louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01515579: Comparison of Two Liraglutide Formulations in Healthy Subjects
Official title: A Randomized, Double-blind, Single-centre, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between the Phase 2 Formulation of Liraglutide at pH 7.7 (Formulation 3) and the Phase 3 Formulation at pH 8.15 (Formulation 4)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7 (formulation 3).


Eligibility criteria: Inclusion Criteria:

* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
* BMI (Body Mass Index) of 18.0-27.0 kg/m\^2, both inclusive

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
* Impaired renal function
* Any clinically significant abnormal ECG, as judged by the Investigator
* Active hepatitis B and/or active hepatitis C
* Positive human immunodeficiency virus (HIV) antibodies
* Known or suspected allergy to trial product(s) or related products
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
* Use of any prescription or non-prescription medication, except for paracetamol and vitamins, as judged by the Investigator

Primary outcomes:
measure: Area under the curve (0-t)
measure: Cmax, maximum concentration
Secondary outcomes:
measure: Area under the curve
measure: tmax, time to reach Cmax
measure: t½, terminal half-life
measure: Terminal elimination rate constant
measure: Adverse events
Other outcomes:
Locations:
city: Lund
country: Sweden
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02663479: Nutraceutical Supplement in the Management of Hypertension
Official title: Proprietary Lipid-Lowering Nutraceutical Supplement in the Management of Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypertension
Lead sponsor: Thorne HealthTech, Inc
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 40
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: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy and safety of a proprietary nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive agents or other nutraceutical supplements.


Eligibility criteria: Inclusion Criteria

* Diagnosed with chronic hypertension: Blood pressure at study entry must be greater than or equal to systolic blood pressure of 140 mm Hg but less than 180 mm Hg or diastolic blood pressure greater than or equal to 90 mm Hg but less than 105 mm Hg
* Subjects are not taking any prescription anti-hypertensive drugs.
* Subjects must be off all nutraceutical supplements for at least 30 days prior to entry into the study.

Exclusion Criteria

* Myocardial infarction, PTCA , stent, CABG within 5 years, known clinical CHD or clinical angina.
* History of cerebrovascular accident (CVA).
* Creatinine over 2.5 mg/dL.
* Known allergy or sensitivity to any components of the study blood pressure supplement.
* Chronic liver disease with AST, ALT, alkaline phosphatase over 1.5 x normal lab values.
* Known cancer within 2 years.
* Clinical congestive heart failure ( systolic or diastolic CHF)
* Pregnant and nursing women and women.
* Women of child bearing age not on approved contraception control.
* Type 1 and Type 2 diabetes mellitus on medications.
* If the study subjects develop BP over 180 mm Hg systolic or 110 mm Hg diastolic during the study, they will be discontinued from the study and the investigator will immediately start rescue drug therapy for BP control.

Primary outcomes:
measure: Blood Pressure
timeFrame: 4 months
Secondary outcomes:
measure: Endothelial Function
timeFrame: 4 months
measure: Small arterial compliance
timeFrame: 4 months
measure: Large arterial compliance
timeFrame: 4 months
measure: Central arterial blood pressure
timeFrame: 4 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Hypertension Institute of Nashville, TN
state: Tennessee
Study officials:
affiliation: Hypertension Institute
name: Mark Houston, MD, MS, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Thorne Research
name: Bodi Zhang, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00981279: Profile of HIV Seropositive Patients
Official title: Profile of HIV Seropositive Patients on Antiretroviral Therapy at the Clinical Hospital of the Federal University of Goiás
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
HIV Infections
Keywords: Health Profile
AIDS
Health Promotion
HIV
treatment experienced
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2009-09-22
Enrollment: 222
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample, with HIV, in drug therapy in the Clinical Hospital of UFG.

Brief summary: The aim of this study was to delineate the epidemiological profile of HIV seropositive patients on antiretroviral therapy at the Clinical Hospital of the Federal University of Goiás.

Detailed description: Objective: To delineate the epidemiological profile of HIV seropositive patients on antiretroviral therapy at the Clinical Hospital of the Federal University of Goiás.

Methods: The present study is documental and analitical descriptive and it was conducted at the Clinical Hospital of the Federal University of Goiás, trough data collection of 222 records of individuals in drug therapy. Data were collected regarding the personal aspects, aspects related to the infection and information about the most used therapeutic.

Eligibility criteria: Inclusion Criteria:

* All of the patients that had data in the hospital
* All with the diagnose of HIV
* Using antiretroviral drugs

Exclusion Criteria:

* Incompleted records
* Patients who didn't take their medicines regularly.

Primary outcomes:
measure: Data regarding the personal aspects, aspects related to the infection and information about the most used therapeutic.
timeFrame: Since the start of the drug therapy ( means of 36 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Goiânia
country: Brazil
facility: Federal University of Goias
state: GO
Study officials:
affiliation: UFG
name: Caroline N Rodrigues, Graduated
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06970379: T-prf Versus T-prf and Low-level Laser Stimulation on Bone Healing at Posterior Mandibular Fractures
Official title: Comparison Between T-prf Versus T-prf and Low-level Laser Stimulation on Bone Healing at Posterior Mandibular Fractures (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Mandibular Fractures
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different types of grafting substances have been used in the recent decade to accelerate bone healing at large bony facial defects. PRF was one of the gold standard materials to be used until it was replaced by its successor T-PRF due to the PRF hazards of preparation. However, T-PRF- still can't stand alone in full bone enhancement procedure. Therefore, the combination with another bone bio-modulation technique, like Low-level Laser Therapy, is a must to approach the full advantage of bone healing. Aim: To compare between the effect of using T-PRF versus T-PRF with Low Level Laser stimulation on bone healing at posterior mandibular fractures


Eligibility criteria: Inclusion Criteria:

* Patients suffering from posterior mandibular fracture

Exclusion Criteria:

* Patients with an untreated old Mandibular fracture.
* Patient with hematological diseases (thrombocytopenia, hemorrhagic disease, and diabetes).
* Comminuted fracture with bone loss.
* There is an infection at the fracture line.

Primary outcomes:
measure: Change in bone density
timeFrame: Baseline and 3 months
measure: Change in mouth opening
timeFrame: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks
measure: Change in wound healing
timeFrame: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks
Secondary outcomes:
measure: change in pain scores
timeFrame: 24 hrs, 1 week, 4 weeks
measure: change in edema
timeFrame: baseline, 24 hrs, 1 week, 4 weeks, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT00770679: Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging
Official title: Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-10-10
Enrollment: 16
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how blood vessels dilate (expand) or contract (narrow) in different situations. This affects how blood flows through those vessels. Magnetic resonance imaging (MRI) can be used to evaluate endothelial function in the arms and legs noninvasively.

Detailed description: Correct

Eligibility criteria: Inclusion Criteria:

* Age 40-90
* Male or female
* Type 2 diabetes

Exclusion Criteria:

* Known pregnancy or nursing.
* Females of child bearing potential must have been surgically sterilized or be post menopausal.
* Smoking
* Known vascular disease
* Inability to complete MRI scan
* Symptoms of claudication
* Use of a nitrate medicine
* Use of any cholesterol-lowering agent
* LDL \< 70
* Acute illness
* Liver disease
* Contraindication to getting an MRI scan (i.e. electronic implant, shrapnel, cerebral aneurysm clip, welding history).

Primary outcomes:
measure: Mean Change in Low Density Lipoprotein (LDL)
timeFrame: Change from baseline to follow-up, up to 5 weeks
measure: Change in Endothelial Function as Measured on MRI in the Arms
timeFrame: chance from baseline to end of study, up to 5 weeks
measure: Change in Endothelial Function as Measured on MRI in the Legs
timeFrame: chance from baseline to end of study, up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Harry SIlber, MD
state: Maryland
Study officials:
affiliation: JHU
name: Harry Silber, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00575679: Behavior and Driving Safety Study
Official title: Behavior and Driving Safety Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholic Intoxication
Keywords: Automobile driving
Driving under the influence
Interview, psychological
Brief intervention
Brief motivational interview
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Sacramento Police Department
name: California Office of Traffic Safety
name: University of Michigan
name: Robert Wood Johnson Foundation
name: Teachable Moment Foundation
First posted: 2007-12-18
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether brief motivational interviews reduce the likelihood of driving under the influence of alcohol (DUI).

Detailed description: Despite extensive legislative, law enforcement, and public awareness efforts, driving under the influence of alcohol (DUI) remains a major cause of mortality and loss of years of productive life. A brief motivational interview (BI) is a non-confrontational, patient-centered discussion during which the individual's motivation and confidence to change health-related behaviors are explored. Previous studies of BIs in health care settings suggest that BIs administered after hospitalization for alcohol-related injury reduce the likelihood of repeat injury hospitalization and arrest for DUI.

Eligibility criteria: Inclusion Criteria:

* Second or greater arrest for driving under the influence of alcohol
* Arrest involved operation of a motor vehicle
* At least 18 years of age
* English-speaking

Exclusion Criteria:

* Arrest involved injury to another person
* Previous participation in this study

Primary outcomes:
measure: Time to repeat arrest for driving under the influence of alcohol
timeFrame: Up until one year after the conclusion of enrollment
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test score
timeFrame: 6 and 12 months
measure: Time to alcohol-related injury hospitalization
timeFrame: Up until one year after the conclusion of enrollment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sacramento County Main Jail
state: California
Study officials:
affiliation: University of California, Davis
name: Garth H Utter, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Leon J Owens, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02334579: Stereotactic Body Radiotherapy for Stage I-III Prostate Cancer
Official title: Function-Preserving Stereotactic Body Radiotherapy for Clinical State I-III Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Prostatic Cancer
Prostate Neoplasms
Prostatic Neoplasms
Cancer of the Prostate
Keywords: Radiation
Stereotactic Radiosurgery
Radiotherapy
Prostate Tumor
Prostate Surgery
CyberKnife
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2015-01-08
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out the effects (good and bad) of highly focused radiation on you and your prostate cancer. The purpose of this evaluation is to see if this treatment causes fewer side effects that other standard treatment approaches, and to evaluate the effect of this treatment on your prostate tumor and your quality of life over time.


Eligibility criteria: Inclusion Criteria:

* Histologically proven prostate adenocarcinoma
* Clinical stage T1a-T3, N0-Nx, M0-Mx
* Patients belonging in one of the following risk groups: (1) LOW RISK: CS T1a-T2a, Gleason 2-6, PSA\<10, Nx-0, Mx-0; (2) INTERMEDIATE RISK: CS T2b, Gleason ≤7, PSA\<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 2-6, PSA≥10 \& \<20, Nx-0, Mx-0, or CS T1a-T2b, Gleason 7, PSA≤20, Nx-0, Mx-0; or (3) HIGH RISK: CS T2c-T3, any Gleason, any PSA, or CS T1-3, Gleason ≥8 and/or PSA≥20
* Karnofsky performance status 70-100
* Hormone therapy: includes LHRH agonists (e.g. leuprolide, goserelin, triptorelin), antagonists (e.g. degarelix), peripheral blockers (e.g. flutamide, bicalutamide, nilutamide), estrogens (e.g. DES) and bilateral orchiectomy
* Low and Intermediate risk groups: no hormone ablation for two months prior to enrollment, or during treatment
* High risk group: three hormone therapy regimens are allowed
* 5-alpha reductase inhibitors (e.g., finasteride or dutasteride) are allowed

Exclusion Criteria:

* Prior prostatectomy or cryotherapy of the prostate
* Prior high-dose radiotherapy to the prostate or lower pelvis
* Implanted hardware or other material that would prohibit appropriate treatment planning or treatment delivery, in the investigator's opinion

Primary outcomes:
measure: Quality of life outcomes (low- and intermediate-risk prostate cancer groups)
timeFrame: 8 years
measure: Rates of acute and late grade 3-5 gastrointestinal and genitourinary toxicities (high-risk group)
timeFrame: 8 years
Secondary outcomes:
measure: Rates of toxicities related to treatment
timeFrame: 5 years
measure: Disease free survival
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
Other outcomes:
measure: Quality of life
timeFrame: 5 years
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center Radiosurgery Center
state: Washington
Study officials:
affiliation: Swedish Medical Center Radiosurgery Center
name: Robert Meier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02465879: Allied Health in Rheumatology Triage Project
Official title: Allied Health in Rheumatology Triage Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Arthritis
Keywords: Psoriatic arthritis
Ankylosing spondylitis
Rheumatoid arthritis
Seronegative
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: The Arthritis Society, Canada
name: Ontario Rheumatology Association
name: Ontario Best Practices Research Initiative
First posted: 2015-06-09
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: There is accumulating evidence that early treatment leads to better outcomes for patients with inflammatory arthritis (IA). Triage, which is the process of identifying the urgency of a patient's disease state efficiently and correctly, may facilitate early referral to a rheumatologist. Several studies have suggested that placing allied health professionals (occupational therapists, physical therapists, nurses, etc.) in a triage roll may reduce wait time for patients with suspected IA. The goal of this investigation will be to demonstrate the system-level impact of an Arthritis Society extended role occupational therapist (OT) or physical therapist (PT) working in a triage role in improving access to rheumatologists for people with IA. In this study two groups will be observed: intervention and "usual care" as determined by historical chart review. Wait times will be compared between both groups.


Eligibility criteria: Inclusion Criteria:

* New referrals from a GP
* Adults with possible IA (determined by rheumatologist through paper triage)

Exclusion Criteria:

* Currently on a disease-modifying antirheumatic drug (DMARD)
* Previously seen by a rheumatologist.
* FM, non-IA OA; soft tissue rheumatism; mechanical LBP

Primary outcomes:
measure: Time to first visit with the rheumatologist (wait time)
timeFrame: 3 months
Secondary outcomes:
measure: Time to diagnosis
timeFrame: 3 months
measure: Time to treatment (disease-modifying antirheumatic drug)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03499379: Stress Hormones and IUDs
Official title: Effect of Initiation of Intrauterine Contraception on Hair Cortisol Concentration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Mood Change
Keywords: Intrauterine device (IUD)
Depression
Stress hormones
Mood changes
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2018-04-17
Enrollment: 39
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be selected from women's health care clinics in the community.

Brief summary: Determine what kind of side effects women experience in the first year after they start using an intrauterine device.

Detailed description: The purpose of this study is to find out if there is a difference in levels of stress hormones in women who use copper or hormonal intrauterine devices (IUDs). This study will provide more information on the potential effect of levonorgestrel intrauterine system (LNG-IUS) use on an individual's stress response. Ultimately, this study hopes to provide data to better counsel women on potential mood effects of the LNG-IUS. From a research and clinical management perspective, hair cortisol may provide a tool to evaluate women at risk for discontinuation of hormonal contraception due to concern of mood symptoms.

Eligibility criteria: Inclusion Criteria:

* Generally healthy
* Age 18-39 years
* Regular menstrual cycles
* Getting an IUD for the purpose of contraception

Exclusion Criteria:

* History of mood disorders
* BMI less than 18.5 or greater than 35
* Chronic medical conditions
* Recently pregnant or lactating

Primary outcomes:
measure: Mean change in hair cortisol concentration - 6 months
timeFrame: Baseline & 6 months post-insertion
Secondary outcomes:
measure: Mean change in hair cortisol concentration - 12 months
timeFrame: Baseline & 12 months post-insertion
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Nora Doty, MD
role: PRINCIPAL_INVESTIGATOR
References: