louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05200234: Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS)
Official title: Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Blood Flow
Cognitive Function
Keywords: Intracranial / Carotid Stenosis
Cerebral Blood Flow
Cognitive Function
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial will be conducted. Patients with asymptomatic intracranial / carotid stenosis will be randomized into two arms (1:1): an intervention arm and a control arm. Patients in the intervention arm will be treated with standard medical treatment combined with Natto Products V, whereas Patient in the control arm will be treated with only standard medical treatment . And the impact of Natto Products V on improving cerebral blood flow and cognitive function in patients with asymptomatic intracranial / carotid stenosis will be assessed by neuropsychological scale and multimode magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 40 years
* ≥ 50% stenosis in unilateral intracranial / carotid artery
* Written informed consent available

Exclusion Criteria:

* Previous history of major head trauma and any intracranial surgery
* Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
* Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
* severe loss of vision, hearing, or communicative ability
* plan to be treated with surgery

Primary outcomes:
measure: Changes in the scores of Montreal Cognitive Assessment
timeFrame: 6 months
Secondary outcomes:
measure: Changes in the scores of Mini-mental State Examination
timeFrame: 6 months
measure: Changes in cerebral blood flow in the territory of the culprit artery
timeFrame: 6 months
measure: Changes in the scores of Colour Trail Test
timeFrame: 6 months
measure: Changes in the scores of Hopkins Verbal Learning Test
timeFrame: 6 months
measure: Changes in the scores of clock drawing test
timeFrame: 6 months
measure: Changes in the scores of Animal Fluency Test
timeFrame: 6 months
measure: Changes in the scores of Olfactory stick test
timeFrame: 6 months
measure: Incidence of stroke event including ischemic and hemorrhagic stroke
timeFrame: 6 months
measure: Changes in cerebral glymphatic function
timeFrame: 6 months
measure: Changes in metabonomics
timeFrame: 6 months
Other outcomes:
Locations:
city: HangZhou
country: China
facility: Second Affilated Hospital of Zhejiang University, School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT00829634: Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Congestion
Keywords: methamphetamine
inpatient
d-MA
l-MA
APRL
San Francisco
metabolism
Metabolism of methamphetamine
Lead sponsor: California Pacific Medical Center Research Institute
Sponsor class: OTHER
Collaborators: name: San Francisco General Hospital
name: University of California, San Francisco
name: National Institutes of Health (NIH)
First posted: 2009-01-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.

Detailed description: Subjects will screen at St. Luke's Hospital in San Francisco to determine their eligibility.

Once enrolled the study will take two weeks. During the first week subjects attend daily, hour-long outpatient visits at San Francisco General Hospital. At these visits subjects will receive an oral dose of l-methamphetamine, have their vitals read, answer questionnaires and receive a blood draw.

During the second week of the study subjects are admitted to San Francisco General Hospital for a week long inpatient stay. During this stay the subject continues to receive l-methamphetamine but also receives three doses of d-methamphetamine on three separate days. In addition the subject receives blood draws, has their urine collected, and answers questionnaires.

Eligibility criteria: Inclusion Criteria:

* Healthy Males and Females Between the Ages of 18 and 50
* Must have some experience with methamphetamine

Primary outcomes:
measure: Serum samples
timeFrame: Predose and Multiple Timepoints Post Doses
measure: Urine Samples
timeFrame: 24 Hour Inpatient Collection
Secondary outcomes:
measure: Questionnaries
timeFrame: Predose and Multiple Timepoints Post Doses
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: CPMC Addiction & Pharmacology Research Laboratory (APRL)
state: California
Study officials:
References:
Clinical trial NCT00140634: The Objectives of the Cartilage Repair Registry is to Report Long Term Efficacy and Safety of Cartilage Repair Procedures in Registry Patients
Official title: Cartilage Repair Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Articular Cartilage
Cartilage Diseases
Lead sponsor: Vericel Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 2233
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Registry of patients with diagnosis of chondral injury.

Brief summary: The objectives of the Cartilage Repair Registry is to report the long term efficacy and safety of cartilage repair procedures in Registry patients.


Eligibility criteria: Inclusion Criteria:

* All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort

Exclusion Criteria:

* All registry patients meeting the cohort definition at the pre-operative visit will be included on the overall summary tables for the patient cohort

Primary outcomes:
measure: Physician assessment of effectiveness of autologous chondrocyte implantation
timeFrame: 6 month post implantation
measure: Physician assessment of effectiveness of autologous chondrocyte implantation
timeFrame: 12 month post implantation
measure: Physician assessment of effectiveness of autologous chondrocyte implantation
timeFrame: 24 month post implantation
Secondary outcomes:
measure: Patient assessment of effectiveness of autologous chondrocyte implantation
timeFrame: 6 month post implantation
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Registry contains data from patients whom were implanted by 1123 surgeons in the U.S. and also data captured on patients treated by 154 surgeons in 15 other countries.
state: Massachusetts
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06961734: Fatmax Exercise in Menstrual Phases: Effects on Fat Metabolism & Body Composition in NWO Women
Official title: Effects of a Fatmax Exercise Intervention During Different Menstrual Cycle Phases on Fat Metabolism and Body Composition in Normal Weight Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Metabolism
Keywords: aerobic exercise
menstrual cycle phase
normal weight obesity
lipid metabolism
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Effects of a Fatmax exercise intervention during different menstrual phases on fat metabolism and body composition in NWO women

Detailed description: This is a randomized clinical trial of single-blind with 3 arms (control group , follicular group and luteal group), in which a pre-treatment-posttest design has been used.

Eligibility criteria: Inclusion Criteria:

* Criteria: Inclusion Criteria:
* Female, aged between 18 and 30 years old;
* BMI between 18.5 and 24.9 kg/m2 with a BF% \> 30% (normal weight obesity determination criteria);
* Regular menstrual cycles for at least 3 months;
* No use of oral contraceptives for at least 6 months before the experiment;
* Non-smoker and non-alcohol abuser.

Exclusion Criteria:

* The presence of CVD;
* A diagnosis of cancer, pulmonary diseases, or other conditions that prevent participation in exercise;
* The use of medications affecting body composition or metabolism.

Primary outcomes:
measure: Lipid profile
timeFrame: 8 weeks
measure: Body Fat Mass
timeFrame: 8 weeks
measure: Percentage of Body Fat
timeFrame: 8 weeks
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 8 weeks
measure: Waist Circumference
timeFrame: 8 weeks
measure: Hip Circumference
timeFrame: 8 weeks
measure: Apolipoprotein A-I (g/L)
timeFrame: 8 weeks
measure: Apolipoprotein B (g/L)
timeFrame: 8 weeks
measure: Maximal Oxygen uptake (VO2max)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Sports Medicine and Rehabilitation, Beijing Sport University
Study officials:
References:
Clinical trial NCT01635634: Cupping in Fibromyalgia
Official title: Randomized Controlled Pilot Trial: The Effectiveness of Cupping in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Cupping
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2012-07-09
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled study is to determine the effectiveness of cupping in patients with fibromyalgia compared to sham cupping.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* FMS diagnosis according to AWMF Guidelines,
* necessary documents: medical records
* Pain intensity \> 45mm VAS
* Participation in cupping twice weekly on appointment

Exclusion Criteria:

* pregnancy
* other study participation
* pain due to other rheumatic disease
* major psychiatric disorder
* substance abuse
* severe somatic disorder (cancer)
* injections, acupuncture, neural therapy within the past 3 months

Primary outcomes:
measure: Pain Intensity
timeFrame: Day 18
Secondary outcomes:
measure: Pain Intensity
timeFrame: Day 200
measure: Fatigue
timeFrame: Day 18
measure: Fatigue
timeFrame: Day 200
measure: Sleep Quality
timeFrame: Day 18
measure: Sleep Quality
timeFrame: Day 200
measure: Quality of life
timeFrame: Day 18
measure: Quality of life
timeFrame: Day 200
measure: Medication
timeFrame: Day 18
measure: adverse events
timeFrame: Day 18
measure: Pressure pain sensitivity
timeFrame: Day 18
measure: Disability
timeFrame: Day 18
measure: Disability
timeFrame: Day 200
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Klinik für Naturheilkunde
Study officials:
affiliation: University of Duisburg-Essen
name: Jost Langhorst, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lauche R, Spitzer J, Schwahn B, Ostermann T, Bernardy K, Cramer H, Dobos G, Langhorst J. Efficacy of cupping therapy in patients with the fibromyalgia syndrome-a randomised placebo controlled trial. Sci Rep. 2016 Nov 17;6:37316. doi: 10.1038/srep37316.
Clinical trial NCT04071834: Observation of Blood Orphanin and Norepinephrine Levels in Diabetic Patients Under Subarachnoid Anesthesia
Official title: Effect of Subarachnoid Anesthesia on Blood Orphanin and Norepinephrine in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraspinal Anesthesia
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: This study aims to investigate the Influence of Intraspinal anesthesia to the concentrations of blood orphanin, norepinephrine in patients with diabetes mellitus. We hope to explain the relationship between sensory and sympathetic nerves in diabetic patients undergoing intraspinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing lower limb surgery under spinal anesthesia

Exclusion Criteria:

* Emergency surgery
* The operation time is more than 3 hours
* Combined general anesthesia or nerve block anesthesia

Primary outcomes:
measure: Blood orphanin concentration
timeFrame: 24 hours
measure: Blood norepinephrine concentration
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Second of Shanxi Medical University
state: Shanxi
Study officials:
References:
Clinical trial NCT03611634: Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine
Official title: Consitution Of A Biological Collection From Samples From The Gut Microbiote In Patients Having A Bone Or Joint Infection Treated By A Suppressive Subcutaneous Antibiotherapy With Betalactamine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone and Joint Infection
Keywords: gut microbiote, bone and joint infection, antibiotics
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine

Brief summary: Optimal surgical therapy (debridement in chronic osteomyelitis; device exchange in patients with chronic prosthetic joint infection \[PJI\]) could be sometimes non-feasible, especially in the elderly population. Therefore, a medical therapy with oral prolonged suppressive antibiotic therapy (PSAT) seems to be an option to prevent recurrence and prosthesis loosening. Unfortunately, some patients are infected with resistant pathogens for which oral antibiotics are not suitable. Subcutaneous (SC) administration of injectable intravenous antibiotics as PSAT could be a convenient way to limit catheter-related complications and facilitate ambulatory care.

However, there are few data concerning the development of resistance under subcutaneous prolonged treatment with betalactamine.

The aim of this study is is just to constitute a biological collection from samples from the GUT microbiote in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. Later analysis will be led on those samples to detect the acquisition of resistance or not.


Eligibility criteria: Inclusion Criteria:

* Patients having an ostéo-articular infection (on material or on native bone) and having an indication of antibiotic treatment suppressive subcutaneous by betalactamine and managed at the Croix-Rousse Hospital
* Patients not opposed to participate to the study

Exclusion Criteria:

* none

Primary outcomes:
measure: BIOLOGICAL COLLECTION FROM SAMPLES FROM THE GUT MICROBIOTE
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon - Hopital de la Croix Rousse
name: Tristan Ferry, Md,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04682834: Expanded Access Use of Sulopenem Etzadroxil/Probenecid for Complicated Urinary Tract Infection
Official title: Expanded Access for the Use of Sulopenem Etzadroxil/Probenecid for the Treatment of Patients With Complicated Urinary Tract Infection Due to Quinolone-nonsusceptible Uropathogens
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Complicated Urinary Tract Infection
Acute Pyelonephritis
Lead sponsor: Iterum Therapeutics, International Limited
Sponsor class: INDUSTRY
First posted: 2020-12-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Sulopenem etzadroxil/probenecid is available to clinicians through an Expanded Access Program for the treatment of complicated urinary tract infections due to quinolone nonsusceptible uropathogens after an initial course of effective intravenous therapy. The investigational product may be requested by sending an email to the Sponsor (EAProgram@iterumtx.com), as listed on the Reagan Udall EAP Navigator website (https://navigator.reaganudall.org/company-directory/i).

Detailed description: This Expanded Access Program will allow clinicians to use sulopenem etzadroxil/probenecid for the treatment of patients with serious or immediately life-threatening complicated urinary tract infection due to quinolone-nonsusceptible uropathogens where there are no satisfactory oral alternatives to use as step-down therapy after receiving an initial course of effective intravenous therapy. The recommended dose of sulopenem etzadroxil/probenecid 500 mg/ 500 mg is one bilayer tablet orally twice daily, taken with food whenever possible. No dose adjustment is required for patients with renal impairment. Duration of therapy will be at the discretion of the prescribing clinician, depending on the type of infection being treated and the response to therapy, and is expected to be less than ten days total.

Eligibility criteria: Inclusion Criteria:

1. Adults ≥18 years of age with complicated urinary tract infection due to a quinolone-nonsusceptible uropathogen
2. Patient or the patient's legally acceptable representative able to provide a signed written informed consent prior to any study-specific procedures.
3. Clinically documented pyelonephritis or complicated urinary tract infection for which at least one dose of effective intravenous antibiotics has been received.

Exclusion Criteria:

1. Patients who require concomitant administration of valproic acid
2. Patients with known hypersensitivity to any component of this product or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactam antibacterial drugs or probenecid.
3. Patients with known uric acid kidney stones
4. Patients requiring concomitant use of ketorolac tromethamine or ketoprofen

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04275934: Blood Pressure First Medication Therapy Management
Official title: Evaluation of the Impact of Self-insured Employer Implementation of an Innovative Care Model Utilizing Pharmacist-delivered MTM Services for Health Plan Beneficiaries With High Blood Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Blood Pressure
Cardiovascular Diseases
Lead sponsor: American Pharmacists Association Foundation
Sponsor class: OTHER
First posted: 2020-02-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Beneficiaries of self-insured employer who may benefit from patient-centered, team-based care that supports blood pressure control.

Brief summary: The primary objective of this project is to improve the health status of participants through pharmacist-delivered blood pressure control programs that demonstrate value to employers and justify adoption, sustainability and scalability of these programs.

Detailed description: Univariate comparisons of the baseline/pre-intervention outcomes to the post-intervention outcomes will be performed on outcomes in order to determine how the intervention affects each. For continuous outcomes data the univariate comparisons of the pre-treatment and post-intervention outcomes will be performed using related samples t-test comparisons. For categorical outcomes data, comparisons of pre-intervention to post-intervention time frames will be performed using McNemar tests.

Eligibility criteria: Inclusion Criteria:

* All health plan beneficiaries 18 years-of-age and older
* Have filled at least one blood pressure medication in the last three months,
* Have a known hypertension diagnosis or have an uncontrolled blood pressure

Exclusion Criteria:

* Not an adult
* Not a health plan beneficiary of the self-insured employer
* Not ambulatory and able to work or participate in care visits

Primary outcomes:
measure: Blood Pressure Control
timeFrame: 6-months
measure: Blood Pressure Change
timeFrame: 6-months
Secondary outcomes:
measure: Blood Pressure Medication Adherence
timeFrame: 6-months
measure: Health Care Utilization of Primary Care Services
timeFrame: 6-months
measure: Health Care Utilization of Emergency Department Services
timeFrame: 6-months
measure: Health Care Utilization of Hospital Services
timeFrame: 6-months
Other outcomes:
Locations:
city: Woodstock
country: United States
facility: Woodstock Pharmaceutical & Compounding Center Inc.
state: Georgia
Study officials:
affiliation: APhA Foundation
name: Benjamin M Bluml, RPh
role: PRINCIPAL_INVESTIGATOR
References: