louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04012112: The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis
Official title: The Effect of Flexible Thoracolumbar Brace on Spinal Alignment, Pain and Quality of Life in Subjects With Neuromuscular Scoliosis : A Longitudinal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Scoliosis
Keywords: brace
neuromuscular disease
scoliosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 12
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In the initial evaluation, the degree of spine is measured quantitatively using Cobb's angle and Muscular Dystrophy Spine Questionnaire (MDSQ). The patients who had Cobbs angle of 20-45 'by spinal plain radiography were evaluated for the effects of flexpine brace wearing and rehabilitation for 6 months. After 12 months, whole spine X-ray was taken for the followed up the patient's status.


Eligibility criteria: Inclusion Criteria:

* 20-45' degrees of cobb's angle in the neuromuscular disease

Exclusion Criteria:

* patient's who had spinal surgery
* less than 20 degree or more than 45 degree of cobb's angle
* acute lumbar pain

Primary outcomes:
measure: change of the scoliosis
timeFrame: 6months
Secondary outcomes:
measure: change of pain
timeFrame: 6months
measure: change of pulmonary function
timeFrame: 6 months
measure: change of quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul national university bundang hospital
state: Bundang
Study officials:
References:
Clinical trial NCT00311012: SPP100 Dose Finding Study in Japan
Official title: Dose-finding Study of SPP100 in Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: Hypertension, Aliskiren
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-04-05
Enrollment: 445
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.


Eligibility criteria: Inclusion Criteria:

1. Mild to moderate essential hypertension
2. Age: ≥20 years old and \<80 years old (at time informed consent obtained)
3. Sex: N/A
4. Admission status: Outpatient

Exclusion Criteria:

1. Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
2. Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
3. Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
4. Patients suspected of having malignant hypertension

Primary outcomes:
measure: Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure after 8 weeks
measure: Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks
measure: Evaluate response to various doses by assessing the difference in mean sitting diastolic blood pressure after 8 weeks
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals, Japan
name: Novartis Pharmaceuticals, Japan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00454012: Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor
Official title: Use of Intrapartum Biophysical Profile When Fetal Heart Rate Monitoring is Non-reassuring in Labor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fetal Distress
Keywords: non reassuring fetal heart rate tracing
biophysical profile
assessing fetal wellbeing
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2007-03-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this research project the investigators want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.

Detailed description: When you are in labor, the heart beat of your fetus is monitored continuously. The normal pattern is reactive and suggests that the fetus is doing well. When the pattern is different from reactive, it is difficult to say if the fetus is doing well or not. Previous investigators have shown that even with the most worrisome fetal heart rate pattern, only 2/1000 cases would require immediate delivery. Currently, we use invasive procedures like taking a drop of blood from fetal head to further assess how the fetus is doing or just proceed with the fastest way of delivery (which could increase the risk associated with surgery). In this research project we want to figure out whether ultrasound (a non-invasive method) can be used to assess how the fetus is doing during labor.

Eligibility criteria: Inclusion Criteria:

* Spontaneous or induced labor
* Gestational ages between 35 - 42 weeks
* Singleton pregnancy
* Intrapartum non-reassuring or uninterpretable FHR tracing defined as any tracing that the Labor and Delivery obstetrician is uncomfortable about or feels does not absolutely provide fetal reassurance. Inclusive FHR patterns will be repetitive late decelerations, recurrent moderate to severe variable decelerations, reduced long or short-term variability, prolonged bradycardia (\<120/min) that resolves, persistent fetal tachycardia (\>160/min for \>60 min,) or any other FHR patterns necessitating further fetal well being evaluation (like scalp pH or scalp stimulation).

Exclusion Criteria:

* Multiple gestation
* Gestational age \< 35 weeks
* Patient denial to undergo ultrasound examination during labor
* Abnormal FHR tracing requiring stat delivery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper UniversityHospital
state: New Jersey
Study officials:
affiliation: The Cooper Health System
name: Meena Khandelwal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manning FA, Platt LD, Sipos L. Antepartum fetal evaluation: development of a fetal biophysical profile. Am J Obstet Gynecol. 1980 Mar 15;136(6):787-95. doi: 10.1016/0002-9378(80)90457-3.
Clinical trial NCT01299012: Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus
Official title: Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus, a Retrospective Chart Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University at Buffalo
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 1 Diabetes Mellitus

Brief summary: Evaluating the use of Liraglutide in patients with Type 1 Diabetes.

Detailed description: This investigation will be a retrospective chart review of in type 1 diabetics who have been treated with liraglutide. The study will be conducted at Diabetes-Endocrinology Center of WNY at Millard Fillmore Hospital, affiliated to the State University of New York at Buffalo.

Study Population: 40 patients with type 1 diabetes on treatment with either continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day on continuous glucose monitoring system (CGMS) will be included in the study. These patients with type 1 diabetes have been treated with liraglutide in addition to insulin. The investigators would retrospectively review their charts to evaluate decreases in fasting, postprandial and the overall mean glucose concentrations.

The investigators will compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following one week and 12 weeks of treatment with liraglutide daily. In addition, the investigators will compare the time spent at glucose concentrations \>150 and 200mg/dl and \<70 and \<40 mg/dl. HbA1c levels before and after 12 weeks of treatment with liraglutide daily will be compared.

Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes Mellitus

Exclusion Criteria:

* Type 2 Diabetes Mellitus

Primary outcomes:
measure: Improved Blood Glucose comtrol in Type 1 Diabetes Patients with Liraglutide
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University at Buffalo
name: Paresh Dandona
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02510612: Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism
Official title: Perioperative Dexmedetomidine Affect Diabetic Patient's Glucose Metabolism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes
Keywords: Dexmedetomidine
Diabetic
glycometabolism
sedation
Lead sponsor: Shaanxi Provincial People's Hospital
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine's Sedative Effect on Diabetic Patient

Detailed description: Dexmedetomidine is a high selective α2 agonist,its sedative and analgesia feature is acclaimed. The pathogenesis of type 2 diabetes mellitus is associated with α2 excessive adrenaline receptors expression. This study is to evaluate whether the use of dexmedetomidine is helpful to Diabetic Patient through its antisympathetic effect

Eligibility criteria: Inclusion Criteria:

* Age between 40 and 60
* Selective epigastrium surgery
* In

Exclusion Criteria:

* American Society of Anesthesiology (ASA) Physical Status\>3
* Duration of operation \>3 hours
* Hypovolemia,sinus bradycardia,atrioventricular block,severe hepatic and renal dysfunction,severe cardiac insufficiency

Primary outcomes:
measure: sedation level
timeFrame: from 5 minutes before medication to 10 minutes after Dexmedetomidine discontinuance，length of time frame is about 2 hours
Secondary outcomes:
measure: Heart rate
timeFrame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
measure: Mean arterial pressure
timeFrame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
measure: blood glucose measured by Biochemical test
timeFrame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
measure: cortisol measured by Biochemical test
timeFrame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
measure: insulin measured by Biochemical test
timeFrame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
measure: adrenaline measured by Biochemical test
timeFrame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
measure: noradrenaline measured by Biochemical test
timeFrame: participants will be followed from operation day to first postoperative day，an expected average of 2 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04179812: Multimodal Modeling of the Knee Joint
Official title: Multimodal Modeling of the Knee Joint
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Arthroplasty
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Targeted patients will be those whose leg image modalities are present in the Brest University Hospital database

Brief summary: The trial will contribute to the development of an innovative algorithm that aims to simplify and improve preoperative knee surgical decision. This will be made by automatically extracting anatomical informations from different images acquired on the patient (scanner, MRI, radiography).

Detailed description: The source population will consist of at least 50 patients whose following modalities of images of the leg are present in the database: scanner, MRI, radiography. No restrictions on age or gender are required.

A dedicated algorithm adapting statistical models of appearance to the specific morphology of the patient acquired through an MRI and / or scanner and radios will then be developed.

Eligibility criteria: Inclusion Criteria:

* Patients having the 3 modality of images : scanner, MRI, radiography
* Patients having osteoarthritis or knee trauma
* Images showing the articualtion of the knee
* having formulated his non opposition

Exclusion Criteria:

* Presentation of a partial view of the knee or any view that does not allow a good segmentation of the total knee joint.
* Refusal to participate

Primary outcomes:
measure: Obtaining a similar knee segmentation for all patient regardless of the input image (MRI, CT or radiography)
timeFrame: Inclusion - Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT03135912: Three-Arm Trial of Novel Treatment for Tinea Pedis
Official title: Three-Arm Trial of Novel Treatment for Tinea Pedis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tinea Pedis
Keywords: Tinea Pedis
Athlete's Foot
Lead sponsor: South End Skin Care
Sponsor class: INDUSTRY
First posted: 2017-05-02
Enrollment: 90
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: This is a three-arm randomized controlled trial to assess the efficacy of an experimental treatment in the treatment of tinea pedis (athlete's foot). The experimental treatment will be tested against a vehicle control to determine efficacy and safety, and against an active comparator to evaluate the success of the treatment relative to an existing gold-standard treatment. Patients will be treated for four weeks, with their condition being assessed at the end of treatment and two weeks after the end of treatment. The primary endpoint for this study is effective treatment rate at the week 6 evaluation, defined as a mycological cure and minimal clinical signs \& symptoms. Secondary endpoints include safety and patient evaluation of treatment.


Eligibility criteria: Inclusion Criteria:

* male or female, aged 18 or above
* clinical diagnosis of tinea pedis
* diagnosis confirmed with potassium hydroxide microscopy
* availability for the duration of the study (6 weeks)
* willingness to comply with study protocol
* informed consent

Exclusion Criteria:

* moccasin-type tinea pedis
* severe maceration of interdigital spaces
* severe fissuring
* history of dry feet, cracking, fissuring
* concurrent onychomycosis
* serous exudate or pus
* topical antifungal treatment in the past 2 weeks
* systemic antifungal treatment in the past 4 weeks
* concurrent immunosuppressive or antimicrobial therapy
* liver disease
* pregnancy or breastfeeding
* known hypersensitivity to any ingredients of trial agents

Primary outcomes:
measure: Effective Treatment (Mycological Cure and Minimal Symptoms)
timeFrame: 6 weeks
Secondary outcomes:
measure: Rate of Adverse Events
timeFrame: 6 weeks
measure: Effective Treatment (Mycological Cure and Minimal Symptoms)
timeFrame: 4 weeks
measure: Patient Satisfaction Score
timeFrame: 4 weeks
measure: Self-Reported Patient Compliance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Milford
country: United States
facility: Kuchnir Dermatology & Dermatologic Surgery
state: Massachusetts
Study officials:
affiliation: South End Skin Care
name: Carl Schanbacher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00464412: The Effect of a Short Educational Program on Young Women's Knowledge and Beliefs About Osteoporosis
Official title: The Effect of a Short Educational Program on Young Women's Knowledge and Beliefs About Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Keywords: Osteoporosis
Knowledge
Beliefs
Education
Women
Lead sponsor: Valdosta State University
Sponsor class: OTHER
Collaborators: name: Roanoke College
First posted: 2007-04-23
Enrollment: 135
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to determine the effect of a short educational program on young women's knowledge and beliefs about osteoporosis. They hypothesis is that following the intervention women who receive the educational program will have greater knowledge and beliefs about osteoporosis.

Detailed description: Objective. To determine the effect of a short osteoporosis educational program on young women's knowledge and beliefs about osteoporosis. Methods. Ten college physical activity classes enrolling 133 predominantly Caucasian women (age range 18 to 21 years) were randomized to an osteoporosis educational program or control. Knowledge and beliefs about osteoporosis were assessed at baseline and at one week and three weeks following the intervention using the Multiple Osteoporosis Prevention Survey. Knowledge was defined as the ability to identify correctly osteoporosis risk factors. Beliefs were measured with the use of a five point Likert type scale. The educational program was comprised of a lecture and printed materials developed by the National Osteoporosis Foundation. Chi-square and analysis of variance evaluated for between group differences. Alpha was set at 0.05.

Eligibility criteria: Inclusion Criteria:

* Women enrolled in a mid-atlantic college physical activity course

Exclusion Criteria:

* Unable to partake in three survey's and one educational lesson

Primary outcomes:
measure: Osteoporosis Knowledge
timeFrame: 7 days and 21 days post educational intervention
measure: Osteoporosis Beliefs
timeFrame: 7 days and 21 days post educational intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Valdosta State University
name: Mark J Kasper, EdD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03362112: Lipoprotein-associated Phospholipase A2 in Patients With Type 2 Diabetes
Official title: Lipoprotein-associated Phospholipase A2 in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Keywords: lipoprotein-associated phospholipase A2
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 1713
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to August 2016 were enrolled in this study.

Brief summary: Lipoprotein-associated phospholipase A2 (LP-PLA2) is a good marker of cardiovascular risk and inflammation. This study aims at the characteristic and clinical significance of LP-PLA2 test in patients with type 2 diabetes(T2D).

Detailed description: The investigators recorded clinical factors, serum levels of glucose, HbA1c, lipids and LP-PLA2 in patients with T2D who visited in the Department of Endocrinology at the Nanjing First Hospital from January 2015 to August 2016. The relationship between levels of LP-PLA2 and diabetic complications are analysed.

Eligibility criteria: Inclusion Criteria:

* Patients with T2D and the diagnostic criteria of T2D is according to the World Health Organization in 1999.

Exclusion Criteria:

1. Patients use systemic steroidal anti-inflammatory drugs.
2. Patients are pregnant.
3. Patients with an acute infection.

Primary outcomes:
measure: Lipoprotein-associated Phospholipase A2
timeFrame: Day one
Secondary outcomes:
measure: HbA1c
timeFrame: Day one
measure: LDL-c
timeFrame: Day one
measure: Diabetic Complication
timeFrame: Day one
measure: C Peptide
timeFrame: Day one
Other outcomes:
Locations:
Study officials:
References:
citation: Hu Y, Li TT, Zhou W, Lu TT, Li FF, Ding B, Liu BL, Xie XJ, Ma JH. Lipoprotein-associated phospholipase A2 is a risk factor for diabetic kidney disease. Diabetes Res Clin Pract. 2019 Apr;150:194-201. doi: 10.1016/j.diabres.2019.03.026. Epub 2019 Mar 20.
Clinical trial NCT01410812: Tying Devices as a Means of Increasing Exercise
Official title: Tying Devices as a Means of Increasing Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Interest in exercising more
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2011-08-05
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators propose that healthy behaviors such as exercise could be increased through the use of tying devices - mechanisms that force a coupling of addictive activities (listening to the next chapter of a page-turner novel) with engagement in a healthy behavior (exercise).

Detailed description: The study will test the effect of the following treatments as a means of increasing gym attendance over 10 weeks: 1. Participants receive access to 4 iTunes audio novels on their own iPods and prompted to listen to those novels only when exercising at the gym; 2: Participants receive 4 iTunes audio novels for a loaned iPod that they will only have access to at the gym; 3: Participants receive weekly emails asking them about their exercise.

Eligibility criteria: Inclusion Criteria:

* Stable health as determined by the screening of their medical history
* Own an iPod
* An interest in exercising more regularly
* Belong to the Pottruck Gym at University of Pennsylvania
* Interested in exercising more through the use of aerobic exercise machines

Exclusion Criteria:

* Recent myocardial infraction
* congestive heart failure
* uncontrolled hypertension
* self-report of 6 or more alcoholic beverages per day or use of any illicit drugs
* bulimia nervosa or related behaviors
* diabetes medication

Primary outcomes:
measure: Average Weekly Gym Attendance From Baseline to Week 9
timeFrame: 9 weeks
Secondary outcomes:
measure: Dollar Amount Participants Would Pay for Enrollment
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine L. Milkman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Julia A Minson
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Kevin G.M. Volpp, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: