louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01153334: Efficacy of Early Intensive ROsuvastatin Therapy in Patients With ST-segment Elevation Myocardial Infarction Undergoing PrimARY Percutaneous Coronary Intervention (the ROSEMARY Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: ST-segment Elevation AMI
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: CardioVascular Research Foundation, Korea
First posted: 2010-06-30
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: An investigator-initiated, double-blind, randomized, placebo-controlled, multi-center study to evaluate the efficacy of early intensive rosuvastatin therapy (rosuvastatin 40 mg for pre-PCI loading and 7 days post PCI and 10 mg daily thereafter) versus low dose conventional statin therapy (placebo for pre-PCI loading and rosuvastatin 10 mg daily after primary PCI) on infarct size measured by cardiac MRI and clinical outcomes in STEMI patients undergoing primary percutaneous coronary intervention (PCI). Hypothesis: The infarct size in the early high dose rosuvastatin group is smaller than that of the control patients treated with low does conventional statin therapy.


Eligibility criteria: Inclusion Criteria:

1. Patient had the symptoms of acute myocardial infarction within 12 hours with ST-segment elevation of more than 1 mm in at least two contiguous leads of EKG or new onset LBBB.
2. Male or female over 20 years of age
3. Signed written informed consent to participate in the study

Exclusion Criteria:

1. Congestive heart failure (NYHA Class III or IV) or LVEF \<35%.
2. Clinically significant heart disease requiring CABG, cardiac transplantation, surgical repair and/or replacement during the course of the study.
3. Previous MI or CABG
4. Known serious or hypersensitivity reactions to statin, antiplatelet agents (aspirin or clopidogrel), or heparin.
5. Known familial hypercholesterolemia
6. Known skeletal muscle disease
7. Known active liver disease such as hepatitis or liver cirrhosis (except for fatty liver)
8. Renal failure (Cr \>2.0 mg/dL)
9. Secondary causes of hyperlipoproteinemia: uncontrolled primary hypothyroidism, and/or nephrotic syndrome
10. Non-cardiac comorbidity with a life expectation \< 1 year
11. Contraindications to CMRI (eg, implanted pacemaker or cardiac defibrillator, claustrophobia, etc.)
12. Pregnant or lactating women or women of childbearing potential
13. Participation in any investigational drug or device study within 30 days prior to study entry

Primary outcomes:
measure: Infarct size measured by cardiac MRI
timeFrame: day 3-7
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University Health System
name: Yangsoo Jang, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01220934: An Observational Study of Herceptin (Trastuzumab) in Patients With HER2-positive Advanced Gastric Cancer
Official title: Clinical Practice Surveillance of the Use of Herceptin in Patients With HER2-positive Advanced Adenocarcinoma of the Stomach or Gastro-esophageal Junction (GEJ) (HERMES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-10-14
Enrollment: 443
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gastric cancer patients receiving Herceptin in routine clinical practice

Brief summary: This observational, multicenter study will assess the efficacy and safety of Herceptin (trastuzumab) in routine clinical practice in patients with HER2-positive advanced adenocarcinoma of the stomach or gastro-esophageal junction. Data from patients will be collected for approximately 12 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Histologically confirmed advanced adenocarcinoma of the stomach or gastro-esophageal junction (GEJ) with locally advanced and/or metastatic disease
* HER2-positive tumor
* Patients who are eligible for treatment with Herceptin according to the judgment of the physician

Exclusion Criteria:

* Unwilling or unable to sign informed consent form
* Any contraindications, interactions and incompatibilities to Herceptin

Primary outcomes:
measure: Response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 12 months
measure: Progression-free survival according to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 12 months
measure: Overall survival according to Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 12 months
Secondary outcomes:
measure: Documentation of the testing process for HER2-positive tumors
timeFrame: 12 months
measure: Assessment of implementation of guidelines and recommendations of Herceptin administration in routine clinical practice
timeFrame: 12 months
measure: Documentation of backbone chemotherapy treatment and concomitant medication
timeFrame: 12 months
measure: Quality of Life questionnaire
timeFrame: 12 months
measure: Surveillance of pain intensity and analgesic consumption
timeFrame: 12 months
measure: Surveillance of weight change
timeFrame: 12 months
measure: Safety (incidence of adverse events)
timeFrame: 12 months
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01683734: Assessing Renal Function in Patients With an Antibiotic Laden Spacer
Official title: Nephrotoxicity Following 2-Stage Exchange With Associated Antibiotic Laden Spacer in Patients With Infected Total Hip/Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infected Total Hip or Knee Arthroplasty
Lead sponsor: Central DuPage Hospital
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with an infected hip or knee arthroplasty scheduled to undergo a 2-stage resection surgery

Brief summary: The purpose of this study is to monitor the renal function of patients who have an antibiotic laden spacer in place to treat an infected hip or knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. All patients undergoing a hip or knee resection arthroplasty by the primary investigator
2. Ages 18+
3. Ability to adhere to follow up schedule

Exclusion Criteria:

1. Unable to give informed consent
2. Age \<18
3. Previous history of infected Total Knee Arthroplasty or Total Hip Arthroplasty
4. History of renal failure or impaired renal function
5. Allergies to aminoglycosides or Vancomycin

Primary outcomes:
measure: Development of acute renal insufficiency or acute renal failure measured by changes in laboratory values assessing renal function
timeFrame: subjects will be followed during the time the antibiotic spacer is in place which is approximately 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: RUSH University Medical Center
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
Study officials:
affiliation: RUSH University Medical Center; Central DuPage Hospital
name: Scott Sporer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02218034: Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 78
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of acne vulgaris on the face
* No tobacco use for the past 30 days, and willing to refrain from nicotine use during the study
* Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weather, such as wind or cold, throughout the study
* If male, willing to maintain routine shaving regimen for the duration of the study and avoid shaving 12 hours prior to specified visits
* Females of childbearing potential must use a reliable method of contraception

Exclusion Criteria:

* Use of phototherapy devices (eg, ClearLight™) and adhesive cleansing strips (eg, Ponds® and Biore®), as well as cosmetic procedures (eg, facials, peeling, and comedone extraction) in the area to be treated in the past 1 week
* Use of topical anti-inflammatory drugs, salicylic acid (eg, Clearasil® and Clean \& Clear®), corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products \[eg, benzamycin\]), retinoids, and other topical acne treatments (eg, photodynamic therapy, laser therapy, and medicated soaps) in the area to be treated in the past 2 weeks
* Ability to abstain from caffeine-containing products on the dates instructed

Primary outcomes:
measure: Maximum Plasma Level (Cmax) of AGN-190168
timeFrame: Day 29
measure: Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
timeFrame: Day 29
measure: Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
timeFrame: Day 29
measure: Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale
timeFrame: Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: College Station
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00815334: Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
Official title: Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vesicoureteral Reflux
Keywords: vesicoureteral reflux
low compliant bladder
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-12-30
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopic subureteral injection for vesicoureteral reflux has become an established alternative to ureter reimplantation in children. Some recent studies suggest that ESI can be also a primary treatment option for VUR in adults. However, the experience with ESI in adults who have VUR associated with decreased bladder compliance is limited. We evaluated the efficacy of endoscopic subureteral injection treatment for vesicoureteral reflux in adults with decreased bladder compliance.


Eligibility criteria: Inclusion Criteria:

* Who is aged 18 and greater
* Who underwent endoscopic subureteral injection for vesicoureteral reflux

Exclusion Criteria:

* Medical records of whom is not evaluabe

Primary outcomes:
measure: Cure rate
timeFrame: 3, 12 months
Secondary outcomes:
measure: adverse events
timeFrame: 3, 12 months
measure: predictive factor for cure
timeFrame: 3, 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choo MS, Hong B, Ji YH, Chung H, Choe JH, Park WH, Park T, Lee KS. Endoscopic treatment of vesicoureteral reflux with polydimethylsiloxane in adult women. Eur Urol. 2004 Jun;45(6):787-9. doi: 10.1016/j.eururo.2003.11.025.
citation: Okeke Z, Fromer D, Katz MH, Reiley EA, Hensle TW. Endoscopic management of vesicoureteral reflux in women presenting with pyelonephritis. J Urol. 2006 Nov;176(5):2219-21. doi: 10.1016/j.juro.2006.07.076.
citation: Puri P. Endoscopic correction of vesicoureteral reflux. Curr Opin Urol. 2000 Nov;10(6):593-7. doi: 10.1097/00042307-200011000-00010.
Clinical trial NCT01733134: Acute Heart Failure Patients With High Copeptin Treated With Tolvaptan Targets Increased AVP Activation for Treatment (ACTIVATE)
Official title: Acute Heart Failure With High Copeptin Levels Treated With Tolvaptan Targets Increased AVP Activation for Treatment Efficacy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Acute Heart Failure
Keywords: acute heart failure
emergency department
copeptin
adh antagonists
Lead sponsor: Maisel, Alan, M.D.
Sponsor class: OTHER
Collaborators: name: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Thermo Fisher Scientific, Inc
First posted: 2012-11-26
Enrollment: 0
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: Patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo, based on the level of copeptin measured in their bloodstream. Patients with high copeptin levels will be able to participate in the trial, patients with low levels will be excluded. Patients being admitted to the observation unit for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo without consideration of the copeptin level. The hypothesis is that patients receiving tolvaptan will have better improvement of shortness of breath than those receiving placebo, within 9 hours of drug administration.


Eligibility criteria: Inclusion Criteria:

1. Older than or equal to 18 years of age, with diagnosis and planned treatment for Acute Heart Failure
2. Dyspnea at rest or minimal exertion per the patient
3. Evidence of extracellular volume expansion by at least one of the following: JVD, Rales, Ascites, Edema or positive Chest X-ray defined as cardiomegaly, pulmonary vascular congestion, Kerley B-lines, pulmonary edema and/or pleural effusion.
4. Elevated BNP level \>200 pg/ml, or NTproBNP \> 1000pg/mL
5. Able to administer study drug within 8 hours from triage time

Inpatient Hospitalized Inclusion Only:

Co-peptin level \> 27 pmol/L

Exclusion Criteria:

1. Unable to provide informed consent
2. Unable to have 30 day telephone follow up
3. Not expected to survive past 6 months
4. On Renal replacement therapy or creatinine \>3.5
5. History of allergy or intolerance to Tolvaptan
6. Suspected Pregnancy
7. Cardiogenic Shock
8. Participation in any interventional trial in prior 30 days.
9. Receiving or planned to receive IV Inotropic therapy
10. ACS now or in the past 30 days
11. Treatment with IV infusion vasoactive drugs in the hour prior to enrollment
12. Temperature \> 100.5
13. Heart Failure due to atrial fibrillation with Rapid Ventricular Response
14. SBP \< 90 mmHg

Primary outcomes:
measure: Dyspnea
timeFrame: 9 hours
Secondary outcomes:
measure: Length of stay
timeFrame: during hospitalizaton
measure: Rehospitalization
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
name: Alan S Maisel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01870934: 3D Camera - Telemedical Foot Ulcer Treatment
Official title: A Feasibility Study on the Development of 3D Optic Ulcer Camera
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Foot Ulcers
Keywords: Telemedicine
Diabetes
Foot Ulcers
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-06-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic foot ulcers patients

Brief summary: Diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). Amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. The ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel.

The 3D photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. The Department of Endocrinology and the section for LEAN and Innovation at Odense University Hospital has developed a prototype for a 3D camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. The camera was developed in close cooperation with TECCLUSTER A/S, Svendborg Municipality, Team Online and ComMed.


Eligibility criteria: Inclusion Criteria:

* Patients with diabetic foot ulcers, which has been the diagnosis, stratification (eg ischemia, neuropathy, etc.) and treatment according to current guidelines refer "Diabetic Foot Study Group". Age 18-90 years

Exclusion Criteria:

* Superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)

Primary outcomes:
measure: Comparison of 3D image and normal assessment of wounds
timeFrame: outcome measure is assessed in 2013
Secondary outcomes:
measure: Comparison of 3D and 2D image assessment of wounds
timeFrame: november 2013
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hosptial
name: Benjamin Schnack Rasmussen, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Knud Yderstræde, MD, Ph.d.
role: STUDY_CHAIR
References:
Clinical trial NCT06423534: Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia
Official title: Empowering New Mothers: Exploring the Effect of Breastfeeding Health Educational Program on Practices and Feeding Self-Efficacy of Primigravida in Saudi Arabia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primigravida Women
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 70
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Being pregnant causes a mother and her child to form a maternal tie, and the birth of the child fills the mother with an immense amount of love and happiness. Breastfeeding is how a mother and infant make their initial touch. Breastfeeding is a mother's priceless gift to her infant and nature's own method of nurturing a baby.

Detailed description: This study will be done to evaluate the primigravida mother's breastfeeding's knowledge, attitude and corrective technique through the implementation of an educational program and to ascertain the efficacy of such a program.

Eligibility criteria: Inclusion Criteria:

* Primigravida mothers who regularly visit maternity hospitals at Hail and Bisha City.
* Primigravida mothers during last three trimester and 1 month after delivery
* No problems during pregnant and have a healthy baby
* Primigravida mothers who are not contraindicated to breastfeeding

Exclusion Criteria:

* Multigravida mothers and pregnant women during first and second trimester

Primary outcomes:
measure: A preformatted structured questionnaire
timeFrame: 3 months
measure: Self-Efficacy Scale - Short-Form (BSES-SF)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hail
country: Saudi Arabia
facility: Faculty of Nursing, Hail university
Study officials:
References:
Clinical trial NCT03566134: A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder
Official title: A Therapeutic Exploratory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-21
Enrollment: 306
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Therapeutic Exploratory Clinical Study to evaluate the efficacy and safety of DA-8010 in Patients with Overactive Bladder and to determine the optimal dose of DA-8010


Eligibility criteria: Inclusion Criteria:

Main Inclusion at Screening (Visit 1):

* Men and women 19 years or older with OAB symptoms for ≥ 3 months.
* Subject who is willing and able to complete the micturition diary correctly.
* Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study

Exclusion Criteria:

* Clinically significant Stress urinary incontinence or Mixed urinary incontinence where stress is the predominant factor
* Diagnosed with interstitial cystitis or bladder pain syndrome
* Clinically significant pelvic organ prolapse
* Subject who has neurologic status which is able to effect vesical function, such as multiple sclerosis, Spinal Injury or Parkinson's disease
* Medical history of malignant tumor in urinary system or pelvic organs
* Clinically significant bladder outlet obstruction or more than 200mL of post-void residual volume

Primary outcomes:
measure: Change From Baseline in mean number of micturitions per 24 hours
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT01185834: Assessment of Lotrafilcon A Contact Lenses
Official title: Assessment of Lotrafilcon A Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-08-20
Enrollment: 118
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this 3-month study is to evaluate subjective responses to an upgraded contact lens.


Eligibility criteria: Inclusion Criteria:

* Have normal ocular findings.
* Be able to wear the study lenses in the available powers.
* Currently wear contact lenses for a minimum of 5 days a week, and at least 8 hours a day.
* Wear Night \& Day contact lenses.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Require concurrent ocular medication.
* Eye injury or surgery within twelve weeks prior to enrollment.
* Currently enrolled in an ophthalmic clinical trial.
* Any active corneal infection.
* Corneal refractive surgery.
* Wear AIR OPTIX NIGHT \& DAY AQUA lenses.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Overall Comfort
timeFrame: 3 months of wear, replacing lenses monthly
Secondary outcomes:
measure: Overall Lens Fit
timeFrame: 3 months of wear, replacing lenses monthly
Other outcomes:
Locations:
Study officials:
References: