louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02707549: Fluid Therapy During Brain Tumor Resection in Children
Official title: Comparison of Balanced Crystalloid Solution and 0,9% Sodium Chloride in Children Undergoing Brain Tumor Resection: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Brain Neoplasms
Keywords: crystalloid solutions
acid-base imbalance
water-electrolyte Imbalance
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-03-14
Enrollment: 53
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fluid management of children during neurosurgery is not well established. Hypotonic solutions, commonly still used in pediatric patients, may enhance cerebral edema and worse operative conditions. This study compares two different isotonic solutions administered perioperatively regarding acid base and fluid electrolyte disturbances.


Eligibility criteria: Inclusion Criteria:

* Children undergoing elective craniotomy for brain tumor resection
* Informed consent form signed and dated by legal guardian and investigator
* Informed assent form signed by the patient if appropriate

Exclusion Criteria:

* Uncontrolled Intracranial hypertension
* Severe heart, kidney, or pulmonary disease
* non-corrected electrolyte imbalance
* allergy to the solution administered

Primary outcomes:
measure: serum chloride difference (mmol/L)
timeFrame: from the admission of the patient in the operating room until the end of the surgery.
Secondary outcomes:
measure: serum chloride difference (mmol/L)
timeFrame: from the end of the surgery until exactly 24 hours after the admission in intensive care unit (ICU)
measure: brain relaxation score
timeFrame: immediately after dura-mater opening
measure: serum sodium difference (mmol/L)
timeFrame: from the admission of the patient in the operating room until the end of the surgery.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
References:
Clinical trial NCT04280549: Platelet PAR-1 Activation in Health and Diabetes
Official title: Platelet PAR-1 Activation in Health and Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Healthy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic and healthy subjects

Brief summary: Platelet activation has been associated with bad events like heart attack and stroke. There are a variety of platelet activators that regulate how active a platelet is. We are interested in Protease-activated receptors (PAR)-1. We are currently studying PAR-1 activation in persons with severe peripheral artery disease. We seek, through this project, to understand PAR-1 activation in persons without peripheral artery disease. As many patients with peripheral artery disease have diabetes, we will also evaluate PAR-1 activation in persons with type 2 diabetes. In addition we will assess the impact of the glucagon-like peptide (GLP)-1 signaling pathway on platelet activation. Levels of platelet activation will be determined using platelet aggregation experiments and assessment of platelet-monocyte aggregates in peripheral blood.


Eligibility criteria: Inclusion Criteria:

* Healthy men and women ≥60 years of age OR
* Type 2 diabetic men and women ≥60 years of age

Exclusion Criteria:

* Active cancer
* Prior myocardial infarction, prior stroke, diagnosed peripheral artery disease
* Severe liver (cirrhosis, cancer, or end-stage liver disease), kidney disease (eGFR \<30 cc/min).
* Pregnancy or lactation
* Active vasculitis
* Anticipated lifespan \< 2 years
* Current use of a DOAC

Primary outcomes:
measure: Platelet Activation
timeFrame: One day
measure: Protease Activated Receptor-1 Activation
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Joshua Beckman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02424149: Phenazopyridine for Confirmation of Ureteral Patency
Official title: Use of Phenazopyridine for Confirmation of Ureteral Patency During Intraoperative Cystoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystoscopy
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2015-04-22
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In this prospective, randomized trial subjects will be randomized to receive phenazopyridine or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm ureteral patency intraoperatively.


Eligibility criteria: Inclusion Criteria:

* Females only
* Planned surgical procedure where cystoscopy will be used to document ureteral urine flow
* Age \> or = 18 years, no upper age limit
* Able and willing to consent

Exclusion Criteria:

* Planned surgical procedure where cystoscopy will not be used
* Planned surgical procedure where cystoscopy is used for a purpose other than documenting ureteral urine flow
* age \<18 years
* pregnancy
* unable/unwilling to participate
* history of allergy or adverse reaction to phenazopyridine
* hepatic dysfunction
* known phenazopyridine hypersensitivity
* history of urologic surgery
* presence of ureteral stents prior to the planned surgical procedure
* concomitant suprapubic catheter placement

Primary outcomes:
measure: Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room
timeFrame: Day of surgery
Secondary outcomes:
measure: Physician Confidence Measured by a Survey
timeFrame: day of surgery (day 0)
measure: Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR
timeFrame: day of surgery (day 0)
measure: Post-operative Urethral Discomfort Measured by Pain Scales
timeFrame: post operative day 1
measure: Trial of Void Results
timeFrame: Day of hospital discharge
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
References:
citation: Propst K, Tunitsky-Bitton E, O'Sullivan DM, Steinberg AC, LaSala C. Phenazopyridine for Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Aug;128(2):348-355. doi: 10.1097/AOG.0000000000001472.
Clinical trial NCT00910949: Sensory Perception After Thoracotomy
Official title: Chronic Pain After Thoracotomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Thoracotomy
Chronic Pain
Keywords: persistent pain
neuropathic pain
Thoracotomy
Chronic Pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2009-06-01
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patients

Brief summary: The study will investigate characteristics of chronic pain after thoracotomy


Eligibility criteria: Inclusion Criteria:

* Able to understand and give consent
* Can read
* Residing in Denmark

Exclusion Criteria:

* Unable to understand the written information in Danish
* Abuse (Medicine, Drugs, Alcohol)
* Severe psychiatric Illness
* Conflicting neurological disease

Primary outcomes:
measure: QST score
timeFrame: 1 y
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Section for Surgical Pathophysiology 4074
Study officials:
References:
citation: Wildgaard K, Ravn J, Kehlet H. Chronic post-thoracotomy pain: a critical review of pathogenic mechanisms and strategies for prevention. Eur J Cardiothorac Surg. 2009 Jul;36(1):170-80. doi: 10.1016/j.ejcts.2009.02.005.
Clinical trial NCT06064149: The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC) Pilot Feasibility Study
Official title: The CArdiovascular Risk Evaluation in Men With Prostate Cancer Study (CARE-PC): Initial Pilot Feasibility Study to Assess Patient Awareness and Risk Mitigation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2023-10-03
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The overarching goal of this trial is to develop mechanisms to improve cardiovascular care among such prostate cancer patients receiving ADT by increasing patient awareness of individualized cardiovascular risk estimates and mitigation opportunities. Patients will be given access to a web-based quality improvement tool to educate patients of cardiovascular risks in prostate cancer and to inform them of their individualized, estimated cardiovascular risk and guideline-based risk mitigation recommendations.

The study will assess the feasibility of this web-based application as a cardiovascular education tool for patients with prostate cancer.

The study will also evaluate if completion of the web-based tool improves cardiovascular care access and risk mitigation for patients with prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Men with prostate cancer \> 18 years of age who are currently receiving or will be receiving treatment with ≥ 6 months of ADT
* Patients must be able to read and understand English.

Exclusion Criteria: n/a

Primary outcomes:
measure: CARE-PC Web-Based Application Completion Rate
timeFrame: 18 months
Secondary outcomes:
measure: Patient acceptance and perception of the web-based application
timeFrame: 18 months
measure: Percent accuracy of patient-derived CV- and prostate cancer-related data elements
timeFrame: 18 months
measure: Prevalence of CV risk factors/disease at the time of CARE-PC web-based application participation
timeFrame: 18 months
measure: Proportion of participants with current cardiologist involvement in CV care at the time of web-based application participation
timeFrame: 18 months
measure: Proportion of participants engaging in CV care within 6 months of CARE-PC web application participation
timeFrame: 18 months
measure: Proportion of participants having changes in CV risk-reducing medications within 6 months of CARE-PC application participation.
timeFrame: 18 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Vivek Narayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05572749: Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents
Official title: Double-blind Randomized Cross-over Clinical Trial of Crocus Kozanis Administration in Obese Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Obesity
Dyslipidemias
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 75
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study aims to investigate possible effects of per os Crocus Kozanis administration in children and adolescents with obesity


Eligibility criteria: Inclusion Criteria:

* Age above 10 year-old
* Diagnosis of Obesity according to International Obesity Task Force Criteria
* Presence of impaired glucose tolerance and/or impaired fasting glucose

Exclusion Criteria:

* Overt diabetes (any type)
* Diagnosis of any chronic disease
* Previous use of dietary supplement with Crocus or Crocus Sativus
* Administration of chronic medication

Primary outcomes:
measure: Glycemic control
timeFrame: Glycemic control will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).
Secondary outcomes:
measure: Lipidemic profile
timeFrame: Lipidemic profile will be assessed for each participant at the beginning of the study and thereafter every 12 weeks, up to 9 months (week 0, week 12, week 24, week 36).
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Unit of Paediatric Endocrinology and Metabolism, 2nd Department of Paediatrics, AHEPA University Hospital
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Assimina Galli-Tsinopoulou, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01819649: Selenium in the Prevention of Cancer
Official title: Prevention of Cancer by Intervention With Selenium - A Pilot Study in a Danish Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: selenium
selenium supplementation
randomised controlled trial
prevention
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: University of Southern Denmark
name: K. A. Rohde's and wife's Foundation
name: The County of Funen, Denmark
name: Cypress Systems, USA
name: The Dagmar Marshall Foundation
name: The N. O. Andersen Foundation
name: The Danish Directory of Food and Agriculture
name: The Foundation of Clinical Experimental Cancer Research, Odense
name: The Foundation of Lily Benthine Lund
name: The Memory Foundation of Merchant Brogaard
name: Pharma Nord
First posted: 2013-03-27
Enrollment: 491
Sex: ALL
Minimum age (years): 60
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: AMENDMENT TO STUDY DESIGN: Towards the end of the intervention period, it was decided to follow-up participants for an additional ten years via Danish public registries for data on morbidity and mortality.
Primary purpose: PREVENTION

Brief summary: This is a pilot study proceeding an intended international trial.

Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast tablets will reduce the risk of cancer in healthy individuals.

Objective: The objective of this pilot study was to assess the viability of a full scale randomised trial.

AMENDMENT TO STUDY OBJECTIVE: Mortality analysis during intervention and follow-up as specified in the sections concerning study design and outcome measures.


Eligibility criteria: Inclusion Criteria:

* WHO performance status 0 or 1
* No active liver- or kidney disease (Serum ALAT (alanine aminotransferase), alkalic phosphatase, bilirubin, creatinin or urea within 2 S.D of laboratory reference range)
* No previous cancer diagnosis
* No known HIV-infection
* Participant must understand oral and written information
* Participant must not use selenium supplementation of above 50 mcg/d
* Participant must give written consent prior to inclusion

Primary outcomes:
measure: Viability of full scale study
timeFrame: At five years intervention
Secondary outcomes:
measure: AMENDMENT TO OUTCOME MEASURES: Mortality analysis.
timeFrame: Up to 17 years
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Selenium Centre, Odense University Hospital
Study officials:
References:
citation: Cold F, Winther KH, Pastor-Barriuso R, Rayman MP, Guallar E, Nybo M, Griffin BA, Stranges S, Cold S. Randomised controlled trial of the effect of long-term selenium supplementation on plasma cholesterol in an elderly Danish population. Br J Nutr. 2015 Dec 14;114(11):1807-18. doi: 10.1017/S0007114515003499. Epub 2015 Sep 30.
Clinical trial NCT00071149: Consistency of Traditional Chinese Medicine Diagnoses and Herbal Prescriptions for Rheumatoid Arthritis
Official title: Consistency of Traditional Chinese Medicine Rheumatoid Arthritis Diagnosis and Herbal Prescriptions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
TCM
Diagnosis
Traditional Chinese Medicine
Complementary Therapies
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2003-10-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Practitioners of Traditional Chinese Medicine (TCM) make diagnoses based solely on clinical symptoms. This study will evaluate whether TCM practitioners make diagnoses consistently.

Detailed description: TCM is one of the oldest and most widely-used indigenous medical systems in the world. It is difficult to effectively practice or evaluate TCM outside of its core framework, which includes a diagnostic system that is more conceptual and less technologically driven than that of conventional medicine. TCM diagnosis relies entirely on clinical symptoms and signs that are discerned by the practitioner. The establishment of diagnostic and prescriptive consistency is crucial for efficacy studies involving individualized treatments within the TCM framework. This study will examine the consistency of TCM diagnoses and herbal prescriptions under controlled conditions.

Rheumatoid arthritis (RA) patients will be individually evaluated by three TCM practitioners; the diagnostic and prescriptive behaviors of the practitioners will be recorded and analyzed to determine: 1) the extent to which two or more TCM practitioners assign comparable TCM diagnoses to the same RA patients; 2) the extent to which two or more TCM practitioners prescribe comparable herbal formulas to the same RA patients; and 3) the extent to which TCM diagnoses are related to conventional clinical assessments and biomedical tests of RA. Variables that cause inconsistency will be identified and analyzed.

Eligibility criteria: Inclusion Criteria

* Rheumatoid arthritis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: University of Maryland
name: Grant G Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01755949: Colchicine and CRP in Atrial Fibrillation and AF Ablation
Official title: Impact and Time Course of Colchicine Therapy on C-reactive Protein Elevation in Chronic Atrial Fibrillation (AF) and Post AF Ablation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
catheter ablation
colchicine
c reactive protein
CRP
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Takeda
name: Detiger Funds
First posted: 2012-12-24
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation

Detailed description: Three groups of patients will be randomized to colchicine 0.6 mg PO bis in die (BID) or matching placebo:

1. Paroxysmal atrial fibrillation, pre-ablation
2. Persistent atrial fibrillation, pre-ablation
3. Chronic persistent atrial fibrillation

Eligibility criteria: Inclusion Criteria:

* Group 1: Persistent or chronic AF presenting for evaluation in cardiology offices. Diagnosis of AF will be made based on the 12 -lead surface ECG.
* Group 2: Paroxysmal AF scheduled to go AF ablation presenting to the electrophysiology laboratory for the procedure in sinus rhythm..
* Group 3:Chronic AF scheduled to go clinically indicated AF ablation, and presenting in the electrophysiology laboratory in atrial fibrillation .

Exclusion Criteria:

1. Abnormal liver function with elevated enzymes\> 1.5 times the normal.
2. Abnormal kidney function with glomerular filtration rate \< 50 ml/min
3. Increased levels of creatine kinase or known myopathy
4. Neutropenia
5. Known GI disorders
6. Women of childbearing age who have not had surgical sterilization and are not using oral contraceptives, or who's spouse has not had surgical sterilization will be excluded due to the length of the trial and the possibility that they could become pregnant after entry.
7. Pregnant and lactating women
8. Lactose intolerance
9. Known sensitivity, allergy, or contraindication to colchicine use

Primary outcomes:
measure: Change in C-reactive Protein
timeFrame: baseline, day 28
Secondary outcomes:
measure: Number of Subjects With Atrial Fibrillation
timeFrame: day 28
measure: Time Course of C-reactive Protein Levels
timeFrame: baseline, day 3, day 7, day 14, day 28
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Consultant in Cardiovascular Diseases
name: Joseph L. Blackshear, MD
role: PRINCIPAL_INVESTIGATOR
References: