louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00991900: Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects
Official title: Short Term and Day to Day Reproducibility of Reflectometric Measurement of Retinal Oxygen Saturation in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ocular Physiology
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 healthy volunteers will be included.

Brief summary: Adequate perfusion and oxygenation is essential for the function of the inner retina. Although this is a well known fact, measurement of oxygen saturation in the eye is still a delicate and not fully explored task. However, recently a new instrument for the non-invasive measurement of retinal vessel oxygen saturation has been introduced. Unfortunately, no data about reproducibility in humans is yet available for this instrument. Consequently, the current study seeks to evaluate the short term and day to day reproducibility of retinal vessel oxygenation in healthy volunteers.

20 healthy volunteers will be included and oxygen saturation of retinal vessels will be determined. The reproducibility of the results will be tested by repeated measurements and the collected data will be independently analyzed by two observers.


Eligibility criteria: Inclusion Criteria:

* Men and Women aged between 18 and 35 years,
* Nonsmokers
* Body mass index between 15th and 85th percentile
* Normal ophthalmic findings, ametropia \< 3 Dpt.

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug except oral contraceptives
* Symptoms of a clinically relevant illness in the 3 weeks before the study day
* Blood donation during the previous 3 weeks

Primary outcomes:
measure: Coefficients of variation of oxygen measurement
timeFrame: 5 measurements on both study days
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT03248700: Vitamin A Kinetics and Mathematical Modeling in American Women
Official title: Vitamin A Kinetics and Mathematical Modeling in American Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin A Kinetics
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 8
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Women were given a vitamin A tracer, and blood was sampled to determine individual and group vitamin A kinetics. Data were subsequently modeled using compartmental analysis to determine effects of study length on model outcomes.

Detailed description: This is a longitudinal study in which American women were given an oral, stable isotope tracer of vitamin A, and blood was sampled in a staggered, serial design to determine individual and group vitamin A kinetics. Data were subsequently modeled using compartmental analysis, and study truncation analysis was performed on data to investigate the factor of study duration on resulting vitamin A kinetic models and outputs related to vitamin A metabolism.

Eligibility criteria: Inclusion Criteria:

* BMI (18.5 - 24.9 kg/m2)

Exclusion Criteria:

* Smoker
* Pregnant
* Trying to become pregnant
* Lactating
* Weight loss \> 4.5 kg during the past 3 months.
* Actively trying to lose weight
* Inability to refrain from drinking alcohol when requested
* Amenorrhea
* Acute or chronic illness including hepatitis
* Current or previous history of anorexia or bulimia
* Concurrent participation in other studies
* Family member already enrolled in the study

Primary outcomes:
measure: Total traced vitamin A mass
timeFrame: Baseline through 152 days
Secondary outcomes:
measure: Compartmental model complexity
timeFrame: Baseline through 152 days
measure: Compartmental model fractional transfer coefficients
timeFrame: Baseline through 152 days
measure: Serum vitamin A half-life
timeFrame: Baseline through 152 days
measure: Vitamin A disposal rate
timeFrame: Baseline through 152 days
measure: Vitamin A equilibration time and partitioning
timeFrame: Baseline through 152 days
measure: Vitamin A tracer partitioning
timeFrame: Baseline through 152 days
measure: Vitamin A dietary intake
timeFrame: Baseline
Other outcomes:
Locations:
city: Madison
country: United States
facility: Department of Nutritional Sciences, University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Sherry A Tanumihardjo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gannon BM, Valentine AR, Davis CR, Howe JA, Tanumihardjo SA. Duration of Retinol Isotope Dilution Studies with Compartmental Modeling Affects Model Complexity, Kinetic Parameters, and Calculated Vitamin A Stores in US Women. J Nutr. 2018 Aug 1;148(8):1387-1396. doi: 10.1093/jn/nxy095.
Clinical trial NCT06609200: Electro-Acupuncture for Obese Patients with Insulin Resistance
Official title: Electro-acupuncture for the Obese Patient with Insulin Resistance: a Randomized Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity
Insulin Resistance
Keywords: electroacupuncture
obesity
insulin resistance
Lead sponsor: Nanyang Technological University
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each patient will be scheduled for 16 treatment sessions, each lasting 30 minutes, twice a week over 8 weeks.
Primary purpose: TREATMENT

Brief summary: This clinical trial aims to evaluate the efficacy and safety of electro-acupuncture for obese patients with insulin resistance. 60 participants will be randomized and allocated to either the electro-acupuncture arm or the sham acupuncture arm.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 21 and 65 years old
* BMI ≥ 25 kg/m2
* HOMA-IR ≥ 2.14, (HOMA-IR = fasting insulin (ųU/mL)\* fasting glucose (mmol/L)/22.5)
* Not receiving any other weight control measures or any medical and/or drug history in the last 3 months

Exclusion Criteria:

* Diabetes mellitus
* Treating with drugs that may affect insulin sensitivity
* Changes 10% of usual body weight in the previous 6 months weight
* Endocrine diseases, including thyroid disorder, pituitary disorder, sex gland disorder, etc.
* Heart diseases, including arrhythmia, heart failure, and myocardial infarction, participants with pacemakers
* Allergy and immunology diseases
* Bleeding tendency
* Pregnant or lactating women
* Impaired hepatic or renal function
* Stroke or unable to exercise

Primary outcomes:
measure: HOMA-IR
timeFrame: From enrollment to the end of follow up at 16 weeks
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: From enrollment to the end of follow up at 16 weeks
measure: Waist-to-hip ratio
timeFrame: From enrollment to the end of follow up at 16 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00226200: Soluble CD23 Expression in Asthma Patients Treated With OMA
Official title: Soluble CD23 Expression as a Marker of Immunomodulation and CLinical Response in Asthma Patients Treated With Omalizumab
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Keywords: Allergic
Non allergic
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2005-09-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study involves a FDA approved drug, Omalizumab, used in the treatment of moderate to severe allergic asthma that cannot be controlled by standard treatment. It works on IgE to control the allergic reaction. We are looking at the effects on non-allergic asthma. We hope to prove that Omalizumab will have the same effect on non-allergic asthmatics as it does allergic asthmatics.

Detailed description: This is a 1 year placebo controlled study looking at moderate to severe asthmatics (allergic or non-allergic) who are controlled by medication.

Skin testing will be done to determine the allergic status, as well as a base line IgE done. The Omalizumab is administered by injection based on weight and IgE level, (once or twice a month).

At several times during the year pulmonary function test will be done, as well blood drawn for immunological assays (CD23 and FcER1 expression, TH1/TH2 cytokines, CD23 production). A battery of questionnaires will also determine quality of life(with asthma), psychological stress measures and parameters of clinical response.

Eligibility criteria: Inclusion Criteria:

Moderate to severe asthmatic (based on 1997 NHLBI guidelines), controlled by medication for at least 6 months, initial IgE level between 30 and 700 IU, weigh between 30 an 150 kg, otherwise healthy.

Exclusion Criteria:

Smoker, uncontrolled asthma, immunotherapy in past six weeks, other diseases

Primary outcomes:
measure: Measure of sCD23 in plasma
measure: CD23 expression on T cell correlated with spirometry, AQLQ and RQLQ.
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D Marshall, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04798300: Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia Monolithic Zirconia
Official title: Wear of Enamel Antagonist to Two Different Types of Monolithic Zirconia: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wear, Occlusal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia

Detailed description: The aim of the present study is to evaluate the wear of enamel opposed by Newly Introduced Gradient Monolithic Zirconia compared to that of enamel opposed by Full Strength Monolithic Zirconia Teeth preparation and impressions, placement and permanent cementation of the final restoration using resin cement, and optical scanning of both the restoration and the opposing tooth. Follow up postoperatively after six and twelve months, and optical scanning of both the restoration and the opposing tooth.

Eligibility criteria: Inclusion Criteria:

-

All subjects are required to be:

1. From 18-50 years old, be able to read and sign the informed consent document.
2. Have no active periodontal or pulpal diseases, have teeth with good restorations.
3. Psychologically and physically able to withstand conventional dental procedures.
4. Patients planned for a single coverage restoration in the posterior area.
5. Patients with a natural (not crowned) opposing antagonist.
6. Able to return for follow-up examinations and evaluation.

Exclusion Criteria:

* Patient less than 18 or more than 50 years 2. Patients with severe clenching or bruxing habits. 3. Patient with active resistant periodontal diseases 4. Patients with poor oral hygiene and uncooperative patients 5. Pregnant women 6. Patients in the growth stage with partially erupted teeth 7. Psychiatric problems or unrealistic expectations 8. Lack of opposing dentition at the area of interest. 9. Presence of dental prosthesis in the opposing arch at the area of interest.

Primary outcomes:
measure: Enamel wear of teeth opposing the restorations to be tested opposing to tested restorations
timeFrame: one year
Secondary outcomes:
measure: Wear of restorations to tested opposed to natural teeth
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01025700: Nabilone & Marijuana Addiction
Official title: A Double-Blind Placebo Control Study on the Use of Nabilone for Outpatient Management of Acute Marijuana Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Marijuana Smoking
Keywords: Efficacy
Marijuana
Reduction
Craving
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 35
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety of Nabilone in reducing marijuana craving

Detailed description: Randomized double blind trial into the safety and efficacy of Cesemat for the treatment of marijuana use

Eligibility criteria: Inclusion Criteria:

* 19 years or older
* History of marijuana use

Primary outcomes:
measure: Safety and tolerability to Nabilone
Secondary outcomes:
measure: Marijuana craving questionnaire
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital - Psychiatry Outpatient
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Shaohua Lu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05593900: Nurse-To-Family Telehealth
Official title: Nurse-to-Family Telehealth for Pediatric Transfers: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Disorder
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 291
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will be a pilot test of using telehealth to allow nurses to connect with parents/guardians of pediatric patients who are being transferred between hospitals.


Eligibility criteria: Inclusion Criteria:

Children who:

* are aged 8 days to \<=18 years
* present to a participating community hospital ED
* are accepted for inter-facility transfer to UC Davis
* are assigned to UC Davis unit D10, D7, or T6
* have an English-speaking adult parent/guardian at the bedside

Exclusion Criteria:

* does not have an English-speaking adult parent/guardian at the bedside

For parent surveys --

Inclusion Criteria:

* are parents/guardians of the eligible patients (described above)
* are age 18 years and older
* are English-speaking

Exclusion Criteria:

* are age less than 18 years
* have a preferred language that is other than English

Primary outcomes:
measure: Assignment Adherence
timeFrame: Day 0
Secondary outcomes:
measure: Fidelity: Percentage of Telehealth Initiated Before Arrival
timeFrame: Day 0
measure: Survey Completion Rate (%)
timeFrame: Day 0
Other outcomes:
measure: Family-Centered Care
timeFrame: Day 0
measure: Family Experience
timeFrame: Day 0
measure: Parent Acute Stress
timeFrame: Day 0
measure: Parent Distress
timeFrame: Day 30
measure: Change in Level of Care
timeFrame: Day 0
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
References:
Clinical trial NCT04361500: Registry of COVID-19 Patients Treated With the Seraph 100 Microbind Affinity Blood Filter
Official title: Registry for the Evaluation of Safety and Effectiveness of the Seraph 100 Microbind Affinity Blood Filter in the Therapy of COVID-19 Patients (COSA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Medical Clinic V Nephrology, Academic Teaching Hospital Brunswick
First posted: 2020-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prooven COVID-19 infection with confirmed or imminent respiratory failure and Treatment with the Seraph® 100 Microbind® Affinity Blood Filter.

Brief summary: The purpose of this registry study is to investigate the effectiveness and safety of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of COVID-19 patients.

Detailed description: During the ongoing COVID-19 pandemic, millions of people have been infected with SARS- Cov-2 worldwide. In the absence of an approved vaccine or medical treatment, there is an emerging need for treatment options, especially in critically ill patients. Multiple pharmacological and non-pharmacological therapies are being investigated. In 2019, the Seraph® 100 Microbind® Affinity Blood Filter (ExThera Medical Corporation, CA, USA) was approved for the removal of pathogens in Europe. On April 17th the FDA granted Authorization for Emergency Use in patients with COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.

Eligibility criteria: Inclusion Criteria:

* COVID-19 infection
* Treatment with the Seraph® 100 Microbind® Affinity Blood Filter
* Voluntary consent to participate in Registry

Exclusion Criteria:

- none

Primary outcomes:
measure: Survival
timeFrame: 30 days
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 30 days
measure: Length of Hospital stay
timeFrame: 30 days
measure: Length of ventilator therapy
timeFrame: 30 days
measure: Adverse events
timeFrame: 30 days
Other outcomes:
Locations:
city: Brunswick
country: Germany
facility: Academic Teaching Hospital Brunswick
state: Lower Saxony
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
References:
Clinical trial NCT01223300: Osteoporosis Research Registry
Official title: Osteoporosis Research Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Shirley Ryan AbilityLab
First posted: 2010-10-18
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with osteoporosis or at risk for osteoporosis. Also, healthy controls.

Brief summary: The aim of this research registry is to collect information on individuals with osteoporosis, those with risk factors for osteoporosis, and comparative healthy controls. Bone mineral density measurements will be done on these individuals to determine bone health.

Detailed description: The goal of this project is to develop a registry of research subjects with OP, with a risk of developing OP, and healthy controls. DXA scans will be performed on willing individuals at the spine, hips, and forearms and possibly the legs and heels in order to determine BMD. Subjects will also be asked to provide two (10 ml) blood samples, which may be used to analyze Vitamin D levels and/or other bone markers. By participating in the registry, subjects will be considered for current and future clinical research studies.

Eligibility criteria: Inclusion Criteria:

* Any subjects who give written informed consent

Exclusion Criteria:

* Any individual who is not willing or able to give written informed consent

Primary outcomes:
measure: BMD
timeFrame: 0 months
Secondary outcomes:
measure: Bone markers
timeFrame: 0 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Thomas J Schnizter, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02523300: Glucocorticoid on the Prognosis of TEVAR
Official title: Prognostic Value of Single-dose Glucocorticoid After Endovascular Repair for Aortic Dissection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Dissection
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 240
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: PREVENTION

Brief summary: To explore the potential prognostic effect of glucocorticoid on the postoperative aorta-related adverse events after aortic dissections patients underwent thoracic endovascular aortic repair (TEVAR), glucocorticoid (30mg/kg) will be intravenously given within 2h after TEVAR.

Detailed description: This is a prospective, open, single-center, randomized controlled trial. Number of patients: 240 patients will be included and undertaken TEVAR.About 120 patients will be given glucocorticoid within 2h after TEVAR as experimental group, and the other 120 patients will be given saline as control group.

Follow-up: 1. aortic computed tomographic angiography (CTA) examination 6, 12 and 24 months after TEVAR; 2. telephone or clinical follow-up at 1, 2, 3, 6, 12 and 24 months.

Primary outcome measure: aorta-related adverse events. Second outcome measure: 30-day mortality after TEVAR, success rate of endovascular repair, drug-related adverse events.

Eligibility criteria: Inclusion Criteria:

1. age from 18 to 80, male or unpregnant female;
2. diagnosed as aortic dissection, excluding intramural hematoma and penetrating aortic ulcer;
3. complicated aortic dissection with definite indications of TEVAR;
4. voluntarily signed the informed consent form;
5. good compliance with the instructions and cooperate with follow-up.

Exclusion Criteria:

1. no appropriate vessel approaches;
2. patients with connective tissue diseases (such as Marfan syndrome);
3. patients with endocrine disease,such as diabetes mellitus, or undergoing hormonotherapy;
4. bad compliance with the instructions and follow-up;
5. allergic to nitinol and contrast medium;
6. estimated life expectancy is less than 24 months.

Primary outcomes:
measure: Aorta-related adverse events
timeFrame: 24 months
Secondary outcomes:
measure: 30-day mortality after TEVAR
timeFrame: 30 days
measure: Success rate of endovascular repair
timeFrame: 24 months
measure: Drug-related adverse events
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Department of Vascular Surgery, Changhai Hospital
name: Zaiping Jing, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu M, Zhang L, Bao J, Zhao Z, Lu Q, Feng R, Song C, Zhou J, Jing Z. Postoperative glucocorticoid enhances recovery after endovascular aortic repair for chronic type B aortic dissection: a single-center experience. BMC Cardiovasc Disord. 2016 Mar 25;16:59. doi: 10.1186/s12872-016-0234-2.