louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01115985: A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers
Official title: ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Atorvastatin -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pharmacokinetics of Atorvastatin
Keywords: ASP1585
Drug-drug interaction
Atorvastatin
Healthy volunteer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is to assess the effect of ASP1585 on pharmacokinetics of atorvastatin in 2x2 crossover method.


Eligibility criteria: Inclusion Criteria:

* Body weight: =\<50.0kg, \<80.0kg
* Body mass index: =\<17.6, \<26.4
* Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data

Exclusion Criteria:

* Attending another clinical trial within 120 days before the study
* Blood donation within 90 days (400ml) or 30 days (200ml) before the study
* Receiving any drugs within 7 days before the study
* History of allergy to drugs
* Having GI disorders
* History or complication of liver diseases
* History or complication of heart disease
* History or complication of respiratory diseases
* History or complication of renal diseases
* History or complication of cerebrovascular diseases

Primary outcomes:
measure: Plasma concentration of atorvastatin
timeFrame: 48 hours after administration
Secondary outcomes:
measure: Safety assessed by AE, vital signs 12-lead ECG and lab tests
timeFrame: 7 days after administration
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT00787085: The Significance of Funguria in Hospitalized Patients
Official title: The Significance of Funguria in Hospitalized Patients (FACES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Keywords: Funguria
Epidemiology
Urinary Tract Infections
Lead sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Cedars-Sinai Medical Center
First posted: 2008-11-07
Enrollment: 919
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized at the Harbor-UCLA Medical Center and Cedars-Sinai Medical Center

Brief summary: This investigation is a epidemiologic case-control study of the risk factors associated with nosocomial funguria (fungi in the urine).

Detailed description: A recent large multi-center national surveillance survey of almost 5000 nosocomial (hospital based) urine isolates from medical intensive care units demonstrated that fungi comprised nearly 40% of urine isolates. Little is known about distinguishing fungi that cause colonization from those causing infection.

The objective of this study is to define the epidemiology of nosocomial funguria and natural history of patients that develop funguria while hospitalized.

Patients who may have eligible for this study will be identified from microbiology laboratory specimens at the Harbor-UCLA Medical Center and Cedars-Sinai Medical Center.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized at least 12 hours of any age (\< 1 day to \> 100 years of age) AND a urine or blood culture positive for fungi, OR urine culture negative for fungi (control group)

Exclusion Criteria:

* Patients already surveyed for funguria during current hospitalization and patients already being followed for recognized funguria

Primary outcomes:
measure: Funguria
timeFrame: Hospitalization day 0, 3, 7, 14, and every 7 days thereafter until hospital discharge or death
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Torrance
country: United States
facility: Harbor-UCLA Medical Center
state: California
Study officials:
affiliation: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
name: Loren G Miller, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06293885: Pleurodesis Using Hypertonic Glucose
Official title: PLeurodesis Using Hypertonic Glucose Administration to Treat Post-operative Air Leaks Following Lung Resection Surgery (PLUG): Phase II Randomized Feasibility Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Air Leak From Lung
Keywords: air leak
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 40
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: Air leaks from unhealed lung tissue following lung resection for benign or malignant lesions are one of the most common complications following thoracic surgery, occurring after 10% of major lung resections. The purpose of this study is to investigate the efficacy of intrapleural administration of Dextrose 50% to resolve air leaks after pulmonary resection.


Eligibility criteria: Inclusion Criteria:

* Adult patients undergoing scheduled pulmonary lobar or sublobar resection for cancer
* Presence of air leak on postoperative day 1 of at least 100 mL/min, as documented on the digital drainage system

Exclusion Criteria:

- None

Primary outcomes:
measure: Prolonged Air Leak
timeFrame: 5 days postoperatively
Secondary outcomes:
measure: Duration of Chest Tubes
timeFrame: immediately after the surgery
measure: Home with Chest Tube
timeFrame: immediately after the surgery
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
References:
Clinical trial NCT02362685: Metabolic Exercise Testing
Official title: Exercise Testing in Metabolic Myopathies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Myopathies
Exercise Test
Myalgia
Keywords: Metabolic myopathies
Exercise testing
Blood sample
Muscle biopsy
Genetic analysis
Cycloergometer
Grip-test
Exercise physiology
Muscle physiology
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2015-02-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects referred to perform a metabolic exercise testing.

Brief summary: Exertional symptoms are the hallmarks of metabolic myopathies, supporting the concept of using functional tests when this diagnosis is suspected. Exercise increases the concentration of muscle metabolites in the venous blood supply (e.g. lactate, pyruvate, and ammonia) especially during recovery. The purpose of this study is to compare the results of exercise testing with to the data from muscle biopsy or genetic analysis.


Eligibility criteria: Inclusion Criteria:

* Referred to the Physiology Department of Brest Hospital for a metabolic exercise test
* Ability to provide informed consent

Exclusion Criteria:

* Contraindication(s) to perform cardiopulmonary exercise testing (ATS/ACCP statement on cardiopulmonary exercise testing, Am J respi Care Med 167: 211-77, 2003)
* Pregnancy or unknown pregnancy status.

Primary outcomes:
measure: Whole-body dynamic exercise
timeFrame: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
measure: Grip-test
timeFrame: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
measure: Blood tests
timeFrame: Participants will be followed for an expected average of 1 year to determine whether a muscle biopsy is performed
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Centre Hospitalier Régional Universitaire
Study officials:
affiliation: CHRU Brest
name: Fabrice Rannou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01816685: Effect of CPAP on Postoperative Delirium
Official title: The Effect of Peri-operative Continuous Positive Airway Pressure (CPAP) on Postoperative Delirium in a Population at High-risk for Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Delirium
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 135
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with a medical condition known as obstructive sleep apnea may be at increased risk of delirium following surgery. This study loans autotitrating CPAP machines to randomly-selected patients who are at high-risk for obstructive sleep apnea with the goal of preventing post-operative delirium.

Detailed description: Patients undergoing elective knee and hip replacements will be prospectively enrolled. These surgical procedures all have an expected length of stay \> 3 days. Immediately following enrollment, patients will be randomized to receive CPAP or routine peri-operative care. Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.

Eligibility criteria: Inclusion Criteria:

* Age 50 and above
* Scheduled for an elective knee or hip replacement
* Ability to speak English and give informed consent
* At risk for obstructive sleep apnea as defined by a STOP-BANG score \> 2

Exclusion Criteria:

* History of psychiatric or neurologic illness that would confound delirium assessment
* Severe tracheal or lung disease
* Contraindications to face-mask CPAP
* Treated OSA

Primary outcomes:
measure: Presence of Postoperative Delirium
timeFrame: Postoperative day 2
measure: Presence of Postoperative Delirium
timeFrame: Postoperative day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Department of Psychiatry, Duke University Medical Center
name: Andrew Krystal, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans JL, Nadler JW, Preud'homme XA, Fang E, Daughtry RL, Chapman JB, Attarian D, Wellman S, Krystal AD. Pilot prospective study of post-surgery sleep and EEG predictors of post-operative delirium. Clin Neurophysiol. 2017 Aug;128(8):1421-1425. doi: 10.1016/j.clinph.2017.05.004. Epub 2017 May 17.
Clinical trial NCT04758585: Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder
Official title: Non-adherence to Pain Medication Increases Risk of Postoperative Frozen Shoulder: A Case Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Depression
Lead sponsor: Kantonsspital Baden
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Postoperative Frozen-Shoulder (FS) or adhesive capsulitis is a relatively frequent complication (5-20%), even after simple arthroscopic shoulder surgeries. The pathophysiology is still unclear, but psychological factors may play a pivotal role. From clinical experience, the investigators hypothesized that participants, who are reluctant to take medications, particularly "pain-killers", have an increased incidence of postoperative FS. The investigators retrospectively compared participants with and without postoperative FS by their attitude towards medication and by depression scale questionnaires.


Eligibility criteria: Inclusion Criteria:

* Shoulder arthroscopy

Exclusion Criteria:

* Active frozen shoulder

Primary outcomes:
measure: Self-developed questionnaire
timeFrame: 1 to 4 years postoperatively
measure: PHQ 4 (Patient Health Questionnaire-4)
timeFrame: 1 to 4 years postoperatively
measure: SMS (Self-Medicating Scale)
timeFrame: 1 to 4 years postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Baden
country: Switzerland
facility: Kantonsspital Baden
state: AG
Study officials:
References:
Clinical trial NCT00543985: Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)
Official title: Exercise in Patients With Metabolic Syndrome and Weight Regain - Echocardiography Substudy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Obesity
Keywords: metabolic syndrome
obesity
exercise
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2007-10-15
Enrollment: 36
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
Primary purpose: DIAGNOSTIC

Brief summary: We plan to test the hypothesis that patients with metabolic syndrome will have impaired left ventricular diastolic parameters. These parameters will be measured before and after a stress test at the end of a 3 month period of exercise training and a 10% weight loss.

Detailed description: Patients must have 2 of the 5 criteria for metabolic syndrome and be able to exercise in a monitored setting for 45 min 5 times a week.

Eligibility criteria: Inclusion Criteria:

* 2 of 5 criteria for metabolic syndrome
* Ability to exercise for 45 min 5 days a week

Exclusion Criteria:

* No diabetes
* Established coronary disease

Primary outcomes:
measure: Mean Resting E/E'
timeFrame: 12 weeks
measure: Post-exercise E/E'
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean Resting Maximal Oxygen Uptake (VO2 Max)
timeFrame: 12 weeks
measure: Change in Maximal Oxygen Uptake (VO2 Max)
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri-Columbia
name: Tom R Thomas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri-Columbia
name: Kevin C Dellsperger, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Missouri-Columbia
name: Anand Chockalingam, MD
role: STUDY_DIRECTOR
References:
citation: Chockalingam A, Linden MA, Dellsperger KC, Thomas TR. Correlation of Normal Diastolic Cardiac Function With VO in the Metabolic Syndrome. Prev Cardiol. 2009 Summer;12(3):163-8. doi: 10.1111/j.1751-7141.2009.00027.x.
Clinical trial NCT05194085: Impact of Male Provider Phone Calls to Increase Men's Clinic Linkage After HIVST
Official title: Kingasa Study: Interventions for Improved Post-partum ART Continuation and HIV Testing of Male Partners of Women in PMTCT B+ in Uganda
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Linkage to Care
PMTCT
PrEP
ART Adherence
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-01-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Evaluate the impact of phone calls from a male counselor in increasing linkage to HIV care and PrEP among male partners of pregnant women attending PMTCT.

Detailed description: Evaluate the impact of phone calls from a male counselor in increasing linkage to HIV care and PrEP among male partners of pregnant women attending PMTCT. Approach: Leveraging the staff and infrastructure of an ongoing study, Kingasa (R01MH113434), this study will evaluate the impact of phone calls from a male counselor to encourage male partners to link to HIV care or prevention services after HIV testing. The intervention will provide male counselor follow-up to 100 male partners of pregnant women in the intervention arm of the Kingasa study. Exit interviews will be conducted with men and their female partners to assess acceptability and challenges associated with the intervention. Outcomes assessed include ART initiation among HIV-positive men and PrEP by HIV-negative men at 6 months.

Hypothesis: The intervention of a phone call from a male counselor to provide counseling and encourage linkage to HIV care or prevention will be feasible and acceptable. It will result in a higher proportion of men linking to treatment and prevention compared to the standard of care arm of the Kingasa pilot study.

Eligibility criteria: Inclusion Criteria for women:

Age ≥18 or 14-17 years if an emancipated minor (pregnant or have a child), Currently pregnant, Not currently enrolled in an HIV treatment study, Male partner not known to be HIV-positive or has not tested in the past 3 months, Able and willing to provide written informed consent, Able and willing to provide adequate locator information for study retention purposes, Screening negative for any indication of intimate partner violence or social harm

Inclusion Criteria for men:

Female partner enrolled in Kingasa pilot study.

Primary outcomes:
measure: Male partner linkage
timeFrame: 6 months from female partner enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Infectious Disease Institute
Study officials:
affiliation: University of Washington
name: Monisha Sharma, PhD, ScM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06241885: Anxiety, Pain, and Satisfaction Related to First Vaginal Examination in Women
Official title: The Effect of Gynaecological Drape and Specially Developed Gynaecological Shorts on Anxiety, Pain, and Satisfaction Related to First Vaginal Examination in Women: a Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Pain
Satisfaction
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Effect of Gynaecological Drape and Specially Developed Gynaecological Shorts on Anxiety, Pain and Satisfaction Related to First Vaginal Examination in Women: A Randomised Controlled Study

Detailed description: Many women feel anxiety and pain about gynecological examination. The aim of the study was to investigate the effect of gynaecological drape and specially developed gynaecological shorts used for the first time in vaginal examination on anxiety, pain and satisfaction related to examination.

Eligibility criteria: Inclusion Criteria:

* Literate,
* 18 years of age or older,
* Can speak and understand Turkish,
* You are a woman who is having a vaginal examination for the first time
* Women who volunteered to participate in the study

Exclusion Criteria:

* Physical or mental illness that prevents them from communicating,
* Vaginal examination by a health professional other than the designated gynaecologist,
* Those who answered the research questions incompletely and
* Women who want to withdraw from the study

Primary outcomes:
measure: Anxiety
timeFrame: 10 minutes before and 10 minutes after vaginal examination
measure: Pain level
timeFrame: 10 minutes before and 10 minutes after vaginal examination
measure: Satisfaction level
timeFrame: 10 minutes after vaginal examination
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcu Imam University
Study officials:
References:
Clinical trial NCT06724185: Effects of LP28 on Immunity Enhancement in the Elderly
Official title: Effects of LP28 on Immunity Enhancement in the Elderly
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Common Cold
Immunity
Probiotic
Lead sponsor: Synbio Tech Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Due to the increasing attention on aging-related health issues, this study focuses on the elderly population as participants. The aim is to investigate whether supplementation with Lactobacillus plantarum LP28 can effectively enhance immunity, reduce the frequency and severity of common cold infections, and ultimately promote overall health in the elderly.


Eligibility criteria: Inclusion Criteria:

* Those who had symptoms of common cold or tonsillitis at least twice in the past year.

Exclusion Criteria:

* People who have liver, kidney, immune, or neoplastic diseases diagnosed by doctor.
* People with mental illnesses such as schizophrenia or depression.
* People who have allergic rhinitis.
* People who have a current condition of drug or alcohol dependence.
* Any person is deemed inappropriate by the researcher for the clinical trial.

Primary outcomes:
measure: WURSS-24
timeFrame: From enrollment to the end of treatment at 12 weeks (measure daily)
Secondary outcomes:
measure: Immune cell ratio
timeFrame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
measure: NK cell activity
timeFrame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
measure: Cytokines measurement
timeFrame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
measure: sIgA
timeFrame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
measure: α-amylase
timeFrame: From enrollment to the end of treatment at 12 weeks (measure every 6 weeks)
measure: GSRS questionnaire
timeFrame: From enrollment to the end of treatment at 12 weeks (measure weekly)
measure: Defecation frequency and stool pattern
timeFrame: From enrollment to the end of treatment at 12 weeks (measure weekly)
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Chung Hsing University
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References: