louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04645784: Long-term Effect of Online Mental Health Literacy Training
Official title: Investigating the Long-term Effect of Online Mental Health Literacy Training in Intercollegiate Sport
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mental Health Literacy
Waitlist
Lead sponsor: Brock University
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess the effectiveness over time of an online mental health in sport module in improving mental health literacy, stigma, and help-seeking behaviors in a sample of Brock student-athletes. Student-athletes will be assigned to one of two conditions, mental health module or the waitlist condition. The mental health module will consist of completing the Supporting Student-Athletes Mental Wellness" online module for the student-athlete by the National Collegiate Athletics Association (NCAA). Participants will complete surveys at pre-intervention, post-intervention, 3-months and 6-month time points.


Eligibility criteria: Inclusion Criteria:

* student-athletes

Exclusion Criteria:

* non student-athletes

Primary outcomes:
measure: Change in Multicomponent Mental Health Literacy Measure
timeFrame: 72 hours pre-intervention, 72 hours post-intervention, 3-months post, 6-months post
measure: Change in Self-Stigma
timeFrame: 72 hours pre-intervention, 72 hours post-intervention, 3-months post, 6-months post
measure: Change in Help seeking intentions
timeFrame: 72 hours pre-intervention, 72 hours post-intervention, 3-months post, 6-months post
Secondary outcomes:
Other outcomes:
Locations:
city: St. Catharines
country: Canada
facility: Brock University
state: Ontario
Study officials:
affiliation: Brock University
name: Philip Sullivan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06291584: Effects of Exercises on Functional Capacity
Official title: Effects of Strengthening and Respiratory Exercises on Face and Online on Functional Capacity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nicotine Addiction
Respiratory Disease
Sedentary Behavior
Keywords: nicotine addiction
respiratory exercise
telehealth
resistance exercise
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consists of three groups. Groups to be formed: Group 1: face-to-face exercise group; Group 2: Online (Telehealth) Exercise Group; Group 3: Control Group
Primary purpose: TREATMENT

Brief summary: In this study, the researchers aim to investigate the effects of strengthening and respiratory exercises on the face and online on functional capacity.

Detailed description: The American Sports Medical Association has reported that a regular exercise program containing endurarans, strength, flexibility, and neuromotor exercise training is required in addition to daily life activities in order to maintain and develop general health. In addition to the increase in muscle strength with resistant exercises, durability and strength are also targeted. When performing resistant exercise, it is important to breathe correctly. The speed of the exercise and the movements are performed throughout the furnishing openness of the joint movement. The effects of exercise on being healthy and good are mentioned in the literature in detail. However, the effects of exercise on the respiratory functions and functional capacity of young people who smoke are not adequately defined. For this reason, the researchers plan to research the effects of strengthening and respiratory exercises on the face and online on functional capacity.

Eligibility criteria: Inclusion Criteria:

Signing the illuminated consent form, Being smoking at least 1 cigarette for the last 6 months, Not having orthopedic or neurological findings that can prevent the exercises included in the study, To have a low- to medium-level physical activity level, Not to have any lower respiratory infection in the last 3 months.

Exclusion Criteria:

The exercise sessions to be held on time and regularly.

Primary outcomes:
measure: International Physical Activity Questionnaire - Short Form
timeFrame: Evaluation should be carried out before the start of exercise proggramme and 8 weeks after.
measure: Six-Minute Walk Test- (6MWT)
timeFrame: Evaluation should be carried out before the start of exercise proggramme and 8 weeks after.
Secondary outcomes:
Other outcomes:
Locations:
city: Kırklareli
country: Turkey
facility: Kirklareli University
state: Kayalı
Study officials:
affiliation: Kırklareli University
name: Burcu ÖZÜBERK, Assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00953784: Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
Official title: Minimization of Surgical Site Infections for Pts Undergoing Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Infections
Colorectal Surgery
Keywords: surgery
wound infections
colorectal
Lead sponsor: Dallas VA Medical Center
Sponsor class: FED
First posted: 2009-08-06
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a comparison, at this VA Hospital, of standard operating room management in colorectal surgery to a more rigid management using an additional five previously tested treatments to determine if this changes the rate of post operative wound infections.

Detailed description: A comparison between standard operating room:

1. use of pre-op bowel prep (Golytely or Phosphosoda,plus 3 doses of oral antibiotics(Erythromycin and Neomycin), and fleets enema the day before surgery
2. Standard anesthesia FiO2 (approx. 30-50%)during surgery
3. Standard IV fluids during surgery(greater than 200cc per hour)
4. Standard post-op O2 by mask for 2 hours

To extended operating room procedures of:

1. No po antibiotics or pre-op bowel prep other than enema prior to surgery
2. Skin warming at least 15 minutes prior to and during surgery(core temp 36C+)
3. IOBAN drapes and Plastic wound protectors used during surgery
4. Restricted IV fluids less than 200cc per hour during surgery
5. Increased FiO2 to 80% during surgery and 2 hours after by mask

Monitoring for post-op wound infections at discharge and up to 30days post-op

Eligibility criteria: Inclusion Criteria:

* Scheduled VA adult elective colorectal surgery patient

Exclusion Criteria:

* Non VA adults, emergent colorectal surgery, scheduled multiple surgery procedures,pts with other infections being treated

Primary outcomes:
measure: %/type Surgical wound infections rated per infection classifications of NNIS/CDC
timeFrame: with in 30 days post-op
Secondary outcomes:
measure: %/type surgical wound infections per classifications per NNIS/CDC
timeFrame: at hospital discharge
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
Study officials:
affiliation: ACOS for Research VANorth Tx Health Care System
name: James LePage, Ph.D
role: STUDY_CHAIR
References:
citation: Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S. Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011 Mar;146(3):263-9. doi: 10.1001/archsurg.2010.249. Epub 2010 Nov 15.
Clinical trial NCT06642584: A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation IV
Official title: A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers Type 2 Diabetes
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. The study will last for about 28 weeks. The study will enroll healthy male participants.


Eligibility criteria: Inclusion Criteria:

1. Male.
2. Age 18-64 years (both inclusive) at the time of signing the informed consent.
3. Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening.
4. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

1. Known or suspected hypersensitivity to study interventions or related products.
2. Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
3. Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days prior to first dosing.

Primary outcomes:
measure: Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve
timeFrame: From 0 to 24 hours after dosing on Days 122 and 132.
measure: Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration
timeFrame: From 0 to 24 hours after dosing on Days 122 and 132.
measure: Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration
timeFrame: From 0 to 24 hours after dosing on Days 122 and 132.
measure: t½,sema; the terminal half-life of semaglutide
timeFrame: From 0 to 840 hours after dosing on Day 132.
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Altasciences
state: Quebec
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01269684: Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients
Official title: A 6-Month Open Pilot Study to Investigate the Safety and Tolerability of Immediate Conversion From Calcineurin Inhibitor Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Kidney Transplantation
Keywords: Kidney
renal
transplantation
tacrolimus
everolimus
stable allograft recipients
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2011-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients.

Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.


Eligibility criteria: Inclusion criteria

* Primary or secondary renal transplantation in the past 12-36 months.
* Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids.
* Moderately impaired renal function

Exclusion criteria

* Multi-organ recipients or previous transplantation with an organ other than a kidney.
* Acute rejection episodes in the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Routine safety laboratory
timeFrame: At baseline
measure: Routine safety laboratory
timeFrame: Week 1
measure: Routine safety laboratory
timeFrame: Month 1
measure: Routine safety laboratory
timeFrame: Week 2
measure: Routine safety laboratory
timeFrame: Week 3
measure: Routine safety laboratory
timeFrame: Month 2
measure: Routine safety laboratory
timeFrame: Month 4
measure: Routine safety laboratory
timeFrame: Month 6
Secondary outcomes:
measure: renal function
timeFrame: At baseline
measure: renal function
timeFrame: Weeks 1, 2 and 3
measure: renal function
timeFrame: Months 1, 2, 4 and 6
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT06508684: Current Status of BTKi Treatment for CLL/SLL in China
Official title: Current Status and Influencing Factors of Chinese Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Undergoing Treatment With Bruton's Tyrosine Kinase Inhibitors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CLL/SLL
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CLL/SLL Patient who receiving BTKi treatment

Brief summary: BTKi has become the standard treatment regimen for CLL/SLL，there is a lack of large-scale real-world studies on the use status and related influencing factors of BTK inhibitors. Therefore, we plan to conduct this multicenter retrospective cross-sectional study to understand the current situation of BTK inhibitor treatment for CLL/SLL patients in China and the related influencing factors, and to explore more suitable treatment patterns based on this.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Patients with a confirmed diagnosis of CLL/SLL;
* Received BTK inhibitor treatment between February 2023 and February 2024.

Exclusion Criteria:

* Patients with other types of lymphoma;
* Cases deemed unsuitable for inclusion in this study by the investigators.

Primary outcomes:
measure: Patient characteristics of those receiving BTKi treatment
timeFrame: up to one year
Secondary outcomes:
measure: overall response rate
timeFrame: up to one year
measure: Incidence of adverse reactions
timeFrame: up to one year
Other outcomes:
Locations:
city: Nanjin
country: China
facility: Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT00233584: Pulmicort Asthma Prevention (Post-PAC)
Official title: A Study to Evaluate the Feasibility of a Treatment Algorithm in Newly Diagnosed Asthmatic Children. An Open Follow-up to Asthma Prevention in Infants/Young Children (PAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Children of asthmatic mothers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 400
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective study will evaluate the feasibility of the defined decision tree for the treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of any troublesome lower respiratory symptoms are treated according to a strictly pre-defined multi-steps treatment algorithm until the age of 6 years.


Eligibility criteria: Inclusion Criteria:

* Children form the COPSAC/PAC study with episodes of troublesome respiratory symptoms. Episodes are defined as 3 consecutive days of any troublesome lower respiratory symptoms.

Exclusion Criteria:

* Differential diagnoses including at least a chest x-ray and sweat test.

Primary outcomes:
measure: Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.
measure: Efficacy - development of lung function.
Secondary outcomes:
measure: Acceptability of the treatment algorithm by the parents.
measure: Growth rate and BMD.
measure: Exhaled nitrogen Oxide, bronchohyperresponsiveness.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Denmark Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03608384: Characteristic of Drug Users Chronic Wound
Official title: Characteristic of Drug Users Chronic Wound
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound
Drug Use
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Drug addict are mainly young man, use intravenous drug ( opioid, cocaine) and inhaled drug ( cannabis).

Brief summary: The aim of this study is to describe demographic, clinical, etiological characteristic and evolution of drug addict's chronic wounds .


Eligibility criteria: Inclusion Criteria:

* all drug addict with chronic wound ( evolving at least since 1 month)

Exclusion Criteria:

* use following medication inductor of cutaneous ulcer: hydroxycarbamide, gefitinib, cetuximab, sunitinib, sorafenib, pazopanib, gemcitabine, sirolimus, methotrexate, nicorandil .

Primary outcomes:
measure: clinical venous insufficiency - presence of oedema
timeFrame: at inclusion
Secondary outcomes:
measure: clinical venous insufficiency - presence of varicose
timeFrame: at inclusion
measure: clinical venous insufficiency - presence of white atrophy
timeFrame: at inclusion
measure: clinical venous insufficiency - presence of varicose eczema
timeFrame: at inclusion
Other outcomes:
Locations:
city: Vandoeuvre Les Nancy
country: France
facility: CHRU De Nancy
Study officials:
affiliation: CHRU Vandoeuvre-Lès-Nancy
name: Jean-Luc Schmutz
role: STUDY_DIRECTOR
References:
Clinical trial NCT03409484: Effects of Concord Grape Juice Alone on Glycemia, Appetite and Cognitive Function in Healthy Adults
Official title: Effects of Concord Grape Juice Alone on Glycemia, Appetite and Cognitive Function in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glycemic Response
Appetitive Behavior
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Welch's Food Corporation
First posted: 2018-01-24
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Assess the impact of 100% grape juice on postprandial glycemic response and subsequent appetite, food intake and cognitive function.

Detailed description: Investigators earlier clinical work and published literature suggest that the phenolic content and strong flavor intensity of 100% Concord grape juice hold potential beneficial effects on appetite and glycemia. Investigators aim to better understand the use of 100% grape juice modifies appetite and glycemia acutely and over the day using a 24 hour glucose monitor.

Eligibility criteria: Inclusion Criteria:

* BMI between 25.0-34.9 kg/m2
* Willingness to eat all test foods
* Low consumer of tea and coffee, willingness to refrain from both during the 48 hours prior to test days and on the test day.
* Fasting blood glucose below 6.1mmol/l via capillary finger-stick blood sample using a SureStep glucometer (Lifescan, Milpitas, CA)

Exclusion Criteria:

* Taking medications known to affect glycemia, lipid metabolism or appetite
* Body weight fluctuation of \>5kg in the past 3 months
* Taking vitamin or other supplements
* Smokers
* Acute or Chronic disease

Primary outcomes:
measure: Change in blood glucose over 24 hours
timeFrame: 24 hours
Secondary outcomes:
measure: Appetite
timeFrame: 24 hours
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Richard D Mattes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Coelho OGL, Alfenas RCG, Debelo H, Wightman JD, Ferruzzi MG, Mattes RD. Effects of Concord grape juice flavor intensity and phenolic compound content on glycemia, appetite and cognitive function in adults with excess body weight: a randomized double-blind crossover trial. Food Funct. 2021 Nov 15;12(22):11469-11481. doi: 10.1039/d1fo02049h.
Clinical trial NCT03912584: Study Comparing the P200TE and the P200TxE in Glaucoma Patients
Official title: Qualitative OCT Image Grading Study Comparing the P200TE and the P200TxE in Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Optos, PLC
Sponsor class: INDUSTRY
First posted: 2019-04-11
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study evaluates the image quality between two OCT devices.

Detailed description: The objective of this study is to collect OCT scans to compare the qualitative B scan images produced by the P200TxE to the P200TE device in glaucoma subjects.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects 22 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed;
* Subjects who can follow the instructions by the clinical staff at the clinical site,
* Subjects who agree to participate in the study;
* Subjects who have been diagnosed with glaucoma in the study eye as confirmed by the investigator;

Exclusion Criteria:

* Subjects unable to tolerate ophthalmic imaging;
* Subjects with ocular media not sufficiently clear to obtain acceptable OCT images;
* Subjects with any clinically significant ocular pathology except glaucoma, as determined by self-report and/or investigator assessment on the day of the study visit;
* Subjects who are not reliably tested with at least one Humphrey Field Analyzer (HFA) visual field (24-2 or 30-2, white on white) measured on the day of the study visit or within the previous year from the study visit, defined as fixation losses \> 20% or false positives \> 33%, or false negatives \> 33%;
* Subjects with history of dementia or multiple sclerosis

Primary outcomes:
measure: Qualitative B-Scan Assessment
timeFrame: 1 day (start: April 29, 2019 - completed: April 30, 2019)
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 1 day
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
References: