louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04577625: Effect of Probiotics on Testosterone in Men
Official title: A Double-blind Randomized Clinical Study Investigating Lactobacillus Reuteri Supplementations Influence on Testosterone Levels in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: BioGaia AB
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 60
Sex: MALE
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the effect of L. reuteri ATCC PTA 6475 supplementation on testosterone in men.

Detailed description: The probiotic Lactobacillus reuteri ATCC PTA 6475 has been shown to modulate testosterone levels in mice. It is not known if these effects are seen in humans and this trial is intended to study this.

The aim of this study is to investigate if L. reuteri ATCC PTA 6475 will effect blood testosterone levels in in healthy male subjects 50-65 years of age.

Eligibility criteria: Inclusion Criteria:

* Willing and able to give signed informed consent for participation in the study.
* Healthy males aged between 50-65 with no known underlying medical conditions
* Subjects who are capable of taking themselves to testing centre at 3 separate timepoints (Baseline, week 6 and week 12).
* Subjects who are available to give fasting blood samples before 10am on day of blood sample collection
* No history of androgen or testosterone supplementation within 6 months prior to study start.
* Subjects who have not been taking antibiotics or probiotic supplements 4 weeks prior to study start 8. Able and willing to comply with the restirictions defined for the study period
* Ability to understand and comply with the requirements of the study, as judged by the investigator physician

Exclusion Criteria:

* Subjects who presently have or have had cardiovascular issues in the past 2 years.
* Subjects who have a Body Mass Index of \< 18 or \> 30
* Known elevated Prostate Specific Antigen levels.
* History of prostate or testicular cancer.
* Nicotine abuse
* Alcohol abuse

Primary outcomes:
measure: Concentration of total testosterone
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Free testosterone index
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Percentage of hematokrit
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Number of adverse events
timeFrame: Continously 12 weeks
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Department of Health & Society, Malmö University
state: Skåne
Study officials:
References:
Clinical trial NCT03184025: Effect of Surface Sealant Application on Clinical Performance Occlusal Restorations
Official title: Effect of Surface Sealant Application on Clinical Performance of HEMA Containing and HEMA-free Self-Etch Adhesives
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Class I Dental Caries
Dental Composite
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim was to evaluate the clinical performance of HEMA-containing and HEMA-free all-in-one self-etch adhesives with and without a surface sealing process with a nanohybrid composite in occlusal caries restorations. The hypothesis is that the HEMA-containing and HEMA-free all-in-one self-etch adhesive and the surface sealing process would significantly effect clinical performance of occlusal restorations.


Eligibility criteria: Inclusion Criteria:

* patients who received four direct Class I composite restorations, those with good oral hygiene with no active periodontal or pulpal diseases, whose permanent first or second molar required restorations for occlusal carious lesions with neighboring teeth and were in occlusion with antagonist teeth, and were willing to return for follow-up examinations as outlined by the investigators.

Exclusion Criteria:

* patients with uncontrolled parafunction, those presenting with poor oral hygiene and disinterested in or refused oral hygiene instructions, molars and premolars with carious lesions on a surface other than the occlusal surface and in continuity with the occlusal cavity, pulp exposure during caries removal procedure or cavities with the risk of pulp exposure, having spontaneous pain or sensitivity to percussion, and patients with periodontal or gingival disease.

Primary outcomes:
measure: Number of failed restorations evaluated according to the modified USPSH criteria in patients with occlusal restorations.
timeFrame: an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02335125: A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot
Official title: A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Depression
Alcohol-Related Disorders
Suicidal Ideation
Substance-Related Disorders
Mild Cognitive Impairment
Quality of Life
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Mental Health (NIMH)
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2015-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this pilot study is to develop and implement a larger scale, multi-site stepped collaborative care trial that targets injured patients with presentations of posttraumatic stress disorder (PTSD) and related comorbidities.


Eligibility criteria: Inclusion Criteria:

* Inpatient/Emergency Admission for traumatic injury

Exclusion Criteria:

* Non-English speaking
* Self-inflicted injury
* Actively psychotic
* Incarcerated or in custody

Primary outcomes:
measure: Change From Baseline PTSD Checklist Civilian (PCL-C) at 1 Month
timeFrame: Baseline and 1-month
measure: Change From Baseline Alcohol Use Disorders Identification at 1 Month
timeFrame: Baseline and 1-month
measure: Change From Patient Health Questionnaire 9 Item Depression Scale at 1 Month
timeFrame: Baseline and 1-month
Secondary outcomes:
measure: Change in Functional Status
timeFrame: Baseline and 1-month
measure: Patient Health Questionnaire Item 9 Suicide Question
timeFrame: Baseline and 1-month
measure: Number of Participants Endorsing a Single Item That Assesses Drug Use
timeFrame: Baseline and 1-month
measure: Cognitive Impairment Scale
timeFrame: Baseline and 1-month
Other outcomes:
measure: Chronic Medical Condition ICD-9 Definition
timeFrame: Baseline
measure: Traumatic Brain Injury Status ICD-9 Definition
timeFrame: Baseline
Locations:
Study officials:
affiliation: University of Washington
name: Douglas Zatzick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06762925: Study on the Efficacy and Mechanism of METTL3 Peptide Inhibitors in Enhancing Anti-tumor Immune Response by Reshaping the Tumor Microenvironment
Official title: Study on the Efficacy and Mechanism of METTL3 Peptide Inhibitors in Enhancing Anti-tumor Immune Response by Reshaping the Tumor Microenvironment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bladder Cancer
Prostate Cancer
Kidney Cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with urological tumors

Brief summary: This study aims to validate the accuracy and clinical value of METTL3 as a biomarker for predicting immune therapy response in patients with urinary tract tumors through observational studies.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with urinary system tumors through pathological examination;
2. Meet specific clinical stages and surgical treatment standards;
3. Intraoperative tissue resection meets the sample testing standards;
4. The patient is willing to participate in the study and sign an informed consent form.

Exclusion Criteria:

1. Not meeting the specific clinical stage and not receiving surgical treatment;
2. Abnormal mental behavior;
3. Intellectual disability;
4. Age under 18 years old or over 75 years old;
5. Low understanding and communication skills.

Primary outcomes:
measure: The expression levels of METTL3 and ANGPTL2
timeFrame: About a year and a half
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01288625: Prospective Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
Official title: Prospective, Open-label, Randomized, Control Study of Head and Neck Cancer Radiation Treatment With or Without Amifostine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Oral Mucositis
Stomatitis
Keywords: Identify whether Cytofos can reduce the incidence and duration of HNC patients' oral mucositis caused by radiotherapy.
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 compare the incidence of stomatitis when treating with amifostine before radiation treatment.


Eligibility criteria: Inclusion Criteria:

1. 18-70 years old, male or female
2. Primary treatment of phase I-IVA head and neck cancer patients, identified by histological and pathological diagnosis
3. Postoperative patients should receive radiation treatment in 12 weeks
4. ECOG \<2
5. Expected lifetime ≥6months
6. No severe complications (hypertension, CHD, diabetes and psychiatric history, etc.)
7. Not involved in other clinical trials
8. Sign ICF

Exclusion Criteria:

1. ECOG \>2
2. Suffered other cancers in the past 5 years
3. Received amifostine treatment in the past 4 weeks
4. Unable to complete treatment or sign ICF because of medical or physical reasons

Primary outcomes:
measure: Incidence and duration of oral mucositis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Wang ge
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05471622: Study of Home-Embedded Palliative Care for Hemodialysis-Dependent End-Stage Renal Disease
Official title: Study of Home-Embedded Palliative Care for Hemodialysis-Dependent End-Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Keywords: palliative
ESRD
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Home palliative care needs are often under-recognized in patients with End-Stage Renal Disease (ESRD). This pilot study is designed to evaluate the feasibility and acceptability of an initiative to enhance referrals to Penn Home Palliative Care compared with usual care among hemodialysis-dependent ESRD patients admitted to a Penn hospital. Results will inform a future pragmatic trial comparing the effectiveness of home palliative care compared with usual care among ESRD patients. Evaluating the effectiveness of home palliative care services is critical to determine whether increasing access to these services would improve patient-centered outcomes for these high-need patients.


Eligibility criteria: Inclusion Criteria:

* Be an adult (18 years of age or older) hospitalized at one of two study hospitals
* Digital signature of ESRD (N18.6) within the last 12 months with an inpatient hemodialysis order
* Patient resides in the five-county area surrounding Philadelphia which is served by the Penn Home Palliative Care services.
* Appropriate for home palliative care, defined as:

  (i) Existing home care eligibility/referral for home care OR (ii) Severe protein malnutrition (E43, E44) OR (iii) Non-ambulatory status determined by a flowsheet completed by nursing on hospital admission with three ambulatory options: (1) non-ambulatory, (2) ambulates with assistance, or (3) ambulates independently. If this information is missing from the electronic health record, the determination will be made using one of the three following options: (1) overall prior home mobility assessment "complete dependence on all aspects," or (2) ambulation or functional transfers domains indicate "dependent," or (3) wheelchair mobility domain was completed (with any non-null/non-empty value).

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of Home Palliative Care Receipt
timeFrame: Baseline - 45 days
Secondary outcomes:
measure: Follow-up Home Palliative Care Visits
timeFrame: Baseline - 180 days
measure: Mortality
timeFrame: Baseline - 180 days
measure: Hospital-free days
timeFrame: Baseline - 180 days
measure: Acceptability of home palliative care referral among clinician stakeholders
timeFrame: Baseline - 180 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02121522: A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration
Official title: A Single Arm Open Label Study to Evaluate the Pharmacodynamics and Safety of a 4 wk Treatment With BI 144807 in Patients With Newly Diagnosed Wet Age Related Macular Degeneration (wAMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Wet Macular Degeneration
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-04-23
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present trial will use an open label design to investigate the effect of BI 144807 on central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD patients. A further objective is to collect data on adverse events, vital signs, ECG and clinical laboratory parameters of BI 144807 in the same patient group.


Eligibility criteria: Inclusion criteria:

Newly diagnosed men and women with unilateral subfoveal choroideal neovascularization secondary to age-related macular degeneration

Exclusion criteria:

Additional eye disease that could compromizse best corrected visual acuity, such as uncontrolled glaucoma

Primary outcomes:
measure: Change From Baseline in CRT as Measured by SD-OCT on Day 29
timeFrame: Baseline (day 1) and day 29
Secondary outcomes:
measure: Change From Baseline in Neovascular Leakage Area as Assessed by FA on Day 29
timeFrame: Baseline and day 29
Other outcomes:
Locations:
city: Wien
country: Austria
facility: 1313.20.43001 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 1313.20.49004 Boehringer Ingelheim Investigational Site
city: Leipzig
country: Germany
facility: 1313.20.49002 Boehringer Ingelheim Investigational Site
city: Lübeck
country: Germany
facility: 1313.20.49001 Boehringer Ingelheim Investigational Site
city: Münster
country: Germany
facility: 1313.20.49005 Boehringer Ingelheim Investigational Site
city: Tübingen
country: Germany
facility: 1313.20.49003 Boehringer Ingelheim Investigational Site
city: Ulm
country: Germany
facility: 1313.20.49006 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1313.20.36002 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1313.20.36003 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1313.20.36001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01496222: The Montreal Cognitive Assessment as a Screening Tool for Preoperative Mild Cognitive Impairment in Geriatric Patients
Official title: The Montreal Cognitive Assessment as a Screening Tool for Preoperative Mild Cognitive
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mild Cognitive Impairment
Keywords: mild cognitive impairment
Montreal Cognitive Assessment test
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 582
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study enrolls 582 consecutive geriatric patients,322 general and vascular patients (male 190, female 132) and 260 urological patients (male 220, female 40) who undergoing general and/or regional anesthesia.

Brief summary: This is a prospective, double-blinded, control trial. The Montreal Cognitive Assessment is used to screen preoperative mild cognitive impairment in 582 consecutive geriatric patients, scheduled for general, vascular or urological surgery under general and/or regional anesthesia.

Detailed description: At the preoperative visit, the co-researcher invites 322 general and vascular patients (male 190, female 132) and 260 urological patients (male 220, female 40) who meet the inclusion criteria to join the study. The process of the project is explained to the interested patients in details before an informed consent is obtained.

All participants are interviewed by using the Montreal Cognitive Assessment test. The history of drug used preoperatively (medication reconciliation) has also been recorded.

Eligibility criteria: Inclusion Criteria:

* male or female aged 65 yr, ASA I-III scheduled for elective general, vascular or urological surgery under general and/or regional anesthesia.

Exclusion Criteria:

* unable to communicate in reading and writing
* psychosomatic patients
* insulin-dependant diabetes
* renal insufficiency (creatinine \>1.5 mg/dL), renal dialysis
* uncontrolled congestive heart failure (American Heart Association Classification III or IV congestive heart failure), unstable angina, untreated cardiac arrhythmia
* active gastrointestinal bleeding.

Primary outcomes:
measure: Incidence of mild cognitive impairment in preoperative geriatric patients
timeFrame: 1 Year
Secondary outcomes:
measure: Relationship between mild cognitive impairment and drug used preoperatively in geriatric patients
timeFrame: 1 year
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Phongthara Vichitvejpaisal, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05398822: The Role of TextRAd on Detection of Liver Metastasis in Rectal Cancer
Official title: The Role of TextRAd on Detection of Liver Metastasis in Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: East Suffolk and North Essex NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with locally advanced rectal cancer (LARC) includes neoadjuvant chemoradiotherapy (NCRT) followed by surgical resection

Brief summary: This is a retrospective analysis of all patients diagnosed with LARC who received NCRT and had MRI scans between 2003-2014 at East Suffolk and North Essex NHS Foundation Trust. Region of interest was drawn around the tumor or its location on T2 MRI images. Six texture parameters were systematically extracted from Textural histograms of post-treatment scans. These parameters were examined to determine their ability to predict local recurrence and distant metastases through Kaplan-Meier survival curves and log-rank tests.


Eligibility criteria: Inclusion Criteria:

* All subjects must have MRI post-Chemotherapy treatment to detect the response to Neoadjuvant treatment and compare it to pre-treatment scans to easily determine if there were a posttreatment liver metastasis.
* Locally advanced rectal cancer (LARC) = MRI stage: T3/T4 and/or N1/N0.

Exclusion Criteria:

* Distant metastases.
* Synchronous tumour.

Primary outcomes:
measure: Local recurrence of rectal cancer
timeFrame: 120 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ipswich
country: United Kingdom
facility: East Suffolk and North Essex NHS Foundation Trust
Study officials:
References:
Clinical trial NCT06701422: Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery
Official title: Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Spinal Cord Injury
Tetraplegia/Tetraparesis
Cervical Myelopathy
Keywords: spinal cord injury
upper-limb muscle activation
cervical spinal cord
myelopathy
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed study seeks to understand how the cervical spinal cord should be stimulated after injury through short-term physiology experiments that will inform a preclinical efficacy trial. The purpose of this study is to determine which cervical levels epidural electrical stimulation (EES) should target to recruit arm and hand muscles effectively and selectively in spinal cord injury (SCI).

Detailed description: For people with cervical spinal cord injury (SCI), regaining hand and arm function is their highest priority. Epidural stimulation enables recovery of walking and autonomic function in people with chronic SCI, but how the spinal cord should be stimulated to restore arm and hand function is not known. This project seeks to advance our understanding of how best to apply epidural electrical stimulation (EES) after cervical SCI using complementary experiments in humans and rats. This improved understanding will be used to conduct a preclinical study of the efficacy of different sites of cervical spinal cord stimulation.

Eligibility criteria: Inclusion Criteria:

•Clinical indication for cervical spine surgery.

Exclusion criteria:

•Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)

Primary outcomes:
measure: Efficacy of epidural SCS
timeFrame: 0-100 milliseconds after each stimulation event during the experiment
measure: Selectivity of epidural SCS
timeFrame: 0-100 milliseconds after each stimulation event during the experiment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/Allen
state: New York
Study officials:
References: