louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01024777: Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis
Official title: A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Vitamin D Deficiency
Keywords: cholecalciferol
multiple sclerosis
vitamin D
D3
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and the immunologic effects of supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with multiple sclerosis.


Eligibility criteria: Inclusion Criteria:

* Between ages of 18-55 years (inclusive)
* Serum 25(OH) vitamin D levels between 20-50 ng/mL and a candidate for vitamin D supplementation
* Patients with or without immunomodulatory therapy for RRMS
* Diagnosis of multiple sclerosis

Exclusion Criteria:

* Serum 25(OH) vitamin D deficient level \< 20 ng/mL
* High dose vitamin D supplementation in the past 3 months
* Pregnancy
* History of tuberculosis, hyperparathyroidism, sarcoidosis or kidney stones
* Baseline serum creatinine above 1.5
* Hypersensitivity to vitamin D preparations
* Milk allergy
* Unable to consent

Primary outcomes:
measure: Assess safety of high dose cholecalciferol in patients with multiple sclerosis
timeFrame: 3-6 months
measure: Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis
timeFrame: 3-6 months
Secondary outcomes:
measure: Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Peter Calabresi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: John Ratchford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105077: Development of a Mass-spectometry Based Method for Detecting Xenon Application in Humans
Official title: Development of a Mass-spectometry Based Method for Detecting Xenon Application in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: xenon
doping
anesthesia
mass spectrometry
surgery
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: German Sport University, Cologne
First posted: 2014-04-07
Enrollment: 8
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 undergoing xenon-based general anesthesia as part of routine care at University Hospital Düsseldorf, Germany

Brief summary: The purpose of this study is to establish a laboratory method to determine from blood samples whether a person has been treated with xenon.

Detailed description: The noble gas xenon is used for general anesthesia in clinical routine. Recent reports indicate that xenon is also used for increasing performance in high-performance sports. The purpose of this study is to establish a method for detecting xenon exposure in humans.

In patients undergoing surgery with xenon anesthesia as part of routine hospital care, small blood samples (3ml) will be taken before anesthesia, during anaesthesia and at 1,2, 4, 8, 16, 24, 32, 40 and 48 hours after anesthesia. These blood samples will be analyzed for traces of xenon.

Eligibility criteria: Inclusion Criteria:

* Age of 18 years and older
* Xenon-based anesthesia as part of routine care

Exclusion Criteria:

* Inability to give written informed consent
* Known pregnancy
* Hemoglobin concentration of less than 12g/dl

Primary outcomes:
measure: Detection of xenon in patient blood sample by mass spectrometry
timeFrame: Immediately before induction of anesthesia
measure: Detection of xenon in patient blood sample by mass spectrometry
timeFrame: During xenon anesthesia
measure: Detection of xenon in patient blood sample by mass spectrometry
timeFrame: 4 hours after extubation
measure: Detection of xenon in patient blood sample by mass spectrometry
timeFrame: 8 hours after extubation
measure: Detection of xenon in patient blood sample by mass spectrometry
timeFrame: 24 hours after xenon anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Klinik für Anästhesiologie, Universitätsklinikum Düsseldorf
Study officials:
References:
Clinical trial NCT00373477: A Study of the Cost Effectiveness of Generalist Care Managers for Depression Treatment in Medicaid Recipients
Official title: A Randomized Trial of the Cost Effectiveness of Generalist Care Managers for the Treatment of Depression in Medicaid Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Primary Care
Care Manager
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2006-09-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will enable the investigators to conduct a randomized clinical trial to demonstrate the value of generalist care managers in the treatment of depression in Medicaid patients seen in primary health care practices. Depressed patients will be recruited at two primary care practices in Western North Carolina and randomly assigned to either generalist care management or usual care. Patients in each condition will be assessed at baseline and six months follow-up. Outcomes will include depressive symptoms, level of functioning, and cost-effectiveness measures.

Detailed description: Randomized trial among depressed Medicaid patients aged 18 years and older in 2 primary care practices in Western NC comparing an intervention with a GCM to usual care (UC) between July 2003 and February 2005. GCMs, already providing diabetes and asthma services, were further trained and given ongoing supervision to provide algorithm-based depression care to enhance guideline concordant treatment. GCMs provided elements of self-management, decision support, use of information systems, and core care management components.

Eligibility criteria: Inclusion Criteria:

* scoring 10 or greater on PHQ-9 and primary care physician verification of major depression by clinical exam; and
* willing to begin or continue antidepressant medication

Exclusion Criteria:

* bipolar disorder, psychotic symptoms, or active suicidal ideation requiring psychiatric admission (

Primary outcomes:
measure: Baseline, 3 and 6-month Patient Health Questionnaire (PHQ9) scores
Secondary outcomes:
measure: Baseline and 6-month Short Form (SF)-12 scores, Medicaid claims data; patient perception of treatment by self-report; review of GCM case notes, physician and office staff time study; physician and office staff focus groups
Other outcomes:
Locations:
city: Asheville
country: United States
facility: Mountain Area Health Education Center (MAHEC)
state: North Carolina
city: Marshall
country: United States
facility: Hot Springs Health Program
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Suzanne Landis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02829177: Microalbuminuria and Allopurinol in Type 1 Diabetes
Official title: A Double-blind, Randomized, Placebo Controlled Trial of Allopurinol in Patients With Type 1 Diabetes and Microalbuminuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Diabetic Nephropathy
Keywords: Type 1 diabetes
Diabetic nephropathy
Albuminuria
Allopurinol
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective is to determine if lowering serum uric acid by means of allopurinol in the course of kidney disease may be effective in preventing or improving albuminuria and renal function in Type 1 Diabetic patients. The study is a double blinded, randomised, placebo-controlled cross-over clinical trial.


Eligibility criteria: Inclusion Criteria:

* Albuminuria (≥30 mg/g)
* Uric Acid ≥ 0,265 mmol/l
* GFR (glomerular filtration rate) \> 40 ml/min/1.73m2

Exclusion Criteria:

* History of gout or xanthinuria or other indications for uric acid lowering therapy such as cancer chemotherapy.
* Recurrent renal calculi.
* Current use of azathioprine, 6-mercaptopurine, didanosine, tamoxifen, amoxicillin/ampicillin, or other drugs interacting with allopurinol.
* Known allergy to xanthine-oxidase inhibitors.
* Renal transplant.
* Non-diabetic kidney disease.
* Home, 24h og clinical BP\>180 or Diastolic BP \>130 mmHg at screening.
* Cancer treatment within two years before screening.
* History of hepatitis B or C.
* History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection.
* History of alcohol or drug abuse.
* Breastfeeding or pregnancy or unwillingness to be on contraception throughout the trial.
* Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study.
* Serious pre-existing medical problems other than diabetes, e.g. congestive heart failure, pulmonary insufficiency.

Primary outcomes:
measure: Improved Albuminuria
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Steno Diabetes Center
Study officials:
References:
Clinical trial NCT06016153: The Efficacy of Basic Life Support Education Among Teenagers
Official title: The Investigation of the Efficacy of Basic Life Support Education Among High School Students
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiopulmonary Resuscitation
Basic Life Support
Premedical Education
Study Skills
Lead sponsor: Semmelweis University
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 360
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Basic life support (BLS) skills are crucial not only for healthcare workers but for all lay people as well. Timely recognition of out-of-hospital cardiac arrest and the initiation of BLS by bystanders before the arrival of healthcare personnel can improve survival.

There are several methods of spreading BLS skills and improve BLS skill retention among lay people. One of these methods can be educating school children. The introduction of mandatory BLS education in schools was very effective in some European countries to increase the rate of bystander BLS.

The current study aims to investigate the efficacy of a BLS training and BLS curriculum among high school children in Hungary. Moreover, the investigators would like to optimise factors influencing skill retention in this first responder group and aim to compare two types of teaching methods: feedback given by the instructor or software-based feedback on the efficacy of chest compressions during the course.


Eligibility criteria: Inclusion Criteria:

* High school teenagers participating in the education of Óbudai High School, Budapest
* Written informed consent received from participants and their parents to participate in the study

Exclusion Criteria:

* No written informed consent provided by the student or parent
* Any injury or health issue influencing the efficacy of BLS skill

Primary outcomes:
measure: End of training BLS skill assessment based on a checklist
timeFrame: up to two hours
Secondary outcomes:
measure: BLS skill assessment after 2 months based on a checklist
timeFrame: 2 months
measure: BLS skill assessment after 6 months based on a checklist
timeFrame: 6 months
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Óbudai Gimnázium
Study officials:
affiliation: Semmelweis University
name: Endre Zima, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03323853: Computerized Assessment and Referral System Screener for Mental Health Evaluations in the Emergency Setting
Official title: The Utility of the Computerized Assessment and Referral System (CARS) Screener for Mental Health Evaluations in the Emergency Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a hybrid effectiveness-implementation randomized controlled trial which will be conducted at the emergency department (ED) at the University of Arkansas for Medical Sciences (UAMS) in Little Rock, Arkansas.

The hypothesis of this study is that use of the CARS (a computerized mental health screener) will modify emergency department treatment of patients with previously undiagnosed mental illness.

Detailed description: This pragmatic mixed methods clinical trial will compare the intervention of providing a CARS screener report to emergency providers to not providing the report. It will also collect qualitative data regarding implementation of the CARS screener and report. Consecutive patients presenting when a research associate is available will be approached to participate. Patients will be approached after evaluation by an emergency physician.

The Computerized Assessment and Referral System (CARS) is based on the Composite International Diagnostic Interview (CIDI), a validated instrument for assessing mental health diagnoses.CARS was piloted at 6 different sites in 2016, all in DUI populations. As CARS has not been specifically validated on non-DUI populations, investigators will collect alcohol history (see below). The CARS self-assessment version (CARS-SA) will be utilized in this study.

Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Not incarcerated
* English-speaking and English-writing (as translators will not be available for this study)

Exclusion Criteria:

* Unable or unwilling to complete CARS screener
* Unable or unwilling to provide any history of alcohol abuse
* Currently presenting with a chief complaint of a psychiatric symptom
* Currently presenting with a substance use complaint
* History of a known psychiatric condition
* Patients taking psychiatric medication

Primary outcomes:
measure: Number of Participants With CARS Mental Health Diagnoses Made in the ED; the Number of Psychiatry Evaluations in the Emergency Department (ED); and the Number of Mental Health Referrals Made From the ED
timeFrame: Up to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Michael P Wilson, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06278753: Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy
Official title: Comparison of Standard Cystoscopy With Carbon Dioxide Cystoscopy Used to Evaluate Lower Urinary Tract Damage After Laparoscopic Hysterectomy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Injury
Ureter Injury
Surgical Injury
Complication of Surgical Procedure
Keywords: laparoscopic hysterectomy
lower urinary tract injury
cystoscopy
Lead sponsor: Tepecik Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who will undergo laparoscopic hysterectomy for benign reasons in our hospital

Brief summary: For the evaluation of the lower urinary tract after laparoscopic hysterectomy, routine standard saline cystoscopy and carbon dioxide cystoscopy will be compared.

Detailed description: It was aimed to investigate whether routine cystoscopy with carbon dioxide is a safer and faster method for the evaluation of lower urinary tract injuries compared to standard saline cystoscopy. In addition, with this study, it will be studied whether bladder bleeding or intra-bladder masses can be evaluated more quickly and clearly.

Eligibility criteria: Inclusion Criteria:

1. laparoscopic hysterectomy for benign reasons planned patients
2. The operation will be performed in our hospital
3. Reporting preoperative endometrial and cervical samplings as benign
4. After discharge, control examinations will be carried out in our hospital.

Exclusion Criteria:

1. Abdominal, robotic or vaginal hysterectomies
2. malignant reporting of preoperative cervical and endometrial samplings
3. Patients do not want to participate in the study

Primary outcomes:
measure: It was aimed to evaluate the effectiveness and reliability of carbon dioxide cystoscopy.
timeFrame: one year
Secondary outcomes:
measure: It was aimed to evaluate the speed and image quality of carbon dioxide cystoscopy in detecting intravesical masses.
timeFrame: one year
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Tepecik Training and Research Hospital
state: Eurasia
Study officials:
References:
Clinical trial NCT00461253: Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
Official title: Case-Control-Study on the Breast Cancer Risk of Mirena® Compared With Copper IUDs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Center for Epidemiology and Health Research, Germany
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2007-04-17
Enrollment: 25565
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases will be identified from population-based cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from.

Brief summary: The objective of this study is to determine the breast cancer risk of Mirena® users compared to copper intrauterine device (IUD) users in a community-based case-control study.

Detailed description: This is a community-based case-control study in Germany and Finland. Cases will be identified from cancer registries, tumor centers and breast centers. Matched controls will be accrued from the same region as the case came from. Breast cancer cases and their controls are women under 50 years of age without known history of malignancies.

Cases are women with a breast cancer who are younger than 50 years of age at cancer diagnosis. The breast cancer was diagnosed between January 2000 and December 2007. Only alive cases and cases in a sufficiently good health status to be interviewed are eligible for the study.

Controls are women without a breast cancer diagnosis who are younger than 50 years of age at the time of the interview. About 3 controls matched by year of birth and region will be allocated to each case.

A standardized questionnaire will be used for all breast cancer cases and controls. The questionnaire will be mailed to cases and controls.

Study participants will be asked for their informed consent. Data confidentiality according to national laws will be ensured by the field organizations.

Eligibility criteria: Inclusion Criteria:

* cases: women with a breast cancer who are younger than 50 years of age at cancer diagnosis
* controls: women without a breast cancer diagnosis who are younger than 50 years at the time of the interview

Exclusion Criteria:

* women who are not willing to participate

Primary outcomes:
measure: Breast Cancer Risk
timeFrame: retrospective, January 2000 to December 2007
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Center for Epidemiology and Health Research
Study officials:
affiliation: Center for Epidemiology and Health Research
name: Juergen Dinger, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dinger J, Bardenheuer K, Minh TD. Levonorgestrel-releasing and copper intrauterine devices and the risk of breast cancer. Contraception. 2011 Mar;83(3):211-7. doi: 10.1016/j.contraception.2010.11.009. Epub 2011 Jan 7.
Clinical trial NCT04175353: Effects of Dairy- and Berry-based Snacks on Postprandial Glucose Metabolism in Older People
Official title: Tailored Food Solutions for Improving Nutrition and Well-being in Older People: Effects on Postprandial Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postprandial Hyperglycemia
Keywords: older people
nutrition
dairy
berries
postprandial
glucose
insulin
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Malnutrition or its risk is common among older people. To maintain adequate nutrition, increased meal frequency is important. In addition to main meals, regular consumption of nutrient- and energy-dense snacks is recommended. The study examines the post-meal responses to dairy- and berry-based snacks tailored for older people. The plasma concentrations of glucose, insulin and free fatty acids are measured during three hours after snack consumption. In addition, subjective satiety responses and heart rate variability are recorded.


Eligibility criteria: Inclusion Criteria:

* Home-dwelling

Exclusion Criteria:

* Smoking
* Type 1 diabetes
* Type 2 diabetes treated with oral medications or insulin
* Cognitive impairment
* Antibiotic medication within the past 3 months
* Blood donation within the past month

Primary outcomes:
measure: Change in postprandial glucose
timeFrame: 3 hrs
measure: Change in postprandial insulin
timeFrame: 3 hrs
Secondary outcomes:
measure: Change in postprandial free fatty acids
timeFrame: 3 hrs
measure: Change in postprandial satiety scores assessed by using visual analogy scales
timeFrame: 3 hrs
measure: Heart rate variability
timeFrame: 3 hrs
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: University of Eastern Finland
Study officials:
affiliation: University of Eastern Finland, Institute of Public Health and Clinical Nutrition
name: Riitta Törrönen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Eastern Finland, Institute of Public Health and Clinical Nutrition
name: Marjukka Kolehmainen, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Eastern Finland, Department of Applied Physics
name: Mika Tarvainen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Torronen R, Jarvinen S, Kolehmainen M. Postprandial glycemic responses to a high-protein dairy snack and energy-enriched berry snacks in older adults. Clin Nutr ESPEN. 2022 Oct;51:231-238. doi: 10.1016/j.clnesp.2022.08.026. Epub 2022 Aug 30.