louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03053622: A Study of Mirikizumab (LY3074828) Injection in Healthy Participants
Official title: A Phase 1, Single-Dose Study to Assess the Relative Bioavailability, Absolute Bioavailability, and Tolerability of LY3074828 Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-02-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. Each participant will be in the study for about 18 weeks, including screening.


Eligibility criteria: Inclusion Criteria:

* Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter squared (kg/m²), inclusive
* Have medical test results that are acceptable for the study
* Must be willing to make oneself available for the whole study and be willing to follow study procedures

Exclusion Criteria:

* Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
* Have known allergies to compounds or drugs similar to Mirikizumab
* Have previously participated or withdrawn from this study
* Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab
timeFrame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Secondary outcomes:
measure: PK: Maximum Observed Concentration (Cmax) of Mirikizumab
timeFrame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
measure: PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab
timeFrame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
state: West Yorkshire
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03057522: Step Rate in Recreational Runners
Official title: The Effect of a Home Training Program on Preferred Step Rate in Recreational Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait Disorder, Sensorimotor
Keywords: Run
Cadence
Home exercise
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled study evaluating whether a home exercise program can increase the running cadence of recreational runners.
Primary purpose: OTHER

Brief summary: This will be a pilot study to determine if a 6 week home training program can increase preferred step rate (cadence) in recreational runners. Increase in step rate has been correlated with decreased stress at lower limb joints in runners. This has the potential of decreasing overuse injuries in this population.

Research participants will have their preferred cadence evaluated at the beginning of the study. The athletes will be randomly assigned to two groups. One group will continue to train without intervention and the other group will train at a cadence of 10% higher than their preferred step rate.

At the end of 6 weeks the participants will have their preferred cadence reevaluated using the same method as pre-participation cadence was determined.

The investigators hypothesis the preferred running cadence of recreational runners following the intervention will be 5-10% greater than prior to the intervention and the increased cadence will be maintained for 6 months following the intervention.


Eligibility criteria: Inclusion criteria:

* healthy male or female runners
* 18 years of age or greater
* run two or more times per week most weeks of the year for at least 4 years
* cadence of 85 strides/min or less as determined at initial evaluation
* no musculoskeletal injuries or illnesses that would limit running in the last 6 months
* currently running at least 15 miles a week

Exclusion criteria:

* baseline running cadence greater than 85 strides/min
* inability to run
* cardiovascular disease
* greater than 2 cardiovascular risk factors
* peripheral vascular disease
* neurological disease
* musculoskeletal injury or disease that causes pain with running

Primary outcomes:
measure: Running cadence
timeFrame: 6 weeks
measure: Running cadence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jonathan T Finnoff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03031522: EGFR Molecular Classification In Vivo
Official title: Molecular Imaging to Identify EGFR-TKIs Benefit Non-small Cell Lung Carcinoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molecular Imaging
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2017-01-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators developed 18F-IRS as a targeted molecular imaging agent for noninvasive and repeatable detecting EGFR-activating mutational status.

Detailed description: The goal of investigators were to evaluate the use of 18F-IRS as a novel PET/CT radiotracer to monitor EGFR-activating mutational status and identify EGFR-TKIs benefit NSCLC patients. the investigators want to evaluated the use of 18F-IRS in lung cancer imaging in adult NSCLC patients with different EGFR mutational status of primary and metastatic cancers.

Eligibility criteria: Inclusion Criteria:

* Advanced NSCLC
* 18 years or older
* A life expectancy of at least 12 weeks
* Presence of a malignant lesion within the chest of at least 0.5 cm diameter as measured by computed tomography (CT)
* Written informed consent

Exclusion Criteria:

* Claustrophobia
* Pregnancy
* Metal implants in the thorax

Primary outcomes:
measure: tumor SUVmax value of 18F-IRS PET/CT Imaging
timeFrame: at time of imaging
Secondary outcomes:
Other outcomes:
Locations:
city: Harbin
country: China
facility: TOF-PET/CT/MR center of the Fourth Hospital of Harbin Medical University
state: Heilongjiang
Study officials:
affiliation: The Fourth Hospital of Harbin Medical University
name: Baozhong Shen, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04426422: Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes
Official title: Effect of Metformin on Gut Microbiota Changes and Glycemic Control of Newly Diagnosed Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: newly diagnosed type 2 diabetes was treated with metfomin for 3 months.
Primary purpose: TREATMENT

Brief summary: This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients.

Detailed description: This study was aimed to investigate the effect of metformin on the gut microbiota and glycemic control in newly diagnosed type 2 diabetes patients. All the recurited patients were treated with metformin 1500-2000mg daily for 3 months. Stool specimens and blood samples were collected at the beginning and 3 months later.

Eligibility criteria: Inclusion Criteria:

newly diagnosis type 2 diabetes ,HbA1c \>7 %

Exclusion Criteria:

history of cardiovascular disease, hypertension, severe renal dysfunction defined as glomerular filtration rate \< 45 mL/min/1.73 m2; severe illness or diabetic ketoacidosis within 30 days, inability to tolerate ≥500 mg metformin twice per day and pregnancy.

Primary outcomes:
measure: gut micribiota
timeFrame: 3 months
Secondary outcomes:
measure: glycemic control
timeFrame: 3 months
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People' S Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen People' hospital
name: fengyi Yuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03389022: Ketamine for Postoperative Pain in Bariatric Surgery
Official title: The Effects of Ketamine on Postoperative Pain After Intraoperative Remifentanil Infusions in Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain, Postoperative
Bariatric Surgery Candidate
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery. Ketamine is an old general anaesthetic. Low doses of it might be used as a adjunct in postoperative analgesia.The investigators expect that the low-dose ketamine reduces postoperative pain after bariatric surgeries.

Detailed description: Effective postoperative pain management enhances early postoperative rehabilitation and may improve outcomes of surgical treatment. New analgetic medications and combinations of these are sought for optimal analgesia with lowest possible incidence of side effects. One of the method of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine. To our knowledge, the role of ketamine in the treatment of postoperative pain after bariatric surgeries is poorly researched. The investigators hypothesize that ketamine, acting through the N-methyl-D-aspartate receptor (NMDA) and opioid receptors, provides favourable conditions for adequate post-operative pain management.

Eligibility criteria: Inclusion Criteria:

* II or III The American Society of Anesthesiologists (ASA) physical status
* age \> 18 years
* bariatric surgery with general remifentanil anesthesia

Exclusion Criteria:

* anamnesis of using opioids for the treatment of chronic pain
* opioid dependence
* younger than 18 years

Primary outcomes:
measure: Postoperative pain intensity
timeFrame: On the first postoperative day
measure: Postoperative morphine requirements
timeFrame: On the first postoperative day
Secondary outcomes:
measure: Incidence of side effects
timeFrame: On the first postoperative day
measure: Patients' satisfaction with postoperative analgesia
timeFrame: On the second postoperative day
Other outcomes:
Locations:
Study officials:
affiliation: Lithuanian University of Health Sciences
name: Aurika Karbonskienė, MDPhDAssProf
role: STUDY_CHAIR
References:
Clinical trial NCT00627822: Medical Education in a Private Hospital
Official title: Patient and Companion Perspectives on Medical Education in a Non-Teaching Private Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Care Quality, Access, and Evaluation
Keywords: Medical students
Medical education
Private hospital
Patient satisfaction
Questionnaires
Lead sponsor: Instituto do Cerebro de Brasilia
Sponsor class: OTHER
First posted: 2008-03-03
Enrollment: 209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Private hospital: Patient and family members

Brief summary: The purpose of this study is to assess patient and companion acceptability of medical education in a non-teaching private hospital


Eligibility criteria: Inclusion Criteria:

* Patients in the hospital ward and in the emergency waiting room
* Family members of patients admitted to the intensive care unit

Primary outcomes:
measure: Patient and companion acceptability of medical education
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto do Cérebro de Brasília
name: Ricardo A Teixeira, MD PhD
role: STUDY_DIRECTOR
References:
citation: Benson J, Quince T, Hibble A, Fanshawe T, Emery J. Impact on patients of expanded, general practice based, student teaching: observational and qualitative study. BMJ. 2005 Jul 9;331(7508):89. doi: 10.1136/bmj.38492.599606.8F. Epub 2005 Jul 4.
citation: O'Flynn N, Spencer J, Jones R. Consent and confidentiality in teaching in general practice: survey of patients' views on presence of students. BMJ. 1997 Nov 1;315(7116):1142. doi: 10.1136/bmj.315.7116.1142. No abstract available.
citation: Grayson MS, Klein M, Lugo J, Visintainer P. Benefits and costs to community-based physicians teaching primary care to medical students. J Gen Intern Med. 1998 Jul;13(7):485-8. doi: 10.1046/j.1525-1497.1998.00139.x.
citation: Cooke F, Galasko G, Ramrakha V, Richards D, Rose A, Watkins J. Medical students in general practice: how do patients feel? Br J Gen Pract. 1996 Jun;46(407):361-2.
citation: Kupersmith J. Quality of care in teaching hospitals: a literature review. Acad Med. 2005 May;80(5):458-66. doi: 10.1097/00001888-200505000-00012.
Clinical trial NCT01459822: MiRNAs Evaluate the Prognosis of Sepsis by Dynamic Study
Official title: MiRNAhs in the Evaluation of the Value of Sepsis Prognosis Dynamics Observational Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis
miRNA
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2011-10-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: within 24 hours after admited in ICU

Brief summary: Sepsis is a common cause of death in intensive care unit, timely and accurate diagnosis and treatment directly affect the survival rate. MiRNA is a post-transcriptional small RNA which regulate mRNA expression. The present study was designed to observe the selected miRNA expression which evaluate the sepsis prognosis in the progression of sepsis in order to be a new target for the treatment of sepsis.

Detailed description: The study is a non-intervention observational study. Purpose of this study is to observe some selected miRNA expression which evaluate the sepsis prognosis in the progression of sepsis . The investigators will collect serum samples from patients with sepsis in SICU, RICU and EICU on the 1st、3rd、5th、7th、10th、14th day of 301 Hospital since November 2011 , and then use mirVana PARIS kit extract total RNA and use qRT-PCR detect miRNAS expression in serum which can evaluate the prognosis of sepsis, and statistical analysis the miRNAS expression correlation with SOFA score.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of sepsis
* Patients who agree with the study

Exclusion Criteria:

* Aged \<18 years;
* Into the group who died within 24 hours;
* Agranulocytosis (\<0.5 × 109 / L);
* Combined HIV infection.

Primary outcomes:
measure: all cause mortality
timeFrame: 28days after admited in ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Haidian
Study officials:
affiliation: Pneumology Department of chinese PLA General Hospital
name: LiXin Xie, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00833222: Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants
Official title: Neuroendocrine Mechanisms of Growth and Body Composition in Preterm and Term Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: premature birth
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2009-02-02
Enrollment: 72
Sex: ALL
Minimum age (years): 31
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature and full term infants admitted to the University of Utah Newborn Intensive Care Unit, Intermediate Nursery or Well Baby Nursery

Brief summary: The purpose of this study is to test the feasibility of measuring body composition by air displacement plethysmography (ADP) in rapidly growing, medically stable late gestation \[32-35 weeks post-menstrual age (PMA)\] premature infants.

Detailed description: 1. To assess the feasibility of measuring body fat deposition by ADP in medically stable late gestation (32-35 weeks), premature infants during a period of rapid postnatal growth.
2. To test the relationship between %BF by ADP to %BF by DXA, as well as characterize the relationship between these fat measures with bone measures by quantitative ultrasound and serum levels of insulin, IGF-1, IGF binding proteins, adiponectin and leptin.
3. To perform inter- and intra-rater testing of anthropometric, ultrasound, and ADP measurements.
4. Compare growth, body composition and bone strength between infants born preterm to infants born full term.

Eligibility criteria: Inclusion Criteria:

* Infants born between 32 4/7 and 35 3/7 weeks gestation or 37 4/7 and 42 3/7 weeks gestation, by physical exam at birth
* Birth weight between the 5th and 95th percentile corrected for gestational age

Exclusion Criteria:

* Chromosomal abnormalities
* Major congenital anomalies
* Major surgery
* Severe CNS injury
* Inborn errors of metabolism
* Assisted ventilation
* Inability to start enteral feeds by 96 hours of age

Primary outcomes:
measure: Growth trajectory
timeFrame: Weekly
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Laurie Moyer-Mileur, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Kristine Jordan, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01570322: Determinants of Quality of Life Related to Health in Alzheimer Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Disease
Keywords: Dementia - Alzheimer - Quality of life
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 400
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Patients with Alzheimer disease (DSM IV - Diagnostic and Statistical Manual of Mental Disorders - and NINCDS/ADRDA - National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association)
* Patients with MMSE (Mini Mental State Examination) \> or = 10

Brief summary: Study the factors that explain Health-Related Quality of Life (HRQL) in patients with Alzheimer disease including:

* The influence of the environment (physical and human) on Health-Related Quality of Life (HRQL),
* The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL),
* The influence of formal and informal help mobilized,
* The influence of interactions "patient - caregiver" on Health-Related Quality of Life (HRQL),
* The influence of the ratio necessary cost on available resources on Health-Related Quality of Life (HRQL)


Eligibility criteria: Inclusion Criteria:

* Patients with Alzheimer disease (DSM IV and NINCDS-ADRDA)
* Patients with MMSE (Mini Mental State Examination) \> or = 10
* Out patients

Exclusion Criteria:

* Severe sensory disturbances,
* Non French speaking

Primary outcomes:
measure: Health-Related Quality of Life (HRQOL) Assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: CHU de REIMS
Study officials:
References:
Clinical trial NCT03559322: Real World Experiences of the iNAP® Lite in OSA Adults in Taiwan
Official title: A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Sleep Therapy System in Adults With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea of Adult
Lead sponsor: Somnics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-18
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with obstructive sleep apnea in Taiwan

Brief summary: A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Lite Sleep Therapy System in Adults with Obstructive Sleep Apnea

Detailed description: Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, we are conducting a prospective, observational, post-market surveillance study to evaluate the long-term safety and efficacy of the iNAP® Lite sleep therapy system (iNAP® Lite), a tongue and soft palate retaining intraoral device, in adults with OSA.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with OSA with AHI\>5

Exclusion Criteria:

* Patients with central sleep apnea (CSA).
* Patients with have severe respiratory disorders such as pulmonary diseases, pneumothorax, etc.
* Patients with loose teeth or advanced periodontal disease.
* Patients with pathologically low blood pressure.

Primary outcomes:
measure: Number of participants with adverse events in this entire study.
timeFrame: through study completion, up to 10 weeks
Secondary outcomes:
measure: iNAP® Lite-treated clinical success rate
timeFrame: a treated polysomnography or polygraphy assessment night
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Somnics, Inc.
name: Chung-Chu Chen, Ph.D.
role: STUDY_CHAIR
References: