louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02045758: A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick
Official title: A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Lead sponsor: Seventh Sense Biosystems
Sponsor class: INDUSTRY
First posted: 2014-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare blood collection from the forearm using an investigational device TAP20-C to blood collection from the fingertip.


Eligibility criteria: Inclusion Criteria:

* Healthy Subject Group

  1. Male and female volunteers 18 years of age or older.
  2. Voluntary written consent to participate in this study. Diabetic Subject Group

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  1. Male and female volunteers 18 years of age or older.
  2. Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report.
  3. Voluntary written consent to participate in this study.

Exclusion Criteria:

1. Subjects who are pregnant or nursing mothers by self-report.
2. Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested.
3. Subjects with a missing index or middle finger on either hand or a missing forearm
4. Subjects who have known allergies to titanium.

Primary outcomes:
measure: Non-Inferiority of Analyte Levels
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Seventh Sense Biosystems
state: Massachusetts
Study officials:
References:
Clinical trial NCT01195558: Patient Registry of Blind Subjects With Sleep-related Problems
Official title: Development of a Patient Registry of Blind Subjects With Sleep-related Problems
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep-wake Disorder in Blind Individuals
Keywords: Non-24
N24HSWD
Blindness
Sleep
Wake
Circadian Rhythm
Nap
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: General population of blind individuals

Brief summary: Non-24-hour sleep-wake disorder (Non-24) is a condition experienced primarily by totally blind individuals that results in abnormal night sleep patterns and chronic daytime sleepiness. This is a research protocol to develop a patient registry of subjects who may suffer from Non-24 and who are blind. Subjects participate in the study through a phone survey. This registry will be used to better understand, sleep related problems in blind individuals, including the investigation of a potential treatment, recruitment for future clinical studies, and to provide a forum for raising awareness about Non-24. The survey consists of questions regarding the degree of vision impairment and sleep problems that the subjects may be experiencing.


Eligibility criteria: Inclusion Criteria:

1. Subjects or legal guardians must be at least 18 years of age to participate in the telephone survey. Parents or legal guardians may represent children from 0 through 17 years who meet the following criteria.
2. Subjects must be blind.
3. Subjects must have some self-described problem with sleep or daytime sleepiness.

Primary outcomes:
measure: Number of blind participants
timeFrame: ongoing
Secondary outcomes:
measure: Sleep/wake disruptions
timeFrame: ongoing
Other outcomes:
Locations:
city: Washington
country: United States
facility: Vanda Pharmaceuticals
state: District of Columbia
Study officials:
References:
Clinical trial NCT00691158: A Study of the Functional Magnetic Resonance Imaging Response to Leptin and Pramlintide
Official title: A Pilot Study of the fMRI Response to Leptin and Pramlintide
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to identify how certain parts of the brain that help control body weight respond to an infusion of hormones called leptin and amylin.

Detailed description: Following an overnight fast, subjects will undergo fMRI measurements of the hypothalamus, brainstem and whole brain during an infusion of either normal saline, pramlintide, leptin, or the combination leptin and pramlintide.

Eligibility criteria: Inclusion Criteria:

* Age 18 year to 45 years of age
* MI 18 to 25 kg/m2 or ≥ 30 kg/m2
* At maximal lifetime weight
* Weight stable for at least 3 months

Exclusion Criteria:

* Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
* Subjects taking psychiatric or centrally-acting (CNS) medications or who are diagnosed with a psychiatric or neurological illness, including:

  * depression
  * anorexia
  * bulimia
  * seizure disorder.
* Exercise \> 30 minutes, 3 times a week
* Alcohol consumption \> 2 drinks / day
* Weight \> 350 lbs (159 kg) (weight limit for MR machine)
* Illicit drug use
* Pregnancy
* Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate or fat intakes
* Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips
* Those with claustrophobia
* Anaphylaxis and known hypersensitivity to E. coli-derived proteins
* Allergies or contraindications to metreleptin or pramlintide
* Renal or hepatic impairment
* Women who are lactating
* Tobacco use

Primary outcomes:
measure: To measure the fMRI response in the hypothalamus and brainstem, and whole brain, to intravenous leptin, pramlintide, combination leptin and pramlintide, and saline control.
timeFrame: over 90 minutes
Secondary outcomes:
measure: Timed blood samples during infusion will establish the time course for peak levels of infused hormones as well as detectable changes in insulin and glucose levels.
timeFrame: over 90 minutes
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: OHSU - Center for the Study of Weight Regulation
name: Jonathan Q. Purnell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03898258: Evaluation of the German Short-Form Qualiveen Questionnaire
Official title: Evaluation of the German Short-Form Qualiveen Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2019-04-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: individuals with chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI

Brief summary: Two questionnaires (Qualiveen full version and Qualiveen short-form (SF)), the project information and the consent form will be sent to individuals who are scheduled for an annual control at the urological out-patient clinic of the Swiss Paraplegic Centre and who fulfill the inclusion criteria. The patients will be asked to complete the two questionnaires and to bring the completed questionnaires and the signed consent form to the annual control at the Swiss Paraplegic Centre. Participants who have consented and completed the two questionnaires will receive the two questionnaires a second time 14 days later.

The primary objective of this project is to validate the German version of the SF Qualiveen questionnaire. The secondary objective is to evaluate the measurement properties of the German SF Qualiveen questionnaire in comparison with the full version.


Eligibility criteria: Inclusion Criteria:

* chronic (≥ 12 months) neurogenic lower urinary tract dysfunction due to SCI
* age ≥ 18 years

Exclusion Criteria:

* no informed consent as documented by signature
* history of concomitant neurological or psychological illness
* history of cognitive impairment
* insufficient German language skills

Primary outcomes:
measure: total score
timeFrame: baseline
Secondary outcomes:
measure: bother with limitations score
timeFrame: baseline
measure: change in bother with limitations score
timeFrame: baseline; 14 days
measure: frequency of limitations score
timeFrame: baseline
measure: change in frequency of limitations score
timeFrame: baseline; 14 days
measure: fears score
timeFrame: baseline
measure: change in fears score
timeFrame: baseline; 14 days
measure: feelings score
timeFrame: baseline
measure: change in feelings score
timeFrame: baseline; 14 days
Other outcomes:
measure: age (years)
timeFrame: baseline
measure: gender
timeFrame: baseline
measure: bladder evacuation method
timeFrame: baseline
measure: number of daily bladder evacuations (n/24h)
timeFrame: baseline
measure: urinary incontinence
timeFrame: baseline
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
affiliation: Schweizer Paraplegiker-Zentrum Nottwil
name: Jürgen Pannek, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00932958: Physicians International Coronary Computed Tomography Angiography (CCTA) Utilization Registry
Official title: Physicians International CCTA Utilization Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Myocardial Infarction
Lead sponsor: MDDX LLC
Sponsor class: INDUSTRY
First posted: 2009-07-07
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults (18 or older) who are scheduled to undergo a CCTA imaging procedure.

Brief summary: This protocol describes an observational study whose goal is to collect de-identified Coronary CT Angiography (CCTA) acquisition factors and interpretations (findings) from several hundred U.S. and international imaging facilities. The study uses an electronic data capture tool to collect de-identified CCTA utilization parameters and clinical findings in order to create a multi-center registry. This registry will be used for scientific analysis and publication of pertinent medical trends such as CT utilization, radiation dose, and common cardiovascular findings. The registry will be used to determine areas of interest for future randomized controlled trials.

All data will be collected with patient identifiers removed and in complete accordance with HIPAA regulations. All data will be analyzed in aggregate, thus further minimizing the risk of patient confidentiality violations.


Eligibility criteria: Inclusion Criteria:

* Adult participants who are able and willing to consent for themselves
* Patients scheduled for CCTA examination

Exclusion Criteria:

* Patients who did not complete the planned CT imaging procedure due to mechanical error of the CT machine.

Primary outcomes:
measure: CCTA utilization parameters and clinical findings
timeFrame: Two years
Secondary outcomes:
measure: 90 day MACE, Intended Care Management and Cost Effectiveness for cardiologists interpreting their CCTA studies
timeFrame: Two years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: MDDX
state: California
Study officials:
affiliation: MDDX LLC
name: Dan Gebow, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02681458: Superficial and Cutaneous Fungal Infections Among Drug-users in Northeast Region of Iran
Official title: The Comparison of Dermatophytosis and Other Fungal Infections Between Drug Users and Non Drug Users
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin and Subcutaneous Tissue Fungal Infections
Lead sponsor: Islamic Azad University of Mashhad
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 1436
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: people from northeast region of Iran referring to Methadone clinics. there were no limitations of age and sex.

Brief summary: The purpose of this study was about survey of prevalence of fungal infections among drug users referring to methadone wards of Hospitals in northeast region of Iran

Detailed description: There were two groups with overall members of 1436. Statistically, the investigators have used "Likelihood ratio " and " Exact's Fisher" tests.

Eligibility criteria: Inclusion Criteria:

* Suspected fungal lesions

Exclusion Criteria:

* non use of local or edible anti-fungal drugs and not taking bath within the last 48 hours of testing

Primary outcomes:
measure: The Prevalence of Superficial and Cutaneous Fungal Infections Among Drug and Non-Drug Users
timeFrame: up to two months
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Islamic Azad University of Mashhad
state: Khorasan razavi
Study officials:
affiliation: assistant professor of mycology and parasitology
name: Hassan Yazdanfar, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00444158: Double-Blind, Double-Dummy, 2-Period Crossover of a 20-Minute Versus a 4-hour IV of MOA-728 in Stable Methadone Subjects
Official title: A Randomized, Double-Blind, Double-Dummy, 2-Period Crossover Study to Characterize the PK/PD Relationship of a 20-Minute Versus a 4-hour Intravenous Infusion of MOA-728 in Subjects on Stable Methadone Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Constipation
Keywords: opioids
chronic pain
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2007-03-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: MOA-728, an investigational drug, is currently being studied for the relief of constipation associated with postoperative ileus and treatment of opioid induced constipation in patients receiving palliative care. This study will further investigate the IV formulation of MOA-728 comparing PK/PD time points for a 20-minute versus a 4-hour infusion.


Eligibility criteria: Inclusion Criteria:

* Generally healthy men and nonlactating, nonpregnant women age 18 to 65 years with BMI of 18.0 to 35.0 kg/m2
* Must have been receiving methadone treatment of greater than or equal to 30 mg/day for at least one month and a positive drug screen for methadone
* High probability for compliance with and completion of the study

Exclusion Criteria:

* Significant cardiovascular, hepatic, renal , respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. Presence or history of any disorder that may prevent the successful completion of the study. Any surgical or medical condition that my interfere with the distribution, metabolism or excretion of the test article.
* Acute disease state, family history of long QT syndrome and/or sudden cardiac death, allergy to opioids or drugs. Use of any investigational or prescription drugs within 30 days, any OTC drugs including herbal supplements within 14 days and drugs required to maintain regulation of bowel movements 48 hours before study day 1.
* History of alcoholism within 1 month before study day 1, admitted alcohol abuse, or consumption of more than 2 standard units of alcohol per day.

Primary outcomes:
measure: It is not known if the activity of MOA-728 is related to the peak concentration or the overall exposure (AUC). This study is designed to evaluate the PK and PD effect of MOA-728 administered either as a 20-minute or 4-hour infusion.
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
state: Florida
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Jeff Cohn
role: STUDY_DIRECTOR
References:
Clinical trial NCT01130558: Efficacy of Structured Insulin Order
Official title: Efficacy of Structured Insulin Orders in Improving Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: type 2 diabetes mellitus
basal-bolus insulin
insulin ordering
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-05-26
Enrollment: 128
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 an electronic order template for basal-bolus insulin will improve mean blood glucose in hospitalized general medical patients with poorly controlled type 2 diabetes.

Detailed description: The study randomly assigned internal medicine residents to use an electronic insulin order template plus basal-bolus ordering education versus education only. For all patients with uncontrolled type 2 diabetes treated by these physicians, mean blood glucose, rate of hypoglycemia, and rate of sliding scale insulin use were measured.

Eligibility criteria: Inclusion Criteria:

* Blood glucose less than 60 mg/dl or greater than 180 mg/dl during hospital stay

Exclusion Criteria:

* Diagnosis of Type 1 Diabetes

Primary outcomes:
measure: Mean blood Glucose
timeFrame: 6 days
Secondary outcomes:
measure: rates of glucose values less than 60 mg/dl or less than 40 mg/dl
timeFrame: 6 days
measure: rate of use of sliding scale insulin
timeFrame: 6 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Enrico Cagliero, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00904358: Estimation of Internal Jugular Vein Central Venous Pressure (CVP) by Ultrasound
Official title: Validity and Reliability of Non-invasive Estimation of Central Venous Pressure by Measurement of Internal Jugular Size Using 2-dimensional Ultrasound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Internal Jugular Size Measured by Ultrasound
Central Venous Pressure
Keywords: internal jugular vein
cross sectional area
ultrasound
central venous pressure
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients scheduled for cardiac surgery in Siriraj Hospital

Brief summary: To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.

Detailed description: Objectives:

1. To study the validity and reliability of estimation of the central venous pressure by measurement of internal jugular vein size using 2-dimensional ultrasound.
2. To evaluate the correlation of internal jugular vein cross sectional area and central venous pressure.

Methods:

1. The study design is prospective observational study.
2. We will include all patients scheduled for cardiac surgery in Siriraj Hospital and record both internal jugular size using 2-dimensional ultrasound just before central venous catheter insertion. The central venous pressure will be recorded and the ultrasound picture will be measured.
3. The data will be analyzed.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for cardiac surgery
* need central venous catheterization intraoperatively
* elective surgery
* age \> 18

Exclusion Criteria:

* neck pathology
* history of internal jugular or SVC thrombosis
* limited neck mobility
* severe valvular lesion
* decompensated heart failure

Primary outcomes:
measure: internal jugular size
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of Medicine, Siriraj Hospital
city: Bangkok
country: Thailand
facility: Kasana Raksamani
Study officials:
affiliation: Mahidol University
name: Kasana Raksamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05449158: The Relationship Between Left Atrial Pressure and Cardiac Function After Atrioventricular Node Ablation
Official title: Effects of Left Atrial Pressure-guided Ventricular Rate Regulation on Cardiac Function in Patients Therapy With Atrioventricular Node Ablation Combined With Left Bundle Branch Pacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation;
atrioventricular node ablation;
left bundle branch pacing
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effects of left atrial pressure-guided ventricular rate changes on cardiac function after atrioventricular node ablation combined with left bundle branch pacing

Detailed description: Effects of left atrial pressure-guided ventricular rate changes on cardiac function after atrioventricular node ablation combined with left bundle branch pacing. For patients with non-valvular atrial fibrillation who received atrioventricular node ablation combined with left bundle branch pacing in our hospital, a left atrial pressure catheter was used to monitor atrial pressure during the operation, and a lower average atrial pressure was obtained by adjusting the pacing frequency of the pacemaker. In a randomized controlled manner, the postoperative echocardiography, cardiothoracic ratio, cardiac function, etc. were compared between patients without atrial pressure monitoring and those who received atrial pressure adjustment, in order to clarify the effect of left atrial pressure-guided ventricular rate adjustment on atrioventricular node ablation combined with left bundle Benefit of pacing patients.

Eligibility criteria: Inclusion Criteria:

18-85 years old atrial fibrillation patients

Exclusion Criteria:

There is a history of pacemaker implantation; patients after coronary artery bypass grafting; severe coronary stenosis or occlusion cannot be treated with reperfusion;

Primary outcomes:
measure: EF%
timeFrame: 1-year
Secondary outcomes:
measure: cardiovascular all-cause mortality
timeFrame: 1week
measure: Hospitalizations for heart failure
timeFrame: 1 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jun Zhang
state: Shanghai
Study officials:
affiliation: Shanghai 10th People's Hospital
name: Yawei Xu, Ph.D
role: STUDY_CHAIR
References: