louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04049734: Oral Losartan in Prevention of Post-ERCP Paancreatitis
Official title: Evaluation of Oral Losartan in the Prevention of Post-ERCP Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Post-ERCP Acute Pancreatitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Oral losartan given in the dose of 50 mg one hour before ERCP was studied in the prevention of post ERCP pancreatitis in 50 patients indicated for ERCP in comparison with another 50 patients underwent ERCP without receiving oral losartan.


Eligibility criteria: Inclusion Criteria:

* Any adult patient indicated for ERCP
* Patients with obstructive jaundice.
* Patients with dilated intra-hepatic or extra-hepatic bile ducts due to malignant or benign lesions.

Exclusion Criteria:

* Patients refusing to undergo the procedure or signing the informed consent
* Patients with clinically evident acute pancreatitis before the procedure
* Patients with previous endoscopic or surgical sphincterotomy
* Patients with current use of losartan
* Patients who are allergic or hypersensitive to losartan or hydro soluble contrast solutions
* Patients receiving NSAIDS within a week prior to assessment
* Patients with severe co-morbid conditions as cardiovascular disease, renal failure or decompensated liver cirrhosis.

Primary outcomes:
measure: Number of participants with development of acute pancreatitis
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01761734: Pilot Text Message for Influenza Vaccination
Official title: Pilot Study of Text Message Reminders for Flu Vaccine For Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza vaccination
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2013-01-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Influenza is an important and potentially preventable cause of morbidity and mortality, yet only 46% of U.S. adults were vaccinated by the end of the 2011-12 influenza season despite influenza vaccination being widely recommended, effective, and safe. Influenza vaccination rates are even lower in racial/ethnic minority groups. In order to address the problem of low influenza vaccination rates in minority adults, we plan to build on the well-accepted practice of immunization recall-reminders and the emerging practice of using text message to pilot the feasibility of using text messaging to improve influenza vaccination coverage rates in a low health literacy, largely minority, publicly insured adult population.


Eligibility criteria: Inclusion Criteria:

* \> or = 18 years of age,
* at least one visit to the AIM clinic during the previous year
* a cell phone number in the registration system
* fluent in English or Spanish. Exclusion criteria

Exclusion Criteria:

* Receipt of influenza vaccination during the 2012-2013 influenza season prior to randomization.

Primary outcomes:
measure: Receipt of an influenza vaccine dose
timeFrame: March 31, 2013
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Steven Shea, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Jessica Singer, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06184334: Management of OAB in Female Patients .
Official title: Assessment of Efficacy of Mirabegron, Solifenacin, Tadalafil 5mg and Combination Therapy in Female Patients With Overactive Bladder: A Double Blinded Prospective Randomized Placebo -Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overactive Bladder
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compare the effectiveness of mirabegron, solifenacin, tadalafil (5mg), and their combination in relieving symptoms of overactive bladder (OAB) in a double-blinded prospective randomized placebo-controlled trial.


Eligibility criteria: Inclusion Criteria:

* Women from 18 to 65 years of age with LUTs due to OAB

Exclusion Criteria:

* Severe cardiovascular disorders. \\

  * Severe neurogenic dysfunction.
  * Drug administration which interfere with bladder function .
  * Abnormal bleeding profile.
  * A verified urinary tract infection as determined by urinalysis and/or urine culture during screening

Primary outcomes:
measure: overactive bladder symptoms score (OABSS)
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University hospital
Study officials:
References:
Clinical trial NCT04513834: Efficacy of a Multi-faceted Intervention Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial
Official title: Efficacy of a Multi-faceted Intervention Combining an Educational Outreach Visit to General Practitioners and Patient Education Material to Deprescribe Proton Pump Inhibitors (PPI): a Population-based, Pragmatic, Cluster-randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proton Pump Inhibitors
Deprescription
Keywords: Proton pump inhibitors
Deprescription
Multi-faceted intervention
Patient-centered
Primary health care
Pharmacoepidemiology
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Deprescribing is defined as "the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing the polypharmacy and improving outcomes". Inappropriate use of proton pump inhibitors (PPI) is associated with severe adverse drug reactions and a major economic impact. Deprescribing should be considered when inappropriate prescription of PPI is identified.

DeprescrIPP DAM is a pragmatic trial, population-based, designed in clusters. It wil assess the efficacy of a multi-faceted intervention (an educational outreach visit to general practitioners associated with the sending of patient education material to their patients) to deprescribe PPI.


Eligibility criteria: Inclusion Criteria:

* General practitioners (GP)

  • All GP settled in the French region Pays-de-la-Loire having seen more than 100 different patients in the year before baseline, will be eligible.
* Patients

  * Aged more than 18 years old
  * Affiliated to the French health insurance CPAM
  * Treated with PPI\> 300DDD/year in the year before baseline (estimated with reimbursement databases).
  * Whose GP is included in the study

Exclusion Criteria:

* General practitioners (GPs) :

  • Participation refusal
* Patients

  * Participation refusal
  * Patients at risk of gastroduodenal lesions i.e. treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and over 65 years old or treated with either corticosteroids or anticoagulants or platelet aggregation inhibitors
  * Patients under legal protection

Primary outcomes:
measure: PPI deprescribing
timeFrame: 12 months
Secondary outcomes:
measure: Characteristics of patients engaging in the deprescription process
timeFrame: 12 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT00801034: The Effects of Potassium on Physiological and Cardiovascular Variables in Healthy Persons
Official title: The Effects of Potassium on Physiological Variables in the Kidney and Cardiovascular Variables in Healthy Persons in a Double-blinded, Randomised, Placebo-controlled, Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Keywords: hypertension
potassium
blood pressure
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2008-12-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In humans living of fruit and vegetables, hypertension is rarely seen. We wish to study if the development of hypertension has a connection to our intake of potassium. We know that fruit and vegetables contain a lot of potassium and we will simulate this intake by giving healthy subjects potassium as tablets.


Eligibility criteria: Inclusion Criteria:

* healthy
* age 18-40 years old
* BMI 18, 5-30
* non-smoker

Exclusion Criteria:

* daily use of medicine
* alcohol or drugs
* desire to become pregnant
* not using safe anti-contraceptive
* abnormal results in the initial testing

Primary outcomes:
measure: Effect on blood pressure
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of medical research
Study officials:
References:
citation: Matthesen SK, Larsen T, Vase H, Lauridsen TG, Pedersen EB. Effect of potassium supplementation on renal tubular function, ambulatory blood pressure and pulse wave velocity in healthy humans. Scand J Clin Lab Invest. 2012 Feb;72(1):78-86. doi: 10.3109/00365513.2011.635216. Epub 2011 Dec 12.
Clinical trial NCT00294034: VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies
Official title: VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker
Bradycardia
Keywords: Registry
Pacemaker
Diagnostics
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
name: Medtronic BRC
First posted: 2006-02-20
Enrollment: 950
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers.

Detailed description: The purpose of this registry is to gain a better understanding of how diagnostic capabilities in four Vitatron pacemakers (Selection AFm, Clarity, C-Series, and T-Series) are being utilized for the clinical management of a general pacing population. Pacemaker information and health status is collected from all patients enrolled.

Eligibility criteria: Inclusion Criteria:

• Class I or Class II indication for dual chamber pacing

Exclusion Criteria:

* Has an ICD or is a known candidate for an ICD

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
state: Arkansas
city: Little Rock
country: United States
state: Arkansas
city: North Little Rock
country: United States
state: Arkansas
city: Ft. Lauderdale
country: United States
state: Florida
city: Largo
country: United States
state: Florida
city: Ormond Beach
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Edgewood
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Hyannis
country: United States
state: Massachusetts
city: Lansing
country: United States
state: Michigan
city: Bay Shore
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Bismark
country: United States
state: North Dakota
city: Barberton
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Marion
country: United States
state: Ohio
city: Massillon
country: United States
state: Ohio
city: Middletown
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Columbia
country: United States
state: South Carolina
city: Arlington
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Beaumont
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: Waukesha
country: United States
state: Wisconsin
Study officials:
affiliation: Onondaga Hill Cardiovascular Group
name: Norman Jaffe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Prairie Cardiovascular Consultants
name: Luis Caceres, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02510534: Effect of Luteal Progesterone Support on Pregnancy Rates With Combined Clomid/ Gonadotropin & IUI
Official title: A Prospective Randomized Trial to Study the Effect of Luteal Progesterone Support on Pregnancy Rates in Combined Clomiphene Citrate and Gonadotropin Ovulation Induction Protocol With Intrauterine Insemination.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pregnancy
Lead sponsor: Northwest Center for Infertility and Reproductive Endocrinology
Sponsor class: OTHER
Collaborators: name: Ferring Pharmaceuticals
First posted: 2015-07-29
Enrollment: 520
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.

Detailed description: To determine the difference in clinical pregnancy rates with and without luteal progesterone support in a young reproductive aged population having undergone ovulation induction with combined clomiphene citrate and gonadotropin protocol with intrauterine insemination.

Patients will be randomized in a treatment arm or control arm. The treatment arm receives the luteal progesterone support and the control arm does not. Each arm will have 260 patients.

Eligibility criteria: Inclusion Criteria:

* Age 18-37
* BMI 19-34 kg/m2
* Day 2-3 Follicle stimulating hormone (FSH) less than 10IU/mL
* Estradiol (E2) less than 80 pg/mL
* Anti-mullerian hormone (AMH) more than 1.5 ng/mL; or antral follicle count (AFC) up to 10
* Two patent fallopian tubes confirmed by hysterosalpingogram (HSG) or chromopertubation
* Normal uterine cavity confirmed by HSG, saline sonohysterogram (SIS) or hysteroscopy

Exclusion Criteria:

* Severe male factor (total count less than 10 million sperm)
* Systemic diseases not limited to diabetes
* Pregnancy within 3 months
* More than 1 prior cycle of gonadotropin treatment
* Any ovarian cyst \>15mm that has persisted for \> 1 month
* Endometrioma and/or Endometriosis-stage III or IV
* Submucosal uterine fibroids; untreated endometrial polyps \>1 cm;abnormal reproductive tract bleeding
* Intolerance or allergy to study drug
* Substance abuse (including alcohol and tobacco)
* History of chemotherapy (except for gestational conditions) or radiotherapy
* Minors and those adults not capable of consenting on their own

Primary outcomes:
measure: Effect on Pregnancy rate measured by detectable embryonic cardiac activity
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Margate
country: United States
facility: Ivf Florida
state: Florida
Study officials:
affiliation: IVF FL
name: Daniel Christie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00456534: The Effect of Smoking on Perception
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nicotine Dependence
Keywords: Smoking
Lead sponsor: American University
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of the experiment is to examine the effect of smoking on how individuals recognize and interpret sensory information.

Detailed description: Participation requires one 90-minute visit on the American University campus that involves completing questionnaires and computer tasks, watching a film, and smoking a cigarette. Participants earn 30 dollars.

Eligibility criteria: Inclusion Criteria:

* Between ages 18 and 60
* Regular, daily smoker
* Smoke for at least 1 year

Exclusion Criteria:

* Color Blind
* Smoking Related Health Problems (Chronic Bronchitis, Chronic Obstructive Pulmonary Disease, Emphysema)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: American University, Dept. of Psychology
state: District of Columbia
Study officials:
affiliation: American University
name: Lisa Fucito, M.A.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04538534: Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention
Official title: Nicardipine to Avoid Spasm in Trans Radial Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spasm Artery
Keywords: radial artery spasm
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2020-09-04
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Radial artery is the recommended route for percutaneous coronary intervention for it significantly reduces net adverse clinical events compared to the femoral approach. The success of the radial approach is therefore of a paramount importance. However, radial artery spasm (RAS) remains one of the major limitations of transradial approach (TRA) and the most frequent cause of TRA failure. Several recommendations has been issued to improve success rate when using the radial route.

In the Tunisian difficult economic context, the use of low end equipment, the unavailability of nitroglycerine and calcium antagonist verapamil, has led to the general feeling that RAS and TRA failure has subsequently increased.

The standard and only used protocol by the Tunisian interventional cardiologist, consists of administrating 1 mg isosorbide dinitrate through the arterial sheath immediately after radial arterial puncture, therefore limiting the options to prevent RAS.

Nicardipine is the only injectable calcium antagonist available in Tunisia. Its spasmolytic action on radial artery has been well demonstrated when used in CABG. However, it has been very poorly investigated in trans radial percutaneous coronary intervention.

Investigators believe that the concomitant use of nicardipine with isorbide might significantly reduce RAS and TRA failure when compared to isosorbide dinitrate only.


Eligibility criteria: Inclusion Criteria:

* All patients scheduled for coronary intervention will be eligible for screening (coronarography or coronary angioplasty).
* Participant is willing and is able to give informed consent for participating in the trial.
* Male or Female, aged 18 years or above.

Exclusion Criteria:

* Planned femoral approach because no radial pulse was perceived
* Cardiogenic shock
* Coronary intervention for ST elevation myocardial infarction during the night shift.

Primary outcomes:
measure: Number of Participants in which radial artery spasm occurred
timeFrame: 24 hours
Secondary outcomes:
measure: Number of Participants in which severe radial artery spasm occurred
timeFrame: 24 hours
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: CHU Fattouma Bourguiba
Study officials:
References:
Clinical trial NCT00174434: Study Of SU011248 In Combination With Paclitaxel In Patients With Metastatic Breast Cancer
Official title: A Phase 1 Study Of Paclitaxel In Combination With SU011248 For Patients With Breast Cancer As First-Line Treatment In The Advanced Disease Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety of SU011248 in combination with paclitaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.


Eligibility criteria: Inclusion Criteria:

* Breast cancer with evidence of unresectable, locally recurrent or metastatic disease.
* Candidate for treatment with paclitaxel.

Exclusion Criteria:

* Prior chemotherapy in the advanced disease setting.
* HER2 positive disease unless previously treated with trastuzumab.

Primary outcomes:
measure: Safety of the combination of SU011248 and paclitaxel
timeFrame: 9/05-7/07
Secondary outcomes:
measure: Pharmacokinetics of each medication
timeFrame: 9/05-7/07
measure: Objective disease response
timeFrame: 9/05-7/07
measure: Progression-free survival.
timeFrame: 9/05-7/07
Other outcomes:
Locations:
city: Harvey
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Harvey
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Munster
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: