louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00865397: Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment
Official title: Observational Study of Glycaemic Control in Type 2 Diabetic Patients Uncontrolled on Oral Antidiabetic Agents and Starting With Once Daily Levemir® (Insulin Detemir) - 24 Weeks, Prospective, Multicentre Observational Study in Hungary
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-03-19
Enrollment: 1032
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A non-randomised sample of approximately 1000 subjects with OAD failure from specialists - diabetologists practice who have been deemed appropriate to receive insulin detemir as add-on to OAD therapy as part of routine out-patient care by the prescribing physician.

Brief summary: This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.


Eligibility criteria: Inclusion Criteria:

* Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician
* Patient willing to sign informed consent
* Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels

Exclusion Criteria:

* Subjects with diagnosed type 1 diabetes mellitus
* Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits)
* Subjects with hypersensitivity to Levemir® or to any of the ingredients
* Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months.

Primary outcomes:
measure: Change in HbA1c
timeFrame: after 24 weeks
Secondary outcomes:
measure: Percentage of subjects to reach HbA1c below 7.0% and equal to or more than 6.5%
timeFrame: after 12 weeks and 24 weeks
measure: Change in FPG (Fasting Plasma Glucose)
timeFrame: after 12 weeks and 24 weeks
measure: Change in body weight
timeFrame: after 12 weeks and 24 weeks
measure: Change in waist and hip circumference
timeFrame: after 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
city: Budapest
country: Hungary
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01853397: Evaluation of the Treatment of Adipose Tissue With Liposonix System (Model 2) Using a New Treatment Method
Official title: An Evaluation of the Safety and Effectiveness of Treatment of Adipose Tissue With the Liposonix System (Model 2) Using a New Treatment Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subcutaneous Adipose Tissue
Lead sponsor: Valeant Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, efficacy, and tolerability of treatment with the Liposonix System (Model 2)using a single pass technique.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 65 years of age
* Body Mass Index of ≤30 kg/m2
* Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.3 cm
* Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study
* Subject must understand the nature of the study and sign an IRB approved Informed Consent

Exclusion Criteria:

* Subject is pregnant
* Subject is diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation
* Subject has diabetes or cardiovascular disease
* Subject has had prior aesthetic procedures to the region to be treated
* Subject has had previous open or laparoscopic surgery in the anticipated treatment area
* Subject is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures
* Subjects undergoing chronic steroid or immunosuppressive therapy
* Subject has cardiac pacemakers or any implantable electrical device
* Subject has a History of cancer
* Subject has sensory loss or dysesthesia in the area to be treated
* Subjects who are unable, or lack the capacity, to self consent

Primary outcomes:
measure: Change in Waist Circumference 12 Weeks After Treatment as Compared to Baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Waist Circumference 4,8, and16 Weeks After Treatment as Compared to Baseline
timeFrame: 4 weeks, 8 weeks, 16 weeks
measure: Investigator Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
timeFrame: 4, 8, 12, and 16 weeks
measure: Subject Assessment of Improvement Using Global Aesthetic Improvement Scale (GAIS)
timeFrame: 4, 8, 12, and 16 weeks
measure: Subject Satisfaction With Treatment
timeFrame: 4, 8, 12, and 16 weeks
Other outcomes:
Locations:
city: Hayward
country: United States
facility: Solta Medical Aesthetic Center
state: California
city: Eugene
country: United States
facility: Jewell Plastic Surgery Center
state: Oregon
Study officials:
affiliation: Jewell Plastic Surgery Center
name: Mark Jewell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Solta Medical Aesthetic Center
name: Ronald Wheeland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03894397: Evaluating Unilateral Deep Brain Stimulation in Patients With Obsessive Compulsive Disorder
Official title: Evaluating Unilateral Deep Brain Stimulation (DBS) of the Bed Nucleus of the Stria Terminalis (BNST) in Patients With Obsessive Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: (Unilateral) Deep brain stimulation
Anxiety
Mood
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: We will evaluate the effect of unilateral and bilateral stimulation of the BNST. Four conditions will be evaluated: left BNST stimulation, right BNST stimulation, bilateral BNST stimulation or no stimulation (OFF). Note that the order of these conditions is stratified beforehand (www.random.org). Each condition takes around 15 minutes.
Primary purpose: TREATMENT

Brief summary: The investigators previously showed that deep brain stimulation (DBS) in the bed nucleus of the stria terminalis (BNST) reduces symptoms in patients with severe obsessive-compulsive disorder (OCD). Although most patients now receive bilateral stimulation, multiple studies suggest that stimulation of the left BNST might be equally effective.

In this study, the investigators will evaluate the effect of unilateral stimulation in OCD patients who currently receive bilateral BNST stimulation to treat their symptoms. We hypothesize that unilateral stimulation of the left BNST will reduce anxious and depressive symptoms, compared to no stimulation.

The study entails a double-blinded, randomized cross-over design during which every patient undergoes four stimulation conditions: stimulation of the left, right or bilateral BNST, or no stimulation. During every condition, which takes about fifteen minutes, the patient is exposed to an individually determined stimulus that normally elicits OCD-related symptoms. The patients are then asked to fill out a short questionnaire to evaluate the severity of their symptoms during the four conditions. At the end of the cross-over phase, the stimulation parameters of each patient are restored.


Eligibility criteria: Inclusion criteria:

* Clinical diagnosis of obsessive-compulsive disorder
* Implanted with DBS system in the bilateral BST (or max. 4mm removed from the BST outline)
* At least three months of chronic BST stimulation
* Compulsive behavior can be provoked within a clinical setting

Exclusion criteria:

* Personality changes evoked by chronic DBS
* Cognitive impairment

Primary outcomes:
measure: Visual analogue scale (VAS) ratings of mood and anxiety/stress
timeFrame: After 15 minutes of stimulation
Secondary outcomes:
measure: VAS ratings of obsessive thoughts, urge to perform compulsive behavior, avoidance and global wellbeing
timeFrame: After 15 minutes of stimulation
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Catholic University Leuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT04344197: Surgery During Covid-19: The Role of Asymptomatic Patients, a Survey
Official title: Surgery During Covid-19: The Role of Asymptomatic Patients, a Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
COVID
Asymptomatic Patient
Covid-19
Preventive Measures
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: surgeon

Brief summary: a brief questionnaire to get a clearer picture of the situation regarding surgical patients with special emphasis on asymptomatic Covid-19 patients.

Detailed description: With new evidence on the role of asymptomatic patients in spreading the disease during the Covid-19 pandemic, symptom driven guidelines for testing, hospital allocation and personal protective equipment (PPE) use do not seem appropriate to limit in-hospital transmission. At time when lockdowns are in place in most countries, hospitals can become the new source of infection.

Guidelines are very variable depending on local policies and availability of medical supplies, resulting in most hospitals taking different preventive measures.

Eligibility criteria: Inclusion Criteria:

general surgeon

Exclusion Criteria:

other speciality

Primary outcomes:
measure: overview of surgical management on preventive measures of hospital infection spread during covid 19
timeFrame: 2/04/2020 to 15/04/2020
Secondary outcomes:
measure: testing policies and preventive measures for Covid-19, and their association with asymptomatic cases.
timeFrame: 02/04/2020 to 15/04/2020
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Tor Vergata Hospital
Study officials:
References:
citation: Bellato V, Konishi T, Pellino G, An Y, Piciocchi A, Sensi B, Siragusa L, Khanna K, Pirozzi BM, Franceschilli M, Campanelli M, Efetov S, Sica GS; S-COVID Collaborative Group. Screening policies, preventive measures and in-hospital infection of COVID-19 in global surgical practices. J Glob Health. 2020 Dec;10(2):020507. doi: 10.7189/jogh.10.020507.
Clinical trial NCT03054597: Use of Eye Exercises to Improve Vision
Official title: Novel Way to Strengthen Eye Muscle and Enhance Peripheral Vision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eye Strain
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Children in the United States watch an average of twenty-eight hours of television and play around thirteen hours of video games per week. The objective of this experiment was to see if a specific eye exercises could strengthen the eye muscles and improve the peripheral vision range of children and adults.

Detailed description: Children in the United States watch an average of twenty-eight hours of television and play around thirteen hours of video games per week. When their eyes are focused, people tend to blink their eyes less, exacerbating the problem of eye fatigue or stress. The objective of this study is to see if a novel exercise technique can increase eye muscle strength and widen peripheral vision. Experiments were conducted by asking the test subjects to follow, with their eyes, a set of blinking LED lights on 3 vision exercise devices. These LED lights were laid in circular or diagonal configurations, and programmed using a microcontroller to blink or 'move' in certain directions and at certain speeds. An endurance score, measured as total time that the test subject completed while following the blinking LED lights before his/her eyes became tired, was recorded. Nineteen test subjects aged 12-81 were asked to exercise their eyes four times over 2 weeks using the devices for as long as they could until they experienced mild eye fatigue. Endurance scores, peripheral vision, and peripheral reading ranges were assessed before and after the training sessions.

Eligibility criteria: Inclusion Criteria:

* Able to read English

Exclusion Criteria:

* Cannot be colorblind

Primary outcomes:
measure: Eye Muscle Endurance
timeFrame: 2 weeks
Secondary outcomes:
measure: Peripheral Vision
timeFrame: 2 weeks
measure: Peripheral Reading Range
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Hopkins Junior High School
state: California
Study officials:
References:
Clinical trial NCT02222597: An Evaluation of Near-Infrared Spectroscopy for Intracranial Hematoma Detection of Head Trauma Patients in the Emergency Department.
Official title: An Evaluation of Near-Infrared Spectroscopy for Intracranial Hematoma Detection of Head Trauma Patients in the Emergency Department.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Within 12 Hrs of Head Injury
Keywords: head injury
infrascanner
intracranial hemorrhage
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-08-21
Enrollment: 400
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: The patients within 12 hours after head injury visit the Emergency Department of the NTUH.

Brief summary: The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma detection of head trauma patients


Eligibility criteria: Inclusion Criteria:

The patients within 12 hours after head injury, visiting the Emergency Department of the National Taiwan University Hospital, and receiving computed tomography of head were enrolled.

Exclusion Criteria:

1. The patients over 12 hours after head injury, visiting the Emergency Department of the NTUH, and receiving computed tomography of head were excluded.
2. Patients with massive scalp laceration or hematoma were excluded. -

Primary outcomes:
measure: detect the predictive value of the infrascanner for intracranial hemorrhage
timeFrame: within 12 hours after head injury
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital Emergency Department
Study officials:
References:
Clinical trial NCT01519297: Preeclampsia: A Marker for Future Cardiovascular Risk in Women
Official title: Preeclampsia: A Marker for Future Cardiovascular Risk in Women
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Preeclampsia
Pregnancy Induced Hypertension
Keywords: Preeclampsia
Pregnancy Induced Hypertension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 150
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study will compare blood vessel and hormone differences between women who have a history of a pregnancy complicated by preeclampsia or high blood pressure, and women who have a history of uncomplicated pregnancy in the last 10 years. The investigators hypothesize that postpartum women with history of preeclampsia will have altered blood vessel function and abnormal hormone levels compared with postpartum women with history of uncomplicated pregnancy.

This study will take place over the course of 2 weeks. Each subject will be assessed on a fixed low-salt diet and a fixed high-salt diet. Subjects will have 2 non-invasive blood vessel imaging tests and fasting blood draws.


Eligibility criteria: Inclusion Criteria:

1. Healthy female premenopausal volunteers, with regular menstrual cycles (at least 8 cycles per year)
2. Age 21 to 50 years
3. Systolic blood pressure \<140 and \>90 mmHg and diastolic blood pressure \<90 and \>60 mmHg at the screening visit
4. Body mass index \< 35 kg/m2
5. History of normotensive pregnancy or history of preeclamptic or hypertensive pregnancy within the last 10 years
6. No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram)

Exclusion Criteria:

1. Current pregnancy
2. Lactation
3. Elevated blood pressure (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg)
4. Current diagnosis of hypertension
5. Current diagnosis of diabetes mellitus
6. Personal history of coronary disease, stroke and kidney disease
7. Use of prescription medications (with the exception of stable thyroid hormone replacement dose) within 2 weeks of study
8. Use of oral contraceptives or other hormone therapy within 3 months of study;
9. Renal impairment (estimated GFR\<60)
10. Active liver disease (AST, ALT, alkaline phosphatase \> 1.5 times normal);
11. Current smoking, defined as smoking within the 6 months before the screening visit
12. Current or past recreational drug use

Primary outcomes:
measure: Vascular function
timeFrame: 60 minutes
Secondary outcomes:
measure: Hormonal measurements
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Ellen W Seely, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02529397: Obesity Treatment Enhanced With Working Memory Training
Official title: Obesity Treatment Enhanced With Working Memory Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Weight Loss
Keywords: Working Memory Training, Weight Loss,
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2015-08-20
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will examine the effects of providing subjects who have attention deficits, with or without a formal diagnosis of attention deficit hyperactivity disorder (ADHD), with Working Memory computerized training and explore whether this training is a feasible way to help them better engage in a weight loss treatment program, thereby enhancing weight loss results. Half of the participants will receive five weeks of online adaptive WM training concurrently while attending an in-person 24-week behavioral weight management program and half will receive five weeks of a non-adaptive form of cognitive training concurrently while attending a 24-week behavioral weight management program in person.

Detailed description: Populations with ADHD or attention issues tend to have more weight loss attempts, struggle more with losing weight, and drop out of treatment more frequently than those without attention difficulties. Adaptive working memory training has been used to strengthen working memory and to mediate the symptoms associated with ADHD. The adaptive training becomes progressively more challenging as participants master each level of the training, while non-adaptive training remains at the same level throughout. Both groups will attend 24 weekly, in-person weight management classes on the University of Vermont Campus. Both groups will do cognitive training on their own home computers five days a week for 30-40 minutes for five weeks concurrently while engaged in the weight loss program.

Eligibility criteria: Inclusion Criteria:

* Must score 4 or higher on the ASRS v. 1.1
* Must live within 45 minutes driving distance from UVM campus
* Must be able to exercise
* Must have a computer with internet access and ability to utilize flash
* Must be 18 or older

Exclusion Criteria:

* Health issues that preclude exercise
* use of medications that interfere with the ability to lose weight
* vacation longer than two weeks
* current participation in another weight loss program
* reside more than 45 minutes from UVM campus in Burlington
* no internet access, no home computer, or computer cannot use flash

Primary outcomes:
measure: Weight
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Behavioral Weight Management Program/Univ of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Doris Ogden, MS
role: PRINCIPAL_INVESTIGATOR
References: