louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01131546: Efficacy and Safety of Levamlodipine Besylate Compared to Amlodipine Maleate in Patients With Essential Hypertension
Official title: A Randomized, Controlled, Multicenter Trial of Levamlodipine Besylate Versus Amlodipine Maleate in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension
Keywords: Essential Hypertension
Levamlodipine Besylate
Amlodipine Maleate
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-05-27
Enrollment: 1080
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 is designed to compare the safety and efficacy of levamlodipine besylate (2.5mg or 5mg) versus amlodipine maleate (5mg) in patients with mild to moderate essential hypertension.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients, 18-75 Years
* Patients with mild to moderate essential hypertension (defined as mean BP of 2 visits ≥140mm/90mmHg, and \< 180mm/110mmHg)
* Written informed consent

Exclusion Criteria:

* Patients with secondary hypertension
* Patients with severe hypertension
* Have to take other drugs that can influence blood pressure during the study
* Allergic to DHP calcium antagonists
* Evidence of congestive heart failure, unstable angina or severe arrhythmia
* Renal or hepatic dysfunction
* Women who are taking contraceptive pills or are likely to be pregnant
* Participate in other clinical trials within 3 months prior to this study

Primary outcomes:
measure: Proportion of patients who reach overall blood pressure control (defined as BP <140/90 mmHg for non-diabetic patients and < 130/80 mmHg for diabetic patients)
timeFrame: Week 8
Secondary outcomes:
measure: Change from baseline in systolic blood pressure (SBP)
timeFrame: Week 8
measure: Change from baseline in diastolic blood pressure (DBP)
timeFrame: Week 8
measure: Incidence of adverse effects
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Dayi Hu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Public Health，Fudan University
name: Jinming Yu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02899546: Study of Peripherally Inserted Central Catheter (PICC)-Related Infections in a Tropical Area
Official title: Suivi Prospectif Des Complications Infectieuses liées Aux PICC Lines en Milieu Tropical
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheterization
Peripheral
Infection
Keywords: Peripherally Inserted Central Catheter
Infections
Radiology
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 283
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: All patients managed for a PICC setting in the tertiary care hospital

Brief summary: Septi-PICC study aims at assessing incidence of Peripherally Inserted Central Catheter (PICC)-related infections among patients managed in the University Hospital of La Reunion for PICC setting.

Detailed description: Septi-PICC is a prospective single-center study of infections related to PICCs setting at the South tertiary site of the University Hospital of La Reunion over one year with a follow-up of 6 months per patient.

All the complications such as thromboembolic, are collected during the follow-up.

It is planned a convenience sample of 400 patients over 18 years of age, except pregnant women.

Eligibility criteria: Inclusion Criteria:

* all patients managed for a PICC setting in the tertiary care hospital

Exclusion Criteria:

* known pregnancy
* minor

Primary outcomes:
measure: Incidence of PICC-related infections
timeFrame: 1 year with 6 months follow-up
Secondary outcomes:
measure: Incidence of other complications following the PICC setting
timeFrame: 6 months follow-up
measure: Incidence of hospitalizations following the PICC setting
timeFrame: 6 months follow-up
Other outcomes:
Locations:
city: Saint Pierre
country: France
facility: Centre Hospitalier Universitaire de La Réunion
Study officials:
References:
Clinical trial NCT01374646: Community-based Program to Treat Childhood Obesity
Official title: Effects of a Community-based Program to Treat Childhood and Adolescent Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: Childhood Obesity
Group Treatment
Community-based Programs
Lead sponsor: UnitedHealth Group
Sponsor class: INDUSTRY
First posted: 2011-06-16
Enrollment: 155
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight in children and teens. This study will recruit 150 participants between the ages of 6-12 and 13-17.

Detailed description: This study will evaluate the effectiveness of a comprehensive community based program on reducing excess weight. Overweight and obese study participants will be grouped with peers of similar ages and their parent/guardians. The participants will be divided into 2 groups, child (6-12 yrs. old) and teens (13-17 yrs. old) and will be accompanied by their parent/guardian. 150 participants will be recruited for this study.

This 6-month program (12 in-person group workshop sessions and 12 at-home sessions) takes the best components of current evidence for individual treatment and places them in a comprehensive community based program. These include:

* Parental involvement
* Reduction in consumption of sugar sweetened beverages
* Reduction of screen time
* Self-monitoring
* Physical activity
* Stimulus control

Eligibility criteria: Inclusion Criteria

* Children and teens between the ages of 6-17
* BMI percentile ≥85
* Participation of a parent/guardian

Exclusion Criteria:

* Enrollment in another weight loss program or study
* Diagnosis of type 1 or type 2 diabetes
* Pre-existing medical conditions (e.g., Prader Willi) that affect weight and appetite
* Medications (e.g., steroids) that affect weight or appetite
* Serious or unstable medical or psychological conditions that, in the opinion of the Principal Investigator, would compromise the participant's safety or successful participation in the study

Primary outcomes:
measure: Change in weight and body mass index (BMI) in children and teens at 6 months
timeFrame: 6 Months
Secondary outcomes:
measure: Change in weight and BMI in parent/guardian/care giver at 6 months
timeFrame: 6 months
measure: Change in physical activity level in children and teens at 6 months
timeFrame: 6 months
measure: Changes in intake and sedentary behavior at 6 months
timeFrame: 6 months
measure: Process Outcomes
timeFrame: 6 Months
Other outcomes:
Locations:
city: Providence
country: United States
facility: YMCA of Greater Providence
state: Rhode Island
Study officials:
affiliation: UnitedHealth Group
name: Deneen Votja, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03358446: The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics
Official title: The Optimal Leg Angulation of Femoral Central Catheterization in Pediatrics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Disorder
Femoral Artery Injury
Emergencies
Keywords: central catheterization
femoral vein central catheterization
leg angulation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 82
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgery.

Brief summary: Evaluation for the range of smallest leg angulation with femoral artery and vein overlap with femoral central catheterization in pediatrics.

Detailed description: In pediatrics, femoral vein catheterization often overlaps with the femoral artery.

In this case, the risk of artery puncture is high, vein collapse when artery puncture 2nd, 3rd times exceeds the success rate of catheterization becomes low. In previous study, comparing 0, 30, and 60 degrees with frog leg position, there was a study that the overlap was the smallest at 60 degrees. A previous study was a simple frog leg position and a study in fragmented predetermined angles. On a continuous measurement, we planned the study under the assumption that there is a more definite range of optimal angulation.

Ultrasound probe in the state of Inguinal crease, we find a part without bifurcation of femoral artery and femoral vein in frog leg position(external rotation + flexion increase). Increase the leg angle and check the vein and arterie relations.

Eligibility criteria: Inclusion Criteria:

1. Pediatric patients younger than 3 years
2. ASA class 1-3
3. Patients scheduled for elective surgery.
4. If the patient's guardian can understand and write the contents of the agreement.

Exclusion Criteria:

1. A patient with previous history of dislocation of the hip.
2. Hip joints with limited hip movement.
3. A patient with vascular malformation of the femoral vein
4. Emergency surgery
5. Hemodynamic unstable patient
6. If the patient's guardian cannot understand and write the contents of the agreement.

Primary outcomes:
measure: A range of angles in which arteries and veins do not overlap
timeFrame: Intraoperative ( after anesthesia induction)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University, School of Medicine
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: jonghwan lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00940446: A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
Official title: A Comparison of INSORB Staples With Metal Staples in Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema
Drainage
Bruising
Pain
Keywords: Insorb staples
Metal Staples
Lead sponsor: Orthopaedic Research Foundation
Sponsor class: OTHER
Collaborators: name: OrthoIndy
First posted: 2009-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the use of INSORB absorbable staples with metal staples on surgical incision healing after total hip replacement. The study evaluates wound healing, complications, and patient satisfaction regarding wound comfort and appearance after surgery.

Detailed description: Subcuticular closure of wounds can provide superior results to percutaneous suture closure due to the elimination of suture or staple tracts. These tracts can lead to infection and migration of epithelial cells adding to scarring, and cross-hatching scars which remain after healing. Absorbable staples can provide a rapid, secure, subcuticular closure of skin as an alternative to the traditional, manual staple or suture closure. This study will compare INSORB absorbable staples to externally applied standard metal staples with respect to effectiveness of incision closure, acute healing, subject comfort level, security and appearance after total hip replacement.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 years or older
* Patient or legal representative is able to understand and provide signed consent for the procedure
* Patient is willing and able to return for required follow-up visits
* Patient needs a total hip arthroplasty surgical procedure

Exclusion Criteria:

* Patient has an active infection
* Patient is enrolled in another similar study
* Patient has a known history of hepatitis
* Patient has a known history of HIV
* Patient has a known history of AIDs
* Patient has a known history of IV drug abuse

Primary outcomes:
measure: Participants With Incisional Drainage, Swelling or Gaps of Incision
timeFrame: Discharge from initial hospital stay (2-5 days post-op)
Secondary outcomes:
measure: Participants With Wound Complications - Hematoma
timeFrame: up to 6 weeks post-op
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana Orthopaedic Hospital
state: Indiana
Study officials:
affiliation: Indiana Orthopaedic Hospital
name: David A Fisher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02029846: Glycemia in Diabetic Elders Trial
Official title: Glycemia in Diabetic Elders Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2014-01-08
Enrollment: 2
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen base solely on traditional drugs, a regimen including newer drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side effects, over the short run.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetics diagnosed for at least 6 months
* Patients ages ≥ 65 years and older
* Active patients in the Bay West Endocrinology practice
* Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12%
* Eligible for randomization to either treatment group
* Patients willing to follow either treatment arm including regimen using one or more injectables
* Patients to have an English Reading Level of Grade 6 or above
* Patients residing at home

Exclusion Criteria:

* Unwilling to use a regimen that may contain using one or more injections
* Using short acting insulin prior to the study
* Using GLP-1 in past 10 weeks
* History of hypoglycemia unawareness or episodes needing emergency intervention
* End-stage renal disease
* Dementia
* Blindness
* Terminal illness

Primary outcomes:
measure: Time to Achieve Glycemic Target (HbA1c <7.5%).
timeFrame: 6 months
Secondary outcomes:
measure: Overall Hypoglycemia Measured by Glucose Meter
timeFrame: 6 months
Other outcomes:
measure: Diabetes Quality of Life
timeFrame: 6 months
Locations:
city: Baltimore
country: United States
facility: Bay West Endocrinology Associates
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Hsin-Chieh Yeh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00178269: Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
Official title: A Phase Ii Clinical Study Using Weekly Low-Dose Taxotere® (Docetaxel) With Concurrent Radiotherapy For Localized, Inoperable Carcinoma Of The Uterine Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervix Neoplasm
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-15
Sex: FEMALE
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: The purpose of this study is to find out how effectively cervix cancer is controlled when radiation is combined with low-dose chemotherapy (Taxotere) . The use of low-dose Taxotere, once per week, with radiation is a new treatment for cervical cancer. This study will also see how well this treatment regimen can be tolerated.


Eligibility criteria: Inclusion Criteria:

* Histologic confirmation of squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix including FIGO (International Federation of Gynecologists and Obstetricians) stage IB to IVA with or without pelvic adenopathy.
* No evidence of para-aortic or distant metastases. Must have evaluable disease.
* Zubrod Performance Status 0-2 or Karnofsky Performance Status \> 60
* Laboratory values must be as follows:

White blood cell count: \> 3,000/mm3,Absolute granulocyte count: \> 1,500/mm3, Hemoglobin \> 8.0 g/dl, Platelets: \> 100,000/mm3, Serum creatinine: \< 2.5 mg/dl, Serum calcium: \< 1.3 x institutional upper normal limit,Hepatic criteria as follows: Total Bilirubin \< ULN for the institution,

* Signed study-specific informed consent p
* Age \> 18 years.
* Peripheral neuropathy must be \< grade 1.

Exclusion Criteria:

* Prior or simultaneous malignancies (other than skin cancer) unless disease-free
* Medical illness preventing the use of taxane-based chemotherapy.
* Carcinoma of the cervix with the following histology: melanoma, sarcoma, small carcinoid, glassy cell, clear cell, and adenoid cystic.
* Previous or current medical or psychiatric illness that would prevent informed consent
* Patients known to be infected with HIV or a history of AIDS are excluded.
* Prior surgery for carcinoma of the cervix other than a biopsy.
* Patients with para-aortic disease.
* Previous pelvic radiation therapy or systemic chemotherapy is not permitted.
* Women who are pregnant or breast-feeding are excluded from this study.
* Previous history of hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80 must be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester, Dept. Radiation Oncology
state: New York
Study officials:
affiliation: Universtiy of Rochester, Dept of Radiation Oncology
name: Yuhchyau Chen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06739369: The Relationship Between Arterial Stiffness and Pulmonary and Extrapulmonary Features in Ankylosing Spondylitis
Official title: Investigation of the Relationship Between Arterial Stiffness and Pulmonary and Extrapulmonary Features in Patients with Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ankylosing Spondylitis (AS)
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients followed up with a diagnosis of ankylosing spondylitis will be included.

Brief summary: The aim of this study was to investigate the relationship between arterial stiffness and pulmonary and extrapulmonary features in patients with ankylosing spondylitis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ankylosing spondylitis according to ASAS diagnostic criteria
* Being aged 18-65
* Stable medication use for at least 3 months
* Voluntary participation in the study

Exclusion Criteria:

* Having uncontrolled cardiopulmonary disease
* Being pregnant
* Having undergone recent surgery
* Presence of malignancy
* Failure to perform to assessments

Primary outcomes:
measure: Arterial stiffness
timeFrame: 1st day
measure: Respiratory muscle strength
timeFrame: 1st day
measure: Respiratory muscle endurance
timeFrame: 1st day
measure: Exercise capacity
timeFrame: 1st day
measure: Peripheral muscle strength
timeFrame: 1st day
measure: Muscle function
timeFrame: 1st day
Secondary outcomes:
measure: Physical activity
timeFrame: 1st day
measure: Forced vital capacity
timeFrame: 1st day
measure: Forced expiratory volume in one second
timeFrame: 1st day
measure: Forced expiratory volume in one second/forced vital capacity ratio
timeFrame: 1st day
measure: Peak expiratory flow
timeFrame: 1st day
measure: Forced mid-expiratory flow
timeFrame: 1st day
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Kirsehir Ahi Evran University
Study officials:
References:
Clinical trial NCT02849769: Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study
Official title: Medtronic Magnetic Resonance (MR) Conditional Tachyarrhythmia Therapy Products Post-approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachyarrhythmia
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2016-07-29
Enrollment: 10979
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Brief summary: Following product approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network.

Detailed description: Pre-clinical testing and clinical data has demonstrated the safety and effectiveness of magnetic resonance (MR) Conditional Tachyarrhythmia Therapy Systems in the MR environment when used according to labeling requirements. Following approval, further confirmation of the MR Conditional Tachyarrhythmia Therapy Systems sensing and detection performance post MRI exposure will be obtained by actively monitoring de-identified device data obtained through the Medtronic CareLink® Network. MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Eligibility criteria: Inclusion Criteria:

* MR conditional tachyarrhythmia therapy system enrolled in the Medtronic CareLink® Network (CL) will be used to prospectively assess spontaneous Ventricular Fibrillation (VF) episode detection following MRI exposure.

Primary outcomes:
measure: The proportion of episodes with ≥ 5 seconds VF detection delay in the MR conditional tachyarrhythmia therapy system following MRI exposure.
timeFrame: up to 5 years post-approval.
Secondary outcomes:
measure: The number of patients with 2 or more scans
timeFrame: up to 5 years post-approval
measure: Pre-MRI and post-MRI LV lead PCT measurements obtained through CareLink
timeFrame: up to 5 years post-approval
Other outcomes:
Locations:
Study officials:
affiliation: Medtronic
name: Product Surveillance Registry Medtronic Product Surveillance Registry
role: STUDY_CHAIR
References: