louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04844255: Acute Salt Sensitivity of Blood Pressure
Official title: HIV Integrated Personalized Care Approach to the Prevention, Diagnosis, and Control of Salt-sensitive Hypertension: The HIPO CAP DICTSH STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: salt sensitivity
salt
acute salt sensitivity
Blood pressure
Mean arterial pressure
Lead sponsor: Mulungushi University
Sponsor class: OTHER
Collaborators: name: University of Zambia
First posted: 2021-04-14
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Time series design
Primary purpose: DIAGNOSTIC

Brief summary: Dietary salt raises blood pressure in certain individuals immediately after ingestion (acute salt sensitivity; ASS) while not affecting others. It is hypothesized that ASS is a risk factor for hypertension. However, no thresholds or diagnostic guideline is available for ASS. This study is the first aim in the main study (HIPO CAP DITSH Study) aimed at determining the threshold or blood pressure cut-offs for ASS upon ingesting dietary salt.


Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and above. Normotensive. If Hypertensive (should be off antihypertensive medication at least 2 weeks prior to the study)

Exclusion Criteria:

* diabetes patients, ill participants

Primary outcomes:
measure: Acute salt sensitivity
timeFrame: 160 minutes
Secondary outcomes:
measure: Diastolic blood pressure change
timeFrame: 160 minutes
measure: Systolic blood pressure change
timeFrame: 160 minutes
Other outcomes:
Locations:
city: Livingstone
country: Zambia
facility: Livingstone Central Hospital
state: Southern
Study officials:
affiliation: Mulungushi University
name: Sepiso K Masenga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00097955: Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria
Official title: Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Keywords: diabetes
nephropathy
hypertension
aliskiren
losartan
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-02
Enrollment: 496
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Study of the efficacy and safety of aliskiren when added to losartan and optimal antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders to monitor improvement in any of these conditions.


Eligibility criteria: Inclusion Criteria:

* Hypertension
* Elevated urinary protein levels
* Confirmed type 2 diabetes

Exclusion Criteria:

* Certain diseases
* Uncontrolled diabetes
* Type 1 diabetes

Primary outcomes:
measure: Change from baseline in urinary albumin creatinine ratio after 24 weeks
Secondary outcomes:
measure: Equal/more than 50% reduction from baseline in urinary albumin creatinine ratio after 24 weeks
measure: Change from baseline in urinary albumin excretion rate after 24 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Quebec
country: Canada
facility: Investigative Site
city: Hillerod
country: Denmark
facility: Investigative Site
city: Paris
country: France
facility: Investigative Site
city: Investigative Centers
country: Germany
city: Athens
country: Greece
facility: Investigative Site
city: Rome
country: Italy
facility: Investigative Site
city: Rotterdam
country: Netherlands
facility: Investigative Site
city: Bucharest
country: Romania
facility: Investigative Site
city: Moscow
country: Russian Federation
facility: Investigative Site
city: Madrid
country: Spain
facility: Investigative Site
city: London
country: United Kingdom
facility: Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Persson F, Lewis JB, Lewis EJ, Rossing P, Hollenberg NK, Parving HH; AVOID Study Investigators. Impact of baseline renal function on the efficacy and safety of aliskiren added to losartan in patients with type 2 diabetes and nephropathy. Diabetes Care. 2010 Nov;33(11):2304-9. doi: 10.2337/dc10-0833. Epub 2010 Aug 6.
citation: Parving HH, Persson F, Lewis JB, Lewis EJ, Hollenberg NK; AVOID Study Investigators. Aliskiren combined with losartan in type 2 diabetes and nephropathy. N Engl J Med. 2008 Jun 5;358(23):2433-46. doi: 10.1056/NEJMoa0708379.
Clinical trial NCT00494455: Continuous Glucose Monitoring in Critically Ill Patients
Official title: Accuracy and Reliability of Continuous Glucose Monitoring in Critically Ill Patients With Shock Requiring Norepinephrine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: critical illness
hyperglycemia
intensive insulin therapy
glucose monitoring
shock
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2007-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether subcutaneous continuous glucose monitoring in critically ill patients is clinically feasible accurate and reliable.

Detailed description: Hyperglycemia is is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses.

Continuous glucose measurement would facilitate blood glucose control in critically ill patients. Numerous studies have shown accuracy of the subcutaneous continuous glucose monitoring derived glucose values compared to blood glucose measurements in diabetics. Studies evaluating the subcutaneous continuous glucose monitoring in an inpatient-population especially in an ICU-setting are rare. Therefore the aim of this study is the prospective evaluation of continuous subcutaneous glucose monitoring in critically ill patients with circulatory shock demanding norepinephrine therapy as compared to critically ill patients without shock.

Eligibility criteria: Inclusion Criteria:

* Admitted patients expected to stay \>48h either with circulatory shock requiring norepinephrine therapy or without circulatory shock.

Exclusion Criteria:

* Admitted patients expected to stay \<48h

Primary outcomes:
measure: correlation of continuous glucose monitoring derived glucose values and arterial blood glucose measurements in critically ill patients with and without shock
timeFrame: 72h
Secondary outcomes:
measure: influence of norepinephrine therapy, body mass index, severity of Illness (APACHE III, SAPS II) and blood glucose level on correlation
timeFrame: 72h
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Department of Medicine III
name: Ulrike Holzinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holzinger U, Warszawska J, Kitzberger R, Herkner H, Metnitz PG, Madl C. Impact of shock requiring norepinephrine on the accuracy and reliability of subcutaneous continuous glucose monitoring. Intensive Care Med. 2009 Aug;35(8):1383-9. doi: 10.1007/s00134-009-1471-y. Epub 2009 Apr 7.
Clinical trial NCT04629755: A Smartphone Intervention for Relational and Mental Well Being
Official title: A Smartphone Intervention for Relational and Mental Well Being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Loneliness
Relation, Interpersonal
Covid19
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 1765
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary aim of this study is to provide and evaluate a phone-based intervention to improve relational and mental well-being during the COVID-19 crisis. This information also will help us understand how individuals are responding to COVID-19 and have the potential to inform psychological and policy level interventions.

Detailed description: We conducted a randomized intervention trial of a mobile-based intervention that offered participants daily suggestions for 14 days on how to improve relational and mental well-being during the COVID-19 pandemic. A sample of 1765 adults residing in the United States participated in the study and were assigned to control or intervention conditions. To measure outcomes, all participants received a daily text message to their smartphones every evening for 28 days linking to a survey on relational and mental well-being. Participants also received a survey link on Days 56 and 72. Intervention participants received additional text messages in the mornings of Days 7 - 22 presenting the intervention suggestions.

Eligibility criteria: Inclusion Criteria:

* Age 18+
* Resides in United States
* Possesses smartphone
* Willing to share phone number and email to researchers

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in depressed mood
timeFrame: Measured every evening for 28 days; the first 6 days constituted baseline measurement; change was assessed over Days 7 - 28 with baseline as a covariate
measure: Change in loneliness
timeFrame: Measured every evening for 28 days; the first 6 days constituted baseline measurement; change was assessed over Days 7 - 28 with baseline as a covariate
measure: Change in relationship quality
timeFrame: Measured every evening for 28 days; the first 6 days constituted baseline measurement; change was assessed over Days 7 - 28 with baseline as a covariate
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jonathan W Kanter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06347055: NeuroControl of Nicotine Dependence
Official title: Neuronavigated Non-invasive Brain Stimulation for Nicotine Dependence.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nicotine Dependence
Keywords: Tobacco
Smoking
TMS
fMRI
Nicotine
Cognitive Control
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to examine the effects of continuous theta burst stimulation (cTBS) on different forms of cognitive control in adults who smoke cigarettes, and to determine if the location where cTBS is delivered may help smokers reduce or quit smoking. Participation in the study will take 3-weeks over 4 visits, with a total time commitment of approximately 12 hours.


Eligibility criteria: Inclusion Criteria:

1. Nicotine Dependence as measured by: Smoke ≥ 8 cigarettes/day for ≥ 2 yrs, expired carbon monoxide (CO) concentration of ≥ 10 ppm, positive urine cotinine test and FTND score ≥ 3 Or ≥ 15 uses of electronic cigarette/day for ≥ 1 year, positive urine cotinine test, and PS-ECDI score ≥ 3
2. English Fluency
3. Functional Vision (with corrective lenses as needed)

Exclusion Criteria:

1. Use of psychotropic and antiepileptic medications in the last month
2. Presence of an untreated illness or serious medical condition
3. History of major neurological illness
4. Contraindication to TMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \>15 min., implanted electronic device, metal in the head) or MRI.
5. Any use of substances that lower seizure threshold.
6. Current or past psychosis
7. Electroconvulsive therapy in the past 6 months
8. Unstable cardiac disease or hypertension, severe renal or liver insufficiency, or sleep apnea
9. BAC greater than 0.0.
10. Positive urine pregnancy test
11. Any other concern that in the investigator's opinion would impact participant safety, study instruction compliance, or confound the interpretation of the study results.

Primary outcomes:
measure: Acute effects of cTBS on cognitive control
timeFrame: 1 hour after receiving cTBS
Secondary outcomes:
measure: Exploratory: Acute effects of cTBS on fMRI brain response
timeFrame: 1 hour after receiving cTBS
Other outcomes:
measure: Safety and Tolerability
timeFrame: 24 hours following receipt of cTBS
Locations:
city: Columbia
country: United States
facility: Health Neuroscience Center
state: Missouri
Study officials:
References:
Clinical trial NCT05313555: The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin
Official title: The Effect of Violet Device Dosed UV-C Exposure on Healthy Hand Skin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Keywords: ultraviolet light
light skin
skin changes
healthy volunteers
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Archimedes Innovations, Pbc
First posted: 2022-04-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the safety of ultraviolet light (UV-C) irradiation as a method to sanitize hands instead of chemical-based sanitizers.

Eligible participants will be enrolled and receive treatment with the Violet UV-C device or UV-B. Punch biopsies will be performed following UV exposure to quantify any changes in cellular and molecular properties of the tissue.


Eligibility criteria: Inclusion Criteria

* Good general health
* Type 1 or type 2 skin (lightly colored skin)
* No history of skin disorders, disease states or physical conditions which would impair evaluation of the test sites
* Willingness and ability to follow the protocol
* No use of lotion or hand sanitizer 3 hours before the experiment

Exclusion Criteria:

* Has received an experimental drug or used an experimental device in the 30 days prior to admission to the study
* Undergoing treatment or taking medication that increases sun sensitivity
* History of keloids
* History of sensitivity to lidocaine or epinephrine
* Pregnant or nursing women, pregnancy status will be self-reported, women unsure of their pregnancy status will be excluded

Primary outcomes:
measure: Deoxyribonucleic acid (DNA) damage in the form of DNA base pair dimers measured by immunohistochemistry microscopy with statistical analysis.
timeFrame: Day 1 (visit 1 after light therapy)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Gary Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03533855: Quality of Image and Performance Diagnoses of the 3D Sequence of Cholangio-pancreatography MRI in Apnea With Compressed Acquisition
Official title: Quality of Image and Performance Diagnoses of the 3D Sequence of Cholangio-pancreatography MRI in Apnea With Compressed Acquisition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cholangiopancreatography
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The sequence of 3D CP-IRM, used in current practice in the protocols of bilio-pancreatic imaging, can be thus optimized to reduce acquisition time, thus the artefacts of movement, in particular in 3T. It remains however to estimate if the quality of obtained image is equivalent at least to that of the conventional sequence, without apnea, 3D CP-IRM.

To summarize, the investigators suggest comparing the classic sequence (Fast Relaxation Fast Spin Echo (FRFSE) 3D) already existing with the same sequence to which will be added a technique of CS allowing its acquisition at shortened time(weather), with respiratory trigger on one hand and in apnea on the other hand. For the patient, this study will have for consequence only the addition of 2 sequence MRI, one of the 2 minutes 30 seconds (with respiratory trigger) and other one of the 20 seconds (in apnea).


Eligibility criteria: Inclusion Criteria:

* age\> 18
* french understanding and speaking patient
* Pancreatic MRI prescription for bilio-pancreatic pathology
* Patient with medical insurance

Exclusion Criteria:

* previous biliary surgery
* MRI contraindication
* Gadolinium recently injected (48 hours)
* Patient couldn't stay on apnea 20 seconds

Primary outcomes:
measure: image quality scale
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: GHPSJ
name: ZINS Marc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03507855: The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider
Official title: The Effect of a Reduced Noise Environment on the Response Time of the Anesthesia Provider to Auditory and Visual Alarms During Induction and Emergence From General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Noise Exposure
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2018-04-25
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This project will investigate whether reduction in ambient light and elimination of noise during induction and emergence from anesthesia influences the response time of the anesthesia provider to auditory and visual alarms when compared to a standard operating room. In addition, the investigators will assess the cumulative level of noise exposure that providers experience during the perioperative period.


Eligibility criteria: Inclusion Criteria:

* Anesthesia providers that have agreed to participate.

Exclusion Criteria:

* none

Primary outcomes:
measure: Induction response time
timeFrame: Within 5 mins of patient entering the OR
measure: Emergence response time
timeFrame: Within 5-15 mins after completion of surgery
Secondary outcomes:
measure: Noise exposure
timeFrame: Average of 30 mins - 3 hrs
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Richard Cartabuke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04488055: Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients (Reach Out)
Official title: Facilitating Use of the National Suicide Prevention Lifeline in Alcohol Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicide
Alcohol Use Disorder
Keywords: National Suicide Prevention Lifeline
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-07-27
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to learn about people who use the National Suicide Prevention (NSP) Lifeline during a suicidal crisis and those who don't. The researchers would also like to learn whether people who have experienced a suicidal crisis could benefit from participating in a therapy session about their thoughts and perceptions of the NSP Lifeline.


Eligibility criteria: Inclusion Criteria:

* Probable alcohol use disorder within the past year based on an Alcohol Use Disorders Identification Test (AUDIT) score of 16 or greater
* Report of a suicide attempt within the past year OR a lifetime suicide attempt more than a year ago and current suicide ideation within the past month based on a score of 5 or greater on the Beck Scale for Suicidal Ideation (BSS) or depression in the past month as measured by the Beck Depression Inventory with a of 20 or higher.

Exclusion Criteria:

* Patients who do not understand English
* Prisoners
* Patients with profound psychotic symptoms and/or cognitive deficits that would prevent patients from understanding the content of the intervention and/or assessments.

Primary outcomes:
measure: Crisis line utilization
timeFrame: Up to 12 months
Secondary outcomes:
measure: Suicidal behavior
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Detroit Rescue Mission Ministries
state: Michigan
city: Waterford
country: United States
facility: Meridian Health Services
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mark Ilgen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06126055: Endoscopic Band Ligation for Treating Reflux Disease
Official title: EndoBand: Endoscopic Band Ligation for Treating Reflux Disease (GERD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: GERD
Keywords: GERD
GastroEsophageal Reflux
Band Ligation
EndoBand
Lead sponsor: El Katib Hospital
Sponsor class: OTHER
Collaborators: name: Kasr El Aini Hospital
First posted: 2023-11-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: GERD is a chronic disease the require different treatment modalities; non have proven long term efficacy with concerns about their safety. The use of band ligation in endoscopy appears safe, repeatable with short learning curve. Placing multiple bands at the Z-line can create a fibrous ring in the distal esophagus acting as a barrier against reflux of gastric content.

Detailed description: The aim of the study is the complete resolution of reflux symptoms without the use of any drug.

Eligibility criteria: Inclusion Criteria:

* Symptomatic GERD

Exclusion Criteria:

* Any previous surgery for GERD

Primary outcomes:
measure: Endoscopic Band Ligation for GERD
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Endoscopy Unit Cairo University
Study officials:
affiliation: Endoscopy Unit Faculty of Medicine Cairo University
name: Mohamed Abeid, MD
role: PRINCIPAL_INVESTIGATOR
References: