louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01394705: FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
Official title: FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease Risk High
Keywords: patients at increased risk for atherosclerosis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 42
Sex: ALL
Minimum age (years): 13
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot study seeks to compare the change in energy expenditure and fitness levels of patients seen in the Children's Hospital Preventive Cardiology program receiving standard of care provider exercise counseling to similar patients receiving Frequency, Intensity, Time, Type (FITT) exercise prescription and counseling combined with BodyMedia supported by an online interactive tool.

The investigators primary hypothesis is that this interactive technology coupled with support from a exercise specialist will increase the energy expenditure of the investigators patients over standard of care provider counseling.

The investigators Secondary hypotheses include greater improvement in measured physical fitness Peak oxygen consumption (VO2max), oxygen consumption (VO2) at anaerobic threshold (AT) and ventilation/carbon dioxide (VE/VCO2) slope, lipid profiles, blood pressure, arterial stiffness, body mass index (BMI), BMI percentile, and self-efficacy in the intervention group compared to control.


Eligibility criteria: Inclusion Criteria:

1. Patients at increased risk of atherosclerosis based on lipid profiles (Total Cholesterol \> 199 mg/dL, High Density Lipoprotein \< 40 mg/dL, LDL \> 129 mg/dL, blood pressure (Systolic Blood Pressure or Diastolic Blood Pressure \> 90th percentile), obesity (\>85%Body Mass Index)
2. Ages 13-21 years
3. Reporting an average of less than 60 minutes per day of moderate to vigorous exercise most (5) days of the week.
4. Regular access to the internet with the capacity to download the device
5. Commitment on the part of a parent to supervise internet access as part of this protocol

Exclusion Criteria:

1. Unable to exercise based on physician recommendations or medical conditions
2. Unable/unwilling to complete requirements of the research study including consent and assent.
3. Not proficient in English

Primary outcomes:
measure: Physical Activity
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Childrens Hospital
state: Massachusetts
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Tracy c Curran, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00327405: Results of Ocular Compression and Suture Release in Trabeculectomy and Combined Surgery
Official title: A Retrospective Study of Surgical Outcomes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open Angle Glaucoma
Keywords: POAG
Primary Open Angle Glaucoma
Trabeculectomy
Combined Phacotrabeculectomy
Combined Glaucoma Cataract Surgery
Releasable Suture
Ocular Compresssion
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2006-05-18
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The use of ocular compression and suture release have helped to improve the safety and decrease the risks of glaucoma filtering surgery. This study looks at the decrease in intraocular pressure and glaucoma medications required following glaucoma filtering surgery.

Detailed description: A retrospective review of surgical results in eyes with at least six months followup was performed for trabeculectomy and combined phacoemulsification-trabeculectomy surgery. A total of 141 eyes were studied.

Eligibility criteria: Inclusion Criteria:

* Primary Open Angle Glaucoma
* Six Months Followup
* No previous surgery

Exclusion Criteria:

* Less Than Six Months Followup
* Previous glaucoma surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
Study officials:
affiliation: University of Cincinnati Department of Ophthalmology
name: John S Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01982305: Pilot Study of a Nerve Block Simulator for the Training in Axillary Blocks
Official title: Simulator Versus Cadaver Training to Perform Ultrasound-guided Axillary Nerve Bocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arm Injuries
Lead sponsor: Fundación Universitaria de Ciencias de la Salud
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether an ultrasound-guided nerve block simulator is effective for the training of the axillary block technique.

Detailed description: Ultrasound-guided nerve blocks are becoming the standard of care in patients requiring regional anesthesia. Cost-effective training is needed for the implementation of these techniques in the global anesthesia practice. Existing simulators are expensive and not available in low income countries. The investigators aimed to test an inexpensive simulator for the training in this technique.

Eligibility criteria: Inclusion Criteria:

* Anesthesia residents

Exclusion Criteria:

* Previous training in regional anesthesia techniques

Primary outcomes:
measure: Time to locate axillary nerve in a cadaver
timeFrame: At the end of the procedure, expected average of 30 seconds
Secondary outcomes:
measure: Time to identify axillary nerve in a cadaver
timeFrame: During the procedure, expected average of 15 seconds
Other outcomes:
Locations:
Study officials:
affiliation: Fundacion Universitaria de Ciencias de la Salud
name: Luis E Reyes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundacion Universitaria de Ciencias de la Salud
name: Luis A Muñoz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03097705: Effect of Steep Trendelenburg in Laparoscopic Surgery on IOP & RNFL Thickness
Official title: The Effect of Steep Trendelenburg Position Used During Laparoscopic Surgery on Intraocular Pressure During Surgery and on the Retinal Nerve Fiber Thickness After Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intraocular Pressure
Retinal Nerve Fiber Bundle Deficiency
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The effect of Steep Trendelenburg position used during laparoscopic surgery on intraocular pressure during surgery and on the retinal nerve fiber thickness after surgery

Detailed description: To measure IOP and RNFL thickness in subjects undergoing laparoscopic operations in steep trendelenburg before, during, and after the operation

Eligibility criteria: Inclusion Criteria:

* SUBJECTS INTENDING TO UNDERGO LAPROSCOPIC SERGURY WHICH HAVE NO EYE DISEASES

Exclusion Criteria:

* SUBJECT WITH EYES DISEASE
* PREGNANCY DURING THE STUDY PERIOD

Primary outcomes:
measure: Intra Ocular Pressure (IOP)
timeFrame: Change in IOP from baseline to IOP during surgery and to one week and to three months following surgery
measure: Retinal Nerve Fiber Layer Thickness (RNFL) using OCT
timeFrame: Change in OCT RNFL thickness from baseline to OCT RNFL thickness during surgery and to one week and to three months following surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06709105: The Effect of Kinesiotaping in Pregnant Women
Official title: The Effect of Kinesiotaping on Clinical Parameters in Pregnant Women With Mechanical Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: KINESIOTAPING
Keywords: Kinesiotaping
Low Back Pain
Pregnancy
Lead sponsor: Firat University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effect of an exercise program combined with Kinesio Taping (KT) and sham KT on clinical parameters in pregnant women with low back pain. A total of 40 participants were included in the study, 20 in the experimental and 20 in the control groups. Visual Analog Scale (VAS), Roland Morris Quality of Life Questionnaire and Pittsburgh Sleep Quality Index were used as data collection tools. The experimental group received KT and an exercise program, while the control group received sham KT and exercise program.

Detailed description: Lumbar-sacral spinal pain is a medical and socioeconomic problem affecting approximately 80% of the population. Pregnancy predisposes women to this pain. The most well-known cause of low back pain during pregnancy is an increase in lumbar lordosis, a lordotic syndrome that develops rapidly due to the pregnant uterus and maternal weight gain. This lordotic posture and the related change in load distribution, along with lengthening abdominal muscles and shortening lumbar muscles, create a mechanical disadvantage. The aim of this study is to examine the effect of an exercise program combined with Kinesio Taping (KT) and sham KT on clinical parameters in pregnant women with low back pain. A total of 40 participants were included in the study, 20 in the experimental and 20 in the control groups. Visual Analog Scale (VAS), Roland Morris Quality of Life Questionnaire and Pittsburgh Sleep Quality Index were used as data collection tools. The experimental group received KT and an exercise program, while the control group received sham KT and exercise program.

Eligibility criteria: Inclusion Criteria:

* 20-32-week pregnant women without neurologic deficits
* Females with mechanical low back pain
* VAS of at least 3

Exclusion Criteria:

* High-risk pregnant women with twin pregnancy
* Placenta previa
* Pre-eclampsia
* Threatened preterm delivery
* Orthopedic and rheumatologic diseases
* Radiculopathy

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Pittsburgh sleep quality index
timeFrame: up to 30 minutes
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Muhammet Şahin Elbastı
state: Firat University
Study officials:
References:
Clinical trial NCT01747005: Effect of Enhanced Recovery After Surgery (ERAS) on Inflammatory Response After Planned Abdominal Hysterectomy
Official title: Effect of Enhanced Recovery After Surgery (ERAS) on Inflammatory Response After Planned Abdominal Hysterectomy: A Prospective Randomized Clinical Trial.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hysterectomy
Keywords: abdominal hysterectomy
enhanced recovery after surgery
inflammatory response
ERAS
combined spinal-epidural anesthesia
Lead sponsor: Samoilova Maternity Home
Sponsor class: OTHER
Collaborators: name: Northern State Medical University
First posted: 2012-12-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Admitted patients in maternity home

Brief summary: The aim of study is to determine effect of enhanced recovery after surgery (ERAS) on inflammatory response after abdominal hysterectomy.


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Abdominal hysterectomy
* ASA class I or II

Exclusion Criteria:

* psychiatric disorders
* ASA III and IV
* Chronic inflammatory disorders
* Pregnancy
* Local anesthetics allergy
* Coagulation disorders
* patients receiving anticoagulants

Primary outcomes:
measure: Change of Serum level of IL-1beta,IL-6,CRP,Cortisol,IL-4 by immuno-ferment analysis.
timeFrame: baseline, 24 hour post-operative and 7 days post-operative
Secondary outcomes:
measure: Change of postoperative pain, fatigue and postoperative nausea and vomiting
timeFrame: baseline,6,12,24,48 hour and 7 days postoperatively
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Samoilova maternity home
state: Arkhangelskya oblast
Study officials:
References:
Clinical trial NCT00129805: Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)
Official title: Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A Randomized, Double-Blind, Aspirin-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Infarction
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2005-08-12
Enrollment: 1510
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease.

S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.


Eligibility criteria: Inclusion Criteria:

* Cerebral infarction except cardiac source of embolism
* Onset ≧ 1 week to ≦ 6 months before randomization
* Neurological signs persisting ≧ 1 day from onset
* Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site
* Age ≧ 20 years
* Systolic pressure ≦ 180 mmHg; diastolic pressure ≦ 110 mmHg

Exclusion Criteria:

* Functional outcome at randomization: Modified Rankin Scale = 4, 5
* Previous or planned vascular surgery for cerebral infarction
* History of intracranial hemorrhage
* History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
* Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.)
* Pregnant or possibly pregnant women, or nursing mothers
* History of sarpogrelate and aspirin sensitivity
* Treating malignant tumor or treated within 5 years
* Current peptic ulceration

Primary outcomes:
measure: recurrence of cerebral infarction
Secondary outcomes:
measure: intracerebral hemorrhage, subarachnoid hemorrhage, undetermined stroke, transient ischemic attack, myocardial infarction, unstable angina, or vascular death
Other outcomes:
Locations:
Study officials:
affiliation: Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital
name: Yukito Shinohara, MD
role: STUDY_CHAIR
References:
citation: Shinohara Y, Nishimaru K, Sawada T, Terashi A, Handa S, Hirai S, Hayashi K, Tohgi H, Fukuuchi Y, Uchiyama S, Yamaguchi T, Kobayashi S, Kondo K, Otomo E, Gotoh F; S-ACCESS Study Group. Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS): A randomized, double-blind, aspirin-controlled trial. Stroke. 2008 Jun;39(6):1827-33. doi: 10.1161/STROKEAHA.107.505131. Epub 2008 Apr 3.
Clinical trial NCT01100905: An Iron-containing Food Product for the Prevention of Diminished Iron Status in Soldiers
Official title: Utility of an Iron-containing Food Product for the Prevention of Diminished Iron Status During Basic Combat Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Iron Deficiency Anemia
Keywords: Iron
Iron status
Iron deficiency
Iron deficiency anemia
Lead sponsor: United States Army Research Institute of Environmental Medicine
Sponsor class: FED
First posted: 2010-04-09
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: Military personnel face intense physical and cognitive demands. Diminished iron status affects physiologic responses to these challenges. Both cross-sectional and longitudinal studies indicate a significant decrement in iron status in enlisted female military personnel immediately following basic combat training (BCT). Decrements in iron status are associated with diminished cognitive and physical performance, and may affect body composition. The primary objective of this randomized, placebo controlled study is to assess the utility of an iron-containing food product for maintaining iron status during BCT. This study will provide insight into the utility and efficacy of an iron-containing food product for the maintenance of iron status during military training. Furthermore, it will provide novel scientific data regarding the relationship between iron status and physical and cognitive performance in female Soldiers.


Eligibility criteria: Inclusion Criteria:

* Female US Army Recruit
* Participating in Basic Combat Training

Exclusion Criteria:

* Male
* Pregnancy
* Diagnosed hemochromatosis
* Diagnosed thalassemia
* History of ulcerative colitis
* Allergy to chocolate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Fort Jackson
state: South Carolina
Study officials:
References:
citation: Karl JP, Lieberman HR, Cable SJ, Williams KW, Young AJ, McClung JP. Randomized, double-blind, placebo-controlled trial of an iron-fortified food product in female soldiers during military training: relations between iron status, serum hepcidin, and inflammation. Am J Clin Nutr. 2010 Jul;92(1):93-100. doi: 10.3945/ajcn.2010.29185. Epub 2010 May 5.
Clinical trial NCT00786305: Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia
Official title: Assessment of Efficiency of Nebulized Ceftazidime and Amikacin in Treatment of Ventilator Associated Pneumonia Caused by Pseudomonas Aeruginosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pneumonia
Keywords: Nebulization
ceftazidime
amikacin
pneumonia
Pseudomonas aeruginosa
mechanical ventilation
Ventilator-associated pneumonia
treatment
Lead sponsor: Groupe Hospitalier Pitie-Salpetriere
Sponsor class: OTHER
First posted: 2008-11-06
Enrollment: 40
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: Pseudomonas aeruginosa is one of the major causative microorganisms of ventilator-associated pneumonia often resistant to antibiotics. In experimental models, nebulization of antibiotics delivers high lung tissue concentrations of antibiotics in infected lungs and increases lung bacterial killing. The aim of the study is to assess the efficiency of nebulized ceftazidime and amikacin in the treatment of pneumonia caused by Pseudomonas aeruginosa in ventilated patients.


Eligibility criteria: Inclusion Criteria:

* Male or female \>18 years old, ventilator associated pneumonia caused by pseudomonas aeruginosa
* Written informed consent provided by the relatives

Exclusion Criteria:

* Pseudomonas aeruginosa resistant to ceftazidime and amikacin
* Pseudomonas aeruginosa pneumonia associated with other infections requiring intravenous treatment
* Severe septic shock and severe hypoxemia
* Allergy to ceftazidime or amikacin

Primary outcomes:
measure: Bacterial killing
timeFrame: 14 days
Secondary outcomes:
measure: Changes of lung aeration
timeFrame: 8 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Intensive care unit, Department of anesthesiology, La pitie-Salpetriere hospital
Study officials:
affiliation: La Pitie-Salpetriere hospital
name: Jean-Jacques Rouby, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02573805: the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
Official title: the Evaluation of Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Erectile Dysfunction
Keywords: nocturnal penile tumescence and rigidity
erectile dysfunction
Chinese males
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2015-10-12
Enrollment: 1000
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese males ≥20 years

Brief summary: The purpose of this study is to evaluate the diagnostic value of Rigiscan (nocturnal penile tumescence and rigidity, NPTR ) test in erectile dysfunction of Chinese males.

Detailed description: The Rigiscan test is used to evaluate the NPTR parameters. The "normal" NPTR parameter is provided by the Rigiscan manufacturer based on a clinical study on 500 American males. Original studies of NPTR parameters on Chinese males are warranted. On the other hand, during the past decades, several new NPTR parameters have been developed, like tip TAU (tip tumescence activity units), tip RAU (tip rigidity activity units), base TAU (base tumescence activity units), base RAU (base rigidity activity units), but their diagnostic values have been less evaluated. Basd on the these background, we determined to observe the clinical manifestation of these new parameters and to establish the "normal criteria" of NPTR parameters in Chinese males. This could be clinically beneficial in the differential diagnosis of organic and psychological erectile dysfunction.

Eligibility criteria: Inclusion Criteria:

1. patients in a stable and heterosexual partnership with a fixed sexual partner for more than 6 months;
2. age≥20 year;
3. complete the validated International Index of Erectile Function (IIEF-5) questionnaire.

Exclusion Criteria:

1. advanced age (≥65);
2. pelvic trauma
3. thyroid diseases
4. metabolic diseases
5. hypogonadism and other hormonal disorders
6. sleep disorders
7. penile deformities
8. taking drugs that may interfere with erectile function.

Primary outcomes:
measure: Previous Rigiscan parameters analyzed by Rigiscan plus software
timeFrame: within 2 days after the Rigiscan test
Secondary outcomes:
measure: newly developed Rigiscan parameters analyzed by Rigiscan plus software
timeFrame: within 2 days after the Rigiscan test
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Yutian Dai
state: Jiangsu
Study officials:
affiliation: Drum tower Hospital, school of Medicine, Nanjing University
name: l zhu, doctor
role: PRINCIPAL_INVESTIGATOR
References: