867-12-2.
Clinical trial NCT04544722: Clinical Study of Jianfei Kangfu Cao in the Treatment of pSS-ILD
Official title: Clinical Study of Jianfei Kangfu Cao in the Treatment of Primary Sjogren's Syndrome Associated Interstitial Lung Disease.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Sjogren's Syndrome
Interstitial Lung Disease
Keywords: Safety
Efficacy
Primary Sjogren's syndrome
Interstitial lung disease
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 138
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 study will evaluate the safety and efficacy of Jianfei Kangfu Cao in the treatment of primary Sjogren's syndrome associated interstitial lung disease.

Detailed description: This study will be a randomized, double-blind, positive control clinical trial with a course of 24 weeks.

1. Random scheme:the DAS for Interactive Web Response System(IWRS) will be used to calculate and distribute random numbers and dispensing drugs.
2. Blind method ：The test process will be in a double-blind state.
3. Control drug: The lung rehabilitation training will be used as control in this trial.

Eligibility criteria: Inclusion Criteria:

1. According to the 2012 ACR classification of primary Sjogren's syndrome .
2. CT confirmed interstitial lung disease;
3. DLCO≧40%;
4. Stable treatment for at least 12 weeks;
5. Patients with good compliance should sign informed consent before the tria.

Exclusion Criteria:

1. The patient is using or has used anti pulmonary fibrosis drugs;
2. Pulmonary infection, tumor and other connective tissue diseases;
3. Chronic obstructive pulmonary disease, bronchial asthma and tuberculosis;
4. Patients with severe hypertension, diabetes and heart, liver and renal failure;
5. Women with reproductive needs;
6. Idiopathic pulmonary interstitial disease;
7. The researcher thinks that it is not suitable to participate in this experiment;
8. Participants in other clinical trials.

Primary outcomes:
measure: FVC
timeFrame: 24 weeks
measure: CAT score
timeFrame: 24 weeks
Secondary outcomes:
measure: 6MWD
timeFrame: 24 weeks
measure: ESSDAI
timeFrame: 24 weeks
measure: ESSPRI
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: Longhua Hospital
name: Zhujing Zhu, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Longhua Hospital
name: Jianchun Mao, Master
role: STUDY_CHAIR
affiliation: Longhua Hospital
name: Huanru Qu, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01584622: Clinical Evaluation of the CADenceTM System in Detection of Coronary Artery Diseases
Official title: Clinical Evaluation of the CADence System in Detection of Coronary Artery Diseases
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: AUM Cardiovascular, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-25
Enrollment: 0
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 purpose of the study is to evaluate the effectiveness of the CADence system, a non-invasive device, in detecting greater than or equal to 50% coronary stenosis anywhere in the coronary tree.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Willing and able to give informed consent
* Indicated for angiography evaluation.

Exclusion Criteria:

* Pregnant or nursing
* Presence of pacemaker/defibrillator
* Presence of artificial valve
* Presence of severe valve disease
* Presence of congenital heart defect
* Left Ventricular Assist Device (LVAD)
* Presence of a bypass graft
* Presence of scars on the site thorax areas
* Coarctation of the aorta
* Participation in trial within 30 days prior to collecting CADenceTM data
* Asthma with wheezing
* Inability to lie flat in the supine position
* Acute STEMI
* Heart Transplant
* Recent Cocaine Use

Primary outcomes:
measure: Efficacy of CADence in detecting greater than or equal to 50% stenosis anywhere in the coronary tree.
timeFrame: within three months
Secondary outcomes:
Other outcomes:
Locations:
city: Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott/Minneapolis Heart Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York City
country: United States
facility: Columbia University
state: New York
city: New York City
country: United States
facility: Mt. Sinai
state: New York
city: Cheyenne
country: United States
facility: Cheyenne Vascular & Heart Institute
state: Wyoming
Study officials:
affiliation: University of Minnesota
name: Robert Wilson, MD
role: STUDY_CHAIR
affiliation: Mt. Sinai
name: Roxana Mehran, MD
role: STUDY_CHAIR
affiliation: Cheyenne Vascular & Heart Institute
name: James Chapman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iowa Heart Center
name: Mark Tannenbaum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott/Minneapolis Heart Institute
name: Robert Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mercy Hospital
name: Jeff Chambers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Giora Weisz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03377322: Trial of Probiotics for Constipation in Parkinson's Disease
Official title: A Randomized Double-Blinded Placebo-Controlled Trial of Probiotics for Constipation in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Placebo Controlled
Primary purpose: TREATMENT

Brief summary: This is a double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics in the treatment of constipation in Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Age 50 to 80 years old
* Provision of written informed consent
* Diagnosis of PD made by a Neurologist using UK Brain Bank Criteria
* Fulfils criteria for functional constipation according to the Rome IV Criteria during in the preceding 6 months with frequency of bowel movements less than 3 times per week

Exclusion Criteria:

* Ingestion of probiotics in the preceding 4 weeks
* Use of antibiotics in the preceding 4 weeks
* History of gastrointestinal disorders or surgery
* Known or suspected allergy to probiotics
* Comorbidities that prevent reliable completion of study assessments
* Prior functional neurosurgery for PD or treatment with apomorphine infusion
* Recent initiation of dopaminergic medications in the preceding 3 months

Primary outcomes:
measure: Change in frequency of bowel opening per week
timeFrame: Week 4 post randomisation
Secondary outcomes:
measure: Change in stool consistency
timeFrame: Week 4 post randomisation
measure: Change in constipation severity score
timeFrame: Week 4 post randomisation
measure: Change in patient's quality of life in relation to constipation
timeFrame: Week 4 post randomisation
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
state: Wilayah Persekutuan
Study officials:
affiliation: University of Malaya
name: Ai Huey Tan, MD,FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tan AH, Lim SY, Chong KK, A Manap MAA, Hor JW, Lim JL, Low SC, Chong CW, Mahadeva S, Lang AE. Probiotics for Constipation in Parkinson Disease: A Randomized Placebo-Controlled Study. Neurology. 2021 Feb 2;96(5):e772-e782. doi: 10.1212/WNL.0000000000010998. Epub 2020 Oct 12.
Clinical trial NCT01650922: Molecular Genetic Studies of Childhood Brain Tumors and Blood Samples
Official title: Molecular Genetic Studies of Childhood Brain Tumors and Blood Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-07-26
Enrollment: 4
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric cancer patients diagnosed with brain tumors

Brief summary: To look for patterns of polymorphisms in DNA repair in both germline and tumor cells samples.


Eligibility criteria: Inclusion Criteria:Pediatric cancer patients diagnosed with brain tumors

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: James M Ford
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00651222: Influence of Hormone Therapy on Heart Attack Incidence in Men Undergoing Prostate Brachytherapy
Official title: Influence of Androgen Suppression Therapy for Prostate Cancer on the Timing and Onset of Fatal Myocardial Infarctions in Men Undergoing Prostate Brachytherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Cardiovascular Death
Lead sponsor: Prostate Cancer Foundation of Chicago
Sponsor class: OTHER
First posted: 2008-04-02
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prostate cancer patients treated with prostate brachytherapy at an ambulatory surgery center

Brief summary: The purpose of this study is to review cause of death in patients undergoing prostate brachytherapy at a single institution. Furthermore, we are analyzing patients undergoing androgen deprivation therapy and whether or not this contributed to cardiovascular deaths, specifically myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Deceased anytime after prostate brachytherapy treatment

Exclusion Criteria:

* Patients whose cause of death was unable to be determined

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Westmont
country: United States
facility: Chicago Prostate Center
state: Illinois
Study officials:
References:
Clinical trial NCT02688322: Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections
Official title: Pharmacodynamics Modeling to Optimize Dosage Regimens of Sulbactam in Patients With Acinetobacter Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acinetobacter Infections
Keywords: sulbactam
pharmacokinetics
pharmacodynamics
Acinetobacter infections
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
Collaborators: name: Prince of Songkla University
First posted: 2016-02-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Acinetobacter species have emerged as agents of serious nosocomial infections in critically ill patients. Only a few effective antibiotics are currently available for the treatment of this pathogen and, therefore, sulbactam is being considered as an alternative treatment option. The aims of this study were to i) reveal the population pharmacokinetics and ii) assess the probability of target attainment (PTA) of sulbactam in septic critically ill patients caused by Acinetobacter spp. infections.

The study was conducted in septic critically ill patients caused by Acinetobacter spp. Each patient received 2 g every 12 h of sulbactam for 10 days, after which PK studies were carried out on day 4 of sulbactam therapy and a Monte Carlo simulation was performed to determine the probability of attaining a specific pharmacodynamic target.


Eligibility criteria: Inclusion Criteria:

* Patient aged ≥ 18 years
* Patients who had diagnosed an Acinetobacter infections that sensitive to sulbactam and colistin
* Infected at sterile site
* Pneumonia was defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent sputum, temperature\>38.3°C or \<36°C, a leukocyte count\>10,000 cell per mm3, heart rate of \>90 beats per min and respiratory rate \>20 breaths per min
* Urinary tract infection: Acinetobacter spp ≥ 100,000 cfu/mm3

Exclusion Criteria:

* Patients who are pregnant.
* Patients who have documented hypersensitivity to sulbactam and colistin
* Patients who are chronic renal disease
* Patients who are shock

Primary outcomes:
measure: concentration of sulbactam in plasma
timeFrame: 12 h profile after 7th of sulbactam
Secondary outcomes:
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
state: Songkla
Study officials:
References:
Clinical trial NCT00799422: Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients
Official title: Evaluation of Lens Fit, Lens Parameters, and Circumlimbal Conjunctival Staining (CSS) in Normal Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conjunctival Staining
Keywords: Conjunctival Staining
lens parameters
lens fit
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-11-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.


Eligibility criteria: Inclusion Criteria:

* Successfully wearing hydrogel and/or silicone hydrogel contact lenses;
* Read, sign, and date informed consent/HIPAA document;
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;
* Willing and able to discontinue contact lens wear when requested during the study;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Evidence or history of ocular disease or pathology;
* One functional eye or a monofit lens;
* Use of concomitant topical ocular prescription or over-the-counter ocular medications;
* History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Circumlimbal Conjunctival Staining Score
timeFrame: 1 week
Secondary outcomes:
measure: Mean Change From Dispense (Day 0) in Lens Base Curve at 1 Week
timeFrame: Dispense (Day 0), 1 week
measure: Mean Change From Dispense (Day 0) in Lens Diameter at 1 Week
timeFrame: Dispense (Day 0), 1 week
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research
name: Alison Ramsey, O.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05714722: Epiction of the Genomic and Genetic Landscape Identifies CCL5 as a Protective Factor in Colorectal Neuroendocrine Carcinoma
Official title: Epiction of the Genomic and Genetic Landscape Identifies CCL5 as a Protective Factor in Colorectal Neuroendocrine Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neuroendocrine Carcinomas (CRNEC); Genomic Landscape; Genetic Landscape; Prognosis; CCL5; PAX5
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asia

Brief summary: Background: Colorectal neuroendocrine carcinomas (CRNECs) are highly aggressive tumours with poor prognosis and low incidence. To date, the genomic landscape and molecular pathway alterations have not been elucidated.

Methods: Tissue sections and clinical information were collected as an in-house cohort (2010-2020). Large-scale genomic and genetic panels were applied to identify the genomic and genetic alterations of CRNEC. Through the depiction of the genomic landscape and transcriptome profile, we compared the difference between CRNEC and CR neuroendocrine tumours (CRNETs). Immunohistochemistry (IHC) staining and immunofluorescence (IF) staining were performed to confirm the genetic alterations.


Eligibility criteria: Inclusion Criteria:

- tissues from colorectal neuroendocrine carcinomas

Exclusion Criteria:

- no

Primary outcomes:
measure: overall survival
timeFrame: 2010-2020
Secondary outcomes:
measure: Comprehensive genomic and expression panels (AmoyDx® Master Panel) for dna and rna detection
timeFrame: 2020
Other outcomes:
Locations:
Study officials:
References: