louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00657527: Evaluation of Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease
Official title: An 8-Week Randomized Double Blind Placebo Controlled Multicenter Trial to Evaluate the Effects of Rosuvastatin 40mg on Myocardial Ischemia in Subjects With Coronary Artery Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Ischaemia
Coronary Artery Disease
Keywords: Crestor
Rosuvastatin
Cholesterol
Coronary artery disease
Myocardial ischaemia.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-14
Enrollment: 280
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: The purpose of this study is to determine whether treatment with 40mg of Rosuvastatin for 8 weeks will reduce the number of episodes of myocardial ischaemia suffered in subjects with coronary artery disease.


Eligibility criteria: Inclusion Criteria:

* Evidence of Coronary arterial disease
* Suffering ischaemic episodes/exercise induced ischaemia
* Not taking any cholesterol lowering medication

Exclusion Criteria:

* Unstable angina or heart attack less than one month before trial entry
* Coronary arterial surgery as defined by protocol
* Uncontrolled hypertension, diabetes, hypothyroidism or laboratory values as defined by the protocol.

Primary outcomes:
measure: Number of episodes of myocardial ischaemia as assessed by ambulatory electrocardiographic monitoring.
timeFrame: 8 weekly
Secondary outcomes:
measure: Change in duration of ischemic episodes
timeFrame: 8 weekly
measure: Safety
timeFrame: 8 weekly
measure: Several laboratory parameters as detailed in the protocol
timeFrame: 8 weekly
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Michael Cressman, DO
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Russell Esterline
role: STUDY_CHAIR
References:
Clinical trial NCT03617627: Self-management Program in Chronic Pelvic Pain
Official title: Self-management Intervention for Women With Chronic Pelvic Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain
Keywords: chronic pain
women
self-management
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic pelvic pain is a serious health condition with an estimated prevalence of 15% women worldwide.Treatment is a challenge given the different pain generators described. It is important to develop self-management interventions to reduce the frustration associated with its management.

Detailed description: Chronic pelvic pain is defined as non-cyclic pain lasting for 6 or more months, that localizes to the anatomic pelvis, anterior abdominal wall at or below the umbilicus, the lumbosacral back, or the buttocks and is of sufficient severity to cause functional disability or lead to medical care. It can occur continuously or intermittently, with intensity severe enough to limit activities of daily living. It is frequent in women. The primary aim of this study isto evaluate the efficacy of a self-management intervention, as compared with an educational booklet in improving health-related quality of life and coping strategies, occupational performance, activity level and psycho-emotional symptoms in women with chronic pelvic pain.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic pelvic pain with at least 6 months of evolution

Exclusion Criteria:

* Active urogenital infection
* Pregnancy
* Cancer
* Dementia
* A surgical intervention involving lumbo-pelvic region over the past year

Primary outcomes:
measure: Perceived health-related quality of life
timeFrame: Change from baseline health-related quality of life at 7 weeks
measure: Change in coping strategies
timeFrame: Change from baseline coping strategies at 7 weeks
Secondary outcomes:
measure: Change in performance of activities
timeFrame: Change from baseline self-perceived performance at 7 weeks
measure: Change in activity levels
timeFrame: Change from baseline self-reported activity levels at 7 weeks
measure: Change in anxiety levels.
timeFrame: Change from baseline anxious symptoms at 7 weeks
measure: Change in depressive symptoms
timeFrame: Change from baseline depressive symptoms at 7 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02632227: Fluid Responsiveness Using TFU (Transfontanel Ultrasound) in Children With Congenital Heart Disease
Official title: Prediction of Fluid Responsiveness Using TFU (Transfontanel Ultrasound) in Children With Congenital Heart Disease After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Responsiveness
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 30
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pediatric patients with congenital heart disease undergoing cardiac surgery

Brief summary: The purpose of this study was to evaluate the clinical usefulness of TFU (transfontanel ultrasound)for the prediction of fluid responsiveness in children undergoing congenital heart surgery.


Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing cardiac surgery

Exclusion Criteria:

* preterm closure of anterior fontanelle
* anatomical abnormalities on aortic arch (ex, patent ductus arteriosus)
* presence of intracardiac and extracardiac shunt

Primary outcomes:
measure: change in respiratory variation of carotid artery blood flow peak velocity after volume expansion
timeFrame: before and after fluid administration (20min)
Secondary outcomes:
measure: change in cardiac index after volume expansion
timeFrame: before and after fluid administration (20min)
measure: change in pleth variability index after volume expansion
timeFrame: before and after fluid administration (20min)
measure: change in respiratory variation of aorta flow blood flow peak velocity after volume expansion
timeFrame: before and after fluid administration (20min)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT00440427: Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)
Official title: A Randomized, Open-Label, Single-Dose Parallel Group Study of the Pharmacokinetic Profile, Safety, and Tolerability of 25- and 50-mg Desvenlafaxine Sustained Release (DVS SR) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder, Major
Keywords: Major Depressive Disorder
MDD
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to healthy subjects.


Eligibility criteria: * Men or non-pregnant, non-lactating women
* Body mass index 18 - 30 kg/m2
* Body weight greater than or equal to 60kg

Primary outcomes:
measure: Safety
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
state: Massachusetts
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05151627: The Effectiveness of Kinesio Taping in Patients With Knee Osteoarthritis
Official title: Effectiveness of Kinesio Taping and Conventional Physical Therapy in the Management of Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee
Osteoarthritis
Kinesio taping
TENS
Stretching
Strengthening exercise
Lead sponsor: University of Tabuk
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis is the most common kind of arthritis that occurs due to degeneration of the joint articular cartilage, producing pain, stiffness, and impaired movement. Kinesio taping is a simple and inexpensive therapeutic procedure that can help with knee osteoarthritis symptoms. Kinesio taping is a high-stretch elastic adhesive material that allows the treated area to have free mobility. This technique was preferred by physical therapists for knee osteoarthritis rehabilitation because of its positive effects, such as decreased pain and increased mobility and muscular performance.


Eligibility criteria: Inclusion Criteria:

* Complaining of knee pain but no serious knee injuries
* No Physical therapy treatment taken for the past 3 months
* Painful range of motion (ROM)
* Significant decrease in active and passive ROM.

Exclusion Criteria:

* Knee surgery within the last three months
* Neural, articular, or muscular conditions affecting lower limb function
* Systemic arthritic diseases

Primary outcomes:
measure: NUMERICAL PAIN RATING SCALE
timeFrame: 6 weeks
measure: GONIOMETRIC MEASUREMENT OF KNEE RANGE OF MOTION
timeFrame: 6 weeks
measure: WESTERN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC)
timeFrame: 6 weeks
measure: TIMED UP AND GO (TUG) TEST
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tabuk
country: Saudi Arabia
facility: University of Tabuk
Study officials:
References:
Clinical trial NCT03713827: Clinical Performance of a Glass Hybrid Restorative in NCCL's of Patients With Bruxism
Official title: 24-Month Performance of a Glass-hybrid-restorative in Non-carious Cervical Lesions of Patients With Bruxism: A Split-mouth, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bruxism
Noncarious Cervical Lesions
Keywords: glass hybrids
bruxism
Non carious cervical lesions
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 25
Sex: ALL
Minimum age (years): 42
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: double blinded, split mouth, randomized clinical trial
Primary purpose: TREATMENT

Brief summary: This is a double blinded, split mouth, randomized clinical study that evaluated the performance of a glass hybrid restorative material in non-carious servical lesions in patients with bruxism. The lesions were restored with glass hybrid restorative (Equia Forte) or nano ceramic composite resin (Ceram-x One). Restorations were evaluated after 24 months according to USPHS criteria and the data were evaluated.

Detailed description: The aim of this study was to evaluate the clinical performance of a glass-hybrid-restorative compared with a nano ceramic composite resin in non-carious cervical lesions (NCCLs) of patients with bruxism.

For this purpose, twenty-five patients having NCCLs and bruxism enrolled to the present study. Before treatment, the dimensions of the NCCLs were measured in depth, gingival-incisal height and mesio-distal width using a CPI probe. Degree of tooth wear (TWI) and gingival conditions (GI) are also recorded. A total of 148 NCCLs were randomly restored with a a glass-hybrid-restorative system (Equia Forte Fil, GC, Tokyo, Japan) or a nano ceramic composite resin (Ceram.X One Universal, Dentsply, DeTrey, Konstanz, Germany) and restorations were evaluated at baseline and after 6,12 and 24 months according to the modified-USPHS criteria. Data were analyzed with Chi- Square, Fisher's Exact Test, Mann Whitney-U and Cochran's Q tests (p \< 0.05).

Eligibility criteria: Inclusion Criteria:

* non-hospitalized, healthy patients that were seeking dental treatmen
* occlusally contacted teeth

Exclusion Criteria:

* Patients having intensive medical history
* Chronic periodontitis,
* high caries activity,
* extremely poor oral hygiene,
* teeth with restorations,
* mobility due to periodontal disease
* in contacted with removable prosthetic construction were excluded from the study

Primary outcomes:
measure: Retention Alpha for at least 90% of the restorations
timeFrame: 24 months
Secondary outcomes:
measure: marginal adaptation score alpha
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03388827: Laminaria and Misoprostol Before Operative Hysteroscopy
Official title: The Use of Laminaria Versus Laminaria Plus Misoprostol Before Operative Hysteroscopy in Nulliparous Women . A Double Blinded Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Spasm
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2018-01-03
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laminaria and Misoprostol before Operative Hysteroscopy

Detailed description: The use of laminaria versus laminaria plus misoprostol was compared before operative hysteroscopy in nulliparous women to assess the efficacy of both methods in cervical dilatation.

Eligibility criteria: Inclusion Criteria: nullipara

* need hystroscopic intervention

Exclusion Criteria: previous pregnancy

cervical lesion

contraindication to misoprostol

-

Primary outcomes:
measure: Preoperative cervical width
timeFrame: 12 hours
Secondary outcomes:
measure: adverse effects
timeFrame: 24 hours
Other outcomes:
Locations:
city: Zagazig ,
country: Egypt
facility: Zagazig University
Study officials:
References:
Clinical trial NCT01816373: Non-invasive Negative Pressure Treatment for Pectus Excavatum
Official title: Efficacy Evaluation of the Non-invasive Negative Pressure Treatment for Pectus Excavatum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pectus Excavatum
Keywords: Chest wall; Chest, funnel; pectus excavatum; congenital abnormality
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the non-invasive negative pressure treatment with the use of the device Vacuum Bellfor is effective for the pectus excavatum treatment


Eligibility criteria: Inclusion Criteria:

* absence of co-morbidities that may interfere with proper placement or function of the apparatus
* test negative for pregnancy in women of childbearing age

Exclusion Criteria:

* skeletal diseases like osteogenesis imperfecta or osteoporosis
* clotting disorders such as hemophilia or thrombopathia
* skin diseases or infections of the anterior chest wall
* angiopathies or vascular fragility
* obesity important with BMI greater than 30
* precarious commitment to the prolonged use of the device protocol

Primary outcomes:
measure: Measurement of the reduction in the deepness of the pectus excavatum
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of quality of life related to self-esteem
timeFrame: One year
Other outcomes:
measure: Evaluate the safety and adherence to the treatment
timeFrame: three months
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
Study officials:
affiliation: Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
name: Miguel L. Tedde, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto do Coracao (InCor), Hospital das Clinicas, FMUSP
name: Jose Ribas M de Campos, MD, PhD
role: STUDY_CHAIR
References:
citation: Haecker FM, Sesia SB. Intraoperative use of the vacuum bell for elevating the sternum during the Nuss procedure. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):934-6. doi: 10.1089/lap.2012.0030.
citation: Schier F, Bahr M, Klobe E. The vacuum chest wall lifter: an innovative, nonsurgical addition to the management of pectus excavatum. J Pediatr Surg. 2005 Mar;40(3):496-500. doi: 10.1016/j.jpedsurg.2004.11.033.
citation: Togoro SY, Tedde ML, Eisinger RS, Okumura EM, de Campos JRM, Pego-Fernandes PM. The Vacuum Bell device as a sternal lifter: An immediate effect even with a short time use. J Pediatr Surg. 2018 Mar;53(3):406-410. doi: 10.1016/j.jpedsurg.2017.04.016. Epub 2017 May 1.
Clinical trial NCT01544673: Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Males
Official title: An Open-label, Placebo-controlled Phase 1 Study to Evaluate the Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gram Positive Infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Results from previous studies have been inconclusive and the effect of linezolid on cytokines remains unclear. This study is designed to evaluate the effect of linezolid on the functionality of white blood cells (neutrophils and monocytes) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects between the ages of 20 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Subject who had a bacterial/viral infection within 2 weeks prior to the first dose of study medication.
* Subjects with current or prior neutropenia (eg, \<1.4 x 109 neutrophils /L).

Primary outcomes:
measure: Change from baseline in phagocytosis of gram-negative bacteria by neutrophils
timeFrame: Baseline, day 4 and day 5
measure: Change from baseline in phagocytosis of gram-negative bacteria by monocytes
timeFrame: Baseline, day 4 and day 5
measure: Change from baseline in interleukin-1 receptor antagonist secretion in response to lipopolysaccharide stimulation
timeFrame: Baseline, day 4 and day 5
measure: Change from baseline in interleukin-1-beta secretion in response to lipopolysaccharide stimulation
timeFrame: Baseline, day 4 and day 5
measure: Change from baseline in interleukin-6 secretion in response to lipopolysaccharide stimulation
timeFrame: Baseline, day 4 and day 5
measure: Change from baseline in interleukin-8 secretion in response to lipopolysaccharide stimulation
timeFrame: Baseline, day 4 and day 5
measure: Change from baseline in tumor necrosis factor alpha secretion in response to lipopolysaccharide stimulation
timeFrame: Baseline, day 4 and day 5
Secondary outcomes:
measure: Linezolid peak concentration on day 4
timeFrame: day 4
measure: Linezolid peak concentration on day 5
timeFrame: day 5
measure: Linezolid trough concentration on day 5
timeFrame: day 5
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05170373: ESP Block in Radical Prostatectomy
Official title: Effects of Ultrasound Guided Erector Spinae Plane Block in Radical Prostatectomy Surgery on Pain and Surgical Stress Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erector Spinae Plane Block
Keywords: Erektor Spinae Plane Block
Postoperative Analgesia
Surgical Stress Response
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 46
Sex: MALE
Minimum age (years): 30
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study aimed to examine the effects of ultrasound guided erector spinae plane block in radical prostatectomy surgery on pain and surgical stress response, to reduce adrenocortical and sympathetic discharge due to anesthesia and surgery, and to reduce peroperative opioid analgesic consumption.

Detailed description: In this study 46 patients between the ages of 30-74, American Society of Anesthesiologists (ASA) score I-II and undergoing radical prostatectomy surgery at T.R. Ministry Of Health İstanbul Göztepe Prof. Dr. Süleyman Yalçın City Hospital were included. The patients were randomly divided into two groups as ESPB applied Group B (n=23) and not Group K (n=23). Patient-controlled analgesia (PCA) was initiated in all patients for postoperative analgesia. Patients' demographic data (age, gender, ASA score), intraoperative hemodynamic data, intraoperative and postoperative additional narcotic consumption, postoperative Numeric Rating Scale (NRS) scores (postoperative 0, 5 and 20 minutes and Then, 1, 3, 6, 12, 18 and 24 h), postoperative nausea-vomiting scores and possible complications related to block and / or surgery were recorded.Intraoperative MAP, HR, SpO2, BIS values of patients in both groups were recorded every 5 minutes. Blood glucose, insulin, cortisol, prolactin and C-reactive protein (CRP) were studied three times; preop morning at 6:00, intraoperative when surgical incision closing and postoperative 24h. in order to evaluate the surgical stress response in the patients.

Eligibility criteria: Inclusion Criteria:

* ASA I-II

Exclusion Criteria:

* diabetes
* coagulopathy
* local anesthetic
* drug allergy
* long hospitalization history,
* hormone disorder
* advanced organ failure
* history of steroid use
* vertebral anomalies
* mental retardation

Primary outcomes:
measure: Numeric Pain Scale
timeFrame: postoperative 24 hours.
measure: Blood glucose
timeFrame: postoperative 24 hours.
measure: insulin
timeFrame: postoperative 24 hours.
measure: cortisol
timeFrame: postoperative 24 hours.
measure: prolactin
timeFrame: postoperative 24 hours.
measure: C-reactive protein
timeFrame: postoperative 24 hours.
Secondary outcomes:
measure: Remifentanil Consumption Speed
timeFrame: 3 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Suleyman Yalcin City Hospital
Study officials:
References: